United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(75O8W)
May 1998
Reregistrafion
Eligibility Decision (RED)
Butralin
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United States
Environmental Protection
Agency ;
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-97-009
May 1998
.E.D. FACTS
Pesticide
Reregistration
Butralin
All pesticides sold or distributed inthe UnitedStates must be
registered by EPA, based on scientific studies showing that they can be used
without posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered before November 1, 1984, be reregistered to ensure
that they meet today's more stringent standards.
^ In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. To implement provisions
of the Food Quality Protection Act of 1996, EPA considers the special
sensitivity of infants and children to pesticides, as well as aggregate
exposure of the public to pesticide residues from all sources, and the
cumulative effects of pesticides and other compounds with common
mechanisms of toxicity. The Agency develops any mitigation measures or
regulatory controls needed to effectively reduce each pesticide's risks. EPA
then reregisters pesticides that meet the safety standard of the FQPA and can
be used without posing unreasonable risks to human health or the
environment.
Use Profile
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 2075, Butralin.
Butralin is a dinitroaniline herbicide used as a plant growth regulator
on flue-cured and air-cured tobacco. The one end use product formulation
is a ready-to-use solution. Tobacco use is considered to be a non food use.
Regulatory
Butralin was first registered as a pesticide in the U.S. in 1976. As
part of the re-registration process the Agency issued a Data Call-in (DCI)
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Human Health
Assessment
The DCI required additional data to support the turf grass uses registered at
that time. In addition, there were tolerances for food uses that were no
longer on the label. The food uses were not supported and the Agency is in
the process of revoking the tolerances.
Toxicity
In studies using laboratory animals, butralin generally has been shown
to be of low acute toxicity. It has. been placed in Toxicity Category III for
effects via the oral route of exposure and eye irritation, and Toxicity
Category IV for the dermal and inhalation routes. The carcinogenicity
classification for butralin has been not determined.
Dietary Exposure
People are not likely to be exposed to residues of butralin either
through their diet or drinking water since there are no food or feed uses and
groundwater contamination from butralin.is unlikely.
Occupational Exposure
Workers can be exposed to this pesticide during mixing/loading and
application to tobacco fields as well as from post application exposure.
EPA is generally not concerned with occupational risk if MOEs
(margins of exposures) are greater than 100. For butralin, the calculation
for intermediate term dermal risk show that MOEs are less than 100 for:
1). mixing/loading liquids for groundboom;
2). mixing/loading/applicators spraying with a backpack sprayer;
3). mixing/loading/applicators spraying with a low volume pressure
hand wand; and,
4). by jug application.
All of the above use scenarios have acceptable MOEs with the use of
chemical resistant gloves.
bther Considerations
Because butralin has no food uses the specific determinations outlined
in FQPA are not required. There are no residential uses and exposure from
drinking water is not expected.
The Agency has not made a determination whether butralin and any
other pesticide have a common mechanism of toxicity that would require a
cumulative risk assessment. For the purposes of this RED, EPA has
considered only the risks from butralin. If required, cumulative risks will
be assessed when methodologies for deterniining common mechanism of
toxicity and for performing cumulative risk assessments are finalized.
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Environmental
Assessment
Environmental Fate
For the currently registered use of butralin, the Agency typically
requires an abbreviated set of environmental fate data on hydrolysis,
metabolism, and mobility.
Based on existing data, butralin is likely to be moderately persistent to
persistent and relatively immobile in terrestrial environments. Butralin is
stable to abiotic hydrolysis arid photodegradatibn on soil. It does not exhibit
fate and transport characteristics similar to chemicals that are known to
leach to groundwater. *
Risk Mitigation
Additional Data
Required
Product Labeling
Changes Required
Ecological Effects/Risk
Calculated acute avian risks do not exceed the Level of Concern
(LOG). The acute LOG has been exceeded for small mammals such as the
meadow vole and least shrew, but the Agency is not recommending a
restricted userclassification since the actual exposure is expected to be
reduced because of the directed spray application method .to the tobacco
plant. The acute LOG to freshwater fish has not been exceeded although
they have been for freshwater invertebrates. The acute LOG for estuarine
and marine fish and shrimp have been slightly exceeded. The Agency
concludes that the overall acute impact on freshwater and terrestrial non-,
target organisms from the use of butralin on tobacco will be minimal. The
" Agency is requiring Tier 2 testing for terrestrial and,aquatic plants. The
Agency cannot determine the impact of butralin to non-target plants but it
can be assumed that the plant growth regulator will adversely affect non-
target plants if they are exposed.
The Agency is requiring the use of chemical resistant gloves and a 12
hour re-entry interval. The Agency js also establishing the nunimum
Worker Protection Standard (WPS) Personal Protective Equipment (PPE) of
coveralls, chemical-resistant gloves, shoes and socks for early re-entry. '
EPA is requiring product-specific data including product chemistry
and acute toxieity studies, and revised labeling for reregistratipn. Some
additional ecological effects and environmental fate data are being required
for confirmatory purposes.
All butralin end-use products must comply with EPA's current
pesticide product labeling requirements and the chemical resistant glove
requirement, the 12 hour restricted entry interval.,1 the early entry PPE
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requirements and the user safety recommendations below. The following
labeling changes are required.
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 protective clothing and equipment
immediately after handling this product. Wash the outside of
gloves before removing. Keep and wash protective clothing and
equipment separately from other laundry."
Regulatory The use of currently registered products containing butralin in
Conclusion accordance with changes specified in this document will not pose
unreasonable risks of adverse effects to humans or the environment.
Therefore, all uses of these products are eligible for reregistration.
Butralin products will be reregistered once the required product-
specific data, any required confirmatory generic data, product specific data,
CSFs, and revised labeling are received and accepted by EPA.
For More
Information
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for butralin 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 Information and Records Integrity
Branch, Information Resources and Services Division (7502C), Office of
Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
Electronic copies of the RED and this fact sheet are available on the
Internet. See http://www.epa.gov/oppsrrdl/REDs/.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-2419, phone 1-800-
490-9198; fax 513-489-8695.
Following the comment period, the butralin RED document also will
be available from the National Technical Information Service (NTIS), 5285
Port Royal Road, Springfield, VA 22161, phone 703-605-6000;
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For more information about JEPA' s pesticide reregistration program,
the butralin RED, or reregistration of individual products containing
butralin, please contact the Special Review and Reregistration Division
(7508W), OPP, US EPA, Washington, DC 20460, phone 703-308-8000.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms^ please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
free 1-800-858-7378, from 6:30 am to 4:30 pm Pacific Time, of 9:30 am to
7:30 pm Eastern Standard Time, seven days a week.
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UNITED STATES ENyiRONMENTAL PROTECTION AGENCY
, ' WASHINGTON, D.C. ^20460
. QEEICE OF '
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Richard J4 Often, Agent
.. , , . ... . MAY 2 1 1998
5 116 Wood Valley Dr.
Raleigh,N.C. 27613 .
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 butralin which
includes the active ingredient butralin. The enclosed Reregistration Eligibility Decision
(RED), which was approved on September 29, 1997, contains the Agency's evaluation of the
data base of these chemicals, its conclusions of the potential human health and environmental
risks of the current product uses, and its decisions and conditions under which these uses and
products will be eligible for reregistration. The RED includes the data and labeling
requirements for products for reregistration. .It may also include requirements for additional
data (generic) on the active ingredients to confirm the risk assessments.
To assist you with a proper response, read th> enclosed document Entitled "Summary
of Instructions for Responding to the RED, " This summary also refers to other enclosed
L documents which include further instructions. You must follow all instructions and submit
complete and timely responses. The first set of required responses is due 90 days from the
receipt of this letter. The second set of required responses is due 8 months from the
receipt of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.
Please note that the Food Quality Protection Act of 1996 (FQPA) became effective on
August 3, 1996, amending portions of both:pesticide law (FIFRA) and the food and drug law
(FFDCA). This RED takes into account, to the extent currently possible, the new safety
standard set by FQPA to consider aggregate risk. However, it should be noted that in
continuing to make reregistration determinations during the early stages of FQPA
implementation, EPA recognizes that it will be necessary to make decisions relating to FQPA
before the implementation process is complete. In making these early case-by-case decisions,
EPA does not intend to set broad precedents for the application of FQPA. Rather, these early
determinatiqhs will be made on a, case-by-case basis and will not bind EPA as it proceeds with
further policy development and any rulemaking that may be required.
If EPA determines, as a result of this later implementation process, that any of the
determinations described in this RED are no longer appropriate, the Agency will pursue
whatever action may be appropriate, including but not limited to reconsideration of any
portion of this RED.
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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
C.P. Moran (703) 308-8590. Address any questions on required generic data to the Special
Review and Reregistration Division representative Tom Luminello at (703) 308-8075.
Sincerely yours,
Enclosures
Sis A. Rossi, ijirector
Special Review and
Reregistration Division
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, SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1. DATA CALL-IN (DCI) OR "90-DAY RESPQNSE"--If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data are
required, a DCI letter will be enclosed listing such requirements. If both generic and
product specific data are required, a combined Generic and Product Specific DCI letter will
be enclosed describing such data. However, if you are an end-use product registrant only and
have been granted a generic data exemption (GDE) by EPA, you are being sent only the
product specific response forms (2 forms) with the RED. .Registrants responsible for generic
dataare being sent response forms for both genericand product specific data requirements (4
forms). You must submit the appropriate response forms (following the instructions
provided) within 90 days of the receipt of this RED/DCI letter; otherwise, your product
may be suspended.
2. TIME EXTENSIONS AND DATA WAIVED REQUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for time extensions for product specific data
should be submitted in the 90-day response. Requests for data waivers must be submitted as
part of the ,90^day response. All data waiver and time extension requests must be accompanied
by a full justification. All waivers and time extensions must be granted by EPA in order to go
into effect.
'-'ป.--... ' _ 't ' _ . - - , - "-.-"-,
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).
1 ' ' " -'''/. ' ' ' ' f ' '*" '
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 hi b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may, but are not
required to, delete uses which the RED says are ineligible for reregistration. For further
labeling guidance, refer to the labeling section of the EPA publication "General Information
on Applying for Registration hi the U.S., Second Edition, August 1992" (available from the
National Technical Information ^Service, publication #PB92-221811; telephone number 703-
487-4650).' '"' ,..-'.- .
c- Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure thai they meet
the Agency's acceptance criteria (attached to the DCI).
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d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 CFR ง158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR ง158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.
e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOHCE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5. WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB) .
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W. .
Washington, D.C. 20460-0001
Attn: P.P. Moran
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
Attn: C.P. Moran
6. EPA'S REVIEWSEPA 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-
mpnth submissions with a final reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
; '..";;' ';". BUTRALIN ' '' '. ' \ '
: :' ;."-. , '-'LISTS - .. .'.' ':;-:;;.-\
' :'".' : ' .. .' CASE 2075 :'.'''' ' .-'
ENVIRONMENTAL PROTECTIOI? AGENCY
OFFICE OX.TESTIC1DE PROGRAMS . .
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
B17TRALIN REREGISTRATION ELIGIBILITY DECISION TEAM ... . . ..'. .... . i
ABSTRACT.^. . .-.'-.;.'. ...^ ...... . . ... .. ;.;;.., . . . ; . ...... ; . v
L INTRODUCTIpN ... ,: . . . . ...... :./,'. ... . !.^ ..... i
IL CASE OVERVIEW . . . . . '. . ; ... . . .... ..... ... ... ...;... . . .2
A. Chemical Overview .. ^ ................................. 2
B. UseProfile . . . ... * -
-, ..' , - . . ; . T ""*-ป""ปป Kซ.ปป*-vtf1ซปB.fc7
C. 'DataRequirements .... . ..-.-> ..............". ... '. . . . ... ....... 4
D. Regulatory History . . . .................. ; . . . ; . ... .... 5
m. SCIENCE ASSESSMENT . . . .... , . . .......... ... . . . ... 5
A. Physical Chemistry Assessment. ..\. .\ ................. 5,
B. Human Health Assessment. . ..... ....... ....... . . . . . . . .... 6
1. Toxicology Assessment ./....................,....... .6
a. Acute Toxicity ................... . . . . . ...... 6
"*. ; Subchronic Toxicity . . ... ... .... . . ... . . ... . . ,-". . .6
c. Chronic Toxicity . . . . . . . .-.'-. . : . ...... .......... 10
d. Carcinogenicity . . . . . . . . . . . .... ..... ; . . ...... 10
. e. Developmental Toxicity . .... . . . ip
f- Reproductive Toxicity ... . .". ... .....; . . . . , . . . . 12
:, g. Mutagenicify : . . . ... . .... ..... k.. . . .\. . . . . ...... 13
h. Metabolism . .... . . . . . . ... . . ... ............ 15
i. Other Toxic Endpohits ... fi . . ............; . . . 15
j. Dose Response Assessment . .................... 16
k- Toxicplogical Endpoints for Risk Assessment ........ 16
2. Exposure Assessment .......................... ...17
. a. FoodSource ............................. .^ 17
b. Drinking Water Source . . . . . ...... . . . 18
Ci Occupational Exposure Assessment/Characterization Assessment
"- ;.-. ' * V ,.'.. -' \ '" .,' . ' '..' ". ' V'. ..". ''' . ' .'" : .:'. '..''^ ' ^'18 '
3. Mixer/Loader/Applicator Exposure Assessment . . . . . ... . . . . 19
a. Occupational Risk Assessment/Characterization ...;... 20
b. Additional Occupational Exposure Studies . . . . . . . .,. . . 23
4. Other Exposure and Risk Considerations ......... v ... .. 24
C. Environmental Assessment. ............................ .24
1. Ecological Toxicity Data , ... .... 4 . . , . . ...... ... . . 25
1 a. Toxicity to Terrestrial Animals . . '..: ..... . . .... . 25
b. Toxicity to Aquatic Animals ... ..... . . . . . . . . . . . . 27
. ' c- Toxicity to Plants ...... . ..;.................. 29
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2. Environmental Fate 29
a. Environmental Fate Assessment 29
b. Environmental Fate and Transport ............... 31
c. Water Resources ........ 39
3. Exposure and Risk Characterization , . 45
a. Ecological Exposure and Risk Characterization ....... 45
b. Water Resources Risk Implication for Human Health ... 50
c. Environmental Risk Characterization 51
IV. RISK MANAGEMENT AND REREGISTRATION DECISION .... 53
A. Determination of Eligibility 53
B. Determination of Eligibility Decision 54
1. Eligibility Decision . ... 54
2. Eligible and Ineligible Uses 54
C. Regulatory Position and Labeling Rationale 54
1. Tolerance Reassessment 55
2. Tolerance Revocations and Import Tolerances . 55
3. Potential Risks to Infante and Children/Aggregate Exposure
/Cumulative Effects 56
<*. Occupational Labeling Rationale/Risk Mitigation . 56
5. Endocrine Disrupter Effects 58
6. Environmental Assessment ..,". 58
7. Restricted Use Classification 58
8. Endangered Species Statement 58
V. ACTIONS REQUIRED OF REGISTRANTS .....,,.. 59
A- Manufacturing-Use Products 59
1. Additional Generic Data Requirements 59
2. Labeling Requirements for Manufacturing-Use Products 59
B. End-Use Products . 60
1. Additional Product-Specific Data Requirements . '..... 60
2. Labeling Requirements for End-Use Products . . . 60
C. Existing Stocks 62
VI. APPENDICES . . . . . . ..,..,, .....'..' 63
APPENDIX A. Table of Use Patterns Subject to Reregistration ...... 65
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 68
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Butralin .. 73
APPENDIX D. Combined Generic and Product Specific Data Call-In ... 81
Attachment 1. Butralin Data Call-In Chemical Status Sheet . . ... 103
Attachment 2. Combined Generic and Product Specific Data Call-In
Response Forms (Form A inserts) Plus Instructions
:......... ;. 105
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Attachment 3.
Attachment 4.
Attachment 5.
Attachment 6.
Generic and Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and
Instructions .......,.'......'.... . . ...... Ill
EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration . . . . .'. . ..... 124
List of All Registrants Sent this Data Call-In Notice
APPENDIX E.
,.
Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions . . .126
List of Available Related Documents ......... .... . 133
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BUTRALIN REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
Steve Jarboe
.Neil Anderson
"Ed Brandt
Biological Analysis Branch
Biological Analysis Branch
Economic Analysis Branch
Environmental Fate and Effects Risk Assessment
Renee Costello
Karen McCormack
James Hetrick
David Wells ,
Health Effects Risk Assessment
Paula Deschamp
Stan Gross
Thomas Campbell
Registration Support Risk Assessment
Daniel Kenney
AlSmith
' - ' ' ' '\ '
Risk Management '"-;
Tom Luminello
Margaret Rice
Environmental Risk Branch II
Environmental Risk Branch II
Environmental Risk Branch II
Environmental Risk Branch II
Reregistratibn Characterization and Assessment
Branch 7
Toxicology Branch II k
Occupational and Residential Exposure Branch
Fungicide-Herbicide Branch
Registration Support Branch
Reregistration Branch HI
Reregistration Branch III
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11
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ADI
AE
a.i.
ARC
CAS
,CI
CNS
CSF
DFR
DRES
DWEL
EEC
EP
EPA
FAO/WHO
FDA
FIFRA,
FFDCA
FQPA
FOB
GLC
GM
GRAS
HA
HOT
LD<,
LEL
LOG
LOD
LOEL
MATC
MGLG
mg/L
MOE
MP
MPI
MRID
GLOSSARY OF TERMS AND ABBREVIATIONS
Acceptable Daily Intake. A now defunct term for reference dose (RfD).
Acid Equivalent , ' , ' ' /
Active Ingredient ,r v* '
Anticipated Residue Contribution . -
Chemical Abstracts Service ,
Cation-" /'/".; - ' '.',;', ''._., ., ' ' - ";-"'.-.
Central Nervous System , , ' '
Confidential Statement of Formuk - :.. !
Dislodgeable Foliar Residue
Dietary Risk Evaluation System ..
Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e. drinking
water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to
occur. .; ,/".' , ''"' .' ' ' ' ' ''.-.''
Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem. . . '
End-Use Product .
U.S. Envkonmental Protection Agency, ,
Food and Agriculture Organization/World Health Organization ^_ ,
Food and Drug Administration ,' .
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act .
Food Quality Protection Act
Functional Observation Battery
Gas Liquid Chromatography
Geometric Mean, . ,,,."';' ,
Generally Recognized as Safe as Designated by FDA : .
Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur. ,
' Highest Dose Tested -
Median Lethal Concentration. A statistically derived concentration of a substance that can be
.expected to cause death in 50% of test animals.,, It is usually expressed as the weight of substance
per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50%
of the test animals when administered by the route indicated (oral, dermal, inhalation). It is
I expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
Lethal Dose-low. Lowest Dose at which lethality occurs.
Lowest Effect Level . ' ; .. '
Level of Concern
Limit of Detection ; - '' - . , -.-.''..
Lowest Observed Effect Level ,
Maximum Acceptable Toxicant Concentration
Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate^
contaminants in drinking water under the Safe Drinking Water Act. ';
Micrograms Per Gram
Micrpgrams per Liteir . ;
Milligrams Per Liter
Margin of Exposure - -
Manufacturing-Use Product
Maximum Permissible Intake " , ;
Master Record Identification (number). EPA's system of recording and tracking studies submitted.
ill
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GLOSSARY OF TERMS AND ABBREVIATIONS
N/A Not Applicable
NOEC No Observable Effect Concentration
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
Pa pascal, the pressure exerted by a force of one newton acting on an area of one square meter.
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*i The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC RedBloodCell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
RUP Restricted Use Pesticide ,
SLN Special Local Need (Registrations Under Section 24 (c) of FDRRA)
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.
WP Wettable Powder
WPS Worker Protection Standard
IV
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: ABSTRACT . ' . ; , '-''' :/: ; ','' ." .-.. . - .. . . " . ' ' ' .'
The U. S. Environmental Protection Agency (referredto as "the Agency") has completed
: its reregistration eligibility decision of the pesticide active ingredient 4-(l ,l7dmiethylethyl)-N-(l-
methylpropyl)-2,6-dinitrobenzeneamine, also known as butralin. This decision includes a
comprehensive reassessment of the required data and the use patterns of currently registered
products. On August 3, 1996, the President signed the "Food Quality Protection Act of 1996"
(FQPA) which amended the Federal Food Drug and Cosmetic Act and the Federal Insecticide,
Fungicide and Rodenticide Act. FQPA requires the Agency to consider the special sensitivity of
ปinfants and children to a pesticide, aggregate exposure to a pesticide from dietary^ drinking water
and non-occupational exposures and cumulative effects from other compounds with a common
mode of toxicity when establishing or reassessing tolerances. Butralin has no food uses. It's only
use is a plant growth regulator on tobacco to control the growth of suckers on the stalk. The
Agency does not consider tobacco a "food" use and does not establish tolerances on tobacco:
However, notwithstanding the lack of a need for a tolerance, the Agency has evaluated potential
butralin exposures from drinking water and non-occupational sources and determined that there
would be no exposure of consequence. Therefore, the only potential exposures of concern are
for handlers and post-application workers. The Agency believes inhalation risks to handlers and
post-application workers from butralin are very low, mat dermal risks to handlers can be
mitigated with chemical-resistant gloves, and that dermal risks to post-application workers can be
mitigated with a restrictedTentry interval and early-entry personal protective equipment. Based
upon available data, the Agency has also concluded that risk to freshwater and terrestrial nontarget
organisms and water resources will be minimal. Therefore, the tobacco use of butralin has been.
determined to be eligible for reregistration. Certain confirmatory! data are being required of the
registrant. . ,
The Agency has not yet made a determination regarding the common mode/mechanism
of toxicity of butralin and whether it is appropriate to consider exposure from butralin with other
compounds in order to address potential cumulative effects. However, based on the lack of food
uses, the unlikelihood of residues in drinking water, and the absence of non-occupational
exposure, the Agency believes that the contribution of butralin exposure to the exposure of other
chemicals with a common mode/mechanism of toxicity is likely tobe minimal.
' ' ' ' - ' ' . I- ' ' -" <>-''.-- " ' . - '-
There are currently tolerances for food uses of butralin listed in 40 CFR ง 180.358 which
have been removed from all butralin labels and will be proposed for revocation. These food uses
were cancelled several years ago. The ornamental grass and turf use was cancelled in March
-1997. There are no existing stocks of any butralin products other! than the currently registered
product, Tamex 3 EC, which is for tobacco use only.
Beforereregisteringthe products containing butralin, the Agency is requiring that product
specific data, confirmatory, ecological effects and environmental fate data, revised Confidential
Statements of Formula (CSF) and revised labeling be submitted within eight months of the
issuance of this document. These data include product chemistry for each registration and acute
toxicity testing. After reviewing these data and, any revised labels and finding them acceptable
in accordance with Section 3(c)(5) of FIFRA, the Agency will reregister a product
v
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I. INTRODUCHQN
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the reregistratioh of products with active ingredients registered prior to November
1,1984. There are five phases to the reregistration process. The first four phases of the process
focus on identification of data requirements to support the reregistration of an active ingredient
and the, generation and submission of data to fulfill the requirements. The fifth phase is a review
by the U.S. Environmental Protection Agency (referred to as "the Agency") of all data submitted
to support reregistration. ,
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for 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
apesticide'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. :
The Food Quality Protection Act of 1996 amends both the Federal Food, Drug, and,
Cosmetic Act (FFDCA) and FIFRA. The F,QPA amendments went into effect immediately.
Among other things, FQPA amended the FFDCA by establishing a new safety standard for the
establishment of tolerances. Although butralin has no food uses and specific determinations
outlined in FQPA aire not required for reregistration, EPA believes that consideration of available
data relating to special sensitivity of infants and children, as well as the potential for aggregate
exposures and cumulative effects is prudent for butralin and all non-food use chemicals.
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of butralin. The -document consists of six sections. Section I is the
introduction. Section II describes butralin, its uses, data requirements and regulatory history.
Section m discusses the human health and environmental assessment based on the data available :
to the Agency. Section IV presents tiie reregistration decision for butralin. Section V discusses
the reregistration requirements for butralin. Finally, Section VI is the Appendices which support
this Reregistration Eligibility Decision. Additional details concerning the Agency's review of
applicable data are available on request.
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H. CASE OVERVIEW
** '''''
A. Chemical Overview
The active ingredient butralin is covered by this Reregistration Eligibility Decision.
The product, CFPI Technical Butralin, is the technical grade active ingredient (TGAT) and
contains the active ingredient chemical butralin. There is one end use product containing
butralin.
Butralin is used as a plant grow regulator on tobacco after the tobacco is topped.
All tobacco is topped to stimulate desirable chemical and physical characteristics but also
stimulates the growth of suckers. Butralin is a contact-local systemic type of plant growth
regulator that inhibits sucker growth.
Common Name:
Chemical Name:
Butralin
4-(l, l-dimethylethyl)-N-(l-methylpropyl)
-2,6-dinitrobenzeneamine
(CAS Name)
N-sec-butyl-4-tert-buryl-2,6-dinitroaniline
(TUPAC Name)
Chemical Structure:
Butralin
Chemical Family: Dinitroaniline
CAS Registry Number: 33629-47-9
OPP Chemical Code: 106501
Empirical Formula: C14H21N3O4
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Molecular Weight:
295.34
Trade and Other Names: Technical Butralin
TamexSEC
Basic Manufacturer:
CFPI (Compagnie Francaise de Produits Industriels)
Agro SA =
B. Use Profile
;. The following is information on the currently registered tobacco use with an
overview of use sites and application methods. A more detailed table of the use
parameters of butralin on tobaccb its found in Appendix Ai >
For Butralin;
Type of Pesticide for Single Active Ingredient:
Herbicide; Plant Regulator ; ^
. " - -' . -' ".- ' -' -. ' ' '! . ' '.'" . ' - : ;" ' .'
Use Sites: Terrestrial Non-Food Crop
Tobacco
. "'. . ' - V ' ''V '... '.,-.. - ' "'''"'"'' ;-' ' ';"'';'''..'.',...'
Types/Formulations Registered:
/ Manufacturing Product
; Waxy Solid 98.8%
End Use Product ,
, Emulsifiable Concentrate 36.5%
- ' =: i. . . . ' A ; . . '
'-"' . - < '-.-'' ':' ^ ' . \ ' ' ' " "- '- '' --T.-' '
Method and Rates of Application:
. Equipment- iSprayers '
- , " ' - ,'-'. . ' ' f
Method and Rate
- Knapsack (pump) sprayer - 1.08 Ib/acre
- Jug Application - 1.08 Ib/acre
-> Handheld dripline - 3.00 Ib/acre ,\
- Motorized sprayers - 3.00 Ib/acre
Timing - Bloom. After sprayMg with contact herbicides, such as fatty
alcohols^for sucker control, butraHn is used with a systemic; herbicide such
as maleic hydrazide for continuous sucker suppression.
Use Practice Limitations: One application per growing season. There is a
twelve hour re-entry restriction following treatment. There is a preharvest interval
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of 7 days for flue-cured tobacco and 30 days for air-cured (hurley or Maryland)
tobacco.
Butralin is a plant growth regulator that provides extended control of
initiation and growth of unwanted vegetative buds in the axils of tobacco plants
after topping. If not controlled, these buds will rapidly develop Into "suckers"
which compete with the leaves for sunlight and nutrients and interfere with curing
of air-cured tobacco. The large suckers are expensive to remove by hand prior to
harvest and if not removed will result in incomplete and inconsistent curing of
marketable leaves causing reduced quality and marketability after curing.
Butralin is applied through commercial equipment by using motorized field
sprayers directing a coarse spray that runs down the stalk. It may also be applied
to individual plants by using a hand-held dropline, knapsack sprayer, or jug
application.
Butralin can be used in a crop management regime that first applies "fatty
alcohols" followed by maleic hydrazide. The fatty alcohols kill buds present on
the day of the treatment but have no effect on new buds which develop within days
after treatment. Maleic hydrazide is a systemic compound which provides longer
hormonal effects than fatty alcohols but often does not provide the season long
control of buds and suckers which tobacco growers need. By using butralin in
Sequence with fatty alcohols and/or in combination with maleic hydrazide growers
will be able to obtain season long control of sucker growth without resorting to
repeated treatments of maleic hydrazide which might result in excessive residues
of maleic hydrazide in cured tobacco leaves. Tobacco is usually moved from field
to field every year and is grown in rotation with grasses that are tilled back under
prior to planting other crops.
C. Data Requirements
There was a December 19, 1984 Data Call-In for Chronic Toxicology
studies. When the accelerated reregistration program started under the revisions
of HFRA in 1988, the Phase 2 Data Call-In was issued in 1990. In response, the
registrant requested low volume minor use waivers and noted that the turf and
ornamental grass use did not trigger most data requirements.
Data required in the Phase 3 Data Call-in of- 1991 included new or
additional product chemistry, a reduced set of ecological effects, environmental
fate, toxicology and spray drift data. During the reregistration process the tobacco
use was registered in various states and a conditional Section 3 registration was
approved in November 1996. Appendix B includes all data requirements identified
by the Agency to support reregistration.
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D. Regulatory History
Butralin was first registered in April 1973 for use on turf by Amchem
Products, Inc. Amchem Products had been issued an experimental use permit for
tobacco field testing in 1971-1973. In 1975 through 1976, preemergent uses of
butralin were registered on lima beans, cottonseed, southern peas, soybeans,and
watermelon. Amchem, Products was acquired by Union Carbide Agricultural
Products Company, Inc. in 1977 as a wholly owned subsidiary. In 1985, Union
'..',- -1 ' Carbide sold their butralin registrations to CFPI. They remain the sole registrant
for products containing butralin. An experimental use permit was* issued' October
1986 to CFPI who intended to register butralin for use in the United States. At the
time butralinhadbeen in use in tobacco production overseas. In January 1991,
. Amex Preemergence Herbicide (33688-3), the registration for the use of butralin
on lima beans, cottonseed, southern peas, soybeans, and watermelons was
-. cancelled. Weedone No Crab (33688-1), registered for use on turf and ornamental
grasses was voluntarily cancelled in March 1997, In November 1994, butralin was
registered for use, on burley tobacco in the States of North Carolina, Tennessee,
and Virginia. Use on burley tobacco in the Stateof Kentucky wasregistered in
June 1996. The use on tobacco was amended in November 1996 to add use on.
flue-cured tobacco and to allow use in any tobacco growing state. At this time>
Tamex 3-EC, is the only registered end use butralin product.
Currently, there are two active products containing butralin which are
registered under Section 3 of the Federal Insecticide, Fungicide, and Rodenticide
." : Act. They consist of one technical (manufacturing use) product containing 98.8 %
active ingredient and one emulsifiable concentrate end-use product containing
: , 36.5% active ingredient. ,
SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Butralin, the active ingredient in reregistration Case 2075, is assigned CAS
#33629-47-9and the isolated technical has the following physical and chemical properties:
melting point 59-61ฐC; vapor pressure 5.79 x 10* mm Hg at 30 C. The octanol/water
partition coefficient is Log P = 4.93. The dissociation constant and pH are not known
due to very low water solubility at 0.3 ppm. Other solubility values are:
Solvent
Methanol , ' ' /
Ethanol
Isopropanol
Benzene
Ethylene.dichloride
Acetone
Water ;
Solubility (grams/lOOg)
9.8
7.S ,"-'
. 8.4
270.0
146.0 ,
448.0
0.3 ppm
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The product identity and composition data requirements for the reregistration of
the isolated technical ingredient for guideline series 61 were satisfied by MRIDs 40979802
and 41225203. The analysis and certification of product ingredients data requirements for
guideline series 62 were satisfied by MRIDs 40979801 and 41225202. The physical and
chemical characteristics data requirements for guideline series 63-2 through 63-13 were
satisfied by MRIDs 40979801, 41225201, 41225202, 41784101 and 42616401. The
additional data requirements 63-14, 63-15, 63-16, 63-17, 63-18, 63-19, 63-20 and 63-21
will be satisfied by the submission of acceptable product specific data being called in as
part of this RED.
B. Human Health Assessment
1. Toxicology Assessment
The toxicology studies reviewed in this human health risk assessment satisfy
established guideline requirements for a non-food use pesticide. The butralin
toxicology database requirements are satisfied.
a. Acute Toxicity
Table 1; Acute Toxicity of Butralin TGAI
l-Stady
H 1,1 , t
GLN 81-1
MRID 42112701
GLN 81-2
MRID 42660701
GLN 81-3
MRID 42488201
GLN 81-4
MRID 42488201
GLN 81-5
MRID 42020702
GLN 81-6
MRID 42660601
KesปJte \ ;,'""""- - *\ ,'/',, i '*""'*' -"'"' '
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Sprague-Pawley rats (5/sex/dose) at dose levels of 0, 2, 10, 50, 250
mg/kg/day for 4 weeks. ; , _
No deaths occurred in any of the experimental groups studied.
Butralin stained the urine and tissues in the 50 and 250 mg/kg/day dose
group animals. Body, weights of the high dose animals were reduced by
22-26%, a difference which is not statistically significant from control
animal data. Clinical chemistries, hematology or urinalyses were not
carried Out. At necropsy, the yellow staining by butralin was seen in the
subcutaneous and fatty tissue of the 50 and 250 mg/kg/day dosage group
animals. Centrilobular hypertrophy was seen in the high dose group males
(3/5) and females (4/5). Based on these results in the range-finding study,
a dosing level of 200 mg/kg/day was chosen for the top dose in the 13
week feeding study.
GLN 82-la: 'in a 90-day ;subchronic feeding study (MRID
43652701), butralin technical (99% a.i.) was administered to Sprague-
Dawley rats (10/sex/dose) in the diet at dose levels of 0 (Gl), 10 (G2), 50
, (G3) and 200 (G4) mg/kg/day for 13 weeks. Ten additional
anirnals/sex/dose group from the control and high dose groups were carried
for 4 weeks beyond the 13 week exposure period as recovery test groups.
'Estimated actual dosages to 10.3 mg/kg/day for low-dose animus-'.
51 mg/kg/day for mid-dose animals; and 202 mg/kg/day for the high-dose
animals. There were no mortalities or toxic signs in any of the test
animals. Animals in all of the butralin treated groups displayed.yellow
coloring in the urine and in fat and various tissues at necropsy. The
yellow coloring was due to the color of butralin and decreased in the
recovery period, persisting only in the high-dose group by the end of the
recovery period. Body weight reductions were observed in high-dose
males (-17%) and females (-23%) and -14% in mid-dose males. Food
consumption was also reduced: -11 % for high-dose males* -7 % for high-
dpse females and -9% for.mid-dose males. During the recovery period, the
high-dose animals gained weight faster than the control animals while
consuming about the same amount of food during this 4 week period.
There was no effect on water intake which was estimated visually "
There were statisticaUy significant alterations in several clinical
chemistry values seen primarily in high-dose males and females as
statistically significant changes and often as similar changes in mid-dose
animals without achieving statistical significance. The following clinical
chemistrychanges were statistically significant (with p ranging from
<0.05 to 0.001): Gamma glutamyrtransferase (GOT) was elevated by
+100% in mid-dose females and +200% in high-dose females. The GGT
-------
elevations reverted to normal by the end of the 4 week recovery period.
Total protein and albumin was elevated in high-dose females (+12%) and
males (+8%) and also low-dose males (+3%) and males (+6%). Urea
was decreased in mid-dose males (-10%) and high-dose males (-13%).
Aspartate amino transaminase was decreased in the high dose males (-28%)
and mid-dose females (-24%) and males (-24%). Alanine amino
transaminase was decreased in females of the low-dose group (-20%), in
mid-dose group females (-27%) and in females of the high-dose group (-
40%). Total bilirubin was increased in the high-dose females (+66%) and
was also elevated after the recovery period. Calcium was increased hi the
high-dose females (+6%). Glucose was decreased in the high-dose females
(-14%).
\
liver weights were elevated in the mid-dose males (+40%), in the
mid-dose females (+11%) and m the high-dose females (+39%). The
liver weight elevation persisted only in the high-dose females (+14%) at
the end of the 4 week recovery period. Centrilobular hypertrophy of the
liver increased from 1/10 in the control males to 3/10, 6/10 and 9/10 in the
low-, mid- to high-dose males, respectively, achieving statistical
significance only in the high-dose group. Eight of 10 males and 9/10
females in the high-dose group had normal thyroids by the end of the
recovery period. Control animals 2/10 males and 2/10 females exhibited
minimal hyperplasia (grade +\-) of the thyroid as did 1/10 high dose
females by the end of the recovery period (week 17). Other organ weight
changes were statistically significant in the adrenals, heart, kidney, and
spleen but occurred as isolated findings without corresponding
morphological changes.
Many of the toxic signs seen in the high dose animals at the end of
the 13 week treatment period were reversed or tended toward reversal by
the end of the 4 week recovery period. These included changes in body
weight, hematology, clinical chemistry, organ weight changes and
histopathology. ,
The NOEL for this study was 10 mg/kg/day. The LOEL was the
50 mg/kg/day based on body weight and food consumption reductions;
reduced RBCs, Ht and Hb; and alterations in liver and thyroid organ
weights. .
GLN 82-2. In a 21-day rabbit dermal toxicity study (MRID
40419601), butralin technical (95% a.i.) was administered topically to the
clipped dorsal trunk and flanks (intact skin) of New Zealand White rabbits
(5/sex/dose) as granular material applied wet (distilled water) to the skin
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at daily dose levels of 0 and 1000 mg/kg/day for 5 days/week for a 3-week
period.
The only clinical sign observed was yellow/orange staining of the
treatment site. There were no signs of toxicity or effects on body weights'
or food: consumption. Hematolpgy, urine analysis, macroscopic pathology
and histology, and organ weights were considered to be unremarkable.
Adrenal glands of treated males and females were somewhat enlarged,
however there were no morphological changes noted.
The.NOEL was considered to be greater than 1000 mg/kg/day, Ihe
limit dose. This 21-day dermal toxicity study is classified acceptable and
does satisfy the guideline requirement for a 21-day dermal toxicity.study
in the rabbit.
GLN 82-4* A subehronic 13 Week inhalation toxiciiy study was
conducted (MR1D 42633601,-03) using butralin in Solvarex 90/18,0, a
proprietary solvent, the study data were submitted to fulfill the 90 day
subehronic inhalation toxicity data requirement. The use of "Solvarex" in
the administered butralin dose,, when considered along with the strong
presence of histopatiiolpgical changes in both the test and vehicle control
test animals, resulted in the study being initially classified as "inadequate".
The registrant submitted additional test data for the 90-day subehronic
inhalation toxicity study which resolved concerns related to the use of
Solvarex to "aerosolize" butralin in the administered dose. The study was
upgraded to "acceptable".
In the submitted study (MRID 42633601), butralin was administered
by the hose-only inhalation route to male and female Fischer F-344 rats (10
animals/sex/group) at concentrations of 0.3, 1.0 and 3.0 mg/L for 6
hours/day, 5 days/week for 13 weeks. Air and vehicle control groups were
included. :
The animals were restrained in cylindrical tubes with their heads
protruding through head ports into a 360 ml flat polycarbonate cylinder
exposure chamber: A collision nebulizer was used to generate the test
atmospheres which were directed into the exposure chamber. Technical
butralin (99.6% a.i.) was dissolved in the Solvarex 90/180/' at a
concentration of 363 grams butralin/liter of solvent. Analytical exposure
concentrations in the chamber were derived from gravimetric filter samples
which were analyzed for butralin. The exposure particle sizes ranged
from 2.81 to 3.41 micrometers, slightly exceeding .the acceptable range of
1-3 micrometers for subehronic studies.
9
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There were no deaths resulting from the administration of the test
agent. All animals treated with butralin developed yellow fur. Body
weight differences from air control groups were seen only in the high dose
animals (male and female) and in the vehicle control animals (male and
female). Significant differences from air control animals were seen in all
for animals in the vehicle controls and all of the butralin treated animals.
These changes included: hematology parameters (primarily related to
RBCs (red blood cell counts)); several blood chemistry parameters (calcium
(Ca), phosphorous (P), alkaline phosphatase (ALP) and glucose (GLU));
organ weights changes (liver, kidney, adrenal and testes); and a variety of
histopathologic findings. The lesions which appeared dose related included
respiratory epithelium hyperplasia, nasal pharyngeal duct goblet cell
hyperplasia, nasal submucosal edema; liver hepatocyte hypertrophy and
cytoplasmic alteration; renal tubular epithelium cytoplasmic droplets; and
trachea! hyperplasia. Much of the histopathological changes were seen
strongly represented in the vehicle controls and dose related in the butralin
treated groups. The NOEL = 0.3 mg/L and the LOEL =1.0 mg/L based
on histopathological effects in the nasal passages, on hematological, clinical
chemistry, and histopathology (much of which was based on the respiratory
system, the liver and kidney).
c. Chronic Toxicity
Based on the current use pattern of butralin, chronic toxicity data
are not required. If in the future additional butralin uses are requested, the
Agency may require additional studies.
d. Carcinogenicity
The Agency determined that data were insufficient to evaluate the
carcinogenic potential of butralin. Because butralin is a non-food use
chemical, chronic data to determine its carcinogenic potential are not
required.
e. Developmental Toxicity /
GLN 83-3a. In a rat developmental toxicity study (MRIDs
40419603, 42156101, -02 and -03) butralin (96% a.i.) was administered by
gavage at 0, 500, 1250 or 2000 mg/kg/day. Maternal toxicity was
demonstrated by a statistically significant decrease in body weight and body
weight gain at the mid-dose tested (MDT) and high dose tested (HDT).
Food consumption and relative efficiency of food utilization was depressed
at these same dose levels. Mortality occurred in 2 dams at the HDT.
Maternal toxicity was also demonstrated by the 2 and 4 dams aborting at
10
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the MDf and HDT, respectively. In addition, vaginal bleeding occurred
in 4 and 6 dams at me MDT and the HDT respectively. Maternal toxicity
was less clear at the low dose tested (LDT) were statistically significant
decreases occurred in food consumption and nominally, m relative
efficiency of food utilization. The maternal toxicity LOEL = 500
mg/kg/day (LDT); a maternal toxicity NOEL was not established.
Malformations were slightly elevated at the MDT and HDT, such
as incomplete ossification of the palate and presphenoidal bone, absent
sacral vertebrae, and dilated brain ventricles. Statisticakanalyses03 and 41742003) was
carried out at 0 and 50 mg/kg/day in order to establish a NOEL for the
above study. The developmental ,and maternal NOEL was 50 mg/kg/day;
the LOELs for these parameters were greater than 50 mg/kg/day, the only
treatment level used. Data from the two studies combined satisfy the
guideline requirement for a rat developmental toxicity study.
GLN 83-3b. In a rabbit developmental study (MRIDs 40419601,
41742002 and 42156104) rabbits were administered butralin (97% a.i.) at
0, 8.2,2714, or 128 mg/kg/day. The study demonstrated maternal toxicity
in the form of decreased body weight aiid decreased body weight gain^
decreased food consumption and decreased deficiency of food utilization.
The maternal toxicity NOEL = 8-2 mg/kg/day; the maternal toxicity
LOEL = 27.4 mg/kg/day. Fetal toxicity was demonstrated at the MDT
and HDT in the form of slight but probable dose related increases! in 5
major defects: enlarged fontanelles, one heart defect, a malrotated hind
limb, arthrogryppsis (major and minor) and scoliosis. The major heart
defect was seen' in one pup in one litter at the highest dose group. In
addition, a probable dose related and compound-related increase was
observed in 1) atrium/atria increased size, 2) incomplete closure of
abdominal muscular layer, 3) parietals incompletely ossified, 4) spatulate
ribs, 5) kinked ribs, 6) fused sternebrae,, 7) other anomalies in the
ossification of sternebrae, and 8) incompletely/not ossified metacarpals,
forelimb phalanges and hindlimbs phalanges. The incidence of these eight
11
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(8) anomalies in fetuses of this study were each higher than historical
control data submitted with the study. When these major defects and minor
anomalies are considered together, a pattern of increased effects and
toxicity appear at the MDT and HDT. The developmental NOEL = 8.2
mg/kg/day; the developmental LOEL = 27.4 mg/kg/day. The study is
acceptable.
In the prenatal developmental toxicity study in rats, developmental
toxicity (delays or absence in ossification of sternebrae, absence of
ossification in thoracic vertebral centra and caudal vertebral arches) was
observed in the presence of significant maternal toxicity (increased
mortality, abortions, and vaginal bleeding; decreases in body weight gain
and food consumption). In contrast, in the rabbit prenatal developmental
toxicity study, developmental toxicity (enlarged heart, malrotated hindlimb,
and scoliosis) occurred in the mid- and high-dose groups (27.4 and 128
mg/kg/day) in the absence of significant maternal toxicity (decreased body
weight and decreased body weight gain).
Based on the results of these studies, the possibility of increased
prenatal sensitivity to.butralin cannot be ruled out. However, we have no
concerns regarding infants* or children's risk to butralin for the following
reasons: (1) the registration for turf use was canceled March 1997 so there
should be no exposure of infants or children to butralin; (2) MOEs for all
butralin use scenarios for which data are available are extremely high
indicating that exposures for children would not be of concern; (3) there is
no toxicity endpoint for short-term (1-7 day) exposure; further, there
would be no intermediate term (one week to several months) exposure
scenario for children; since there is no infant's or children's exposure
scenario for which a toxicity endpoint has been identified, significant risk
to infants and children is unlikely; (4) there was no evidence of increased
prenatal or postnatal sensitivity in either the developmental toxicity or the
three-generation reproductive toxicity study hi rats; and, (5) exposures.,
should they occur, would be of a dermal nature, whereas in the
developmental toxicity study of concern, butralin was administered to the
maternal rabbits by gavage. ,. '
f. Reproductive Toxicity
Reproductive toxicity data have not been required to support the
reregistration of the non-food uses of butralin. In a preliminary Agency
review of a three-generation reproduction study in rats (MRIDs 92014039
and d0154259), toxicity in the offspring (decreased pup survival during the
lactation period, in association with decreased mean pup weights) was
observed in the presence of parental toxicity (decreased body weight) in all
three generations at the HDT (1000 ppm; 50 mg/kg/day). The NOELs for
the parental rats and their offspring appear to be equivalent (6 mg/kg/day).
i r ,' Jl ' ' ',
12' " ' " .' ' ' , '
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g. Mutagenicity , ,
GLN 84-2. The mutagenicity data evaluation concluded .that
butralin exhibits mutagenic activity in the in vitro studies conducted,
Butralin is structurally related to trifluralin, a known carcinogen (see NTP
Technical Report No. 34, 1977 ; EPA Peer Review, 1986, Doc. No.
005578/007362). ,Trifluralin exhibits a mutagenic profile in the Ames test
(pre-incubation modification) that is similar to butralin (i.e., positive in S.
typhimurium strain TA 100 only in the presence of S9 activation and only
at high precipitating doses). With the exception of the positiveปresults for
butralin in the mouse lymphoma assay, the overall genetic toxicology
profUe for the two compounds is similar.
The following studies satisfy guideline requirements (GLN 84-2) for
gene mutations: ฐ
>'""'''' ;
Gene Mutations
Salmonella typhimiirium reverse gene mutation assay (MRID 40121101):
Eight concentrations of butralin (1.0 to 10,000 ^tig/plate) were evaluated in
two independent Sahnonella typhimurium microsome mutagenicity assays.
Results indicated that at highprecipitating concentrations (5000 and 10,000
jug/plate), the test material induced reproducible and dose-related increases
(1.8 to 2.0- and 2,2 to 2.4-fold, respectively), in revertant colonies of S.
typhimurium TA100 in the presence of S9 activation; It was therefore
concluded that butralin was mutagenic in thjs,test system. The study is
acceptable. -
Mouse lymphoma L5178Y TK*'" forward gene mutation assay (MRID
40121102): Butralin was assayed over a concentration range of 7.5 to 50
/ig/mL without S9 activation and at doses ranghtg from 7.5 to 60 /zg/mL
with S9 activation in independent mouse lymphoma forward mutation
assays. Without S9 activation, increased mutant colonies and mutation
frequencies (MFs) were seen at 40, 45 and 50 y^g/mL; cell survival at these
levels was 23.2, 7.7, and 6.5%, respectively. In the presence of S9
.activation, mutagenic activity was confined to the highest dose; however,
less than 10% of the cells survived treatment. Based on the
reproduceability of the results, the increased MFs, which were.
accompanied by increased mutant colony counts, and the evidence of a
dose-related effect under non-activated conditions, it was concluded that
butralin is mutagenic in this test system; metabolic activation was not
required. The study is acceptable. ' \ ..
Chinese hamster ovary (CHO) cell HGPRT gene mutation assay (MRID
40551909): Butralin was negative in the Chinese Hamster ovary (CHO)
' : - . " 1-3 . ' , ''-. -. " -'''.''
-------
cell HGPLT gene mutation assay with and without S9 activation at up to
cytotoxic concentrations. The compound was insoluble at concentrations
to or greater than 100 /fg/mL without S9, and equal or greater near 70
/jg/mL with S9. The study is acceptable. v
Chromosome Aberrations
In vitro CHO cell chromosome aberration assay (MRID 40551910): Under
the conditions of this assay, four doses of butralin ranging from 25 to 1000
/zg/mL with or without S9 activation did not induce a clastogenic response
in the chromosomes of Chinese hamster ovary (CHO) cells harvested 20
hours after nonactivated dosing or 10 hours after treatment in the presence
of metabolic activation, The test material was assayed up to an acceptable
cytotoxic dose (100 jwg/mL), which approached the limit of solubility (100
/ig/mL/-S9; 75 /zg/mL/+S9), with no clastogenic effect. The study is
acceptable and satisfies guideline requirements (GLN 84-2) for
chromosome aberrations.
GLN 84-4. Other Mutagenic Mechanisms
In vitro unscheduled DNA synthesis in primary rat hepatocytes (MRID
40350901): Primary rat hepatocytes from Fischer 344 males were exposed
for 18 hours to butralin in DMSO (94.5% a.i.) at 10 concentrations
ranging from 0.5 to 150 fj-g/noL. The HDT proved to be lethal;
precipitation was evident at 25 ^g/mL and above. There was no evidence
of induced DNA repair (as determined by net nuclear silver grain counts,
which measures unscheduled DNfA synthesis) at any dosage up to 75.1
/jg/mL, a severely toxic (6.6% relative survival) dose. The positive
control (2-AAF) responded appropriately. The study is acceptable.
In vitro CHO cell sister chromatid exchange assay (SCE) (MRID
40121103): Under conditions of two independent sister chromatid
exchange (SCE) assays, butralin over a concentration range of 2.5 to 30
//g/mL without S9 activation and 5 to 80 /*g/mL with S9 activation did not
induce a reproducible increase in the SCE frequency of Chinese hamster
ovary (CHO) cells. The test material did, however, induce severe mitotic
suppression, and prolonged cell harvests were required for high test doses.
Although significant (p<0.05) increases in the SCE frequency were seen
in the initial assay (highest nonactivated and S9-activated doses), the
response occurred at severely cytotoxic doses, was not reproducible, and
did not show a dose-response relationship. It was therefore concluded that
butralin was assayed to levels inducing cytotoxicity with no genotoxic
effects.
These studies satisfy the guideline requirements (GLN 84-4) for
other genotoxic effects.
14
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Other Studies: An unclassified mouse dominant lethal assay (MRID
00078460) is listed in the one-liners as negative up to 1000 mg/kg/day
(HDT); no further information was available, i
h.
Metabolism
1 GLN 85-1. In a metabolism study (MRID 42743201), rats were
dosed by gavage with butralin (ring labeled) in corn oil at 8 mg/kg/day
(low dose levels) for single and multiple dosing and; biliary excretion
studies and at 800 mg/kg/day (high dose single dosing) and the distribution
and excretion of butralin followed over a 7 day period. Low dose results
indicate that about 100 percent of the dosed material was excreted in about
2 days, with 55 to 60% excreted in the feces and 35-45% in urine. The
feces contained about 10% unmetabolized butralin. The excretory half life
was about 12. hours. Tissues retained only about 1% of the labeled
butralin. A similar excretion pattern 'Was seen in the repeat low dose
' ' ' ' " '' ' ' '
High dose administration of butralin took 5-7 days to achieve 100%
excretion of butralin in the urine and feces. The excretory half life was
between 2 and 4 days. Of the various tissues, fat and liver tended to retain
more butralin residues. Females excreted the butralin residues more slowly
than males and retained more metabolite in the tissue (especially the liver
and fat).. '. -'''.-.-.'
' In abile excretion study using low dose levels (8 mg butralin/kg),
enterohepatic circulation was determined to be a primary pathway for
butralin excretion and metabolism. Twelve butralin metabolites were
identified in pooled urine, feces and/or bile samples. Metabolites identified
at concentrations of 5% to 10% of the administered dose were: 2-methyl-
/5(6)[l-(l-carboxy-l-methyl)ethyl3-7(4)-nitrobenzimidazole, 2-methyl-
5(6)[2-(l-hydroxy-2-methyl)propyl]-7(4)-nitrobeiizimidazole, 2-methyl-2(4-
amino-3,5-dinitrophenyl)propionic acid arid 2-methyl-2(4-amino-3,5-
dinitrdphenyl)propanol-glucutonide. Butralin, the parent chemical, was
present at 10% of the administered dose. There were no metabolites at
concentrations greater than 10% of the, administered dose identified in the
study. The Agency determined the stjidy satisfies the guideline requirement
for a metabolism study in rats.
. - ' i ' ' ''.','.
L Other Toxic Endpoints ''.-,,
. ' ' '*,'' ' ' . . '
Neurotoxicity
Neurotoxicity studies were not required or evaluated in this risk
assessment.
15
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Incident Data
No information is available on incidents related to the use of
butralin from any of the available databases reviewed.
Potential Risks to Infants and Children
Butralin is not registered for food uses nor is it available for use in
the residential setting.
j. Dose Response Assessment
Reference Dose , '
A Reference Dose (RfD) for butralin is not warranted for the
current non-food use pattern of this pesticide. However, if the use pattern
and/or registrations change exposure to butralin an RfD determination may
be required (RfD Peer Review Committee, September 1996).
Carcinogenicity Classification
A carcinogenicity classification was not determined due to
insufficient data to evaluate the carcinogenic potential of butralin (RfD Peer
Review Committee, September 1996).
k. . lexicological Endpoints for Risk Assessment
f '
In July 1996 the Toxicological Endpqint Selection Committee met
and established endpoints for use in acute dietary and worker risk
assessments. The conclusions of the committee are summarized in Table
2 below.
Table 2; Toxicological Endpoints for Butralin
fypwd^itfatwaof , "w
Exposore'
Acute Dietary
Short Term Occupational
Exposure (1 to 7 days)
Intermediate Term
Occupational Exposure
(1 week to several months)
Any Exposure Duration
Tfe^^^B^^t^'^l^t-/'''''^/'5'^ <<" "' ''*""'**]
None. An acute dietary risk assessment is not required since butralin is a
non-food-use chemical.
A short-term risk assessment is not required; no systemic toxicity was
observed at 1000 mg/kg/day in a 21-day dermal rat study.
10 mg/kg/day NOEL based on decreased body weight and food
consumption, alterations in hematology and clinical chemistry seen at 50
mg/kg/day LOEL in a 13-week rat feeding study. A dermal absorption
value of 5% should be used for route-to-route extrapolation.
0.3 mg/L NOEL (80.2 mg/kg/day) based on histopathological effects in
nasal passages seen at 1.0 mg/L LOEL in a 90-day rat inhalation study.
-HSoateftf .
J^OSBtfc'
Oral
Dermal
Dermal
Inhalation
16
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2.
Dermal Absorption
A dermal absorption study was not available, A dermal absorption
value of 5% was calculated based on the route-to-route extrapolation using
the maternal NOEL of 45 mg/kg/day from the developmental toxicity study
in rabbits and the systemic NOEL of 1000 mg/kg/day from the 21-day
dermal toxicity study in rabbits. The calculated value of 5% for butralin
is comparable to the 1 % dermal absorption value estimated for trifluralin,
a compound structurally similar to butralin. This dermal absorption value
will be used for intermediate-term risk assessment smceord studies were
selected for this exposure scenario. _ '
A short term (1-7 days) occupational dermal exposure endpoint of
toxicological concern was not established. The intermediate term (1 week
to several months) occupational dermal exposure endpoint is a NOEL of 10
mg/kg/day observed in a 90-day subchronic rat feeding study. A risk
assessment of intermediate term dermal exposure is required.
Inhalation
Based on the physical/chemical properties of butralin (e.g.low
volatility) and the formulation/application methods (e.g. no exceptionally
high applicator exposure such as from air blast applications), the Agency
would not anticipate any mixer/loader/applicator concerns. However, the
Agency' s database does contain a 90-day rat inhalation study which was
evaluated as part of the reregistration prpcess. These data show, as one
would expect, that margins of exposure are very high. Inhalation MOEs
are in the tens of thousands for all mixer/loader/applicator scenarios.
, Based on the tobacco use pattern chronic worker exposure (several
months-lifetime) is not expected to occur. The Agency has determined that
a risk assessment for chronic occupational exposure is not required at this
time.- -:'.' ' : . . , ;.:. ;' -'- "
Exposure Assessment
a. Food Source
The currently registered tobacco use of butralin does not result in
dietary exposure. Tobacco is never fed to cattle, goats, pigs or iny known
rurninants since the tobacco is unpalatable and the nicotine in tobacco
makes the animals sick. ,
17
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b. Drinking Water Source
Ground Water: Butralin is persistent but relatively immobile in terrestrial
environments. Based upon qualitative leaching index and mobility studies,
butralin is not expected to leach into ground water.
Surface Water: Butralin detections were not reported in STORET. Based
on the Tier I GENEEC EEC, the peak EEC for butralin is 16.89 /zg/L-
A more reliable surface water characterization will be determined when
additional batch equilibrium data are received and evaluated. Neither a
maximum contamination level (MCL) nor Lifetime Health Advisory Level
(HAL) has been established for butralin. The Agency believes foliar
interception and subsequent foliar dissipation processes will affect the
magnitude of butralin residues available for surface water runoff. Butralin
residues that are oversprayed or washed off from the treated plants are
likely to be the only butralin residues available for runoff into surface
waters.
Considering the limited potential for butralin residues in ground and
surface water, butralin drinking water contamination is not expected to be
a dietary risk concern.
c. Occupational Exposure Assessment/Characterization Assessment
Handler Exposures & Assumptions
The Agency has determined there are potential exposures to mixers,
loaders, applicators, and other handlers during usual use-patterns associated
with butralin. Based on the current registered use patterns five (5) major
exposure scenarios were identified for butralin:
(1) mixing/loading liquids for groundboqm application.
(2) applying sprays with groundboom equipment.
(3) mixing/loading/applying liquids with a backpack sprayer.
(4) mixing/loading/applying liquids with a low-pressure handwand.
(5) jug application of liquids.
; " "' :, ' I" ' ' '' '''',"','-
Post Application Exposure & Assumptions
Occupational: The Agency has determined that there is an exposure
potential for persons entering treated sites after application is complete.
Workers may be entering treated tobacco areas to perform hand-suckering
(hand-labor task) as a supplement to the chemical-suckering treatment.
There are no chemical-specific data available upon which to assess the risks
from post-application exposures.
18
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3. Mixer/Loader/Applicator Exposure Assessment
Potential daily exposure is calculated using the following formula:
Daily Exposure ( SSL#\ i Unit 'Exposure f
{Day},, \
xMax. Appl. Rate ( 1ฑ*\ x Max. Area Treated {
(Acre) ' \ Day
'
The calculations of daily exposure to butralin by handlers are used to
calculate the daily dose'to those handlers. Intermediate4erm dermal and short- and
intermediate-term inhalation exposure assessments using PHED Version 1.1
surrogate data are presented in Table 3. '> No chemical-specific data, were
- submitted. , ; : V
TakkSr fate^
*, t ''?
IM&
Mixer/Loader Exposure Estimates
Mixing/Loading Liquids for
Groundboom Application (1)
2.9
1.2
3.0
80
696
0.29
Applicator Exposure Estimates
Groundboom Application (2)
0.015
0.7
3.0
80
3.6
0.17
Mixer/Loader/Applicator Exposure Estimates
Bac]q)ack Sprayer(3)
No data ,
(see additional
PPE)
30.2
3.0
No data (see
additional
PPE)
0.09
Low Pressure Handwand (4)
103.8
31.2
3.0
.311
0.09
Scenario (4) also represents jug application method.
No data means no data are available for hand exposure.. -
1 Baseline dermal unit exposure represents long pants, long sleeve shirt, no gloves, open mixing/loading, open cockpit,
open cab tractor. ' ' . . . ..'
* Baseline inhalation exposure represents no respirator.
c Application rates are maximum values found on butralin label [EPA Reg. No.t 33688-4].
d Daily acres treated values are from EPA OREB estimates of acreage that could be treated in a single day for each
exposure scenario of concern. ,, , ' / .';' ; .
e Daily dermal exposure (mg/day) = Exposure (mg/lb a.i.) * Appl. rate (lb a;i./A) * Acres Treated.,
f Daily inhalation exposure (mg/day) = Exposure 0/g/lb a.i.) * (lmg/1000 ^conversion * Appl. Rate (lb a.i./A)
* Acres Treated -_,'.' ' ; ',
19
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a. Occupational Risk Assessment/Characterization
Risk from Dermal and Inhalation Exposures
Dermal: The daily dermal dose is calculated using a 70 kg body weight in
the following formula:
Dotty Dermal Dose fCTgaiM = Daily Dermal Erasure (
*
( Day }
{ Day J \ Body Weight |
x 5% dermal absorption
These calculations of daily dermal dose of butralin received by handlers are
used to assess the dermal risk to those handlers. The intermediate-term dermal
MOEs were calculated using a NOEL of 10 mg/kg/day in the following formula:
MOE =
day }
Daily Dermal Dose \ mg/kg}
( day }
. Inhalation: The daily inhalation dose is calculated using a 70 kg body
weight in the following formula:
DaOy Inhalation Dose fmga//M = Daily Inhalation Exposure (ฃJLฃ\ x {
{ Day J ( Day ) \
Body Weight (kg))
These calculations of daily inhalation dose of butralin received by handlers
are used to assess the inhalation risk to those handlers. The inhalation MOEs were
calculated using a NOEL of 80.2 mg/kg/day in the following formula:
NOEL
MOE =
(mglkg\
( day
Daily Inhalation Dose [
\ day )
Table 4 presents the risk assessment for intermediate-term dermal and
short- and intermediate-term inhalation exposures. The caveats and parameters
specific to each exposure scenario and corresponding risk assessment are
summarized in Table 5.
20
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I^I-^IQ^! ii I
3-2E3~^* '^ ปH
o2;j| g W "Bb'^2-ซ2'- *
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Ifljiili!"
ง!ง< ง .-ป.^2 8
-------
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II II II
-------
Estimated Risk From Handler Exposures
Dermal: The calculations of intermediate-terni dermal risk indicate that the MOEs
-ate more than 100 at baseline for the spray application with a groundboom sprayer
scenario. : -; , , '.'.",'"' ':. v. . .' ' '
The calculations of intermediate-term dermal risk indicate that the MOEs are more
than 100 with the addition of chemical-resistant gloves to baseline attire for the
following scenarios:
* (1) mixing/loading liquids for groundboom application;
(2) mixing/loading/applying sprays with a backpack sprayer; and,
(3) mixing/loading/applying sprays with a low pressure handwand.
Jug application is represented by scenario (3).
Inhalation: The calculations of short-term and intermediate-term inhalation risk
indicate that the MOEs are more than 100 at baseline for all scenarios.
'' ' * " . ' - \
Risk From Post-Application Exposures A
Occupational: Based on relatively low dermal tpxicity, EPA concludes that risk
due to post-application exposure^ fpllqwing applications of the liquid formulation
to tobacco would be minimal, provided entry does not occur immediately following
applications. The Agency ttbtes that label directions indicate that hand-suekering
of any suckers that escaped treatment should occur two to three weeks after
treatment and that this product should be applied at least 30 days before anticipated
harvest dates. .
b. Additional Occupational Exposure Studies
Handler Studies
Based on the risk assessment of the current uses of butralin, handler
.exppsure studies are not required at this time.
i . .' --'- ^ . .;'.'' - . ' i. - '- .
Post-Application Studies
Based on the risk assessment of .the current uses of butralin, post-
application exposure studies are not required at this time.
23
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4. 'Other Exposure and Risk Considerations
The Food Quality Protection Act of 1996 amends both FFDCA and FIFRA by
setting a new safely standard for the establishment of tolerances. In determining whether
or not a tolerance meets the new safely standard, FQPA directs EPA to consider
information concerning: the susceptibility of infants and children to residues of the
pesticide in food; the potential for aggregate exposure from dietary as well as non-
occupational sources, such as pesticides used in and around the home; and the potential
for cumulative effects from a pesticide and other substances that have a common
mechanism of toxicity.
Because the use of butralin on tobacco is not a food use and no tolerance has been
established, the specific determinations outlined in FQPA are not required for this
chemical. However, EPA also believes that for non-food chemicals it should evaluate
available data relating to the special sensitivity of infants and children, as well as the
potential for aggregate exposures and cumulative effects if infants, children or the general
population may be exposed from drinking water or non-occupational uses. The tobacco
use of butralin does not result in any drinking water or non-occupational exposure.
Therefore, there is no need to consider an additional uncertainty (safety) factor nor
conduct an aggregate exposure/risk assessment.
With regard to cumulative risk, butralin is structurally similar to some
dinitroaniline compounds. However, EPA has not made a determination regarding a
cumulative risk assessment. For the purposes of this Reregistration Eligibility Decision
document, the Agency has considered only risks from butralin. However, the contribution
of butralin exposure to the exposure from other chemicals with a common mode of toxicity
is likely to be minimal. If required, cumulative* risks will be assessed when methodologies
for determining common mode of toxicity and for performing cumulative risk assessment
are finalized.
C. Environmental Assessment
.,' ,, ' 'l : ,''
The environmental assessment consists of four sections: Ecological Toxicity,
Environmental Fate and Transport, Ecological Exposure and Risk Assessment, and
Environmental Risk Characterization. The first and third sections report the ecological
toxicity data from laboratory studies, estimates ecological exposure and assesses the effects
to nontarget terrestrial and aquatic organisms. The second section depicts the
environmental fate and transport data from field and laboratory studies, analyzes the
impact to water resources, and details the environmental fate assessment. The section on
environmental risk characterization integrates the exposure and effects assessments to
determine the extent and potential for risk to the environment.
24
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1. Ecological Toxicity Data
Ecological toxicity studies indicate that butralin is practically nontbxic to
terrestrial organisms on an acute oral and subacute dietary basis, but is highly toxic
to aquatic organisms on an acute basis. At this time, the Agency does not have
sufficient data to adequately assess the ecological toxicity of butralin and is
requesting the following studies: chronic toxicity to invertebrates (GLN 72-4b);
either a 48-hour embryo-larvae study or 96-hour shell deposition study with
oysters (GLN 72-3 b); toxicity to terrestrial (GLN 123-1 a and b) and aquatic
(GLN 123-2) plants; aady avian reproduction (GLN ^1-4 a* and b> with both the
mallard duck and bobwhite quail.
a. Toxicity to Terrestrial Animals
, (1) Birds, Acute and Subacute
, In order to establish the toxicity of butralin to birds, the
following tests are required using the technical grade material: one
avian single-dose oral (LD5p) study on one species (preferably
mallard or tobwhite quail); two subacute dietary studies (LCSO) on
one species of waterfowl (preferably the mallard duck) and one
, species of upland game bird (preferably bobwhite quail).,
Table 6; Avian Acute Oral Toxicity Findings
Bobwhite Quail
96
2250
160643 Beavers/1986
Practically nontoxic
Yes
Table 7; Avian Acute Dietaiy Toxicity
Northern Bobwhite
98
> 10,000
160644 Fink/1975
Practically nontoxic
Yes
Mallard Duck
98
> 10,000
160645 Fink/1975
Practically nontoxic
Yes
, These results indicate that butralin is practically nontoxid to avian
species on an acute oral and subacute dietary basis. The guideline
requirements (71-2) are fulfilled. .
(2) Birds,'Chronic
" Avian reproduction studies are required when birds may be
exposed to a pesticide repeatedly or. continuously through
persikerice, bioaccumulation, or multiple applications; or if
25
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mammalian reproduction tests indicate reproductive hazard. The
environmental fate data suggest that butralin should be moderately
persistent to persistent (t,/2=3'months to 3 years) and relatively
immobile in terrestrial environments. Based upon the persistence
of butralin in terrestrial environments, birds are expected to be
exposed repeatedly and for a long period of time.
Two avian reproduction studies completed in 1972 were
reviewed and classified as supplemental, not-upgradeable. That is,
they provided information to be used in the risk assessment, but did
not fulfill current guideline requirements. There were numerous
guideline deviations in these studies, such as the lack of sufficient
treatment levels, inadequate description of testing facilities, and the
lack of raw data.
Conclusions: Technical butralin (purity not identified) did
not impair the reproductive ability of mallard ducks, with the
exception of increased eggshell cracks, at 80 ppm (MRID
44074105). Technical butralin, fed to bobwhite quail for a total of
15 weeks, did not impair the reproductive ability at either the 4 or
80 ppm levels (MRID 44074101). However, these studies are
inadequate and the highest tested level (80 ppm) does not adequately
represent avian exposure levels expected in the environment
according to Kenaga as modified by Fletcher (1994). The guideline
requirements, 71-4(a & b), are not fulfilled. The supplemental
studies indicate that butralin may adversely affect the reproduction
of mallard ducks, therefore a reproduction study with the mallard
duck is required. Based on the persistence of butralin,,the Agency
is also requiring a reproduction study for the bobwhite quail
because of the high potential for exposure.
(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
subacute testing, intended use pattern, and pertinent environmental
fate characteristics. Acute toxicity studies show that butralin is not
acutely toxic to the animals tested to date. Therefore, an acute oral
LD50 from the Agency's database is sufficient to assess toxicity to
mammals. This LDSO is reported below.
Table 8; Mammalian Acute Oral Toxic
Rat (small mammal surrogate)
1049
42112701
Slightly toxic
26
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b.
The available mammalian data .indicate that butralin is
slightly toxic to small mammals on an acute oral basis (MRID
42112701). ''..' :
Chronic ;
Currently, the Agency does not have reproductive
mammalian data because chronic data are not required for non-food
uses.'Tobacco is a non-food use;
(4) Insects , .
A honeybee acute contact LD^ study is required if new uses
will result in honey bee exposure. Based on the, use pattern,
tobacco, it is unlikely mat honeybees will be exposed to butralin,
therefore, honeybee testing is not required.
Toxicity to Aquatic Animals
(1) Freshwater Fish
In order to establish the toxicity of butralin to freshwater
fish, the minimum data required on the technical grade of the active
ingredient are two freshwater fish toxicity studies. One study used
a cold-water species (preferably the rainbow trout), and the other
used a warm-water species (preferably the bluegill sunfish).
Table 9; Freshwater Fish Acute Toxicity
Rainbow trout'
0.37
160647, Swigert & Bowman/1986
Highly toxic
Yes
Bluegill Sunfish
96
1.0
160647, Swigert & Bowman/1986
Highly toxic
Yes
The results of the 96-hour acute toxicity studies indicate that
butralin is highly toxic to freshwater fish. It should be noted that
the LC50 for bluegill sunfish is at the solubility limit for butralin.
The guideline requirements (72-1) are fulfilled.
(2) Freshwater Invertebrates
= -j, . '* - , ^
The minimum testing required to assess the hazard of
butralin to freshwater invertebrates is a freshwater aquatic
invertebrate toxicity test, preferably using first iristar Daphnia
rnagia or early instar amphipods, stoneflies, mayflies, or midges.
27
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Table 10; Freshwater Invertebrate Toxicity
*'!,'#
DapJmia magna
98.77
0.12
42636101, Evers/1992
Highly toxic
Yes
Daphnia magna
96
Not determined
159513, Forbis & Frazier/1986
N/A
No - supplemental
The results indicate butralin is highly toxic to freshwater
aquatic invertebrates. The guideline requirement (GLN 72-2) is
fulfilled (MRID 42636101). ,
Data from an aquatic invertebrate life-cycle test (GLN 72-4
b) is required for butralin because the following criteria have been
met: ..'.'.. "' '
o the product is expected to be transported to surface water from
the intended use site;
o the acute EC50 is less than 1 mg/L; and,
.0 the GENEEC estimated EEC in water is slightly greater than
0.01 of the acute ECSO value.
Because aquatic invertebrates appear to be more sensitive to
butralin than freshwater fish, chronic testing with invertebrates is
required instead of chronic freshwater fish testing. It should be
noted that the Agency does not have acceptable aquatic metabolism
data to confirm the persistence of butralin in aquatic environments,
and additional data may be required in the future depending on the
results of requested batch equilibrium and field dissipation studies.
(3) Estuarine and Marine Animals
The following table outlines , the acute RQs for
estuarine/marine organisms: ,
Table 11: Risk Quotients (RQ) for Freshwater Invertebrates
Tobacco/ 3.0 Ibs a.i./A
Tobacco/ 3.0 Ibs a.i./A
Sheepshead minnow (LC50 > 0.18 mg/L)
Mysid (LC50 = 0.069 mg/L)
0.09
0.2
The acute LOG (0.09) for endangered estuarine/marine fish
has been exceeded by a small margin. Also, the acute LOG (0.23)
for risk that may be mitigated through .restricted use has been
exceeded for estuarine/marine shrimp by a small margin.
28
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c. Toxicity to Plants /
(1) Terrestrial 7
Most herbicides, including plant growth regulators, require
a tier I or tier n data set for terrestrial plant testing, including a
seedling emergence and a vegetative vigor study (guideline 123-1
a and b). The registrant has not fulfilled this data requirement and
needs to submit seedling emergence and vegetative vigor studies for
butralin.
(2) Aquatic
Aquatic plant testing (guideline 123-2) is required for any
, herbicide, or plant growth regulator, which has outdoor non-
residential terrestrial uses that may move off-site of application by
runoff or by drift (aerial or irrigation). The registrant has not
fulfilled this requirement and needs to submit aquatic toxicity
testing for the following species:, Selenastrum capricdmutum,
Lemna gibba, Skeletonemacostatum, Anabaenaflos-toquae,
freshwater diatom.,
2. Environmental Fate .
a. Environmental Fate Assessment
Laboratory studies1 suggest that the primary routes of
dissipation for butralin are aqueous photolysis and to a lesser extent
microbial-mediated degradation and volatilization. Other potential
routes of dissipation are soil binding, surface water runoff, and
foliar interception/dissipation processes. , '
, Based .upon available environmental fate data, butralin
appears to be moderately persistent to persistent and relatively
immobile in terrestrial environments. The importance of the routes
1 The environmental fate assessment for butralin is based on acceptable as well ^s
supplemental, upgradeable data Environmental fate data which was found in Agency
reviews from the 1970's are regarded as supplemental, non-upgradeable data and are
referenced as 6PP File Symbol Nos. 2^4-ELNand -EAL and Pesticide Petition Nosf.4F1431
and 2G1285. Although these earlier 1970 studies and reviews contain useful information,
they do not meet current guideline requirements and can not be used in the butralih risk '
assessment . - ; '''-. ; '-' ' . : - . ''.';' ' ''-.'' ''. ' '
-------
of dissipation of butralin is unclear at this time because there is a
lack of consistent and comprehensive data on the contribution of
individual dissipation routes to the total degradation pathway. The
Agency is requesting that the registrant submit additional
environmental fate data to confirm the extent of butralin binding to
spil/sediment and to assess rates and routes of dissipation for
butralin and its degradates under typical use conditions.
Butralin is stable to abiotic hydrolysis and photodegradation
on soil (tj/2 = 99.6 days). In sunlight irradiated water, butralin
photodegrades with a half-life of 13.6 days. The major
transformation product (>10% of applied) is 4-tert-butyl-2,6-
dinitroaniline (DNTBA), and possibly 4-tert-butyl-2-nitro-6-
nitrosoaniline (DBNNA). The degradate, DBNNA, was identified
as a major photodegradate in an earlier aqueous photodegradation
study.
Laboratory metabolism studies show that butralin is
moderately persistent to persistent (ti/2 = 3 months to 3 years) in
aerobic mineral soils. The degradate DNTBA has been identified
at a maximum of 2 % of the applied at i 2 months posttreatment. In
soil metabolism studies, volatile ("Q residues account for
approximately 15% of applied after 12 months. These studies show
that >95% of the volatiles are butralin. Earlier degradation studies
in soil and water also show evidence of microbial mediated
degradation of butralin.
A half life of 35 days has been observed in an earlier
anaerobic soil metabolism study where the majority of the 14C
residue was bound to the soil. Supplemental non-upgradeable
aquatic metabolism data suggest that butralin degrades in non-sterile
water and binds to the sediment. The, Agency does not have
acceptable data to confirm routes and rates of dissipation of butralin
in aquatic and anaerobic soil environments.
Soil mobility studies indicate that butralin is relatively
immobile. In acceptable soil column leaching studies, butralin is
relatively immobile (0.25% of applied butralin in leachate) in sand,
sandy loam, loam, and clay soils. Supplemental, non-upgradeable
soil TLC/batch equilibrium studies confirm these results and show
that butralin is relatively immobile. The Agency estimates a K,,,. of
3,219 ml/g for butralin, using a first order linear regression model
based on the K;W (Lyman, W.J. 1990). Although there is
uncertainty with this estimate, the high value of the estimated
30
-------
along with the soil column leaching studies suggest that butralin has
a relatively high binding affinity to soil. Additional batch
equilibrium data are needed to confirm the estimated K^. for
butralin and to provide a more accurate quantitative mobility
assessment for risk characterization. . t
Soil metabolism, studies indicate that volatilization is a
possible route of dissipation even though butralin has a low vapor
pressure (5.79 x W6 torr) and low Henry's Constant (7,50*10?
atmrrrVmol). As mentioned above, volatilization*of butralin from
soil has been observed (approximately 15% of applied butralin
during a 12 month study) in a soil metabolism study.
Several field dissipation studies conducted in Georgia, North
Garblina, California, and Mississippi indicate that butralin, applied
at 1:5-4.0 lb/A, dissipated with half-lives ranging from 10 to 72
days. .Only one of these studies is considered supplemental and can
be upgraded to meet current guideline requirements; In the Georgia
turf study, the registrant Calculates a half-life of approximately 73
days in bare ground plots of loamy sand soil and in sandy loam turf
plots. Residues of the butralin metabolite DNTBA have been
detected only in the 0- to 6-inch soil depth in baregrpund and turf
plots. Other metabolites have not been analyzed in this study.
The registrant has conducted several laboratory fish
bioaccurnulation studies in microcosms, aquariums, and ponds, all
of which show'that butralin bioconcentrates in bluegill sunfish,
channel catfish, and crayfish. In a more recent acceptable
laboratory study, bluegill sunfish bioaccumulated butralin in 39
days of continuous exposure. Bioconcentration factors ranged from
765X, 3410X, and 1870X for edible, non-edible, and whole body
tissues, respectively at a nominal butralin concentration of 3.0
pg/L. At 30 /tg/L, butralin bioconcehtfation factors were 734X,
3590X, and 1950X for edible, non-edible, and whole body tissues,
respectively. Elimination of butralin residues exceeded 50% by 7-
10 days, and 95 % by 35 days of depuration.
Environmental Fate and Transport
(1) Degradation
Abiotic Hydrolysis
31
-------
Butralin was stable to abiotic hydrolysis in sterile buffered
aqueous solutions at pH 4,7 and 9 at 25ฐC (MRID 43669401). The
data requirement (GLN 161-1) is fulfilled. No additional data are
needed at this time.
Photodegration in Water
Radiolabeled butralin photodegraded in an aqueous solution
buffered at pH 7 when irradiated with a filtered xenon sunlamp for
15 days. The registrant calculated the half-life of butralin to be
13.6 days, while the half-life of the dark control samples was
calculated to be 138.2 days.
The major transformation product was 4-tert-butyl-2,6-
dinitroaniline (DNTBA), which accounted for 31.8% of the applied
radiocarbon on day 11 and 23.4% on day 15 in the irradiated
samples. In addition, a region of diffuse radioactivity (16% of
applied) was observed in the HPLC radiochromatogram which did
not contain discernible discrete peaks. The author of the study
reported that this diffuse region of radioactivity consisted of highly
water soluble components displaying acidic and basic properties and
probably resulted from the rupture of the aromatic ring of the major
degradate DNTBA with subsequent formation of multiple products
(MRID 44064901).
.In a supplemental non-upgradeable study, butralin
photodegraded under natural sunlight and mercury arc vapor lamp
to form 4^ert-bulyl-2-nitro-6-nitix)soaniline (76%) and several other
minor photolabile transformation products (e.g., DNTBA) (Ace
No. 24863). In another supplemental non-upgradeable study,
butralin degraded with a half-life of 7.7 days in irradiated buffer
solution (pH 7). This study was unacceptable because the dark
cdntrol also showed degradation (26% in 30 days) (MRID
42620701). In this study, major degradates were identified as 4-
tert-butyl-2,6-dinitroaniline (17.4% of applied at 30 days) and 3-
nitro-l,2-phenylenediamine (19.3% of applied at 30 days). These
degradates were detected in both irradiated and dark control
treatments. Additional open literature data indicate that nitroaniline
compounds may be intermediate photoprodiicts from the
photodegradation of dinitroaniline compounds (Harris, J. 1990).
The data requirement (GLN 161-2) is not fulfilled.
However, the most recent photolysis study (MRID 44064901) is
considered supplemental and can be upgraded after the registrant
32
-------
provides a complete explanation of the differences in metabolites
identified among the different aqueous photolysis studies.
(2) Mobility
i , 7 , ... ',. / , .
Pihotodegradation on Soil
- . " : " r . -, "" ' ' * ''.',, '?
Radiolabeled butraliri, at 374 /ag/g, phbtodegraded slowly on
sandy loam soil irradiated with natural sunlight for 30 days. Using
linear regression, the registrant calculated the half-Jife-to be 99.6
days. Butralin also degraded slowly (t1/2 = 112.7 days) in the daik
control. At 30 days posttreatment, butralin was 76.7-80.4% of the
applied in the irradiated soil, and .78.2-81.4% of the applied !in the
dark controls. During the experiment, DNTBA and nine other
unidentified transformation products were detected (all <2.3 of the
applied) in the irradiated soil and dark controls (MRID 42496201).
A supplemental non-upgradeable study, which assessed the
photodecomposition of butralin applied to soil TLC plates and
irradiated with natural, sunlight, showed that 91% of parent
compound remained after 7 days (MRID 50500010).
This data requirement (GLN 161-3) is not required for non-
food terrestrial uses.
Photolysis in Air
The data requirement (GLN 161-4) was waived because it
is not requited to support terrestrial ^non-food uses. Potential
volatilization of butralin into air is expected to below because of
butralin's low vapor pressure (5.79 x 10"6 Torr) and low Henry's
Constant (7.50 * 10"6 arm. rrf/rnol) the Agency's Pesticide One-
Liner Database (EFGWB). The Agency notes, however, that
volatilization of butralin from soil was observed (15% of applied
butralin during.a 12 month study) in a soil metabolism study
(MRID 43201901):
' , '..'''> . ' "' ' ' ' '
' Aerobic Soil Metabolism ;
Radiolabeled butralin, at 3.9 |&g/g, was persistent'
(extrapolated half-life of 1126 days or approximately 3 years) in
sandy loam soil incubated ,in the dark at 25 ฐC and 75% field!
moisture capacity. Radiolabeled butralin was 95.9 - 96.4% of the
33
-------
applied immediately ppsttreatment, and decreased to 71.6 - 73.1 %
at 12 months.
The degradate, 4-tert-butyl-2,6-dinitroaniline (DNTBA),
was identified at a maximum of 1.9 - 2.2% of the applied at 12
months posttreatment. Various other, degradates, which were
present at
-------
products of butralin were a dealkylated metabolite (1 % of applied)
and unidentified polar metabolites (12% of applied). , -
The data requirement (GLN 162-2) is not fulfilled; however,
it is not required for terrestrial non-food uses.
Aquatic Metabolism
Aquatic metabolism data were taken from supplemental non-
upgrideable studies/on butralin degradation in non-sterile water,
accumulation in artificial aquatic ecosystems, and field runoff
studies (MRID 42069703, OPP File Nos. 264-ELN and -EAL and
PP#4F1431 and 2G1285). The Agency reviewed revipus agency
reviews for pertinent data relating to the fate of butralin in aquatic
environments1. These aquatic metabolism studies provide limited
information regarding the fate of butralin in aquatic environments
and cannot be used as supporting data for a risk assessment.
, j , , \ ' " ' ' " - ':' , ' - , " ' _ '
In laboratory studies, butralin in non-sterile water degraded
to form four polar metabolites: 2,3 diaminonitrobenzene, 4-tert-
butyl-2,6-dinitroacetanilide, N-isopropyi-2-amuio-4-tert-butyl-6-
nitroaniline, and N-emyl-2-nitroso-4-tertiaiy-butyl-6-nitroanilirie
(OPP File No; 264-ELN). ".-
In artificial aquatic ecosystems; radiolabeled butralin,
applied at 2 Ibs a.i/A in flooded sediment/test; water, was detected
at maximum sediment concentration of 23 to 25.50 mg/kg at 7 and
10 days posttreatment and then declined to 4.80 to 6.85 mg/kg at
35 days posttreatment. Butralin water concentrations ranged from
0.14 mg/L to 0.81 mg/L (MRID 42069703). In another artificial
aquatic ecosystem study, bluegill sunfish, channel catfish and
crayfish were exposed to radiolabeled butralin, applied at 3 Ibs
a.i./A for 35 days in a static pool. The sediment in the pool was
.treated with radiolabeled butralin and then aged aerobically for 27
days before flooding. Butralin residues in the water ranged from
0.02 (ftg/ml to a maximum of 0.06 /^g/ml ppm on day 35 of
. exposure. In the soil, total 14C-residues were 13.73 /tg/g
immediately posttreatment, 10.25 /^g/g at 30 days ,and ranged from
8.66 - 9.80 /ig/g during the animal exposure period (MRID
42069704).
Runoff studies in Pennsylvania and Mississippi on sites with
3 to 6% slopes showed that butralin, at 3 Ibs a,i./A, was detected
in adjoining farm pond water and sediment at .maximum
35
-------
concentrations of <2 /ng/ml and <30 /*g/g, respectively
(PP#4F1431).
Guidelines 162-3 and 162-4 are not required for terrestrial
non-food uses. ;
Soil Column LeachingNBatch Equilibrium
, Radiojabeled butralin, at 0.197 ug/g, was relatively
immobile in 30-cm columns of sand, sandy loam, loam, and clay
soil eluted with 20 inches of 0.01 M calcium chloride solution.
Trace quantities (0.14-0.25% of applied) of radiolabeled material
in the leachates were not identified. In all soil columns, the
radiolabeled material was predominantly detected (>81.86% of
applied) in the 0-6 cm soil layer. The major compound detected in
the 0-6 cm soil layer was parent butralin. The degradate 4-tert-
butyl-2,6-dinitroaniline, and two unidentified 14C compounds were
each j<3.8% of applied (MRID 42842301).
Supplemental, non-upgradeable TLC studies showed that
butralin and its metabolites (DNBTA and 2,6-dinitroaniline) were
immobile (Helling-Tumer mobility classification of 1) on sand, silt
loam, and muck soil plates. (OPPFileNo. 264-EAL).
i
In a supplemental, non-upgradeable batch equilibrium study,
adsorption coefficients (Kd's) of 2, 6.5, and 90 ml/g for butralin
were measured in sand, sandy loam, and clay soil, respectively.
These values could not be used to calculate KO,. values because the
soil organic matter content was not reported (MRID 35622).
The data requirement for an imaged mobility study (GLN
163-1) is satisfied (MRID 42842301). At this time, the Agency is
not requiring an aged mobility study. The Agency is, however,
requesting additional batch equilibrium data to confirm the
estimated K^ for butralin. The Agency estimated a 1^. value of
3,219 ml/g using a Kow which was based upon an ^invalidated first
order regression analysis (Lyman, W.J. 1990).
Volatility
The data requirement (GLN 161-4) was waived because it
is not required for terrestrial non-food uses. Potential volatilization
of butralin into air is expected to be low because of butralin1 s low
vapor pressure (5.79 x 10* Torr) and low Henry's Constant (7.50
36
-------
* 10* atm.m3/mol). The Agency notes, however, that volatilization
of butralin from soil was observed (approximately 15%; of applied
butralin during a 12 month study) in a soil metabolism study
(MRID 43201901).
i '._%" _ ' ... '
1 ; Bioaccumulation in Fish .; ....
Radiolabeled butralin bioconcentrated in bluegill sunfish
which were continuously exposed to nominal butralin concentrations
of 3.0 and 30 jtig/Lfor 39 days. For bluegiE exposed to a nominal
butralin concentration of 3.0 jtg/L, bioconcentration factors (BCF)
of 765X, 3410X and 1870X were calculated for edible, non-edible,
and whole body tissues, respectively. Elimination of accumulated
butralin residues exceeded 50% by day 10 and was greater than
95%byday35.
For bluegill exposed to a nominal butralin concentration of
30 /tg/L, BCFs of 734X, 3590X, and 1950X were calculated for
edible, non-edible, and whole body tissues, respectively.
Elimination of 14C-residues exceeded 50% by day 7 and was greater
than 95% by day 35 of depuration. After 39 days of exposure to
30 ptg/L, radiokbeled butralin was detected in both viscera (82.2%
of TRR) and edible tissues (81.9% of TRR) of bluegill along with
several minor metabolites. The study authors concluded that the
glutathione pathway was used in the metabolism of butralin by
bluegm sunfish (MRID 4408.1601).
Supplemental, non-upgradeable flow-through accumulation
Studies at 0.01 and 0.75 mg/L of butralin showed that radiolabeled
butralin bioaccumulated in edible portions of bluegill (2200 to
4260X) and in non-edible portions (32,000 to 33,OOOX). Ninety to
ninety-nine percent of the residues were eliminated after 7-35 days
of depuration. Butralin was the only compound identified in the
edible tissues. At the higher concentration of 0.75 mg/L of butralin,
mortality was observed after 19 days. of exposure (MRIDs
42069702 and 42069705).
Supplemental, non-upgradeable static accumulation studies,
at application rates of 2-3 Ibs a.i./A in soil and water, showed that
radiolabeled butralin bioaccumulated in edible portions of bluegill
(123 to 473X), channel catfish (115 to 1250X), and crayfish (5 .to
10X). Biocdncentratioh factors found in non-edible portions'Of
bluegill ranged between 1561 to 7000X, and in channel catfish they
ranged from 1000 to 2682X. Residues were eliminated to
-------
of the highest level in bluegill and catfish after 7-35 days of
depuration. Butralin was the only compound identified in fish
tissues (MRIDs 42069703 and 42069704).
,>.
Field runoff-accumulation studies in Pennsylvania and
Mississippi showed that butralin, at 3 Ibs a.i./A, bioaccumulated to
150 - 1200X in edible portions of bluegill and catfish, respectively.
Bioconcentration factors in non-edible portions of bluegill was
1000X and in channel catfish was 75QOX. Maximum concentrations
in the .water and sediment were 2 /*g/L and 30 us/kg, respectively
(PP#4F1431).
The data requirement (GLN 165-4) is fulfilled. No
additional data are needed at this time.
(3) Field Dissipation
Terrestrial Field Dissipation
Several field dissipation studies conducted in Georgia, North
Carolina, California, and Mississippi indicated that butralin, at 1.5-
4.0 Ib/A dissipated with half-lives ranging from 10-72 days. None
of these studies met guideline requirements for the reasons listed
below. The most recent field studies were conducted in tobacco
and bare ground in North Carolina and in turf and bare ground in
Georgia. The North Carolina study was not acceptable because of
low and highly variable recoveries in the frozen storage stability
analysis. In addition, the application rate of butralin could not be
confirmed, the pattern of decline of butralin in soils planted to
tobacco was not established, the concentration data on butralin and
the metabolite DNTBA in tobacco plants were not submitted, and
only one metabolite was identified.
The Georgia study with turf provided supplemental
information, but could not be used to fulfill the guideline
requirement. If someone decides to register the turf use, then
additional data will need to be submitted concerning the application
rate of butralin, storage stability data for butralin beyond 651 days
and for the metabolite bNTTBA, and the identification of all
metabolites at concentrations above 10% of applied.
The Georgia turf study showed that butralin dissipated in
Norfolk loamy sand and sandy loam soils with registrant calculated
half-lives of approximately 73 days in bare ground plots and in,
38
-------
c.
plots with previously established turf. However, the actual half-
lives may be much shorter than the calculated half-lives because
butralin residues decreased to less than half of the nominal,
concentrations by 15 days posttreatment (DPT). Residues of the
metabolite DNTBA were detected only in the 0- to 6-inch soil depth
, in bare ground and turf plots. Maximum DNTBAJevels were 0.04
/ig/g in bare ground plots at 18 months post-treatment (MPT) and
0.12 /ig/g in turf plots at 5 MPT. The soil and turf were not
.analyzed .for other metabolites, such as 3-nitro-l,2-
phenylenediamine, 2,6-dinitroaniline, 3-(4-tert-bUtylanilin6-2i6-
dinitro)-2-butanol (MRIDs 42069701, 43749801, 43764001).
Supplemental, non-upgradeable field studies in California
and Mississippi were conducted on soils'planted with crops and
treated with butralin at 1.5-4.0 lb/A. In these studies, the reported
half-lives of butralin ranged from 42 to 72 days. Metabolites were
not identified in thesb studies (PP#2G1285).
The terrestrial field dissipation data requirement (164-1)/is
not fulfilled at this time.
(4) Spray Drift
The Droptlet Size Spectrum (201-1) and Drift Field
Evaluation (202-1) data requirements do not apply for butralin
because it is not applied aerially.
Water Resources
(1) Ground Water <:
The Agency evaluates the persistence and mobility of each
pesticide for ground water concerns. If data indicate that the parent
and/or degradates are persistent and mobile, then a small-scale
prospective ground water study may be required. The basic.
triggering criteria include: weight of the evidence from laboratory
and field dissipation studies indicating that die pesticide has
properties and characteristics similar to pesticides that are known to
leach or have been detected in ground water; movement of the
parent or degradates 75-90 centimeters through the soil profile or
plow layer in a field dissipation study; reports of detections in
ground water from other monitoring studies and information about
toxicity. In addition, use patterns, application rates, timing of
application, potential acreage treated, depth to ground water, soil
39
-------
types, hydraulic gradient, and climate are also evaluated as part of
the triggering criteria. Persistence, mobility, detections in ground
water and tpxicity are also used to evaluate a chemical to determine
whether its use should be restricted. A compound may be
recommended for Restricted Use if it exceeds these criteria.
Persistence and Mobility
Butralin was evaluated for persistence and mobility in
relation to its potential to leach to ground water. Below is a
summary of that evaluation.
Table 12: Physical and Chemical Characteristics of Butralin Relative to Mobility and
Persistence Criteria
Crftcrloa
Persistence
Mobility
Xi 3ma6*&&ซ*'^ ' \ > , ,
Field dissipation half-life
Lab-derived aerobic soil metabolism half-
life
Hydrolysis half-life
Photolysis half-life (soil)
Soil adsorption: K^
Soil adsorption: K,,.
Depth of leaching in field dissipation study
ฎ)tmp&f W&tet (Mferia
> 3 weeks or
> 3 weeks or
< 10% in 30 days or
< 10% in 30 days and
^ 5 ml/g or
z 500 ml/g or
75 cm
" ซ^''?l&kta8a"'"
1 ,43 to 1&5 wfeifia- 72,6 ซ0
- ' ' ',\' '<. ~* ''? "'-ฃ / " - - <
- r -, ;;s wฃg;i& rj&aป ', ; '-.^ v
?'l " ;;stawf ; j^f^^/* ': j
19.6-23.3 % in 30 days
^7;?^^^^xrH,a:
3,219 ml/g** (est. by EPA)
15.2cm (6")
Shaded ceils in cofoma indicates i
* (^lalitative data from soil column leaching studies show that butralin is relatively immobile.
** The K^. was estimated from a first order regression analysis using the K,,,, for butralin.
Ground Water Detections
EPA's "Pesticides in Ground Water Database" (Hoheisel et al.,
1992) does not report any sampling for butralin in the U.S. A search of
the Agency records found no other sampling for butralin in ground water.
' . . , ." : ''" , '' ' ' .;i ' '',".,,'./'
Butralin is currentiy not regulated under the Safe Drinking Water
Act (SDWA). The Agency's Office of Water has not established a
Maximum Contaminant Level (MCL) or Lifetime Health Advisory Level
(HAL) for butralin in drinking water.
Ground Water Leaching Index Evaluation.
40
-------
A numerical scale or index was used tot assess the leaching potential
according, to environmental fate properties, soil properties, and soil
hydrology. It can be used to compare the relative mobility of different
pesticides under the same environmental conditions. A Leaching Index
(LI) was developed by the Agency to divide the pesticide mobility index
into three discrete classes: low (1), moderate (2), and high (3) potential to
leach to ground water.
,- i .f , ', ' _ _ ' -\ ' .' ' ' , t. . .. ' '.''-,'" ' '
The Agency used this method to calculate an attenuation factor (AF)
for butralin in five different Major, Land Resource Areas - (MLRA's). using
the soil metabolism half-life of 150 days and estimated K^. of 3,219 ml/g.
Below are the calculated retardation and .attenuation factors for butralin:
Table 13; Retardation and Attenuation Factor
I xv-kv,,.,', 'MLRA*^";/^'
108
129
133a
139 ,
142
l&taBMtm Pas&ar <&!# ':' "' " i
2053.09
. , 1566.00 . I
.-". 2140.19 '
' 3248.25
.3184.45
j&feM&M re3erซ*ป' T -',"<
0
0
'" "' T o
0
" ':'', ' o ''-' " -
The Agency compared the calculated attenuation factors of butralih
to those calculated for a number:of well-known herbicides used inMLRA
' ; 108.' ; . . " /'- ; , -v .' ' '.'.-.: .' t ' '. :
Table 14: Comparison of Attenuation Factors (AF) for Various Pesticides
f*ซ^.?..jf'
chlorpyrifos
butralin
alachlor
bentazon
atrazine
terbacil
tebutbiuron
;TV'**"-&;I
0.000000
"0"
0.000000
, 0.000110
0.002165
0.44222
0.93648
^*'/,
. -.1 ' ,
, 1
:2
'3
' 3,;-.
3
3
r^^i wf^^^&Ms^^^^.^rf^^^^ .'*si
Low Risk, may get to ground water in only a small number of wells
Moderate Risk, will probably get to ground water in a number of
wells '-".' \ :''.-, !. -
High Risk, will probably reach ground water in a high number of
wells - : . '\ ;.-' ' -'..' ./' " . -': -
Compared to other pesticides, butralin has a rating of "1 "indicating
"low risk, butralin may get to ground water hi only a small number of
wells." From this evaluation, the Agency concluded that butralin ranks
very low in its potential to leach to ground water and can essentially be
considered a "non-leacher," This assessment is based on an estima.ted
41
-------
value for butralin. Additional batch equilibrium data are needed to confirm
the leaching potential of butralin.
Tobacco Production ,
" ' , ! ' ' ' " ', ' ' !l . . . '
Tobacco production acreage is large, however unlike the large
mono-culture crops, it is usually grown in small (less than 1-10 acres),
plots widely dispersed over large geographic areas (U.S. Dept. of
Commerce, 1992). Much of the use of butralin is expected to be on flue-
cured and air-cured tobacco which is grown in the Southeastern U.S., the
Mid-Atlantic States, and the mid-southern States2. There will be some use
on Maryland dark type tobacco which is grown in parts of central and
southern Maryland and southern Pennsylvania.
The effect of butralin to the environment would be limited to these
tobacco use areas. In addition, this type of use on many small plots
distributed over many states, would reduce any potential impact to ground
water. The Agency does not anticipate any impact to ground water from
butralin use on turf since this use is no longer registered.
Ground Water Conclusions ป.
Butralin is persistent but .relatively immobile in terrestrial
environments. Based upon qualitative leaching index and mobility studies,
butralin is not expected to leach into ground water. Additional batch
equilibrium data are needed to confirm the soil binding affinity of butralin.
The Agency concludes that use of butralin on tobacco should have minimal
impact on ground water.
(2) Surface Water
/ " , '',',,' >, . ; '
The current surface water assessment for butralin is an
adequate qualitative characterization of the runoff potential for
butralin. A more reliable surface water exposure characterization,
which is based on PRZM, cannot be adequately determined until the
Agency receives additional batch equilibrium data.
2 The major tobacco growing regions correspond to the following major land resource
areas (MRLA): Southern Coastal Plains (MRLA 133), Southern Piedmont (MRLA 136),
Carolina/Georgia Sand Hills (MRLA 137), western edge of the Atlantic Coast Flat Woods
(MRLA 153); Kentucky and Indiana Sandstone and Shale Hills and Valley (MRLA 120);
Kentucky Bluegrass (MRLA 121), and Highland Rim and Pennroyal (MRLA 122) (Austin
1972).
' . ' / 42
-------
The potential for surface water runoff of butralin is expected
to be dependent on the cumulative impacts of foliar
interception/dissipation, binding on soil/sediment;, degradation
processes, and site hydrology. Since the current label for butralin
(TAMEX-3EC) recommends foliar spray application onto the leaf
axial, stalk, and crown of flue-cured and air-cured tobacco, the
Agency believes foliar interception and subsequent foliar dissipation
processes will affect the magnitude of butralin residues available for
surface water runoff. The potential effect of foliar interception may
be gauged from unacceptable field dissipation studies on tobacco in
which 87% of applied butralin was intercepted by tobacco plants
(MRID 43749801). Environmental fate data suggest that direct
photolysis will contribute to foliar dissipation of butralin. The
impact of foliar interception and subsequent foliar,dissipation
processes oh potential butralin loading into surface waters cannot be
fully assessed without data on rates and routes of foliar interception
and dissipation of butralin and its transformation products. Butralin
residues that are over-sprayed or washed-off from the treated plants
are expected to be the only butralin residues available for runoff
into surface waters,
Environmental fate studies indicate that butralin is relatively
immobile and moderately persistent in mineral soils. In terrestrial
environments, the main routes of butralin dissipation appear to be
dependent on microbiat-mediated degradation (tin 3 months to 3
years) and soil binding (1^=3219 ml/g). Acceptable soil column
leaching studies and supplemental batch equilibrium/soil TLG
studies indicate'butralin should be relatively immobile in terrestrial
and aquatic environments (Accession No. 35622; MRID 42842301;
OPP File No. 264-EAL); These data indicate that butralin will be
bound on entrained sediments in surface water runoff. However,
the soil binding affinity of butralin cannot be adequately evaluated
until the Agency receives confirmatory batch equilibrium data.
The major tobacco growing regions are, classified as
predominantly upland soils GJdalfs or Udults) and alluvial soils
(Fluvents)2. These are somewhat freely-drained soils (Soil Survey
Staff, 1975). Soils with regional importance are the Psamments in
MRLA 137 and poorly drained soils (Aquents, Aquepts, Aquults)
in MRLA 153. Psamments (sandy soils) are expected be of
minimal importance for surface water runoff because of their high
water permeability. Although poorly drained soils, as noted in
MRLA 153, would be expected to be tile drained for tobacco
production, they may serve as d groundwater recharge areas from
43
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surface water. These soils are predominately limited to the Atlantic
Coast Flat Woods region (MRLA 153).
1 ( '
Based on laboratory aerobic soil metabolism studies and the
relatively high estimated K,,,., butralin is expected to be persistent
and to bind on suspended and bottom sediments in surface waters.
Dissolved butralin in the water column should be susceptible to
direct photolysis which is dependent on the clarity and depth of the
surface water body. Direct aqueous photolysis of butralin is more
likely in shallow, clear water bodies with long hydrologic residence
times (MRID 44064901). Currently, there are no acceptable data
to confirm the fate of butralin in aquatic environments.
Butralin detections in surface water were not reported in
STORET. Runoff studies in Pennsylvania and Mississippi on sites
3 to 6% slopes indicate butralin, at 3 Ibs a.i./A, was detected in
adjoining farm pond water and sediment at a maximum
concentration of 2 /tg/L and 30 jtg/kg, respectively (PP#4F1431).
Based on the Tier 1 GENEEC EEC, the peak EEC for butralin is
16.89 jBg/L. No maximum contaminant level (MCL) or Lifetime
Health Advisory Level (HAL) has been established for butralin.
Expected Aquatic Concentrations: Butralin displays high
toxicily to most aquatic organisms tested to date. The Agency
calculated generic EECs for butralin application to tobacco (3.00
Ibs a.i./A). These EECs are designed as a coarse screen and
estimate expected concentrations from a few basic chemical
parameters and pesticide label application information. GENEEC
is a tier one model which uses a chemical's soil/water partition
, coefficient and degradation half-life values to estimate runoff from
a ten hectare field into a one hectare by two meter deep pond.
GENEEC calculates both acute and chronic generic expected
environmental concentration (GEEC) values. It considers reduction
in dissolved pesticide concentration due to adsorption of pesticide
to soil or sedjment, incorporation, degradation in soil before wash
off to a water body, direct deposition of spray drift into the water
body, and degradation of the pesticide within the water body. It is
designed to mimic a PRZM-EXAMS simulation.
The following environmental fate parameters were used to
calculate the generic EECs:
44
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Table IS; Environmental Fate Parameters
>'&&&ฅ!<" ฃฃ'',:*?''ฃ*? ?~
Solubility in water
Aerobic soil half-life i
Aerobic aquatic half-life data2
Aqueous photolysis
Hydrolysis half-life ; ; ,
v ' ' ' ''>
^H**; '
0.3 ppm
stable1^
stable
13.6 days
stable
3,219 mi/g
:*afa#s?f<*^*%, *,,',
EFGWB One-liner
MRID 432019-01
no data
MRID 440649-01
MRID 436694-01
Regression Equation:
*//jft*. ^"^^.rf, *;*ป^
"..'-'. . ' . .
3 logK^^O.937 x log(Kow>0.006
1 The aerobic soil half-life is >365 days.
2 No data,are available to assess the degradation rate of butralin in aerobic aquatic environments. Therefore, butralin
is assumed to be persistent (or stable) to aerobic aquatic metebolism.
3LymanW.J.1990. : ; . . :
The following table outlines the Generic EEGs which were
calculated for butralin application to tobacco:
Table 16: Generic Estimated Environmental Concentrations (GEEC) For Butralin
Tobacco
Broadcast - ground
3.00(1)
16.89
15.69
11.15
7.70
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 LOG (acute and chronic)
for each of the four nontarget fauna! groups and one category (acute) for
each of two nontarget floral groups. In order to determine if an LOG has
been exceeded, a risk quotient must be derived and compared to the
_, LOC's. A risk quotient is calculated by dividing an appropriate exposure
estimate, e.g! tfie estimated environmental concentration (EEC), by an
appropriate toxicity test effect level, e.g. the LCS0. The acute effect levels
, typically are: ^
(terrestrial plants),
-EC50 (aquatic .plants and invertebrates),
-LC50 (fish and birds), and
-LD50,(birds and mammals)
45
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The chronic test results are the:
-NOEL (sometimes referred to as the NOEQ for avian and
mammal reproduction studies, and either the NOEL for chronic
aquatic studies, or the Maximum Allowable Toxicant Concentration
(MATQ which is the geometric mean of the NOEL and the LOEL
(sometimes referred to as the LOEC) for chronic aquatic studies.
When the risk quotient exceeds the LOG for a particular category, risk to
that particular category is presumed to exist. Risk presumptions are presented
along with the corresponding LOG' s.
Table 17; Levels of Concern (LOG) and Associated Risk Presumption
ss:::1 :? ',; ',,
acute RQ>
acute RQ>
acute RQ>
chronic RQ>
W*We ""'' ' "
acute RQ>
acute RQ>
acute RQ>
chronic RQ>
Ifflto' "" , "- ^
RQ>
RQ>
,;--UDC '
0.5
0.2
0.1
1
" LOC >
0.5
0.1
0.05
1
IQ&s*-
1
1
Pซs8ปtpซioa' - ',f/"/f' ' ' ' -',,;/^//M>
Mammals, Birds
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.
Fish, Aquatic invertebrates
PfeSUltlptjCtt ^ s/Sf,ff' ;,'"', '; , ,'''", ''',''' f'
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.
Plants
t^s&ftisj,< "*'* " * - ' ' , ซ* *> ,;, ,,ป~ '?-' "7" - " '- "i
High risk.
Endangered plants may be affected.
Currently, no separate criteria for restricted use or chronic effects
for plants exist.
Butralin use patterns addressed in this assessment: Butralin is registered
on flue-cured and air-cured at a use rate of 3.0 Ibs a.i./A. For the purposes of this
assessment, all types of tobacco will be referred to as "tobacco." This assessment
is based primarily on the predominant method of application, boom application to
foliage (one application per season). The label also includes individual manual
application methods using a handheld dropline, knapsack sprayer or jug
application.
46
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(1) Exposure and Risk to Nontarget Terrestrial Animals
V-- (a) Birds
Butralin residues foundon dietary food items following
application are compared to LCSO values to predict hazard. The
maximum concentrations of butralin residues which may occur on
selected avian dietary food items following a. single application of
3.0 Ibs a.i./A, the maximum application rate for tobacco, and the
corresponding acute risk quotients are provided in the table below:
Table IS: Estimated Environmental Concentrations on Avian Dietary
Food Items in PPM and Corresponding Risk Quotients
\^^^^^/^\''':^'^l''\
Short Grasses
Long Grasses
Broadleaf Plants and Insects , ,
Fruits and pods :
720
330
405
45
!, *?^" frfaXQ'*- -f~^
<0.07
<0.033
<0.041
<0.005
The LOCs have not been exceeded for acute avian risk.
Therefor?, avian species are not likely to be acutely affected by the
use of butralin. Data from supplemental studies, showing a NOEL
of 4 ppm, indicate the potential for high chronic risk.
(b) Mammals
Small mammal exposure is addressed using acute oral LDSO
values converted to estimate an LC50 value for dietary exposure.
The estimated LC5Q is derived using the following formula:
, LCSO = LDso xbody weight (g)
food cons, per day (g)
Table 19: Small Mammal Food Consumption in PPMs (Based on an LD^ = 1049
mg/kg MRID 42112701)
Small Mammal
f * . '''''', * ;
Meadow vole
46 g
61 %
1,717 ppm
Adult field mouse
13 g
16%
2.1 g
6,493 ppm
Least shrew
5g
110%
5.5 g,
953 ppm
The above table is based on information contained in Principles of Mammology by D. E, Davis and F. Golly, published
by Reinhold Corporation, 1963.
The estimated LC56is tien compared to the EEC 'values
Hsted above to calculate a risk quotient. The table below indicates
the mammalian dietary risk quotients. ,
47
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Table 20: Mammalian Dietary Acute Risk Quotients
feXK&MM'S * A, f $?} '*'$ f s, . ,
xjySiซall Mairimai{ ^ ' ' ,,
Meadow vole (short grasses)
Adult field mouse (seeds)
Least shrew (insects)
'/<ซ*",ป,,<;,,;,?,, ff ifeSj^ ซ,ฃbv^/^\
0.4
; 0.06
0.4
The acute LOG for endangered species has been exceeded
by four times the recommended LOG for the meadow vole and the
least shrew. Therefore, the use of butralin on tobacco at this use
rate may cause adverse effects to herbivorous and insectivorous
endangered mammals. Although the LOG for restricted use
mitigation has been slightly exceeded, the Agency is not
recommending restricted use classification at this time. The actual
exposure to small mammals is expected to be reduced because of
the directed method of application to the tobacco plant.
Chronic risk to mammals cannot be assessed at this time
because chronic mammalian data are not available.
(c) Insects
Honeybees are not likely to be exposed to butralin and are
not likely to be adversely affected by its use (Vaughan, A. 1983).
(2) Exposure and Risk to Nontarget Aquatic Animals
(a) Freshwater Fish
The following table outlines the acute RQs for freshwater
fish based on EECs calculated in the GENEEC model.
Table 21: Risk Quotients (RQ) for Freshwater Fish
Tobacco/3
catioa iste^ ^ , ,-
.0 Ibs a.i./A
Speaks ป ''. ' , ' '',"'
* t r f f t* f f
Rainbow trout LC^
Bluegill Sunfish LC.
= 0.37 mg/L
,0 = 1.0 mg/L
0.046
0.02
The acute LOCs for freshwater fish have not been
exceeded.
48
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(b) Freshwater Invertebrates
The following table outlines the acute RQs for
-,. aquatic invertebrates.
Table 22: Risk Quotients (RQ) for Freshwater Invertebrates
~''} s>
"< f.
Tobacco/3.0 Ibs a.i./A Deqthnia magna ECy, = 0.12 mg/L
0,14
the acute LOG for restricted use (LOC?= 0.1) for
freshwater invertebrates has been slightly exceeded.
. Chronic toxicily to freshwater invertebrates cannot
be assessed at this time. ''-'.'
(c) Estuarine and Marine Animals
; The following table outlines the acute RQs for
estuarine/marine organisms:
Table 23; Risk Quotients (RQ) for Freshwater Invertebrates
Tobacco/ 3.^0 Ibs a.i./A
Sheepshead minnow (LC50 > 0.18 mg/L)
0.09
Tobacco/ 3.0 Ibs a.i./A
Mysid (LC50 = 0.069 mg/L)
0.2
The acute LOG (O.Qi?) for endangered estuarine/marine fish
has been exceeded by a small margin. Also, the acute LOG (0.23)
for risk that may be mitigated through restricted use has been
exceeded for estuarine/inarine shrimp by a small margin.
(3) Exposure and Risk to Nontarget Plants
The Agency does not have adequate data to assess the risk
of butralin to npntargel plants. The Agency is requiring that the
registrant submit nontarget plant data.,
(4) Endangered Species
-The following endangered species LOCs have been
exceeded: herbivorous and insectivorous endangered mammals and
freshwater aquatic invertebrates, and estuarine/marine fish and
shrimp. Also, there may be possible reproductive effects to birds.
' . -^ 49 ' '"''' ''' -' , , : ,: : : '
-------
Acute risk to endangered plant species cannot be determined
due to insufficient data.
The Endangered Species Protection Program is expected to
be finalized in the near future. Limitations in the use of butralin
may be required to protect endangered and threatened species, but
these limitations have not been defined yet, and they may be
formulation specific. EPA anticipates that a consultation with the
Fish and Wildlife Service will be conducted in accordance with the
species-based priority approach described in the Program. After
completion of consultation, registrants will be informed if any
required label modifications are necessary. Such modifications will
most likely consist of the generic lat>el statement referring pesticide
users to use limitations contained in county bulletins.
"''',ซ. '.','"', !
b. Water Resources Risk Implication for Human Health
The Agency has no data indicating an undue risk to human health
from water resources as a result of butralin use on tobacco.
(1) Ground Water
Butralin is persistent but relatively immobile in terrestrial
environments Based upon qualitative leaching index and mobility
studies, butralin is not expected to leach into ground water.
Additional batch equilibrium data are needed to confirm the soil
binding affinity of butralin. The Agency has concluded that use of
butralin on tobacco will have minimal impact on ground water.
(2) Surface Water
Butralin detections were not reported in STOKET. Based
on the Tier 1 QENEEC EEC, the peak EEC for butralin is 16.89
Aig/L. A more reliable surface water exposure characterization
based on GENEEC or PRZM cannot be adequately determined until
the additional batch equilibrium data are received and evaluated.
No maximum contamination level (MCL) or Lifetime Health
Advisory Level (HAL) has been established for butralin. The
Agency believes foliar interception and subsequent foliar dissipation
processes will affect the magnitude of butralin residues available for
surface water runoff. Butralin residues that.are oversprayed or
washed off from the treated plants are likely to be the only butralin
residues available for runoff into surface water.
50
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c. Environmental Risk Characterization
Background Information
.' Butralin is a post emergent plant growth regulator which is
registered to control suckers on flue-cured and air-cured tobacco. Butralin
will be applied as an emulsifiable concentrate (36.5%) by direct spraying
of the tobacco stalks, leaf axils, and crown using directed, coarse, low
pressure spraying techniques. The maximum application rate is 3.0 Ibs
a.i./A. According to the registrant, the use of butralin is expected to be
limited to-the southeastern U.S., the mid-Atlantic states and the mid-
southern states. In these regions, most of the tobacco is grown on small
(less than 1-10 acre) plots which are widely dispersed over large
geographic areas. ,
Aquatic Organisms , ,
Even though laboratory studies show that butralin is highly toxic to
fish and invertebrates, the Agency expects that the overall acute risk to
aquatic organisms in the environment will be low. The risk quotients,
which are based upon screening level exposure estimates, indicate that only
three LOCs were slightly exceeded (freshwater invertebrates,
estuarine\marine fish test\maririe shrimp)^ Furthermore, the estimated
EEC values for butralin use on tobacco are conservative because the model
does not account for foliar interception/dissipatipn.and aquatic metabolism
of butralin. As previously mentioned, the exposure assessment is uncertain
because the EECs are based on an estimated K^ value of 3,219 ml/g
(Lyman, WJ. 1990). Additional batch equilibrium data are needed to
confirm the GENEEC EECs for butralin.
',.( The label for TAMEX-3EC.recommends foliar boom or manual
spray application over the row, delivering a coarse spray that runs down
the stalk and wets suckers in the leaf axils. Butralin may also be applied
to individual plants using a handheld dropline, knapsack sprayer or jug
application. Butralin residues from foliar over-spray or wash-off from the
treated plants are expected to be the only residues available for runoff in
surface waters. Although the full magnitude of butralin loading into
surface waters cannot be assessed without additional data on rates and
routes of foliar interception and dissipation, supplemental terrestrial field
dissipation studies suggest that 87% of applied butralin is intercepted by
tobacco plants (MRID 43749801). Therefore, the actual amount of butralin
reaching surface water is expected to be considerably lower than predicted
by GENEEC. , , ' ' , :
-------
Butralin also has the potential to move into surface waters on
entrained sediments and is expected to be bound on suspended and bottom
sediment in the aqueous environment. Dissolved butralin in the water
column is expected to be degraded by photolysis (t If2 ' 13.6 days)
(MRIDs 44064901 and 00024824). Supplemental runoff studies in
Pennsylvania and Mississippi on sites with 3 to 6% slopes indicate butralin,
applied at 3 Ibs a.i./A, was detected in adjoining farm pond water and
sediment at maximum concentrations of <_ 2 pg/L, and <_ 30 jug/kg,
respectively (PP#4F1431).
The following study is required for butralin: either a 48-hour
embryo-larvae study or a 96-hour shell deposition study with oysters.
The Agency does not have data to assess the chronic effects of
butralin to freshwater invertebrates and is requesting an aquatic invertebrate
life-cycle test.
. ' * ' ' '
(1) Nontarget Plants
The Agency cannot determine the impact of butralin
application to nontarget terrestrial and aquatic plants at this time.
It can be assumed that butralin, an herbicide, will adversely affect
nontarget plants if they are exposed. The Agency is requiring that
the registrant submit Tier 2 testing for terrestrial and aquatic plants.
(2) Terrestrial Organisms
Although, environmental fate characteristics indicate that
butralin is persistent to moderately persistent (aerobic soil half-life
is stable), the overall acute risk to terrestrial organisms is expected
to be low. No avian LOCs were exceeded; the only acute LOG
which was exceeded was for endangered mammals, specifically the
meadow vole and the least shrew, and those only by a small margin
(RQ - 0.4, LOG = 6.1 - 0.2). Although the LOG for restricted
use mitigation has been slightly exceeded, the Agency is not
recommending restricted use classification. The method of
application (coarse spray directed onto the plant) is expected to
reduce the amount of butralin which will reach potential food items
eaten by small mammals in the field.
Supplemental data suggests that butralin may impair the
reproductive ability of mallard ducks at 80 ppm. However, the
Agency cannot fully assess the chronic affects of butralin to birds
without valid data. The supplemental studies only tested at two
52
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levels, the highest being 80 ppm. , These test levels do not
adequately represent avian exposure according to Kenaga as
modified by Fletcher (1994). A mallard reproduction study is
required based on an increase in eggshell' cracking. A bobwhite
reproduction study is also required based on the persistence of
butralin in terrestrial environments.
(3) Conclusions ,
Based upon limited data, the Agency concludes that the
overall, acute impact on freshwater and terrestrial nontarget
organisms and water resources, including ground and surface water,
from the use of butralin on tobacco will be minimal. Available
ecological toxiciry data indicates that there is a "may effect" for
endangered species of aquatic invertebrates, including mollusks and
crustaceans, for acute effects to estuarine marine fish, for acute
effects to mammals, and for ppssible reproductive effects to birds.
Compared to many other pesticides, the amount that the RQ exceeds
the LOG for endangered species is relatively low (Consultation
Request, 1991). This data also shows that the LOG for restricted
use mitigation has been slightly exceeded. However, the Agency
is not recommending restricted use classification because of the
directed method of application. At this time, the Agency does not
have sufficient data to assess the chronic impact .of butralin on
aquatic and terrestrial nontarget organisms and the acute impact on
estuarine and marine invertebrates, and nontarget plants. A more
complete characterization cannot be made until additional
environmental fate and ecological toxicity data are submitted.
These include batch equilibrium data to confirm the estimated K^
value, clarification of different metabolites identified in aqueous
photolysis studies'^ additional terrestrial field dissipation data,
chronic aquatic invertebrate studies, non-target plant studies,
marine/estuarine mollusk studies, and chronic reproduction studies
for mallard duck and bbbwliitequail.
TV. RISK MANAGEMENT AND REREGISTRAUON 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 the submission of the generic (i.e. active ingredient specific) data required to
.' -- :" '.: '-'- " - :.":.-'' ' ''53-"'' '-' '- ' "' ':' ''. ' ; :
-------
support reregistration of products containing butralin as an active ingredient. The Agency
has completed its review of these generic data, and has determined that the data are
sufficient to support reregistration of all products containing butralin for use on tobacco.
Appendix B identifies the generic data requirements that the Agency reviewed as part of
its determination of reregistration eligibility of butralin, 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 butralin and to determine that butralin can be used without resulting in
unreasonable adverse effects to humans and the environment. The Agency therefore finds
that all products containing butralin as the active ingredient for the use on tobacco are
eligible for reregistration. The reregistration of particular products is addressed in Section
V of this document. . -. ,',..'-
The Agency made its reregistration eligibility decision based upon the target data
base required for reregistration, the current guidelines for conducting acceptable studies
to generate such data, published scientific literature, etc. and the data identified in
Appendix B. Although the Agency has found that the use of butralin on tobacco is eligible
for reregistration, it should be understood that the Agency may take appropriate regulatory
action, and/or require the submission of additional data to support the registration of
products containing butralin, if new information comes to the Agency's attention or if the
data requirements for registration (or the guidelines for generating such data) change.
B. Determination of Eligibility Decision
1. Eligibility Decision
Based on the reviews of thegeneric datafor the active ingredient butralin,
the Agency has sufficient information on the health effects of butralin and on its
potential for causing adverse effects in fish and wildlife and the environment. The
Agency has determined that butralin products, labeled and used as specified in this
Reregistration Eligibility Decision, will not pose unreasonable risks or adverse
effects to humans or the environment. Therefore, the Agency concludes that
products containing butralin for tobacco use as a plant growth regulator are eligible
for reregistration.
2. Eligible and Ineligible Uses
The Agency has determined that all currently registered tobacco uses of
butralin are eligible for reregistration.
C. Regulatory Position and Labeling Rationale
The following is a summary of the regulatory positions and rationales for butralin.
Where labeling revisions are imposed, specific language is set forth in Section V of this
document.
' ' ' '. , , 54
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1. Tolerance Reassessment
'- . "" . ' ' "' - 'f '- '
Existing tolerances of 0.1 ppm are currently established for the herbicide
butralin in or oh lima beans, cottonseed, southern peas, soybeans forage, soybeans
and watermelon (40 CFR ง180.358). Products beating these uses have not been
marketed for sometime and the tolerances will be proposedfor revocation.
2L. Tolerance Revocations and Import Tolerances
As part of EPA's reregistration eligibility decision for butralin, all
tolerances cited will be proposed for revocation. Once a pesticide use is no longer
registered in the United States, the related pesticide residue tolerance and/or
food/feed additive regulation generally is no longer needed It is EPA's policy to
propose revocation of a tolerance, and/or food/feed additive regulation, following
the deletion of a related food use from a registration, or following the cancellation
of a related food-use registration. ,EPA has the responsibility under the Federal
Food, Drug, and Cosmetic Act (FFDCA) to revoke a tolerance/ regulation on the
grounds that the Agency cannot conclude that the tolerance/ regulation is protective
of the public health.
The Agency recognizes, however, that interested parties may want to retain
a tolerance and/or food/feed additive regulation in the absence of a U.S.
registration, to allow legal importation of food into the U.S. To assure mat all
food marketed in the U.S. is safe^ under FFDCA, EPA requires the same technical
chemistry and toxicology data for such import tolerances (tolerances without
related U.S. registrations) as are required to support U.S. food use registrations
and any resulting tolerances. See 40 CFR Part 158 for EPA's data requirements
to support domestic use of a pesticide and establishment and maintenance of a
tolerance and/or food/feed, regulation. In addition, EPA requires residue
chemistry data (crop field trials) that are representative of growing conditions in
exporting countries in the same manner that EPA requires representative residue
chemistry data from different U.S. regions to support domestic use of the pesticide
and the tolerance and/or regulation. Additional guidance on the Agency's import
tolerance policy will be published in an upcoming Federal RegisterNoti.ee.
Parties interested insupporting an existing, butralin tolerance as an import
tolerance shouldensure that all pf the data noted above are available to EPA during
its further assessments of existing tolerances and regulations, so that the Agency
may determine whether maintenance of the tolerance and/or regulation would be
protective of the public health.
Codex, Harmonization ' >
Codex harmonization is, not a concern in this reregistration case since
butralin food use registrations have been canceled and no RfD is established.
Butralm is classified as a non-food use pesticide.
--.. .''. "' , "' ' ''..- 55 ' ' . .: , . . ' ' " ' ''. '
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3. Potential Risks to Infants and Children/Aggregate Exposure
/Cumulative Effects
In determining whether infants and children are particularly susceptible to
the toxic effects of a pesticide, EPA considers the completeness and reliability of
the toxicity data base, the nature of the effects observed in toxicity studies, and
other information. Based on current data requirements, only one developmental
study is usually required for non-food use chemicals. However, because butralin
at one time had food uses, a developmental study in a non-rodent species and a two
generation reproduction study are also available for evaluation. There was no
evidence of pre or post natal sensitivity in any of these three studies. The
developmental effects and effects on offspring occurred at dose levels that were
equal to or greater than the maternal NOELs. Thus, the Agency has concluded
that there is no special sensitivity to infants and children from butralin exposure.
. i - - - ' , .
In addition, the Agency believes there is little likelihood of direct exposure
to infants and children since butralin has no food uses and its only use, on tobacco,
will not result in drinking water exposure nor would the tobacco use result in any
non-occupational exposures. The Agency does not have concerns for prenatal
exposures based on the adequate MOEs for handlers and the lack of special
sensitivity seen in the developmental and reproduction studies.
In examining aggregate exposure, EPA takes into account available
information concerning exposures from dietary sources, drinking water and non-
occupational sources. As noted in the preceding paragraph, the only source of
butralin exposure is occupationally related.
The Agency has not yet made a determination regarding the common
mode/mechanism of toxicity of butralin and whether it is appropriate to consider
exposure from butralin with other compounds in order to address cumulative
effects. However, based on the high MOEs for butralin and its lack of dietary
sources, drinking water and non-occupational exposures, the contribution of
butralin exposures to the risks of, other compounds with a common
mode/mechanism of toxicity is likely to be minimal.
4. Occupational Labeling Rationale/Risk Mitigation
A " r , ' ' ' 'i , i ' '''!"" .
;, ,'' ซ i /y1 ',''' ,''',' ',''"' , ' ' . ' ,' ,' " ' ,
All butralin pesticide products are intended for occupational use. There are
currently no butralin products intended for homeowner use.
The Worker Protection Standard (WPS)
On August 21, 1992, the Agency issued worker protection regulations
affecting all pesticide products whose labeling reasonably permits;use in the
production of agricultural plants on any farm, forest, nursery or greenhouse. In
general, products within the scope of the Worker Protection Standard (WPS) had
56
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to bear complying labeling when sold or distributed by the registrant after April
21, ,1994. ,
The WPS labeling requirements pertaining to personal protective equipment
(PPE), restricted entry intervals (REI); and notification are interim. The interim
WPS handler PPE requirements are based solely on the acute dermal and inhalation
toxicity and skin and eye irritation potential of the end-use product. The interim
WPS restricted-entry intervals for agricultural workers are based solely on the
acute dermal toxicity and skin and eye irritation potential of the active ingredient.
The interim WPS "double" notification requirement is imposed if the active
ingredient is classified as toxicity category I for acute dermal toxicity or skin
irritation potential. "Double" notification is the statement on the labels of some
pesticide products requiring employers to notify workers about pesticide-treated
areas orally as Well as by posting of the treated areas. The WPS retained more
stringent PPE, REI, and notification requirements from existing labeling. These
requirements are to be reviewed; and revised, as appropriate, during reregistration
and other Agency review processes. During reregistration, the Agency reviews
risks resulting from WPS uses as well as from all other occupational and
residential uses. .
Personal Protective Equipment for Handlers (Mixers, Loaders, Applicators)
Occupational handler exposures and risks are evaluated jointly. As a result
of the reregistration evaluation of the acute and other adverse effects of butralin,
the Agency has determined that risks to handlers do not Warrant the establishment
of active-ingredient-based minimum personal protective equipment or engineering-
control requirements that would apply to all butralin end-use products. The risks
to handlers are adequately mitigated with the addition of chemical-resistant gloves
for most handler scenarios. .Therefore, the Agency is requiring that all handlers
wear chemical-resistant gloves. ' " ''
Entry Restrictions ,
As a result of the reregistration evaluation of the acute and other adverse
effects of butralin, the Agency has determined that the risks from post^application
exposures to butralin by workers warrant the niinimum WPS REI of 12 hours
following applications of the liquid formulation to tobacco. Furthermore, since
:EPA has determined that the risks from adverse effects following such applications
are" minimal, EPA is establishing the minimum WPS early-entry PPE of coveralls,
chemical-resistant gloves, shoes and socks. At this time, butralin is not a candidate
for a 4-hour REI, since there are no chemical-specific post-application exposure
data and there is a dermal NOEL of 10 mg/kg/day.
57
-------
Worker Notification
Butralin is not classified as toxicity category I for select acute dermal
toxicity or skin irritation potential and is not classified as a severe skin sensitizer.
EPA has no special concerns about butralin for adverse effects where a single
exposure can trigger the effect and EPA has not established an unusually long
restricted-entry interval. Therefore, at this time, EPA is not requiring a WPS
"double" notification statement on the labeling of butralin end-use products.
Other Labeling Requirements
, , " / .''', ' -
The Agency is requiring additional end use labeling statements addressing
application restrictions and user safety requirements.
5. Endocrine Disrupter Effects
EPA is required to develop a screening program to determine whether
certain substances (including all pesticides and inerts) "may have an effect in
humans that is similar to an effect produced by a naturally occurring estrogen, or
such other endocrine effect,.." The Agency is currently working with interested
stakeholders, including other government agencies, public interest groups, industry
and research scientists in developing a screening and testing program and a priority
setting scheme to implement this program. Congress has allowed 3 years from the
passage of FQPA (August 3,1999) to implement this program. At that time, EPA
may require further testing of this active ingredient and end use products for
endocrine disrupter effects.
6. Environmental Assessment
Based upon available data, the Agency concludes that risk to freshwater and
terrestrial organisms and water resources will be minimal. No additional label
statements are required. Certain additional confirmatory data are being required.
7. Restricted Use Classification
Butralin does not require and is not being considered for restricted use.
8. Endangered Species Statement
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
restrictions to protect endangered and threatened species at the county level.
58
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Consultations with the Fish and Wildlife Service may be necessary to assess risks
to newly listed species or from proposed new uses, m the future, the Agency plans
to publish a description of the Endangered Species Program in the Federal Register
and have available voluntary county-specific bulletins. Because the Agency is
taking this approach for protecting endangered and threatened species, it is not
imposing label modifications at this time through the RED. Rather, any
requirements for product use modifications will occur in the future under the
Endangered Species Protection Program." .
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 butralin for the above
eligible uses has been reviewed and determined to be substantially complete.
However, additional confirmatory data are required to fulfill the requirements
h'sted below. Some of these requirements were levied in the Phase 2 and Phase 4
Data Call-in Notices (DO). Only the data requirements that have not been
previously levied by the Agency will be included in the generic DGI -included as
an attachment to this RED document:
; Avian reproduction with quail data, GLN71-4(a)
, Avian reproduction with duck data, GLN 71-4(b)v
Estuarine/Marine toxicity mollusk, GLN 72-3(b)
Life cycle with freshwater invertebrate, GLN72-4(bj
Seedling germination/seedling emergence, GLN 123-1 (a)
Vegetative vigor, GLN 123-l(b)
Aquatic Plant Growth, GLN 123-2
Leaching/adsorption/desorption, GLN 163-1
2. Labeling Requirements for Manufacturing-Use Products
To'remain in compliance with FIFRA, manufacturing use product (ME)
labeling must be revised to comply with all current EPA regulations, PR Notices
; and applicable policies. The MP labeling must bear the following statement under
' Directions for Use: .
' ' ~ " 'I'"''".'' ' - ' , ' , ' Y '
"Only for formulation into an herbicide for use on tobacco" ,
59
-------
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 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 support of such
B. End-Use Products
i1 ' ^
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility has
been made. Registrants must review previous data submissions to ensure that they
ineet current EPA acceptance criteria and if not, commit to conduct new studies.
If a registrant believes that previously submitted data meet current testing
standards, then study MRID numbers should be cited according to the instructions
in the Requirement Status and Registrants Response Form provided for each
product.
2. Labeling Requirements for End-Use Products
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. All end-use product labels [e.g. multiple active ingredient (MAI) labels,
SLN's, and products subject to generic data exemption] must be amended such that
they are consistent with the basic producer labels. See Appendix A for appropriate
rates and restrictions for those supported uses,
a. Occupational Protection
PPE/Engineering Control Requirements for Pesticide Handlers
For sole-active-ingredient end-use products that contain butralin, the
handler personal protective equipment requirements set forth in this section must
be incorporated on all butralin product labels. Any conflicting PPE requirements
on current labeling must be removed. There are currently no multiple-active-
ingredient end-use products that contain butralin.
60
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Products Intended Primarily for Occupational Use (WPS)
,.- -. _ ป .'.''- / ' F '' ~ " -
Minimum (Baseline) PPE Reqmrements The minimum (baseline) PPE for all
occupational uses of butralin end-use products is:
"Applicators and other handlers must wear:
long-sleeve shirt and long pants, :
chemical-resistant gloves*, and ;
shoes phis socks." _./ ; v ; ; ''','
- " _. . - ' , - ,' ' i ' ' ' .- V . ' " ""'
* For the glove statement, use the statement established for butralin through the
instructions in Supplement Three of PR Notice 93-7.
Actual end-use product PPE requirements: The PPE, if any, that would be
established on the basis of Hie acute toxicity category of each end-use product must
be compared to, the active-ingredient-based minimum (baseline) personal protective
equipment specified above. The more protective PPE must be placed on the
product labeling. For guidance on which PPE is considered more protective, see
PR Notice 93-7.
' - ' '. ' ' * " ' . ', -'.-' t
Placement in labeling: The personal protective equipment must be placed on the
end-oise 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. " . ,
Entry Restrictions
-' ' ' '.,.. '... ...' -: - ' '"'
For sole-active-ingredierit end-use products that contain butralin, product
labels must be revised to adopt the entry restrictions set forth in this section. Any
conflicting entry restrictions on current labeling must be removed.
Restricted-entry interval: A 12-hour restricted entry interval (REI) is required for
uses within the scope of the WPS (see tests in PR Notices 93-7 and 93-1 i) on all
end-use products. . '
Early-entry personal protective equipment (PPE): The PPE required for early
entry is:
'-vcoveralls, .'.."' -,^; .. ...... . ' . ' ;/' ' ' '.'' .''..'.' _ -. ^ ;.
chemical-resistant gloves, and .
shoes plus socks. ;
-, ' - ' >.',' '~ ' -. S. s'>
Placement in. labeling: The RE! and^^ early-entry PPE must be inserted into the
standardized REI arid early-entry PPE statements required by Supplement Three
of PR Notice 93-7.
61
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b. Additional Labeling Requirements
The Agency is requiring the following labeling statements to be located on
all end use products containing butralin that are intended 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."
User Safely Requirements
"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."
ซ "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."
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 Reregistratipn Eligibility Decision
(RJED). 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 butralin for
tobacco 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.
' ' ' .' 62
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VI. APPENDICES
63
-------
64
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-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case ButraJin covered by this Reregistration Eligibility Decision Document.
It contains generic data requirements that apply to Butralin in all products, including data
requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Dafa. Requirement (Column 1). The data requirements are listed in the order in which
they appear in 40 CFR Part 158. the reference numbers accompanying each test refer to the test
protocols set in the Pesticide Assessment Guidelines, which are available from the National
Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data hi its files, this
column lists the identifying number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
68
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Butralin
REQUIREMENT .
USE
PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1
61-2A
61-2B
62-1
"62-2
62-3
63-2
63-3
63-4
63-5
;'-
63-6
.. -' '-"" ,
63-7
. .
63-8
63-9
63-10
63-11
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point .
Density
, '- ' " ---
Solubility
/ - " i , ' ' ",-'
Vapor Pressure
Dissociation Constant .
Octanoi/Water Partition
,''' . . ''' ' ' ':
'. .'.. c ;.',
. ' c ;'
'; '-. C
c
'-./...' c:"
c
- \;:c'. /
. ./ ',',,
"'..".c '.
- " "' ... -c, -:
.''-
-'".'' c - '
'.-."CV--
c ''
c
c
: ' C ' -
' ' . c
40979802,41225203
40979802,41225203
40979802,41225203
40979801,41225202
40979801,41225202
40979801,41225202
40979801, 41225201, 41225202,
41784101,42616401
40979801, 41225201, 41225202,
41784101,42616401,
, 40979801 , 41225201 , 41225202,
41784101,42616401
40979801, 41225201, 41225202,
41784101, 42616401 .
40979801, 41225201, 41225202,
41784101,42616401
40979801, 41225201, 41225202,
41784101,42616401 :
40979801,41225201,41225202,
41784101,42616401
40979801,41225201,41225202,
41784101,42616401 ; ;
. 409798Q1, 41225201, 41225202,,
41784101^42616401
40979801, 41225201, 41225202,
41784101,42616401
69
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' ' ' ' .. " ' ' '-. ' ' . . , '. . ' i.
Data Supporting Guideline Requirements for the Registration of Butralin
I^QIMEMENT
63-12 pH
63-13 Stability
ECOLOGICAL EFFECTS
71-1A Acute Avian Oral - Quail/Duck
71-2A Avian Dietary - Quail
71-2B Avian Dietary - Duck
71-3 Wild Mammal Toxicity
72-1A Fish Toxicity Bluegill
72-1C Fish Toxicity Rainbow Trout
72-2A Invertebrate Toxicity
TOXICOLOGY
81-1 Acute Oral Toxicity - Rat
81-2 Apute Dermal Toxicity -
Rabbit/Rat
81-3 Acute Inhalation Toxicity - Rat
8 1-4 Primary Eye Irritation - Rabbit
81-5 Primary Dermal Irritation -
Rabbit
81-6 Dermal Sensitization - Guinea
pig " ' ;
82-1 A 90-Day Feeding - Rodent
82-2 21-Day Dermal - Rabbit/Rat
82-4 90-Day Inhalation - Rat
USE
PATTERN
C
C
C
C
C
C
C
C
C
C
C
C
C
C
>< c
C
c
c
CITATION(S)
40979801, 41225201, 41225202,
41784101, 42616401
40979801, 41225201, 41225202,
41784101,42616401
1606^43
160644
160645
42112701
160647
160647
42636101
42112701
"42660701
42488201
42488201
42020702
42660601
,:,','' ' ~ . ' A ii
43626401,43652701
40419601
42633601
70
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Pata Supporting Guideline Requirements for the Reresistration of Butralin
REQUIREMENT
. USE
PATTERN
CITATION(S)
83-3A Developmental Toxicity - Rat
83-3B Developmental Toxicity - Rabbit
83^4 2-Generation Reproduction - Rat
84-2A Gene Mutation (Ames test)
84-2B Structural Chromosomal
Aberration
84-4 Other Genotoxic Effects
85-1 General Metabolism
ENVIRONMENTAL FATE
160-5 Chemical Identity
161-1 Hydrolysis
162-1 Aerobic Soil Metabolism
163-1 ' Leaching/Adsorption/Desorption
165-4 Bioaccumulation in Fish
C --.. 40419601,40419602,40419603,
41742003^42156101,42156102,
^2156103
C 40419601,41742002,42156104
C 92014039,00154259
C 40121101, 40121102, 40551909
C 40551910
G 00078460, 40121103, 40350901
C 42743201
' i' ' , ' -''''' ; ' ; ., -: '
C 40979802,41225203
C 43669401
C 43201901,' . .,
C 42842301
C 42069702,42069703,42069704,
42069705,'44081601
71
-------
72
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3.
4.
GUIDE TO APPENDIX C
CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Reregistration Eligibility 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,
areincluded.
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
tinpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a
single study,
IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4(d)(4) below for further explanation). In a few
cases, entries added to the bibliography late in the review may be precededby a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is needed.
FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American Rational, Standards Institute
(ANSI), expanded to provide forcertain special needs.
a Author. Whenever the author could confidently be identified, the, Agency has
Chosen to show a personal author. When ho 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. Thedateofthestudyis taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
the date from the evidence contained in the document. When the date appears
-------
as (19??), the Agency was unable to determine or estimate the date of the
document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the
following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
, word "under" is the registration number, experimental use permit
number, petition number, or other administrative number associated
with the earliest known submission.
(3) Submitter, The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume
in which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for
"Company Data Library." This accession number is in turn followed by
an alphabetic suffix which shows the relative position of the study within
the volume.
74
-------
MRID
BIBLIOGRAPHY
-. , /-" /
CITATION
00078460
, 00154259
00160643
00160644
i
00160645
00160647
.ป
40121101
40121102
40121103
Baldwin, J.K. (1972) Evaluation of Compound A-820 on Spermatogenesis of
Mice, Using the Dominant Lethal Test: Contract No. 120-666-12-70. Final rept.
(Unpublished study received Oct 13, 1972 under 2G1285; prepared by Affiliated
Medical Enterprises, Inc., submitted by Union Carbide Agricultural Products Co.,
Inc., Ambler, Pa.; CDL:091821-K)
- ..''.' ' .' ' ' '''.- , ' " '''./'':''
Litton Bionetics, Inc. (1978) Three-generation Reproduction Study in Rats:
Technical Butraliri: Final Report: Project No. 20634. Unpublished study. 75 p
Beavers, J. (1986) Technical Butralin: An Acute Oral Toxicity Study with the
Bobwhite: Final Report: Project No. 215-101. Unpublished study prepared by
Wildlife International Ltd. 17 p.
Fink, R. (1975) Eight-day Dietary LC50-Bobwhite Quail: Technical Butralin:
Final Report: Project No. 113-109. Unpublished study prepared by Truslow
Farms Incorporated. 9 p.
Fink, R. (1975) Eight-day Dietary LC50-Mallard Duck: Technical Butralin: Final
Report: Project No. 113-110. Unpublished study prepared by Truslow Farms
Incorporated. 9 p.
Swigert, J.; Bowman, J. (1986) Acute Toxicity ^f Technical Butralin to Bluegill
Sunfish (Lepomis macrochirus): Report No. 34102. Unpublished study prepared
by Analytical Bio-Chemistry Laboratories, Inc. 43 p.
Hoorn, A- (1986) Muitagenic Evaluation of N-sec butyl-4 tertbuty!2,6
dinitroaniline in the Ames Salnionella/Microsome Plate Test: Laboratory Project
ID: E9461-AM S/M. Unpublished study prepared by Hazelton Biotechnologies.
24p. .".-.-.; .'.'/';:: : ' .'":.-" .''' '' ' ' ,.' '
Boer, W. (1986) Mutagenicity Evaluation of N-sec butyl-4 tertbutyl-2,6
dinitroaniline in the L5178YTK +/Mouse Lymphoma Forward Mutation Assay:
Laboratory Project ID: E9469^1L FM. Unpublished .study prepared by Hazleton
.Biotechnologies. 19p. , '.-.
-' - - ' ' ' ' '' . ' ,''"''-"' ' ' ' 'v -
Taalman, R. (1986) Clastogenic Evaluation of N-sec butyl -4 tertbutyl-2,6
dinitroaniline in an in vitro Sister Chromatid Exchange Assay Chinese Hamster
Ovary (CHO) CeUs: Laboratory Project ID: E9469-SCE. UnpubHshed; study
prepared by Hazleton Biotechnologies. 18 p.
75
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BIBLIOGRAPHY
MRID
CITATION
40350901 Qfone, M. (1986) Evaluation of N-sec butyl-4 Tertbutyl-2,6 Dinitroaniline in the
Rat Primary Hepatocyte Unscheduled DNA Synthesis Assay: Laboratory Project
ID 2099L Unpublished study prepared by Hazleton Laboratories America, Inc.
23 p.
40419601 Leeming, N. (1986) N-sec Butyl-4 Tertbutyl-2,6 Dinitroaniline: Oral (Gavage)
Teratology Study in the Rabbit: Laboratory Project ID: 80/104. Unpublished
study prepared by Hazelton Laboratories Europe Ltd. 143 p.
40419602 Monnot, G. (1987) N-sec Buryl-4 Tertbutyl-2,6 Dinitroaniline: Teratology Study
in ihe Rat by the Oral Rout: Part II: Laboratory Project ID: 609488. Unpublished
study prepared by Hazeltonlnstitut Francais de Toxicologie. 130 p.
'" ( , i ,[' " | ..!, "',,'., v ''' ' ',
40419603 Monnot, G. (1986) N-sec Buryl-4 Tertbutyl-2,6 Dinitroaniline: Teratology Study
in the Rat by the Oral Route: Part I: Laboratory Project ID: 606217. Unpublished
study prepared by Hazeltonlnstitut Francais de Toxicologie. 209 p.
40551909 Young, R. (1988) Mutagenicity Test on N-sec butyl-4 tertbutyl-2,6 dinitraniline
in the CHO/HGPRT Forward Mutation Assay: HLA Study No. 10067-0-435.
Unpublished study prepared by Hazleton Laboratories America. 39 p.
40551910 Murli, H. (1988) Mutagenicity Test on: N-sec butyl-4 tertbutyl-2,6 dinitroaniline
in an in vitro Cytogenetic Assay Measuring Chromo somal Aberration Frquencies
in Chinese Hamster Ovary (CHO) Cells: HLA Study No. 10067-0-437.
Unpublished study prepared by Hazleton Laboratories America, Inc. 35 p.
40979801 Pertuisot, J. (1988) N-sec butyl-4 tertbutyl-2,6 dinitroaniline: Technical Grade
Active Ingredient (Manufacturing Product) Product Chemistry: Laboratory Project
ID: LA/CLD/1291b. Unpublished compilation prepared by Compagnie Francaise
de Produits Industrials. 39 p.
40979802 Pertuisot, J. (1988) N-sec butyl-4 tertbutyl-2,6 dinitroaniline: Technical Grade
Active Ingredient (Manufacturing-use Product): Product Chemistry: Laboratory
Project ID: LA/CLD/1291. Unpublished compilation prepared by Compagnie
Francaise de Produits Industrials. 25 p.
41225201 jPertuisot, J. (1988) N-sec butyl-4-tertburyl-2,6-dinitroaniline: Validation of the
N-Nitrosobutralin Assay Method: Product Chemistry: Preliminary Analysis.
" Unpublished study. 61 p.
76
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BIBLIOGRAPHY
MRID
CITATION
41225202<
41225203
41742002
41742003
41784101
42020702
42069702
42069703
42069704
42069705'
42112701 ,
Pertuisbt, J. (1988) N-sec-butyl^tertbutyl-2,6-dinitroanaine: Product Chemistry.
Unpublished study. 35 p.
Pertuisot, J. (1988) N-sec-butyl-4-tertbutyl-2,6-dinitro;aniluie: Product Chemistry.
, Unpublished study . 25 p.
'f .'.'': * ' -..'. - , ^ ' _ '
Leeming, N. (1987) Butralin: Oral (Gavage) Teratology Study in the Rabbit:
Amendment to Final Report: Lab Project No. 5284-80/104. Unpublished study
prepared by Hazletpn UK. 15 p. , \
Monnot, G. (1986) Butralin: Teratology Study In The Rat By The Oral Route:
Unpublished study prepared by Hazleton FR. 23 p
>' . ' ' ... , . .
Pertuisot, J. (1988) N-sec butyl-4 tertbutyl-2,6 dinitroaniline: Validation of the N.
. Nitrosobutralln Assay Method: Product Chemistry: Preuminary Analysis.
Unpublished study prepared by CFPI Analytical Laboratory. 52 p.
David, R. (1991) Primary Dermal Irritation Test of Technical Butralin in Rabbits:
Lab Project Number: G-7346.242. Unpublished study prepared by
Microbiological Associates, Inc. 21 p.
Sleight, B.; Maceln, K. (1972) Exposure of a Fish to [carbon 14]Labeled A-820
Accumulation, Distribution and Elimination of Residues: Butralin. Unpublished
study prepared by Bionomics, Inc. i9p.
Sleight, B.; Macek, K. (1973) Kinetics of [carbon 14]-A-82Q in Synthetic Aquatic
Ecosystems: Butralin. Unpublished study preparedly Bionomics, Inc. 25 p.
Barrows, M.; Sleight, B. (1974) Kinetics of [carbon 14]-Butralin in a Model
Aquatic Ecosytems. Unpublished study prepared by Bionomics, Inc. 2Tp.
Parkhis, M. (1991) Identity of Accumulated Radioactivity in Blue Gills Exposed ,
to [carbon 14>A-820: Butralin. , Unpublished study prepared by Amchem
Products, Inc., Analytical Research Lab. 11 p.
. ."..","' -. ', - , . ,J,. ' ' '"".'''
David, R. (1991) Acute Oral Toxicity Study of Technical Butralin in Rats: Lab
Project Number; G-7346.220. Unpublished study prepared by Microbiological
Associates Inc. 58 p.
77
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BIBLIOGRAPHY
MRID
CITATION
42156101 Monnot, G. (1991) Supplement to MRID No. 404196-2: Revised Pages from
Hazleton France: ButralinTeratology Study in the Rat by the Oral Route, Part I.
Unpublished study prepared by Hazleton France. 7 p.
42156102 Monnot, G. (1991) Supplement to MRID No. 404196-3: Revised Pages from
- Hazleton France: ButralinTeratology Study in the Rat by the Oral Route, Part EL
Unpublished study prepared by Hazleton France. 7 p.
42156103 CFPI (1991) Supplement to MRID No. 404196-3: CFPI Worksheets: Assay of
Butralin Solutions Used by Hazleton for Dosing Animals. Unpublished study. 6
.'p., . , ,'' ''' ' ' ' ,,'' ".", , . . '.. ;," ;
42156104 CFPI (1991) Supplement to MRID No. 404196-1: Revised Pages from Hazleton
UK: Butralin-Oral (Gavage) Teratology Study in the Rabbit (Unpublished study).
HP-
42488201 Weir, R. (1992) Acute Inhalation Toxicity Study of Butralin in Solvarex 90/180.
in the Rat: Lab Project Number: 1-7356.212. Unpublished study prepared by
Microbiological Associates Inc. 65 p.
42616401 Morrissey, M. (1992) Series 63 Product Chemistry Determinations of Butralin
(Density, Solubility, Vapor Pressure, Octanol/Water Partition Coefficient): Final
Report: Lab Project Number: HWI 6461-100. Unpublished study prepared by
Hazleton Wisconsin, Inc. 71 p.
42633601 Weir, R. (1992) 13-week Subchronic Inhalation Toxicity Study of Butralin in
Solvarex 90/180 in Rats: Lab Project No. 1-7356.142. Unpublished study prepared
by Microbiological Associates. 708 p.
42636101 Evers, R, (1992) Butralin Technical-Acute Toxicity to Daphnids (Daphnia magna)
iinder Static Renewal Conditions: Final Report: Lab Project Number: 92-11-0001:
12874.0892.8101.110. Unpublished study prepared by Springborn Labs (Europe)
AG. 78 p.
42660601 Wenk, M. (1993) Dermal Sensitization Test of Technical Butralin in Guinea Pigs:
Final Report: Lab Project Number: G-7346.245. Unpublished study prepared by
Microbioligical Associates, Inc. 42 p.
78
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BIBLIOGRAPHY
MRH>
CITATION
42660701
42743201
42842301
43201901
43626401
43652701
43669401
44081601
92014039
Wenk, M. (1993) Acute Dermal Toxicity Study of Technical Butralin in Rats:
Final Report: Lab Project No. G-7346.232. Unpublished study prepared by
Microbiological Associates Inc. 30 p. '
Krautter, G. (1993) The Disposition and Metabolism of (carbon 14)Butralin in the
Rat: Lab Project Number: 522:1429. Unpublished study prepared by PTRL East.
522 p. ' - '.--' ' V. -,--, V '' ,,' . .;./-. .;'
- " - : . " ป ' , N ' "
Atkins, R? (1993) Column Leaching of (carbon 14) Butralin in Four Soil Types:
Lab Project Number: 745: 1526. Unpublished study prepared by PTRL East, Inc
9ip. ... -;; , -.', ' , - -- . :..... .. ..- ;-. ,-._;
Atkins, R. (1994) Aerobic Metabolism of (carbon 14) Butralin in Sandy Loam
Soil: Lab Project Number: 1567: 722. Unpublished study prepared by PTRL
East. 103p. .,
Martin, T.; Heath, J.; Duffen, J. (1993) Butralin: 4 Week Dietary Dose Range
Finding Study in Rats: Lab Project Number; 7875: 451031. Unpublished study
prepared by Inveresk Research International. 103 p.
Martin, T.; Heath, J.; Hudson, P.; et al. (1994) Butralin: 13 Week Dietary
Toxicity Study in Rats With 4 Week Recovery Period: Reissued Report: Lab
Project Numbers: 451047: 7947: IRI 451047. Unpublished study prepared by
Inveresk Research Int'l. 366 p.
Bonhoff, A. (1994) (Carbon-14)-Butralin~Determination of Aqueous Hydrolysis
Rate Constants and Half-Lives: Final Report; Lab Project Number: 93-004-1002- \
1002.0593.18103.1715: 04JUN93/OECD 111. Unpublished study prepared by
Springborn Labs (Europe) AG. 59 p.
Hartley, D. (1996) (Carbon-14)-Butralin-Bioconcentratioa and Metabolism Study
with Bluegill Sunfish (Lepomis macrochirus): Final Report: Lab Project Number
12983.0895.6110.140: 052695: 96-2-6388. Unpublished study prepared by
Springborn Labs., Inc.^ 215 p. ; *
Johnston, G. (1990) Scientific & Regulatory Assistance Phase 3 Reformat/of
MRID 00154259. Three Generation Reproduction Study in Rats: Technical
Butralin: Final Report: Study No. 20634; Project No. 2634. Prepared by Litton
Bionetics, Inc. 75 p.
79
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80
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
GENERIC AND PRODUCT SPECIFIC
DATA CALL-IN NOTICE
MAY 27-1998
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
produces) containing this active ingredient. Within 90 days after you receive this Notice you
must respond as. set forth in Section ffl below. Your response must state:
1,
2.
3.
How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 6 or .
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 ni-g): or
Why you believe EPA should not require your submission of data in the manner
specified by this Notice (see section m-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
ypur produces) subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2. All products are listed on both the
generic and product specific Data Call-In Response Forms. Also included is a list of all
registrants who were sent this Notice (Attachment 5).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and,Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No
2070-0107 and 2070-0057 (expiration date 3-31-99). , - '
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This Notice is divided into six sections and six 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 n
Section m
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-
2-
3-
4-
5-
SECTION I.
Data Call-In Chemical Status Sheets
Generic Data Call-In and Product Specific Data Call-In Response Forms with
Instructions (Form A) ..-..,
Generic Data Call-In and Product Specific Data Call-In Requirements Status
&od Registrant's Response Forms with Instructions (Form B)
EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
List of Registrants Receiving This Notice
Confidential Statement of Fohnula, Cost'Share and Data Compensation Forms
\\nHYYOUAREMCEIVINGTHISNOtlCE
The Agency has reviewed existing data for this active ingredient and reevaluated the
data needed to support continued registration of the subject active ingredient. This reevaluation
identified additional data necessary to assess the health and safety of the continued use of
products containing this active ingredient. You have been sent this Notice because you have
produces) containing the subject active ingredient. '
SECTION H. ,PATA REQUIRED BY THIS NOTICE
n-A. DATA REQUIRED
The data required by this Notice are specified in the Requirements Status and
Registrant's Response Forms: Attachment 3 (for both generic and product specific data
requirements). Depending on the results of the studies required in this Notice, additional
studies/testing may be required.
H-B. SCHEDULE FOR .SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified
in the Requirements Status and Registrant's Response Forms (Attachment 3) within the
timeframes provided.
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H-C. TESTING PROTOCOL ' .':'.
' f " ' - '''/-'', ' ' - \ ' ': - -
All studies required under this Notice mustbe Conducted in accordance with test
standards outlined in the PesticideAssessment 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: 703-605-6000). .<. .
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD recommended test standards conform to those
specified in the Pesticide Data Requirements regulation (40 CFR ง 158.70). When using the
OECD protocols, they should be modified, as appropriate so that the data generated by the
study will satisfy the requirements of 40 CFR ง 158. Normally, the Agency will not extend
deadlines for complying with data requirements when the studies were not conducted in
accordance with acceptable standards. The OECD protocols are available from OECD, 2001 L
Street; N.W., Washington, D.C. 20036 (Telephone number 202-785-6323: Fax telephone
number 202-785-0350). , . ,
All new studies and proposed.protocols submitted in response to this Data Call-in
Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160]. V
H-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES ISSUED
BY THE AGENCY ~. ., *, '. . ~~ ~
Unless otherwise noted herein, this Data Call-in does not in any way supersede or
change the requirements of any previous Data Call-In(s), or any other agreements entered into
wifltthe 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 ffi. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
You must use the correct forms and instructions when completing your response to this
Notice. The typeof^Data Call-In you must comply with^(Generic or Product Specific) is
specified m item number 3 on me four Date CaU-In forms (Attachments 2 and 3).
m-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this^Notice for generic and product
specific date 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
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issuance of NOIS due to failure to comply with this Notice are presented in Section IV-A and
IV-B.
m-B. OPTIONS FOR RESPONDING TO THE AGENCY
1. Generic Data Requirements
The options for responding to this Notice for generic data requirements are: (a)
voluntary cancellation, (b) delete use(s), (c) claim generic data exemption, (d) agree to satisfy
the generic data requirements imposed by this Notice or (e) request a data waiver(s).
"i! '. : ^ ^ ^ . * ^ ,,v '',''," ', ' ; "., . ,
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 DI-C. A discussion of options relating to requests for data waivers is
contained in Section m-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
-------
You may avoid the requirements of thisNotice by eliminating the uses of your product
to which the requirements apply. If you wish to amend jtour 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 the1^
Registration Support Branch, Registration Division, Office of Pesticide Programs EPA bv
calling (703) 308-8358. , J '
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 yearfrom the due
date of your 90 day response, is allowed only if the product bears an amended label.
e. Generic Data Exemption -
Under section3(c)(2)(D) of FIFRA, an applicant for registration of a product is
exempt,from the requirement to submit or cite generic data concerning an active ingredient if
the active ingredient in the product is derived exclusively from purchased, registered pesticide
products containing the active ingredient. EPA has concluded, as an exercise of its discretion,
that it normally will not suspend the registration of a productwhich 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 ingredieiit 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;
"a ' " ' | - ' ' , " - '"",',' ' ''' - - '
(ii). Every registrant who is the ultimate source ofthe active ingredient in your
product subject to this DCI must be in compliance with the requirements of this Notice
and must remain in compliance; and
(iii). You must have provided to EPA an accurate and current "Confidential Statement
of Formula".for each of your products to which this,Notice applies. >-.--
To apply for the Generic Data Exemption you must submit a completed Data Gall-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 registrants) who have committed to
generate and submit the required data fail to take appropriate steps to meet requirements or are
85
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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 HI-C.l. of this^Notice and comprise options 1
through 6 of item 9 in the instructions for the Requirements Status and Registrant's Response
Form and item 6b on the Data Call-In Response Form. If you choose item 6b (agree to satisfy
the generic data requirements), you must submit the Data Call-In Response Form and the
Requirements Status and Registrant's Response Form as well as any other information/data
pertaining to the option chosen to address the data requirement. 'Your response must be on the
forms marked "GENERIC" in item number 3-
e. Request for Generic Data Waivers
tyaiveirs for generic data are discussed in Section HI-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
* ' - ';-" - ^ "^ - -- ln , ,
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 IQ-C.2: A discussion of
options relating to requests for data waivers is contained in Section HI-D.2.
Two forms apply to the product specific data requirements one or both of which must
be used in responding to the Agency, depending upon your response. These forms are the
Data-Call-in Response Form, and the Requirements Status and Registrant's Response Form,
for product specific data (contained in Attachments 2 and 3, respectively). The Data Call-In
Response Form must be submitted as part of every response to this Notice. In addition, one
copy of tiie 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
86
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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 productฎ containuig the active ingredient that is the subject of this Notice. If you wish
to voluntarily cancelyour product, you must submit a completed Data CaUL-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; fiuther 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 TV-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 fulfillinggeneric data requirements.
Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
product specific data requirements; It is important to ensure that you are using the correct
forms and instructions when completing your response to the Reregistration Eligibility
Decision document. '-.''
c. Request for Product Specific Data Waivers
Waivers for product specific data are discussed in Section IH-D.2. of this Notice and
are covered by option 7 of item 9 in the instructions for the Requirements Status and
Registrant's Response Form. If you choose this option, you must-submit the Data 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.
m-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
1. Qeneric Data ' ,". ' J
' If you acknowledge on the Generic Data Call-In Response Form that you agree to v
satisfy the generic data requirements (i.e. you select item number 6b), then you must select
'- ' : -. ' ."'' ' - ' 87 '' ' ' '. ' . '.:" '
-------
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 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
; -. . '
If you choose to develop the required data it must be hi conformance with Agency
guidelines 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 n-C of this Notice, you must submit a detailed
description of the proposed protocol and your reason for wishing to use it. The Agency may
choose to reject a protocol not specified in Section II-C. If the Agency rejects your protocol
you will be notified in writing, however, you should be aware that rejection of a proposed
protocol will not be a basis for extending the deadline for submission of data.
A progress report must be submitted for each study within 90 days from the date you
are required to commit to generate or undertake some other means to address that study
requirement, such as making an offer to cost share or agreeing to share in the cost of
developing that study. This 90-day progress report must include the date the study was or will
be initiated and, for studies to be started withia 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
, , . ' ' ..'.-:'. 88 / ' .- '' ' ' '
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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 ti 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 dpes
not grant your request, the original deadline remains. Normally, extensions can be requested
only incases ofextraordinary testing problems beyond the expectation or control of the
registrant. Extensions will not be given in submitting lie 90-day responses,. Extensions will
not be considered if the request for extension is not made in a timely fashion; in no event shall
an extension request be considered if it is submitted at or after the lapse of the subject
deadline; ' -; /'.' ; : ;'. -." ..'.'. . .'..-. .- ; ''. '-. ; '"' '. ''. :-''. ,/
Option 2. Agreement to Share in Cost to Develop Data
If you choose to enter into an agreement to share in the cost of producing the required
data but will not be submitting the data yourself, you must provide the name of the registrant
who will be submitting the data. You must also provide EPA with documentary evidence that
an agreement has been formed. Such evidence may be your letter offering to join in an
agreement and the other registrant's acceptance of your offer, or a written statement by the
parties that an agreement exists. The agreementto 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 did 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
'' ' .'.'-' '' '..-" ' , - . '" ' 89 '' ,. ^ ' . ' -' . .;-- ''.'.''
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registrantฎ 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 6. In addition, you must
demonstrate that the other registrant to whom the offer was made has not accepted your offer
to enter into a cost-sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that offer (such as a certified mail receipt). Your offer must, in. addition
to anything else, offer to share in the burden of producing the data upon terms to be agreed to
or, failing agreement, to be bound by binding arbitration as provided by FIFRA section
3(c)(2)(B)(iii) and must not qualify this offer. The other registrant must also inform EPA of its
election of an option to develop and submit the data required by this Notice by submitting a
Data Call-In Response Form and a Requirements Status and Registrant's Response Form
committing to develop and submit the data required by this Notice.
In order for you to avoid suspension under this option; you may not withdraw your
offer to share in the burden of developing the data. In addition, the other registrant must fulfill
its commitment to develop and submit the data as required by this Notice. If the other
registrant fails to develop the data or for some other reason is subject to suspension, your
registration as well as that of the other registrant normally will be subject to initiation of
suspension proceedings, unless you commit to submit, and do submit, the required data in the
specified time frame. In such cases, the Agency generally will not grant a time extension for
submitting the data.
Option 4. Submitting an Existing Study
If you choose to submit an existing study in response to this Notice, you must
determine that the study satisfies the requirements imposed by this Notice. You may only
submit a study that has not been previously submitted to the Agency or previously cited by
anyone. Existing studies are studies which predate issuance of this Notice. Do not use this
option if you are submitting data to upgrade a study. (See Option 5). >
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid.
and needs to be repeated. .
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
liie requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR
Part 160. As stated in 40 CFR 160,3, "Raw data " means any laboratory
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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 mclude photographs, microrilm or microfiche copies, computer
printouts, magnetic media, mcluding dictated observations, and recorded data
from automated instruments." The term "specimens1', according to 40 CFR
160.3, means "any material derived from a test system for examination or
.' analysis." . ;
b. Health arid safety studies completed after May 1984 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
submission of the existing; study thatsuch 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 mat each study fulfills the acceptance criteria for the
Guideline relevant to thestudy providedinthe 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 documents 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 to40 CFR 158.70 which states the
Agency's policy regarding acceptable protocols. If you wish to submitthe
study, you must, in addition to certifying that the purposes of the PAG are met
by the study, qlearly articulate the rationale why you believe the study meets
,the purpose of the PAG, including copies of any supporting information or
data. It has been the Agency's experience that studies completed prior to
January 1970 rarely satisfied the purpose of the PAG and that necessary raw
data usually are not available :for such studies.
If you submit an existing study, you must certify that the; study meets all requirements
of the criteria outlined above.
If EPA has previously reviewed a protocol for a study you are submitting^ you.must
identify any action taken by the Agency on the protocol and must indicate, as part of your
certification, the manner in which all Agency comments, concerns, or issues were addressed
in the final protocol and study.
If you know of a study pertaining to any requirement in this Notice which does hot
meet the criteria outlined above but does contain factual information regarding unreasonable
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adverse effects, you must notify the Agency of such a study. If such a 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 . .
> , n ' , ' , " ' ' '
If a study has been classified as partially acceptable and upgradeable, you may submit
data to upgrade mat study. The Agency will review the data submitted and determine if the
requirement is satisfied. If the Agency decides the requirement is not satisfied, you may still
be required to submit new data normally without any time extension. Deficient, but
upgradeable studies will normally be classified as supplemental. However, it is important to
note that not all studies classified as supplemental are upgradeable. If you have questions
regarding the classification of a study or whether a study may be upgraded, call or write the
contact person listed in Attachment 1. If you submit data to upgrade an existing study you
must satisfy or supply information to correct all deficiencies in the study identified by EPA.
You must provide a clearly articulated rationale of how the deficiencies have been remedied
or corrected and why the study should be rated as acceptable to EPA. Your submission must
also specify the MRID number(s) of the study which you are attempting to upgrade and must
be in qonformance with PR Notice 86-5..
Do nojt submit additional data for the purpose of upgrading a study classified as
, unacceptable and determined by the Agency as not capable of being upgraded.
This option also should be used to cite data that has been previously submitted to
upgrade a study, but has not yet been reviewed by the Agency. You must provide the MRID
number of the data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to
all data submissions intended to upgrade studies. Additionally, your submission of data
intended to upgrade studies must be accompanied by a certification that you comply with
each of those criteria, as well as a certification regarding protocol compliance with Agency
requirements.
Option 6. Citing Existing Studies . .
If you choose to cite a study that has been previously submitted to EPA, that study
must have been previously classified by EPA as acceptable, or it must be a study which has
not yet been reviewed by the Agency. Acceptable toxicology studies generally will have been
classified as "core-guideline" or "core-minimum." For ecological effects studies, the
classification generally would be a rating of "core." For all other disciplines the classification
would be "acceptable." With respect to any studies for which you wish to select this option,
you must provide the MRID number of the study you are citing and, if the study has been
reviewed by the Agency, you must provide the Agency's classification of the study.
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If you are citing a study of which you are not the original data submitter, you must
submit a completed copy of EPA Form 8570-31. Certification wife 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 dati
production are the first six options discussed under item 9 in the instructions for completing
the Requirements Status and Registrant'sResponse 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) 'f I am submitting an existing studythathas riot been submitted previously to the
Agency by, any one (Submitting ah Existing Study) 1
(5) I am submitting or citing data tp 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 IHC.1, Option 1) except that normally
no protocols or progress reports are required.
Option 2. Agree to Share in Cost to Develop Data If you enter into an agreement to cost
share, the same requirements apply to product specific data as to generic data (see Section
III.C.I, Option 2). However, registrants may only choose this option for acute toxicity data
and certain efficacy data and only if EPA has indicated in the attached data tables thatyour
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 productfor which data will be submitted must be noted in the
agreement to cost share by the registrant selecting tins option.
Option 3. Offer to Share in the Cost of Data Development The same requirements for
generic data (Section IH.C.L, Option 3) apply to this option. This option only applies to acute
toxicity and certain efficacy data as described in option 2 above.
' ,- -.'''.'- 93 "... : '';. '.' . ' ' .:' ' . ';.' . /'. '
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Option 4. Submitting an Existing Study The same requirements described for generic data
(see Section HI.C.1., Option 4) apply to this option for product specific data,
Option 5. Upgrading a Study ~ The same requirements described for generic data (see
Section me.}., Option 5) apply to this option for product specific data,
' , '.', ,: I ," " , . ,."/,; .'.'i."1; '-." r .:,; ':".' ,; :';/'..:; .:;'',' .'.'-' ', ,
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 (m.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 requirements) 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 1he appropriateness of requiring data
for low volume, minor use pesticides. In implementing this provision, EPA considers low
volume pesticides to be only those active ingredients whose total production volume for all
pesticide registrants is small. In determining whether to grant a low volume/minor use waiver,
the Agency will consider the extent, pattern and volume of use, the economic incentive to
conduct the testing, the importance of the pesticide, and the exposure and risk from use of the
pesticide. If an active ingredient is used for both high volume and low volume uses, a low
volume exemption will not be approved. If all uses of an active ingredient are low volume and
the combined volumes for all uses are also low, then an exemption .may be granted, -
depending on review of other information outlined below. An exemption will not be granted
if any registrant of the active ingredient elects to conduct the testing. Any registrant receiving
a low volume/minor use waiver must remain within the sales figures in their forecast
supporting the waiver request in order to remain qualified for such waiver. If granted a
waiver, a registrant will be required, as a condition of the waiver, to submit annual sales
reports. The Agency will respond to requests for waivers in writing.
To apply for a low volume, minor use waiver, you must submit the following
information, as applicable to your product(s), as part of your 90-day response to this Notice:
x . . . . . i
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(i). Total company sales (pounds and dollars) of all registered produces)
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 yeaf 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. "'.'' , '. . s: \
(iii). Total directproduction 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. plairt overhead, amortized plant and
equipment) charged to produces) containing the active ingredient by year for the past
five years. Exclude all non-recurring costs that were directly related to the active
ingredient, such as costs of initial registration arid any data development.
(v) A list of each data requirement for which you seek awaiver. Indicate the
type of waiver sought and the estimated cost to you (listed separately for ซach 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) ofconducting 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 produces) 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 theeffectiveness of the active
ingredient relative to registered alternative chemicals and non-chemical control
strategies. Fpciis on benefits unique to the active ingredient, providing information that
is as quantitative as possible. If you do not have quantitative data upon which to base
your estimates, then present the reasoning used to derive your estirnates. 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 produces): (a) documentation of the usefulness of the active ingredient in
v . . , " . ( "-'/*'' ""*>-,'. " -,*"' - V '=,'."
'..'' ; - . : ' ' .. '95 ' . -, : -,.-': '' '' - -. ' ' ;
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Integrated Pest Management, (b) description of the beneficial impacts on the
environment of use of the active jngredient, 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 produces) 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 hi writing. If the Agency
determines that the data requirements of this Notice are not appropriate to your
produces), you will not be required to supply the data pursuant to section 3(c)(2)(B). If
EPA determines that the data are required for your product(sV 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 FJFRA. 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 arid submit the Pption chosen on the product specific Requirements
Status and Registrant's Response Form. Product specific data requirements for product
chemistry, acute toxicity and efficacy (where appropriate) are required for all products
and the Agency would grant a waiver only under extraordinary circumstances. You
should also be aware mat submitting a waiver request will not automatically extend the
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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 fore
SECTION IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS
', ' NOTICE :':., V ; - - : . ..- . , . ... .
IV-A NOTICE OF INTENT TO SUSPEND
The Agency mayissue a Notice of Intent'.to Suspend products subject to. tiii& 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 arenot limited to, the following:
1.
2.
3.
4.
7.
8.
Failure to respond as required by this Notice within 90 days of your receipt of
this Notice. .;'-, .
Failure to submit on the required schedule an acceptable proposed or final
protocol when such is requireifto be submitted to the Agency for review.
Failure to submit on the required schedule an adequate progress report on a -
study as required by mis Notice. ;
Failure to submit on the required schedule acceptable data as required by this
Notice; .". . . .'.'.. .-....'; ..-.''..'' -_.- . ; _ ,
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 withany terms of a'data
waiver). ,
Failure tosubmit supportable certifications as to the conditions of submitted
studies, as required by Section ffl-C of this Notice.
Withdrawal of an offer to share in the cost of developing required data.
Failure of the registrant to whom you have tendered an offer to share in the cost
of developmg data and provided proof of me registrant's receipt of such offer or
failure of a registrant on whom you rely for a generic data exemption either tor
a). Inform EPA of intent tb develop and submit the data required by this
Notice on a Data Calkin Response Form and a Requirements Status and
Registrant's Response Form.
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9.
b). Fulfill the commitment to" develop and submit the data as required by this
Notice; or ,
c). 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.
1 ' ' ' ' "'"',. Jf " ... '.'''' . ' 1
Failure to take any required or appropriate steps, not mentioned above, at any
time following the issuance of this Notice.
IV-B. BASIS FOR DETERMlMATTON THAT SUBMITTED STUDY IS
UNACCEPTABLE ".'..'''... :
1 , VV1 ' ., ' :', " ; ' ' '!! , , ; '.' : , . .', i, , - ..,;,. ' ; .. ; . ' ' ; . \ . 1 .
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, DataReportihg Guidelines, and GeneTox Health Effects Test Guidelines)
regarding the design, conduct, and reporting of required studies. Such requirements
include, but are not limited to, those relating to test material, test procedures, selection
of species, number of animals, sex and distribution of animals, dose and effect levels
to be tested or attained, duration of test, and, as applicable, Good Laboratory Practices.
2) EPA requirements regarding the submission of protocols, including the
incorporation of any changes required by the Agency following review.
3) EPA requirements regarding the reporting of data, including the manner of
reporting, the completeness of results, and the adequacy of any required supporting (or
raw) data, including, but not limited to, requirements referenced or included in this
Notice or contained in PR 86-5. All studies must be submitted in the form of a final
report; a preliminary report will not be considered to fulfill the submission
requirement
IV-C
5TING STOCKS OF SUSPENDED OR CANCELED PRODUCTS
EPAhas statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or canceled if doing so would be'
consistent with the purposes of the Act
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding generally would
not be consistent with the Act's purposes. Accordingly, the Agency anticipates granting
registrants permission to sell, distribute, or use existing stocks of suspended product(s) only in
exceptional circumstances. If you believe such disposition of existing stocks of your
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produces) 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 ifte quantity of existing stocks and your estimate ofIhe
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 produces) as a response to this Notice
and your product is in full compliance with all Agency requirements, you will have, under
most circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agencywill allowpersons Other thanthe
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 canceled products containing an active ingredient for which the Agency has
particular risk concerns will be determined.on a case-by-casebasis.
Requests for voluntary cancellation received after the 90 day response period required :
by Ibis Notice will notxesult in the agency granting any additional time to sell, distribute, or
use existing slocks beyond ayear from Hie 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 mis Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3-year study is scheduled to be submitted, all progress
reports and other information necessary to establish that you have been conducting the study
in an acceptable and good faith manner must have been submitted to the Agency, before EPA
will consider granting an existing stocks provision.
SECTION V.
REGISTRANTS* OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
. Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the
information to the Agency. Registrants must notify the Agency of any factual information
they have, from whatever source, including but not limited to interim or preliminary results of
studies, regarding unreasonable adverse effects on man or the environment. This requirement
continues as long as the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by
this Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status
Sheet.' ; - . ' ' ' : ' - . .. ..-...-. ' ~~ , v , : ~ r~~
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All responses to this .Notice must include completed Data Call-fa 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,
b (2-
Lois A. Rossi, Director
Special Review and
Reregistration Division
Attachments
The Attachments to this Notice are: -
1- Data Call-In Chemical Status Sheets
2 - Generic Data Call-in and Product Specific Data Call-in Response Forms with
, ' ' '"instructions , ' ( ,..'.'' , :
Generic Data Cali-In and Product Specific Data Call-In Requirements Status
and Registrant's Response Forms with Instructions
EPA Batching of End-Use Produces fior Meeting Acute Toxicology Data
3-
4-
5-
6-
Requirements for Reregistration
List of Registrants Receiving This Notice
Confidential Statement of Formula. Cost Share and Data Compensation Forms
. 100
-------
BUTRALIN DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION ,
' '-'-''' t ' - ' - ' ' .-.-"' "'i -
You have been sent this Product Specific Data Gall-In Notice because you have '
produces) containing Butralin. i
This Product Specific Data Call-in Chemical Status Sheet, contains an nvftrviW ปf
data required by this notice, and point of contact for inquiries pertaining to the reregistration
of Butralin. 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) a list of
registrants receiving this DCI (Attachment 5) and (7) the Cost Share and Data Compensation
Forms in replying to this Butralin Product Specific Data Call-M (Attachment 6). Instructions
and guidance accompany each form. , .,
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete Hie data base for Butralin are
contained in the Requirements Status and Registrant's Response Attachment 3. The Agency
has concluded that additional data on Butralin 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 Butralin products. .-V-
INOUIRIES AND RESPONSES TO THIS NOTICE
; .If you have any questions regardingthis product specific data requirements and
procedures established by this Notice, please contact C.P Moran at (703) 308-8590.
All responses to this Notice for the Product Specific date requirements should be
submitted to:
C.P. Moran, Chemical Review Manager , ;
Product Reregistration Branch
Special Review and Reregistration Branch (7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
; Washington, D.C. 20460 - - :
RE:Butraliri , n
101
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BUTRALIN DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
, ' /
1 ', ' '! ' ' ,",,',,. i ', ,, ,,'; ' _ '
You have been sent this Generic Data Call-In Notice because you have produces)
containing Butralin.
This _(jeneric'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
Butralin. 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 3), (4) a list of registrants receiving this DCI
(Attachment 5), (5) the Cost Share and Data Compensation Forms in replying to this Butralin
Generic Data Call In (Attachment D). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for Butralin
are contained in the Requirements Status and Registrant's Response. Attachment 3. The
Agency has concluded that additional product chemistry data on Butralin are needed. These
data are needed to fully complete the reregistration of all eligible Butralin products.
PTOUIRIES AND RESPONSES TO THIS NOTICE ,
If you have any questions regarding the generic data requirements and procedures
established by mis Notice, please contact Tom Luminello at (703) 308-8075.
All responses to this Notice for the Generic data requirements should be submitted to:
Tom Luminello, Chemical Review Manager
Reregistration Branch III.
Special Review and Reregistration Division (7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460 ,
RE: Butralin
102
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Instructions For Completing The "Data Call-in Response Forms" For The Generic And
Product Specific Data Call-In
INTRODUCTION
\ "--'.; ''' , - v . -J, '. "' ' ',,' '
These instructions apply to the Genetic 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.
Ahhough 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! through-4have been preprinted on thefbrm. Items 5 through7 must be mpleted
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, Regulatory Information
Division, Mail Code 2137, 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. ' ,
105
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In .
Item 1. ON BOTH FORMS: This item identifies your company name, number and
address.
Item 2. ON BOTH FORMS: This item identifies the case number, case name, EPA
chemical number and chemical name.
Item 3. ON BOTH FORMS: This item identifies the type of Data Call-In. The date of
issuance is date stamped. .
Item 4. , ON BOTH FORMS: This item identifies the EPA product registrations relevant
to the data call-in. Please note that you are also responsible for informing the
Agency of your response regarding any product that you believe may be covered
by this Data Call-In but that is not listed by the Agency in Item 4. You must bring
any such apparent omission to the Agency's attention within the period required
for submission of this response form.
Item 5. ON BOTH FORMS: Check this item for each product registration you wish to
cancel voluntarily. If a registration number is listed for a product for which you
- previously requested voluntary cancellation, indicate in Item 5 the date of that
request. Since this Data Call-In requires both generic and product specific data,
you must complete item 5 onboth Data Call-In response forms. Youdonotneed
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 chemicallisted.in Item 2 and used in the subject product. By
electing this exemption, you agree to the terms and conditions, of a Generic Data
Exemption as explained in the Data Call-In Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA
registration Number of each registered source of that active ingredient that you use
in your product. .
Typically, if you purchase an EPA-registered product from one or more other
producers (who, with respect to the incorporated product, are in compliance with
this and any other outstanding Data Call-in Notice), and incorporate that product
into all your products, you may complete this item for all products-listed on this
form. If, however, you produce the active ingredient yourself, or use any
unregistered product (regardless of the /act that some of your sources are
registered), you may not claim a Generic Data Exemption and you may not select
this item.
106
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INSTRUCTIONS FOR COMPLETING THE DATA GALL4N RESPONSE FORMS
Generic and Product Specific Data Call-In ~~~' .- .',-;" . . .' ' . T.,'
Item 6b. ON THE GENERIC DATA FORM; Check this Item if the Data Call-In is for
generic data as indicated in Item 3 and if you are agreeing to satisfy the generic
'..'<"''" data requirements of this Data Call-In, Attach the Requirements Status and
Registrant's Response Form that indicates how you will satisfy those requirements.
NOTE: Item 6a and 6b are not applicable for Product Specific Data.
Item 7a. ON THE PRODUCT SPECIFIC DATA FORM; For each manufacturing use
product (MUP) for which you wish to maintain registration, you must agree to
satisfy the data requirements by responding "yes."
Item 7b. For 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 (7afor MUP's and 7b for EUP's) if
yourproduct 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.
107
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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 initialed and dated in the space
provided for the certification. '
Item 9. QN 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. 0N BOTH FORMS: Enter the phone number of your company contact.
Note
th^
wish to report flat yoOTproA*rthปiakMdybe P1"" "Wfr ซU relevant details so that EPA can emuwtiist its reeoids are comet
108
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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
Fungicide, and Rodenticide Act. If you are an end-use product registrant only and have been
sent this DCI letter as part of a RED document you have been sent just the product specific
"Requirements Status and Registrant's Response Forms." Only registrants responsible for generic
data have been sent the generic data response forms. The type of Data Call-In (generic, or
product specific) is indicated in item number 3 ("Date and Type of DCI") on each form.
Although the form is the same for both product specific and generic data, instructions for
completing the forms differ slightly. Specifically, options for satisfying product specific data
requirements do not include deletion of uses or 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 oh 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. , '
i 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 mamtaiiing 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, Regulatory Information
Division, Mail Code 2137, 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. -
115
-------
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
, , 11 . ." , ', '. i1' :' "'i < . ."' > " '..,
Generic and Product Specific Data Call-In
Item 1.
Item 2.
ItemS.
Item 4.
ItemS.
ON BOTH FORMS:
address.
Thjs item identifies your company name, number and
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.
ON THE GENERIC DATA FORM: This item identifies the type of Data
Call-In. The date of issuance is date stamped.
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 lie transmittal document for any data submissions in response to this Data Call-
in Notice.
ON BOTH FQRMS: This item identifies the guideline reference number of
studies required. These guidelines, in addition to the requirements specified in the
Data Call-In Notice, govern the conduct of the required studies. Note that series
61 and 62 in product chemistry are now listed under 40 CFR 158.155 through
158.180, Subpartc.
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 in of the Data Call-In Notice, 90-day progress reports are required for all
studies.
:i . " ' ' -,,; . . .). ' .' " ] ..... ,, ; ..... ""'. .-,. , . - ,
If an asterisk appears hi Item 5, EPA has attached information relevant to this
guideline reference number to the Requirements Status and Registrant's Response
Form.
116
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specifip Data Call-In
Item 6. ON BOTH FORMS: This item identifies the code associated with the use patteni
of the pesticide, In the case of efficacy data (product specific requirement), the
required study only pertains to products whichL havethe use sites and/or pests
indicated. A brief description of each code follows:
L ,* - " " -* ' .' ' ' "
' ' ' A Terrestrial food
B Terrestrial feed ;v ;
C Terrestrial non-food
P Aquatic food .
x 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 v ' /
L Indqorfodd ,
M Indoor non-food
N Indoor medical
O Indoor residential
Item?. ON BOTH FORMS: This itemIdentifies^e^^code assigned.to the substance that
must be used for testing. A brief description of each code follows:
EUP
MP
MP/TGAI
PAI
PAI/M
PAI/PAIRA
PAIRA
PAIRA/M
PAIRA/PM
TEP
TEP %
TEP/MET
End-Use Product
Manufacturing-Use Product !
Manufacturing-U-se Product and Technical Grade Active
Ingredient
Pure Active Ingredient
Pure Active Ingredient and Metabolites
Pure Active Ingredient or Pure Active
Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled and Metabolites
Pure Active Ingredient Radiolabelled and Plant Metabolites
Typical End-Use Product ,
Typical End-Use Product, Percent Active Ingredient
Specified
Typical End-Use Product and Metabolites
117
-------
Item 8.
tEP/PAI/M
TGAI
TGAI/PAI
TGAI/TEP
MET
IMP
DEGR
Typical End-Use Product or Pure Active Ingredient and
Metabolites
Technical Grade Active Ingredient
Technical Grade Active Ingredient or Pure Active
Ingredient
Technical Grade Active Ingredient or Pure Active
Ingredient Radiolabelled
Technical Grade Active Ingredient or Typical End-Use
Product
Metabolites
Impurities
Degradates
See: guideline comment
This item completed by the Agency identifies the time frame allowed for
submission of the study or protocol identified in item 5.
ON THE GFJSERIC 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.
. lii > - ;'. ".,ป.:;""' 'I1 '', ! f' '.'..:' ::'.;' '..,:";':; " / P .:: i't') - ";; lf:\, ' ', ,,:' '.
Item 9. ON BOTH FORMS: Enter the appropriate Response Code or Codes to show how
y8u intend to comply with each data requirement. Brief descriptions of each code
fallow. The Data Call-in Notice contains a fuller description of each of these
options.
Option L 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 mis option, I certify that I will comply with all the
J requirements pertaining to the conditions for submittal of this study as
outlined in the Data^ Call-in Notice and that I will provide the prptocols 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.
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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 quality for this option. I certify that another party in
the agreement is committing to submit or provide the required data; if the
required study is, not submitted on time, my product may be subject to
suspension. ,
Option 3. ON BOTH FORMS: (Offer to Cost Share) I have made an offer to enter
- into an agreement with one or more registrants to develop data jointly. I
am also submitting a convicted "Certification of offer to Cost Share in the
Development of Data" form. I am submitting evidence that I have made
ah offer to another registrant (who has an obligation to submit data) to
share in the cost of that data. lam including a copyof my offer and proof
of the other registrant's receipt of tiiat offer. I am identifying the party
which is committing to submit of 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 Cail-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 wiU submit an existing
study by the specified due date that has never before been submitted to ,
EPA. By indicating that I have chosen this option, I certify that this study
meets all the requirements pertaining to the conditions for submittal of
existing data outlined in the Data Call-In Notice and I have attached the
needed supporting information along with this response.
Option 5. ON BOTH FORMS: (Upgrading a Study) I will-submit by the specified
due date, or will cite data to upgrade a study that EPA has classified as
partially acceptable and potentially upgradeable. By indicating that I have
chosenthis option,I certify that I have met all the requirements pertaining
to the conditions for'submitting or citing existing data to upgrade a study
described in the Data Call-in Notice. I am indicating on attached
correspondence the Master Record Identification Number (MRID) that
EPA has assigned to the data that I am citing as well as the MRID of the
study I am attempting to upgrade. , .
Option 6. ON BOTH FORMS: (Citing a Study) I am citing an existing study that
has been previously classified by EPA as acceptable, core, core minimum,
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or a study that has not yet been reviewed by the Agency. If reviewed, I am
providing the Agency's classification of the study.
However, for Product Specific Data, I am citing another
registrant's study. I understand that this option is available ONLY for
acute toxicity or certain efficacy data and ONLY if the cited study was
.conducted on my product, an identical product or a product which the
Agency has "grouped" with one or more other products for purposes of
depending on the same data. I may also choose this option if I am citing my
own data. In either case, I will provide the MRID or Accession number (s).
If I cite another registrant's data, I will submit a completed "Certification
With Respect to Data Compensation Requirements" form.
FOR THE GENERIC DATA FORM ONLY; The following three options (Numbers
7, 8, and 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
f registration deleting the uses for which the data are required.
Option 8. (Low Volume/Minor Use Waiver Request) I have read the statements
concerning low volume/minor use data waivers in the Data Call-In Notice
and I request a low volume/minor use waiver of the data requirement. I am
attaching a detailed justification to support this waiver request including,
among other things, all information required to support the request. I
understand that, unless modified by the Agency in writing, the data
requirement as stated in the Notice governs.
Option 9. (Request for Waiver of Data) I have read the statements concerning data
waivers other than low volume/minor use data waivers in the Data Call-in
Notice and I request a waiver of the data requirement. I am attaching a
rationale explaining why I believe the data requirements do not apply. I am
also submitting a copy of my current labels. (You must also submit a copy
of your Confidential Statement of Formula if not already on file with
EPA). I understand that, unless modified by the-Agency in writing, the
data requirement as stated in the Notice governs.
FOR PRODUCT SPECIFIC DATA; The following option (number 7) is a response
that applies to the "Requirements Status and Registrant's Response Form" for
product specific data.
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
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Item 10.
Item 11,
Item 12.
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 J?e required to supply the data pursuant to Section 3(C)(2) (B) of
. FIFRA. If the Agency denies my waiver request,! 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 thes
Agency's written decision, submit a revised "Requirements Status" form
-.: specifying the option chosen. ,1 also understand that the deadline for
submission of data as specified by the original Data Call-in notice will not .
change.
ON BOTH FORMS: This item must be signed by an authorized representative of
your company. The person signing must include his/her tide, and must initial and
date all other pages of this form.
ON BOTH FORMS: Enter the date of signature:
'.''' - '
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 mat 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;keen transferred to another company or that youhave already voluntarily canceled '
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EPA'S BATCHING OF BUTRAUN PRODUCTS FOR MEETING REREGISTRATION
ACUTE TOXICITY DATAREQUIREMENTS
In. an. effort to reduce the time, resources and number of animals- needed to fulfill the acute
tpxicity data requirements for reregistration of products, the Agency has batched products which
can be considered similar for purposes of acute toxicity. Batching was not done for Butralin
since there are only two products.
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Cost Share, Data Compensation Forms, Confidential Statement of Formula
Form and Instructions
1 , , ", , , , , . *
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:
All the blocks on the form must be filled in and answered completely.
If any block is not applicable, mark it N/A. \
The CSF must be signed, dated and the telephone number of the responsible party
must be provided. . ,
All applicable information which is on the product specific data submission must
also be reported on the CSF.
All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids.
Flashpoint must be in degrees Fahrenheit and flame extension in inches.
For all active ingredients, the EPA Registration Numbers for the currently
registered source products must be reported under column 12.
the Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
eoirinion names for the trade names must be reported.
For the active ingredients, the percent purity of the source products must be
reported under column 10 and must be exactly the same as on the source product's
'.label. , " " '" . ''... '
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
tlnits (i.e., pounds and kilograms).
All the items under column 13.b. must total 100 percent.
All items under columns 14.a. and 14.b. for the active ingredients must represent
pure active form.
The upper and lower certified limits for ail active and inert ingredients must follow
the 40 CFR 158.175 instructions. An explanation must be provided if the proposed
limits are different than standard certified limits.
When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific formulation.
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126
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United States Environmental Protection Agency
Washington, D.C. 20460
Certification of Offer to Cost
Share in the Development of Data
Perm Approved
OMB No. 2070-0106,
2070-0057
Approval Expires "
3-31-99
PubBc 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-O106), Washington, DC 20503. ' .
Please fill in blanks below:
Company Nanw
BnoactNanป
BPAIUC.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 developingdata.
' ' ' - " ' '. ' ' ' ' : ' jf* '-'.' ' ' ' - .... .
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)(2MB)(Hi) of FIFRA if final agreement on all terms
could not be reached otherwise. This offer was made to the following firms on the following
date(s): _
Dm of Offer
Certification:
Icertiry 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.
Signatw of Company's Authorized nซnraaantaซiiป
Date
Nam* and TMI* (PlMW Typ* or Flint)
EPA Form 8570-32(5/91} Replaces EPA torn 8580 which is obsolete
127
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128.
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Form Approved
OMB No. .2070-0107,
2070-0057 '
Approval Expires
3-31-99 ;
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, Regulatory Information Division, Mail Code 2137, 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. , N
Company Name ' '-''.- .''".
Product Name ' ,/-.,.- "'..''".'-.
=-. * t '
Company Number
EPA Reg. No.
I Certify that: v
1. For each study cited in support of registration or reregistration 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 ah exclusive use study, lam 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 ariyi 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
reregSstration 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)
tHA l-orm 8570-31 (4-96)
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APPENDIX E - LIST OF AVAILABLE RELATED DOCUMENTS
The following is a list of available documents for Butralin that may further assist you in
responding to this Reregistration Eligibility Decision document. These documents may be obtained
by the following methods:
Electronic .
File format: Portable Document, Format (.PDF) Requires Adobeฎ Acrobat or compatible reader.
Electronic copies can be downloaded from the Internet using World Wide Web on
http://www.epa.gov/ElEDs/, or contact G.P. Moran at (703) 308-8590.
1. PR, Notice 86-5.
2. PR Notice 91-2 (pertains to the Label Ingredient Statement)!
3. A full copy of this RED document.
4. A copy of the fact sheet for Butralin.
The following documents are part of the Administrative Record for Butralin and may be included
in the EPA's Office of Pesticide Programs Public Docket. Copies of these documents are not
available electronically, but may be obtained by contacting the person listed on the Chemical Status
Sheet.
1. Health and Environmental Effects Science Chapters.
2. Detailed Label Usage Information System (LUES) Report.
The following Agency reference documents are not available electronically, but may be obtained
by contacting the person listed on the Chemical Status Sheet of this RED document.
1. The Label Review Manual.
2. EPA Acceptance Criteria.
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