&EPA
United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA 738-R-95-005
March 1995
Reregistration
Eligibility Decision (RED)
Terbuthylazine
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TERBUTHYLAZINE RED FACT SHEET
ERRATA PAGE
June 1995
Please note that an error appears in the Terbuthylazine RED Fact Sheet: t
Title: EPA R.E.D. FACTS; Terbuthylazine
EPA Publication Number: EPA 738-F-95-006
Date: January 1995
This Fact Sheet is published inside the back of the Terbuthylazine RED Document:
Title: Reregistration Eligibility Decision (RED); Terbuthylazine
EPA Publication Number: EPA 738-R-95-005
Date: March 1995
NTIS Number: [unassigned]
Error: ..'-,-•.. •.,;";' ' ": • .. • " : ••
On page 3, in the fourth paragraph (or first paragraph under the subheading
"Human Risk Assessment"), the last word in the paragraph should be "rats"
instead of "rabbits". So the last sentence in this paragraph should say, "However,
it is associated with developmental toxicity in a study using rats."
How Error is Being Corrected:
OPP/EPA is issuing a corrected Terbuthylazine RED Fact Sheet (EPA
publication number EPA 738-F-95-006A, June 1995-please see copy attached),
and is distributing the errata page and corrected fact sheet through normal
document distribution channels. The Agency also is correcting the fact sheet .-
electronically on Internet and the Pesticide Special Review and Reregistration
Information System, an electronic bulletin board system.
Sorry for the Inconvenience!
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
APR 19
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case terbuthylazine.
The enclosed Reregistration Eligibility Decision (RED) contains the Agency's evaluation of
the data base of this[these] chemical[s], its conclusions of the potential human health and
environmental risks of the current product uses, and its decisions and conditions under which
these uses and products will be eligible for reregistration. The RED includes the data and
labeling requirements for products for reregistration. It may also include requirements for
additional data (generic) on the active ingredients) to confirm the risk assessments. ,
To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED". This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses. The first set of required responses are due 90 days from
the date of this letter. The second set of required responses are due 8 months from the
date of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.
If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative C.P.
Moran at (703) 308-8590.
Sincerely yours,
Peter Caulkins, Acting Director
Special Review and
Reregistration Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATIQN ELIGIBILITY DECISION (RED)
1. DATA CALL-IN (PCI) OR "90-DAY RESPONSE"-If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data
are required, another DCI letter will be enclosed listing such requirements. Complete the two
response forms provided with each DCI letter by following the instructions contained in each
DCI. You must submit the response forms for each product and for each DCI within 90
days of the date you receive the RED; otherwise, your product may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER REQUESTS No time extension
requests will be granted for the 90-day response. Time extension requests may be submitted
only with respect to actual data submissions. Requests for data waivers must be submitted as
part of the 90-day response. Requests for time extensions should be submitted in the 90-day
response, but certainly no later than the 8-month response date. All data waiver and time
extension requests must be accompanied by a full justification. All waivers and time
extensions must be granted by EPA in order to go into effect.
3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE" You
must submit the following items for each product within eight months of the RED
issuance date (the cover letter date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in
item 5.
b. Five copies of draft labeling which complies with the RED and current
regulations and requirements. Only make labeling changes which are required by the
RED and current regulations (40 CFR 156.10) and policies. Submit any other
amendments (such as formulation changes, or labeling changes not related to
reregistration) separately. You may delete uses which the RED says are ineligible for
reregistration. For further labeling guidance, refer the labeling section of the EPA
publication "General Information on Applying for Registration in the U.S., Second
Edition, August 1992" (available from the National Technical Information Service,
publication #PB92-221811; 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the
EPA identifier (MRID) numbers. Before citing these studies, you must make sure
that they meet the Agency's acceptance criteria (attached to the DCI).
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
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standard certified limits (see 40 CFR §158.175) or (2) provide certified limits that are
supported by the analysis of five batches. If you choose the second option, you must
submit or cite the data for the five batches along with a certification statement as
described in 40 CFR §158.175(e). A copy of the CSF is enclosed; follow the
instructions on its back.
e. Certification With Respect to Citation of Data. Complete and sign this form
(EPA form 8570-29) for each product. Cite-all is not a valid option for
reregistration.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE
Comments pertaining to the content of the RED may be submitted to the address shown
in the Federal Register Notice which announces the availability of this RED.
5. WHERE TO SEND ALL PCI RESPONSES (90-DAY) AND APPLICATIONS
FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-2646)*
Office of Pesticide Programs (H7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
* 2645 = the
case code for the
RED (see front
cover of RED)
By express:
Document Processing Desk (RED-SRRD-2645)*
Office of Pesticide Programs (H7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVCEWS-EPA will screen all submissions for completeness; those which are
not complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
TERBUTHYLAZINE
LIST B
CASE 2645
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
TERBUTHYLAZINE REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
H. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Estimated Usage of Pesticide 4
D. Regulatory History 4
m. SCIENCE ASSESSMENT 5
A. Physical Chemistry Assessment 5
B. Human Health Assessment 6
1. Toxicology Assessment 6
a. Acute Toxicity 6
b. Subchronic Toxicity 7
c. Chronic toxicity and carcinogenicity 8
d. Developmental Toxicity 10
e. Reproductive Toxicity 11
f. Mutagenicity 12
g. Metabolism 12
h. Reference Dose 13
2. Exposure Assessment 13
a. Dietary Exposure 13
b. Occupational and Residential Exposure 13
3. Risk Assessment 17
a. Dietary 17
b. Occupational and Residential Risk Characterization .... 17
C. Environmental Assessment 20
1. Environmental Fate 20
a. Environmental Chemistry, Fate and Transport 20
b. Environmental Fate Assessment 21
2. Ecological Effects 23
a. Ecological Effects Data 23
(1) Terrestrial Data 23
(2) Aquatic Data 24
(3) Non-Target Insects Data 25
(4) Non-Target Plants Data . 25
b. Ecological Effects Risk Assessment 26
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IV. RISK MANAGEMENT AND REREGISTRATION DECISION 29
A. Determination of Eligibility 29
1. Eligibility Decision 29
2. Eligible and Ineligible Uses 30
B. Regulatory Position '. 30
1. Tolerance Reassessment 30
2. Potential Discharge to Surface Waters 30
3. Endangered Species 31
4. Labeling Rationale 32
V. ACTIONS REQUIRED BY REGISTRANTS 34
A. Manufacturing-Use Products 34
1. Additional Generic Data Requirements 34
2. Labeling Requirements for Manufacturing-Use Products 34
B. End-Use Products 34
1. Additional Product-Specific Data Requirements 34
2. Labeling Requirements for End-Use Products 35
C. Existing Stocks 36
VI. APPENDICES 37
APPENDIX A. Table of Use Patterns Subject to Registration 39
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 55
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Terbuthylazine 67
APPENDIX D. List of Available Related Documents 74
APPENDIX E 77
PR Notice 86-5 79
PRNotice 91-2 101
APPENDIX F. Product Specific Data Call-In 107
Attachment 1. Chemical Status Sheet 121
Attachment 2. Product Specific Data Call-In Response Forms (Form A
inserts) Plus Instructions 123
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions 129
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 133
Attachment 5. EPA Acceptance Criteria 137
Attachment 6. List of All Registrants Sent This Data Call-in (insert) Notice
151
Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 153
APPENDIX G. FACT SHEET 163
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TERBUTHYLAZINE REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Jihad Alsadek
Phyllis Johnson
Environmental Fate and Effects Division
Jose Melendez
Conception Rodriguez
Mary Frankenberry
Health Effects Division
Winston Dang
William Grear
Marion Copley
Charles Frick
Registration Division
Velma Noble
Valdis Goncarovs
Sami Malak
Tom Ellwanger
Economic Analysis Branch
Biological Analysis Branch
Environmental Fate and Groundwater Branch
Ecological Effects Branch
Science Analysis and Coordination Staff
Occupational and Residential Exposure Branch
Toxicology Branch I
Toxicology Branch I
Chemical Coordination Branch
Antimicrobial Program Branch
Antimicrobial Program Branch
Registration Support Branch
Registration Support Branch
Special Review and Reregistration Division
Virginia Dietrich Accelerated Reregistration Branch
Office of Compliance
Phyllis Flaherty Agriculture Branch
Office of Water:
Donna Reed
NPDES Program Branch
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE
a.i.
ADI
ARC
CAS
CI
CNS
CSF
DFR
ORES
DWEL
EEC
EP
EPA
FDA
FIFRA
FFDCA
GLC
GM
GRAS
HA
HOT
LC
•50
LD
50
LD10
LEL
LOG
LOD
LOEL
MATC
MCLG
mg/L
MP
MPI
MOE
MRID
N/A
NPDES
NOEL
OP
OPP
Acid Equivalent
Active Ingredient
Acceptable Daily Intake. A now defunct term for refernce dose (RfD).
Anticipated Residue Contribution
Chemical Abstracts Service
Cation
Central Nervous System
Confidential Statement of Formula
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. Environmental Protection Agency
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
"Federal Food, Drug, and Cosmetic Act
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/L, mg/kg or ppm.
Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50% of the
test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as a
weight of substance per unit weight of animal, e.g., mg/kg.
Lethal Dose-low. Lowest Dose at which lethality occurs
Lowest Effect Level
Level of Concern
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
Milligrams Per Liter
Manufacturing-Use Product
Maximum Permissible Intake
Margin of Exposure
Master Record Identification (number). EPA's system of recording and tracking studies submitted.
Not Applicable
National Pollutant Discharge Elimination System
No Observed Effect Level
Organophosphate
Office of Pesticide Programs
111
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GLOSSARY OF TERMS AND ABBREVIATIONS
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
PPE Personal Protective Equipment
ppb Parts Per Billion
ppm Parts Per Million
PRN Pesticide Registration Notice
Q', The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
SLN Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TMRC Theoretical Maximum Residue Contribution
TLC Thin Layer Chromatography
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
The Agency has completed its review of the target database for terbuthylazine and has
concluded that terbuthylazine products labeled and used as specified in this Reregistration
Eligibility Decision will not cause unreasonable risk to humans or the environment and that
terbuthylazine uses are eligible for reregistration.
Terbuthylazine is an algicide, a microbicide and microbistat used to control algae and
slime-forming algae, fungi, and bacteria. It is formulated as a fiowable concentrate. It is
labeled for aquatic non-food industrial, commercial, and residential uses. Industrial and
commercial uses are for ornamental fountains, ponds, and for water cooling systems,
including evaporative condensers, heat-exchange systems, and commercial and industrial
cooling towers. Residential uses are for ornamental ponds/aquaria. Applications are made as
continuous feed or intermittent slug treatments. Previous to this reregistration decision,
application was allowed either by the open-pouring method or by closed system such as a
metering pump.
The Agency's assessment found unacceptable risk from short and intermediate-term
exposure to workers who use the open-pouring method of application for commercial uses.
Therefore this application method is no longer being allowed. Rather, the Agency is
restricting product application to closed systems and the use of certain personal protection
equipment to reduce exposure and risk to acceptable levels for commercial uses. Risks
associated with residential uses are acceptable and no restrictions are necessary.
Also, risk to aquatic plants is of concern. Phytotoxicity data addressing this concern
recently have been called-in so that the Agency can evaluate the potential environmental
impact of discharges of terbuthylazine under the permitting process of the National Pollutant
Discharge Elimination System.
Before reregistering products containing terbuthylazine, the Agency is requiring that
product specific data, revised Confidential Statements of Formula (CSF) and revised labeling
be submitted within eight months of the issuance of this document. These data include product
chemistry for each registration and acute toxicity testing. After reviewing these data and any
revised labels and finding them acceptable in accordance with Section 3(c)(5) of FIFRA, the
Agency will reregister a product.
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I.
INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregistration of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregistration process to be
completed in nine years. There are five phases to the reregistration process. The first four
phases of the process focus on identification of data requirements to support the reregistration
of an active ingredient and the generation and submission of data to fulfill the requirements.
The fifth phase is a review by the U.S. Environmental Protection Agency (referred to as "the
Agency") of all data submitted to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for registration" before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review of the scientific data base underlying
a pesticide's registration. The purpose of the Agency's review is to reassess-the potential
hazards arising from the currently registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to determine whether the pesticide
meets the "no unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of terbuthylazine. The document consists of six sections. Section I is the
introduction. Section II describes terbuthylazine, its uses, data requirements and regulatory
history. Section III discusses the human health and environmental assessment based on the data
available to the Agency. Section IV presents the reregistration decision for terbuthylazine .
Section V discusses the reregistration requirements for terbuthylazine. Finally, Section VI is
the Appendices which support this Reregistration Eligibility Decision. Additional details
concerning the Agency's review of applicable data are available on request.
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H. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Decision Document:
Common Name:
Terbuthylazine
Chemical Name:
2-(tert-butylamino)-4-chloro-6-(ethylamino)-s-
triazine
Chemical Family:
tnazmes
CAS Registry Number: 5915-41-3
OPP Chemical Code: 080814
Empirical Formula:
C9H16C1N5
Trade and Other Names: Gardoprim, Primatol M, Primatol M80,
Sorgoprim, Bellacide 325, and Bellacide 329
Basic Manufacturer: FMC Corporation
B. Use Profile
The following is information on the current registered uses with an overview of
use sites and application methods. A detailed table of these uses of terbuthylazine
appears in Appendix A.
Type of Pesticide: Algicide, microbicide/microbistat (slime-forming algae,
fungi, and bacteria).
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Use Sites: Aquatic Non-food Industrial - recirculating .
commercial/industrial water cooling systems, recirculating
evaporative condenser water systems, recirculating heat
exchanger water systems, lakes/ponds/reservoirs (without
humanor wildlife use) [e.g. wastewater ponds].
Aquatic Non-food Residential - ornamental ponds/aquaria.
Aquatic Non-Food Outdoor - Aquatic areas/water (e.g. .
aquatic noncrop use products).
Target Pests: slime-forming algae, fungi and bacteria
Formulation Types Registered:
Soluble Concentrate/Liquid - 4 %- 44.7%
'..•'• Technical Grade-96%
Method and Rates of Application:
Equipment -
Method and Rate -
unspecified
Recirculating water system
treatment: continuous or
intermittent (slug) treatment; open
pouring or closed system pump
application. .
Rates and Timing for Terbuthylazine Application in
Chlorinated or Brominated Recirculating Industrial Water
Cooling Systems
*"• , j , I f , *, *• j-ry Hf r
^fAppJIcatioE^Tjiiiing '
Initial
Subsequent
f - i » f* -^ ^ (fs -,
Continuous Feed,
1 ppm
1-9 ppm
" 3 11 " CT ~ * ' $ *" •*
?Slug Application f>t
1-2 ppm
1-9 ppm
For non-chlorinated or non-brominated systems for both
continuous feed and slug treatments, initial application is made at
3 ppm and subsequent applications at 3-9 ppm. Applications to
recycled cooling water ponds is made at 2 ppm by weight.
3.
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Use Practice Limitations:
Preclean systems before applying the pesticide.
Do not discharge effluent containing this pesticide into sewage
systems without notifying the sewage treatment plant authority.
Do not discharge effluent containing this pesticide into lakes,
streams, ponds, estuaries, oceans, or public water. (NPDES
license restriction.)
Do not use where treated water will come into contact with
lawns, trees, shrubs, or .other desirable plants, since injury may
result.
Do not use water from treated systems for irrigation or spraying
of agricultural crops, lawns, or ornamental plants, or for
watering cattle, goats, hogs, horses, poultry or sheep, or for
human consumption.
C. Estimated Usage of Pesticide
According to the manufacturer annual production of terbuthylazine for the years
1992 and 1993 was less than 100,000 pounds. A portion of this production was
exported, no terbuthylazine was imported. It is not known what portion of the
production is used for each of the two sites of use: commercial and industrial water
cooling towers systems and ornamental ponds, fountains and aquaria.
D. Regulatory History
Terbuthylazine was registered in the United States in 1975. Tolerances were
established for terbuthylazine in or on corn fodder and forage, corn grain (including
popcorn grain), and sorghum forage and grain (40 CFR 180.333). However, since no
end-use products were registered for use of terbuthylazine as a herbicide these
tolerances were revoked in 1992 (53 FR 4860, 56 FR 14471, and 57 FR 30132).
Products formulated for end-use were registered as algicide and
microbicides/microbistats starting in 1986. Currently, five products containing
terbuthylazine are registered to a total of three companies.
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A Data Call-In for data required to support the reregistration of terbuthylazine
was issued in 1991. Certain chemical, toxicological, and environmental fate data were
required. Three additional data call-ins were issued: one requiring worker exposure
information, and another requiring specific manufacturing information with respect to
dioxin formation, and a third requiring aquatic plant testing data.
SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Color: Off-white.
Physical State: Powdery solid, waxy and globular.
Odor: Rancid, putrid.
Melting Point: 178 to 179.3°C
Specific Gravity: 22.04 lb/ft3
Solubility at 25°C:
Water 11.5 ppm
Acetone 4.13 g/100 ml
Ethanol 1.50 g/100 ml
Toluene 1.04 g/100 ml
n-Octanol 1.25 g/100 ml
Ethylene glycol..0.236 g/100 ml
Vapor Pressure: 5.8 X 10-7 mm Hg at 25°C
Dissociation Constant: pKb = 1.9 _+ 0.1 at 21 °C
Octanol/Water Partition Coefficient: 1.6 X 103
pH: 6.6 to 7.8 at 25°C
Stability: Not sensitive to metals, metal ions; stable at elevated
temperature, not sensitive to sunlight.
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B. Human Health Assessment
1. Toxicology Assessment
The lexicological data base on terbuthylazine is adequate and will
support reregistration eligibility.
a. Acute Toxicity
The table below summarizes the results of acute toxicity studies
on terbuthylazine and the toxicity categories for the different routes of
exposure.
ACUTE TOXICITY DATA FOR TERBUTHYLAZINE
TEST
Oral LD50 in rat
(MRID 41907702)
4 hr inhalation LC50 in rat
(MRID 41603305)
Dermal LD50 in rat
(MRID 41907703)
Eye irritation in rabbit
(MRID 41907704)*
Dermal irritation in rabbit
(MRID 41907705)*
Dermal sensitization in Guinea pig
(MRID 41907706)*
~1 RESULT'" '" 'fcl
LD50
1000 - 1590 mg/kg (males);
1503 mg/kg (females)
LC50 >5.3 mg/L
LD50 > 2000 mg/kg
Mildly-to-moderately irritating
Slightly irritating
Not a sensitizer
CATEGORY
in
in
in
in
in
N/A
ak
Note: Date pertaining to primary eye irritation, primary dermal irritation, and dermal sensitization are not required to
support the reregistration of the TGAI. These data are presented for informational purposes.
Treatment-related clinical' signs reported following acute oral or
inhalation exposure included piloerection, dyspnea, reduced locomotor
activity and/or diarrhea.
Slightly different results were obtained in two acute toxicity
studies not reported above. In an acute oral toxicity study (MRID
41603304) in rats, an LD50 of >2000 mg/kg was determined (Toxicity
Category III). In an ocular irritation study in rabbits (MRID 41603306),
terbuthylazine caused minimal eye irritation (Toxicity Category IV). The
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more sensitive studies (listed in the above table) are used for regulatory
purposes.
b. Subchronic Toxicity
Subchronic oral toxicity:
In a 28-day oral toxicity study (MRID 00161104), terbuthylazine
(technical, 99.8% a.i.) was administered to male and female RAI (SPF)
rats in the diet at concentrations of 0, 25, 75, 250 or 750 ppm
(corresponding to doses of 0, 2.4, 7.7, 26.6 or 68.7 mg/kg/day in males
and 0, 2.3, 8.1, 27.9 or 63.4 mg/kg/day in females).
At 25 ppm (2.4 mg/kg/day) and higher, dose-related, statistically
significant decreases in mean body weight gain compared to controls
were observed in males (at termination body weight gain was 12, 18, 22
and 35% less than controls, low to high dose, respectively). Relative
thymic weight was reduced (-17%, decreasing to -36% at 750 ppm) and
slight decrease in absolute 1 week kidney weight was also observed
(-4%, decreasing to -25% at 750 ppm). In females, both absolute liver
weights and livenbrain weights were decreased at 25 ppm (2.3
mg/kg/day) and higher (reductions ranged from about -20% to about
-30% at 750 ppm). At 250 and 750 ppm, mean body weights of females
were statistically significantly.reduced in females (-25 and -41%,
respectively). The LEL is 25 ppm (2.3 mg/kg/day) based on decreased
body weight gain, relative thymic weight and absolute kidney weight in
males and possibly decreased liver weight in females. The NOEL is less
than 25 ppm (lowest dose tested).
Subchronic dermal toxicity:
In a repeated dose dermal toxicity study (MRIDs 40514802 and
42059804), terbuthylazine (technical, 97.1% a.i.) was applied daily to
the intact skin of 5 male and 5 female New Zealand White rabbits for 29
consecutive days. Test material was moistened with distilled water and 0
(distilled water), 0.05, 0.5 or 500 mg/kg/day were applied for 6 hrs/day
under occlusive wrap.
At 500 mg/kg/day, reduced body weight gain compared to
controls at day 28 was observed in males (-36%) and females (-39%).
Food consumption was also decreased (-76% and -89% of controls
during week 1 in males and females; between -11% to -54% of controls
at other times). Reduced fecal output was observed sporadically among
both sexes. Mortality occurred in one female, preceded by cachexia,
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hypothermia and muscle wasting. The LEL of 500 mg/kg/day is based
on decreased body weight gain and food consumption in males and
females and, in one female, hypothermia, cachexia and mortality. The
NOEL is 0.5 mg/kg/day.
The following dermal toxicity study was classified as
Core-supplementary due to several study deficiencies (NOEL not
determined, less than 10 animals/dose and some information lacking in
study report) but was considered in determination of appropriate toxicity
endpoints for short- and intermediate-term occupational and residential
risk assessment.
In a siibchronic dermal toxicity study (MRID 00151622), male
and female New Zealand White rabbits were dermally exposed to
terbuthylazine (technical, 99.8% a.i.) at 0, 5, 50 or 500 mg/kg/day (10
animals/sex at 500 mg/kg/day; (5 animals/sex at all other dose levels).
Doses were administered in an aqueous vehicle of 0.1 %
polysorbate/0.5% carboxymethylcellulose. Animals were exposed for 6
hrs/day, 5 days/week. Five high dose animals/sex were sacrificed at 29
days and 5 after a 2-week recovery period.
At 5.0 mg/kg/day, several clinical signs classified as minimal
were observed among males and females. During the first 7 days of the
study, clinical signs were observed only in 1 male (dyspnea,
piloerection, sedation) and 1 female (curved body position). Thereafter,
all animals developed dyspnea, piloerection, sedation and curved body
posture, a few developed tremors (1 male, 2 females), and 1 female had
ataxia. Dermal irritation was also observed hi treated animals. At 50
and 500 mg/kg/day, clinical signs occurred earlier and with greater
severity (classified as moderate). At 500 mg/kg/day, body weight gain
was decreased compared to controls (-87% for males and -73% for
females) and food consumption was decreased compared to controls
during weeks 1 and 2 (- 2% to - 71% for males; 23% -37% for
females). The LEL of 5.0 mg/kg/day is based on clinical signs in males
and females. The NOEL is less than 5.0 mg/kg/day.
c. Chronic toxicity and carcinogenicity
Mouse;
In a 2-year chronic feeding/carcinogenicity study (MRID
00156487), terbuthylazine (technical, 98% a.i.) was administered in the
diet to 50/sex/dose Tif:MAGF (SPF) mice at dose levels of 0, 30, 150
-------
or 750 ppm (males: 0, 3.28, 16.99 or 86.76 mg/kg/day; females - 0,
3.22, 16.66 or 88.54 mg/kg/day).
Percent body weight gain of males in the 750 ppm group was
decreased by approximately 10%, while in females it decreased by
approximately 23% throughout most of the study. Food consumption in
males at 750 ppm was decreased by approximately 20% throughout most
of the study. The LEL for systemic toxicity is 750 ppm based on
decreased body weight in females and a possible decrease in food
consumption in males. The NOEL for systemic toxicity is 150 ppm.
there was no evidence that administration of terbuthylazine was
associated with an increase in tumors.
Rat:
In a 2- year chronic feeding/carcinogenicity study (MRID
00156486), terbuthylazine (technical, 96.8% a.i.) was administered'for
24 months to a total of 80/sex/dose Tif:RAIF(SPF) rats at dose levels of
0, 30, 150 or 750 ppm (males: 0, 1.24, 6.97 or 41.47 mg/kg/day;
females: 0, 1.37, 7.81 or 52.80 mg/kg/day). Twenty sex/dose of these
were sacrificed at 24 months and 10/sex/dose at 12 months. The
remaining animals received terbuthylazine for 24 months and were then
placed on untreated diet until terminal sacrifice at weeks 112 (males) or
122 (females).
At 30 ppm and above, decreased body weight gain was observed
in males (10%, 28% and 49% less than controls at week 54, low to high
dose) and females (12%, 32% and 47% at week 54, low to high dose).
At 30 ppm and above, food consumption was decreased in males (9%,
14% and 25% at 54 weeks) while in females only at 150 ppm and above
(10% at 54 weeks). At 150 ppm and above in females, BUN and urinary
specific gravity were increased while urinary volume and pH were
decreased. These changes were noted in males at 750 ppm only. At 750
ppm, there were increased lesions observed in males compared to
controls, including macroscopic hepatic cysts, Leydig cell nodular
hyperplasia of the testes (27% vs 9% in the controls) and increases in
benign interstitial cell tumors of the testes (13% vs. 4% in the controls).
In females at the 750 mg/kg/day dose there were increased lesions
including macro- and microscopic hepatic cysts and mammary gland
carcinomas (18% vs. 5%, controls). The LEL for systemic toxicity is 30
ppm (1.24-1.37 mg/kg/day) based on decreased body weight gain in
males and females and food consumption in males. The NOEL is less
than 30 ppm. Terbuthylazine was associated with increased incidence of
testicular interstitial cell tumors in males and mammary gland
-------
carcinomas in females, but only at a dose at which excessive systemic
toxicity was also observed. The Office of Pesticide Program's Health
Effects Division (HED) Carcinogenicity Peer Review committee
considered the systemic toxicity observed at 750 ppm to be excessive
(exceeding the maximum tolerated dose or MTD) and the slight
increases in tumor incidence to be of uncertain relevance to human
cancer risk assessment (see "Carcinogenicity", below).
In a second 2-year chronic feeding/carcinogenicity study
designed to determine a NOEL for chronic systemic toxicity (MRID
00157342), terbuthylazine (technical, 98% a.i.) was administered to
80/sex/dose Tif:RAIF(SPF) rats at dose levels of 0, 6 or 30 ppm (males
- 0, 0.35 or 1.6 mg/kg/day; females - 0, 0.36 or 1.6 mg/kg/day).
Animals fed for 98 weeks were placed on diets lacking the test material
until final sacrifice at week 118 (males) and 121 weeks (females).
At 30 ppm there were decreases in percent body weight gain in
males (7% less) and females (12% less) as well as decreases in food
consumption in males (6% less than controls) and females (11% less) as
compared to controls. The LEL for systemic toxicity is 30 ppm based on
transient decreases in body weight and food consumption consistent with
another study. The NOEL for systemic toxicity is 6 ppm.
Terbuthylazine administration was not associated with an increase in
tumors at the doses tested.
On May 25, 1994 (Peer Review Document dated August 24,
1994), the Agency's Carcinogenicity Peer Review Committee classified
terbuthylazine as a Group D Carcinogen (inadequate evidence to
determine Carcinogenicity in humans). The incidence of benign
interstitial tumors in testes of male rats and of mammary gland
carcinoma in female rats was increased, but the increase was only
observed at a dose at which excessive toxicity was observed (750 ppm).
The classification was assigned because although terbuthylazine is
structurally related to other s-triazines that induce similar types of
tumors, tumors were only observed at a dose that exceeded the MTD
and were only seen in one species.
d. Developmental Toxicity
Rabbit;
In a rabbit developmental toxicity study (MRID 00130744),
female New Zealand White rabbits were dosed by gavage from days 7
through 19 of gestation with terbuthylazine (technical, 98.5% a.i.) in
10
-------
1% methylcellulose atO, 0.5, 1.5 or 4.5 mg/kg/day. Animals were
sacrificed on day 29 of gestation.
No signs of maternal toxicity were observed at any dose tested
(in a preliminary study, body weight loss was observed at 12.5
mg/kg/day but not at 5 mg/kg/day in the rabbit). The maternal toxicity
LEL is greater than 4.5 mg/kg/day. The maternal toxicity NOEL is
equal to or greater than 4.5 mg/kg/day. No signs of developmental
toxicity were observed in the rabbit at any dose tested. The NOEL for
developmental toxicity is equal to or greater than 4.5 mg/kg/day. The
LEL for developmental toxicity is greater than 4.5 mg/kg/day.
Although an LEL for developmental toxicity was not established, this
study is considered adequate for regulatory purposes since (1) the data
indicate that the rabbit is not more sensitive than the rat for
developmental toxicity since the NOEL is not significantly lower in the
rat (4.5 mg/kg/day vs. 5.0 mg/kg/day, respectively), as described
below, and (2) the rabbit preliminary study indicated that maternal
toxicity was observed at 12.5 mg/kg/day.
Rat:
In a rat developmental toxicity study (MRID 41962701), female
Tif:RAI (SPF) rats were administered 0, 1, 5 or 30, mg/kg/day
terbuthylazine (technical, 96.4% a.i.) by gavage in an aqueous 3% corn
starch vehicle (10 ml/kg) on days 6 through 15 of gestation, inclusive.
Animals were sacrificed on day 19 of gestation.
Maternal toxicity was observed at 30 mg/kg/day as significantly
reduced body weight gain (60% less than controls) during the treatment
period compared to controls and food intake was also reduced (18%).
The maternal toxicity LEL is 30 mg/kg/day based on decreased body
weight gain and food intake. The maternal toxicity NOEL is 5
mg/kg/day. Developmental toxicity was also observed at 30 mg/kg/day
based on a dose-related increased incidence of absent ossification of the
posterior phalanx of anterior digit 2 (30% litter incidence vs. 10% of the
controls). The developmental toxicity LEL is 30 mg/kg/day based on
absent ossification in anterior digit 2. The developmental toxicity NOEL
is 5 mg/kg/day.
e. Reproductive Toxicity
Acceptable data on reproductive toxicity is not available to the
Agency at this time. However, a 2-generation reproduction study in the
rat is not required to support reregistration of terbuthylazine and its
11
-------
current uses. In the future if food uses are proposed a 2-generation
reproduction study will be required to support registration.
f. Mutagenicity
Terbuthylazine was negative for reverse gene mutation in
Salmonella typhimurium strains in assays when tested with or without
metabolic activation up to limits of solubility (5 mg/ml) in two
independently conducted studies (MRIDs 00108817 and 00140816;
MRID 41634001).
In a mouse L5178T/TK+/- assay, terbuthylazine did not cause
increased mutation frequency with or without metabolic activation when
tested up to 1 mg/ml (MRID 00151618).
In a mouse micronucleus assay, terbuthylazine did not cause
increased micronuclei formation in bone marrow following
administration to mice up to the limit dose of 5000 mg/kg (MRIDs
41418102 and 42059805).
Terbuthylazine did not induce unscheduled DNA repair in
cultured rat hepatocytes at test concentrations up to 125 //g/ml or 1000
//g/ml in two independently performed studies (MRIDs 41391801 and
42059806; MRID 00151619). Terbuthylazine was also negative when
tested for unscheduled DNA repair at concentrations of up to 125 //g/ml
in cultured human fibroblasts (MRID 00151620).
g. Metabolism
Although a guideline metabolism study has not been required (or
submitted) for the nonfood uses, adequate information is available from
two published metabolism studies to provide a general characterization
of metabolism of terbuthylazine in rats. Metabolism of terbuthylazine in
rats is similar to other chloro-s-triazine herbicides. The major routes of
metabolism are hydrolysis of the chlorine moiety and mono- or
didealkylation. Hydroxylation of one or both of the dealkylated amine
groups may also occur (MRID 00055672).
In a rat metabolism study (MRID 00038018), 14C-terbuthylazine
(3.6 mg) was administered orally to Wistar rats. Terbuthylazine was
rapidly (50% excreted by 16-17 hrs) and completely metabolized and did
not accumulate in tissues. Radioactivity was excreted equally in urine
and feces in males, but in females about 66% of the radiolabel was
12
-------
excreted in the urine. Urine and feces contained up to 25 and 15
identified metabolites, respectively, most of which were polar. .
Degradation of the triazine ring did not occur. Ammeline and ammelide,
2 dechlorinated and dealkylated/hydroxylated metabolites common to all
triazines, were identified in low amounts in the feces.
h.
Reference Dose
The Agency's Office of Pesticide Program's HED RfD/Peer
Review Committee recommended establishing an RfD of 0.00035
mg/kg/day for terbuthylazine. This was based on an NOEL of 0.35
mg/kg/day from the chronic toxicity study in rats, where effects on body
weight and food consumption were observed in males and females at 1.6
mg/kg/day. An uncertainty factor of 100 was used to account for inter-
and intra-species variability, with an additional factor of 10 to
compensate for lack of non-rodent chronic toxicity data and reproductive
toxicity data. A reference dose is used in assessing risk from food
treated with a pesticide registered with the Agency. Before registering
uses of terbuthylazine the Agency's RfD Committee would need to
approve the RfD.
2. Exposure Assessment
a. Dietary Exposure
No dietary exposure is expected since there are no pesticidal
products with food uses currently registered.
b. Occupational and Residential Exposure
The Agency requires an occupational and/or residential exposure
assessment for an active ingredient if (1) certain lexicological criteria are
triggered and (2) there is potential exposure to mixers, loaders, or
applicators during use or to persons entering sites after application is
complete. The Agency has determined that an exposure assessment is
required for terbuthylazine, since it triggers the lexicological criteria
(systemic toxicity in the developmental toxicity study) and the normal
use-patterns identified for terbuthylazine products potentially expose
persons associated with its use.
The Agency has identified potential for exposure to loaders and
applicators during commercial/industrial applications of terbuthylazine.
The Agency also has identified potential for post-application exposure to
. persons cleaning or maintaining water cooling towers and to persons,
13
-------
especially children, wading or swimming in commercial or residential
fountains or ornamental ponds. Assessments of these exposures are
described below.
Mixer/Loader/Applicator (Handler) Exposure;
Toxicological data submitted to support reregistration indicate
that short and intermediate-term exposures to terbuthylazine may cause
health effects, and therefore, an occupational and/or residential exposure
assessment is warranted. No exposure data specific to terbuthylazine are
available. However, surrogate exposure data from the Chemical
Manufacturers Association's Antimicrobial Exposure Assessment Study
(MRIDs 41412201, 41742601, and 42587501) is considered by the
Agency to be appropriate for use in estimating human exposure to most
uses of antimicrobials, including those of terbuthylazine.
The Agency conducted exposure assessments for applicators of .a
typical product used in industrial water cooling tower systems and
commercial and residential/homeowner ornamental fountains for control
of algae. Use practices for a typical industrial use product, Belclene
329® (EPA Registration Number #279-3137), containing 44.7%
terbuthylazine, were used in the analysis. (Another formulation
containing 4.0% terbuthylazine is registered but due to low
concentration of terbuthylazine in this formulation lower exposure would
be expected during its use.) The Agency assumes the quantity of active
ingredient used in ornamental fountains is less than one-tenth of that
used in typical industrial sites based on smaller volumes of water at
ornamental fountains.
14
-------
I. Open-Pouring Application Method
Belclene 329®, is applied by open pouring where there is good
mixing with the water such as in the cooling tower sump near the
recirculating pump or near the fountain recirculatory pump. Eight fluid
ounces of Belclene 329® are applied into 10,000 gallons of water in
industrial/commercial systems (this results in a concentration of 3 ppm
of active ingredient). This assessment assumes no use of personal
protective equipment since no such requirement is specified on labels.
Assuming one gallon of Belclene 329 is equivalent to 11 pounds, a total
amount of product equal to 0.31 Ib of a.i. is added into 10,000 gallons
of water in industrial/commercial systems each application time (or one-
tenth as much to ornamental fountain).
Estimates for daily exposure can be calculated as (MCS X Ib ai
used ai) / BW, where the Maximum Credible Sum (MCS) is assumed to
be the amount of a.i. the applicator is exposed to from each pound of
a.i. applied and the applicator is an adult female of average body weight
(BW). Based on these assumptions for open-pouring of a terbuthylazine
product, the Agency estimates daily exposure to be 140.17 //g/kg/day
for the industrial/commercial uses or 14.02 //g/kg/day for the residential
use. Exposure from open pouring would be greater in larger systems ~
increasing with the volume of water treated. It would also be expected
to increase with a higher frequency of application, for example during
the initial charging of the system until a maintenance level was obtained.
,X '', ' 'V W ^^>®$
j( 6 i>S f
Site of Use Jr" ;
s ' ~ r s*1
Cooling
Tower & Commercial
Ornamental Fountain
Residential Ornamental
Fountain
iii^otJto^tkDtif^' % -'u'r'^: ?
, 'MCS1
(ug/lb ai)
27130
27130
} ^
$> -
ai/used
0.31
0.03
flW2
. ' (kg) '
60
60
Daily Exposure5'
(Aig/kg/d)
140.17
14.02
1 MCS = Maximum Credible Sum, or the unit exposure, derived from the CMA Study.
2 BW = Body Weight
3 Daily exposure = the estimated exposure during a single application of the chemical.
15
-------
n. Metering-Pump Application Method
Based on the use of a metering pump application method and an
estimate for exposure (MCS) from the CMA study, the Agency
estimates daily exposures to be 4.81 ug/kg/day for exposure to
commercial applicators and 0.0048 mg/kg/day to homeowner users.
Unlike the open-pouring application where applicators could potentially
be exposed during each application, exposure to workers using a closed
application system is expected to be lower since exposure would occur
less frequently during handling when bulk containers are coupled to and
uncoupled from the closed application system. For this reason the size
of the system treated is expected to have a negligible effect on exposure
to workers. In addition, a higher frequency of application as in the
initial charging of the system until a maintenance level is obtained is also
not expected to increase exposure significantly.
J"1"?"* * V £{;,>' v ;V V Hi^i^O-BT
Site of Use
Cooling Tower &
Commercial Fountain
Residential Ornamental
Fountain
MCS1
930
930
ilp-t tffrttn4*'* ' ''* '
t
lb ai/used
0.31
0.03
BW2
(kg)
60
60
' ' -s
i !',u j i (
Oaity; , „
Bi?posui;e3
4.81
0.48
1 MCS = Maximum Credible Sum was derived from the CMA Study.
2 BW = Body Weight
3 Daily exposure = the estimated exposure during a single application of the chemical.
Post-Application Exposure;
Because of the use patterns and the dilution factors in the water cooling
tower systems and ornamental fountains (3 ppm of terbuthylazine), post-
application exposure is expected to be minimal. Therefore, the Agency has not
required post-application exposure data or attempted to quantify such potential
exposure.
16
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3. Risk Assessment
a. Dietary
The Agency did not conduct a dietary risk assessment for
terbuthylazine since there are no food or feed uses for this chemical at
this time.
b. Occupational and Residential Risk Characterization
Toxicological Endpoints
Short-term occupational exposure (1-7 days): The Agency
believes the pertinent lexicological endpoint for short-term occupational
or residential exposure and risk assessment for the current use patterns
of terbuthylazine is the LEL (5.0 mg/kg/day; LDT) from the 28-day
rabbit dermal toxicity study (MRID 00151622) described above in
Section II; A NOEL was not determined in this study). Although this
study has certain deficiencies the LEL of 5.0 mg/kg/day from this study
is considered appropriate for risk assessment because 1) exposure was
via the dermal route and (2) the summarized daily clinical observation
data indicate that during days 1-7 of the study, only marginal clinical
signs of toxicity were observed in 1-2 males and females. For short-
term exposure, 5.0 mg/kg/day is therefore considered a threshold LEL
and an appropriate-endpoint for risk assessment. The NOEL of 0.5
mg/kg/day from the other 28-day dermal toxicity study (MRIDs
40514802 and 42059804) was considered not representative of
terbuthylazine toxicity due to: 1) the large difference between doses
selected for this study — the 1000-fold difference between the two
highest doses -- 0.5 vs. 500 mg/kg/day means the study was not very
precise in measuring toxicity and 2) oral toxicity data from both the
rabbit and the rat are consistent with this selection (for example the
NOEL of 2.4 mg/kg/day in the rat subchronic dermal toxicity study
demonstrates toxicity occurs at exposure much closer to 5 mg/kg/day
than 0.5 mg/kg/day).
Intermediate-term occupational or residential exposure (1 week-
several months): The pertinent toxicological endpoint for intermediate
term occupational or residential exposure risk assessment is 1.5
mg/kg/day (mid-dose in the gavage rabbit developmental toxicity study).
The duration of the study used as an endpoint to assess occupational or
residential risk should be comparable to intermediate-term exposure.
Consideration was given to the fact that in the two subchronic dermal
toxicity studies, there were no doses tested between 0.5 (NOEL) and 5.0
17
-------
(LOEL) mg/kg/day. Therefore, the rabbit gavage developmental
toxicity (NOEL >4.5 mg/kg/day) and the rat subchronic oral toxicity
(LOEL=2.3 mg/kg/day) studies were considered in selecting the
intermediate exposure endpoint. Because the 4.5 mg/kg/day NOEL was
so close to the 5.0 mg/kg/day LOEL observed in the subchronic dermal
study, the mid-dose from the rabbit developmental toxicity (1.5
mg/kg/day) was selected as the intermediate-term exposure endpoint.
Although no toxicity was observed in the rabbit developmental
toxicity study up to 4.5 mg/kg/day or at 5.0 mg/kg/day in the rat
developmental toxicity study, systemic toxicity was observed in a rabbit
dermal study at 5.0 mg/kg/day mentioned above, and in the 28-day
rabbit feeding study at 2.3 mg/kg/day. A NOEL of 0.5 mg/kg/day was
established for rabbit dermal toxicity, but no intermediate doses were
tested between 0.5 and 5.0 mg/kg/day. The rabbit developmental study
mid-dose (1.5 mg/kg/day) was therefore considered by the Agency to be
a more realistic endpoint for risk assessment.
Risk Characterization
Application:
The Agency is concerned for potential risk of toxicity to handlers
based on the above two endpoints demonstrating toxicity to laboratory
animals and the presumption that handlers will be exposed to
terbuthylazine. To provide a quantified comparison between the
estimate of the lexicological endpoints and exposure for handlers, the
Agency used the following equation for calculating the margin of
exposure (MOE):
MOE = Toxicological endpoint (mg/kg/day)
Daily exposure (mg/kg/day)
Based on the endpoints for short-term occupational or residential
exposure (5.0 mg/kg/day) and for intermediate term occupational or
residential exposure (1.5 mg/kg/day) the following MOEs are calculated
for applying Belclene 329® at typical rates to water cooling towers or
ornamental fountains using either an open pouring or a closed pump
method.
18
-------
Margins of Exposure From Typical (3 ppm) Terbuthylazine
Application to Industrial and Residential Sites
X&rameMial:
i- trj „,
'Open..flooring System
fclosed Pump System
Short-term
36
1000
Intermediate-term
11
310
One product, Biosperse 288 Algistat (EPA Registration Number
279-3137), may be maintained at up to 9 ppm a.i. (20 ppm of product
containing 44.7% a.i.) for the control of algae within the system. This use
increases estimates of exposure for the open poring system by a multiple
of three (see table below). However, this higher exposure does not alter
the Agency's position; risk from open-pouring is unacceptable. With a
closed system greater risk from a higher rate of application is not expected
because workers are not exposed to the pesticide during application.
Margins of Exposure from B(igh (9 ppm) Terbuthylazine Application
to Industrial Sites
';"" $""; '"4"s '^ '" -v ' i
, >i J1 i , ' " '* T
Commercial: «
i<- r,
>. f , ' "
Short-term
Intermediate-term
£''*'" ^* *' £ ^ v V "" " ^ % ^
' 5 ' ' ''*- 'l^af|l»s olS^6strCat ^fptB; Rafe ' '" ^
*.», L z j* «-f -r
,- Open Pouring - i
* System ; ^ l>
12
4
•>!!<'? < s f > / sr
Closed-Pump System
( K « «#* i "••
1000
310
In contrast, the Agency believes there are acceptable margins of
exposure from use of the products intended for residential use for both the
open pouring and closed system methods of application.
Margins of Exposure from Terbuthylazine Application to Residential
Sites
fBx|K>s^.,S£^aE|^ f i
Residential:
Short-term
Intermediate-term
'/',, \ ' •• * ' ^ ' , c/ S1> i
, ' v" ; ^ * * ' Maj^ia^of;ixp6sure , \, f "
^
Open Pouring System
360
110
Closed Pump'System
> 10,000
3000
19
-------
Post-Application:
Because of the use patterns and the dilution factors in the water
cooling tower systems and ornamental fountains, MOEs from post-
application exposure are expected to be much higher than those presented
above for handlers.
C. Environmental Assessment
1. Environmental Fate
At this time, all data requirements in the environmental fate
guidelines are fulfilled for the current use pattern of terbuthylazine.
a. Environmental Chemistry, Fate and Transport
Hydrolysis
There are sufficient data available to conclude that
terbuthylazine is stable to hydrolysis. Terbuthylazine was stable in
sterile aqueous pH 7 and 9 buffer solutions, and relatively stable in
pH 5 buffer solutions that were incubated in the dark at 25 °C for
50 days. The registrant-calculated half-lives were 73.0 days at pH
5, 204.6 days at pH 7, and 194.0 days at pH 9. In the pH 5
buffered solution, the degradate hydroxy-terbuthylazine was a
maximum of 15.6% of the applied radioactivity at 50 days
posttreatment. The hydrolysis (161-1) data requirement has been
fulfilled (MRID #41907707).
Photodegradation in Water
There are sufficient data available to conclude that
terbuthylazine is stable to aqueous photolysis. [14C]-Terbuthylazine
(uniformly ring-labeled), at 5 ug/mL, was relatively stable in sterile
aqueous buffered pH 7 solutions that were continuously irradiated
with artificial light (xenon arc lamp) at 25°C for 30 days. The
intensity of the light source was approximately one-half that of
natural sunlight. At 30 days posttreatment, terbuthylazine was
95.6-97.7% of the applied radioactivity in the irradiated samples
and 94.2-98.3% in the dark control samples.
20
-------
b.
The degradate 2-tert-butylamino-4-chloro-6-amino-5-triazine
(GS-26379) was <;3.61% of the applied radioactivity and was
present in both the irradiated and the dark control samples. The
photodegradation in water (161-2) data requirement has been
satisfied (MRID #41994801).
Aerobic Aquatic Metabolism
There are sufficient data to conclude that terbuthylazine
degrades very slowly under aerobic aquatic conditions.
Terbuthylazine degraded slowly with registrant calculated half-life
of 38.8 days in flooded loam sediment that was incubated
aerobically in darkness for 30 days at 25°C. The degradate GS
26379 was a maximum of 6.62% of the applied at 22 days. This
degradate was also present in the aqueous photolysis study. The
degradate GS 23158 was a maximum of 8.07-8.72% of the applied
at 30 days. The unextracted [14C] residues increased to 29.70% of
the applied at day 30. At day 30 only 0.11% of the applied had
been volatilized. The aerobic aquatic metabolism (162-4) data
requirement has been fulfilled (MRID#42790001).
Environmental Fate Assessment
Based on the results of acceptable studies, it is reasonable to
conclude that terbuthylazine will persist under most aquatic conditions.
To aid in the aquatic risk assessment of terbuthylazine from
industrial discharge of treated water, the Agency used a screening model.
Tier 1C EEC (estimated environmental concentration) calculations were
used (Jones) to assess the estimated environmental concentrations of residue
levels of terbuthylazine immediately downstream from an industrial
discharge site. A tier 1C EEC is a preliminary or lower tier exposure
assessment for industrial biocides. The EECs are presented in the
following table. This model provides two types of estimates:
High exposure case: This is a reasonable worst case of a high exposure site
with a return frequency of 1 in 10 years. The high exposure site represents
a site that would be expected to produce larger EEC's than 90% of all sites
with the specified use pattern. It would be expected that the EEC would
be equaled or exceeded once every 10 years, i.e., there is a 10% chance in
any given year that the EEC will be equaled or exceeded.
Typical case: This represents a median site at mean flow concentration.
Inspection of the labels of terbuthylazine products shows that it is used in
21
-------
industrial cooling towers at a maximum application rate of 9 ppm active
ingredient. The estimated environmental concentrations (EECs) are
presented in the following Table. For the same site, different products
have different maximum application rates. For the purpose of EEC
calculations these products are placed in different groups (Groups A and
B). To calculate the EEC, the concentration in the waste stream was
assumed to be the same as the application rate; this assumes that no
degradation occurred in the processing stream. The concentration in the
receiving body of water, immediately downstream from the discharge site,
was estimated. Dilution factors were taken from a compilation of dilution
factors compiled for the Agency's Office of Pollution Prevention and Toxic
Substances1. .
It is noted that terbuthylazine is also used in decorative and
ornamental fountains. Discharges from these sites would probably occur
infrequently and would likely be to a waste treatment facility. Therefore,
the Agency did not calculate EECs for this use.
Tier 1C EECs for Terbuthylazine
Use site
Industrial cooling
towers: Group A2
Industrial cooling
towers: Group B2
SIC
Code1
4911
4911
xBSgk'Sfli«ib^ur«
Appl.
Rate
3 ppm
9 ppm3
MS&^.V;.
BBC
3 ppm
1.6 ppm
%^]&^4cri;
Appl.
Rate
3 ppm
3 ppm
' 'i (
! !
i, it 'I
BBC
0.005 ppm
0.005 ppm
1 SIC is the Standard Industrial Classification
1. Office of Prevention and Toxic Substances. 1992. Summary of Stream Dilution Factor Program (SDFP) Outputs for 40
Industrial Categories (Updated January, 1991, IQ10 & 3Q5 added October, 1992).
2. Groups A or B refer to a group of products with similar application rates for a common use site. The products in each
group areas follows: Group A - Bellacide* 325 (Reg. No. 279-3139), and AMA-204 (Reg. No. 9386-34) application
rates 3 ppm; Group B - Belclene 329* (Reg. No. 279-3137) application rates 9 ppm.
3. The label for Belclene 329* states a maximum application rate of 9 ppm a.i.. This appears to be the clean-out rate. As it
is recommended, the 90% exceedence site, mean flow is used to estimate the high exposure case, as it would be unlikely
that a clean-out and a low flow condition would occur simultaneously. A maximum application rate of 3 ppm, which is
recommended for maintenance in non-chlorinated (continuous addition) systems, was used to estimate' the typical exposure
case.
22
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2. Ecological Effects
a. Ecological Effects Data
(1) Terrestrial Data
(a) Avian Toxicity
Results from available studies indicate that terbuthylazine
with an LD50 > 2,510 mg/kg is practically non-toxic to birds.
Results from these studies also indicate that a Level of Concern has
not been exceeded for either endangered or non-endangered avian
species. The guideline requirement for the avian acute oral LD50
study is fulfilled (MRID #129142).
(b) Avian Subacute Dietary Toxicity
'Species
Bobwhite Quail
Mallard Duck
Material
99.8%
99.8%
> 5,620
> 5,620
Conclusions
practically non-toxic
practically non-toxic
On a subacute dietary basis, terbuthylazine is practically
non-toxic to birds. Two studies, one on the mallard duck and one
on the bobwhite quail produced LC50s > 5,620 ppm. The Level of
Concern has not been exceeded for either endangered or non-
endangered avian species. The guideline requirement is fulfilled
(MRID #s 129144 and 129143).
(c) Avian Reproduction
Avian reproduction studies are required when birds may be
exposed repeatedly or continuously through persistence,
bioaccumulation, or multiple applications, or if mammalian
reproduction tests indicate reproductive hazard. The use of
terbuthylazine in ornamental fountains and cooling towers is not
expected to provide significant exposure or risk to birds; therefore,
these studies were not required.
23
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(d) Toxicity to Nontarget Mammals
Based on the use pattern no testing is required.
(2) Aquatic Data
(a) Freshwater Fish Toxicity
In order to establish the toxicity of a pesticide to freshwater
fish, the minimum data required on the technical grade of the active
ingredient is one freshwater fish toxicity study, using either a
coldwater species (preferably the rainbow trout), or a warmwater
species (preferably the bluegill sunfish). For terbuthylazine the
Agency has data on both species.
-:,'•' •*, -4 ' i
' ' *•
, ' A \
Species
Rainbow trout
Bluegill sunfish
'if i1* Ai<3Sl*t££ X \' ^l-^s - "
Freshwater Fish Acute
-% Test Material
(TGAD
98%
98%
IPasacity landings
*Ao
3.4 ppm
7.5 ppm
->' \ ' ?; <; - , _
, > ,i!,i ; v/""^
% ^
Conclusions :,
moderately toxic
moderately toxic
The results of the 96-hour acute toxicity studies indicate that
terbuthylazine is moderately toxic to both cold and warm water
fish. The guideline requirement for acute toxicity testing of the
technical on freshwater fish is fulfilled (MRID #s 129594 and
129593).
(b) Freshwater Invertebrate Toxicity
The minimum testing required to assess the hazard of a
pesticide to freshwater invertebrates is a freshwater invertebrate
toxicity test, preferably using first instar Daphnia magna or an
early instar amphipod, stonefly, mayfly, or midge species.
24
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Daphnia magna
50.9 ppm
slightly toxic
Based on available data there is sufficient information to
characterize terbuthylazine as slightly toxic to aquatic invertebrates.
The guideline requirement is fulfilled (MRID #129595).
(c) Estuarine/Marine Toxicity
Acute toxicity testing with estuarine and marine organisms
is required when an end-use product is intended for direct
application to the marine/estuarine environment or is expected to
reach this environment in significant concentrations. Although such
a study was not required for terbuthylazine's uses, one study was
submitted and reviewed.
, , ' \ , - -V'" - / ," <- " " ','"• , " 4 I
.,•' '^, -• \,' , ^tiMta^/Wa^»A^te,%^^T^^^ . .
i\ f \ * 1*1 f „ %-
Species
Pink Shrimp
f %. M
% Test Material
CTGA1) „ i
99.24%
V} s.
t ^
TK5,,t ,' t /
109.7 ug/1
i 1 "
1 (
r
(- 5. * 1
Conclusions , „
p. £"**
highly toxic
The submitted study is sufficient to characterize
terbuthylazine as highly toxic to estuarine/marine invertebrates
from acute exposures. (MRID #0543701)
(3) Non-Target Insects Data
No testing is required for terrestrial non-target insects such
as honeybees since significant exposure is unlikely due to the use
pattern.
(4) Non-Target Plants Data
25
-------
No data are currently available. However, data have
recently been called in concerning phytotoxicity to aquatic plants.
Phytotoxicity can reasonably be expected since terbuthylazine
belongs to the triazine chemical family (which include many
herbicides), is released to the environment, and does not
immediately degrade in the environment.
b. Ecological Effects Risk Assessment
(1) Risk to Terrestrial Animals
The criterion for the determination of hazard and presumption of
unacceptable risk from exposure for acute avian and mammalian species is
a value greater than or equal to 0.5 for the quotient of the preliminary
estimated environmental concentration (EEC) divided by the lowest LDSO
value for birds and mammals. This is known as the risk quotient (RQ).
Acute and Dietary RQ = EEC/LD50 or EEC/LC50 > or =
0.5 for birds and mammals
(a) Avian Acute Oral and Subacute Dietary Effects
No significant risks are expected from terbuthylazine. The
results from acceptable studies show that terbuthylazine is
practically non-toxic to birds.
Exposure to birds can occur at ponds, aquaria, and waste
water ponds. The typical exposure case EEC as estimated above at
these sites is 0.005 ppm ai. The high exposure case EEC is
estimated to be 3 ppm for certain products applied to industrial
cooling towers. The practically non-toxic nature of terbuthylazine
to birds when compared to these concentrations suggests that it does
not exceed the levels of concern.
Given the use patterns for terbuthylazine, avian and
mammalian species are not expected to be significantly exposed to
terbuthylazine.
(b) Avian Chronic Effects
No significant risks are expected.
26
-------
(2)
(c) Mammalian Acute Oral and Subacute Dietary Effects
Due to the use pattern the Agency believes exposure of
terbuthylazine to mammalian species through dietary residues is not
expected to be significant. No significant risks are expected.
Risk to Aquatic Animals
Fresh Water
The available information indicates that terbuthylazine is moderately
toxic to fish and slightly toxic to freshwater invertebrates on an acute basis.
The Agency screening model (see Section ni.C.l.b) estimates the
concentration of the chemical in the receiving body of water immediately
downstream from the discharge site to range from 0.005 ppm ai (typical
case) to 1.6 ppm ai (high exposure case). Based on the typical exposure
scenario, freshwater fish and invertebrates are not expected to be at risk
(see table below). However, on the basis of a high exposure scenario, the
acute levels of concern for high risk, restricted use and endangered species
are met or exceeded for freshwater fish and invertebrates (see table below).
Aquatic Acute Risk Quotient and LOG for the high and typical exposure scenarios of
Terbuthylazine. (LC50 = 3.4 ppm rainbow trout)
« j, s
"OseSite-^ ' ' • ,
** ** 4 $ i
.%- - " , I \
~ -r -,
Industrial Cooling
Towers - Group A
Industrial Cooling
Towers - Group B
"App., "
Rate ,
- * »
3 ppm
9 ppm
mgh - r;
Exposure *
(Hg)BEC
3 ppm
1.6 ppm
< * 3.
Tyjpical
Exposure ,
EEC ' -' "
0.004 ppm
0.004 ppm
Risk Quotient^ "
(EEC/LC50).,
0.882 HE
0.001 TE
0.470 HE
0.001 TE
Level of Concern -
v !
High Risk ;> 0.5
RU ;> 0.1
ES > 0.05
High Risk > 0.5
RU * 0.1
ES > 0.05
RU = Restricted Use
ES = Endangered Species
Estuarine/Marine
Terbuthylazine is highly toxic to estuarine/marine invertebrates.
The typical exposure results in a Risk Quotient of 0.04. No significant risk
is expected from the use of terbuthylazine at the typical use rate. For the
high exposure scenario the Risk Quotient is 30. However, the Agency
believes the presently registered use patterns are not associated in a
significant way with estuarine or marine environments. Therefore,
although the RQ for the high exposure scenario exceeds the Agency's
27
-------
LOG, the Agency expects actual risk from current use of terbuthylazine to
be insignificant for these species.
(3) Risk to Terrestrial, Semi-Aquatic and Aquatic Plants
No data are available to assess the effects to plants. Phytotoxicity
is expected, especially to aquatic plants, since terbuthylazine is a triazine
chemical (and chemically similar to the herbicides atrazine, cyanazine, and
simazine), is released to waterways, and dissipates slowly in the
environment. Certain labels warn against using the product in systems
where the treated water would come into contact with lawns, trees, shrubs,
or other desirable plants "since injury may result". Because of this possible
phytotoxic property, the Agency has required Tier I aquatic plant testing
data on the chemical for confirmatory purposes. The Agency has required
these data to be submitted by January 1996. These results will be used by
the Agency in evaluating the downstream risk aquatic plants from effluents
containing the chemical.
(4) Risk to Endangered Species
For endangered avian and mammalian species the risk quotient is a
value greater than or equal to 0.1. For endangered aquatic vertebrate and
invertebrate species, the risk quotient is 0.05.
RQ = EEC/LCjo > or = 0.1 for endangered birds and
mammals; the
RQ = EEC/LC50 > or = 0.05 for endangered aquatic animals; and the
RQ = EEC/EC25 and the EEC/EC50 > or = 1 for terrestrial, semi-aquatic and aquatic
plants.
No significant risk is expected for terrestrial avian endangered
species since the level of concern is not exceeded. A risk to endangered
freshwater and estuarine/marine organisms is expected from the high
exposure scenario. The Level of Concern for the high exposure scenario
is exceeded.
Even though no data are available on non-target plants, if exposed,
endangered aquatic would presumably be at risk for the reasons presented
above. The nature of this chemical and the label warning indicate
phytotoxicity.
28
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IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether products containing the active
ingredients are eligible for reregistration. The Agency has previously identified and
required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing terbuthylazine 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 terbuthylazine. Appendix
B identifies the generic data requirements that the Agency required as part of its
determination of reregistration eligibility of terbuthylazine, 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 terbuthylazine and to determine that terbuthylazine when used as
directed in this document can be used without resulting in unreasonable adverse effects to
humans and the environment. The Agency therefore finds that all products containing
terbuthylazine as the active ingredient are eligible for reregistration. The reregistration
of particular products is addressed in Section V of this document.
The Agency made its reregistration eligibility determination based upon the target
data base required for reregistration, the current guidelines for conducting acceptable
studies to generate such data and the data identified in Appendix B. Although the Agency
has found that all uses of terbuthylazine are eligible for reregistration, it should be
understood that the Agency may take appropriate regulatory action, and/or require the
submission of additional data to support the registration of products containing
terbuthylazine, if new information comes to the Agency's attention or if the data
requirements for registration (or the guidelines for generating such data) change.
1.
Eligibility Decision
Based on the review of the generic data for the active ingredient terbuthylazine, the
Agency has sufficient information on the health effects and its potential for causing
adverse effects in fish and wildlife and the environment. The Agency has determined that
terbuthylazine 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 terbuthylazine
for all uses are eligible for reregistration.
29
-------
2. Eligible and Ineligible Uses
The Agency has determined that all uses of terbuthylazine as specified in this
document are eligible for reregistration.
B. Regulatory Position
*
The following is a summary of the regulatory positions and rationales for
terbuthylazine. Where labeling revisions are imposed, specific language is set forth in
Section V of this document.
1.
Tolerance Reassessment
The Agency did not conduct a tolerance reassessment for terbuthylazine
because no tolerances are currently established. Previous tolerances for this
chemical were revoked as discussed above in Section in.
2. Potential Discharge to Surface Waters
The Agency has determined that discharge to surface waters of effluent
containing terbuthylazine .may result from its use as a pesticide. Its use as a
pesticide and its potential release to the environment subjects it to the requirements
of both FIFRA and the National Pollutant Discharge Elimination System (NPDES)
which is administered by the Federal Office of Water (OW) with the states.
By their nature, industrial biocides are often toxic to aquatic organisms.
The environmental effects of discharges containing biocides may depend heavily
upon the volume, concentration, and other constituents of a particular discharge,
as well as the size, nature, and flow rate of waters receiving the discharge. FIFRA
permits EPA to require the generation of data on the effects of biocides and to set
general limits and conditions of use of a biocide through statements on its labeling.
However, because FIFRA regulation is generally national in scope, these
mechanisms are not readily adaptable to varied and changing local conditions.
Generalized regulation of a pesticide under FIFRA may be insufficiently protective
under some local conditions. The NPDES process is designed to take local
conditions into account through the issuance of facility- specific permits for the
discharge of pollutants to bodies of water. However, historically, specific
information about the toxicological and environmental properties of biocides in
effluent streams was not always readily available or considered in writing permits.
EPA's Office of Pesticide Programs and Office of Water intend to
cooperate in the oversight of biocide uses to take advantage of the strengths of each
program while avoiding duplication of regulation. Under FIFRA, OPP will
require the submission to the Agency of information that will be used to identify
30
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potential hazards from the discharge of biocides from pesticidal use that may
require control measures under either regulatory program. This information will
be shared with the Office of Water where it can be made available to NPDES
permit writers to address aquatic effects of point source biocide use. In turn, OW
will forward to OPP any information that becomes available concerning
unanticipated aquatic effects of the use of biocides for OPP's use in national
registration decisions for these products. EPA believes this approach will provide
adequate environmental safeguards since it allows OPP to control the general
approval of the biocide as required by FIFRA, but includes a mechanism for
recognizing and regulating potential local unacceptable effects through the NPDES
program. Improved limitations on use under FIFRA and more targeted NPDES
permitting decisions for industrial biocides may be developed in the future as the
information gathering and exchange program between the Offices progresses.
Absent extraordinary concern about the adverse effects of the uses of
terbuthylazine from its potential discharge to surface waters, the Agency concludes
that the use of terbuthylazine will not cause unreasonable adverse effects if an
effluent discharge label statement (requiring that any such discharge is subject to
the NPDES process) is required for all products which have a potential for
discharge to surface waters.
3. Endangered Species
The Agency is concerned about the exposure of endangered aquatic animal
and plant species as discussed above in the science assessment chapter.
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 in the county.
Consultations with the Fish and Wildlife Service will be necessary to assess risks
to newly listed species or from proposed new uses.
The Agency plans to publish a description of the Endangered Species
Program in 1995 and have enforceable county-specific bulletins available after that
time. 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.
31
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4. Labeling Rationale
Risk Mitigation to Handlers
For each end-use product, PPE requirements for pesticide handlers
will be set during reregistration in one of two ways:
(a) If EPA has no special concerns about the acute or other
adverse effects of an active ingredient, the PPE for pesticide
handlers will be based on the acute toxicity of the end-use
product. For occupational-use products, PPE will be
established using the process described in PR Notice 93-7 or
more recent EPA guidelines;
(b) If EPA has special concerns about an active ingredient
due to very high acute toxicity or to certain other adverse
effects, such as allergic effects or delayed effects (cancer,
developmental toxicity, reproductive effects, etc).
In the RED for that active ingredient, EPA may establish minimum or
"baseline" handler PPE requirements that pertain to all or most
occupational end-use products containing that active ingredient. These
minimum PPE requirements must be compared with the PPE that would be
designated on the basis of the acute toxicity of each end-use product. The
more stringent choice for each type of PPE (i.e., body wear, hand
protection, footwear, eyewear, etc.) must be placed on the label of the
end-use product.
There is a special toxicological concern for terbuthylazine;
systemic toxicity in the rabbit developmental toxicity study. Risk
assessment determined that unacceptable risk (i.e. margins of exposure less
than 100) occurred during the open pouring application to industrial water
systems. This application method may result in exposure to the applicator
since the applicator manually pours terbuthylazine into the system. The
main concern is for dermal exposure. One-hundred percent absorption is
assumed in absence of acceptable dermal absorption data. However,
terbuthylazine is not believed to be a respiratory risk because of its low
vapor pressure. The Agency considered personal protective equipment but
found that exposure is not sufficiently reduced by these measures. For
example, requiring applicators to wear chemical resistant gloves doubles
the MOE from typical exposure (3 ppm) to approximately 20. Respiratory
protection was not considered. However, this MOE is still far away from
acceptable. Personal protective equipment does not reduce exposure to
32
-------
acceptable levels with the open pouring application method. In contrast,
the MOEs for closed systems are of an acceptable level.
Therefore the Agency is prohibiting the open-pouring method of
application for commercial uses. Instead, a closed-system metering pump
system of application will be required for all currently registered uses of
terbuthylazine. This decision is based on the unacceptable risk levels to
workers applying terbuthylazine as discussed above. No such restriction
will be placed on homeowner uses because homeowners are exposed to
much less terbuthylazine from typical use of homeowner products.
It is worth noting that developmental toxicity was observed in the
rat at 30 mg/kg/day in another developmental toxicity study. As discussed
in Section III.B.l.d. developmental toxicity in the fetus and maternal
toxicity were observed at the same dose. Therefore it is impossible to
separate maternal toxicity from fetal toxicity. However, risk mitigation
measures as discussed further in this chapter are based on a risk assessment
using the mid level dose from the developmental toxicity study in the rabbit
(1.5 mg/kg/day for intermediate-term exposure) and therefore should also
mitigate any potential for developmental toxicity.
Personal Protective Equipment
While the assessment for the use of a closed-system suggests the
risks to workers is acceptable, the Agency believes it is prudent to have
handlers wear certain personal protective equipment to further reduce
dermal exposure. This exposure may occur inadvertently during
attachment of the metering equipment. Persons using closed systems must
wear a long-sleeved shirt, long pants, shoes, socks, and chemical-resistant
gloves. A chemical-resistant apron must be immediately available during
loading and application and must be worn in case of a leak, spill, or other
exposure to the concentrate.
The minimum PPE for professional applicators (non-homeowners)
at residential sites who mix, load, or apply terbuthylazine using the open
pouring application method is long-sleeved shirt, long pants, shoes, socks,
and chemical-resistant gloves.
Homeowners who mix, load, or apply terbuthylazine using the open
pouring application method must wear a long-sleeved shirt, long pants,
shoes, socks, and chemical-resistant gloves.
33
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Risk to Aquatic Organisms
Since the Agency has concerns for risk to aquatic organisms, the
Agency is requiring an effluent discharge label statement (requiring that
any such discharge is subject to the National Pollutant Discharge
Elimination System process) when a product has a potential for discharge
to surface waters.
V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistration
of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of terbuthylazine for
the above eligible uses has been reviewed and determined to be substantially
complete. However, since exposure and toxicity to aquatic plants can reasonably
be expected since terbuthylazine is discharged to waterways and is a member of the
triazine herbicide class of chemicals, data measuring the toxicity of terbuthylazine
to aquatic plants have recently been required of registrants. These data will be
used as necessary by the Agency to confirm the presumed phytotoxicity and to
support regulation of discharge of terbuthylazine in effluent.
2. Labeling Requirements for Manufacturing-Use Products
Effluent Discharge Labeling Statements
All manufacturing-use products that may be contained in an effluent
discharged to the waters of the United States or municipal sewer systems must bear
the effluent discharge labeling statements as described in PR Notice 93-10.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility has
been made. The product specific data requirements are listed in Appendix G, the
Product Specific Data Call-in Notice.
34
-------
Registrants must review previous data submissions to ensure that they meet
current EPA acceptance criteria (Appendix F; Attachment E) and if not, commit
to conduct new studies. If a registrant believes that previously submitted data meet
current testing standards, then study MRID numbers should be cited according to
the instructions in the Requirement Status and Registrants Response Form provided
for each product.
2. Labeling Requirements for End-Use Products
Effluent Discharge Labeling Statements
All manufacturing-use products that may be contained in an effluent
discharged to the waters of the United States or municipal sewer systems must bear
the effluent discharge labeling statements as described in PR Notice 93-10.
Other Labeling Requirements
The Agency is requiring the following statements to be located on all end-
use products containing terbuthylazine that are intended primarily for industrial
use:
Application Restrictions:
For products intended for industrial uses:
"Open pouring of this product is prohibited."
"Mixing, loading, and application must be with a closed system (one that
prevents the chemical from contacting handlers or other persons) and
during handling of the chemical personal protective equipment must be
worn. Personal Protective equipment includes a long-sleeved shirt, long
pants, shoes, socks, and chemical-resistant gloves. A chemical-resistant
apron must be immediately available during loading and application and
must be worn in case of a leak, spill, or other exposure to the concentrate."
For products intended for homeowner uses:
"Persons that mix, load, or apply this product must wear long-sleeved
shirt, long pants, shoes, socks, and chemical-resistant gloves."
35
-------
User Safety Requirements:
"Follow personal protective equipment manufacturer's instruction for
cleaning/maintaining Personal Protective Equipment. If no such
instructions for washables exists, use detergent and hot water. Keep and
wash personal protective equipment separately from other laundry."
User Safety Recommendations:
"Users should wash 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 Personal protective equipment 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 Reregistration Eligibility Decision
(RED). Persons other than the registrant may generally distribute or sell such products for
50 months from the date of the issuance of this RED. However, existing stocks time
frames will be established case-by-case, depending on the number of products involved,
the number of label changes, and other factors. Refer to "Existing Stocks of Pesticide
Products; Statement of Policy"; Federal Register, Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell terbuthylazine
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.
36
-------
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APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
55
-------
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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 Terbuthylazine covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to Terbuthylazine in all products,
including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in
which they appear in 40 CFR Part 158. the reference numbers accompanying each test refer
to the test protocols set in the Pesticide Assessment Guidelines, which are available from the
National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703)
487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files,
this column lists the identifying number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
57
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APPENDIX C. Citations Considered to be Part of the Data Base
Supporting the Reregistration of Terbuthylazine
67
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BIBLIOGRAPHY
MRID
CITATION
00038018 Marbach, P. (1970) Metabolic Behaviour in Rats of GS 13'529 and Its Plant
Metabolites GS 23'158 and GS 28'620. (Unpublished study received Jun 19,
1973 under 3F1409; prepared by J.R. Geigy, S.A., submitted by Ciba-Geigy
Corp., Ardsley, N.Y.; CDL:093767-0.
00055672 Ciba-Geigy Chemical Corporation (1971) Metabolism of- s ~ -Triazine
Herbicides. (Unpublished study including letter dated Dec 29, 1971 from J.R.
Forsythe to Harold G. Alford, received Dec 29, 1971 under 100-437;
CDL:231915-A)
00108817 Ami, P.; Muller, D. (1977) Salmonella/Mammalian-microsome Mutagenicity
Test with GS 13529 (Test for Mutagenic Properties in Bacteria). (Unpublished
study received Jun 3, 1982 under 40810-5; prepared by Ciba-Geigy, Ltd.,
Switz., submitted by Ciba-Geigy Corp., Ardsley, NY; CDL:247619-F)
00129142 Fink, R.; Beavers, J.; Joiner, G.; et al. (1983) Acute Oral LD50: Mallard
Duck: Terbuthylazine: Project No. 108-213. Final rept. (Unpublished study
received Jul 1, 1983 under 40810-6; prepared by Wildlife International Ltd.,
submitted by Ciba-Geigy Corp., Ardsley, NY; CDL:250654-E)
00129143 Fink, R.; Beavers, J.; Joiner, G.; et al. (1983) Eight-day Dietary
LC50-rMallard Duck: Terbuthylazine: Project No. 108-212. Final rept.
(Unpublished study received Jul 1, 1983 under 40810-6; prepared by Wildlife
International Ltd., submitted by Ciba-Geigy Corp., Ardsley, NY;
CDL:250654-F)
00129144 Fink, R.; Beavers, J.; Joiner, G.; et al. (1983) Eight-day Dietary
LC50~Bobwhite Quail: Terbuthylazine: Project No. 108-211. Final rept.
(Unpublished study received Jul 1, 1983 under 408106; prepared by Wildlife
International Ltd., submitted by CibaGeigy Corp., Ardsley, NY;
CDL:250654-G)
00129593 Rufli, H.; Cheron, A.; Kurmann, F.; et al. (1983) Report on the Test for Acute
Toxicity of TK 12669/1 to Bluegill: Project No. 83 00 64. (Unpublished study
received Jul 27, 1983 under 40810-6; prepared by Ciba-Geigy Ltd., Switz.,
submitted by CibaGeigy Corp., Ardsley, NY; CDL:250837-E)
00129594 Rufli, H.; Cheron, A.; Kurmann, F.; et al. (1983) Report on the Test for Acute
Toxicity of TK 12669/1 to Rainbow Trout: Project No. 83 00 63.
(Unpublished study received Jul 27, 1983 under 40810-6; prepared by
Ciba-Geigy Ltd., Switz., submitted by CibaGeigy Corp., Ardsley, NY;
CDL:250837-F)
69
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BIBLIOGRAPHY
MOEUD
CITATION
00129595 Rufli, H.; Kurmann, F.; Cheron, A.; et al. (1983) Report on the Test for Acute
Toxicity of TK 12 669/1 to Daphnia magna: Project No. 83 00 62.
(Unpublished study received Jul 27, 1983 under 40810-6; prepared by
Ciba-Geigy Ltd., Switz., submitted by CibaGeigy Corp., Ardsley, NY;
CDL:250837-G)
00130744 Bottomley, A.; Mayfield, R.; Clark, R. (1983) Effect of TK 12 6697 1 on
Pregnancy of the New Zealand White Rabbit: CBG 345/341/ 83354.
(Unpublished study received Aug 26, 1983 under 408106; prepared by
Huntingdon Research Centre, Eng., submitted by by Ciba-Geigy, Ardsley, NY;
CDL:251076-A)
00140816 Ciba-Geigy Corporation (1977?) Summary of Human Safety Data. Summary of
studies 246364-B through 246364-E. (Unpublished study received Dec 1, 1981
under 40810-6; CDL:246364-A)
00151618 Strasser, F. (1983) L5178Y/TK+/Mouse Lymphoma Mutagenicity Test: GS 13
529: (In vitro Test for Mutagenic Properties of Chemical Substances in
Mammalian Cells): Exp. No. 820911. Unpublished study prepared by
Ciba-Geigy Limited. 10 p.
00151619 Puri, E. (1984) Autoradiographic DNA Repair Test on Rat Hepatocytes: GS
13'529 Techn: Final Report: Report No. 831174. Unpublished study prepared
by Ciba-Geigy Limited. 12 p.
00151620 Puri, E. (1984) Autoradiographic DNA Repair Test on Human Fibre-blasts: GS
13*529: Final Report: Rep. No. 831175. Unpublished study prepared by
Ciba-Geigy Limited, lip.
00151622 Seifert, G. (1984) 28 Day Repeated Dose Dermal Toxicity Study in Rabbits:
GS 13529: Final Rep: Project No. 83 02 87. Unpublished study prepared by
Ciba-Geigy, Stein, Switzerland. 249 p.
00156486 GfeUer, W. (1983) Lifetime Carcinogenicity and Chronic Toxicity Study in
Rats: GS 13529: Finalised Report: GU Project No. 785196. Unpublished study
prepared by Ciba-Geigy Ltd. 1577 p.
00156487 Gfeller, W. (1982) Chronic Toxicity and Carcinogenicity Study in Mice: GS
13529 Techn.: Final Report: GU Project No. 785195. Unpublished study
prepared by Ciba-Geigy Ltd. 965 p.
00157342 Gfeller, W. (1983) GS 13529: Lifetime Carcinogenicity and Chronic Toxicity
Study in Rats: Finalised Report: GU Project No. 791229. Unpublished study
prepared by Ciba-Geigy Ltd. 1384 p.
70
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BIBLIOGRAPHY
MRID
CITATION
00161104 Easier, W. (1984) GS 13529: 28 Days Toxicity Study in Rats: Final Report:
GU Project No. 830289. Unpublished study prepared by Ciba-Geigy Ltd. 222
P-
40514801 Schiavo, D.; Hazelette, J.; Green, J. (1987) Terbuthylazine: 28-day Oral
Toxicity Study in Rabbits: Toxicology/Pathology Report 86178. Unpublished
study prepared by Ciba-Geigy Corp. 192 p.
40514802 Schiavo, D.; Hazelette, J.; Green, J. (1987) Terbuthylazine: 28-day Dermal
Toxicity Study in Rabbits: Toxicology/Pathology Report 86143. Unpublished
study prepared by Ciba-Geigy Corp. 204 p.
40543701 Ward, G. (1988) Acute Toxicity of Technical Terbuthylazine to Mysid Shrimp
(Mysidopsis bahia) Under Static Conditions: Laboratory Project ID
87356-2210-2130. Unpublished study prepared by Environmental Science and
Engineering, Inc. 23 p.
41391801 Hertner, T. (1989) Belclene 329: Autoradiographic DNA Repair Test on Rat
Hepatocytes (OECD Conform): Lab Project Number: 881606. Unpublished
study prepared by Ciba-Geigy Ltd. 105 p.
41418102 Hertner, T. (1989) Belclene 329: Micronucleus Test, Mouse: Lab Project
Number: 891393. Unpublished study prepared by Ciba-Geigy Co. 33 p.
41412201 Popendorf, W.; Selim, M.;Kross, B. (1990) Chemical Manufacturers
Association Antimicrobial Exposure Assessment Study ID:Q626. Unpublished
study prepared by University of Iowa Institute of Agricultural Medicine and
Occupational Health.
41603301 Schwemmer, B. (1990) Terbuthylazine Product Chemistry: Product Identity
and Composition. Unpublished study prepared by CibaGeigy Corp. 185 p.
41603302 Schwemmer, B. (1990) Terbuthylazine Product Chemistry: Analysis and
Certification of Product Ingredients. Unpublished study prepared by
Ciba-Geigy Corp. 114 p.
41603303 Schwemmer, B. (1990) Terbuthylazine Product Chemistry: Physical and
Chemical Characteristics: Lab Project Number. Unpublished study prepared by
Ciba-Geigy Corp. 132 p.
41603304 Hartmann, H. (1990) Terbuthylazine: Acute Oral Toxicity in the Rat: Report:
Lab Project Number: 891215. Unpublished study prepared by Ciba-Geigy Ltd.
17 p.
71
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BIBLIOGRAPHY
MRID
CITATION
41603305 Hartmann, H. (1989) Terbuthylazine: Acute Inhalation Toxicity in the Rat:
Report: Lab Project Number: 891219. Unpublished study prepared by
Ciba-Geigy Ltd. 22 p.
41603306 Schneider, P. (1989) Terbuthylazine: Acute Eye Irritation/Corrosion Study in
the Rabbit: Report: Lab Project Number: 891216. Unpublished study prepared
by Ciba-Geigy Ltd. 14 p.
41634001 Ogorek, B. (1987) Salmonella/Mammalian-Microsome Mutagenicity Test
(OECD-Conform): Report: Lab Project Number: 874192. Unpublished study
prepared by Ciba-Geigy Ltd. 22 p.
41742601 Popendorf, W.; Selim, M.;Kross, B. (1990) Chemical Manufacturers
Association Antimicrobial Exposure Assessment Lab project number:Q626.
Unpublished study prepared by University of Iowa.
41907702 Mercier, O. (1991) Terbuthylazine: Test to Evaluate the Acute Toxicity
Following a Single Oral Administration (LD 50) in the Rat: Lab Project
Number: 012333: 904139. Unpublished study prepared by Hazleton France.
45 p.
41907703 Mercier, O. (1991) Terbuthylazine: Test to Evaluate the Acute Toxicity
Following a Single Cutaneous Application (Limit Test) in the Rat: Lab Project
Number: 012319: 904151. Unpublished study prepared by Hazleton France.
30 p.
41907704 Mercier, O. (1990) Terbuthylazine: Test to Evaluate Acute Ocular Irritation
and Reversibility in the Rabbit: Lab Project Number: 904140: 009324.
Unpublished study prepared by Hazleton France. 29 p.
41907705 Mercier, O. (1990) Terbuthylazine: Test to Evaluation Acute Primary
Cutaneous Irritation and Corrosivity in the Rabbit: Lab Project Number:
008327: 904141. Unpublished study prepared by Hazleton France. 28 p.
41907706 Mercier, O. (1991) Test to Evaluate the Sensitizing Potential in the Guinea-Pig
"Guinea-pig Maximization Test": Lab Project No: 101322: 904152.
Unpublished study prepared by Hazleton France. 59 p.
41907707 Doyle, R. (1991) Hydrolysis of [carbon 14]-Terbuthylazine: Lab Project
Number: IITRI-VTC-9004. Unpublished study prepared by IIT Research
Institute. 90 p.
72
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BIBLIOGRAPHY
MRID
CITATION
41962701 Fitzgerald, R. (1990) Developmental Toxicity (Teratogenicity) Study in Rats
with GS 13529 Technical (Oral Administration): Final Report: Lab Project
Number: 891220. Unpublished study prepared by Ciba-Geigy. 302 p.
41994801 Head, L.; Schmidt, J. (1991) Determination of the Aqeous Photolysis Rate of
[Carbon 14]-Bellacide 320: Lab Project Number: 39309. Unpublished study
prepared by ABC Labs, Inc. 483 p.
42059804 Verma, M. (1991) 28-Day Dermal Toxicity Study in Rabbits: Purity of the Test
Material Used (Batch FL 860558): Terbuthylazine: Lab Project Number:
MIN-862131. Unpublished study prepared by CibaGeigy Corp. 5 p.
42059805 Puri, E. (1991) Supplement to Micronucleus Test, Mouse: Terbuthylazine: Lab
Project Number: 891393. Unpublished study prepared by Ciba-Geigy Corp. 4
P-
42059806 Puri, E. (1991) Supplement to Autoradiographic DNA Repair Test on Rat
Hepatocytes: Terbuthylazine: Lab Project Number: 881606. Unpublished study
prepared by Ciba-Geigy Corp. 4 p.
42409401 Fuldner, H. (1992) Determination of the Density of Terbuthylazine (TK
12669): Lab Project Number: AD 91/1 IT. DES. Unpublished study prepared
by Ciba-Geigy Ltd. 7 p.
42587501 Popendorf, W.; Selim, M.;Kross, B. (1992) Chemical Manufacturers
Association Antimicrobial Exposure Study: Second replacement to MRID
41761201: Lab project number Q626. Unpublished study prepared by the
University of Iowa.
42567401 Nye, D. (1992) Discussion of the Formation of Impurities in the Manufacture
of Terbuthylazine. Unpublished study prepared by FMC Corp. lip.
42677401 Morrissey, M. (1993) Stability Determinations of Terbuthylazine: Final Report:
Lab Project Number: 6124-111: P92-0004. Unpublished study prepared by
Hazleton Wisconsin, Inc. 41 p.
42790001 Wu, D. (1992) Aerobic Aquatic Metabolism of (carbon 14)-Bellacide 320: Lab
Project Number: 92041: RPT0094. Unpublished study prepared by Xenobiotic
Labs, Inc. 83 p.
73
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APPENDIX D. List of Available Related Documents
74
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The following is a list of available documents related to Terbuthylazine. It's purpose is
to provide a path to more detailed information if it is needed. These accompanying documents
are part of the Administrative Record for Terbuthylazine and are included in the EPA's Office
of Pesticide Programs Public Docket.
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Information System (LUIS) Report
3. Terbuthylazine RED Fact Sheet
4. PR Notice 86-5 (included in this appendix)
5. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
75
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APPENDIX E. PR Notices 86-5 and 91-2
77
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PR Notice 86-5
79
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, B.C. 20460
July 29,1986
PR NOTICE 86-5
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Attention: Persons responsible for Federal registration of pesticides.
Subject: Standard format for data submitted under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) and certain provisions of the Federal Food,
Drug, and Cosmetic Act (FFDCA).
I. Purpose
To require data to be submitted to the Environmental Protection Agency (EPA) in a
standard format. This Notice also provides additional guidance about, and illustrations of, the
required formats.
II. Applicability
This PR Notice applies to all data that are submitted to EPA to satisfy data
requirements for granting or maintaining pesticide registrations, experimental use permits,
tolerances, and related approvals under certain provisions of FIFRA and FFDCA. These data
are defined in FIFRA §10(d)(l). This Notice does not apply to commercial, financial, or
production information, which are, and must continue to oe, submitted differently under
separate cover.
III. Effective Date
This notice is effective on November 1, 1986. Data formatted according to this notice
may be submitted prior to the effective date. As of the effective date, submitted data packages
that do not conform to these requirements may be returned to the submitter for necessary
revision.
IV. Background
On September 26, 1984, EPA published proposed regulations in the Federal Register
(49 FR 37956) which include Requirements for Data Submission (40 CFR §158.32), and
Procedures for Claims of Confidentiality of Data (40 CFR §158.33). These regulations
specify the format for data submitted to EPA under Section 3 of FIFRA and Sections 408 and
409 of FFDCA, and procedures which must be followed to make and substantiate claims of
confidentiality. No entitlements to data confidentiality are changed, either by the proposed
regulation or by this notice. - .
OPP is making these requirements mandatory through this Notice to gain resource-
saving benefits from their use before the entire proposed regulation becomes final. Adequate
lead time is being provided for submitters to comply with the new requirements.
81
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V. Relationship of this Notice to Other OPP Policy and Guidance
While this Notice contains requirements for organizing and formatting submittals of
supporting data, it does not address the substance of test reports themselves. "Data reporting"
guidance is now under development in OPP, and will specify how the study objectives,
protocol, observations, findings, and conclusions are organized and presented within the study
report. The data reporting guidance will be compatible with submittal format requirements
described in this Notice.
OPP has also promulgated a policy (PR Notice 86-4 dated April 15, 1986) that
provides for early screening of certain applications for registration under FIFRA §3. The
objective of the screen is to avoid the additional costs and prolonged delays associated with
handling significantly incomplete application packages. As of the effective date of this Notice,
the screen will include in its criteria for acceptance of application packages the data formatting
requirements described herein.
OPP has also established a public docket which imposes deadlines for inserting into the
docket documents submitted in connection with Special Reviews and Registration Standards
(see 40 CFR §154.15 and §155.32). To meet these deadlines, OPP is requiring an additional
copy of any data submitted to the docket. Please refer to Page 10 for more information about
this requiremenT.
For several years, OPP has required that each application for registration or other
action include a list of all applicable data requirements and an indication of how each is
satisfied—the statement of the method of support for the application. Typically, many
requirements are satisfied by reference to data previously submitted—either by the applicant or
by another party. That requirement is not altered by this notice, which applies only to data
submitted with an application.
VI. Format Requirements
A more detailed discussion of these format requirements follows the index on the next
page, and samples of some of the requirements are attached. Except for the language of the
two alternative forms of the Statement of Data Confidentiality Claims (shown in Attachment 3)
which cannot be altered, these samples are illustrative. As long as the required information is
included and clearly identifiable, the form of the samples may be altered to reflect the
submitter's preference.
- INDEX-
A.
B.
C.
D.
Text Example
Page Page
. . 3 17
Organization of the Submittal Package
Transmittal Document 4 11
Individual Studies 4
C. 1 Special Considerations for Identifying Studies 5
Organization of each Study Volume 6
D. 1 Study Title Page 7
D. 2 Statement of Data Confidentiality Claims
(based on FIFRA §10(d)(l)) 8
D. 3 Confidential Attachment 8
D. 4 Supplemental Statement of Data Confidentiality
Claims (other than those based on FIFRA §10(d)(l)) 8
D. 5 Good Laboratory Practice Compliance Statement 9
17
12
13
15
14
16
82
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E. Reference to Previously Submitted Data 9
F. Physical Format Requirements & Number of Copies 9
G. Special Requirements for Submitting Data to the Docket 10
A. Organization of Submittal Package
A "submittal package" consists of all studies submitted at the same time for review in
support of a single regulatory action, along with a transmittal document and other related
administrative material (e.g. the method of support statement, EPA Forms 8570-1, 8570-4,
8570-20, etc.) as appropriate.
Data submitters must organize each submittal package as described in this Notice. The
transmittal and any other administrative material must be grouped together in the first physical
volume. Each study included in the submittal package must then be bound separately.
Submitters sometimes provide additional materials that are intended to clarify,
emphasize, or otherwise comment to help Product Managers and reviewers better understand
the submittal.
- If such materials relate to one study, they should be included as an appendix to that
study.
- If such materials relate to more than one study (as for example a summary of all
studies in a discipline) or to the submittal in general, they must be included in the
submittal package as a separate study (with title page and statement of confidentiality
claims).
B.
Transmittal Document
The first item in each submittal package must be a transmittal document. This
document identifies the submitter or all joint submitters; the regulatory action in support of
which the package is being submitted—i.e., a registration application, petition, experimental
use permit (EUP), §3(c)(2)(B) data call-in, §6(a)(2) submittal, or a special review; the
transmittal date; and a list of all individual studies included in the package in the order of their
appearance, showing (usually by Guideline reference number) the data requirement(s)
addressed by each one. The EPA-assigned number for the regulatory action (e.g. the
registration, EUP, or tolerance petition number) should be included in the transmittal
document as well, if it is known to the submitter. See Attachment 1 for an example of an
acceptable transmittal document.
The list of included studies in the transmittal of a data submittal package supporting a
registration application should be subdivided by discipline, reflecting the order in which data
requirements appear in 40 CFR 158.
The list of included studies in the transmittal of a data submittal package supporting a
petition for tolerance or an application for an EUP should be subdivided into sections A, B,
€,.... of the petition or application, as defined in 40 CFR 180.7 and 158.125, (petitions) or
Pesticide Assessment Guidelines, Subdivision I (EUPs) as appropriate.
When a submittal package supports a tolerance petition and an application for a
registration or an EUP, list the petition studies first, then the balance or the studies. Within
these two groups of studies follow the instructions above.
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C. Individual Studies
A study is the report of a single scientific investigation, including all supporting
analyses required for logical completeness. A study should be identifiable and distinguishable
by a conventional bibliographic citation including author, date, and title. Studies generally
correspond in scope to a single Guideline requirement for supporting data, with some
exceptions discussed in section C.I. Each study included in a submittal package must be
bound as a separate entity. (See comments on binding studies on page 9.)
Each study must be consecutively paginated, beginning from the tide page as page 1.
The total number of pages in the com-plete study must be shown on the study tide page. In
addition (to ensure that inadvertently separated pages can be reassociated with the proper study
during handling or review) use either of the following:
- Include the total number of pages in the complete study on each page (i.e., 1 of 250,
2 of 250, ...250 of 250).
- Include a company name or mark and study number on each page of the study, e g ,
Company Name-1986-23. Never reuse a study number for marking the pages of
subsequent studies.
When a single study is extremely long, binding it in mul-tiple volumes is permissible
so long as the entire study is pag-inated in a single series, and each volume is plainly identified
by the study title and its position in the multi-volume sequence.
C.I Special Considerations for Identifying Studies
Some studies raise special problems in study identification, because they address
Guidelines of broader than normal scope or for other reasons.
a. Safety Studies. Several Guidelines require testing for safety in more than one
species. In these cases each species tested should be reported as a separate study, and bound
separately.
Extensive supplemental reports of pathology reviews, feed analyses, historical control
data, and the like are often associated with safety studies. Whenever possible these should be
submitted with primary reports of the study, and bound with the primary study as appendices.
When such supplemental reports are submitted independently of the primary report, take care
to fully identify the primary report to which they pertain.
Batteries of acute toxicity tests, performed on the same end use product and covered by
a single title page, may be bound together and reported as a single study.
b. Product Chemistry Studies. All product chemistry data within a submittal package
submitted in support of an end-use product produced from registered manufacturing-use
products should be bound as a single study under a single tide page.
Product chemistry data submitted in support of a technical product, other
manufacturing-use product, an experimental use permit, an import tolerance petition, or an
end-use product produced from unregistered source ingredients, should be bound as a single
study for each Guideline series (61, 62, and 63) for conventional pesticides, or for the
equivalent subject range lor biorati9nal pesticides. The first of the three studies in a complete
product chemistry submittal for a biochemicalpesticide would cover Guidelines 151-10,
151-11, and 151-12; the second would cover Guidelines 151-13, 151-15, and 151-16; the third
would cover Guideline 151-17. The first study for a microbial pesticide would cover
Guidelines 151-20, 151-21, and 151-22; the second would cover Guidelines 151-23 and
151-25; the third would cover Guideline 151-26.
Note particularly that product chemistry studies are likely to contain Confidential
Business Information as defined in FIFRA §10(d)(l)(A), (B), or (C), and if so must be
handled as described in section D.3. of this -notice.
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c. Residue Chemistry Studies. Guidelines 171-4, 153-3, and 153-4 are extremely
broad in scope; studies addressing residue chemistry requirements must thus be defined at a
level below that of the Guideline code. The general principle, however, of limiting a study to
the report of a single investigation still applies fully. Data should be treated as a single study
and bound separately for each analytical method, each report of the nature of the residue in a
single crop or animal species, and for each report of the magnitude of residues resulting from
treatment of a single crop or from processing a single crop. When more than one commodity
is derived from a single crop (such as beet tops and beet roots) residue data on all such
commodities should be reported as a single study. When multiple field trials are associated
with a single crop, all such trials should be reported as a single study.
D. Organization of Each Study Volume
Each complete study must include all applicable elements in the list below, in the order
indicated. (Also see Page 17.) Several of these elements are further explained in the following
paragraphs. Entries in the column headed "example" cite the page number of this notice
where the element is illustrated.
Element
Study Title Page
Statement of Data
Confidentiality
Claims
Certification of Good
Laboratory Practice
Flagging statements
Body of Study
Study Appendices
Cover Sheet to Confi-
dential Attachment
When Required
Always
One of the two alternative
forms of this statement
is always required
If study reports laboratory
work subject to GLP require-
ments
For certain toxicology studies (When
flagging requirements are finalized.)
Always - with an English language
translation if required.
At submitter's option
If CBI is claimed under FIFRA
§10(d)(l)(A), (B), or (C)
Example
Page 12
Page 13
Page 16
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
If CBI is claimed under FIFRA
§10(d)(l)(A), (B), or (C)
Only if confidentiality is
claimed on a basis other than
FIFRA §10(d)(l)(A), (B), or (C)
Page 15
Page 14
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D.I. Tide Page
A title page is always required for each submitted study, published or unpublished.
The titiepage must always be freely releasable to requestors; DO NOT INCLUDE CBI ON
THE TITLE PAGE. An example of an acceptable title page is on page 12 of this notice.
The following information must appear on the title page:
a. Study title. The study title should be as descriptive as possible It must clearly identify
the substance(s.) tested and correspond to the name of the data requirement as it appears in the
Guidelines.
b. Data requirement addressed. Include on the tide page the Guideline number(s) of the
specific requirement's; addressed by the study.
c. Author(s). Cite only individuals with primary intellectual responsibility for the content
of the study, identify them plainly as authors, to distinguish them from the performing
laboratory, study sponsor, or other names that may also appear on the title page.
d. Study Date. The title page must include a single date for the study. If parts of the
study were performed at different times, use only the date of the latest element in the study.
e. Performing Laboratory Identification. If the study reports work done by one or more
laboratories, include on tne title page tne name and address of the performing laboratory or
laboratories, and the laboratory's internal project number(s) for the work. Clearly distinguish
the laboratory's project identifier from any other reference numbers provided by the study
sponsor or submitter.
f, Supplemental Submissions. If the study is a commentary on or supplement to another
previously submitted study, or it it responds to EPA questions raised with respect to an earlier
study, include on the title page elements a. through d. for the previously submitted study,
along with the EPA Master Record Identifier (MRID) or Accession number of the earlier
study if you know these numbers. (Supplements submitted in the same submittal package as
the primary study should be appended to and bound with the primary study. Do not include
supplements to more than one study under a single title page).
g. Facts of Publication. If the study is a reprint of a published document, identity on the
title page all relevant facts of publication, such as the journal title, volume, issue, inclusive
page numbers, and publication date.
D.2. Statements of Data Confidentiality Claims Under FIFRA §10(d)(l).
Each submitted study must be accompanied by one of the two alternative forms of the
statement of Data Confidentiality Claims specified in the proposed regulation in §158.33 (b)
and (c) (See Attachment 3). These statements apply only to claims of data confidentiality
based on FIFRA §10(d)(l)(A), (B), or (C). Use the appropriate alternative form of the
statement either to assert a claim of §10(d)(l) data confidentiality (§158.33(b)) or to waive
such a claim (§158.33(c)). In either case, the statement must be signed and dated, and must
include the typed name and tide of the official who signs it. Do not make CBI claims with
respect to analytical methods associated with pet-itions for tolerances or emergency
exemptions (see NOTE Pg 13).
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D.3. Confidential Attachment
If the claim is made that a study includes confidential business information as defined
by the criteria of FIFRA §10(D)(1)(A), (B), or (C) (as described in D.2. above) all such
information must be excised from the body of the study and confined to a separate
study-specific Confidential Attachment. Each passage of CBI so isolated must be identified by
a reference number cited within the body of the study at the point from which the passage was
excised (See Attachment 5).
The Confidential Attachment to a study must be identified by a cover sheet fully
identifying the parent study, and must be clearly marked "Confidential Attachment." An
appropriately annotated photocopy of the parent study title page may be used as this cover
sheet. Paginate the Confidential Attachment separately from the body of the study, beginning
with page 1 of X on the title page. Each passage confined to the Confidential Attachment
must qe associated with a specific cross reference to the page(s) in the main body of the study
on which it is cited, and with a reference to the applicable passage(s) of FIFRA §10(d)(l) on
which the confidentiality claim is based.
D.4. Supplemental Statement of Data Confidentiality Claims (See
Attachment 4)
If you wish to make a claim of confidentiality for any portion of a submitted study
other than described by FIFRA §10(d) (1)(A), (B), or (C), the following provisions apply:
- The specific information to which the claim applies must be clearly marked in the
body of the study as subject to a claim of confidentiality.
- A Supplemental Statement of Data Confidentiality Claims must be submitted,
identifying each passage claimed confidential and describing in detail the basis for the
claim. A list of the points to address in such a statement is included in Attachment 4
on Pg 14.
- The Supplemental Statement of Data Confidentiality Claims must be signed and dated
and must include the typed name and title of the official who signed it.
D.5. Good Laboratory Practice Compliance Statement
This statement is required if the study contains laboratory work subject to GLP
requirements specified in 40 CFR 160. Samples of these statements are shown in Attachment
6.
E. Reference to Previously Submitted Data
DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it. A copy of the title page
plus the MRID number (if known) is sufficient to allow us to retrieve the study immediately
for review. This prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study. References to previously submitted studies
should not be included in the transmittal document, but should be incorporated into the
statemenFbf the method of support for the application.
F. Physical Format Requirements
All elements in the data submittal package must be on uniform 8 1/2 by 11 inch white
paper, printed on one side only in black ink, with high contrast and good resolution. Bindings
for individual studies must be secure, but easily removable to permit disassembly for
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microfilming. Check with EPA for special instructions before submitting data in any medium
other than paper, such as film or magnetic media.
Please be particularly attentive to the following points:
• Do not include frayed or torn pages.
• Do not include carbon copies, or copies in other than black ink.
• Make sure that photocopies are clear, complete, and fully readable.
• Do not include oversize computer printouts or fold-out pages.
• Do not bind any documents with glue or binding tapes.
• Make sure that all pages of each study, including any attachments or
appendices, are present and in correct sequence.
Number of Copies Required - All submittal packages except those associated with a
Registration Standard or Special Review (See Part G below) must be provided In three
complete, identical copies. (The proposed regulations specified two copies; three are now
being required to expedite and reduce the cost of processing data into the OPP Pesticide
Document Management System and getting it into review.)
G. Special Requirements for Submitting Data to the Docket
Data submittal packages associated with a Registration Standard or Special Review
must be provided in four copies, from one of which all material claimed as CBI has been
excised. This fourth copy will become part of the public docket for the RS or SR case. If no
claims of confidentiality are made for the study, the fourth copy should be identical to the
other three. When portions of a study submitted in support of an RS or SR are claimed as
CBI, the first three copies will include the CBI material as provided in section D of this
notice. The following special preparation is required for the fourth copy.
• Remove the "Supplemental Statement of Data Confidentiality Claims".
• Remove the "Confidential Attachment".
• Excise from the body of the study any information you claim as confidential,
even if it does not fall within the scope of FIFRA §10(d)(l)(A), (B), or (C).
Do not close up or paraphrase text remaining after this excision.
• Mark the fourth copy plainly on both its cover and its title page with the phrase
"Public Docket Material - contains no information claimed as confidential".
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V.
For Further Information
For further information contact. John Carley, Chief, Information Services Branch,
Program Management and Support Division, (703) 305-5240.
/S/
James W. Akerman
Acting Director,
Registration Division
Attachment 1.
Attachment 2.
Attachments.
Attachment 4.
Attachment 5.
Attachment 6.
Attachment 7.
Sample Transmittal Document
Sample Title Page for a Newly Submitted Study
Statements of Data Confidentiality Claims
Supplemental Statement of Data Confidentiality Claims
Samples of Confidential Attachments
Sample Good Laboratory Practice Statements
Format Diagrams for Submittal Packages and Studies
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ATTACHMENT 1
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
1. Name and address of submitter (or all joint submitters**)
+Smith Chemical Corporation
1234 West Smith Street
Cincinnati, OH 98765
-and-
Jones Chemical Company
5678 Wilson Blvd
Covington, KY 56789
* Smith Chemical Corp will act as sole agent for all submitters.
2. Regulatory action in support of which this package is submitted
Use the EPA identification number (e.g. 359-EUP-67) if you know it. Otherwise describe the
type of request (e.g. experimental use permit, data call-in - of xx-xx-xx date).
3. Transmittal date
4. List of submitted studies
Vol 1. Administrative materials - forms, previous corres-pondence with Project
Managers, and so forth.
Vol 2. Title of first study in the submittal (Guideline No.)
Vol n Title of nth study in the submittal (Guideline
No.)
* Applicants commonly provide this information in a tran-smittal letter. This
remains an acceptable practice so long as all four elements are included.
* Indicate which of the joint submitters is empowered to act on behalf of all joint
submitters in any matter concerning data compensation or subsequent use or
release of the data.
Company Official:
Company Name
Company Contact:
Nam p.
Signature
Name
Phone
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ATTACHMENT 2
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
Study Title
(Chemical name) - Magnitude of Residue on Corn
Data Requirement
Guideline 171-4
Author
John C. Davis
Study Completed On
January 5, 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Project ID
ABC 47-79
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Page 1 of X
(X is the total number of pages in the study)
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ATTACHMENT 3
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under FIFRA §10(d)(l)(A),(B), or (C).
STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
No claim of confidentiality is made for any information contained in this
study on the basis of its falling within the scope of FIFRA.
6§10(d) (1) (A), (B), or (C) .
Company
Company Agent:
Title
Typed Name
Date:
Signature
2. Claim of confidentiality under FIFRA §10(d)(l)(A), (B), or (C).
Information claimed confidential on the basis of its falling within the
scope of FIFRA §10(d)(1)(A), (B), or (C) has been removed to a
confidential appendix, and is cited by cross-reference number in the body
of the study.
Company:
Company Agent:
Typed Name
Date:
Title
Signature
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
NOTE: Applicants for permanent or temporary tolerances should note that it is OPP policy
that no permanent tolerance, temporary tolerance, or request for an emergency exemption
incorporating an analytical method, can be approved unless the applicant waives all claims of
confidentiality for the analytical method. These analytical methods are published in the FDA
Pesticide Analytical Methods Manual, and therefore cannot be claimed as confidential. QPP
implements this policy 6y returning submitted analytical methods, for which confidentiality
claims have been made, to the submitter, to obtain the confidentiality waiver before they can
be processed.
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ATTACHMENT 4
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described by FIFRA §10(d)(l)(A), (B),
or (C), but for which you claim confidential treatment on another basis, the following
information must be included within a Supplemental Statement of Data Confidentiality Claims:
Identify specifically by page and line number(s) each portion
which you claim confidentiality.
of the study for
Cite the reasons why the cited passage qualifies for confidential treatment.
Indicate the length of time—until a specific date or event, or permanently—for
which the information should be treated as confidential.
Identify the measures taken to guard against undesired disclosure of this
information.
Describe the extent to which the information has been disclosed, and what
precautions have been taken in connection with those disclosures.
Enclose copies of any pertinent determinations of confidentiality made by EPA,
other Federal agencies, of courts concerning this information.
If you assert that disclosure of this information would be likely to result in
substantial harmful effects to you, describe those harmful effects and explain
why they should be viewed as substantial.
If you assert that the information in voluntarily submitted, indicate whether you
believe disclosure of this information might tend to lessen the availability to
EPA of similar information in the future, and if so, how.
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ATTACHMENT 5
EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
Example 1. (Confidential word or phrase that has been deleted from the study)
CROSS REFERENCE NUMBER 1 This cross reference number is used in the study in place of the
following paragraph(s) at the indicated volume and page
references. ,
DELETED WORDS OR PHRASE: Ethylene Glycol
PAGE LINES REASON FOR THE DELETION FIFRA
REFERENCE
6
28
100
14 Identity of Inert Ingredient
25
19
§10(d)(C)
Example 2. (Confidential paragraph(s) that have been deleted from the study)
CROSS REFERENCE NUMBER 5
DELETED PARAGRAPH^):
This cross reference number is used in the study in place of the
following paragraph(s) at the indicated volume and page
references.
PAGE
20.
Reproduce the deleted paragraph(s) here
LINES REASON FOR THE DELETION
2-17 Description of the quality control process
FIFRA REFERENCE
Example 3. (Confidential pages that have been deleted from the study)
CROSS REFERENCE NUMBER 7
This cross reference number is used in the study in place of the
following paragraph(s) at the indicated volume and page
references.
DELETED PAGES(S): are attached immediately behind this page
PAGES REASON FOR THE DELETION
35-41. Description of product manufacturing process
FIFRA REFERENCE
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ATTACHMENT 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
This study meets the requirements for 40 CFR Part 160
Submitter
Sponsor
Example 2.
This study does not meet the requirements of 40 CFR Part 160, and
differs in the following ways:
1..
2..
3.
Submitter.
Sponsor
Study Director.
Example 3.
The submitter of this study was neither the sponsor of this study nor
conducted it, and does not know whether it has been conducted in
accordance with 40 CFR Part 160.
Submitter •
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ATTACHMENT 7.
FORMAT OF THE SUBMITTAL PACKAGE
Transmfttal Document
Related Administrative Materials
(e.g. Method of Support Statement, etc.)
' Other materials about the submittal
(e.g., summaries of groups of studies
to aid in their review).
Studies submitted as unique
to the format below.
FORMAT OF SUBMITTED STUDIES
LEGEND
•Study title page.
• Statement of Confidentiality Claims.
. GLP and flagging* statements - as appropriate.
Body of the study, with English
language translation if required.
Appendices to the study.
Title Page of the Confidential
Attachment.
Confidential Attachment.
Supplemental Statement
L.-r—' J of Confidentiality Claims
' "* * When flagging requirements
are finalised.
Documents which must be submitted as
appropriate to meet established requirements.
Documents submitted at submitter's option.
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PR Notice 91-2
101
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
PR NOTICE 91-2
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDES
ATTENTION: Persons Responsible for Federal Registration of Pesticide Products.
SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement
I. PURPOSE:
The purpose of this notice is to 9larify the Office of Pesticide Program's policy with
respect to the statement of percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(s) specified in the ingredient
statement on the label must be stated as the nominal concentration of such ingredient(s), as that
term is defined in 40 CFR 158.153(i). Accordingly, the Agency has established the nominal
concentration as the only acceptable label claim for the amount of active ingredient in the
product.
II. BACKGROUND
For some time the Agency has accepted two different methods of identifying on the
label what percentage is claimed for the ingredient(s) contained in a pesticide. Some applicants
claimed a percentage which represented a level between the upper and the lower certified
limits. This was referred to as the nominal concentration. Other applicants claimed the lower
limit as the percentage of the ingredient(s) that would be expectedto be present in their
product at the end of the product's shelf-life. Unfortunately, this led to a great deal of
confusion among the regulated industry, the regulators, and the consumers as to exactly how
much of a given ingredient was in a given product. The Agency has established the nominal
concentration as the only acceptable label claim for the amount of active ingredient in the
product.
Current regulations require that the percentage listed in the active ingredient statement
be as precise as possible reflecting good manufacturing practices 40 CFR 156.10(g)(5). The
certified limits required for each active ingredient are intended to encompass any such "good
manufacturing practice" variations 40 CFR 158.175(c)(3).
The upper and lower certified limits, which must be proposed in connection with a
product's registration, represent the amounts of an ingredient that may legally be present 40
CFR 158.175. The lower certified limit is used as the enforceable lower limit for the product
composition according to FIFRA section 12(a)(l)(C), while the n9minal concentration
appearing on the label would be the routinely achieved concentration used for calculation of
dosages and dilutions.
The nominal concentration would in fact state the greatest degree of accuracy that is
warranted with respect to actual product composition because the nominal concentration would
be the amount of active ingredient typically found in the product.
It is important for registrants to note that certified limits for active ingredients are not
considered to be trade secret information under FIFRA section 10(b). In this respect the
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certified limits will be routinely provided by EPA to States for enforcement purposes, since
the nominal concentration appearing on the label may not represent the enforceable
composition for purposes of section 12(a)(l)(C).
III. REQUIREMENTS
As described below under Unit V. " COMPLIANCE SCHEDULE," all currently
registered products as well as all applications for new registration must comply with this
Notice by specifying the nominal concentration expressed as a percentage by weight as the
label claim in the ingredient(s) statement and equivalence statements if applicable (e.g.,
elemental arsenic, metallic zinc, salt of an acid). In addition, the requirement for performing
sample analyses of five or more representative samples must be fulfilled. Copies of the raw
analytical data must be submitted with the nominal ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR 158.170. All products are
required to provide certified limits for each active, inert ingredient, impurities of toxicological
significanceti.e., upper limit(s) only) and on a case by case basis as specified by EPA. These
limits are to be set based on representative sampling and chemical analysis(i.e., quality
control) of the product.
The format of the ingredient statement must conform to 40 CFR 156-Labeling
Requirements For Pesticides and Devices.
After July 1,1997, all pesticide ingredient Statements must be changed to
nominal concentration.
IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore, the certified lower limits may
not be lower then the minimum level to achieve efficacy. This is extremely important for
products which are intended to control pests which threaten the public health, e.g., certain
antimicrobial and rodenticide products. Refer to 40 CFR 153.640.
In those cases where efficacy limits have been established, the Agency will not accept
certified lower limits which are below that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make the registration process
more uniform and more manageable for both the agency and the regulated community. It is
the Agency's intention to implement the requirements of this notice as smoothly as possible so
as not to disrupt or delay the Agency's high priority programs, i.e., reregistration, new
chemical, or fast track (FIFRA section 3(c)(3)(B). Therefore, applicants/registrants are
expected to comply with the requirements of this Notice as follows:
t
(1) Beginning July 1, 1991, all new product registrations submitted to the Agency
are to comply with the requirements of this Notice.
(2) Registrants having products subject to reregistration under FIFRA section 4(a)
are to comply with the requirements of this Notice when specific products are
called in by the Agency under Phase V of the Reregistration Program.
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(3) All other products/applications that are not subject to (1) and (2) above will
have until July 1, 1997, to comply with this Notice. Such applications should
note "Conversion to Nominal Concentrations on the application form. These
types Or amendments will not be handled as "Fast Track" applications but will
be handled as routine requests.
VI. FOR FURTHER INFORMATION
Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.
/s/ '
Anne E. Lindsay, Director
Registration Division (H-7505C)
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APPENDIX F. Product Specific Data Call-In
107
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-in Chemical Status Sheet, to
submit certain product specific data as noted herein to the U.S. Environmental Protection
Agency (EPA, the Agency). These data are necessary to maintain the continued registration
of your product(s) containing this active ingredient. Within 90 days after you receive this
Notice you must respond as set forth in Section in below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments A through G; or
2. Why you believe you are exempt from the requirements listed in this Notice and
in Attachment 3, Requirements Status and Registrant's Response Form, (see
section ni-B); or
3. Why you believe EPA should not require your submission of product specific
data in the manner specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list
of all of your products subject to this Notice in Attachment 2, Data Call-In Response Form, as
well as a list of all registrants who were sent this Notice (Attachment b).
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 (expiration date 12-31-92).
This Notice is divided into six sections and seven Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
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Section I -
Section II -
Section IE -
Section IV -
Section V -
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
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 -
2 -
3 -
4 -
5 -
6 -
7 -
Data Call-In Chemical Status Sheet
Product-specitic Data Cali-in Response Form
Requirements status and Registrant's Response Form
A Grouping ot Jbmd-use Products for Meeting Acute Toxicology Data
Requirements tor Keregistraon
urA Acceptance criteria
List or Registrants Receiving This Notice
(Jost share and uata compensation ^orms, and Product Specific Data Report
Form
SECTION!. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the
data needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional
generic data requirements are being imposed. You have been sent this Notice because you
have product(s) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment 3,
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in tms Notice, additional 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
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided.
H-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD
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protocols, they should be modified as appropriate so that the data generated by the study will
satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for
complying with data requirements when the studies were not conducted in accordance with
acceptable standards. The OECD protocols are available from OECD, 1750 Pennsylvania
Avenue N.W., Washington, D.C. 20006.
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 160.3(a)(6)].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
BY i hLfc, AUEMUY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or change
the requirements of any previous Data Call-lnCs), or any other agreements entered into with the
Agency pertaining to such prior Notice. Registrants must comply with the requirements of all
Notices to avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific data must
be submitted to the Agency within 90 days after your receipt of this Notice. Failure to
adequately respond to this Notice within 90 days of your receipt will be a basis for issuing a
Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for issuance of
NOIS due to failure to comply with this Notice are presented in Section IV-A and IV-B.
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
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 chose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product specific
data requirements of this Notice is contained in Section III-C. A discussion of options relating to
requests for data waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used in your response to the Agency. These forms are the Data-Call-in
Response Form, and the Requirements Status and Registrant's Response Form, Attachment 2 and
Attachment 3. The Data Call-in Response Form must be submitted as part of every response to
this Notice. In addition, one copy of the Requirements'Status and Registrant's Response Form
must be submitted for each product listed on the Data Call-in Response horm unless the
voluntary cancellation option is selected or unless the product is identical to another (refer to the
instructions for completing the Data Call-in Response Form in Attachment 2). 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 rorm (if this form is
required) and initial any subsequent pages. The forms contain separate detailed instructions on the
response options. Do not alter the printed material. If you have questions or need assistance in
preparing your response, call or write the contact person(s) identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this N9tice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must submit a completed Data Call-
in Response Form, indicating your election of this option. Voluntary cancellation is item number
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5 on the Data Call-in Response Form. If you choose this option, this is the only form that you
are required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements ot this Notice. These options
are discussed in Section IU-C of this Notice and comprise options 1 through 6 on the
Requirements Status and Registrant's Response Form and item numbers 7a and 7b on the Data
(Jall-ln Response form. Deletion ot a USG(S) and the low volume/minor use option are not valid
options lor'fulfilling product specific data requirements.
3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section m-L> ot this Notice and are covered by option 7 on the Requirements Status
and Registrant's Response Form. If you choose 9ne 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.
ni-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy the
product specific data requirements (i.e. you select item number 7a or 7b), then you must select
one of the six options on the Requirements Status and Registrant's Response Form related to data
production for each data requirement. Your option selection should be entered under item
number 9, "Registrant Response." The six options related to data production are the first six
opti9ns discussed under item 9 in the instructions for completing the Requirements Status and
Registrant's Response Form. These six options are listed immediately below with information in
parentheses to guide registrants to additional instructions provided in this Section. The options
are:
I will generate and submit data within the specified time frame (Developing Data)
I have entered int9 an agreement with one or more registrants to develop data
jointly (Cost Sharing)
I have made offers to cost-share (Offers to Cost Share)
I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study)
Option 1, Developing Data — If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein
and in the attachments. All data generated and submitted must comply with the Good Laboratory
Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide Assessment
Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.
The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing tor the submission of completed study reports. The noted
deadlines run from the date of the receipt 9f this Notice by the registrant. If the data are not
submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected registration(s).
(5)
(6)
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If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements(s), you must submit a request to the
Agency which includes: (1) a detailed description of the expected difficulty and (2) a proposed
schedule including alternative dates for meeting such requirements on a step-by-step basis. You
must explain any technical or laboratory difficulties and provide documentation from the
laboratory performing the testing. While EPA is considering your request, the original deadline
remains. The Agency will respond to your request in writing. If EPA does not grant your
request, the original deadline remains. Normally, extensions can be requested only in cases of
extraordinary testing problems beyond the expectation or control of the registrant. Extensions
will not be given in submitting the 90-day responses. Extensions will not be considered if the
request for extension is not made in a timely fashion; in no event shall an extension request be
considered if it is submitted at or after the lapse of the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data ~ Registrants may only choose
this option tor acute toxicity data and certain etticacy data and only if EPA has indicated in the
attached data tables that your product and at least one other product are similar for purposes of
depending on the same data. If this is the case, data may be generated for just one of the
products in the group. The registration number of the product for which data will be submitted
must be noted in the agreement to cost share by the registrant selecting this option. If you choose
tcTenter into an agreement to share in the cost of producing the required data out will not be
submitting the data yourself, you must provide the name of the registrant who will be submitting
the data. You must also provide EPA with documentary evidence that an agreement has been
formed." Such evidence may be your letter offering to join in an agreement and the other
registrant's acceptance of your offer, or a written statement by the parties that an agreement
exists. The agreement to produce the data need not specify all of the terms of the final
arrangement between the parties or the mechanism to resolve the terms. Section 3(c)(2)(B)
provides that if the parties cannpt 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 — This option only applies to
acute toxicity and certain etticacy data as described in option 2 above. 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 discretipn not to suspend your registration(s), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general
policy, absent other relevant considerations, it will not suspend the registration of a product of a
registrant who has in good faith sought and continues to seek to enter into a joint data
development/cost sharing program, but the other registrant(s) developing the data has refused to
accept your offer. To qualify for mis option, you must submit documentation to the Agency
proving that you have made an offer to another registrant (who has an obligation to submit data)
to share in the burden of developing that data. You must also submit to the Agency a completed
EPA Form 8570-32, Certification of Offer to Cost Share in the Development of Data,
Attachment 7. In addition, you must demonstrate that the other registrant to whom the offer was
made has not accepted your offer to enter into a cost sharing agreement by including a cppy 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 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 tms Notice.
In order for you to avoid suspension under this option, you may not withdraw your 9ffer
to share in the burdens 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
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well as that of the other registrant will normally 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 or submission. The Agency may determine at any time that a study is not valid and
needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data
and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in accordance with the
requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part
160. As stated in 40 CFR 160.3(j) " 'raw data' means any laboratory worksheets,
records, memoranda, notes, or exact copies thereof, that are the result of priginal
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 haye been prepared (e.g., tapes which have been transcribed verbatim, dated,
and verified accurate by signature), the exact copy or exact transcript may be
substituted for the original source as raw data. Raw data' may include
photographs, microfilm or microfiche copies, computer printouts, magnetic media,
including dictated observations, and recorded data from automated instruments."
The term "specimens", according to 40 CFR 160.3(k), means "any material
derived from a test system for examination or analysis."
b. Health and 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 must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study
signed by an authorized official -or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according to the PAG may be
submitted to the Agency for consideration if the registrant believes that the study
clearly meets the purpose of the PAG. The registrant is referred to 40 CFR
158.70 which states the Agency's policy regarding acceptable protocols. If you
wish to submit the study, you must, in addition to certifying that the purposes of
the PAG are met by the study, clearly articulate the rationale why you believe the
study meets the purpose of the PAG, including copies of any supporting
information or data. It has been the Agency's experience that studies completed
prior to January 1970 rarely satisfied the purpose of the PAG and that necessary
raw data are usually not available for sucn studies.
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If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.
If you know of a study pertaining to any requirement in this Nptice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such study is in the Agency's files, you
need only cite it along with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
Option 5, Upgrading a Study — If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement is
not satisfied, you may still be required to submit new data normally without any time extension.
Deficient, but upgradeable studies will normally be classified as supplemental. However, it is
important to note that not all studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a study may be upgraded, call or
write the contact person listed in Attachment 1. If you submit data to upgrade an existing study
?>u must satisfy or supply information to correct all deficiencies in the study identified by EPA.
ou must provide a clearly articulated rationale oflow the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA. Your submission must also
specify the MRID number(s) of the study which you are attempting to upgrade and must be in
conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option should also 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 JiFA, 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 all other
disciplines the classification would be "acceptable." With respect to any studies for which you
wish to select this option you must provide the MRID number of the study you are citing and, if
the study has been reviewed by the Agency, you must provide the Agency's classification of the
study.
If you are citing a study of which you are not the 9riginal data submitter, you must submit
a completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements.
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, as appropriate.
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HI-D REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a completejustificatiqn 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
Sgehcy approves your waiver request, you will not be required to supply the data pursuant to
section 3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an
option for meeting the data requirements or this Notice within 30 days of the receipt of the
Agency's decision. You must indicate and submit the option chosen on the Requirements Status
and Registrant's Response Form. Product specific data requirements for product chemistry,
acute toxicity and efficacy (.where appropriate) are required for all products and the Agency
would grant a waiver only under extraordinary circumstances. You should also be aware that
submitting a waiver request will not automatically extend the due date for the study in question.
Waiver requests submitted
without adequate supporting rationale will be denied and the original due date will remain in
force.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a N9tice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-in Notice, pursuant to
FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:
Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
1 .
2.
3.
4.
5.
6.
7.
8.
Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
Failure to submit on the required schedule an adequate progress report on a study
as required by this 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 with any terms of a data waiver).
Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section ni-C of this Notice.
Withdrawal of an offer to share in the cost of developing required data.
Failure of the registrant 19 whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or
failure of a registrant on whom you rely for a generic data. exemption either to:
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a. inform EPA of intent to develop and submit the data required by this
Notice on a Data Call-In Response Form and a Requirements Status and
Registrant's Response horm; ~~
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.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines)
regarding the design, conduct, and reporting of required studies. Such requirements
include, out are not limited to, those relating to test material, test procedures, selection of
species, number of animals, sex and distribution of animals, dose and effect levels to be
tested or attained, duration of test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation
of any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting,
the completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or
contained in PR 86-5. All studies must be submitted in the form of a final report; a
preliminary report will not be considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not
be consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may
be suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act.
You must also explain why an "existing stocks" provision is necessary, including a statement of
the quantity of existing stocks and your estimate of the time required for their sale, distribution,
and use. Unless you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
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If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you win have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use such
existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has particular
risk concerns will be determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you demonstrate
to the Agency that you are in full compliance with all Agency requirements, including the
requirements of this Notice. For example, if you decide to voluntarily cancel your registration
six months before a 3 year study is scheduled to be submitted, all progress reports and other
information necessary to establish that you have been conducting the study in an acceptable and
good faith manner must have been submitted to the Agency, before EPA will consider granting
an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information to
the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-in Response Form and a completed
Requirements Status and Registrant's Response Form (.Attachment 2 and Attachment 3 for
product specilic 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 Data Call-in Response Form need be submitted.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Peter Caulkins, Acting Director
Special Review and
Reregistration Division
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Attachments
1 - Data Call-In Chemical Status Sheet
2 - Froduct-Specitic Data Call-in Response Form
3 - Requirements Status and Registrant's Response Form
4 - liFA Grouping ot End-Use Products tor Meeting Acute Toxicology Data
Requirements for Reregistration
5 - urA Acceptance criteria ~
6 - List or Registrants Receiving This Notice
7 - Cost share and Data compensation Forms, and Product Specific Data Report
Form !
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Attachment 1. Chemical Status Sheet
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TERBUTHYLAZINE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing Terbuthylazine.
This Product Specific Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point ol contact lor inquiries pertaining to the reregistration of
Terbuthylazine. 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 (Attachments), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA
Acceptance Criteria (Attachment 5), (o) a list of registrants receiving this DCI (Attachment 6)
and (7) the Cost Share and Data Compensation Forms in replying to this Terbuthylazine Product
Specific Data Call-In (Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for Terbuthylazine are
contained in the Requirements Status and Registrant's Response, Attachment 3. The Agency has
concluded that additional data on 1 erbutnyiazme are needed lor 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 Terbuthylazine products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of Terbuthylazine, please contact
Virginia Dietrich at (703) 308-8157.
If you have any questions regarding the product specific data requirements and procedures
established by this Notice, please contact CP Moran at (703) 308-8590.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
CP Mpran
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Terbuthylazine
122
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Attachment 2. Product Specific Data Call-In Response
Forms (Form A inserts) Plus Instructions
123
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4.
Item 5.
Item 6.
Item 7a.
Item 7b..
Already completed by EPA.
If you wish to voluntarily cancel your product, answer "yes." If you choose this
option, you will not have to provide the data required by the Data Call-in Notice and
you will not have to complete any other forms. Further sale and distribution of
groduct after the effective date of cancellation must be in accordance with the Existing
locks provision of the Data Call-In Notice (Section IV-C).
Not applicable since this form calls in product specific data only. However, if your
product is identical to another product and you qualify for a data exemption, you
must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide the
EPA registration numbers of your source(s); you would 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.
For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes." 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. See Item
6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
125
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier number assigned by EPA in Item
3. This number must be used in the transmittal document for any data
submissions in response to this Data Call-In Notice.
Item 4. The guideline reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the requirements
specified in the Notice, govern the conduct of the required studies. Note that series
61 and 62 in product chemistry are now listed under 40 CFR 158.155 through
158.180, SubpartC.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use pattern(s) of the pesticide associated with the product specific requirements
is (are) identified. For most product specific data requirements, all use patterns are
covered by the data requirements. In the case of efficacy data, the required studies
only pertain to products which have the use sites and/or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Document unless EPA
determines that a longer time period is necessary.
Item 9. Enter only one of the following response codes for each data requirement to show
how you intend to comply with the data requirements listed in this table. Fuller
descriptions of each option are contained in the Data Call-In Notice.
1. I will generate and submit data by the specified due date (Developing Data). By
indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined in the
Data Call-In Notice. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form (EPA
Form 8570-29) and (2) two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4).
2. I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing). I am submitting a copy of this agreement. I understand that this
option is available only for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this Notice that my product is similar enough to another
product to qualify for this option. I certify that another party in the agreement is
committing to submit or provide the required data; if the required study is not
submitted on time, my product may be subject to suspension. By the specified due
date, I will also submit: (1) a completed "Certification With Respect To Data
Compensation Requirements" form (EPA Form 8570-29) and (2) two completed
and signed copies of the Confidential Statement, of Formula (EPA Form 8570-4).
3. I have made offers to share in the cost to develop data (Offers to Cost Share). I
understand that this 9ption is available only for acute toxicity or certain efficacy data
and only if EPA indicates in an attachment to this Data Call-In Notice that my product
is similar enough to another product to qualify for this option. I am submitting
evidence that I have made an offer to another registrant (who has an obligation to
submit data) to share in the cost of that data. I am also submitting a completed
126
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"Certification of Offer to Cost Share in the Development Data" form. I am
including a copy of my offer and proof of the other registrant's receipt of that offer.
I am identifying the party which is committing to submit or provide the required data;
if the required study is not submitted on time, my product may be subject to
suspension. I understand that other terms under Option 3 in the Data Call-In Notice
(Section in-C.l.) apply as well. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
4. By the specified due date, I will submit an existing study that has not been submitted
previously to the Agency by anyone (Submitting an Existing Study). I certify that
this study will meet all the requirements for submittal of existing data outlined in
Option 4 in the Data Call-In Istotice (Section III-C.l.) and will meet the attached
acceptance criteria (for acute toxicity and product chemistry data). I will attach the
needed supporting information along with this response. I also certify that I have
determined mat this study will fill the data requirement for which I have indicated this
choice. By the specified due date, I will also submit a completed "Certification With
Respect To Data Compensation Requirements" form (EPA Form 8570-29) to
show what data compensation option I have chosen. By the specified due date, I will
also submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed copies
of the Confidential Statement of Formula (EPA Form 8570-4).
5. By the specified due date, I will submit or cite data to upgrade a study classified by
the Agency as partially acceptable and upgradable (Upgrading a Study). I will
submit evidence of the Agency's review indicating that the study may be upgraded
and what information is required to do so. I will provide the MRID or Accession
number of the study at the due date. lunderstand that the conditions for this option
outlined Option 5 in the Data Call-In Notice (Section III-C.l.) apply. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies or the Confidential Statement of Formula (EPA Form
8570-4).
6. By the specified due date, I will cite an. existing study that the Agency has classified
as acceptable or an existing study that has been submitted but not reviewed by the
Agency (Citing an Existing Study). If 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 EPA 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) for the cited
data on a "Product Specific Data Report" form or in a similar format. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies or the Confidential Statement of Formula (EPA Form
8570-4).
7. I request a waiver for this study because it is inappropriate for my product (Waiver
Request). I am attaching a complete justification for this request, including technical
reasons, data and references to relevant EPA. regulations, guidelines or policies.
[Note: any supplemental data must be submitted in the format required by P.R. Notice
86-5]. I understand that this is my only opportunity to state the reasons or provide
information in support of my request. If the Agency approves my waiver request, I
will not be required to supply the data pursuant to Section 3(c)(2)(B) of FIFRA. If
the Agency denies my waiver request, I must choose a method of meeting the data
127
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requirements of this Notice by the due date stated by this Notice. In this case, I must,
within 30 days of my receipt of the Agency's written decision, submit a revised
"Requirements Status and Registrant's Response" Form indicating the option chosen.
I also understand that the deadline for submission of data as specified by the original
data call-in notice will not change. By the specified due date, I will also submit: (1)
a completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
Items 10-13. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
128
-------
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Attachment 3. Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and
Instructions
129
-------
-------
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
Item 1-3. Completed by EPA. Note the unique identifier number assigned by EPA in item 3.
This number must be used in the transmittal document for any data submissions in
response to this Data Call-In Notice.
Item 4. The guidelines reference numbers of studies required to support toe product's
continued registration are identified. These guidelines, in addition to toe requirements
specified in toe Notice, govern the conduct of toe required studies. Note that series
61 and 62 in product chemistry are now listed under 40 CFR 158.155 through
158.180, Subpartc.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use patters (s) of toe pesticide associated with the product specific requirements
is (are) identified. For most product specific data requirements, all use patterns are
covered by the data requirements. In the case of efficacy data, the required studies
only pertain to products which have toe use sites and/ or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, toe
product as formulated for sale and distribution is toe test substance, except in rare
cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Documents unless EPA
determines that a longer time period is necessary.
Item 9. Enter Only one of the following response codes for each data requirement to show
how you intend to comply with the data requirements listed in this table. Fuller
descriptions of each option are contained in the Data Call-In Notice.
1. I will generate and submit data by the specified due date (Developing Data).
By indicating that I have chosen this option, I certify that I will comply with all toe
requirements pertaining to toe conditions for submittal of this study as outlined in the
Data Call-In Notice.
2. I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing). I am submitting a copy of this agreement. I understand that
this option is available on for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this notice that my product is similar. Enough to another
product to qualify for this option, I certify that another party in toe agreement is
committing to submit or provide toe required data; if the required study is not
submitted on time, my product my be subject to suspension.
3. I have made offers to share in toe cost to develop data (Offers to Cost Share).
I understand that this option is available only for acute toxicity or certain efficacy data
and only if EPA indicates in an attachment to this Data Call-In Notice that my product
is similar enough to another product to qualify for this option. I am submitting
• J J_t_ f. T «-. J ff A * 1 * * S \ 1 It* A* M
Development Data" form. I am including
a copy of my offer and proof of the other registrant's receipt of that offer. I am
identifying the party which is committing to submit or provide the require data; if the
required study is not submitted on time, my product may be subject to suspension.
I understand that other terms under Option 3 in the Data Call-In Notice (Section III-
C.l.) apply as well.
131
-------
4. By the specified due date, I will submit an existing study that has not been
submitted previously to the Agency by any9ne (submitting an Existing Study). I
certify that this study will meet all the requirements for submittal of existing data
outlined in option 4 m the Data Call-in Notice (Section III-C.l.) and will meet the
attached acceptance criteria (for acute toxicity and product chemistry data). I will
attach the needed supporting informati9n along with this response. I also certify that
I have determined that this study will fill the data requirement for which I have
indicated this choice.
5. By the specified due date, I will submit or cite data to upgrade a study
classified by the Agency as partially acceptable and upgrade (upgrading a study). I
will submit evidence of the Agency's review indicating that the study may' be
upgraded and what information is required to do so. I will provide the MRID or
Accession number of the study at the due date. I understand that the conditions for
this Option outlined Option 5 in the Data Call-in Notice (Section III-C.l.) apply.
6. By the specified due date, I will cite an existing study that the Agency has
classified as acceptable or an existing study that has been submitted but not reviewed
by the Agency (Citing an Existing Study). If 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 EPA 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) number (s) for
the cited data on a "Product Specific Data Report" form or in a similar format. If I
cite another registratrant's data, I will submit a completed "Certification With Respect
To Data Compensation Requirements" form.
7. I request a waiver for this study because it is inappropriate for my product
(Waiver Request). I am attaching a complete justification for this request, including
technical reasons, data and references to relevant EPA regulations, guidelines or
policies. [Note: any supplemental data must be submitted in the format required by
P.R. N9tice 86-5]. I understand that this is my only opportunity to state the reasons
or provide information in support of my request. If the Agency approves my waiver
request, I will not be require to supply the data pursuant to Section 3(c) (2) (B) of
FEFRA. If the Agency denies my waiver request, I must choose a method of meeting
the data requirements of this Notice by the due date stated by this Notice. In this
case, I must, within 30 days of my receipt of the Agency's written decision, submit
a revised "Requirements Status chosen. I also understand that the deadline for
submission of data as specified by the original data cal-in notice will not change.
Items 10-13. Self-explanatory.
NOTE:You may provide additional information that does not fit on this form in a signed letter
that accompanies this form. For example, you may wish to report that your product has already been
transferred to another company or that you have already voluntarily cancelled this product. For
these cases, please supply all relevant details so that EPA can ensure that its records are correct.
132
-------
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Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
133
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EPA'S BATCHING OF PRODUCTS CONTAINING TERBUTHYLAZINE AS THE ACTIVE
INGREDIENT FOR MEETING ACUTE TOXICITY DATA REQUIREMENTS FOR
REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregistration of products containing the active ingredient
terbuthylazine (2-tert-Butylarnino-4-chloro-6-ethylamino-s-triazine) the Agency has batched products
which can be considered similar in terms of acute toxicity. Factors considered in the sorting process
include each product's active and inert ingredients (identity, percent composition and biological
activity), type of formulation (e.g., emulsinable concentrate, aerosol, wettable powder, granular,
etc.), and labeling (e.g., signal word, use classification, precautionary labeling, etc.). Note that the
Agency is not describing batched products as "substantially similar since some products within a
batch may not be considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in the
preceding paragraph. Notwithstanding the patching process, the Agency reserves the right to require,
at any time, acute toxicity data for an individualproduct should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite a
single battery of six acute lexicological studies to represent all the products within that batch. It is
the registrants' option to participate in the process with all other registrants, only some of the other
registrants, or only their own products within a batch, or to generate all the required acute
lexicological studies for each of their own products. If a registrant chooses to generate the data for
a batch, he/she must use one of the products within the batch as the test material. If a registrant
chooses to rely upon previously submitted acute toxicity data, he/she may do so provided that the
data base is complete and valid by today's standards (see acceptance criteria attached), the
formulati9n tested is considered by EPA to be similar for acute toxicity, and the formulation has not
been significantly altered since submission and acceptance of the acute toxicity data. Regardless of
whether new data is generated or existing data is referenced, registrants must clearly identify the test
material by EPA Registration Number. If more than one confidential statement of formula (CSF)
exists for a product, the registrant must indicate the formulation actually tested by identifying the
corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-in Notice and its attachments appended to the RED. The DCI
Notice contains two response forms which are to be completed and submitted to the Agency within
90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant will meet
the data requirements for each product. The second form, "Requirements Status and Registrant's
Response," lists the product specific data required for each product, including the standard six acute
toxicity tests. A registrant who wishes to participate in a batch must decide whether he/she will
provide the data or depend on someone else to do so. If a registrant supplies the data to support a
batch of products, he/she must select one of the following options: Developing Data (Option 1),
Submitting an Existing Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an
Existing Study (Option 6). If a registrant depends on another's data, he/she must choose among:
Cost Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6).
If a registrant does not want to participate in a batch, the choices are Options 1, 4, 5 or 6. However,
a registrant should know that choosing not to participate in a batch does not preclude other registrants
in the batch from citing his/her studies and offering to cost share (Option 3) those studies.
135
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Table 1 displays the batches for the active ingredient terbuthylazine.
Table 1 .
Batch
1
2
Registration
Number
279-3139
9386-34
• 279-3137
UT93000300
Percent Active Ingredient ,
-. > *-
terbuthylazine ... 4.0%
terbuthylazine ... 4.0%
terbuthylazine ... 44.7%
terbuthylazine ... 44.7%
j*>, •< • ~, l
Form ,
< f •'
liquid
liquid
liquid
liquid
Table 2 lists the product the Agency was unable to batch. This product was considered not to be
similar to other products in terms or of acute toxicity. Registrants of this product are responsible
for meeting the acute toxicity data requirements for this product. -
Pable 2.
Registration Number
279-3138
Percent Active Ingredient
terbuthylazine ... 96%
Form '. , « !>
wettable powder
136
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Attachment 5. EPA Acceptance Criteria
137
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SUBDIVISION D
Guideline
Series 61
Series 62
Series 63
Study Title
Product Identity and Composition
Analysis and Certification of Product Ingredients
Physical and Chemical Characteristics
139
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61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Name of technical material tested (include product name and trade name, if appropriate).
2. Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each
intentionally-added inert ingredient.
3. Name and upper certified limit for each impurity or each group of impurities present at > 0.1% by weight and
• for certain lexicologically significant impurities (e.g., oioxins, nitrosamines) present aF< 0.1%.
4. Purpose of each active ingredient and each intentionally-added inert.
5. Chemical name from Chemical Abstracts index of Nomenclature and Chemical Abstracts Service (CAS)
Registry Number for each active ingredient and, if available, for each intentionally-added inert.
6. Molecular, structural, and empirical formulas, molecular weight or weight range, and any company assigned
experimental or internal code numbers for each active ingredient.
7. Description of each beginning material in the manufacturing process.
EPA Registration Number if registered;
for other beginning materials, the following:
Name and address of manufacturer or supplier.
. Brand name, trade name or commercial designation.
Technical specifications or data sheets by which manufacturer or supplier describes composition,
properties or toxicity.
8. Description of manufacturing process.
Statement of whether batch or continuous process.
Relative amounts of beginning materials and order in which they are added.
Description of equipment.
Description of physical conditions (temperature, pressure, humidity) controlled in each step and the
parameters that are maintained.
Statement of whether process involves intended chemical reactions.
Flow chart with chemical equations for each intended chemical reaction.
Duration of each step of process.
Description of purification procedures.
Description of measures taken to assure quality of final product.
9. Discussion of formation of impurities based on established chemical theory addressing (1) each impurity which
may be present at > 0.1% or was found at >_ 0.1% by product analyses and (2) certain lexicologically
significant impurities~(see #3).
140
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62 Analysis and Certification of Product Ingredients
2.
3."
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered. Use a table to present the
information in items 6, 7, and 8.
Does your study meet the following acceptance criteria?
1. Five or more representative samples (batches in case of batch process) analyzed for each active ingredient and
all impurities present at > 0.1%.
Degree of accountability or closure > ca98%,
Analyses conducted for certain trace toxic impurities at lower than 0.1 % (examples, nitrosamines in the case of
products containing dinitroanilines or containing secondary or tertiary amines/alkanolamines plus nitrites;
polyhalogenated dibenzodioxins and dibenzofurans). [Note that in the case of nitrosamines both fresh and stored
samples must be analyzed.].
Complete and detailed description of each step in analytical method used to analyze above samples.
Statement of precision and accuracy of analytical method used to analyze above samples.
Identities ana quantities (including mean and standard deviation) provided for each analyzed ingredient.
Upper and lower certified limits proposed for each active ingredient and intentionally added inert along with
explanation of how the limits were determined.
Upper certified limit proposed for each impurity present at > 0.1% and for certain lexicologically significant
impurities at <0.1 % along with explanation or how limit determined.
Analytical methods to verify certified limits of each active ingredient and impurities (latter not required if exempt
from requirement of tolerance or if generally recognized as safe by FDA) are fully described.
Analytical methods (as discussed in #9) to verify certified limits validated as to their precision and accuracy.
4.
5.'
6."
8.
9.
10.
141
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63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered.
Does your study meet the following acceptance criteria?
63-2 Color
Verbal description of coloration (or lack of it)
Any intentional coloration also reported in terms of Munsell color system
63-3 Physical State .
Verbal description of physical state provided using terms such as "solid, granular, volatile liquid
Based on visual inspection at about 20-25° C
63-4 Odor
Verbal description of odor (or lack of it) using terms such as "garlic-like, characteristic of aromatic
compounds"
Observed at room temperature
63-5 Melting Point
Reported in °C
Any observed decomposition reported
63-6 Boiling Point
—„.__... in°C
. Pressure under which B.P. measured reported
Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25° C
Density of technical grade active ingredient reported in g/ml or the specific gravity of liquids reported with
reference to water at 20° C. [Note: Bulk density of regisTered products may be reported in Ibs/ft or
Ibs/gallon.]
63-8 Solubility
Determined in distilled water and representative polar and non-polar solvents, including those used in
formulations and analytical methods for the pesticide
Measured at about 20-25° C
Reported in g/100 ml (other units like ppm acceptable if sparingly soluble)
63-9 Vapor Pressure
Measured at 25° C (or calculated by extrapolation from measurements made at higher temperature if pressure
too low to measure at 25° C)
Experimental procedure described
Reported in mm Hg (torr) or other conventional units
63-10 Dissociation Constant
Experimental method described
Temperature of measurement specified (preferably about
20-25°C)
63-11 Octanol/water Partition Coefficient
Measured at about 20-25° C
Experimentally determined and description of procedure provided (preferred method-45 Fed. Register 77350)
Data supporting reported value provided
63-12 pH
Measured at about 20-25° C
Measured following dilution or dispersion in distilled water
63-13 Stability
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined
1.42
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SUBDIVISION F
Guideline Study Title
81-1 Acute Oral Toxicity in the Rat
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
81-3 Acute Inhalation Toxicity in the Rat
81-4 Primary Eye Irritation in the Rabbit
81-5 Primary Dermal Irritation Study
81-6 Dermal Sensitization in the Guinea Pig
143
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81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 young adult rats/sex/group.
3% Dosing, single 9ral may be administered over 24 hrs.
4? Vehicle control if other than water.
5. Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mg/kg).
6. Individual observations at least once a day.
7. Observation period to last at least 14 days, or until all test animals appear normal whichever is longer.
8. Individual daily observations.
9. Individual body weights.
10. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
144
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81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 animals/sex/group.
3.* Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
4. Dosing, single dermal.
5. Dosing duration at least 24 Irours.
6.^ Vehicle control, only if toxicity of vehicle is unknown.
7. Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
8. Application site clipped or shaved at least 24 hours before dosing.
9. Application site at least 10% of body surface area.
10. Application site covered with a porous nonirritating cover to retain test material and to prevent
ingestipn.
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
145
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81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
'Docs your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use or
contains particles of inhalable size for man (aerodynamic diameter 15 pirn or less).
3. At least 5 young adult rats/sex/group.
4. Dosing, at least 4 hours by inhalation.
5. Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
6. Chamber temperature, 22° C (+2°), relative humidity 40-60%.
7. Monitor rate of air flow.
8. Monitor actual concentrations of test material in breathing zone.
9. Monitor aerodynamic particle size for aerosols.
IP)Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of respirable
substance).
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
146
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81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive, causes severe
dermal irritation or has a pH of <2 or >11.5.
3. 6 adult rabbits.
4. Dosing, instillation into the conjunctival sac of one eye
per animal.
5. Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or particulate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24 hours.
8. Eyes examined and graded for irritation before dosing and
at 1, 24, 48 and 72 nr, then daily until eyes are normal
or 21 days (whichever is shorter).
9.* Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
147
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81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Docs your study meet the following acceptance criteria?
Identify material tested (technical, end-use product, etc).
Study not required if material is corrosive or has a pH of <2 or >11.5.
6 adult animals.
Dosing, single dermal.
Dosing duration 4 hours.
Application site shaved or clipped at least 24 hours prior to dosing.
Application site approximately 6 cm2.
Application site covered with a gauze patch held in place with nonirritating tape.
Material removed, washed with water, without trauma to application site.
1.
2."
3."
4.-
5."
6."
7,"
8~,
10', Application site examined and graded" for irritation at 1, 24", 48 and 72 hr, then daily until normal or 14 days
(whichever is shorter).
11.* Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
148
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81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1 . _ Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a
- pHof <2or >11.5.
3. _ C)ne offfie following methods is utilized:
_ Freund's complete adjuvant test
_ Guinea pig maximization test
• Split adjuvant technique
_ Buehler test
_ Open epicutaneous test
_ Mauer optimization test
_ Footpad technique in guinea pig.
4. _ Complete description of test.
5.^ Reference for test.
6. _ Test followed essentially as described in reference document.
7. _ Positive control included (may provide historical data conducted within the last 6 months).
Criteria marked with an * are supplemental and may not be required for every study.
149
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Attachment 6. List of All Registrants Sent This Data Call-in (insert) Notice
151
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Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions
153
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed copies of the form are
Required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible party must be provided.
d. All applicable information which is on the product specific data submission must also be reported on the
CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and pounds per cubic feet
for solids.
f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently registered source products
must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all common names for
the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be reported under column 10
and must be exactly the same as on the source product's label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or grams. In no case will
volumes be accepted. Do not mix English and metric system units (i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must represent pure active form.
m. The upper and lower certified limits for ail active and inert ingredients must follow the 40 CFR 158.175
instructions. An explanation must be provided if the proposed limits are different than standard certified
limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs become obsolete for that
specific formulation.
157
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&EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
Approve! Expire* 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223. U.S. Environmental Protection Agency, 401 M St.. S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill In blanks below.
Company Name
Product Name
Company Number
EPA Keg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B){iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Name of Flrm(s)
Oil* of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature
Nam* and
of Company's Authorized Repreaentativa
Title (Pleaae Type or
Dale
Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580. which is obsolete
159
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Form Approved
OMB No. 2070-0107,
2070-0057
Approval Expires
3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. SencTcomrnents regarding the burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, U.S. Environmental Protection
Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project
(2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
I Certify that:
1. For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
data submitter to cite that study.
2. That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the
original data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writing the
company(ies) that submitted data I have cited and have offered to: (a) Pay cpmpensation for those data in accordance with sections
3(c)(1)(F) ana 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
requirement of FIFRA and the amount of compensation due, if any. The companies I have notified are. (check one)
f ] 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 j 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, wi
reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
with regard to the registration or
Signature
Date
Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
161
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APPENDIX G. FACT SHEET
163
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-95-006
January 1995
R.E.D. FACTS
Pesticide
Reregistration
Use Profile
Terbuthylazine
All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can be used
without posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered years ago be reregistered to ensure that they meet
today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews
appropriate studies from pesticide producers, describing the human health
and environmental effects of each pesticide. The Agency imposes any
regulatory controls that are needed to effectively manage each pesticide's
risks. EPA then reregisters pesticides that can be used without posing
unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
fact sheet summarizes the information in the RED document for
reregistration case 2645, terbuthylazine.
Terbuthylazine is an algicide, microbicide and microbiostat used to
control slime-forming algae, fungi, and bacteria. It is registered for use in
commercial and industrial water cooling systems, and in residential and
commercial ornamental ponds, fountains and aquaria. Terbuthylazine is
formulated as a soluble concentrate/liquid, and is applied as a continuous
feed or intermittent slug treatment, using either open pouring or closed
system methods.
Use practice limitations currently require users to preclean systems
before applying the pesticide, and prohibit: discharge of effluent containing
the pesticide into sewage systems without notifying the sewage treatment
plant authority; discharging effluent containing the pesticide into lakes,
streams, ponds, estuaries, oceans, or public waters; use where treated
water will come into contact with lawns, trees, shrubs, or other desirable
plants since injury may result; and using water from treated systems for
irrigation or spraying of agricultural crops, lawns, or ornamental plants, or
for watering cattle, goats, hogs, horses, poultry or sheep, or for human
consumption.
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Regulatory
History
Human Health
Assessment
Initially, in 1975, terbuthylazine was registered as a herbicide in the
U.S., and several tolerances for residues in food and feed were established.
However, since no end-use products were registered for these uses, the
tolerances were revoked in 1992. Meanwhile, in 1986, algicide and
microbicide/microbistat end-use products were registered. EPA has issued
four Data Call-In notices for terbuthylazine. Five products currently are
registered.
Toxicity
Terbuthylazine generally is of relatively low acute toxicity. It has
been placed in Toxicity Category III, the second-to-lowest of four
categories, for acute oral, dermal, and inhalation effects. Terbuthylazine is
mildly to moderately irritating to the eyes, and slightly irritating to the skin,
and has also been placed in Toxicity Category III for these effects. It is not
a skin sensitizer.
In a subchronic toxicity study using rats, terbuthylazine caused
decreased body weight gain as well as decreased thymic, kidney and liver
weights. A study using rabbits resulted in decreased body weight gain and
food consumption, and mortality in one female. In another rabbit study, all
the animals developed difficulty in breathing, piloerection, sedation, curved
body posture, dermal irritation, and decreased body weight gain and food
consumption.
In chronic toxicity and carcinogenicity studies using mice and rats,
decreases in body weight gain and food consumption were observed. Two
studies using mice and rats caused no increase in tumors. However, a third
study using rats caused an increased incidence of testicular tumors in males
and mammary gland carcinomas in females, but only at a dose at which
excessive systemic toxicity also was observed. Based on this study, EPA's
Carcinogenicity Peer Review Committee has classified terbuthylazine as a
Group D carcinogen—one for which there is inadequate evidence to
determine carcinogenicity in humans.
Terbuthylazine caused no signs of developmental toxicity in a study
using rabbits. However, in a study using rats, maternal toxicity was
observed as reduced body weight gain and food intake, and developmental
toxicity was observed in the litter as a lack of bone formation in one toe.
Reproductive toxicity data is not available, but will be required if food uses
are proposed in the future. Available studies indicate that terbuthylazine is
not mutagenic.
Dietary Exposure
Dietary exposure to terbuthylazine is not expected since no products
with food uses currently are registered.
Occupational and Residential Exposure
2
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Environmental
Assessment
Workers may be exposed to terbuthylazine during applications in
commercial/industrial settings. In addition, workers may be exposed to this
pesticide after application, while cleaning or maintaining water cooling
towers, and other people (including children) may be exposed while wading
or swimming in treated ornamental ponds or fountains. Because of the use
patterns and dilution factors involved, however, EPA believes that post-
application exposure to terbuthylazine in both commercial and residential
settings is minimal.
Since terbuthylazine is associated with developmental toxicity effects,
EPA assessed the risks to workers who apply this pesticide using the open
pouring method compared to the metering pump method. The Agency
found that the risk to commercial applicators who routinely use the open
pouring method is unacceptable. Margins of Exposure (MOEs) for these
workers are very low for both typical and high use rates, both short- and
intermediate-term. However, MOEs for workers using closed pump
systems are well above 100, the margin generally considered acceptable.
MOEs for workers using both open pouring and metering pump methods in
residential settings also are acceptably high.
EPA therefore is prohibiting commercial applications of terbuthylazine
using the open pouring method, and is requiring use of closed systems along
with certain personal protective equipment (PPE), to reduce exposure and
risk to acceptable levels for all commercial uses.
Human Risk Assessment
Terbuthylazine is of relatively low acute toxicity, and is classified as a
Group D carcinogen because there is inadequate evidence to determine its
carcinogenicity in humans. However, it is associated with developmental
toxicity in a study using 4-^Kfefe R«vr5.
Terbuthylazine has no food-related uses at present so dietary exposure
is not of concern. However, workers are exposed while applying this
pesticide in commercial/industrial and residential settings, using open
pouring and closed system methods. EPA has found that the risk to
commercial/industrial workers using open pouring methods is unacceptable.
The Agency is prohibiting open pouring methods for commercial/industrial
uses of terbuthylazine, and requiring use of closed systems with PPE in
commercial/industrial settings.
Environmental Fate
Terbuthylazine is stable to hydrolysis, and to aqueous photolysis. It
degrades very slowly under aerobic aquatic conditions, and will persist
under most aquatic conditions.
Ecological Effects
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Terbuthylazine is practically nontoxic to birds on an acute and
subacute dietary basis. However, it is moderately toxic to both cold and
warm water fish, slightly toxic to aquatic invertebrates, and highly toxic to
estuarine/marine invertebrates from acute exposures. Terbuthylazine is
expected to be phytotoxic to aquatic plants because it belongs to the triazine
family (which includes many herbicides), is released to waterways, and
dissipates slowly in the environment.
Ecological Effects Risk Assessment
No significant risks to birds or mammals are expected from use of
terbuthylazine. Although terbuthylazine is moderately toxic to fish and
slightly toxic to freshwater invertebrates, these species are not expected to
be at risk under typical use and exposure scenarios. In high exposure
situations, however, levels of concern for high risk, restricted use, and
endangered species are met or exceeded. Because its use patterns are not
associated with estuarine or marine environments, significant risk to
estuarine/marine invertebrates is not expected. Phytotoxicity to aquatic
plants is anticipated, and EPA has required relevant studies as confirmatory
data.
Risk Mitigation
Additional Data
Required
EPA is requiring the following risk mitigation measures for
terbuthylazine, as discussed earlier:
o To reduce risks to commercial/industrial applicators, EPA will
prohibit open pouring methods and require that only closed system methods
of application, with specified PPE, be used for commercial application of
terbuthylazine.
o To adequately mitigate potential risks to fish, freshwater invertebrates,
and aquatic plants from release of effluent to waterways:
• EPA will coordinate regulatory oversight of terbuthylazine under
FIFRA, the federal pesticide law administered by the Agency's Office
of Pesticide Programs, and the National Pollutant Discharge
Elimination System (NPDES) administered by the Office of Water in
conjunction with the states.
• EPA will require compliance with the Endangered Species
Protection Program when it goes into effect.
The generic database supporting terbuthylazine is substantially
complete. Confirmatory data measuring the toxicity of this pesticide to
aquatic plants were recently required of registrants, and must be submitted
to EPA by January 1996. The Agency also is requiring product-specific
data including product chemistry and acute toxicity studies, revised
Confidential Statements of Formula (CSFs), and revised labeling for
reregistration.
Product Labeling
All terbuthylazine end-use products must comply with EPA's current
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Changes Required pesticide product labeling requirements, and with the following:
Effluent Discharge Labeling Statements
All end-use products that may be contained in an effluent discharged
to the waters of the U.S. or municipal sewer systems must bear the effluent
discharge labeling statements described in PR Notice 93-10.
Other Labeling Requirements
Except where indicated otherwise, the following statements must
appear on all end-use products containing terbuthylazine that are intended
primarily for industrial use:
Application Restrictions:
For products intended for industrial use:
"Open pouring of this product is prohibited."
"Mixing, loading, and application must be with a closed system (one
that prevents the chemical from contacting handlers or other persons)
and during handling of the chemical personal protective equipment
must be worn. Personal protective equipment includes a long-sleeved
shirt, long pants, shoes, socks, and chemical-resistant gloves. A
chemical-resistant apron must be immediately available during loading
and application and must be worn in case of a leak, spill, or other
exposure to the concentrate."
For products intended for homeowner use:
"Persons that mix, load, or apply this product must wear a long-
sleeved shirt, long pants, shoes, socks, and chemical-resistant gloves."
User Safety Requirements:
"Follow manufacturer's instructions for cleaning/maintaining Personal
Protective Equipment. If no such instructions for washables exist, use
detergent and hot water. Keep and wash personal protective
equipment separately from other laundry."
User Safety Recommendations:
"Users should wash hands before eating, drinking, chewing gum,
using tobacco, or using the toilet."
"Users should remove clothing immediately if pesticide gets inside.
Then wash thoroughly and put on clean clothing."
"Users should remove personal protective equipment immediately
after handling this product. Wash the outside of gloves before
removing. As soon as possible, wash thoroughly and change into
clean clothing."
Regulatory
Conclusion
Currently registered pesticide products containing the active ingredient
terbuthylazine, labeled and used as specified in the RED document, will not
pose unreasonable risks or adverse effects to humans or the environment.
Therefore, all uses of these products are eligible for reregistration.
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For More
Information
Terbuthylazine products will be reregistered once the required product
specific data, revised Confidential Statements of Formula, and revised
labeling are received and accepted by EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for terbuthylazine 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 cbmments,
please contact the Pesticide Docket, Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of Pesticide
Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregistration Information System at
703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA.GOV., or using ftp on FTP.EPA.GOV, or using
WWW (World Wide Web) on WWW.EPA.GOV.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fax 513-489-8695.
Following the comment period, the terbuthylazine RED document also
will be available from the National Technical Information Service (NTIS),
5285 Port Royal Road, Springfield, VA 22161, telephone 703-487-
4650.
For more information about EPA's pesticide reregistration program,
the terbuthylazine RED, or reregistration of individual products containing
terbuthylazine, please contact the Special Review and Reregistration
Division (7508W), OPP, US EPA, Washington, DC 20460, telephone
703-308-8000.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
free 1-800-858-7378, between 8:00 am and 6:00 pm Central Time, Monday
through Friday.
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