xvEPA
United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA 738-R95-019
August 1995
Re registration
Eligibility Decision (RED)
Picloram
-------
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
SEP 26 1995
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 Picloram which
includes the active ingredients triisopropanolamine picloram, isooctyl picloram, and potassium
picloram. The enclosed Reregistration Eligibility Decision (RED) contains the Agency's
evaluation of the data base of this chemical case, 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 ingredient(s) 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
receipt 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
Emily Mitchell at (703) 308-8583. Address any questions on required generic data to the
Special Review and Reregistration Division representative, Venus Eagle at (703) 308-8045.
Sincerely yours,
Enclosures
Lois A. Rossi, Director
Special Review and
Reregistration Division
-------
-------
SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1 DATA CALL-IN (PCI) OR "90-DAY RESPONSE"-If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data
are required, a DCI letter will be enclosed listing such requirements. If both generic and
product specific data are required, a combined Generic and Product Specific DCI letter will
be enclosed describing such data. However, if you are an end-use product registrant only and
have been granted a generic data exemption (GDE) by EPA, you are being sent only the
product specific response forms (2 forms) with the RED. Registrants responsible for generic
data are being sent response forms for both generic and product specific data requirements (4
forms). You must submit the appropriate response forms (following the instructions
provided) within 90 days of the receipt of this RED/DCI letter; otherwise, your product
may be suspended.
2". TIME EXTENSIONS AND DATA WAIVER REQUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for time extensions for product specific data
should be submitted in the 90-day response. Requests for data waivers must be submitted as
part of the 90-day response. All data waiver and time extension requests must be accompanied
by a full justification. All waivers and time extensions must be granted by EPA in order to go
into effect.
3 APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a- Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b- Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies: Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may, but are not
required to, delete uses which the RED says are ineligible for reregistration! For further
labeling guidance, refer to the labeling section of the EPA publication "General Information
on Applying for Registration in the U.S., Second Edition, August 1992" (available from the
National Technical Information Service, publication #PB92-221811; telephone number 703-
487-4650).
c- Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI).
-------
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.
e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5. WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
-------
REREGISTRATION ELIGIBILITY DECISION
PICLORAM
LIST A
CASE 0096
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
-------
-------
TABLE OF CONTENTS
PICLORAM REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY
•••••••••••.......- v
I. INTRODUCTION ....
• * * • ••••••• . . • •••••.................„ i
H. CASE OVERVIEW 2
A. Chemical Overview ..........
B. Use Profile 3
C. Estimated Usage of Pesticide g
D. Data Requirements . o
E. Regulatory History 9
SCIENCE ASSESSMENT 10
A. Physical Chemistry Assessment 10
B. Human Health Assessment '.'.'''' n
1. Toxicology Assessment U
a. Acute Toxicity 12
b. Subchronic Toxicity '.','.''' 13
c. Chronic Toxicity ...!.'"' 15
d. Combined Chronic Toxicity and Carcinogenicity 15
e. Developmental Toxicity u
f. Reproductive Toxicity ^9
g. Mutagenicity ^
h. Metabolism 21
i. Other Toxic Endpoints 22
j. Reference Dose 23
2. Exposure Assessment 23
a. Dietary 23
b. Occupational and Residential 26
3. Risk Assessment ;...... 33
a. Dietary „ 33
b. Occupational and Residential ................... 36
C. Environmental Assessment 41
1. Environmental Fate 41
a. Environmental Chemistry, Fate and Transport 41
b. Environmental Fate Assessment 44
2. Ecological Effects ........'....... 46
a. Ecological Effects Data 46
(1) Non-target Terrestrial Animals . 46
(2) Non-target Aquatic Animals 49
-------
(3) Non-Target Insects Data 52
(4) Non-Target Plants Data 53
(5) Adequacy of Toxicity Data 57
b. Ecological Effects Risk Assessment 58
(1) Calculation of Estimated Environmental
Concentrations 62
(2) Non-target Terrestrial Animals 66
(3) Non-target Terrestrial Plants 69
(4) Non-target Aquatic Plants 72
(5) Non-target Aquatic Animals 73
(6) Non-target Insects 76
IV. RISK MANAGEMENT AND REREGISTRATION DECISION > 76
A. Determination of Eligibility 76
1. Eligibility Decision . 77
2. Eligible and Ineligible Uses 77
B. Regulatory Position 77
1. Tolerance Reassessment 77
2. Restricted Use Classification 80
3. State Management Plan 81
4. Reference Dose 81
5. Cancer Risk Assessment 82
6. Endangered Species Statement 82
7. Worker Protection 82
8. Spray Drift Advisory 86
9. Ground Water and Surface Water Advisories 87
10. Phytotoxic Concerns 87
a. Risk Reduction Measures 87
b. Monitoring and Other Programs . 88
c. Benefits 89
d. DowEIanco's Stewardship . 89
V. ACTIONS REQUIRED BY REGISTRANTS 90
A. Manufacturing-Use Products 90
1. Additional Generic Data Requirements 90
2. Labeling Requirements for Manufacturing-Use Products 91
B. End-Use Products 92
1. Additional Product-Specific Data Requirements 92
2. Labeling Requirements for End-Use Products 93
a. Reduced Use Rates and Increased Intervals 93
b. Other Labeling Requirements 93
c. Spray Drift Labelling 95
d. Ground Water Statements 98
e. Surface Water Statements 98
f. Phytotoxicity Statements 98
-------
209
C. Existing Stocks ..... ....... on
VI. APPENDICES 1Q1
APPENDIX A. Table of Use Patterns Subject to Reregistration . . . . . . . '. . 103
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 119
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Picloram 149
APPENDIX D. List of Available Related Documents
APPENDIX E
PR Notice 86-5 ................'''''''' '
PR Notice 91-2 ^
APPENDIX F. Combined Generic and Product Specific Data Call-In '. . 215
Attachment 1. Chemical Status Sheets . 235
Attachment 2. Combined Generic and Product Specific Data Call-in
Response Forms (Form A inserts) Plus Instructions 239
Attachment 3. Generic and Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and Instructions
• • • • 245
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 253
Attachment 5. EPA Acceptance Criteria 257
Attachment 6. List of All Registrants Sent This Data Call-in Notice (insert)
271
Attachment 7. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 273
APPENDIX G. FACT SHEET .'.'.'.'!'"" 283
-------
-------
PICLORAM REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
John Faulkner
George Keitt
James Saulmon
Thomas C. Harris
Environmental Fate and Effects Division
David Farrar
Kevin Poff
Branch
Kevin Costello
Branch
Estella Waldman
Branch
Health Effects Division
Jane Smith
Brian Dementi
William Smith
Al Nielson
Branch
Shanaz Bacchus
Branch
John Bazuin
Registration Division
Karen Hicks
Joanne Hayes
Special Review and Reregistration Division
Venus Eagle
Walter Waldrop
Carol Stangle
Economic Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Science Analysis and Coordination Staff
Environmental Fate and Groundwater
Environmental Fate and Groundwater
Environmental Fate and Groundwater
Chemical Coordination Branch
Toxicology Branch
Reregistration Support Chemistry Branch
Occupational and Residential Exposure
Occupational and Residential Exposure
Dietary Risk and Evaluation Section
Fungicide-Herbicide Branch
Registration Support Branch
Reregistration Branch
Reregistration Branch
Policy, Planning and Operations Branch
-------
Policy and Special Projects Staff
Jean Frane
Office of Compliance Monitoring
Phyllis Flaherty
Office of Compliance Monitoring
11
-------
AE
a.i.
ADI
ARC
CAS
CI
CNS
CSF
DFR
ORES
DWEL
EEC
EP
EPA
FDA
FIFRA
FFDCA
GLC
GM
GRAS
HA
HOT
LD.
LEL
LOG
LOD
LOEL
MATC
MCLG
mg/L
MP
MPI
MOB
NOEC
MRID
N/A
NPDES
NOEL
OP
GLOSSARY OF TERMS AND ABBREVIATIONS
Acid Equivalent
Active Ingredient
Acceptable Daily Intake. A now defunct term for reference 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
Estunated 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
No effect concentration
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
111
-------
GLOSSARY OF TERMS AND ABBREVIATIONS
OPP Office of Pesticide Programs
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*j 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
-------
EXECUTIVE SUMMARY
Background
This Registration Eligibility Decision document (RED) addresses the eligibility for
reregistration of pesticide products containing picloram acid and its derivatives; specifically it
includes triisopropanolamine picloram (TIPA-salt), isooctyl/ethylhexyl picloram (IOE) and
potassium picloram (K-salt). Hereafter, in this document, the term "picloram" refers to
picloram acid and these three derivatives.
Picloram is a systemic herbicide used to control deeply rooted herbaceous weeds and
woody plants in rights-of-ways, forestry, rangelands, pastures and small grains. Picloram
salts and ester are manufactured by an integrated system from picloram acid. Picloram acid
has no end uses. TIPA-salt and K-salt have food/feed uses. The IOE of picloram is registered
for non-food uses only. TIPA-salt and K-salt are currently applied pre or postemergence as a
ground or aerial broadcast or spot treatment.
In March 1985, the Agency issued a Registration Standard for picloram! This
document required additional data and imposed a maximum level of hexachlorobenzene (HCB)
in the technical product of 200 ppm. It also required testing for nitrosoamines. The sole
registrant of picloram has complied with these requirements; no nitrosoamines were detected
in picloram products (< 1 ppm) and the level of HCB, an impurity that results from the
manufacturing process, has been certified to be less than 100 ppm. The picloram Final
Reregistration Standard and Tolerance Reassessment (FRSTR) was issued 5/18/88.
Supporting Rationales for Reregistration Decision
A reference dose (RfD) for picloram was calculated to be 0.20 mg/kg/day based on a
NOEL of 20 mg/kg/day body-weight per day from a two-year rat chronic feeding study. An
uncertainty factor of 100 was used to account for the inter-species extrapolation and intra-
species variability. The picloram chronic dietary exposure/risk estimates are extremely low
For the United States population as a whole, the Theoretical Maximum Residue Contribution
(TMRC) is 0.9% of the RfD. For this same group, the Anticipated Residue Contribution
(ARC) is 0.5% of the RfD. Because the dietary exposure/risk is so low, about l/200th of the
RfD, there are no concerns regarding chronic dietary exposure to picloram.
The Agency has classified picloram as a Group E carcinogen (evidence of non-
carcinogenicity for humans). Even though picloram was shown to be non-carcinogenic, a
cancer risk assessment was performed on the maximum HCB concentration since HCB has
been classified by the Agency as a Group B2 carcinogen. The refined, ARC dietary
carcinogenicity risk estimates for the United States population as a whole for the impurity,
HCB, is 7 x lO'7, which is less than 1.0 x 10'6 point below which risk is generally considered
to be negligible.
-------
Picloram IOE bears structural similarity to di(2-ethylhexyl)phthalate (DEHP) in that
both possess a 2-ethylhexyl moiety. DEHP and certain other substances containing the 2-
ethylhexyl moiety have been found to be carcinogenic in rodents. The Agency performed a
cancer risk assessment for workers and found that the risk associated with post-application
exposure is not a major concern since exposure to workers is minimal due to the use patterns
defined by the IOE labels and the cultural practices typically associated with a broad spectrum
herbicide of this type. The Agency is requiring that the restricted reentry intervals (REI) of
12 hours for all end use products containing picloram as required by the Worker Protection
Standard PR Notice for in-scope uses be retained.
There is minimal concern for risk to fish and wildlife based on picloram's low toxicity
to avian and aquatic test species. However, potential phytotoxic risks to nontarget terrestrial
plants from exposure to picloram are very significant. Additionally, picloram is very mobile
and persistent which heightens the concern for exposure of nontarget plants since .picloram is
highly toxic to a wide range of plant species. Picloram is occasionally transported from the
site of application and causes unintentional damage to crops and other nontarget plants. The
1992 Pesticides and Ground Water Database survey showed detects in groundwater in 10
states.
Reregistration Decision
Picloram may pose a significant risk to on- and off-site endangered terrestrial, semi-
aquatic, and aquatic plant species and may also have adverse effects on other on and off-site
nontarget plants. In addition, the Agency is concerned about the potential for further ground
water contamination from registered uses of picloram.
However, the Agency has determined that despite phytoxicity and ground water
concerns, all the uses of picloram are eligible for reregistration based on A) implementation of
risk reduction measures (reduced use rates and frequencies); B) registrant commitment to
better define the nature and scope of potential ground water contamination and nontarget plant
effects C) a cursory benefits analysis; D) the tightly controlled product distribution system that
has been put in place by the sole producer, DowElanco and; E).State regulation of picloram
(see section IV).
The residual risks, with the modified use rates and frequencies, are not well understood
but could likely remain high. The additional information generated by the registrant's
commitment to a mapping program and a monitoring program, may be used to further refine
local restrictions and possible prohibitions of use in sensitive areas.
The Agency consulted with several state lead Agencies regarding use practices and
their regulatory experience with picloram. These consultations provided valuable guidance in
refinement of the reduction in application rates and timing of application.
VI
-------
To further refine the risk assessments in this document, the Agency is requiring
additional ecotoxicity, phytoxicity and mixer/loader data for aU three derivatives of picloram.
Before reregistering the products containing picloram acid and its derivatives the
Agency is requiring that product specific data, revised Confidential Statements of Formula
(CSF) and revised labeling be submitted within eight months of the issuance of this document.
These data include product chemistry and acute toxicity testing for each registration-. After
reviewing these data and any revised labels and finding them acceptable in accordance with
Section 3(c)(5) of FIFRA, the Agency will reregister a product. Those products which contain
other active ingredients will be eligible for reregistration only when the other active
ingredients are determined to be eligible for reregistration.
VII
-------
-------
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 picloram (TGAI) and its derivatives: triisopropanolamine picloram (TIPA-
salt), isooctyl/ethylhexyl picloram (IDE) and potassium picloram (K-salt). The document
consists of six sections. Section I is the introduction. Section H describes picloram and its
derivatives, their uses, data requirements and regulatory history. Section m discusses the
human health and environmental assessment based on the data available to the Agency. Section
IV presents the reregistration decision for picloram and its derivatives. Section V discusses the
reregistration requirements. Finally, Section VI is the Appendices which support this
Reregistration Eligibility Decision. Additional details concerning the Agency's review of
applicable data are available on request.
-------
H. CASE OVERVIEW
A. Chemical Overview
The following active ingredient(s) are covered by this Reregistration Eligibility
Document:
(1) Picloram acid (TGAI)
Chemical Name:
CAS Registry Number:
OPP Chemical Code:
Empirical Formula:
Trade and Other Names:
Basic Manufacturer:
Piclqram acid
1918-02-1
005101
C6H3C13N2O2
Manufacturing Use Only
DowElanco
(2) Picloram triisopropanolamine salt (TIPA)
Chemical Name:
CAS Registry Number:
OPP Chemical Code:
Empirical Formula:
Trade and Other Names:
Basic Manufacturer:
(3) Isooctyl Picloram (IOE)
Chemical Name:
CAS Registry Number:
OPP Chemical Code:
Empirical Formula:
Trade and Other Names:
Basic Manufacturer:
(4) Potassium Picloram (K-salt)
Chemical Name:
CAS Registry Number:
OPP Chemical Code:
Empirical Formula:
Trade and Other Names:
Basic Manufacturer:
Picloram triisopropanolamine salt
6753-47-5
005102
C15H24C13N305
Tordon 101 Mixture, Grazon P+D, Tordon 101R,
Tordon RTU, Pathway.
DowElanco
Isooctyl Picloram, also known as ethylhexyl ester.
26952-20-5
005103
C14H19C13N2O2
Access
DowElanco
Potassium Picloram
2545-60-0
005104
C6H2C13KN2O2
Tordon 22K, Tordon K, Grazon PC, Tordon
K salt Liquor.
DowElanco
-------
B. Use Profile
The following is a general use profile for the registered uses for picloram. A
detailed table of eligible uses as well as the methods, application rates, and use
restrictions is included in Appendix A.
1) Chemical: picloram acid
Type of Pesticide: Herbicide
Formulation Types Registered: This is a manufacturing-use product
only.
2) Chemical: picloram, triisopropanolamine
Type of Pesticide:
Mode of action:
Herbicide
pyridinecarboxylic acid herbicide,
auxin type
Use groups: Terrestrial feed crop-pastures, rangeland
Terrestrial nonfood crop-industrial areas (outdoor), nonagricultural
rights-of-way/fencerows/hedgerows, nonagricultural uncultivated
areas/soils
Forestry-forest plantings (reforestation program), forest trees, forest
roadsides
Pests: ailanthus, alder, aspen, birch, bitterweed, blackberry, bouncingbet,
brackenfern, broom snakeweed, buffalobur, bullnettle, bursage,
buttonbush, camphorweed, cedar, cherry, chicory, Chinese tallowtree,
clover, cocklebur, common broomweed, croton, dandelion, dock,
dogfennel, dogwood, Drummond's goldenweed, elm, field bindweed,
fir, fleabane, goldenrod, gorse, green ash, groundsel,- gum, hawthorn,
hemlock, hickory, honeysuckle, hornbeam, horsenettle, knapweed,
kudzu, leafy spurge, loco, locust, maple, marshelder, mesquite,
milkweed, oak, persimmon, pine, plantain, poison oak, prickly lettuce,.
pricklypear, ragweed, rose, rush skeletonweed, sassafras, serviceberry,
silverleaf nightshade, smartweed, sourwood, spruce, sumac, sunflower,
tansy ragwort, tasajillo, toadflax, tuliptree, upright prairie coneflower,'
vetch, wild carrot, willow, yankeeweed
Formulation
types: Emulsifiable concentrate-10.2% + 39.6% 2,4-D (0.54 Ib AE
picloram/gal)
Soluble concentrate/liquid (water)~10.2% + 39.6% 2,4-D (0.54 Ib AE
picloram/gal)
3 .
-------
Liquid ready to use-5.4% + 20.9% 2,4-D (0.25 Ib.AE picloram/gal)
Methods and rates of application:
EMULSIFIABLE CONCENTRATE-to pastures or rangeland,
in spring or fall when target plants are actively growing,
broadcast foliar application at up to 0.54 Ib acid
equivalent(AE)/acre by aircraft or ground sprayer.
SOLUBLE CONCENTRATE, LIQUID-to pastures or
rangeland, in spring or fall when target plants are actively
growing, broadcast foliar application at up to 0.54 Ib acid
equivalent(AE)/acre by aircraft or ground sprayer.
—to forest sites:
•in preparation for reforestation, apply coarse foliar spray at up
to 1.62 Ib AE/A by aircraft or ground sprayer, when target
plants are actively growing.
•to forest roadsides, wildlife openings in forests, apply in spring
or late summer or fall, when target plants are actively growing:
• high volume leaf/stem/root collar treatment at up to 1.08 Ib
AE/A by ground spray at up to 200 gal spray/A.
• low volume foliage treatment at up to 1.08 Ib AE/A by ground
spray at up to 15 gal spray/A.
• cut surface treatment, at any season except when there is rapid
sap flow, apply 5.4 percent or 10.2 percent AE/A of soluble
concentrate/liquid, by injector, oil can or brush to cut surfaces of
injector wounds, frill/girdle cuts, or stump surfaces. About 10
ml. treats a tree 6 inches in diameter.
•to naturally regenerated spruce and firs in Northeast U.S. for
strip thinning, apply up to 1.62 Ib AE/A in bands, using 12-20
gal spray/A, by helicopter using Microfoil or Thru-Valve boom,
when trees are actively growing.
—to non-crop and industrial storage sites and. rights-of-way
apply in spring or late summer or fall, when target plants are
actively growing:
• high volume leaf/stem/root collar treatment at up to 1.08 Ib
AE/A by ground spray at up to 200 gal spray/A.
• low volume foliage treatment at up to 1.08 Ib AE/A by ground
spray at up to 15 gal spray/A.
• cut surface treatment, at any season except when there is rapid
sap flow, apply 5.4-percent or 10.2 percent AE/A of soluble
concentrate/liquid, by injector, oil can or brush to cut surfaces of
injector wounds, frill/girdle cuts, or stump surfaces. About 10
ml. treats a tree 6 inches in diameter.
• broadcast stubble treatment, at up to 2.16 Ib AE/A , using
ground sprayer, to cut stumps of mowed or hand-cut woody
-------
Use limitations:
species, before of during periods of active root growth, soon
after cutting, .; ,
LIQUID READY TO USE (0.25 Ib AE/gal)~to forest
and other non-crop sites such as fence row, roadsides
and rights-of-way, at any season (maples should not be
treated during spring sap flow), apply frill, girdle, or
stump treatment with paintbrush or sprayer, or injection
treatment with injection equipment at 0.008 to 0.0013 Ib
AE/tree.
Do not apply through any type of irrigation system. Observe 30 days
preharvest interval for forage/fodder. Observe 7 days pregrazing
interval. Use only once per year.
3) Chemical: picloram, isooctyl/ethylhexyl esters
Type of Pesticide: Herbicide
Mode of action: - pyridinecarboxylic acid herbicide, auxin type
Use groups: Terrestrial nonfood crop-industrial areas (outdoor),
nonagricultural rights-of-way/fencero ws/hedgerows,
nonagricultural uncultivated areas/soils
Forestry—forest trees
Pests: ash, aspen, birch, cherry, elm, hackberry, hickory, locust, maple,
multiflora rose, oak, oceanspray, pine, poplar, sassafras, tanoak
Formulation
types: Soluble concentrate/liquid (oil)-17.1% + 32.5% butoxyethyl triclopyr
Method and rate of application:
Basal bark and soil treatment, high volume (to stems less than 6 inches
diameter): Use low pressure knapsack, backpack, or power sprayer, at
0.02 Ib acid equivalent (AE)/gal of oil spray (100 gal), or 0.02 to 0.03
Ib AE/gal of oil/water emulsion spray when needed (best results are
obtained when applied during late dormant or active growing season).
Basal bark and soil treatment, low volume (to stems less than 6 inches
diameter): Use backpack or knapsack sprayer at 0.2 to 0.3 Ib AE/gallon
of oil spray when needed. (Best results are obtained when applied
during late dormant or active growing season.)
Thinline basal bark treatment, to stems less than 6 inches diameter,
apply as a thin stream around the trunk 0.0005 to 0.004 Ib AE (2-15
-------
Use limitations:
ml) of undiluted product (1 Ib AE/gal) per stem to be treated, using
equipment metered or calibrated to deliver these small amounts.
Do not contaminate water intended for irrigation or domestic purposes.
Do not apply to snow or frozen ground.
Do not apply near desirable trees if injury from potential transfer
through roots cannot be tolerated.
4) Chemical: picloram, potassium salt
Type of Pesticide:
Mode of action:
Herbicide
pyridinecarboxylic acid herbicide, auxin type
Use groups: Terrestrial food + feed crop—agricultural fallow/idle land, barley, oats, wheat
Terrestrial feed crop—pastures, rangeland
Terrestrial nonfood crop—nonagricultural rights-of-way/fencerows/hedgerows,
nonagricultural uncultivated areas/soils, industrial areas (outdoor)
Pests: absinth wormwood, acacia, aspen, bitterweed, black henbane, blackberry,
bouncingbet, brackenfern, buffalobur, bullnettle, burroweed, bursage, buttonbush,
cactus, camelthorn, camphorweed, cedar, chaparral, chicory, Chinese tallowtree,
clover, cocklebur, common broomweed, common crupina, croton, dock,
dogwood, field bindweed, fleabane, fringed sagebrush, goldenrod, gorse,
granjeno, groundsel, guava, gum, hemlock, hickory, horsenettle, horseweed,
huisache, ironweed, Java plum, juniper, knapweed, lambsquarters, lantana,
larkspur, leafy spurge, loco, locust, lupine, maple, marshelder, mesquite,
milkweed, oak, oxeye daisy, persimmon, pigweed, pine, poison oak, poplar,
prickly lettuce, pricklypear, rabbitbrush, ragweed, rush skeletonweed, St.
Johnswort, salmonberry, sassafras, Scotch broom, sea hibiscus, silverleaf
nightshade, smartweed, snakeweed, sourwood, spruce, sulphur cinquefoil, sumac,
sunflower, tansy ragwort, tasajillo, thistle, toadflax, trumpetcreeper, upright
prairie conefiower, wild buckwheat, wild carrot, wild licorice, wild parsnip,
willow, yankeeweed
Formulation
types: Soluble concentrate/liquid (water)—24.4% (can be used as invert emulsion)
Liquid—34.7% (Formulating intermediate)
Methods and rates of application:
EMULSIFIABLE CONCENTRATE (as invert emulsion):
—to forest sites preparatory to reforestation, southern US, apply broadcast spray
at 1.5 Ib AE/A by air or ground spray after foliage is well developed.
-------
-to rangeland and permanent grass pasture (west of Mississippi R.), apply up
to 0.5 Ib AE/A as low volume broadcast spray by air or ground equipment, when
target vegetation is actively growing.
SOLUBLE CONCENTRATE, LIQUID:
—to forest sites:
* preparatory to reforestation (Southern U.S.), apply broadcast spray at
1.5 lb.AE/A by air or ground spray after foliage is well developed.
*to forest roadsides, wildlife clearings, (southern U.S.), apply:
•low volume broadcast treatment, at 1 Ib AE/A by air or ground sprayer,
in spring or late in summer or fall.
•high volume leaf/stem/root collar treatment at I Ib AE/A by ground
sprayer.
•spot treatment at 0.5 to 2 Ib AE/A/season by ground spray to foliage
when target plants are actively growing
•spot, concentrate application of up to 24 ml/tree of undiluted product
(0.013 Ib AE/tree; max. limit of 0.5 Ib AE/A/year) to soil under dripline
of Eastern red cedar, in spring or fall.
•injector or frill/girdle treatment (Hawaii) using ca. 0.002 to 0.003 Ib
AE/tree of product diluted 1:4 with water, applied when target trees are
actively growing.
-to rangeland and permanent grass pasture (west of Mississippi R )
apply:
•low volume broadcast spray at up to 0.5 Ib AE/A, by air or ground
equipment, when target vegetation is actively growing.
•high volume broadcast spray at up to 0.5 Ib AE/A by ground sprayer,
when target vegetation is actively growing.
-to noncroplands, fencerows (southern U.S.), apply:
•low volume broadcast treatment, at 1 Ib AE/A by air or ground sprayer,
. in spring or late in summer or fall.
•high volume leaf/stem/root collar treatment at 1 Ib AE/A by ground
sprayer.
• spot treatment at 0.5 to 2 Ib AE/A/season by ground spray to foliage
when target plants are actively growing
•spot concentrate application of up to 24 ml/tree of undiluted product
(0.013 Ib AE/tree; max. limit of 0.5 Ib AE/A/year) to soil under dripline
of Eastern red cedar, in spring or fall.
•injector or frill/girdle treatment (Hawaii) using ca. 0.002 to 0.003 Ib
AE/tree of product diluted 1:4 with water, applied when target trees are
actively growing;
Use limitations:
Do not: apply through any type of irrigation system; graze or feed forage
from treated areas for 2 weeks after treatment; or harvest hay from treated
grain fields.
-------
C. Estimated Usage of Pesticide
This section summarizes the best estimates available for the pesticide uses of
picloram and its derivatives. These estimates are derived from a variety of published and
proprietary sources available to the Agency. The data, reported on an aggregate and site
(crop) basis, reflect annual fluctuations in use patterns as well as the variability in using
data from various information sources.
The table below summarizes the pesticides use by site:
ESTIMATED ANNUAL U.S. USAGE OF PICLORAM
*X^ ;,
SITE , ' <, >„;
', •• x 1
- K"c "
Pasture & rangeland
Wheat
Barley
Oats
Cropland not used for
crops
Other crops/farmland
Forestry (commercial)
Total Agriculture and
Forestry
Rights-of-way
Electric utilities
Roadways
Industrial facilities
Railroads
Pipelines
Total Rights-of-Way
Total ' :l,c!(io>
-"; t, Y,-' "«, '
* SITE
: 'ACRB&G&,
530,000
64,000
8,000
6,000
107,000
267,000
482,000
1,464,000
9,400
11,000
1,900
1,100
2,200
25,600
"• *" s vfr }f v. yW£
- - ACBE,, >
TSBATMBNTS
$8T' /
2500 - 5000
300 -900
75 -150
< 25
100 -600
< 700
25 -100
3000 - 7475
100 - 180
15 - 35
< 9
< 6
15-35
130 -265
•V/.J. "
' , 3138- 7740"
SITE ' \
TKEATED,
t
-------
D. Data Requirements
Data requested in the revised September 30, 1988 Registration Standard for
picloram and its derivatives (triisopropanolamine picloram, isooctyl picloram, and
potassium picloram) included studies on product chemistry, ecological effects,
toxicology, environmental fate, and residue chemistry. These data were required to
support the uses listed in the Registration Standard. Appendix B includes all data
requirements identified by the Agency for currently registered uses needed to support
reregistration.
E. Regulatory History
Picloram and its derivatives were registered in the United States in 1964 for use
as a systemic herbicide to control woody plants and broadleaf weeds. In 1978 the
Agency classified picloram as a Restricted Use pesticide based on hazard to nontarget
organisms (specifically nontarget plants both crop and noncrop). Considerable
emphasis for restriction was based on recurring reports of phytotoxicity to such
economically important crops such as tomatoes, potatoes, and succulent ornamentals
caused by contaminated water supplies (1 part per billion [ppbj) range. This action
was taken by the Agency through regulations proposed in the September 1 1977 (42
FR 44170) and finalized in the February 9, 1978 (43 FR 5782) issues of the
FEDERAL REGISTER.
On March 29, 1985, the Agency issued a Registration Standard for picloram.
The Standard required: 1) precautionary label statements advising against the use of
picloram in very permeable soils such as karst limestone and loamy sands; 2) a
groundwater monitoring study; 3) retention of Restricted Use classification ; 4)
additional wildlife testing on the technical; 5) a field monitoring study to determine
concentrations of picloram in runoff water and sediment, leachate, groundwater, and'in
water and sediment of receiving aquifers to complete a hazard evaluation of wildlife; 6)
development of analytical methods for metabolite residues in plant and animal samples;
7) storage stability data; 8) additional oncogenicity data; 9) limiting the level of
hexachlorobenzene (HCB) in the technical to a maximum of 200 parts per million
(ppm); 9) nontarget area phytoxicity data on the technical; and 10) testing for
nitrosamines and certification that the upper limit of nitrosamines occurring in the
technical is not greater than 1 ppm.
The Agency has since received and reviewed the additional data and has revised
its scientific and regulatory conclusions in light of those data, other information on the
chemical, and expanded data requirements promulgated in 1984, at 40 CFR Part 158,
for registration and reregistration of pesticides under FIFRA. A revised Registration'
Standard (issued 9-30-88), which supersedes the earlier Standard, is the Agency's
updated scientific assessment of the pesticide, and the data needed to support its
-------
continued registration. This Reregistration Eligibility -Decision reflects a reassessment
of all data which were submitted in response to the revised Registration Standard,
SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
This structure of picloram acid and its derivatives are presented below:
NH2
Picloram acid
Empirical Formula: C6H3C13N2O2
Molecular Weight: 241.5
CAS Registry No..: 1918-02-1
ShaughnessyNo.: 005101
NH
Cl
Cl
Picloram isooctyl ester (IOE aka EHE)
Empirical Formula: CuHjgClsNaC^
Molecular Weight: 353.5
ShaughnessyNo.: 005103
ONH [CH2CH (OH) CH3]:
Picloram triisopropanolamine salt (TIPA)
Empirical Formula: C^H^C^Oj
Molecular Weight: 432.6
ShaughnessyNo.: 005102
NH,
Cl
c
Cl
OK
Picloram potassium salt (K-salt)
Empirical Formula: CgHjC^KNjC
Molecular Weight: 280.6
ShaughnessyNo.: 005104
IDENTIFICATION OF ACTIVE INGREDIENT
The picloram acid technical is an off-white to brown powder which decomposes
at 215°C, photodegrades, and is non-volatile. The acid is only slightly soluble in
water at 430 ppm at 25°C, and is more soluble in ethanol, acetone, and methanol. The
picloram salt derivatives are water soluble; the isooctyl ester is not water soluble.
10
-------
MANUFACTURING-USE PRODUCTS
There are two picloram manufacturing-use products (MPs) registered to
DowElanco Company: the 72% picloram acid technical (T; EPA Reg. No. 62719-
179) and the 34.7% picloram K-salt formulation intermediate (FI; EPA Reg. No
62719-30). There are no registered MPs for the TIPA and IOE; TIPA and IOE end-
use products (EPs) are manufactured by integrated systems.
At the time of the Registration Standard dated 10/84 and the Final Registration
Standard and Tolerance Reassessment (FRSTR) dated 5/18/88, the only registered MP
was the 34.7% K-salt FI. The 72% T was registered in 1990, following issuance of
. the FRSTR. The DowElanco 72% T and the 34.7% K-salt FI are the only MPs subject
to a reregistration eligibility decision.
REGULATORY BACKGROUND
The Picloram FRSTR dated 5/18/88 required that all new data be submitted in
support of the reregistration of picloram and its salts and ester. After the 72% T was
registered, the product chemistry database submitted since the FRSTR was re- '
evaluated. Additional MP data were required for the now registered picloram acid
technical, and data were required for the "practical equivalent of the technical grade of
the active ingredient" for the picloram salts and ester manufactured by integrated
systems.
The Picloram Registration Standard dated 3/29/85 required the limiting of the
level of hexachlorobenzene (HCB) in the technical to a maximum of 200 ppm and also
required testing for nitrosoamines in picloram products. The sole registrant of
picloram products has complied with these requirements; no nitrosoamines were
detected in picloram products (< 1 ppm) and the level of HCB has been certified to be
less than 100 ppm.
B. Human Health Assessment
1. Toxicology Assessment
The lexicological data base in support of the food uses for picloram (the
acid, potassium salt, isooctyl ester, and triisopropanolamine salt) is adequate
and will support reregistration eligibility.
11
-------
a. Acute Toxicity
Table I; Acute Toxicity - Picloram, Acid (94.1% a.L)
:. -Test ' VI V s •
Oral LD,,, (rat)1
Dermal LD 5000 mg/kg (males)
4012 mg/kg (females)
> 2000 mg/kg (both sexes)
> 0.035 mg/L (both sexes)
Moderate eye irritant
Non irritant
Non sensitizer
~~ Category '
IV
m
m
i
m
rv
N/A
N/A
1-6 MRID,Cs 404794-13 thru -18; HED Document Number 006787
* Note: Data pertaining to acute eye irritation, dermal irritation, dermal sensitization, and delayed neurotoxicity are not required to support the
rcrcgistration of the picloram acid. These data are presented for informational purposes.
Table n; Acute Toxicity - Picloram Potassium Salt (38.8% a.L)
-Test'"'-:- r "^:-
Oral LD50 (rat)7
Dermal LD50 (rabbit)8
Inhalation LC30 (rat)9
Eye Irritation10
Dermal Irritation11
Dermal Sensitization12 '
Delayed Neurotoxicity
'''•"• % •>, •. *»~/'f" /' "fti' ,/t ',''(.':,
; \" ' ^ ~-'S^ait s " ;
> 5000 mg/kg (males)
3536 mg/kg (females)
> 2000 mg/kg (both sexes)
> 1.63 mg/L (both sexes)
Moderate eye irritant
Non irritant
Positive skin sensitizer
, ', ,;« , -CafegiH^
IV
m
m
n
m
IV
N/A
N/A
MR1D#S 404794-01 thru -06; HED Document Number 006787
12
-------
Table HI: Acute Toxicity - Picloram, Isooctyl ester (IOE) (85 9% a i)
- '- . ' Itest
Oral LD 3500 mg/kg (both sexes)
> 2000 mg/kg (both sexes)
> 0.35 mg/L (both sexes)
Moderate eye irritation
Mild dermal irritation
Positive skin sensitizer
J.3-1S MRID#s 404794-07 thru -12; BED Document Number 006787 ~1
Category
in
in
n
m
in
N/A
N/A
Table IV: Acute Toxicity - Picloram, Triisopropanolamine Salt (61% a.i )
- Test
Oral LD,n (rat)19
Dermal LD50 (rabbit)'20
Inhalation LC30 (rat)21
Eye Irritation22
Dermal Irritation23
Dermal Sensitization24
Delayed Neurotoxicity
Result ; ,
> 5000 mg/kg (both sexes)
> 2000 mg/kg (both sexes)
> 0.07 mg/L (both sexes)
Minimal irritant (both sexes)
Slight irritant (females)
Not an irritant (males)
Positive
' Category
IV
m
n
m
rv
N/A
N/A
iy-24 MKID#s 413812-01 thru -06; HED Document Number 010173 ' ~ ~ — '
b. Subchronic Toxicity
In a 90-day oral toxicity study, picloram acid was administered
via the diet to groups of 15 F344 rats/sex/dose at dosage levels of 0, 15,
50, 150, 300 or 500 mg/kg/day. Based upon liver weight changes and '
minimal microscopic changes in the liver, the systemic LOEL is 150
mg/kg/day. The NOEL is 50 mg/kg/day. (MRID# 001105-37)
In a 1982 6-month dog dietary study, picloram acid was
evaluated at dosage levels of 0, 7, 35 or 175 mg/kg/day. The systemic
NOEL is 35 mg/kg/day and the LOEL is 175 mg/kg/day based on
decreases in the following: body weight gain, food consumption, liver
weights (relative), alkaline phosphatase and alanine transaminase.
13
-------
Increased liver to body weight ratios and absolute weights were observed
in only two males at the 35 mg/kg/day dosage level. (MRID# 001105-
34). .- .
In a 21-day dermal toxicity study, the potassium salt of picloram
was administered dermally to groups of five New Zealand white rabbits
of each sex at doses of 0 (vehicle control), 75.3, 251 or 753 mg/kg/day
(0, 65, 217 or 650 mg/kg/day picloram acid equivalents) for a total of
15 applications over the 21-day period. The NOEL is greater than or
equal to 753 mg/kg/day for both sexes: hence, a LOEL was not
established for either sex. Although the limit dose of 1000 mg/kg/day
was not achieved, practical difficulties precluded administering more test
material. The study revealed the non-systemic effects of dermal
irritation and very slight to well defined edema and/or erythema in both
sexes at all dose levels. (MRID# 413849-01)
In a 13-week oral toxicity study in the F344 rat, picloram
isooctyl ester was evaluated by dietary administration at dosage levels of
0, 22, 73, 220 or 733 mg/kg/day (0, 15, 50, 150 or 500 mg/kg/day
picloram acid equivalents). There were 10 rats/sex/group employed in
the study. The LOEL is 220 mg/kg/day, where the findings were
increased'liver weights in both sexes accompanied by slight/very slight
hepatocellular hypertrophy and increased kidney weight in males only.
The NOEL is 73 mg/kg/day. (MRID# 422970-01)
In a 21-day dermal toxicity study in the rabbit, picloram isooctyl
ester (89.9% purity) was evaluated at dosage levels of 0 (vehicle control)
250, 500 or 1000 mg/kg/day. There were 5 rabbits/sex in each of the
study groups. The LOEL is 500 mg/kg/day based upon increased
bilirubin (males) and increased BUN (males/females). The NOEL is
250 mg/kg/day. There were dermal responses at the site of application,
at all doses, but such do not constitute findings of systemic toxicity.
There were no dose related histopathologic findings. (MRID#s 421716-
01; 428707-01)
In a 21-day dermal toxicity study the triisopropanolamine salt of
picloram was administered dermally to groups of five New Zealand
white rabbits of each sex at doses of 0 (vehicle control),. 132, 440 or
1320 mg/kg/day (0, 73.8, 246 or 738 mg/kg/day picloram acid
equivalents) for a total of 15 applications over the 21-day study period.
The NOEL is greater than or equal to 1320 mg/kg/day for both sexes;
hence, a LOEL was not established for either sex. The study revealed
dermal irritation and very slight to well defined edema and/or erythema
among animals of both sexes at all doses. (MRID# 413849-02)
14
-------
In a 13-week oral tdxieity study in the F344 rat, picloram,
triisopropanolamine salt was evaluated by dietary administration at
dosage levels of 0, 25, 90, 550 or 1800 mg/kg/day. There were 10
rats/sex/group employed in the study. The LOEL is 550 mg/kg/day
based on hepatocellular hypertrophy observed in males at 550 and 1800
mg/kg/day with a dose-response relationship. Hepatocellular
hypertrophy and increased liver and kidney weights were observed in
females at 1800 mg/kg/day. There was decreased body weight gain in
both sexes at 1800 mg/kg/day. The NOEL is 90 mg/kg/day (MRID#
414427-01)
c. Chronic Toxicity
In a 1988 1-year chronic feeding study in the dog, picloram acid
was administered orally via the diet at dosage levels of 0, 7, 35 or 175
mg/kg/day. The LOEL is 175 mg/kg/day based on increased liver
weight (absolute and relative). The NOEL is 35 mg/kg/day (MRID#
408343-01)
d. Combined Chronic Toxicity and Carcinogenicity
The following studies were submitted prior to the Picloram
Registration Standard (1988) under the same identifier (MRID#
00081275) and were referenced in the Registration Standard.
In a study performed for the NTP by Gulf South Research
Institute (GSRI), Osborne-Mendel rats were fed picloram (technical
grade 90% pure with 130 ppm HCB) at dosages corresponding to time
weighted average (TWA) dosages of 372 mg/kg/day (7437 ppm) and
747 mg/kg/day (14,875 ppm) for 80 weeks. At the highest dose, 747
mg/kg/day, an carcinogenic effect (neoplastic nodules) was seen in
females. This study was considered supplementary since the matched
control groups were not adequate size, the study was conducted for a
shorter than 2-year lifetime exposure limit, and the supporting data to
determine if the maximum tolerated dose (MTD) was attained at 747
mg/kg/day was not provided. (MRID# 00081275)
In a second NTP study, E6C3Fl mice were fed picloram
(technical grade 90% pure with 130 ppm HCB) at dosages of 357 or 714
mg/kg/day for 79 weeks and allowed to recover for 10 weeks prior to
sacrifice. Picloram did not show a carcinogenic response up to 714
mg/kg/day for 79 weeks. This study was considered deficient since
available information did not assure that an MTD was attained. (MRID#
00081275)
15
-------
The following studies were submitted in response to the
deficiencies cited in the Registration Standard.
In a chronic toxicity/carcinogenicity feeding study conducted in
the F344 rat, picloram acid (technical grade 93% containing 197 ppm
hexachlorobenzene as an impurity) was evaluated at 0, 20, 60 or 200
mg/kg/day for 2 years. The chronic toxicity LOEL was 60 mg/kg/day
as evidenced by altered size and tinctorial properties of centrilobular
hepatocytes and increased absolute and/or relative liver weights in both
sexes. The NOEL was 20 mg/kg/day. The study was negative for
carcinogenicity, but due to concerns that a MTD may not have been
achieved and the fact that the test material contained 197 ppm
hexachlorobenzene impurity, the study was not considered to fulfill
adequately the carcinogenicity testing requirement. (MRID# 001559-40)
In response to the deficiencies cited in the study above, an
additional 2-year dietary chronic/carcinogenicity study was conducted
(in 1992) using F344 rats administered picloram acid at dosage levels of
0, 250 or 500 mg/kg/day for 104 weeks. Chronic toxicity was observed
at 250 mg/kg/day among males only (increased incidence and severity of
glornerulonephritis, blood in urine, decreased specific gravity of urine,
increased size of hepatocytes that often had altered staining properties).
Among females there were chronic effects only at 500 mg/kg/day-
(increased glomerulonephropathy, increased absolute and relative kidney
weight). There was no evidence of carcinogenicity in this study. It
should be noted that use of the Osborne-Mendel rat was waived due to
lack of availability of the strain of rat. In addition, the level of
hexachlorobenzene in the test material employed in this study was 12
ppm.. These two studies (MRID# 001559-40, 426193-02) fulfill the
guidelines 83-l(a) and 83-2(a) for rats.
In a 1992 2-year dietary carcinogenicity study in B6C3F1 mice,
picloram acid was evaluated at doses of 0, 100, 500 or 1000 mg/kg/day.
The systemic NOEL in this study is 500 mg/kg/day based on a
significant increase in absolute and relative kidney weights in males (at
the high dose level). No histopathological lesions were found to
corroborate these changes. There was no evidence of carcinogenicity.
(MRID# 426193-01)
The dose levels tested in the 1992 carcinogenicity studies in rats
and mice were considered adequate for carcinogenicity testing. The
treatment did not alter the spontaneous tumor profile in mice or different
strains of rats tested under the testing conditions. The chemical was
classified as a "Group E - Evidence of non-Carcinogenicity for
16
-------
humans." This classification applies to the picloram acid and potassium
salt forms for which acceptable carcinogenicity studies were available
for review by the HED Carcinogenicity Peer Review Committee
(5/26/88). Carcinogenicity studies had not been required for the other
forms of picloram. However, subsequent to the carcinogenicity peer
review meeting, it was reported that 2-ethylhexanol was detected as a
metabolite of the picloram ethylhexyl ester in Fisher 344 rats. This
metabolite is thought to play a role in the ability of di-(2-
ethylhexyl)phthalate (DEHP) to act as a peroxisome proliferator and it
has been suggested that peroxisome proliferation might be the/an
underlying mechanism in DEHP carcinogenicity. Based on this
information the Agency decided it was appropriate to use a Qt* for di-(2-
ethylhexyl) phthalate and perform an initial assessment of possible risk
to workers from potential exposure to picloram ethylhexyl ester.
e. Developmental Toxicity
The HED RfD Peer Review Committee concluded that there was
no evidence, based on the available data, that picloram and its salts and
ester were associated with significant reproductive or developmental
toxicity under the testing conditions.
In the following developmental toxicity studies, the dose levels
that appear in parenthesis are picloram acid equivalents where the
conversion factors employed were 0.86, 0.68 and 0.56 as applied to
doses of potassium salt, isooctyl ester and triisopropanolamine salt,
respectively.
Picloram potassium salt was administered to New Zealand rabbits
by oral gavage at dosage levels of 0, 40, 200 and 400 mg/kg/day
(picloram acid equivalents) during days 6 to 18 of gestation. The
maternal NOEL is 40 (34) mg/kg/day, where the LOEL is 200 (172)
mg/kg/day based on reduced maternal weight gain during gestation.
The developmental NOEL is 400 mg/kg/day and the LOEL was not
determined. (MRID# 410695-01, 001387-03, Accession^ 252493)
The potassium salt of picloram was administered to CD rats by
gastric intubation at dosage levels of 0, 35 (30), 174 (150) and 347 (298)
mg/kg/day during day 6-15 of gestation. The test vehicle was distilled
water. There was no evidence of developmental toxicity at doses up to
and including the high dose of 347 (298) mg/kg/day. The maternal
LOEL is 347 (298) mg/kg/day based upon excessive salivation in the
dams of the high dose group. Hence, the developmental toxicity NOEL
is greater than or equal to 347 (298) mg/kg/day. The maternal toxicity
17
-------
LOEL is 347 (298) mg/kg/day'and NOEL is 174 (150) mg/kg/day.
(MRID# 413825-02)
Picloram isooctyl ester was administered to New Zealand white •
rabbits via oral gavage at dosage levels of 0, 20 (14), 100 (68) or 500
(340) mg/kg/day during days 7-19 of gestation. Developmental toxicity
was not observed at any dose level. Hence, the developmental toxicity
NOEL is greater than or equal to 500 (340) mg/kg/day. Maternal
toxicity was observed at 100 (68) mg/kg/day manifested as an increase
in the incidence of clinical signs (decreased feces at 500 (340)
mg/kg/day and decreased body weight gain at 100 (68) mg/kg/day and
above). Hence, for maternal toxicity, the LOEL is 100 (68) mg/kg/day
and the NOEL is 20 (14) mg/kg/day. (MRID# 421211-04)
Picloram isooctyl ester was evaluated in CD rats. The chemical
was administered via oral gavage at dosage levels of 0, 100 (68), 500
(340) or 1000 (680) mg/kg/day during days 6-15 of gestation. There
was no evidence of developmental toxicity at any dosage level; hence,
the developmental toxicity NOEL is greater than or equal to 1000 (680)
mg/kg/day. The maternal toxicity LOEL is 500 (340) mg/kg/day based
on decreased body weight gain during early gestation, days 6-9. The
maternal toxicity NOEL is 100 (68) mg/kg/day. (MRID# 422969-01)
Picloram triisopropanolamine salt was administered to New
Zealand white rabbits via oral gavage at dosage levels of 0, 180 (101),
538 (301) or 1,000 (560) mg/kg/day during days 7-19 of gestation
(phase 1) and at doses of 0, 54 (30), 180 (101), 538 (301) or 1,000
(560) mg/kg/day (phase II). Developmental toxicity was not observed at
any dose level in either of the two phases of the study. Hence, the
developmental toxicity NOEL is greater than or equal to 1000 (560)
mg/kg/day. Maternal toxicity was observed in both phases of the study
at greater than or equal to 180 (101) mg/kg/day manifested as increased
rate of abortions at 1000 (560) mg/kg/day; increased incidence of
clinical signs at 538 (301) and 1000 (560) mg/kg/day; and decreased
food consumption and body weight gain at 180 (101), 538 (301) and 00
(560) mg/kg/day. The maternal toxicity LOEL is 180 (101) mg/kg/day
and the NOEL is 54 (30). mg/kg/day. (MRID# 424609-01)
Picloram triisopropanolamine salt was administered to CD rats
by gastric intubation at dosage levels of 0, 100 (56), 500 (280) or 1000
(560) mg/kg/day during days 6-15 of gestation. The test vehicle was
distilled, deionized water. The picloram salt did not elicit evidence of
developmental toxicity at doses up to and including the high dose of
1000 (560) mg/kg/day. The developmental toxicity NOEL is 1000
. 18
-------
(560) mg/kg/day. Maternal toxicity was observed at 1000 (560)
mg/kg/day manifested as excessive salivation, decreased body weight
gain and decreased food consumption. The maternal toxicity LOEL is
1000 (560) mg/kg/day and the NOEL is 500 (280) mg/kg/day (MRID#
413825-04)
f. Reproductive Toxicity
t
Picloram acid was evaluated in a 2-generation reproduction study
in the CD rat. Dosage levels employed were 0, 20, 200 or 1000
mg/kg/day. The parental LOEL is 1000 mg/kg/day based on
histopathological lesions in the kidney of males of both generations and
some females. In males of both generations, blood in the urine,
decreased urine specific gravity, increased absolute and relative kidney
weight, and increased body weight gain was observed at the high dose.
The parental LOEL is 1000 mg/kg/day and the NOEL is 200
mg/kg/day. The reproductive LOEL was not identified and the NOEL
is 1000 mg/kg/day. (MRID# 420787-01)
g. Mutagenicity
Picloram acid was evaluated in the Ames test using Salmonella
typhimurium. Doses ranged up to 5000 ug/plate, with and without
metabolic activation. The test substance did not produce a mutagenic
response either in the presence or absence of activation. (MRID#
414859-02)
Picloram acid was evaluated for gene mutation in mammalian
cells (HGPRT/CHO). As evaluated up to toxic levels (750 ug/ml
without metabolic activation; 1250 ug/ml with metabolic activation), the
compound was found to be negative for inducing forward mutation in
Chinese hamster ovary (CHO) cells. (MRID# 400726-01)
Picloram acid was evaluated for cytogenetic effects on bone
marrow cells of rats via intragastric administration at dosage levels of 0
(vehicle), 20, 200 or 2000 mg/kg. The test material did not produce
cytogenetic effects in the study. (MRID# 000983-22)
Picloram acid was evaluated for genotoxic potential as
administered to primary rat hepatocyte cultures at concentrations of 0
(vehicle), 10, 33.3, 100, 333.3 or 1000 ug/ml. The test material was
negative for unscheduled DNA synthesis (UDS, a measure of DNA
damage/repair) treated up to cytotoxic levels of (1000 ug/ml) (MRID#
415497-01)
19
-------
Picloram isooctyl ester was evaluated in the Ames test using
Salmonella typhimurium. Dosages ranged from 16.7 to 1667 ug/plate in
studies with and without S9 activation. The test compound did not
induce a mutagenic response in the presence or absence of metabolic
activation. (MRID# 421211-06)
Picloram isooctyl ester was evaluated in two independent Chinese
Hamster Ovary Cell HGPRT forward gene mutation assays, one of these
with, and the other without, S9 activation. Concentrations of the
picloram isooctyl ester employed in the non-activated trial ranged 1.25
to 50 ug/ml as conducted in two assays of overlapping dosage range.
The second trial, also conducted in two assays of overlapping dose and
including S9 activation, utlilzed dosages ranging from 2.50 to 200
ug/ml. Concentrations _>_ 40 ug/ml in the non-activated trial and _>_ 125
ug/ml in the activated trial were severely cytotoxic. There was no
evidence of a mutagenic response at any dosage level in either the S9
activated trial(s)/or the non-activated trial(s). (MRID# 424140-01)
Picloram isooctyl ester was evaluated in two independent rat
lymphocyte cytogenetic assays with and without S9 activation.
Concentrations ranging from 2.67 to 800 ug/ml +/-S9 were assayed in
Trial 1; severe cytotoxicity was observed at levels J>_ 80 ug/ml +/-S9.
In. Trial 2, no cytotoxicity was seen in cells exposed to 8.04 or 17.4
ug/ml +/-S9 and harvested at 24 hours. However, reductions in the
mitotic index (MI) were observed in cells harvested 24 or 48 hours
postexposure to 26.8 ug/ml +/-S9. Although a number of minor
deficiencies rendered the purported negative results of this study
inadequate in initial review, subsequent re-evaluation with additional
information and data supplied by the performing laboratory were
adequate to upgrade this assay to fully acceptable in demonstrating no
potential for inducing chromosomal aberrations. (MRID# 423687-01)
Picloram isooctyl ester was evaluated in the mouse micronucleus
assay at single oral gavage doses of 0(2), 500, 1667 or 5000 mg/kg
(limit dose) using 24, 48 or 72 hour sacrifice times. The material was
found not to be clastogenic. No lethality was reported and there was no
evidence of target tissue cytotoxicity. The picloram compound was
tested at a sufficiently high level and found not to be clastogenic.
(MRID# 421716-02)
.Picloram triisopropanolamine salt was evaluated in the Ames test
using Salmonella typhimurium. Doses ranged up to 5000 ug/plate, with
and without metabolic activation. The test material did not produce a
20
-------
mutagenic response either in the presence or absence of activation
(MRID# 414859-01),
Picloram triisopropanolamine salt was evaluated by oral
administration to mice in the mouse bone marrow micronucleus test, at
dosage levels of 0, 300, 1000 or 3000 mg/kg. The test agent was
determined to be non-clastogenic in mice, as determined by lack of
mutagenic effect at doses up to lethality (3000 mg/kg). (MRID#
415397-01)
Picloram triisopropanolamine salt (MRID# 415397-02) was
evaluated for genotoxic (DNA damage/repair) potential when
administered to primary rat hepatocyte cultures at concentrations up to
1500 ug/ml. The test material was negative for inducing unscheduled
DNA synthesis (UDS) at doses up to toxic levels (1500 ug/ml)
(MRID# 415397-02)
h. Metabolism
The absorption, distribution, metabolism and excretion of
picloram acid was evaluated in female rats administered-a single i.v. or
oral gavage dose of 10 mg/kg, an oral gavage dose of 1000 mg/kg 14C-
picloram, or 1 mg/kg/day unlabeled picloram by gavage for 14 days
followed by a single oral gavage dose of 10 mg/kg 14C-picloram on day
15. The study demonstrates that 14C-picloram is rapidly absorbed,
distributed and excreted following oral and i.v. administration. This
study alone is not adequate; however, this study is acceptable when
considered in conjunction with a male rat metabolism study (MRID#
00098321) which yielded similar results. (MRID# 412096-02)
The absorption, metabolism and excretion of picloram isooctyl
ester (also referred to as picloram ethylhexyl ester) was studied in male
F344 rats following single oral (gavage) dosing with 15 mg/kg of 14C-
picloram isooctyl ester. The ester was absorbed and excreted rapidly.
By 48 hours post-exposure, mean recovery of radioactivity was 96.4%.
The urine was the major elimination route (68 % of administered dose).
The feces and expired 14CO2 represented 16.35% and 10.16%,
respectively, of the administered dose. Elimination of picloram
ethylhexyl ester was rapid, as indicated by 67% recovery at 24 hours
post-dosing. The major metabolite was 2-ethyl-l, 6-hexanoic acid. This
study supports the fact that picloram ethylhexyl ester is hydrolyzed
rapidly to picloram (free acid) and 2-ethyl hexanol, and that picloram
ethylhexyl ester does not influence the excretion of picloram in the rat
(MRID# 421716-03)
21
-------
The absorption, metabolism and excretion of picloram
triisopropanolamine salt was studied in male F344 rats following
administration of single oral doses (gavage) of 9.5 mg/kg of C14-
triisopropanolamine and 9.8 mg/kg of picloram. This level of dosing
delivered 20-30 uci per animal in the forms of 14C-triisopropanolamine.
The 14C-triisopropanolamine was absorbed readily, with peak plasma
radioactivity being observed at 0.25 hours post-dosing. The
administered dose of radioactivity as recovered primarily in urine, feces,
expired carbon dioxide, tissue/carcass and final cage rinse was 94%.
Unchanged triisopropanolamine accounted for 80% of the total
radioactivity excreted in the urine. No other metabolites were identified
in the 0-6 hour pooled urine sample. The data suggest that the
conversion of picloram triisopropanolamine salt to picloram was not
affected by the presence of triisopropanolamine. (MRID# 423431-01)
i. Other Toxic Endpoints
Picloram isooctyl ester (also referred to as picloram ethylhexyl
ester) bears structural similarity to di(2-ethylhexyl)phthalate (DEHP) in
possessing a 2-ethylhexyl moiety. DEHP and certain other substances
containing the 2-ethylhexyl moiety have been found to be positive for
carcinogenicity in rodent bioassays. 2-Ethylhexanol was detected as a
metabolite in the metabolism studies summarized above. This metabolite
is also a primary hydrolytic cleavage product of DEHP, a positive
rodent liver carcinogen. This metabolite is thought to play a role in the
ability of DEHP to act as a peroxisome proliferator and it has been
suggested that peroxisome proliferation might be the underlying
mechanism in DEHP carcinogenicity. Available data indicate that
DEHP is most potent among the 2-ethylhexyl containing compounds
tested. For the purposes of carcinogenicity risk assessment for
occupational exposure with respect to picloram isooctyl ester, the
recommended toxicological endpoint is the Q^ value of 3.29 x 10"4
(mg/kg/day)"1 obtained for DEHP in a carcinogenicity risk assessment on
this compound [D. Turnbull and J.V. Rodricks (1985)]. this Qj* is
based upon a 2-year carcinogenicity bioassay of DEHP in female mice
[National Toxicology Program (1982)] and although this Qx* was
generated by Turnbull et al., the value was generated using the same
model the Agency uses.
Hexachlorobenzene (HCB), a recognized impurity in picloram
compounds, is considered to be an animal carcinogen and probable
human carcinogen as discussed in the 1988 Registration Standard for
picloram.
22
-------
j. Reference Dose
In the meeting of September 30, 1993, the OPP RfD Peer
Review Committee recommended that the RfD for this chemical be
based on a NOEL of 20 mg/kg/day for a dose-related increase in size
and altered tinctorial properties of centrilobular hepatocytes in males and
females at 60 and 200 mg/kg/day in a chronic toxicity study in rats
(MRID# 00155940). An uncertainty factor (UF) of 100 was used to
account for the inter-species extrapolation and intra-species variability.
On this basis, the RfD was calculated to be 0.20 mg/kg/day. It should
be noted that no regulatory value has been established for this chemical
by the World Health Organization (WHO) up to this date. The
committee classified picloram as a "Group E" chemical, no evidence of
carcinogenicity for humans.
There was no evidence, based on the available data, to suggest
that the chemical was associated with significant reproductive or
developmental toxicity under the testing conditions.
2. Exposure Assessment
a. Dietary
The qualitative nature of the residue in plants is adequately
understood based on a wheat metabolism study. The residue of concern
in wheat forage, straw, and grain is conjugated picloram, which is
hydrolyzable by acid, base, and B-glucosidase. The minor metabolites
that were identified in grain and straw were 4-amino-6-hydroxy-3,5-
dichloropicolinic acid and 4-amino-2,3,5-trichloropyridine. The data
support the current uses. Additional plant metabolism studies may be
required if picloram uses are expanded to other crops. (MRID#s
00037880, 00041136, 00059411, 00111527, 00157171, and 42579004).
The qualitative nature of the residue in animals is adequately
understood. Picloram is the residue of concern in meat, milk, poultry
tissues, and eggs. The available ruminant metabolism study indicates
that picloram is the major residue in animal tissues of interest and that
picloram is not metabolized in ruminants to a significant degree; only
minor amounts (< 10% of total radioactive residues) of 4-amino-2,3,5-
trichloropyridine were detected in goat fat and liver. In the submitted
poultry metabolism study, 99.9% of the recovered radioactivity was
found in the excreta and virtually all of the 14C-residues were identified
as picloram. (MRID#s 00023105, 00041125, 00161306, 00163216, and
42535301).
23
-------
Adequate enforcement methods are available for the
determination of residues of picloram per se in/on plant and animal
commodities. All of these methods use GLC with electron capture
detection of the methyl ester of picloram. The Pesticide Analytical
Manual (PAM), Vol. n lists Methods A and IE for plant commodities.
DowElanco method ACR 73.3.S2 is a GC/ECD method based on
Method IH with substantial modifications. Method ACR 73.3.S2 was
validated using samples from the wheat metabolism study and is
adequate for data collection of picloram residues. Method ACR
79.7.S.I is adequate for collection of picloram data on grass forage and
hay. DowElanco Method ACR 91.4 is adequate for HCB data collection
from plant commodities.
PAM Vol. E Methods I and E are used to enforce tolerances for
picloram residues in animal commodities. DowElanco GC/ECD
methods ACR 67.2 and ACR 67.3 are equivalent to Methods E and I,
respectively, except that toluene is used in place of benzene. These
animal commodity methods have been validated using samples from the
goat metabolism study and are adequate for data collection and tolerance
enforcement for milk and animal tissues. (MRID#s 00026748,
00026749, 00026750, 00026751, 00026752, 00026753, 00027288,
00035959, 00045363, 00045366, 00045373, 00045374, 00045375,
00045376, 00045409, 00062818, 00069973, 00073972, 00073974,
00078483, 00085060, 00111404, 00111407, 00131364. 00132986,
00156366, and 42380201).
FDA has tested picloram using the PAM, Vol. I Multiresidue
Method for acids and phenols (Sec 221.1). Table 201-D of the volume
reports that picloram in nonfat foods is recovered completely through
PAM I 221.1 if a 100 mL ethyl ether Florisil elution is included whereas
only 6-10% is recovered from fatty foods.
Adequate storage stability data on picloram are available to
support the collected samples from metabolism and magnitude of the
residue studies in plants and animals. Residues of picloram per se are
stable under frozen storage conditions in/on: (i) wheat and barley grain,
forage, and straw; and grasses for up to 2 years; (ii) egg whites for up
to 18 months; (iii) milk for up to 15 months; and (iv) liver and muscle
for up to 6 months. Adequate storage stability data for HCB residues
are available for grass and small grain commodities; residues of HCB
are stable in frozen storage for up to 17 months. (MRID#s 00164725,
40082701, 40435601, 40731901, 41442301, 41976701 and 42494001).
All data requirements for magnitude of picloram residues in
plants have been evaluated and deemed adequate. The registered uses of
24
-------
picloram on barley, oats, and wheat along with the established tolerances
on these commodities are supported by acceptable field residue data
from trials reflecting the maximum registered use patterns. Field trial
data representing maximum registered use patterns are available for
grasses and support the proposed tolerance of 225 ppm for grass hay;
however, residues on grass forage exceed the proposed tolerance of 225
ppm. The data indicate that a value of 300 ppm would be appropriate
for grass forage.
The Agency has acceptable field residue data at the 0.5 Ib. ae/A
and 2 Ib. ae/A. However, through negotiations with the registrant the
new maximum use rate will be lowered to 1 Ib. ae/A. Ordinarily, field
residue data would be required for this new maximum use rat?,
however, since there are minimal dietary concerns involved with
picloram, no field residue data will be required for the 1 Ib. ae/A
maximum use rate. Picloram tolerances are based on the 2 Ib. ae/A data
and will remain in effect unless the Agency revisits the tolerance setting
database and lowers the tolerance based on the 0.5 and 2 Ib. ae/A
residue field data or the registrant proposes a lower tolerance based upon
the 0.5 and 2 Ib.'ae/A.
Acceptable grain dust data have been submitted for wheat, which
show that residues of picloram concentrate 7x in aspirated grain dust.
The registrant must propose a suitable tolerance for grain dust.
The available field residue data on HCB residues in/on plants are
adequate. HCB residues were nondetectable in/on wheat grain(< 0.001
ppm), grain dust(<0.001 ppm) and wheat straw (< 0.002 ppm)
following applications of registered formulations of picloram according
to the maximum registered use patterns. Residues of HCB were
< 0.001 ppm in/on grass forage and hay treated using the 2 Ib/gal SC/L
potassium salt formulation at a rate of 2 Ib ae/A, and containing residues
of picloram as high as 480 ppm. One hay sample, containing 270 ppm
picloram, bore 0.001 ppm HCB. Residues of HCB were shown to
dissipate from grass at a greater rate than picloram residues. (MRID#s
00026753, 00036168, 00036170, 00036171, 00045369, 00085060
00108862, 00108864, 00111404, 00111470, 00111482 00111557'
00128714, 41905401, 42037601, 42380201, 42535303, and 42784401).
The data requirements for magnitude of the residue in processed
food/feed have been evaluated and deemed adequate. Acceptable wheat
grain processing data have been submitted; the wheat processing data
will be translated to barley and oats. The wheat data indicate that
residues of picloram concentrate up to 5x in bran. HCB residues were
25
-------
not detected in/on wheat grain or processed fractions. The existing feed
additive tolerance of 3 ppm for picloram residues in milled products of
wheat (exc. flour) is adequate. (MRID# 42535303).
The ruminant and poultry feeding studies that were reviewed in
the Residue Chemistry Chapter of the Picloram Reregistration Standard,
dated 10/29/84, are adequate to satisfy animal feeding study data
requirements. These feeding studies indicate that the existing tolerances
on animal commodities are supported by residue data from dietary
intakes exceeding the maximum dietary burden. (MRID#s 00045372,
00045374, 00045376, 00073921, and 00073973).
An acceptable confined rotational crop study has been submitted.
Field rotational crop studies are not required; in addition, tolerances for
rotational crop commodities need not be established. (MRID#
42641801).
b. Occupational and Residential
Picloram is applied by ground, aerial, wiper applicator,
backpack, handheld sprayer/spraywands, tree injection, and
paintbrushes. Applicati9n types include: aerial and ground broadcast
spray treatments; band applications with helicopters; frill, girdle, and
stump treatments; spray or paint-on treatment to the base of a target
plant; direct injection into a target plant; high-volume spray treatments
using ground, handheld, or wiper-applicator equipment; spot treatments
(soil or plant) using ground, handheld, low-pressure, or wiper-applicator
equipment; basal bark and soil treatments using backpack, power, or
knapsack sprayers and low-volume ground equipment.
Minimum application volumes range from using small amounts
of undiluted end-use-products in some spot and basal bark treatments to
using various formulations diluted in up to approximately 100 gallons
per acre in some ground applications. Diluents include water and
various petroleum based derivatives. The maximum application rate,
regardless of the crop/target for all equipment categories, application
targets and formulation types is 2.16 Ib active ingredient/acre. All
application rates are based on the acid moiety of picloram, the active
agent, -and not each specific salt or ester of picloram contained in each
formulation. For a significant number of other application techniques,
picloram essentially is applied at the discretion of the applicator to a
particular target of choice (e.g., ad libitum or to run-off to a tree trunk
in a spot or frill/girdle treatment). For these types of application
scenarios, an application rate on a per acre basis was not calculated
26
-------
because it is not expectedLto be worse than the backpack/knapsack
sprayer scenario which is considered the worst-case.
The maximum duration of any exposure for workers on a yearly
basis is likely to range from 10 to 40 days for commercial applicators,
i.e., rights-of-way spraying operations are likely to require 40 days.
Occupational-use products and homeowner-use products
At this time no products containing picloram are registered for
homeowner use. All products containing picloram are for occupational
use (all products are restricted-use pesticides). None of the registered
uses are likely to involve applications at residential sites.
Uses within the scope of the Worker Protection Standard
The 1992 Worker Protection Standard for Agricultural Pesticides
(WPS) established certain worker-protection requirements (personal
protective equipment, restricted entry intervals, etc.) to be specified on
the label of all products within the scope of the WPS. Uses within the
scope of the WPS include all commercial (non-homeowner) and research
uses on farms, forests, nurseries, and greenhouses to produce
agricultural plants (including food, feed, and fiber plants, trees, turf
grass, flowers, shrubs, ornamentals, and seedlings). Uses within scope
include not only uses on plants, but also uses on the soil or planting
medium the plants are (or will be) grown in.
At this time some of the registered uses of picloram are within
the scope of the Worker Protection Standard for Agricultural Pesticides
(WPS) and some uses are outside the scope of the WPS. Those that are
outside the scope of the WPS include use:
- on pastures or rangelands,
- in a manner not directly related to the production of
agricultural plants, including, for example, control of
vegetation along rights-of-way and in other noncrop
areas.
The WPS does not cover workers who are working in an area
where a pesticide has been injected directly into plants, i.e., there are no
entry restrictions or notification requirements. However, people who
handle pesticides that are to be applied by direct injection are covered by
the WPS and must receive WPS handler protection. Direct injection
does not include chemigation, soil incorporation, soil injection, hack and
squirt, or frill and spray application techniques.
27
-------
Previous Data Requirements
Requirements for mixer/loader/applicator (i.e. handler) exposure
studies are addressed in Subdivision U of the Pesticide Assessment
Guidelines. Mixer/loader/applicator (M/L/A) exposure data for
picloram have not been required in the past, since no lexicological
criteria had been identified at that time. The complete review of the
lexicological data submitted to support reregistration indicates that these
data are now warranted.
Requirements for post-application exposure studies are addressed
by Subdivision K of the Pesticide Assessment Guidelines. Post-
application exposure data have not been required in the past, since no
lexicological criteria had been triggered for picloram. The complete
review of the dala submitted to support reregistration now indicates thai
picloram does Irigger the toxicological criteria, but not for the
requirement of posl-appUcation exposure dala.
Occupational and Residential Exposure Assessment
An occupational and/or residential exposure assessment is
required for an active ingredient if (1) certain toxicological criteria are
triggered and (2) there is an exposure risk for handlers (mixers, loaders,
applicators) during use or for persons entering irealed sites after
application is complete.
The lexicological dala base for picloram is adequate and will
support reregistration. Sludies for acute loxicily indicate that picloram
is classified as category HI for acute oral toxicily, category HI for acute
dermal toxicity, category I/II (depending on whelher acid, ester or sails)
for acute inhalation loxicily, category III/IV (depending on whelher
acid, ester or salts) for skin irritation potential, and category III for eye
irritation potential. The polassium sail, triisopropanolamine sail, and
isooctyl ester are classified as skin sensitizers. In addition, picloram has
a low vapor pressure.
The toxicology criteria that trigger the requirements for an
exposure assessment include: (1) systemic toxicity at 500 mg/kg/day
(LOEL) based on the 21-day dermal study conducted, (2) classification
of the impurity, hexachlorobenzene as a Group B2, (probable human
carcinogen) having a Q^ X 1.7 (mg/kg/day)"1, and (3) classification of
DEHP as having a Qj* 3.29 X 10"4 (mg/kg/day)'1. (Picloram isooctyl.
ester bears structural similarity to DEHP since both possess a 2-
elhylhexyl moiefy.)
28
-------
There is an exposur^risk for mixers, loaders, applicators, and
handlers for both dermal arid inhalation routes during usual use-patterns
associated with picloram. Therefore, an occupational and/or residential
exposure assessment for handlers is required for picloram. A limited
exposure assessment was conducted for picloram using data from the
Pesticide Handlers Exposure Database (PHED) and surrogate data from
the open literature. No chemical-specific data are available for
picloram. It should be noted that all methods of application cited above
and in Table V are applicable to the ester but there are no terrestrial
food uses for this compound.
Based on the use patterns and potential exposures described
above, major exposure scenarios were identified for picloram. Each
scenario is defined by the types of equipment that could be used on the
four major use-sites on which picloram is applied: terrestrial food crops,
terrestrial non-food crops, forestry sites, and terrestrial feed crops. The
scenarios include; (1) mixing/loading to support aerial applications, (2)
applying with a groundboom sprayer, (3) applying with a fixed-wing
aircraft, (4) applying with a rotor-wing, (5) applying with a paintbrush,
(6) applying through direct injection into a woody plant, (7) applying
with a high-pressure handwand, (8) applying with a hand-cannon along
right-of-ways, (9) applying with a wiper applicator, (10) applying with
backpack/knapsack equipment, (11) applying with a powered personal
sprayer, and (12) applying with a low-pressure handwand. These
exposure scenarios are presented in Table V along with the
corresponding exposure/risk assessment. The data for five scenarios
(5), (7), (9), (10) and (12), were insufficient to complete an
exposure/risk assessment. However, for the scenarios for which mere
are insufficient data, exposures are expected to be no greater than
maximum exposure scenario, which is applying with a
backpack/knapsack sprayer.
There is a risk associated with post-application exposure for
persons entering treated sites after application is complete particularly
following aerial and ground broadcast spray treatments. However, the
crops and sites where picloram is applied are not those where post-
application activities (harvesting, scouting, irrigation, etc.) would be
expected soon after application is complete. Therefore, an occupational
and/or residential exposure assessment for post-application workers is
not required for picloram.
Additionally, to clarify the Table V, the Exposure Scenario
Description (Table VI) was developed. Table VI summarizes the
caveats and parameters specific to each exposure scenario. This table
29
-------
also includes a description of the sources for each data point as well as
general information pertaining to the techniques used to calculate the
corresponding exposure values. The "Data Source" is self-explanatory.
The "Clothing Scenario" represents the clothing worn by the test
subjects during the generation of the referenced exposure values.
"Equipment" describes the application techniques used to generate the
referenced data. "Formulation" is self-explanatory. "Standard
Assumptions" represent the use scenarios employed by EPA to estimate
daily exposure levels. The "Comments" section includes any other
critical descriptions of the data including information pertaining to the
quality of the exposure data.
30
-------
0
^ ~*vT
CO'm CO
' b ^ g ^
O >- o =¥
S? ~ a. en
J- co x c
Q LU -S
_o
CO "Cr*
-C SO. -D
>, o =5:
~ Q. 0)
CO X c
Q LU S,
ca ,—
J— -a ^"
= co «
DO Q S ^
O >, o =^
Q UJ •£.
CO —,
Ex. >»
Q 3 D)
>< o ^£
~ Q. D)
CO X c
Cl LU Jr.
O
C' '
co CD 2
ill
iilil
§ 2.r-
•4= ^ co
J!: a-;§
r— X ij
£ LU S
"CD _
— 3 CO
§!i
QL^S
o
co
CO
0
CO
if
.
••
% :
£
1
o
!
V
,:
v
i
O
T—
X
co"
X
co"
•e
O
X
"CM
CO
CD
o =:
ca o
Si
s
CO
CO
o
1 —
C)
CO
o
CO
2
^~
O)
_c
if
c
CO
Q_
0
•"
"s
. X
CO
*
c
o
"co
D5
0
O
O
T—
CO
"co
co >.—
§ 2 |
O eo v.
o>
o
C5
o
>,
High Pressure Handwand
co
to
Q
O
CO
"co
o
CO
CO
o •
z
co
to
Q
0
as •
CO
Q
O
Is
co
.Q
CO
T—
CM
CO
CO
o
o
co
CO
Q
o
~c
c:
CO
O
T3
c:
CO
1
"o
£ z?
D5 —
c
I
1
o
^~
co
c
o
'z-
a.
ti
C
"Z.
\
CO
cc
C
-
CO
CO
Q
o
Wiper Applicator (IX)
fc>
X
o
X
*f
o
X
to
"*
to
•*
i
o
CO
CO
CO
CM
**-*
>_ CD
§|
co S
co -2.
t_
^
D)"c?
O5 2
Backpack/Knapsack (X)1
c
-
i
i
z
co
cc
O
z
a
tl
C
2
j
co
cc
C
CO
to
Q
O
X
Powered Personal Sprave
ffi
1
£
|
«
-1.
c
<3
i
'
-
N
o
CM
O
X
CM
TJ-
t—
X
CM
CO
'CM
CO
CD
£
o
CO
CM
Is
.Q
CO
c\i
o
CO
CO
o
X
Low Pressure Handwand (
O)
S
«£
0
D)
f
g
OT
5
75
•co
S
o
15
g.
^2
5
n
®
*7 £
1 §
S 0
3 0
g 1
1 £
• o
S 8-
•= 0
S -S
s are reported as
9 treatments for ea
i .2
s £
ill
"fill
= ^s j
« 1 i 1.
fill
HP
fo 2 «
C Q. eo
•°1^5
I il|
i 1 15
•2 SS-§
||f |
s §• 1 i
a | £§
•S i ? S
normal distributed
b Inhalation exposur
c Valuos represent tt
d Dally Exposure (m
i *
i 2l S?
„ e-sf i 8-s
» £ ^ ^ 2 o
2sl£S|i
Ulslll
-Itsfii
Il3llll
-------
a
2
o
a
0
•*-
CO
c
.2
f>
•S
o
I
^%,
Scenaric
£
3
TABLE VI: Expos
Commented
1
J
»•
1 8
M^Eb
g
Groundboom Application (II)
n
d
§
Q
i"
1 s
- g
z£ ^
•g S
§»
0 11
Inllalation grades A, B, C;
- 41 replicates; Inhalation :
•o
g
O
ra
1
All Cab types
g
•e
1
•g
1
00
a
,0
ta
1-J 'OO
1
i
CS
>
No Data
I
Q
I
No Data
No Data
1 Helicopter (IV)
•a
. M
H
2
o
Q
...
U
ea
8
•0
s
00
Inhalation grade C; Derma
Inhalation = 15 replicates.
1
•3
1
00
Paint brush
g
1
1
"w
C?
J
c/T
o JD
1
Paintbrush (V)
No Data
1
Q
No Data
No Data
No Data
S
Tree Injection/Hypo-Hatchet 0
S
S
Q
•a
c
n
fl>
2
oo
"g
Q 3
Inhalation grades B and C;
and Inhalation = 9 replical
s>.
a
1
OO
1
o
3 -J2
S|
a?
High pressure i
hand wand on
a
1
1
"w
C?
O
5
c/T
Long pant
no gloves
£
High Pressure Handwand (VII)
.«
No Data
1
Q
No Data
No Data
No Data
Right-of Way Cannon (VIII)
No Data
•i
a
No Data
No Data
No Data
Wiper Applicator (IX)
«o
II
rt
s
Q
j£
*?-s vs
« «>
=3 S
> S
&§
Laboratory and field recov
replicates; Inhalation = K
•a
"I
t-4
1
OO '
££
*
Knapsack with
boom
55
•J3
"I
Q
1
Abbott et
al. 1987
Backpack/
Knapsack (X)
1
Q
1
Q
No Data
No Data
No Data
1
o
•§
s.
f
'-
"*
^
t
i
"" A ^
, i
1 1
'1
; j*
•.'
; ••
,
II
"3
g
0>
Q
Sa>
*S
*O ™
2 :=•
OO Pj
^ ""
"t3 °*
S ii
G "
Q g
Inhalation grades B and C;
25 to 95 replicates; Inhalat
Si"
1
%
0)
•a
«
Portable handv
o
tt
1
1
1
00
f3
J5
c/r
i
Cu co
OO ^
o 5
j_J OO
Q
1
Low Pressure Handwand (XH)
1*
|i
"*l
ii
?i
s -
^i ^ "S
|1 B
5ll
I. BEAD dau were i
to pcrtah to both de
od grade C for hind i
compfete an eipoture ai;
ay as estimated by ORE!
ratefy, ften tbe listed grac
dermal and iilvahtfon, n
IN?
Sg|S
a a - <
a 'No Data* Eodkaut that no data were
b Standird Auitopljcini bated on an 8
c If dermal uri fatuhtko grade* are nc
SuWivbboU Guideline*, are grades
-------
Data Requirements " ti "; ''T
Although data are available to estimate the worker exposure for
the maximum exposure scenarios for the purposes of risk assessment,
the data sets available-are limited in both quantity and quality as shown
in Table VI. In order to reduce the uncertainty associated with the
exposure assessments and thus the risk assessment and because the
following scenarios lack exposure data and have a potential for as high a
worker exposure as the backpack/knapsack scenario, these data must be
submitted for confirmation purposes:
1) Guideline 231: Estimation of Dermal Exposure at Outdoor Sites for
mixer/loaders and applicators using the hand cannon equipment.
2) Guideline 232: Estimation of Inhalation Exposure at Outdoor Sites
for mixer/loaders and applicators using the hand cannon equipment.
3) Guideline 231: Estimation of Dermal Exposure at Outdoor Sites for
mixer/loaders and applicators using the backpack/knapsack equipment.
4) Guideline 232: Estimation of Inhalation Exposure at Outdoor Sites
for mixer/loaders and applicators using the backpack/knapsack
equipment.
3. Risk Assessment
a. Dietary
There are two primary dietary exposure/risk analysis
considerations for picloram: (1) the chronic dietary exposure/risk to
picloramper se, and (2) dietary carcinogenicity exposure/risk to HCB,
an impurity. An acute oral toxicity endpoint has not been identified for
picloram; therefore, an acute dietary exposure/risk analysis was not
conducted for picloram per se. Picloram isooctyl ester has no food uses,
therefore no dietary exposure is expected. Thus, a dietary carcinogenic
exposure/risk analysis was not conducted for picloram IOE.
The chronic analysis for picloram used a Reference Dose (RfD)
of 0.2 mg/kg bodyweight per day, based on a NOEL of 20.0 rag/kg
body-weight per day from a two-year rat feeding study and an
uncertainty factor of 100 to account for interspecies extrapolation and
intraspecies variability. The endpoint effects noted were altered size and
tinctorial properties of centrilobular hepatocytes in both male and female
33
-------
rats. HCB is considered a Group B2 carcinogen. The carcinogenicity
analysis that was performed for HCB used a Qj* of 1.7 (mg/kg
body weight per day)"1. The residue values used are summarized in
Table YE. Residue values are based on the assumption of tolerance
level residues .of picloram on crops. Residues of HCB were estimated
by assuming presence on all crops in direct proportion to the maximum
level of HCB in picloram TGAI as certified by the producer, i.e., at
0.01 % of the picloram tolerance. All percent crop treated values were
available.
Table VII. Picloram and HCB Residue Values on Foods Used to Determine Dietary Risk.
GoaOTTo'dity:.,,. -^ ;
Barley, grain
Barley, milled fractions (exc. flour)
Oats, grain
Oat, milled fractions (exc. flour)
Wheat, grain
Wheat, milled fractions (exc. flour)
PferoraF& 8,©5fdues {pprft}
0.5
3
0.5
3
0.5
3
HCS R'esfdues (ppmj
0.00005
0.0003
0.00005
0.0003
0.00005
0.0003
% crop if Bated
2
2
1
1
2
2
Secondary Residues ' ' ° ' " --ir-0 <^«,\ v - , , " "",„,, 7 r« JM .. jk -•• -
Milk
Cattle, fat
Cattle, kidney
Cattle, liver
Cattle, mbyp (exc kidney and liver)
Cattle, meat
Poultry, fat
Poultry, mbyp
Poultry, meat
Eggs
Hogs, fat
Hogs, kidney
Hogs, liver
Hogs, mbyp (exc kidney and liver)
Hoqs, meat
Horses, fat
Horses, kidney
Horses, liver
Horses, mbyp (exc kidney and liver)
Horses, meat
Sheep, fat
Sheep, kidney
0.05
0.2
5
0.5
0.2
0.2
0.05
0.05
0.05
0.05
0.2
5
0.5
0.2
0.2
0.2
5
0.5
0.2
0.2
0.2
5
0.00001 1 (whole milk)
0.000265 (milk fat only
assuming 4% fat)
0.00045
0.000023b
0.000023"
0.000023"
0.000023"
0.000007
0.0000001°
0.0000001 c
0.000002 (yolk)
0.000000007° (white)
0.000008
0.0000004°
0.0000004°
0.0000004°
0.0000004°
0.00045
0.000023"
0.000023" .
0.000023"
0.000023"
0.00045
0.000023"
34
-------
Commodity '
Sheep, liver
Sheep, mbyp (exc kidney and liver)
Sheep, meat
Goats, fat
Goats, kidney
Goats, liver
Goats, mbyp (exc kidney and liver)
Goats, meat
Pfc&fsna Fte&c&afcs (ppm)
0.5
0.2
0.2
0.2
5
0.5
0.2
0.2
H£$ B$s|dy$s foprrrf
0.000023b
0.000023b
0.000023"
0.00045
0.000023b
0.000023"
0.000023"
0.000023"
,:%oroft&Bated
These residue values w«e ,ound=d up to Ihe usable six decimal limit for the analysis Bulling in a very sligh. overestimation of Ih. risk
These raufae valueswere so small. Ihey rounded loiess than 0.000000. Ihe decimal places allowed in the analysis which lowered the risk jus! slightly.
The chronic dietary exposure/risk estimates for picloram are
extremely low. For the United States population as a whole, the
Theoretical Maximum Residue Contribution (TMRC) is 0.001845 mg/kg
bodyweight per day, only 0.9% of the RfD. For this same group, the
Anticipated Residue Contribution (ARC) is 0.001053 mg/kg bodyweight
per day, only 0.5% of the RfD. The subgroup with the greatest routine
chronic exposure/risk is Non-nursing Infants (Less Than One Year Old),
which has a TMRC of 0.004753 mg/kg bodyweight per day (2.4% of
the RfD) and an ARC of 0.003805 mg/kg bodyweight per day (1.9% of
the RfD). All of the exposure/risk for the U.S. population as a whole
and each of the. 22 subgroups are contributed by published tolerances.
The HCB upper-bound carcinogenicity exposure/risk estimate,
which is performed only for the U.S. population as a whole, was an
ARC of 3.94 x 10'7 mg/kg bodyweight per day and produced a
calculated ARC upper-bound carcinogenicity risk estimate of 6.7 x 10'7.
As a note, the estimated chronic toxicity ARC exposures and risks for
HCB, using an RfD of 8 x 10"4 mg/kg bodyweight per day and the same
residue figures that were used in the carcinogenicity analysis, were very
low. For all groups and subgroups, the exposure was 1 x 10'6 mg/kg
bodyweight per day or less and the calculated risk was less than 0.14%
of the RfD. The following commodities contributed the large majority
of the HCB carcinogenicity and chronic toxicity exposure/risk estimate:
Commodity
Cattle (beef)
Milk
Carcinogenic
ARC Exposure*
0.000000195
0.000000193
Carcinogenic
ARC Risk**
0.33 (49.5%)
0.33 (49.0%)
0.66 (98.50%)
Totals for both 0.000000388
* In units of mg/kg body weight per day
* *In units of E-6 (percent of the total risk-and exposure)
35
-------
The Picloram chronic dietary TMRC and ARC exposure/risk
estimates are exceedingly low, about l/200th of the RfD for each of the
groups and subgroups. There appears to be no reason for concern with
regards to chronic dietary exposure to Picloram at this time.
The refined, ARC upper-bound dietary carcinogenicity risk
estimate for the U.S. population as a whole for Picloram's impurity
Hexachlorobenzene is 0.7 E-6; a risk below 1.0 E-6 is generally
considered to be negligible. It is also likely that this upper-bound risk
estimate is a substantial overestimate because the worst-case scenarios
and assumptions were used for determining HCB residues. The
rounding of the residue level numbers also may have contributed to
overestimation of the HCB exposure/risk because more happened to
require upward rounding. The estimated dietary carcinogenicity risk
from HCB, when dietary exposure to HCB is considered only for its
occurrence as an impurity of picloram, is within Agency acceptability
guidelines. It should be noted that HCB also occurs as an impurity in
several other pesticide technical products, so overall dietary exposure to
HCB is likely to be appreciably higher than HCB considered simply as a
picloram impurity as considered in this analysis.
b. Occupational and Residential
Picloram acid, potassium salt, triisopropanolamine and
isooctyl ester
In order to adequately determine the risk associated with a
chemical the toxicological end-points of concern must be identified in
relation to the duration of the exposures. The toxicological endpoints of
significance for occupational exposure are as follows:
1) There are no short term (one to seven day exposures) toxicological
concerns indicated for occupational exposure.
2) The intermediate term exposure (1 week to several months)
toxicological endpoints are indicated by the 21-day dermal rabbit studies
based upon increased bilirubin (males) and BUN (blood urea nitrogen
males/females). The NOELs range from 250 to 1320 mg/kg/day for the
picloram compounds. For the purposes of risk assessment, the lowest
LOEL of 500 mg/kg/day should be used as the toxicological end-point
(rather than 250 mg/kg/day). The effects observed at the LOEL of 500
mg/kg/day from the 21-day dermal rabbit study using picloram isooctyl
ester were minimal and of questionable biological significance. In
36
-------
addition, studies conducted over a longer period of time by the oral
route do not show effects until a dose level of 500 mg/kg/day.
3) Long-term non-cancer lexicological endpoints for worker exposure
are not required based on the use patterns of this chemical (<90
days/year worker exposure).
The Margins of Exposure (MOE) for workers involved with
mixing/loading and applying these chemicals for 7 to 40 days/year may
be estimated by the following equation:
MOE = NOEL (mg/kg/day)
Exposure (mg/kg/day)
For regulatory purposes the lexicological endpoint of concern is
500 mg/kg/day (LOEL) based on the 21-day dermal rabbit study
conducted with the picloram isooctyl ester (MRID#s 421716-01,
428707-01). The highest potential worker exposure by the dermal and
inhalation routes is represented by applicators in the backpack/knapsack
sprayer scenario at 4,5 mg/kg/day exposure; and the lowest by
applicators in the groundboom scenario at 0.012 mg/kg/day exposure.
Therefore, the range of MOEs for workers involved in mixer/loader
and/or application activities is between 111 and 42,000. The risk to
mixers/loaders/applicators is considered to be minimal. The MOEs for
picloram are summarized in the Table Yin below:
37
-------
TABLE VDPE: The Margins of Exposure (MOE) for Picloram per se
Scenario / Mixer(M), Loader (L), Applicator (A)
Open Mixing Liquids (aerial) (I) / M,L
Groundboom Application GO) / A
Fixed-Wing Aerial (IE) / A
Helicopter (IV) / A
' Paintbrush (V) / A
Tree Injection/Hypo-hatchet (VI) / A
High Pressure Handwand (VH) / A
Right-of-Way Hand Cannon (VHI) / A
Wiper Applicator (IX) / A
Backpack/Knapsack (X) / A
Powered Personal Sprayer (XI) / A
Low Pressure Handwand (XII) / M,L,A
Daily Dermal and Inhalation
Exposure (mg/kg/day)
Picioram
1.2
0.012
0.042
_b
1.10
.
0.18
_
.
4.50
—
3.20
Margin of Exposure
(MOE)
Picloram
417
42,000
12,000
455
2778
111
.
156.
A_ UMWUJH n uwi-.u tuu-h nj\f AT*uj_r rr«j wtuwbLuiLEu. vdiiig a. vidiuai ±j\sdl^ O11U. UJC utHHiiuten UcIUUU UUU LDHaUtUOIl CXpOSUre
which would not be considered appropriate'except that the inhalation exposure is so low it represents less that 0.1 % of the
dennal exposure for the scenarios.
No Data. Exposures for the scenarios for which there are no data are expected to be no greater than the maximum
exposure scenario, backpack/knapsack.
M'L. and A wear gloves
Hexachlorobenzene (HCB) and Picloram Isooctyl Ester
The Agency has classified HCB as a probable human carcinogen
(Group Bj) based on an increased incidence of malignant tumors in two
species, hemangioendothelioma in hamsters and hepatocellular
carcinoma in rats, as well as confirmed reports of hepatoma in both of
these species. A Q:* of 1.7 (mg/kg/day)"1 was derived using data
regarding the incidence of hepatocellular carcinoma in female rats. For
these reasons, an occupational carcinogenic risk assessment associated
with picloram is required since HCB could be present up to 100 ppm.
Picloram isooctyl ester (also referred to as picloram ethylhexyl
ester) bears structural similarity to di(2-ethylhexyl)phthalate (DEHP) in
possessing a 2-ethylhexyl moiety. DEHP and certain other substances
containing the 2-ethylhexyl moiety have been found positive for
carcinogenicity in rodent bioassays. 2-Ethylhexanol was detected as a
metabolite in the metabolism studies summarized above. This metabolite
38
-------
is also a primary hydrolytie cleavage product of DEHP, a known rodent
liver carcinogen. This metabolite is thought to play a role in the ability
of DEHP to act as a peroxisome proliferator and it has been suggested
that peroxisome proliferation might be the underlying mechanism in
DEHP carcinogenicity. Available data indicate that DEHP is most
potent among the 2-ethylhexyl containing compounds tested. For the
purposes of carcinogenicity risk assessment for occupational exposure
with respect to picloram isooctyl ester the recommended lexicological
endpoint is the Q:* value of 3.29 x KT4 (mg/kg/day)-1 obtained for
DEHP in a carcinogenicity risk assessment on this compound. [D.
Turnbull and J. V. Roderick (1985)] This Qj* is based upon a 2-year
carcinogenicity bioassay of DEHP in female mice [National Toxicology
Program (1982)] and although this Q/ was generated by Turnbull and
Rodricks, the value was generated using the same model the Agency
uses.
The estimated excess carcinogenic risk to agricultural workers
from HCB and picloram isooctyl ester based on the use patterns (Tables
V and VI) for picloram are calculated as follows:
Excess Carcinogenic Risk = Qj* x LADD
where LADD represents the lifetime (35 work years/ 70 average -
Lifetime years) times the Average number of work days over a year (40
work days/365 days) times the Daily Dose for each exposure scenario
(mg/kg/day) from Table V for HCB and Table VTfl for picloram
isooctyl ester. The daily dose includes the dermal and inhalation
exposures combined. A dermal absorption factor of 100% was assumed
for both chemicals since an adequate dermal absorption study is not
available.
All exposure scenarios are appropriate for risk assessment for
HCB. The highest potential worker exposure by the dermal and
inhalation routes is represented by applicators in the backpack/knapsack
sprayer scenario at 4.50 x lO"4 mg/kg/day exposure; and the lowest by
applicators in the groundboom scenario at 1.16 x 10"6 mg/kg/day
exposure. The excess carcinogenic risk estimates for workers from
exposure to HCB are between 4.19 x 10'5 and 1.07 x 10'7.
Picloram isooctyl ester is generally applied by spot treatment and
the exposure and risk are expected to be no greater than that determined
for the backpack sprayer. Since backpack sprayers represent the highest
exposure scenario, it is also representative of the worst-case scenario.
The potential worker exposure for this scenario by the dermal and
39
-------
inhalation routes is 4.50 nig/kg/day exposure. The excess carcinogenic
risk estimate for workers from exposure to picloram isooctyl ester is 8.6
x 10~s. The groundboom scenario is not represented since picloram
isooctyl is currently not applied by this method.
These risk assessments are considered worst-case since (1) a
100% dermal absorption factor was used (although the dermal
absorption is expected to be < 23% for HCB in picloram and < 10%
for picloram isooctyl ester), (2) a Q/ from DEHP was used for the
picloram isooctyl ester which assumes the peroxisome proliferator
mechanism of carcinogenicity to be valid, and (3) the picloram isooctyl
toxicity endpoint was used as most representative, but it also happens to
be more toxic by comparison to the other forms of picloram.. There is a
degree of uncertainty associated with this risk assessment which is highly
dependent on the quality and quantity of the exposure values summarized
in Table VI and the choice of the toxicity endpoint. Additional exposure
data for the most highly exposed scenario would reduce the uncertainty.
This is a restricted use chemical that has no residential uses at
this time; therefore, there are no human risks associated with residential
uses.
Entry into a treated area soon after the application of picloram is
expected to be rare given the cultural practices typically associated with
the use-sites (rights-of-way, forestry, pastures, rangelands, and small
grains) defined by the picloram labels at this time. Furthermore, if
entry should occur, the potential exposures are expected to be minimal
due to the characteristics of those use-sites. However, due to the
toxicity concerns associated with picloram, EPA has determined that
entry should not be permitted immediately following application.
Therefore, the Agency is establishing restrictions on entry to treated
areas.
WPS Entry Restriction: For occupational end-use products
containing picloram as an active ingredient, the Agency is requiring a
12-hour restricted-entry interval for each use of the product that is
within the scope of the Worker Protection Standard for Agricultural
Pesticides (WPS) (except when it is applied by direct injection into the
treated plants).
NonWPS Entry Restriction: For occupational end-use products
containing picloram as an active ingredient, the Agency is requiring a
prohibition on entry until sprays have dried for each use of the product
40
-------
that is outside the scope .of,the; Worker Protection Standard for
Agricultural Pesticides (W]PS).
C. Environmental Assessment
1.
Environmental Fate
The principal environmental risks of picloram relate to contamination of
surface and groundwater, and damage to nontarget terrestrial plants including.
crops, in areas adjacent to areas of application, via runoff or drift, and possibly
from more distant areas where groundwater is used for irrigation or discharged
into surface water. Nontarget plants, in areas adjacent to areas of application,
may be exposed to chemical concentrations many times the levels that have been
associated with toxic effects. Some incidents of purported damage to crops
have in fact been reported. Additional concerns are identified relating to
endangered terrestrial mammals and endangered aquatic animals.
Picloram (in all of the forms considered) is among the most mobile of
currently registered pesticides, and in some soils it is nearly recalcitrant to all
degradation processes. As of 1992, detections of picloram in ground water
have been reported to the Agency for 10 states.
Limitations of the quantitative ecological risk assessment include: a.
Risk assessments are based on a single assumed application, because labels for
the most part do not specify maximum annual rates, b. Risks are not assessed
quantitatively for nontarget organisms exposed via irrigation with contaminated
surface or ground water at sites distant from areas of application. Effects at
distant locations are plausible in view of the high persistence, mobility, and
phytotoxicity of these chemicals.
These chemicals are expected to be similar in their biological and
chemical characteristics in the environment. As a consequence of this
similarity, the different active ingredients are not usually distinguished in the
ecological chemistry and fate review (Section 1), which refers to. "picloram" or
"the chemical" genetically. The ecological effects review (Section 2)
distinguishes among active ingredients on the basis of use profiles of registered
products containing a given active ingredient. In particular, picloram acid is
not used as an end product, and so the ecological risk assessment is limited to
the salts (TIPA and potassium) and IDE.
a. Environmental Chemistry, Fate and Transport
The four active ingredients are expected to have very similar fate
and transport characteristics in the environment. For the three excluding
41
-------
IOE, the part of the molecule that is principally responsible for
biological activity is the anion, which is chemically identical for all three
active ingredients. For all three, the molecule will dissociate in the
environment to yield the free anion, and the dissociation process is
governed by a rate constant (pKa) that is practically the same in value
for all three: literature submitted by the registrant indicates measured
pKa approximately 2 for the acid and salts (Osteryoung and Wittaker,
1980; Reim, 1989; Woodburn et al. 1989; Skurlatov et al., 1983). IOE
is expected to degrade rapidly (measured aerobic half-life 2 days), to
forms with the same anion as the acid and the salts. Consequently, IOE
is expected to have environmental fate characteristics very similar to
those of the other active ingredients.
The acid and salts are highly soluble in water (> 100 ppm). The
Picloram acid water solubility is 560 ppm, while that of the Potassium
salt is 740,000 ppm at 20° C. From these values, it follows that at
typical soil pH (5-9) the anionic form comprises greater than 99% of the
dissolved chemical, regardless of the original molecular species.
Therefore, regardless of the original molecular form, the
physical/chemical properties of the anion may be used to predict the
environmental fate of the applied molecule or formulation. IOE water
solubility is considerably lower at 0.23 ppm at 20° C. However, again,
IOE degrades quickly to the highly soluble anion.
Based on the high solubility of picloram in water, and on
resistance to biotic and abiotic degradation processes, as well as the
proven mobility of the chemical under both laboratory and field
conditions, it appears that the major route of dissipation for the chemical
is leaching. Based on low vapor pressure of picloram, volatilization
from soils will not be an important dissipation mechanism.
Picloram acid has a significant number of physical/chemical
characteristics in common with various pesticides known to leach to
ground water. Picloram acid has a water solubility of 560 ppm, and is
anionic at the environmentally significant pH ranges. Picloram is stable
to hydrolysis in acidic, neutral and basic media. Data on aerobic soil
metabolism show that picloram acid degrades with half-lives ranging
from 167 to 513 days in seven soils, with carbon dioxide the major
degradate. (Two minor degradates are 4-amino-3,5-dichloro-2-pyridinol
and 4-amino-2,3,5-trichloro pyridine.) Data on anaerobic soil and
anaerobic aquatic metabolism indicate that picloram acid is stable to
anaerobic degradation, with over 90% of the chemical not degraded
after 300 days of incubation. Soil photolysis data indicate that picloram
acid is stable when irradiated on soil. Batch equilibrium studies of soils
42
-------
with varying cation exehattge; capacity indicate that the chemical will be
very mobile (Freundlich Kd(ads) values < 1), for soils with organic matter
(OM) content as high as 4.2% „
No acceptable ground water monitoring studies have been
submitted to the Agency; however, available soil residue studies clearly
indicate that picloram has very high potential to leach into ground water
in most soils and the chemical has been detected in 10 states to date
(USEPA 1992; 734/12-92-001) .. For picloram that reaches surface
waters through runoff there would be some degradation, as indicated by
the aqueous photolysis study which showed a first-order half-life of 2.6
days for the acid, at 25°C.
Forestry and terrestrial field data available to the Agency indicate
that picloram is extremely mobile under field conditions. In a forestry
dissipation study conducted in South Carolina, picloram applied at the
maximum application rate of 2.0 Ib ai/A (see Use Profile Section) was
detectable 840 days after application, in the deepest samples (1.8 m). In
a study conducted in North Carolina, picloram applied at 2 Ibs ai/A to a
bare soil plot and short grass plot (both with 4.01% OM) was detected in
all sampling intervals beyond 8 weeks, in the deepest soil samples (75 to
90 cm). In a field dissipation study conducted in Montana (MRID
#42535302, 42558302), picloram applied at half the maximum label rate
(i.e. at 1 Ib ai/A) was detectable 790 days after application in the 48 to
60 inch soil layer (maximum sampling depth 72 inches; soil with 2.2%
OM). In a forestry dissipation study conducted near Ostrander
Washington, picloram applied at half the maximum label rate to exposed
soil was detectable nine months after treatment in the deepest samples
(36 inches). (Soil with 3.7% OM.)
Data recently submitted to the Agency by T.L. Lavy and
colleagues (University of Arkansas) indicate that picloram leached but
did not degrade over a three-year period in a Crevasse loamy fine sand
treated at depths of 0 to 1.5 meters (data resulted from cooperative
special project CR-815154-03-0). In fact, nearly 100% of the applied
chemical leached from the treated soil over the first three years of the
study, but none of the picloram degraded. In a Captina silt loam,
picloram was mostly degraded within six months to one year, depending
on soil depth. Given the high persistence of picloram in coarse^textured
soils, it appears unlikely that picloram will degrade once it reaches
ground water, even over a period of several years.
Supplemental laboratory studies by Watson et al. (1989) found
that picloram was more persistent and mobile in a coarse-textured soil
43
-------
(sandy loam with 61% sand and about 1.4% organic matter) than in a
finer textured soil (loam with 33% sand and about 3% organic matter).
Given the low octanol-water partition coefficient, significant
bioaccumulation in aquatic organisms is not anticipated.
b.
Environmental Fate Assessment
The MCL for picloram has been established at 500 ppb.
Picloram has been classified as a Group E chemical. Picloram generally
does not pose a threat to human health at the levels that have been
detected in ground water to this date.
As described in greater detail in Section 2, concerns are related
principally to effects on nontarget plants. Exposure to nontarget plants
may occur via the following transport mechanisms.
• Exposure of terrestrial plants in areas adjacent to areas of
application, by drift and/or runoff from areas of application.
• Exposure of crops by irrigation with contaminated surface or
ground water.
• Exposure of aquatic plants, via runoff or drift from application
areas, and via discharge of contaminated ground water into
surface water.
Ground Water., Data currently available to EPA indicate that picloram
has been detected in ground water in 10 states at concentrations ranging
up to 30 ppb. The following concerns have been identified:
• high mobility and persistence. Environmental fate data indicate
that picloram is mobile and persistent in laboratory and field
studies. Picloram (in all of the forms considered) is among the
most mobile of the currently registered pesticides. In some soils
it is nearly recalcitrant to all degradation processes.
• ground water quality. The Pesticides in Ground Water
Database (USEPA 1992; 734/12-92-001) indicates that as of
1992, detections of picloram in ground water have been reported
in Iowa, Kansas, Maine, Minnesota, Montana, North Dakota,
South Dakota, Texas, Virginia, and Wyoming. Concentrations
in ground water range up to 30 ppb. Picloram has been detected
44
-------
in a variety o£ environments in these states, although below the
toxicity threshold for human health.
Considering the widespread use of picloram and the detections in
many states, the Agency is concerned about degradation of water
quality in picloram use areas. Despite a specialized use pattern,
eventual contamination of ground water is virtually certain in
areas where residues persist in the overlying soil. Once in
ground water, the chemical is unlikely to degrade even over a
period of several years.
Surface Water. Picloram has high potential to contaminate
surface water by runoff from use areas. Regardless of the
original chemical form, substantial quantities of the anion will be
available for runoff for several months following application,
considering its persistence in the environment. As indicated'
leaching will be the major route of dissipation from soil.
Picloram that leaches into ground water may contaminate surface
water in places where ground water discharges into surface
water.
Except in clear shallow water with substantial mixing, or waters
with short hydraulic residence times, picloram is expected to be
persistent in surface water. Picloram is susceptible to direct
photolysis in water, but not to abiotic hydrolysis or volatilization.
Biological degradation will be slow under aerobic or anaerobic
conditions.
Based on the Kd values observed, picloram in runoff and in
surface water will be mostly dissolved in the water rather than
absorbed to the surface of suspended particles.
The STORET database maintained by the USEPA Office of
Drinking Water, indicates that picloram in an unspecified form
has been reported for 420 of 744 surface water samples, collected
at 135 sampling locations, before 1988. Of these detections 85%
were at concentrations 0.13 ug/L or lower and the maximum was
4.6 ug/L. The maximum concentration reported was 4.6 /tg/1.
At present, the Agency does not have data from monitoring of
picloram in surface water. However, picloram is regulated under
the Safe Drinking Water Act (SDWA), so water supply systems
are now required to sample for it. An MCL of 500 pg/l and a 1-
10 day health advisory of 20,000 /*g/l have been established.
45
-------
Picloram Acid
These values are not likely to be exceeded by annual or short
term average concentrations; however considering the application
rates, mobility, and persistence of picloram, occasional
exceedances cannot be ruled out. Therefore the Agency will
carefully review picloram data collected under SDWA and in the
U.S. Geological Survey NAWQA Program when it becomes
available.
2. Ecological Effects
a. Ecological Effects Data
The following acute and chronic studies have been reviewed and
can be used in risk assessment for birds for the four active derivatives of
Picloram.
(1) Non-target Terrestrial Animals
(a) Birds
P.C. Code: 005101
•GLNI
71-lta)
_ f •,
, - -
Mallard, Acute
Oral LDio
=MR|I>#:;;}}^!
\ ^ ' ? ' % '*'•'$ S* '? ':
Accession #'s
261883
265983
40054501
MRID # 157173
*W&Lira'
I%TE%^ ^ ;
7/1/87
CLA^f'
,
core
i ''
AX
93.8
TEST
Ifc&rE
1983
i RESIST
~ V
LD50
>2150
mg/kg
This avian study conducted with technical grade acid indicates that it is practically nontoxic to
birds on an acute oral basis (LDSO > 2150 mg/kg). This was the only avian study conducted
with the acid.
46
-------
Picloram TIPA Salt P.C. Code: 005102
\jrJwsNS?'
71-2(a)
71-2(b)
71-4(a)
(Not required)
71-4(a)
(Not required)
UST TKPE „,
Quail, Dietary
LC50
Mallard,
Dietary LC50
Ring-neck
pheasant,Avian
Reproduction
Chicken, Avian
Reproduction
MRID#
not listed
not listed
not listed
not listed
EVAMJAH
QNDATE
10/14/82
10/14/82
10/14/82
10/14/82
CLASSED
supplemental (not
completed with TGAI)
supplemental (not
completed with TGAI)
supplemental (not
completed with TGAI
or correct test species)
supplemental (not
completed with TGAI
or correct test species)
%-
AJL
10.2
10.2
10.2
10.2
' TEST
»AT£
1975
1975
1974
1974
HESEfLT
LC50
> 10,000
LC50
> 10,000
NOEC =
2.8 kg/ha '
NOEC =
2.8 kg/ha
The avian dietary studies conducted with a product with 10.2 % of technical grade active
ingredient indicate that the test material is practically nontoxic to birds on an acute dietary
basis (LC50 > 5620). Additionally, two reproduction studies put NOECs at 2.8 kg/ha.
Picloram IOE P.C. Code: 005103
<3L»#
71-2(a)
71-2(a)
IXSTTHHS
Quail, Dietary LC50
Quail, Dietary LC,n
M8Ii>#
Accession
#'s 265982
164726
Ev&LZf&mm
DATS
6/29/87
5/5/88
C&ASSSF.
core
core
%AJL ;
100
Tech. (% not given)
TEST
J>ATE-
1986
1986
J8ESI&S1 ,
LC50 >5620 ppm
LC50 >5620 ppm
The avian dietary studies conducted with technical grade active ingredient indicate that IOE is
practically nontoxic to birds on an acute dietary basis (LC50 > 5620).
Picloram Potassium Salt P.C. Code: 005104
«£N#
71-l(a)
71-l(a)
71-2(a)
71-2(a)
71-2(a)
TpST ^TYPE-
Mallard, Acute Oral
LDSO
Quail, Acute Oral
LD50
Quail, Dietary ,LC50
Mallard, Dietary
LC30
Mallard, Dietary
LC50
MRBO#^
164726
164727
REOPIC 08
REOPIC 07
129070
EVALUATION
BA11
5/20/88
5/20/88
10/14/82
10/14/82
10/14/82
OASsaFx
core
core
supplemental because
study was not
conducted with TGAI
supplemental because
study was not
conducted with TGAI
supplemental because
study was not
conducted with TGAI
%• AJL ,
tech.
(% not
given)
tech.
(% not given)
11.6
11.6
24.4
I35ST
DAT
IE-'
1985
1985
1975
1975
1975
UEseiar
LD50
> 2250 mg/kg
LD50
> 2250 mg/kg
LC50
> 10,000 ppm
LC50
> 10,000 ppm
LCSO
> 10,000 ppm
47
-------
GLN#
71-2(a)
71-2(a)
71-4(a)
(not
required
)
TESTT^PE
Quail, Dietary LC30
Quail, Dietary LCJO
Chicken, Avian
Reproduction
;MBID£
; < ;V^r
: > / V,-,.? ., f ;
s - *.:; "" ";>
129068
Accession
ff's 261883
265983
40054501
not given
EVALBAH0W
DATE
V.X i
10/14/82
7/1/87
10/14/82
CLASSIFY ,
•• -" •• f
supplemental because
study was not
conducted with TGAI
core
supplemental was not
conducted with TGAI
and required species
was not used
%A:I*
24.4
38.6
24.4
HEST
BA1< =
JE,,, ,;
1975
1982
1978
SESBLT
"4
LC50
> 10,000 ppm
LC50
>5620 ppm
NOEL
= 11. 2 kg/ha
The two avian acute oral studies conducted with technical grade active ingredient imply that
Picloram Potassium Salt is practically nontoxic on an acute oral basis (LD50 > 2250 mg/kg).
Testing on products containing 11.6, 24.4, and 38.6% of technical grade active ingredient
indicate that this salt is practically nontoxic on an acute dietary basis (LC50 > 5620). A
poultry study revealed a NOEC of 11.2 kg/ha for reproductive effects.
(b) Mammals
Essential results, by active ingredient are:
• Picloram acid, the parent compound, is practically
nontoxic to mammals based on an acute oral rat
LD50 > 5000 mg/kg for males and a LDSO = 4012
mg/kg for females. Acute inhalation LC50 >
0.035 mg/1 for both sexes.
• The TIPA salt tested with 33.9% a.i. is practically
nontoxic to. mammals based on an acute oral rate
LD50 > 5000 mg/kg for males and females. The
LC50 for an acute inhalation is > 0.07 mg/1.
• IOE is practically nontoxic to mammals based on
an acute oral rate LD50 = 2830 mg/kg for males
and LD50 = 3250 mg/kg for females.
• The Picloram Potassium Salt TIPA salt tested with
38.8% a.i. is practically nontoxic to mammals
based on an acute oral rate LD50 > 5000 mg/kg
for males and a LD50 = 3536 mg/kg for females.
The LC50 for an acute inhalation is > 1.63 mg/1.
48
-------
(2) Non-target Aquatic Animals
(a) Freshwater Animals
The following table summarizes the acute and chronic
data which can be used in risk assessment for freshwater
organisms for the four active ingredients of Picloram.
Picloram Acid P.C. Code: 005101
<#£«#
72-1 (a)
72-l(a)
72-l(c)
72-2(a)
72-6
Bluegill, Acute LCJO
Bluegill, Acute LC50
j
Rainbow, Acute LC30
Daphnia, Acute LC30
Aquatic Org. Accum.
(Bluegill)
Aquatic Org. Accum.
(Channel Catfish)
Field runoff conditions
or cutthroat trout
Field runoff conditions
or cutthroat trout
mm*
'
00129078
112016
112016
0096-008 '
.218947 (acces.
DO.)
none listed
29085
REOPIC02
E-VAXJDA310N
DA1B
10/15/82
10/14/82
10/14/82
12/21/88
7/29/82
10/14/82
2/6/82
0/14/82
ci^gs-iF,
s
core
core
core
core
core, but was
classified as
supplemental
because it was
never required
for registration
ore, but was
lassified as
upplemental
ecause it was
ever required
or registration
upplemental
ecause it was
ever required
or registration
upplemental
ecause it was
ever required
or registration
%&JL
92.74
92.9
92.9
90
99.6
99.6
0
0
JEST
DATE
1978
1974
1974
1977
1980
1980
979
979
&3%gffr.iy 1
LC50= 19.4
mg/1
LC50= 14.5
mg/1
LC50=
5.50 .
mg/1
LC50=
34.4
mg/1
< 1 (Won't
accum.in
aquatic
organisms)
< 1 (Won't
ccum.in
quatic
rganisms)
tudy
oncludes that
one. as low as
10 Mg/1 will
ffect survival
& growth.
tudy
oncludes that
one. as low as
90 Mg/1 will
"feet survival
& growth.
The above table characterizes the Picloram acid as moderately toxic to freshwater fish with a
LC50 of 5.5 mg/1 (ppm) and slightly toxic to freshwater invertebrates (LC50 of 34.4 mg/1)
Field runoff studies conducted with cutthroat trout conclude that concentrations as low as 290
49
-------
/ig/1 and 610 ^g/1 will affect survival & growth of cutthroat trout. However, since these
' studies were only conducted on the acid and not one of the salts or ester which are the actual
end-use products, these data were not used in the risk assessment.
There are no records indicating that tests for freshwater invertebrates (Daphnia magna) have
been conducted. The acid is not used as an end product, so this test is not required.
Picloram TEPA Salt P.C. Code: 005102
GLW
72-1(0
72-l(d)
72-l(d)
No guideline
requirement
KESFTEEE, ", ^ - -,
L'JL.''fV~,>s --
Rainbow, Acute LCSO
Rainbow, Acute LCJO - TEP
Rainbow, Acute LC50 - TEP
Coho salmon, Acute LC50
W$BS>#
<
not listed
not listed
not listed
not listed
BTALIJAJSON
DAW
10/14/82
10/29/82
10/29/82
10/29/82
CL&S8G?.
supplemental
supplemental
supplemental
supplemental
%AJU
98-99
8.1
2.5
10.2
TMS>
t&m
1968
1968
1968
1979
Rim? :
fff
LC50=375 mg/1
LC50=25 mg/1
LC50= 1250 mg/1
LC50=20mg/i
The above table characterizes this Picloram salt as slightly toxic to freshwater fish with a LC50
of 25 mg/1 (ppm). However, a test with cohp salmon yielded a LC50 of 20 ppm.
Picloram IDE P.C. Code: 005103
There are no data for freshwater organisms for IOE. An acute LC50s for a coldwater fish
(rainbow trout), a warmwater fish (Bluegill), and a freshwater invertebrate (Daphnia magna)
are required.
Pidoram Potassium Salt P.C. Code: 005104
GLN#
72-l(a)
72-l(c)
72-l(d)
72-2(a)
72-2(b)
72-4(a)
72-4(b)
EESTTSSfcS *;,S/X
- s V
Bluegill, Acute LC50
Rainbow, Acute LCJO
Rainbow, Acute LCio
Daphnia, Acute LC50
Daphnia, Acute LCSO
(TEP)
Rainbow Trout, Early
life Stage
Life-Cycle Aquatic
tnvertebrate
MR1D#
•v f, ^-
GS0096-007
GS0096-007
Not given
151783
Not given
151784
151783
EVALUAHON
P&33E * -
10/29/82
10/29/82
10/14/82
5/20/85
10/14/82
2/12/85
5/20/85
-------
The above table characterizes this Picloram Potassium salt as moderately toxic to freshwater
risn with a LC50 of 13 mg/1 (ppm) and slightly toxic to freshwater invertebrates (LC50 of 68 3
oo The/lsh early life sta§e and t116 Life-Cycle Aquatic Invertebrate Studies gave LOECs
.8S mg/1 and 18.1 mg/1 respectively as indicated.
(b) Marine and Estuarine Organisms
As the use of products containing picloram may be
expected to enter a marine/estuarine environment a
limited amount of data which can be used in risk
assessment for marine/estuarine organisms is required.
The data presently reviewed for the marine/estuarine
studies are presented below.
Picloram Acid
P.C. Code: 005101
There are no marine/estuarine data for the parent compound Picloram acid. As no products
containing the acid are used for anything other than manufacturing use products no data
requirements are required at this time.
Picloram TIPA Salt P.C. Code: 005102
<3£Sr#
"
rEsriwjE
Oyster, Shell deposition ECjo
Shrimp, Acute EC50
MRFD.?
not listed
not listed
ErAIXJATiQSf
DATE
10/14/82
10/14/82
CLAgSH?,
supplemental (not
tested with TGAI)
supplemental (not
tested with TGAI)
*AJL
10.3
10.3
H5SQT
BATE
1975
1975
RESULT „
10 < ECSO < 18 ppm
ECSO = 306 ppm
The above table characterizes this Picloram salt as slightly toxic to marine/estuarine mollusc
with anECjo between 10 and 18 mg/1 (ppm) and practically nontoxic to marine crustaceans
(bCjo -306 ppm). As this salt is lacking data on marine/estuarine fish, an acute
marine/estuarine fish study is required.
Picloram IOE P.C. Code: 005103
There is no data for marine/estuarine or freshwater organisms for IOE. As the use of
products containing picloram may be expected to enter a marine/estuarine environment a
limited amount of data which can be used in risk assessment for marine/estuarine organisms is
required. An acute LC/EC50 study for marine/ fish, mollusc, shrimp is required
51
-------
Picloram Potassium Salt P.C. Code: 005104
GLN#
72-3(e)
72-3(e)
EESTTYPE
Oyster, 48-h Embryo
Larvae EC50
Oyster, 48-h Embryo
Larvae ECJO
MKO),# '
111560
129073
EVALUATION
DATS,
10/14/82
10/14/82
CLASSIFY
' ' '/f
core for formulated
product only
core for formulated
product only
% A J, :
11.6
24.9
TEST
DATE
1975
1975
RESULT
EC50> 1000
ppm
18 ppm <
EC50 < 32
ppm
The above table also characterizes this Picloram salt as slightly toxic to marine/estuarine
mollusks and invertebrates with an EC50 between 18 and 32 mg/1 (ppm). As with the TIPA
salt this salt is lacking data on marine/estuarine fish; an acute marine fish study will be
required.
.(3) Non-Target Insects Data
Available data for honeybees suggest that picloram is
practically nontoxic on an acute basis. In each study available
there was no significant mortality at the highest dose level
evaluated. In the table that follows, the toxicity (LD50 or LC50) is
reported as larger than the highest dose evaluated, for example
"LD50>25 /ag/bee" indicates that doses up to 25 jig/bee were
evaluated, with no significant mortality observed at that level. •
The table indicates the highest dose evaluated in each study.
Picloram Acid
P.C. Code: 005101
GLN0
141-1
Nfo required
guideline
No required
guideline
lESTTtPE
Honey Bee LC50
Study
Honeybee LC50
Honeybee LC50
MRID#
None
Not given
129066
EVALUATION
DATE
10/29/82
12/14/82
10/29/82
CLASSDF. ' , '
supplemental; test
conducted with a mixture
supplemental (not required
guideline requirement)
supplemental (not required
guideline requirement)
&A.L
8.7 as mixture
Aqueous
emulsion
(% not given
Aqueous
emulsion
(% not given)
TEST
DATE
1965
1965
1965
RESULT
LC50
> 1000 ppm
LC50
> 4,000 ppm
LC50
> 500 ppm
Picloram TIPA Salt P.C. Code: 005102
GLN#.
141-1
No required
quideline
TESTTHPE :
Honey Bee Acute
Contact Study
Honeybee LCJO
MRED£ ;
413669-01
No given
EVALUATION,
BATE ,
4/90/92
10/29/82
CLASSED
core
supplemental
%AJ. /
5.68
8.7
TEST ,
DATE
1989
1965
RESULT
LD50> 100
jug/bee
LC50
>1000 ppm
52
-------
Picloram IOE P.C.
GLN-# , ^
141-1
141-1
TEST TYPE
Honey Bee Acute
Contact Study
Honey Bee Acute
Contact Study
Code: 005103
MBOB#
421211-07
426259-01
EV|XITATI0E?
BATE
1/4/93
6/3/93
CLASSIF.
core
core
% AJk
89.7
4.7 as
mixture
•¥£&&-
1991
1992
RESULT
LD50> 25
Atg/bee
LD50 > 25
pg/bee
Picloram Potassium Salt
GLf?#
141-1
No required
guideline
No required
guideline
3PESTTYPE. ^
Honey Bee Acute
Contact Study
Honeybee LCSO
Honeybee LC50
P.C. Code: 005104
MRI3>#
413669-02
Not given
Not given
ETAimUQISi
DATE
4/92
12/14/82
10/29/82
CLASSED
core
supplemental
because test not
conducted with
TGAI
supplemental
because test not
conducted with
TGAI
%AX
35.2
23.6
8.7
SEAR
1989
1965
1965
RESIST
LD50> 100
fig/bee
LCSO > 5,000
ppm
LCSO> 500
jpm
(4) Non-Target Plants Data (Terrestrial, Aquatic)
Generally, nontarget plant data are required only for
herbicides and fungicides, but may be required for any pesticide
if phytotoxicity concerns cannot be resolved from the open
literature or existing Agency data bases. Testing can be
accomplished at the Tier 1 and/or Tier 2 level. Before the
implementation of the current policy paper ("the White Paper "or
"New Paradigm") resulting from the Ecological Fate and Effects
Task Force, the Agency requested tier 3 field studies when the
Estimated Environmental Concentration (EEC) exceeded the
EC25 for terrestrial plants or the EC50 for aquatic plants. After
reevaluating.the appropriateness of Tier 3 field studies, the
Agency no longer routinely requires these studies. The Tier 1
level tests are carried out at the maximum label rate, and if more
than 50% adverse effects are noted for aquatic plants and 25%
adverse effects for terrestrial plants, Tier 2 testing will be
required. Tier 2 tests use multiple dosages to determine an EC50
or EC25 and a NOEC for the plant species tested in Tier 1.
Nontarget phytotoxicity data are required automatically at the
Tier 2 level for all herbicides applied aerially, via mist blowers,
and with most irrigation equipment. In many cases Tier 1 tests
are bi-passed and the registrant begins with Tier 2 tests. The
current data base is presented in the tables below.
53
-------
Picloram Acid
P.C. Code: 005101
GLN#
122-l(b)
122-2
122-2
TESTTliPE -* 1
•. " •x
Vegetative Vigor
Tier 1
Aquatic plant Tier 1
Aquatic plant -
freshwater &
saltwater species
(Euglena gracilis &
Pedisastrumsp.)
M8H>#
'
261128 (accession
no.)
261128 (accession
no)
none listed
JBTALUA31Q3SC
8A1*E :
4/29/86
4/29/86
10/29/82
CLASSY
' ft A '
-. X-v s
supplemental
(needs to be
repeated or go
to Tier 2)
core for
Selenastrum.
capricornutum
supplemental
%AJL
•*
not given
93.4
91
TEST
BATE
1985
1986
1970
KES13LT
"- •"• ?
fffjff
No valid
results
EC50=
36.9mg/l
NOEC < 24
mg/1
Picloram TEPA Salt P.C. Code: 005102
GLN#
122-2
123-l(a)
123-l(b)
123-2
TEST TYPE . " ' ,!
) & :
Aquatic plant - freshwater
& saltwater species
(Euglena gracilis &
Pedisastrum sp.)
Seed Germination
/Seedling Emerg. - Tier 2
Vegetative Vigor - Tier 2
Growth & Reproduction
of Aquatic Plants - Tier 2
TO»#*j
f ' '
<,},*'''" -
none
listed
412965-
01
412965-'
01
414077-
01
ETAttTAHON
JDA1E , ' ;,
•* ^ f f
10/29/82
5/25/93
5/25/93
5/26/93
CLASSED ;
supplemental
supplemental
(NOECs lacking
for soybean and
EC^ missing for
barley)
supplemental
(NOECs lacking
for soybean &
tomato)
core for S.
capricornutum
only
^AJ*
91
6.094
6.094
5.7
T^ST'
BAT '
E -:
1970
1989
1989
1990
IBtESPUT [\/ef , \
* ,*^ /
•• y
Sj, f : ff
•, f ff f A ffffff
NOEC < 24 mg/1
Seed Germ.
Soybean EC^ = 2.3 &
NOEC < 0.25 g ae/ha
Barley EC^
> 70 &
NOEC = 35 g ae/ha
Seed Emerg.
Soybean EC^ = 0.027
& NOEC < 0.031 g.
ae/ha
Wheat EC.JJ
= 38.8 &
NOEC = 17.5 g ae/ha
Tomato EC^ = 0.22 &
NOEC < 0. 125 g ae/ha
Wheat EC^
= 227.7 & NOEC = 70
g ae/ha
EC50 = 234 mg/1
NOEC = 18.5 mg/1
54
-------
PicloramlOE P.C. Code: 005103
-
123-l(a)
/
TESs^ncras
Seed Germination/ Seedling
Emerg. - Tier 2
Vegetative Vigor - Tier 2
Growth and Reproduction
of Aquatic Plants - Tier 2
MRIJ>#
412965-01
412965-01
426459-01
JCTALUATIOK
BATE
5/25/93
5/25/93
6/15/93
JXASSIF*
supplemental
(NOEC
lacking for
drybean)
supplemental
(NOECs
lacking for
soybean)
core for S.
capricomutu
m only
%A,l.
11.7
11.7
4.7 as
mixture
TEST BATE
1989
1989
1993
SSSUL-T
Seed Germ.
Drybean EC* = 1.5 & NOEC
< 0.25 g ae/ha
Barley EC^
= 3.6 &
NOEC = 1.1
Seed Emerg.
Drybean EC^ = 0.004 &
NOEC < 0.031 g ae/ha
Wheat ECjj
= 28.4 &
NOEC = 8.8 g ae/ha
Soybean EC^ = 0.24 &
NOEC < 0. 125 g ae/ha
Wheat ECj;
= 235.3 &
NOEC = 70 g ae/ha
EC.,, = 4.9 mg/1
NOEC = 3.2 mg/1
LOEC = 5.5 mg/1
Picloram Potassium Salt
122-1 (b)
123-l(a)
123- l(b)
'i'JSSJ:,3TBE
s
Vegetative Vigor Tier 1
Growth and Reproduction
of Aquatic Plants - Tier 2
Seed Germination/
Seedling Emerg. - Tier 2
Vegetative Vigor - Tier 2
P.C. Code: 005104
MRJ0#
261128 (accession
no.) (Hemphill, D.D.)
414077-02
412965-01
412965-01
EVALUA7IO??
BAtE
4/29/86
5/26/93
5/25/93
5/25/93
CLASSIC
supplemental (needs
raw data or go to Tier
2)
core for S.
capricornutum only
supplemental (lacks
NOECs for soybean &
drybean and lacks
ECjj for barley)
core for veg. vigor test
of potassium alt only
1&A>I>
not
given
for
Tordon
22K
35.2
0.2885
0.2885
Noie: Only studies on wmcn tne Agency can make a judgement are included in the table above.
TEST DATE
1986
1990
1989
1989
jaESULT
Info, in summary
form. Need raw
data.
£0^= 52.6 mg/1
NOEC= 13.1 mg/I
Seed Germ. Soybean
EC-a = 3.5 &
NOEC = 0.25 g
ae/ha
Barley ECjs > 70 &
NOEC = 4.4 g '
ae/ha
Seed Emerg.
Soybean EC^ =
0.014 & NOEC <
0.03 Ig ae/ha
Wheat ECa
= 23.5 &
NOEC = 8.8 g
ae/ha
Soybean EC^ = 0.4
&NOEC = 0.125 g
ae/ha
Wheat EC^
= 310 &
NOEC = 70 g ae/ha
55
-------
-------
(5) Adequacy of Toxicity Data
Based on Picloram's extreme phytotoxicity, its persistence
under typical environmental conditions, and its extreme
propensity to leach into ground water in all soil types the
following additional data are needed as confirmatory data to
support this risk assessment.
Picloram TEPA Salt P.C. Code: 005102
Reason
123-l(b)
123-l(a)
Seed Germination/Seedling Emergence - Tier 2
Vegetative Vigor - Tier 2
•* <=». ,
Need missing EC^s and NOECs for most sensitive plants
Need missing EC^s and NOECs for most sensitive plants
Seed Germination/Seedling Emergence - Tier 2
123-l(b)
Vegetative Vigor - Tier 2
Need EC^s and NOECs for sensitive crops which were
reported in damages from incident reports. These crops
include potatoes, tobacco, pasture, watermelons, tomatoes,
bell peppers, and hay
123-2
Growth & Reproduction of Aquatic Plants - Tier
Need EC^s and NOECs for sensitive crops which were
reported in damages from incident reports. These crops
include potatoes, tobacco, pasture, watermelons, tomatoes,
bell peppers, and'hay
Due to extreme phytotoxicity, Rights of Way's (ROWs),
aerial treatments, etc. all aquatic plant species must to
tested. These include Lemna. gibba, Skeletonema costaturn,
Anabaena flos-aquae, & a freshwater diatom.
Toxicity to Marine/Estuarine Fish LC50 (TEP)
This study is a minimum core requirement for all active
Ingredients.
Early Life Stage - Fish
This pesticide is highly persistent and likely to be present
'.n water on a recurrent basis.
Picloram IOE
P.C. Code: 005103
<*t4detia& #
123-l(a)
123-l(b)
123-l(a)
123-l(b)
72-l(b)
72-l(d)
72-2(b)
$£»<§* *- ,
-------
Guideline #
72-3(d)
72-3(6)
72-3(0.
72-4(a)
Stticiy -v ,, ", ^ -.,<"•• ",T<
Toxicity to Marine/Estuarine Fish LCSO
(TEP)
Toxicity to Marine/Estuarine Mollusc
EC,,, (TEP)
Toxicity to Marine/Estuarine Shrimp ECSO
(TEP)
Early Life Stage - Fish
Reason He^tiesfing
This study is a minimum core requirement for all active ingredients
This study is a minimum core requirement for all active ingredients
This study is a minimum core requirement for all active ingredients
This pesticide is highly persistent and likely to be present in water on
a recurrent basis.
Picloram Potassium Salt P.C. Code: 005104
Guideline #
123-l(a)
123-l(a)
123-l(b)
123-2
72-3(d)
Study „„ ; '-,--f r \^ - ,,;,
Seed Germination/Seedling Emergence - Tier
2
Seed Germination/Seedling Emergence - Tier
2
Vegetative Vigor - Tier 2
Growth & Reproduction of Aquatic Plants -
Tier 2
Toxicity to Marine/Estuarine Fish LC50 (TEP)
Reasoa Seqiiestiftg - f - ',, - ' ' * ,.
Need missing EC^s and NOEC for most sensitive plants
Need EC^s and NOECs for sensitive crops which were reported
in damages from incident reports. These crops include potatoes,
tobacco, pasture, watermelons, tomatoes, bell peppers, and hay
Need EC^s and NOECs for sensitive crops which were reported
in damages from incident reports. These crops include potatoes,
tobacco, pasture, watermelons, tomatoes, bell peppers, and hay
Due to extreme phytotoxicity, Right of Ways (ROWs), aerial
treatments, etc. all aquatic plant species must to tested. These
include Lemna gibba, Skeletonema costatum, Anabaena flos-
aquae, & a freshwater diatom.
This study is a minimum core requirement for all active
ingredients
b. Ecological Effects Risk Assessment
The Agency's principal index of ecological risk is a risk
quotient or RQ, calculated by dividing a value of exposure by a value of
toxicity. The assessment in this document was developed just before a
recent standardization of terminology and does not use the new standard
definitions. These differences relate to presentation and do not concern
actual findings. The differences between usage in this document and the
new standard definitions are clarified below.
58
-------
Usage in this document
LOG = Estimated environmental concentration (EEC) value that results in a concern
= k x [toxicity index, e.g., LC50 or MATC].
• k depends on endpoint.
RQ = EEC / LOG
= EEC / (k x toxicity index).
RQ is how many times the EEC exceeds the LOG, so there is a concern when RQ
exceeds 1.
Example. For endangered small mammal exposed to TIPA salt,
EEC = 528 ppm, LC50 = 4545 ppm. There is a concern if the EEC exceeds a tenth
of the LC50 (k= 1/10). It does:
LOG = 0.1 X 4545 = 454.5.
RQ = 528/454.5 = 1.16.
• RQ > 1 so there is a concern.
New standard definition
• RQ = EEC/[toxicity index] by definition.
• LOG is the RQ value that results in a concern, and depends on endpoint.
• LOG in new standard terminology equals k for this document.
Example (same endpoint).
• LOG =0.1 for endangered small mammal.
RQ = 528/4545 = 0.116.
* RQ > LOG so there is a concern. ^ '
Details of the computation of levels of concern are presented in
the sequel in sections devoted to specific categories of nontarget
organisms. The toxicity measure is most often an ECp or some variant
(effective concentration for p% response, e.g. EC50 for 50% response).
Depending on the type of biological response measured, an ECp may be
the concentration corresponding to a p% change in mean response (e.g.
p% reduction in mean weight), or the concentration corresponding to
p% of organisms responding (usually p% mortality). In some cases, the
toxicity measurement is a low-effect level (LEL), i.e. the lowest dose
that resulted in a recognizable effect in a laboratory experiment.
Standard exposure scenarios for ecological risk involve transport by
runoff or drift of chemical applied to a target plot, to adjacent land or
water. Specific details of exposure scenarios are presented in (2) below.
59
-------
The following important limitations of the standard exposure
scenarios are noted here. a. For picloram active ingredients, risk
calculations are based on a single assumed application, because, as
indicated in the Use Profile Section, labels for the most part do not
specify maximum annual rates, b. The standard exposure scenarios do
not address the potential of picloram to contact nontarget plants as a
result of irrigation with contaminated surface or ground water. Further
consideration of these issues would be necessary in order to do a more
complete risk assessment for the chemical.
The principal findings and data gaps of the Agency's quantitative
risk assessment are summarized as follows, by category of nontarget
organism.
Terrestrial Plants. Risks to nontarget terrestrial plants are very
significant (endangered species and otherwise) for all active ingredients
and all application methods considered. The following table of risk
quotients represents the most significant results of the Agency's
quantitative risk assessment. For these quotient values, the toxicity
measure is the LC25 for soybean seedling emergence, which is the
concentration that causes a quarter of seedlings to fail to emerge. The
EEC values used in these computations represents exposure to nontarget
plants in areas adjacent to the areas of application, with standard
assumptions regarding drift or runoff (Section below on Calculation of
EECs).
Number of Times the Level of Concern (LOG) is Exceeded by the Estimated Environmental Concentration (EEC)a
(Based on Terrestrial Plants)
Active Ingredient
Application Method
Unincorporated Ground
Aerial/
SoU
Aerial/ Foliar
TIPA
Salt
IDE*
Potassium Salt
4600 X 7500 X 550 X
5700 x
8100 x 13000 x 280 x
For example (row 1 column 2) the EEC for TIPA salt administered to the ground without
incorporation is 4600 times a concentration level of concern.
With current registered products, IOE is appliedonly using backpack sprayers.
For example, a quotient of 4600 is . obtained for TIPA administered by
ground application without incorporation. This means that estimated
60
-------
concentrations in the environment are 4600 times a magnitude that, in the
laboratory context, causes 25% of soybean seedlings to fail to emerge. (The
" x" symbol is used in the table to emphasize this interpretation.) Soybean
seedling emergence was chosen for this calculation because, in keeping with
standard practice, it has the smallest of available EC25 measurements (greatest
apparent sensitivity) among the measurement endpoints available, representing
four different terrestrial plant response variables. The other response variables
considered also had quotients mostly greater than one, indicating substantial
risk.
Based on reports of incidents involving damage to crops, a complete risk
assessment would require additional phytotoxicity data for various crops
including potatoes, tobacco, soybeans, corn, watermelons, tomatoes, bell
peppers, hay,.and pasture.
Aquatic Organisms (Plants and Animals). Data requirements are not
fulfilled for aquatic plants or for aquatic animals. There are currently
no registered aquatic uses of picloram; however, again, picloram is
exceptionally mobile and persistent, and therefore has exceptional
potential for exposure of aquatic organisms, relative to other pesticides
with terrestrial uses only. Also, picloram has been shown to be very
toxic to terrestrial plants, for which the database is more complete than
for aquatic plants.
For aquatic, animals, estimated exposures exceed levels of
concern in two cases: Levels of concern are exceeded for endangered
fish species for the potassium salt administered by ground application
without incorporation, and for endangered mollusks based on the TIPA
salt applied aerially. A complete risk assessment for aquatic animals
would require the following acute toxicity studies. For IOE, no aquatic
toxicity studies are available. The minimal set of additional studies
would comprise coldwater fish (rainbow trout), warmwater fish
(bluegill), freshwater invertebrate, and marine invertebrate. For
potassium and TIPA salts, a marine fish study would be required. In
addition a fish early life cycle study would be required for TIPA salt and
IOE. Availability of complete toxicity data could likely result in
identification of additional concerns for aquatic animals, because
exposures approach levels of concern for various combinations of
species, chemical and application method.
For aquatic plants, only one species has been tested (Selenastrum
carpricornutuni), of the five that are normally required. The
Selensastrum data did not indicate a concern. The additional studies
would have substantial informational value in view of the high mobility,
persistence, and phytotoxicity of the chemicals. The aquatic vascular
61
-------
plant study (Lemna sp.) could be particularly important, because of the
demonstrated high toxicity to several terrestrial vascular species.
Given the low octanol-water partition coefficient, significant
bioaccumulation in aquatic organisms is not anticipated.
Terrestrial birds and mammals. For mammals, exposure to endangered
terrestrial species will likely exceed levels of concern for TIPA and
potassium salts, administered by all application methods considered.
For non-endangered species, exposures were not found to exceed levels
of concern.
For birds (endangered and non-endangered), exposures were not found
to exceed levels of concern based on acute or chronic toxicity.
Terrestrial plant. For terrestrial plants, use rates that would result in
estimated environmental concentrations below levels of concern vary by
application procedure and product, but are uniformly lower than 1 % of
current label rates.
(1) Calculation of Estimated Environmental
Concentrations
" EEC calculations are based on maximum use rates
identified in the previous section (2.2 Ib ai/A for TIPA salt; 2 Ib
ai/A for IOE and Potassium salt), along with additional
assumptions regarding transport, dilution, and concentration. As
indicated, results are based on a single application. This section
describes the procedures used by EFED for calculating EECs:
the numerical results are presented in sections devoted to specific
categories of nontarget organisms.
Nontarget Terrestrial vertebrates, dietary exposure. EEC values
for assessment of risk to terrestrial vertebrates are based on the
procedure of Kenaga and Hoerger, as described in the ecological
risk Standard Evaluation Procedure (USEPA, 1986; 540/9-85-
001). Results are illustrated for TIPA salt: Corresponding to a
single application of TIPA salt at 2.2 Ib ai/A, the dietary EECs
based on the method of Kenaga and Hoerger are given by
wildlife use site as follows.
62
-------
Use Sites
Range grasses (short)
Long grasses
Leaves and leafy crops
Forage crops (small insects)
Pods containing seeds
(large insects)
Fruits
Soil (Top 1 inch)
Residues (pom)
(TIPA salt)*
,528
242
275
128
26
15
49
Corresponding to an application of TIPA salt at 2.2 Ib
ail A, the EEC is the maximum value (528 ppm), based on short
range grasses. For an application oflOE or potassium salt
applied at 2 Ib ai/A the EEC is 480ppm (=528*2/2.2).
Nontarget Terrestrial Plants. EEC values are based on the
assumption that chemical applied to a target plot is transported by
drift and/or runoff (depending on the application method), to an
adjacent "nontarget" plot, of area equal to that of the target plot,
where it is distributed evenly. Application methods, considered'
separately for picloram active ingredients-, are unincorporated
ground application, and aerial application (foliar and soil).'
" For unincorporated ground applications exposure to
nontarget organisms is assumed to result from runoff. The
fraction of chemical applied that is transported to .the nontarget
plot is based on water solubility as follows:
Water Solubility (ppm) % Runoff
< 0.001 0.1
0.001 to 10 1
10 to 100 2
> 100 5
Therefore, it is assumed that 5% of chemical applied is
transported by runoff for TIPA salt and potassium salt, 1 % for
IOE. Total mass transported by runoff (per application) is
therefore'as follows:
63
-------
Active Ingredient EEC (%RunoffxAppl.Rate)
TIPA salt
IOE
Potassium salt
O.lllbai/A
0.02 Ib ai/A
O.lOlbai/A
(=2.2 x 0.05),
(=2.0 x 0.01),-
(=2.0 x 0.05).
However, IOE is expected to degrade rapidly to forms with high
water solubility (over 100 ppm). For IOE, substitution of a 5%
runoff assumption would multiply by 5 various risk quotients
presented in the sequel.
• For aerial application to soil it is assumed that the
chemical is transported by both runoff and drift, and the EEC is
•calculated as the sum of terms representing these two transport
mechanisms.
EEC Gb/A) = Runoff (Ib/A) + Drift (Ib/A)
It is assumed that the nontarget plot receives 5 % of the chemical
administered to the nontarget plot, by drift. The quantity
transported by runoff is given by
Maximum
Appl. Rate
(Ib/A)
x 60% Application
Efficiency
x % Runoff.
Percentage runoff is calculated based on water solubility in the
same way as just described for unincorporated ground
application.
• For aerial application to foliage, it is assumed that the
nontarget plot receives 5% of the quantity applied on the target
plot, by drift.
Nontarget Aquatic Organisms (Plants and Animals). It is
assumed that a fraction of'chemical applied to a 10-acre plot is
transported by drift and/or runoff to a body with surface area one
acre and depth 6 feet ("deep" water body) or 6 inches ("shallow"
water body). Identification of risk levels of concern is based on
the shallow water body scenario (6 inch depth) for endangered
species, and on the deep water body scenario (6 feet depth) for
non-endangered species.
64
-------
• F°r unincorporated ground applications, it is assumed that
transport is by runoff. The fraction of material transported from
a 10-acre catchment is estimated based on solubility, as for
terrestrial plant exposures (5% for TIPA salt and potassium salt,
1 % for IOE). It is assumed that all of the runoff from the 10-
acre catchment is intercepted by the 1-acre water body. The
mass loading for the receiving water body (w.b.) is therefore
given by
Mass Maximum
Loading = Appl.Rate X % Runoff x 10 A catchment
(Ib./A (Ib./A / A surface
w.b.) catchment)
Conversion of the mass loading to an EEC (in ppb), is
based on the assumed depth of the water body. For the deeper
water body the EEC is obtained by multiplying the mass loading
by 61.2 («61) ppb/(lb./A). For the more shallow water body the
same mass will be concentrated in a volume one twelfth of the
volume of the deeper water body, so the conversion factor is 734
ppb/(lb.A)(=61.2xl2).
For example, the EEC for TIPA salt in the deeper water body is
67 ppb = 2.2 x 0.05 x 10 x 61
• For aerial applications (not assessed separately for soil
and foliage), transport is by both runoff and drift, and the
resulting EEC is the sum of terms representing these two
transport mechanisms. For runoff, it is assumed that 60% of the
material appk'ed is susceptible to runoff (60% is the "application
efficiency"). Of that fraction, the assumed percentage runoff is
based on water solubility as described for nontarget terrestrial
plants (5% for TIPA salt and potassium salt, 1% for IOE). All
of the runoff from a 10-acre catchment is received by a 1-acre
water body. Accordingly the mass loading resulting from runoff
is given by
Mass
catchment
Loading = Appl.Rate
surface
(Ib./A (Ib./A
w.b.) catchment)
Maximum 60% Appl.
10 A
X Efficiency X % Runoff X /A
65
-------
For input by drift, it is assumed that the water body
receives 5 % of the quantity applied to an adjacent equal-area
plot. Finally, the total mass loading (representing drift plus
runoff) is converted to an EEC (in ppb) by the procedure just
described for unincorporated ground applications. (Multiply by
61 for the deeper water body or by 734 for the more shallow
water body.)
(2) Non-target Terrestrial Animals
(a) Avian Acute Risk
For avian acute risk, exposure levels of concern
are LC50/2 for non-endangered species and LC50/10 for
endangered species. Calculation of the EEC representing
dietary exposure is based on maximum application rates
identified in the Use Profile Section (repeated in tables
following), using procedures described in Section (1), for
nontarget terrestrial vertebrates.
Additional calculations that are standard for
granular pesticide formulations, involving numbers of
LD50s per square feet, are not applicable to products
containing picloram salts and IOE.
Endangered Bird Species. As indicated in the following
table, the estimated exposure levels do not exceed levels
of concern.
Acute Avian Dietary Risk for Endangered Species1
Active Ingredient
UFA Salt
IOE
Potassium Salt
Dietary LC50 (ppm)
> 10000
> 5620
> 5620
Highest Calculated
EEC (ppm)
528
480
480
Risk Quotient (RQ)
EEC/(LC50/10)
< 0.528
< 0.854
< 0.854
Non-endangered species: RQ values are values given for endangered species, divided by 5. (All
Non-Endangered Bird Species. Estimated exposures do
not exceed levels of concern for non-endangered bird
species. Risk assessment for non-endangered species is
66
-------
similar to that for.endangered species (just described),
except that levels of concern are calculated as LC50/2
rather than LC50/10. It follows that for nonendangered
species, the RQ values are <0.11 for TIPA salt, <0.17
for IOE and Potassium salt.
(b) Avian Chronic Risk
For avian chronic risk, estimated exposures do not
exceed levels of concern. Levels of concern are lowest
effect levels (LEL). Supplemental studies conducted
more than 10 years ago give NOELs 2.8 kg ai/ha (15.2 Ib
ai/A) for TIPA salt and 11.2 kg ai/ha (60.9 Ib ai/A) for
Potassium salt. (NOEL= "No Observed Effect
Level"
-------
Assumptions regarding body weight and food
consumption are here based on Davis and Golly (1963).
The RQ calculations for an endangered mammal are illustrated in the following table,
for picloram TIPA salt. LC50s are for three species that are representative of small wild
mammals. The lowest relevant LD50 measurement was more than 5000 mg/kg:
Risk Quotient Calculation Illustrated for a Hypothetical Endangered Mammal with LC50 5000 mg/kg, Based on
picloram TIPA salt
Species
Meadow vole (herbivore)
Old-field mouse (granivore)
Least shrew (Insectivore)
Body
Weight
(gms)
46
13
5
1 Based on LD50 = 5000 mg/kg.
2 RQ = EEC / (0.1 x LC50);
EEC = 528 ppm
Non-Endangered: use RQ = EEC / (0.5
Daily Food Intake
% Body Weight grams
61 28.1
16 2.1
110 5.5
X LC50 )
LC50
(ppm)1
8185
30952
4545
Risk Quotient
(RQ)2
0.645
0.17
1.16
•
Acute Risk to Endangered Mammalian Species. Risk quotients computed as just described are
presented in the following table. These results indicate exceedance of exposure levels of
concern for acute risk, for endangered insectivores from exposure to picloram TIPA and
Potassium salts, and for mammalian herbivores exposed to IOE.
Acute Risk Quotients for Endangered Mammals
Active Ingredient
(P.C Code)
TIPA Salt (5102)
LDM > 5000 mg/kg
IOE (5103)
LDj,, — 2830 mg/kg
Mammal LC50 (ppm)
8185
Meadow vole (herbivore)
3095
2 Old field mouse (granivore)
4545
Least shrew (insectivore)
4632
Meadow vole (herbivore)
17519
Old field mouse (granivore)
2572.7
Least shrew (insectivore)
Highest Calculated
EEC Value (ppm)
528
480
Risk Quotient (EEC/
(O.lxLCSO)
0.645
0.17
1.16
1.036
0.274
1.866
68
-------
Active Ingredient
(P.C.Code)
Potassium Salt (5104)
LDSO = 3536 mg/kg
480
0.829
0.219
5788.5
Meadow vole (herbivore)
21889.5
Old field mouse (granivore)
3214.6
Least shrew (insectivore)
Acute Risk to Nonendangered Mammal Species.
Estimated exposures do not exceed levels of concern for
nonendangered mammals. Levels of concern are
calculated as LC50/2, rather than LC50/10 as for
endangered mammals. Therefore RQ values for
nonendangered mammals are equal to the values displayed
above for endangered mammals, divided by 5. The
maximum RQ value for nonendangered mammals is
therefore 0.37 (=1.866/5), corresponding to IOE and
least shrew.
(d) Mammalian Chronic Risk
Because risks are low for acute effects, as just
described, chronic toxicity studies are not required. For
both endangered and non-endangered mammal species,
levels of concern for chronic effects are lowest effect
levels (LEL).
(3) Non-target Terrestrial Plants
For non-target terrestrial plants (endangered or
nonendangered), exposure levels of concern are equated to the
lowest relevant EC25 measurements. Risk is assessed by
application method: unincorporated ground, aerial to soil, or
aerial to foliar. Calculation of EECs is based on maximum
application rates identified Section (1), repeated in subsequent
tables.
Unincorporated Ground Application. The following table gives
risk quotients for each active ingredient, along with the
application rates that would yield RQ= 1. As described
previously, EECs are based on the assumption that chemical
applied to a target plot is transported by runoff to an adjacent
69
-------
nontarget plot, with the assumed percentage runoff based on
water solubility. The results displayed below indicate that
picloram salts and IOE are very likely to affect nontarget plants
(especially dicots) in areas adjacent to areas of application. The
requirement for Tier 3 plant field testing has been met; however
the Agency does not routinely require these studies.
Terrestrial Plants Exposed via Runoff, Uaincarjpetodsd Groand Application
Active Ingredient
(P.C Code)
. .
TIPA Salt (5102)
IOE (5103)
Potassium Silt (5104)
Seed Germination
Seedling Emergence
(Ibai/A)
0.002
(Dicots-Soybeans)
> 0.035
(Monocots-barley)
0.0000239
(Dicots-Soybeans)
0.0346
(Monoeots-wheat)
0.0013376
(Dicots-Drybeans)
0.0032103
(Monocots-barley)
3.5 X 10"5
(Dicots-Soybeans)
0.0253259
(Monoeots-wheat)
0.0031
(Dicots-Soybeans)
0.062
(Monocots-Barley)
0.0000124
(Dicots-Soybeans)
0.02
(Monocots-Wheat)
Maximum
Application Rate
(Ibai/A)
2.2
2.0
2.0
% Runoff Based on
Solubility
5'
1
5
EEC
(Ib ai/A)
0.11
0.02
0.1
Risk Quotient
(EEC/EC^)
55
< 3.14
4603
3.18
14.99
6.23
5714
0.790
. 32.3
1.61
8065
5
Aerial Application to Soil. As described previously, EECs are based on the assumption that
chemical applied to a target plot is transported by both drift and runoff to an adjacent
nontarget plot of equal area. Results of these calculations (displayed in the following table)
indicate that picloram salts pose significant risks to nontarget plants (especially dicots) in areas
adjacent to application plots, when the chemical is applied aerially to soil. The same result is
obtained for IOE; however IOE is currently applied only using backpack sprayers.
70
-------
BMs to Naat
Active Ingredient
(P.C Code)
TIPA Salt (5102)
IOE (5103)
Potassium Salt (5104)
ajse*T N^-Badiagerfed}, AerM/Ssil Application
Seed Germination
Seedling Emergence
(lb ai/A)
0.002
(Dicots-Soybeans)
0.035
Monocots-barley)
0.0000239
(Dicots-Soybeans)
0.062
(Monocots-wheat)
0.0013376
(Dicots-Drybeans)
0.0032103
(MoBocots-barley)
3.5 X 10-*
(Dicots-Soybeans)
0.0253259
(Monocots-wheat)
0.0031
(Dicots-Soybeans)
0.062
(Monocots-Barley)
0.0000124
(Dicots-Soybeans)
0.02
(Monocots-Wheat)
Maximum
Application Rate
(lb ai/A)
2.2
2.0
2.0
%Runoff
Based on
Solubility
5
1
5
EEC
(lb
ai/A)
0.18
0.032
0.16
•
Risk
Quotien
t
(EEC/E
90
5.1
7531
2.9
23.9
9.9679
9143
1.2635
51.6
2.5
12,903
S
Aerial Application - Foliar. As described previously, EECs are calculated under the
assumption that 5% of the chemical applied to a nontarget plot is transported by runoff to an
adjacent nontarget plot of equal area. The resulting risk quotient values (displayed in the
following table) indicate that picloram salts pose significant risks to nontarget dicot plants and
root crops in areas adjacent to application areas when the chemical is applied by foliar aerial
applications. The same result is obtained for IOE; however IOE is currently applied only
using backpack sprayers.
71
-------
5 * ' 'I * •.^syf,,,irz ", j, .. ;,-, ' , "J. ',„ ,f, "• "•
Risk to Nontarget Xw racial Hants CEa&*agp*e3, No^-elbd^ered) from Aerial Foliar
\ 'v;\' *'-;, -, \^jppeAn. ^v' -'/^ ,* : ~, ;,, '-/ ^ ,
Active Ingredient
(P.C Code)
TIPASaU (5102)
IOE(5103)
Potassium Salt (5104)
Vegetative Vigor
ECa
(Ibai/A)
0.0002
(Dicots-Tomatoes)
0.20
(Monocots-Wheat)
0.012
(Root crops-Radish)
0.000214
(Dicots-Soybeans)
0.2098307
(Monocots-WheaO
0.0346893
(Root crops-Radish)
0.00036
(Dicots-Soybeans)
0.276
(Monocots-Wheat)
0.062
(Root crops-Radish
Maximum Application Rate
(lb ai/A)
2.2
2.0
2.0
% Runoff Based on
Drift
5
1
5
EEC
Ob ai/A)
0.11
0.02.
0.1
Risk Quotient
(EEC/ECjj)
550
0.55
9.2
93.
0.095
0.58
277.7
0.36
1.6
Additional Phytotoxicity Information. The use of products
containing picloram has on occasion resulted in unintentional
damage to crops outside of areas where applied. Based on the
data available, picloram appears to have caused adverse effects to
trees, grasses, shrubbery, strawberries, watermelons, potatoes,
grapes, peanuts, and soybeans. Three incidents are reported of
damage to potatoes. Therefore confirmatory toxicity data are
needed for various crops, and for potatoes in particular.
(4) Non-target Aquatic Plants
For nontarget aquatic plants, a complete risk assessment
involves toxicity tests for five plant species. At present data are
available only for Selenastrum capricornutum (a freshwater green
alga).
Standard quantitative risk calculations have been
performed based on the S. capricornutum toxicity measurements.
This incomplete risk assessment, which is not presented here in
detail, indicates that exposure levels of concern are not exceeded
for picloram salts and IOE. This result does not indicate that
current picloram uses are benign for nontarget aquatic plants in
general: testing of the additional species are being required as
confirmatory data.
72
-------
(5) Non-target Aquatic Animals
(a) Acute Risks
f
Acute risk to non-target aquatic animals is presumed low
for risk quotient (RQ) values less than 1, calculating RQ as
EEC/(0.1xLC50) (nonendangered species) or
EEC/(0.05xLC50) (endangered species), based on the lowest
relevant LC50 measurement. The calculation of EECs depends
upon the maximum use rates identified in the Use Profile Section
and formula given in Section (1). EEC calculations assume that
a proportion of chemical applied in a 10 acre drainage basin is
transported by drift and/or runoff (depending on the application
method) to a 1 acre water body, depth 6 feet or 6 inches. Again,
concentration levels of concern are based on the 6 inch depth for
endangered species and on 6 foot depth for non-endangered
species.
A reasonably complete acute risk assessment would
require, at minimum, the following acute toxicity studies not
presently available: for TIPA salt and IOE, LC50s for a
coldwater fish (rainbow trout), a warmwater fish (bluegill)s and a
freshwater invertebrate (Daphnia magna); for potassium salt the
LC50 for bluegill. For IOE, there are no available acute toxicity
data for freshwater marine/estuarine organisms.
Standard calculations have been performed using the
available toxicity data. The results are presented in detail only
for endangered species, for which in some cases the risk.
quotients approach or exceed one. For non-endangered species,
risk quotients can be obtained as 0.5 times the values presented
for endangered species. This incomplete risk assessment has
identified the following ecological risk concern: The potassium
salt is likely to affect endangered fish with unincorporated
ground application (risk quotient= 1.13). With plausible levels
of variation in sensitivity among species, it is not improbable that
additional concerns would be identified if the minimal toxicity
data requirements identified were fulfilled. An additional risk
quotient greater than one is obtained with the endangered species
risk assessment for TIPA salt, based on the eastern oyster shell
deposition test (unincorporated ground application); however,
currently there are no federally listed marine or estuarine
organisms.
Unincorporated Ground Applications, Endangered Species. As
described previously for aquatic organisms (plants and animals)
EEC calculations assume that chemical applied to a target plot is
73
-------
transported by runoff to an adjacent plot of equal area, at a rate
that depends on water solubility of the chemical. Results are
presented separately for TIPA salt and potassium salt in the
following tables. (For IOE there are no available aquatic toxicity
data.) For TIPA and potassium salt, it is assumed that 5% of
chemical applied is transported to the nontarget plot, based on the
high water solubility of these chemicals.
For nonendangeredsped.es, risk quotients will equal 0.5
times the values presented.
Risk Quotients (RQ) for Endangered Aquatic Animals,
based on Unincorporated Ground Applications
1. Picloram TIPA salt Applied at 2.2 Ib. ai/A
„ ,,*'K '.:
Sp«efcs f ••'' , "'- > '; ; ••' ..
Coho Salmon
(FW fish - coldwater)
Marine Shrimp
Eastern Oyster
(Shell deposition)
- - - * **• , ' v r , "
fcCjjj-fjfijii} ' '.
20,000
306,000
10,000
•" ?/.*'•,'•. '
\ . #& ' -/
$ Ffe4t.Seeg eS7JWei>«? fctCjj)
0.067
0.0044
0.134
,V, ', - S$ ' t "
fcfech Etedji (S&1*!(0-8S'* 1,^
0.807
0.0528
1.615
2. Picloram IOE: no toxicity data.
3. Picloram Potassium Salt Applied at 2.0 Ib. ai/A
^ •• f,f-,t '
Sfwies"" s; •• ';%„
5 , ' ^ s
Rainbow Trout
(FW fish - coldwatcr)
Daphoia
(FW Invertebrate)
Eastern Oyster
(Embryo Larvae)
<.
- t-Csa. J '
s;- "$)&
13,000
68,300
18,000
'" :<- - -^
' 8Qt
' * PtetfteSp " ' /
'„, (w^ossic^
0.0938
0.0179
0.0677 '
fjr "f f ^ y ?jtffSff
" ;, ' j«r "'
e^SSjaUows '
, 034^65 »LCpS
1.13
0.215
0.816
Aerial or Mist Blower Applications (endangered species). EECs are calculated as
described in Section (1) for aquatic organisms (both animals and plants), under the
assumption that a water body with 1 acre surface receives input of chemical by both
drift and runoff from the 10-acre plot.
74
-------
Results are presented separately for TIPA salt and potassium salt in the following
tables. (For IOE there are no available aquatic toxicity data and no aerial or mist
Mower applications, only backpack.) For nonendangered species, risk quotients will
equal 0.5 times the values presented. The results for the TIPA salt and the oyster shell
deposition study indicate a concern for endangered species of mollusks.
Risk Quotients (RQ) for Endangered Aquatic Animals
based on Aerial Application
1. Picloram TIPA Salt Applied at 2.2 Ib. ai/A
2. Picloram IOE: No toxicity data.
SPECtES\ , "''"',"' r
Rainbow Trout (FW fish - coldwater)
Daphnia (FW Invertebrate)
Eastern Oyster (Embryo Larvae)
»**
pj*.
13,000
68,300
18,000
gQ.
5'Eg.ETDggP
&&1&J& x fcC«)> ,
0.066
0.12
0.047
/.tt.
®3
, SINGH SJ&UX3WS
<5l45/(ft,-(»-x«y3
0 79
.12
0.57
0>) Chronic Risk
Subdivision E, Section 72-4 of FIFRA requires
submission of a fish early life-cycle test for pesticides that
are likely to be highly persistent in the aquatic
environment. The only picloram active ingredient for
which this requirement is satisfied is potassium salt.
Chronic fish studies are needed for the remaining active
ingredients.
For risks of chronic effects, levels of concern are
equated to Maximum Acceptable Concentrations
(MATC). For the picloram potassium salt, MATCs for
the fish early life stage and aquatic invertebrate life-cycle
tests are 700 ppb and 14600 ppb respectively. Neither of
these values exceeds relevant EECs based on the
75
-------
r
application methods considered here (unincorporated
ground application and aerial application).
(6) Non-target Insects
As indicated in discussion of toxicity data, honey bee
acute toxicity studies indicate that all active ingredients of
picloram are practically nontoxic to that species, with contact
LD50 > 25 nig per bee.
TV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine., after
submission of relevant data concerning an active ingredient, whether products
containing the active ingredient are eligible for feregistration. 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 picloram acid
and its derivatives as active ingredients. The Agency has completed its review of these
generic data, and has determined that the data are sufficient to support reregistration of
all products containing picloram acid and its derivatives. Appendix B identifies the
generic data requirements that the Agency reviewed as part of its determination of
reregistration eligibility of picloram acid and its derivatives, 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 picloram acid and its derivatives and to determine that picloram
and its derivatives can be used without resulting in unreasonable adverse effects to
humans and the environment. The Agency therefore finds that all products containing
picloram acid and its derivatives as the active ingredients are eligible for reregistration
conditional upon implementation of the mitigation measures specified in this document.
The reregistration of particular products is addressed in Section V of this document.
The Agency made its reregistration eligibility determination based upon the
target data base required for reregistration, the current guidelines for conducting
acceptable studies to generate such data and the data identified in Appendix B.
Although the Agency has found that all uses of picloram acid and its derivatives 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 picloram acid and its derivatives, if new
information comes to the Agency's attention or if the data requirements for registration
(or the guidelines for generating such data) change.
76
-------
lo Eligibility Decision
Based on the reviews of the ^eni^ic data for the active ingredients picloram acid
and its derivatives, the Agency has sufficient information on the health effects of
picloram and on its potential for causing adverse effects in fish and wildlife and the
environment. The Agency concludes that products containing picloram for all uses are
eligible for reregistration provided the risk mitigation measures specified in this
document are implemented.
The Agency has determined that picloram, labeled and used as specified in this
Reregistration Eligibility Decision, will not pose unreasonable risks or adverse effects
to humans or the environment.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of picloram and its derivatives
are eligible for reregistration.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for
picloram acid and its derivatives. Where labeling revisions are imposed, specific
language is set forth in Section V of this document.
1. Tolerance Reassessment
Tolerances Listed Under 40 CFR §180.292:
The tolerances listed in 40 CFR §180.292 are for residues of picloram
per se. Sufficient data are available to ascertain the adequacy of the established
tolerances listed in 40 CFR §180.292 for the foUowing commodities: barley
grain; barley forage; barley straw; oat grain; oat forage; oat straw; wheat grain;
wheat forage; wheat straw; fat, meat, kidney, liver, and meat by-products of
cattle; goats, hogs, horses, and sheep; and fat, meat, and meat by-products of
poultry, milk, and eggs. See Table IX for modifications in commodity
definitions.
Sufficient field residue data are available for grasses, although the data
indicate that the established tolerance of 80 ppm for picloram residues in/on
grass forage is not adequate. Tolerances of 225 ppm have been proposed for
pieloram residues in/on grass forage and hay. The available data support the
proposed tolerance for grass hay but show that a higher tolerance must be
proposed for grass forage. The data indicate that a level of 300 ppm would be
appropriate.
The Agency has acceptable field residue data at the 0.5 Ib. ae/A and 2
Ib. ae/A. However, through negotiations with the registrant the new maximum
77
-------
use rate will be lowered to 1 Ib. ae/A. Ordinarily, field residue data would be
required for this new maximum use rate, however, since there are minimal
dietary concerns involved with picloram, no field residue data will be required
for the 1 Ib. ae/A maximum use rate. Picloram tolerances are based on the 2
Ib. ae/A data and will remain in effect unless the Agency revisits the tolerance
setting database and lowers the tolerance based on the 0.5 and 2 Ib. ae/A
residue field data or the registrant proposes a lower tolerance based upon the
0.5 and 2 Ib. ae/A.
A wheat grain dust study has shown that a tolerance must be proposed.
The available data indicate that a tolerance of 4 ppm would be appropriate for
grain dust.
The established tolerances for picloram residues in/on flax seed and flax
straw will be proposed for revocation, as there is no registered use of picloram
on flax.
Tolerances Listed Under 40 CFR §185.4850 and 40 CFR §186.4850:
The tolerances listed in 40 CFR §185.4850 and 40 CFR §186.4850 are
for residues of picloram per se. Sufficient data are available to ascertain the
adequacy of the established food/feed additive tolerances listed in 40 CFR
§185.4850 and 40 CFR §186.4850 for barley, oat, and wheat milled fractions
(excluding flour),
CODEX HARMONIZATION
There are no Codex MRLs established or proposed for residues of
picloram. Therefore, there are no questions with respect to compatibility of .
U.S. tolerances with Codex MRLs.
Table IX. Tolerance Reassessment Summary for Picloram
Commodity
Current
Tolerance
(ppm)
Tolerance
Reassessment
(ppm)
Comment/ Correct
Commodity Definition
Tolerances listed under 40 CFR §180.292:
Barley, grain
Barley, green forage
Barley, straw
Cattle, fat
Cattle, kidney
Cattle, liver
0.5
1
1
0.2
5
0.5
0.5
1
1
0.2
5
0.5
Barley, forage
78
(continued)
-------
Table C (continued).
Commodity
Cattle, mbyp (exc kidney
and liver)
Cattle, meat
Eggs
Flax, seed
Flax, straw
Goats, fat
Goats, kidney
Goats, liver
Goats, mbyp (exc kidney
and liver)
Goats, meat
[Grain dust]
Grasses, forage
[Grass, hay]
Hogs, fat
Hogs, kidney
Hogs, liver
Hogs, mbyp (exc kidney
and liver)
Hogs, meat
Horses, fat
Horses, kidney
Horses, liver
Horses, mbyp (exc
kidney and liver)
Horses, meat
Milk
Current
Tolerance
(ppm)
0.2
0.2
0.05
0.5
0.5
0.2
5
0.5
0.2
0.2
none
80
none
0.2
5
0.5
0.2
0.2
0.2
5
0.5
0.2
0.2
0.05
Tolerance
Reassessment
(ppm)
0.2
0.2
0.05
Revoke
Revoke
0.2
5
0.5
0.2
0.2
4
300
225
0.2
5
0.5
0.2
0.2
0.2
5
0.5
0.2
0.2
0.05
Comment/ Correct
Commodity Definition
Cattle, mbyp (exc. liver
and kidney)
No registered use
No registered use
Goats, mbyp (exc. liver
and kidney)
Registrant must propose
tolerance
Revised tolerance
proposal of 225 ppm
pending (PP#6F3367);
registrant must propose
higher tolerance/ Grass,
forage
Tolerance pending
(PP#6F3367)/Gra^, hay
Hogs, mbyp (exc. liver
and kidney)
Horses, mbyp (exc. liver
and kidney) .
79
(continued)
-------
Table C (continued).
Commodity
Oats, grain
Oats, green forage
Oats, straw
Poultry, fat
Poultry, mbyp
Poultry, meat
Sheep, fat
Sheep, kidney
Sheep, liver
Sheep, mbyp (exc kidney
and liver)
Sheep, meat
Wheat, grain
Wheat, green forage
Wheat, straw
Current
Tolerance
(ppm)
0.5
1
1
0.05
0.05
0.05
0.2
5
0.5
0.2
0.2
0.5
1
•1
Tolerance
Reassessment
(ppm)
.0.5
1
1
0.05
0.05
0.05
0.2
5
0.5
0.2
0.2
0.5
1
1
Comment/ Correct
Commodity Definition
Oats, forage
Sheep, mbyp (exc. liver
and kidney)
Wheat, forage
Tolerances listed under 40 CFR §185.4850
Barley, milled fractions
(exc. flour)
Oat, milled fractions
(exc. flour)
Wheat, milled fractions
(exc. flour)
3
3
3
3
3
3
*
Tolerances listed tinder 40 CFR §186.4850
Barley, milled fractions
(exc. flour)
Oat, milled fractions
(exc. flour)
Wheat, milled fractions
(exc. flour)
3
3
3
3
3
3
2. Restricted Use Classification
All the picloram derivatives (potassium picloram, triisopropanolamine
picloram and isoocryl picloram) are currently classified as restricted use
pesticides by regulation (40 CFR section 152.175) on the basis of being a
80
-------
hazard to non-target organisms both crop and non-crop. Picloram will remain a
restricted use pesticide. Picloram iriay also be considered for restricted use for
ground water concerns once the Ground Water Restricted Use Rule is finalized.
The eligibility determination made at this time is based upon a presumption that
registrations will conform to all applicable regulatory conditions included in the
final restricted use rule for groundwater.
3. State Management Plan
EPA is proposing regulations that will: 1) designate certain pesticides to
be subject to EPA-approved State Management Plans (SMPs) as a condition of
their legal sale and use; and 2) establish these SMPs as an "other regulatory
restriction" by specifying procedures and criteria for SMP development, review
and approval, as provided under the Federal Insecticide, Rodenticide and
Fungicide Act (FIFRA) Section 3(d). In proposing these individual pesticides
to be subject to SMPs, EPA has determined that these pesticides may pose an
unreasonable adverse effect to the environment by their ground-water
contamination potential, in the absence of effective local management measures
provided in a State plan. Any uses of picloram allowed pursuant to the final
rale will be predicated on a finding that such uses will not pose unreasonable
adverse effects on the environment when used pursuant to the conditions
contained in the rule. Upon promulgation of this rule, the labels for these
pesticides will be changed to require use in accordance with an EPA-approved
SMP, and to prohibit sale and use in those States without such an EPA-
approved SMP, after a period (to be established in the rule) allowed for
development and approval of these State plans. The eligibility determination
made at this time is based upon a presumption that registrations will conform to
all applicable requirements of the final regulation addressing this issue.
Picloram is not now one of the pesticides that EPA will be proposing to
be subject of a SMP. However, the Agency may consider picloram as a
candidate for a SMP at some later date.
4. Reference Dose
A reference dose (RfD) for the picloram acid and its derivatives was
calculated to be 0.20 mg/kg/day based on a NOEL of 20 mg/kg/day body-
weight per day from a two-year chronic rat feeding study. An uncertainty
factor of 100 was used to account for the inter-species extrapolation and intra-
species variability. The picloram chronic dietary exposure/risk estimates are
extremely low. For the United States population as a whole, the Theoretical
Maximum Residue Contribution (TMRC) is 0.9% of the RfD. For this same
group, the Anticipated Residue Contribution (ARC) is 0.5% of the RfD.
Because the dietary exposure/risk is so low, about l/200th of the RfD, there are
no concerns regarding chronic dietary exposure to picloram at this time.
81
-------
5.
Cancer Risk Assessment
The Agency has classified picloram as a Group E (evidence of non-
carcinogenicity for humans). Even though picloram was shown to be non-
carcinogenic, a cancer risk assessment was performed on the maximum
concentration of the impurity HCB, since HCB has been classified by the
Agency as a- Group B2 (probable human carcinogen). The refined, ARC dietary
carcinogenicity risk estimates for the United States population as a whole for the
impurity, HCB, is 7 x 10~7. A risk less than 1.0 x 10~6 is generally considered
to be negligible.
Picloram IOE bears structural similarity to di(2-ethylhexyl)phthalate
(DEPH) in that both possess a 2-ethylhexyl moiety. DEPH and certain other
substances containing the 2-ethylhexyl moiety have been found to be
carcinogenic. The Agency performed a cancer risk assessment for workers and
found that the risk associated with post-application exposure is not a major
concern since exposure to workers is minimal due to the use patterns defined by
the picloram IOE labels and the cultural practices typically associated with a
broad spectrum herbicide of this type. This-ester formulation is not used on
food.
6. Endangered Species Statement
Currently, the Agency is developing a program ("The Endangered
Species Protection Program") to identify all pesticides whose use may cause
adverse impacts on endangered and threatened, species and to implement
mitigation measures that will eliminate the adverse impacts. The program
would require use restrictions to protect endangered and threatened species at
the county level. Consultations with the Fish and Wildlife Service may be
necessary to assess risks to newly listed species or from proposed new uses. In
the future, the Agency plans to publish in the Federal Register a description of
the program and have available enforceable county-specific bulletins. Because
the Agency is taking this approach for protecting endangered and threatened
species, it is not imposing label modifications at this time through the RED.
Rather, any requirements for product use modifications will occur in the future
under the Endangered Species Protection Program.
7. Worker Protection
a. Compliance with Worker Protection Standard
Any product whose labeling reasonably permits use in the
production of an agricultural plant on any farm, forest, nursery, or
greenhouse must comply with the labeling requirements of PR Notice
93-7, "Labeling Revisions Required by the Worker-Protection Standard
82
-------
(WPS), and PR Notice 93-11, "Supplemental Guidance for PR Notice
93-7, which reflect the requirements of EPA's labeling regulations for
worker protection statements (40 CFR part 156, subpart K). These
labeling revisions are necessary to implement the Worker Protection
Standard for Agricultural Pesticides (40 CFR part 170) and must be
completed in accordance with, and within the deadlines specified in PR
Notices 93-7 and 93-11. Unless otherwise specifically directed in this
RED, all statements required by PR Notices 93-7 and 93-11 are to be on"
the product label exactly as instructed in those notices.
After April 21, 1994, except as otherwise provided in PR
Notices 93-7 and 93-11, all products within the scope of those notices
must bear WPS PR Notice complying labeling when they are distributed
or sold by the primary registrant or any supplementally registered
distributor.
After October 23, 1995, except as otherwise provided in PR
Notices 93-7 and 93-11, all products within the scope of those notices
must bear WPS PR Notice complying labeling when they are distributed
or sold by any person.
Post-application Reentry
Under the Worker Protection Standard (WPS), interim restricted
entry intervals (REI) for all uses within the scope of the WPS are
established on the basis of the acute toxicity of the active ingredient. The
toxicity categories of the active ingredient for acute dermal toxicity, eye
irritation potential, and skin irritation potential are used to determine the •
interim WPS REI. If one or more of the three acute toxicity effects are
in toxicity category I, the interim WPS REI is established at 48 hours.
If none of the acute toxicity effects are in category I, but one or more of
the three is classified as category H, the interim WPS REI is established
at 24 hours. If none of the three acute toxicity effects are in category I
or E, the interim WPS REI is established at 12 hours. A 48-hour REI is
increased to 72 hours when an organophosphate pesticide is applied
outdoors in arid areas. In addition, the WPS specifically retains two
types of REI's established by the Agency prior to the promulgation of
the WPS: product-specific REI's established on the basis of adequate
data and interim REI's that are longer than those that would be
established under the WPS.
At this time some registered uses of picloram are within the
scope of the Worker Protection Standard for agricultural pesticides
(WPS) and some are outside the scope of the WPS. EPA has
determined that entry should not be permitted immediately following
83
-------
application. Therefore, the Agency is establishing restrictions on entry
to treated areas. For each use of the product that is within the scope of
the Worker Protection Standard for Agricultural Pesticides (WPS)
(except when it is applied by direct injection into the treated plants), the
Agency is requiring a 12-hour restricted-entry interval on all
occupational end-use products containing picloram as an active
ingredient. For each use of the product that is outside the scope of the
Worker Protection Standard for Agricultural Pesticides (WPS), the
Agency is requiring a prohibition on entry until sprays have dried on
occupational end-use products containing picloram as an active
ingredient.
The WPS places very specific restrictions on entry during
restricted-entry intervals when that entry involves contact with treated
surfaces. The Agency believes that these existing WPS protection are
sufficient to mitigate post-application exposures of workers who contact
surfaces treated with picloram. The WPS REI in effect until now was a
12-hour REI placed on picloram- products by PR Notice 93-7.
When picloram is applied by direct injection into treated plants,
there are no entry restrictions. The WPS does not cover workers who
are working in an area where a pesticide has been injected directly into
plants, therefore, there are no entry restrictions or notification
requirements.
.Personal Protective Equipment (PPE) Requirements
Mixer/loader/applicator PPE For each end-use product, PPE
requirements for pesticide handlers will be set during
reregistration in one of two ways:
1. If the Agency has no special concerns regarding other adverse
effects of an active ingredient, the PPE for pesticide handlers will be
established-based on the acute toxicity of the end-use product. For
occupational-use products, PPE will be established using the process
described in PR Notice 93-7 or more recent EPA guidelines.
2. If the Agency has special concerns about an active ingredient due
to very high acute toxicity or certain adverse effects, such as allergic
effects or other effects (cancer, developmental toxicity, reproductive
effects, etc):
• In the RED document for that active ingredient, the Agency may
establish minimum or "baseline" handler PPE requirements that
84
-------
pertain to all or most occupational end-use products containing
that active ingredient.
• These minimum PPE requirements must be compared with the
PPE that would be designated on the basis of the acute toxicity of
each end-use product.
• The more stringent choice for each type of PPE (i.e., bodywear,
hand protection, footwear, eyewear, etc.) must be placed on the'
label, of the end-use product.
There are special toxicological concerns about picloram that
warrant the establishment of active-ingredient based PPE requirements.
The MOE's for some of the use-scenarios for handlers (mixers, loaders,
applicators, etc.) are acceptable only with the addition of chemical-
resistant gloves.
.To the Agency's knowledge, at this time some of the registered
uses of picloram are within the scope of the Worker Protection Standard
for Agricultural Pesticides (WPS) and some are outside the scope of the
WPS. However, the minimum (baseline) PPE requirements for both the
• WPS and nonWPS uses are the same, since the potential exposure to
handlers is similar for WPS and nonWPS uses.
The minimum (baseline)PPE for all WPS and nonWPS uses of
picloram end-use products is: chemical-resistant gloves.
Personal Protective Equipment (PPE) Requirements
Early Entry PPE The WPS establishes very specific restrictions on
entry by workers to areas that remain under a restricted-entry by
workers if the entry involves contact with treated surfaces. Among
those restrictions are a prohibition of routine entry to perform hand
labor tasks and requirement that personal protective equipment be worn.
Personal protective equipment requirements for persons who must enter
areas that remain under a restricted-entry interval are based on the
toxicity concerns about the active ingredient. The requirements are set
in one of two ways.
1. If the Agency has no special concerns about the acute or other
adverse effects of an active ingredient, it establishes the early-entry PPE
requirements based on the acute dermal toxicity, skin irritation potential,
and eye irritation potential of the active ingredient.
2. If the Agency has special concerns about an active ingredient due
to very high acute toxicity or to certain other adverse effects, such as
85
-------
allergic effects, cancer, developmental toxicity, or reproductive effects,
it may establish early-entry PPE requirements that are more stringent
than would be established otherwise.
Since there are special toxicological concerns about picloram and
picloram is classified as toxicity category El or IV for acute dermal
toxicity and skin irritation potential, the PPE required for early entry is
coveralls, chemical-resistant gloves, shoes, and socks. Since picloram is
classified as toxicity category EH for eye irritation potential, no
protective eyewear is required. The Agency will not require a respirator
for early-entry workers, since the WPS places very specific restrictions
on early entry and the Agency believes that these existing WPS
protections are sufficient to mitigate post-application inhalation
exposures of workers.
There are no special toxicological concerns about picloram that
warrant the establishment of active-ingredient-based early entry PPE
requirements.
Entry Restrictions for Occupational-Use Products (nonWPS
uses)
At this time some registered uses of picloram are outside the
scope of the WPS. The Agency is requiring the following entry
restrictions for all nonWPS occupational uses of picloram end-use
products:
"Do not enter or allow others to enter the treated area until
sprays have dried."
Entry Restrictions for Residential-Use Products
At this time no products containing picloram are registered for
residential use.
8. Spray Drift Advisory
The Agency has been working with the Spray Drift Task Force, EPA
Regional Offices and State Lead Agencies for pesticide regulation to develop the
best spray drift management practices. The Agency is now requiring interim
measures that must be placed on product labels/labeling as specified in Section
V. Once the Spray Drift Task Force completes their studies, submits data, and
the Agency evaluation is completed, there may be further refinements in spray
drift management practices.
86
-------
9. Ground Water and Surface Water Advisories
Because picloram has been shown to be exceptionally mobile and
persistent the Agency is requiring ground and surface water advisories.
To better refine the extent and nature of the ground water
contamination, the Agency has required a surveillance/monitoring program
Based on the data, the Agency may require further registrant action, including
prohibition in vunerable areas or possible cancellation.
See section V for labeling statements.
10. Phytotoxic Concerns
\
The Agency is very concerned about the phytotoxicity effects of '
picloram. As an indication of potential for mitigation of phytotoxic effects by
use reduction, one can estimate the maximum use rate that would correspond to
an environmental concentration not exceeding the level of concern The
reciprocal of the risk quotients (i.e. 1/RQ) gives ^fraction of the current use
rate that would result in an EEC equal to the LOG. For example, if the risk
quotient is 2, then a halving of the application rate would result in an EEC
equal to the LOG. Results of such calculations, based on RQ values in tables
found in section 3, vary according to product and application procedure, but
uniformly indicate that application rates less than 1 % of current rates would be
required, for the EECs to not exceed the LOCs.
Currently,- most of the picloram products can be applied at any season
and there are no limitations or restrictions on the maximum number of
treatments per season. The maximum rates per application are also unclear for
some products.
Products containing picloram are on occasion transported from where
they are applied so that crops and other nontarget plants are damaged
unintentionally. Not withstanding these serious phytotoxic concerns, the
Agency believes that sufficient measures are in place such that all the uses for
picloram are eligible for reregistration. These measures include a)
implementation of risk reduction measures; b) monitoring programs and current
state regulation of picloram c) a cursory benefits analysis and; d) the tightly
controlled product distribution system that has been put in place by the sole
producer, DowElanco.
a. Risk Reduction Measures
• The Agency is requiring lower application rates and limits on the
number and frequency of applications for all use patterns:
87
-------
o the broadcast rate for range and pasture use will be lowered from the
current maximum of 2.0 Ib. ae/A to 0.5 ae/A for control of broadleaf
weeds and woody plants. For the control of noxious weeds, a broadcast
application of up to 1.0 Ib. ae/A may be used annually. Spot treatment
will be lowered to a maximum of 1.0 Ib. ae/A with no more than 50%
of an acre being treated. Spot treatments and broadcast treatments can
be applied during the same growing season only if the total amount
applied does not exceed 1.0 Ib. ae/A per annual growing season. The
range and pasture use accounts for over 85% of picloram's use.
o the forestry use rate will be lowered from a maximum of 2.2 Ibs.
ae/A to 1.0 Ib. ae/A for spot and broadcast treatment. Use will be •
allowed only once every 2 years. There is no interval currently listed on
the label.
o the rights-of-Ways use rate will be lowered from a maximum of 2.2
Ib ae/A to 1 Ib ae/A annually. There is no interval currently listed on
the label.
• Finally picloram will remain classified for restricted use and may be
identified as a candidate for the State Management Plan.
b. Monitoring and Oither Programs
• Through negotiations with the Agency the registrant has committed to
a state ground water monitoring/surveillance plan. The plan will be
based on modeling which will be completed by 6-30-95. Parameters of
the monitoring/surveillance program (e.g. location, duration, etc.) will
be defined based on the results of the modeling effort. The results of the
monitoring/surveillance program, will determine if additional data (e.g.
prospective study) may be required or if other appropriate regulatory
action is necessary.
• Additionally, through negotiations with the Agency, the registrant has
committed to provide financial support to the Heritage programs for the
six states with the highest usage of picloram. These six states cover
75% of all picloram usage in pounds and most geographic/climatic
conditions. State Heritage programs are responsible for mapping and
monitoring sensitive habitat in 48 states. A geographical information
system (GIS) will be developed that will relate sensitive habitat to land
use and land characteristics. The registrants financial support of the
State Heritage programs will greatly facilitate and speed the mapping
and implementation of the Endangered Species Task force efforts. This
program will enhance the capability of the states to identify sensitive
habitat, based on the presence of endangered species and other
considerations. Ultimately, this approach will help secure protection for
sensitve habitats/endangered species while providing state and federal
88
-------
agencies with the critical information needed to identify any further
mitigation measures should picloram use be found to effect any sensitive
habitat/endangered species.
• Although these measures will reduce risks, the remaining potential
risk to nontarget plants and the potential for ground water contamination
are still expected to be high.
• The Agency has also consulted with State Lead Agencies in States
with high picloram use (TX, OK, KS, MT, ND, NE5 WY, SD and
WA). Most of the states responded and identified picloram as an
important weed control chemical. States believe they have programs in
place to adequately deal with phytotoxicity. The States responses were
also useful in establishing acceptable modifications of reduced
application rates and treatment frequencies.
c. Benefits
The Agency has done a cursory benefits analysis for picloram
and found that it is an extremely effective herbicide at relatively low
rates. It also controls a wide spectrum of unwanted broadleaf and brush
species without causing injury to grass.
Some alternatives for picloram are 2,4-D, triclopyr, dicamba,
clopyralid and tebuthiuron. However, it should be noted that in order to
achieve the same spectrum of control as picloram, especially for weed
control in rangeland and pasture, a combination of 2,4-D and some other
herbicide (e.g. triciopyr or dicamba) would probably have to be. used.
The Agency has not completed its evaluation of the carcinogenic
potential of 2,4-D. New chronic studies for 2,4-D are due to the
Agency hi the spring of 1995. Therefore, the Agency would be
concerned about restricting picloram use in favor of 2,4-D at this time.
Picloram. alternatives will generally have to be used at higher rates to
achieve control. Additionally, picloram is the only effective herbicide
that can control pricklypear cactus, a significant economic pest in range
and pastureland.
d. DowElanco's Stewardship
DowElanco has instituted a strict product distribution system.
There are only 53 companies that DowElanco aUows to distribute
picloram. Of the 53 companies, 19 companies account for 90% of the
total sales in the U.S.. All 53 companies and their employees must
attend DowElanco training program(s) annually in order to continue to
89
-------
sell picloram. Additionally, every company has a contractual obligation
to represent strict DowElanco product stewardship or otherwise lose
their privilege to sell picloram. This limited distribution approach
allows consistent product stewardship and enables Dow to effect use
recommendations/changes immediately throughout the U.S.
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 picloram acid and
its derivatives for the above eligible uses has been reviewed and determined to
be substantially complete. The following generic data will be required on a
confirmatory basis:
• For Triisopropanolamine Picloram
Guideline 72-3(d), Toxicity to marine/estuarine fish (TEP)
Guideline 72-4(a), Early life stage - fish
Guideline 123-l(a), Seed germination/emergence
Guideline 123-l(b), Vegetative vigor
Guideline 123-2, Aquatic plant growth (marine diatom)
• For Isooctyl Picloram
Guideline 72-l(b), Bluegill, Acute LC50 (TEP)
Guideline 72-l(d), Rainbow, Acute LC50 (TEP)
Guideline 72-2(b), Invertebrate toxicity (Daphina magna)
Guideline 72-3(d), Toxicity to marine/estuarine fish (TEP)
Guideline 72-3 (e), Toxicity to marine/estuarine mollusk (TEP)
Guideline 72-3(f), Toxicity to marine/estuarine shrimp (TEP)
Guideline 72-4(a), Early life stage - fish
Guideline 123-l(a), Seed germination/emergence
Guideline 123-l(b), Vegetative vigor
Guideline 123-2, Aquatic plant growth (diatoms, algae)
• For Potassium Picloram .
Guideline 72-3(d), Toxicity to marine/estuarine fish (TEP)
Guideline 123-l(a), Seed germination/emergence
Guideline 123-l(b), Vegetative Vigor
Guideline 123-2, Aquatic plant growth (marine diatom)
90
-------
• Mixer/Loader/Applicator Exposure Monitoring
Guideline 231* Estimation of Dermal Exposure at Outdoor Sites for
mixer/loaders and applicators using the hand cannon equipment.
Guideline 232, Estimation of Inhalation Exposure at Outdoor Sites
for mixer/loaders and applicators using the hand cannon equipment.
Guideline 231, Estimation of Dermal Exposure at Outdoor Sites for
mixer/loaders and applicators using the backpack/knapsack
equipment.
Guideline 232, Estimation of Inhalation Exposure at Outdoor Sites
for mixer/loaders and applicators using the backpack/knapsack .
equipment.
• Ground Water/Surveillance Monitoring
Through negotiations with the Agency the registrant has committed to a
state ground water monitoring/surveillance plan. The plan will be based on
modeling which will be completed by 6-30-95. Parameters of the
monitoring/surveillance program (e.g. location, duration, etc.) will be defined
based on the results of the modeling effort and in cooperation with the States.
The results of the monitoring/surveillance program, will determine if additional
data (e.g. prospective study) may be required or if other appropriate regulatory
action is necessary.
• State Heritage Programs for Endangered Species
Through negotiations with the Agency, the registrant has committed to
provide financial support to the Heritage programs for the six states with the
highest usage of picloram. These six states cover 75% of all picloram usage in
pounds and most geography/climatic conditions. State Heritage programs are
responsible for mapping and monitoring sensitive habitat/endangered species in
48 states. A geographical information system (GIS) will be developed that will
relate sensitive habitat to land use and land characteristics. The registrants
financial support of the State Heritage programs wiU greatly facilitate and help
speed up the mapping and implementation of the Endangered Species Task
Force efforts. Ultimately, this approach will help secure protection for sensitve
habitats/endangered species while providing state and federal agencies with the
critical information needed to identify any further mitigation measures should
picloram use be found to affect any sensitive habitat/endangered species.
2. Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing use
product (MP) labeling must be revised to comply with all current EPA
91
-------
regulations, PR Notices and applicable policies. The MP labeling must bear the
following statement under Directions For Use:
"Only for formulation into an
[fill blank with Insecticide,
Herbicide or the applicable term which describes the type of pesticide uses(s)]
for the following uses(s): (fill blank only with those uses that are
being supported by MP registrant),"
An MP registrant may, at his/her discretion, add one of the following
statements to an MP label under "Directions for Use" to permit the
reformulation of the product for a specific use or all additional uses supported
by a formulator or user group:
(a) "This product may be used to formulate products for specific
use(s) not listed on the MP label if the formulator, user group, or
grower has complied with U.S. EPA submission requirements
regarding the support of such uses(s)."
(b) "This product may be used to formulate products for any
additional use(s) not listed on the MP label if the formulator,
user group, or grower has complied with U.S. EPA submission
requirements regarding the support of such uses(s)."
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility
has been made. The product specific data requirements are listed in Appendix
G, the Product Specific Data Call-in Notice.
Registrants must review previous data submissions to ensure that they
meet current EPA acceptance criteria (Appendix F; Attachment E) and if not, .
commit to conduct new studies. If a registrant believes that previously
submitted data meet current testing standards, then study MRID numbers should
be cited according to the instructions in the Requirement Status and Registrants
Response Form provided for each product.
92
-------
2. Labeling Requirements for End-Use Products
a. Reduced Use Rates and Increased Intervals
• Labels must be amended to reflect the following changes in maximum
application rates and treatment intervals:
o the broadcast rate for range and pasture use is lowered from
the current maximum of 2.0 Ib. to 0.5 ae/A for control of
broadleaf weeds and woody plants. For the control of noxious
weeds, a broadcast application of up to 1.0 Ib. ae/A may be used
annually. Spot treatment will be lowered to a maximum of 1.0
Ib. ae/A with no more than 50% of an acre being treated. Spot
treatments and broadcast treatments can be applied during the
same growing season only if the total amount applied does not
exceed 1.0 ae/A per annual growing season.
o the forestry use rate is lowered from a maximum of 2.2 Ib. 's
ae/A to 1.0 Ib. ae/A for spot and broadcast treatment; Use is
allowed only once every 2 years.
o the rights-of-ways use rate is lowered from a maximum of 2.2
Ib. ae/A to 1 Ib. ae/A annually.
b. Other Labeling Requirements
The Agency is requiring the following labeling statements to be
located on all end-use products containing picloram:
• Personal Protective Equipment for Handlers (mixers, loaders,
applicators, etc.) :
The minimum (baseline) handler personal protective equipment (PPE)
for all WPS and nonWPS uses of picloram end-use products is chemical-
resistant gloves. The remaining PPE for handlers is to be based on the
toxicity of the end-use product. See PR Notice 93-7 or more recent
Agency guidance for instructions on establishing PPE for occupational
handlers.
• Entry Restrictions for Occupational-Use Products (WPS uses):
The Agency is establishing a 12-hour restricted-entry interval (REI).
Personal protective equipment required for WPS-permitted early entry
into treated areas that involves contact with anything that has been
• treated, such as plants, soil, or water is: coveralls, chemical-resistant
gloves, socks, and shoes.
93
-------
• Entry Restrictions for Occupational-Use Products (NonWPS
Uses):
For nonWPS uses of picloram the Agency is requiring the following:
"Do not enter or allow others to enter the treated area until sprays have
dried."
The following statements are required on all picloram end-use
product labeling:
Application Restrictions:
"Do not apply this product in a way that will contact workers or other
persons, either directly or through drift. Only protected handlers may
be in the area during application."
Engineering Controls:
"When handlers use closed systems, enclosed cabs, or aircraft in a
manner that meets the requirements listed in the WPS (40 CFR
170.240(d)(4-6)), the handler PPE requirements may be reduced or
modified as specified in the WPS."
User Safety Requirements:
"Follow manufacturer's instructions for cleaning/maintaining PPE. If
no such instructions exist for washables, use detergent and hot water.
Keep and wash PPE separately from other laundry."
User Safety Recommendations:
"Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet."
"Users should remove clothing immediately if pesticide gets inside.
Then wash thoroughly and put on clean clothing."
"Users should remove PPE immediately after handling this product.
Wash the outside of gloves before removing. As soon as possible, wash
thoroughly and change into clean clothing."
In addition, because picloram potassium salt, picloram isooctyl
ester, and picloram triisopropanolamine salt are classified as skin
sensitizers, the following statement is required in the "Hazards to
Humans (and Domestic Animals)" section of the Precautionary
Statements on the labeling of all end-use products containing picloram in
those forms:
94
-------
"Prolonged or frequent repeated skin contact may cause allergic
reactions in some individuals."
Type of Respirator: If the acute inhalation toxicity of the end-use
product is in category I or II, a respirator is required for pesticide
handlers. The following type of respirator is appropriate to mitigate
picloram inhalation concerns:
"A dust/mist filtering respirator (MSHA/MOSH approval number prefix
TC-21C).". F
c. Spray Drift Labelling
The following language must be placed on each product label that
can be applied aerially:
Avoiding spray drift at the application site is the responsibility of the
applicator. The interaction of many equipment-and-weather-related
factors determine the potential for spray drift. The applicator and the
grower are responsible for considering all these factors when making
decisions.
The following drift management requirements must be followed to avoid
off-target drift movement from aerial applications to agricultural field
crops. These requirements do not apply to forestry applications, public
health uses or to applications using dry formulations.
1. The distance of the outer most nozzles on the boom must not
exceed 3/4 the length of the wingspan or rotor.
2. Nozzles must always point backward parallel with the air stream
and never be pointed downwards more than 45 degrees.
Where states have more stringent regulations, they should be observed.
The applicator should be familiar with and take into account the
information covered in the Aerial Drift Reduction Advisory.
The following aerial drift reduction advisory information must be
contained in the product labeling;
[This section is advisory in nature and does not supersede the mandatory
label requirements.]
95
-------
INFORMATION ON DROPLET SIZE
The most effective way to reduce drift potential is to apply large
droplets. The best drift management strategy is to apply the largest
droplets that provide sufficient coverage and control. Applying larger
droplets reduces drift potential, but will not prevent drift if applications
are made improperly, or under unfavorable environmental conditions
(see Wind, Temperature and Humidity, and Temperature Inversions).
CONTROLLING DROPLET SIZE
• Volume - Use high flow rate nozzles to apply the highest
practical spray volume. Nozzles with higher rated flows produce larger
droplets.
• Pressure - Do not exceed the nozzle manufacturer's
recommended pressures. For many nozzle types lower pressure
produces larger droplets. When higher flow rates are needed, use
higher flow rate nozzles instead of increasing pressure.
• Number of nozzles - Use the minimum number of nozzles that
provide uniform coverage.
• Nozzle Orientation - Orienting nozzles so that the spray is
released parallel to the airstream produced larger droplets than other
orientations and is the recommended practice. Significant deflection
from horizontal will reduce droplet size and increase drift potential.
• Nozzle Type - Use a nozzle type that is designed for the intended
application. With most nozzle types, narrower spray angles produce
larger droplets. Consider using low-drift nozzles. Solid stream nozzles
oriented straight back produce the largest droplets and the lowest drift.
BOOM LENGTH
For some use patterns, reducing the effective boom length to less than
3/4 of the wingspan or rotor length may further reduce drift without
reducing swath width.
APPLICATION HEIGHT
Applications should not be made at a height greater than 10 feet above
the top of the largest plants unless a greater height is required for
96
-------
aircraft safety. Making applications at the lowest height that is safe
reduces exposure of droplets to evaporation and wind.
SWATH ADJUSTMENT
When applications are made with a crosswind, the swath will be
displaced downward. Therefore, on the up and downwind edges of the
field, the applicator must compensate for this displacement by adjusting
the path of the aircraft upwind. Swath adjustment distance should
increase, with increasing drift potential (higher wind, smaller drops
etc.) * '
WIND
Drift potential is lowest between wind speeds of 2-10 mph. However,
many factors, including droplet size and equipment type determine drift
potential at any given speed. Application should be avoided below 2
mph due to variable wind direction and high inversion potential.
NOTE: Local terrain can influence wind patterns. Every applicator
should be familiar with local wind patterns and how they affect spray
drift.
TEMPERATURE AND HUMIDITY
When making applications in low relative humidity, set up equipment to
produce larger droplets to compensate for evaporation. Droplet
evaporation is most severe when conditions are both hot and dry.
TEMPERATURE INVERSIONS
Applications should not occur during a temperature inversion because
drift potential is high. Temperature inversions restrict vertical air
mixing, which causes small suspended droplets to remain in a
concentrated cloud. This cloud can move in unpredictable directions due
to the light variable winds common during inversions. Temperature
inversions are characterized by increasing temperatures with altitude and
are common on nights with limited cloud cover and light to no wind.
They begin to form as the sun sets and often continue into the morning.
Their presence can be indicated by ground fog; however, if fog is not
present, inversions can also be identified by the movement of the smoke
from a ground source or an aircraft smoke generator. Smoke that layers
and moves laterally in a concentrated cloud (under low wind conditions)
97
-------
indicates an inversion, while smoke that moves upward and rapidly
dissipates indicates good vertical air mixing.
SENSITIVE AREAS
The pesticide should only be applied when the potential for drift to
adjacent sensitive areas (e.g. residential areas, bodies of water, known
habitat for threatened or endangered species, non-target crops) is
minimal (e.g. when wind is blowing away form the sensitive areas).
d.
Ground Water Statements
The following ground water advisory language must be placed on all
picloram labels:
"This chemical is known to leach through soil into ground water
under certain conditions as a result of agricultural use. Use of
this chemical in areas where soils are permeable, particularly
where the water table is shallow, may result in ground-water
contamination."
e.
Surface Water Statements
The following surface water advisory language must be placed on all
picloram labels:
"This chemical can contaminate surface water through spray
drift. Under some conditions, picloram may also have a high
potential for runoff into surface water (primarily via dissolution
in runoff water), for several months post-application. These
include poorly draining or wet soils with readily visible slopes
toward adjacent surface waters, frequently flooded areas, areas
over-laying extremely shallow ground water, areas with in-field
canals or ditches that drain to surface water, areas not separated
from adjacent surface waters with vegetated filter strips, and
areas over-laying tile drainage systems that drain to surface
water."
f. Phytotoxicity Statements
The following phytotoxicity advisory language must be placed on
all picloram labels:
98
-------
"This pesticide is toxic to some plants at very low
concentrations. Non-target plants may be adversely
affected if pesticide is allowed to drift from areas of
application."
Precautionary hazard labelling should include the following based
on PR Notice 93-3,
"Do not apply this product to water, or to areas where
surface water is present, or to intertidal areas below the
mean high water mark."
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 picloram
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..
99
-------
-------
cc
w
U
HH
Q
-------
-------
o
•>r—i
+4
OS
2
0)
o
•*•>
|
f
05
3
Q
1
cn
o
-------
-------
•—-co ^- r
tH ^— rH -
O CTl O C
JJ If)
' £•§
Ed -
U O
io go
UK UK CJ tC
Ed
g
r~l g
r-I O
as O
w P
CD Q
-SS
o s
fi f
aa
O E<
k H
HI W
•H 0
US
"§
r-4 ril
*g
•H
P) W
l~~' Q
CN E
0
O rtj
o
CO
U Z
•H «<
e tc
S o
w
si
M CU
U
•H a
CM 0
*— ' H
E-J
vo~ 2
Io"
JJ £? CO >i
W JJ JJ is
co c a -d
as Ed M ' — '
> ~
• i-t Ul
c; a) >
S c: §
i— t - — •
M M
^ >i
Q) 0 GJ
w a cn
0 -H
Q 01 £
03 JH Oj Q>
• (D (D O rH
(d d J-> 0 >1
S 3 0 <- 0
cn a) ^
QjJ (d
Q (0 0)
* PI
CU O "H
j< Q] £ 5
• tO W fl)
X EC W ,C
td Q) -U
S rH 0
C
3
c •
rH Q) Q)
Qj M 4-> 0)
Oj ti 0
H
rH
<^f (d
-H
— rQ
G | >, 0
O rH iH
H c! 0
JJ JJ O -H
to c e
U Q) rH -iH
H g cd jj
rH a-H C
Qi-H ,Q <
Oj D O ~—
< O1 S-l
W 0 ^ ;:«:
*• -rH O ;£&;
p< O -H 0 ;U3ij
r1 JJ C b4 :w::
g 0 — Di jSj
H rH OJ --H ^ : W
xJ Qj a, 0 jg|: b3
O , 1^: Q
^
3^
o o
OS S
< 2-
<:B
z
z
CO
Z
Q
•y co
63
<*i
•& co
S3
K
^ CO
<, z
&
I *
VJ
***
v*s>
W —
ja £]
' ^
•* ' '
*£ -Q
IT)
-
^ ^
_^
, S
J
S
_.
^c
Jj
(d
B
M
-H
<
-
n-' In
Broadcast., Folia
s
3g
o o
os a
<2
z
CO
2
CO
Z
Z
CO
2
CO
Z
*
^ *
<
• •
rQ
LO
2
..
^
0
CO
Ground .
>
^
Broadcast., Folia
-
5g
o o
as a
3%
*
z
CO
2
:Sjl-
co ^i
2 |$:
i^ii
i^i:
S :t#:
"§
CO €H
2
* f
55
"^
— $
Hd p
<
*~" ,.
J2 ^
tn 'J
*°
,.
^ "*
^ V,
" , -
^
CO *
-,
CD
a 4
(0 %
•H \,
S
"oT ••
jj ^
3
is
High volume spray
volume ground.
3^
o o
03 S
< Z
3%
Z
CO
CO
CO
CO
2
CO
*
^
Ed"
S.
a
"I •
<
Z
~^
o
CO
Aircraft
~
.^
Broadcast., Folia:
SB
U O
§s
^g
3
CO
2
i
i
CO
2
Z
-
*3j
I
J2
*".
Z
^
O
CO
Ground .
~
ij
Broadcast., Folia:
as
CJ O
^ S
J CO
SSSIS
CQ CO CO
Z Z Z
CO CO CO
Z Z Z
W CO CO
CO CO CO
Z Z . Z
fco CO fi5 CO
as I-
2 2 ^'2
81 S-
w * * J3- -jc
W °
•MJ wj
rtj fdj *• o
>a £f £? ^3.
^ ^ — ' <.
. ,£, jq .Q -^
oa CN
'^ tH *H
*" t*
,", /
g g ' g
%
iJ »-3 J-
^ CO CO "* " CC
i^
itt;1 o o iSr -H x!
:
i-3iet;cj>< JrfOX
-------
§«l
= 38
Id
g
g
!Si£
SS&
S Ctl
i n
!R
S B
n
g ,
2
I
I
TJ
0)
0)
C
I
W Q t
Q S I
«; o s f
8&
§§
•H -H
4J JJ
O O
01 (U
•n-n
C C
<
sr
<
S
o
-------
I
Cd
S
63
g
61
g
61
g
•*-*" §
•H U
(tf O
10 Q
CD Q
•SS
nj ra
rH W
O EE
ftg
O E<
O
01 W
•H 0
•H Z
^ §
ro o
k *C
U H
-H
CM H
' — ' Q
CM E
0
0 S
o
(Q
t-1 W
us 3
0) O
CJ Q
?ei
}•< O
0 PS
IS
•— ' H
uTg
0 OJ
0 W
o
TO S
o 2
os
1 0 •
< «
x «
H H
O 0
2 M
a J
ft W
, 5 ~
J-) J~l QJ >i
W JJ jj tO
,
>" C
U-) o
61
^j n]
C 1 'S 0
O rH t(
H CO
aJ aJ o ^-i
Application Type, Applica
ming, Application Equipmen
rface Type (Antimicrobial i
Influencing Factor (Antim
FOOD/NON-FEED (con't)
a -H 3 >, a; T
s^e
61 Q CJ
Q B W
0? rf M <:
< J O >
J < U >^
*3. O 2 r^
Co
2
lu
S 2
•^i
I s
•CJ
:•_.
•hj 2
O
^
B
en 2
w
&q
1. §
1 *
i s
'
f
,
?
•C)
B g
^
S OS
tn
^i
•^
S (3
1 ^
^
L treatment.. When needed.,
c stream type applicator) .
^ rH 0>
1 -as
IS 6, O
£ i g gig
Ed" a" eT td" Q o"
Q S CO Q E; CO
«:<&?<; ai <" fcd" <
Sggg
CO
2
g
g
W
CO
2
CO
*
B
<:
1
4S
W
2
X!
JJ
C!
-rH
tf
e treatment., When needed.
rH
B
^ig
61 Q O
Q B CO
S S a e"3
CO
s
g
CO
2
g
CO
2
CO
2
*
B
rf
g
OS
JJ
"1
CO
e- treatment., When needed.
e.
rH rH
•O JJ
i-l JJ
-H O
O A
CO
2
g
g
CO
g
2
*
<
g
^
i-H
CO
0
TH
<
2
^
x:
en
•H
a:
-H
tH
£
S
3
-H
tJ
&
g, -
W 'O
0) §
g o
3 i-)
i-H Ol
O
> 0)
tTlrH
s3Sg
Q E W
g .
4.ggg
CO
2
CO
2
.g
CO
§
W
2
*
g
<
2
1 •
jJ
1
treatment . , When needed . ,
&
w
J ra z
Cu B P
H Q O
Q S co
CZ f£ i£ <
«; >3 o i>
J ^ u *:
< 0 2 S
CO
2
g
i
CO
g
CO
2 •
*
B
«:
&•
1
^
T3
Q)
-------
a-
g
1
f3
rH
U
rH
(0
1
S
E
•d
&>
13
rH
U
u
!
M
5
n
e
t-t
Ol
G
a
a
S
1
1
r~i
c
*-l
OT
U
O
&
n
o
V3
m.
C
••
w
n
*c
3
S O
Sol
CQ '
«<
g •
II
application to a single site. System calculated.
.-(
tn
c
f4
W
a
o
&
BI
0
•o
E:
X
2
••
tt
c
3
e» 0
o •
1|
1*
application to a single site as related to soil texture (Herbicide claims only) .
tions at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per :
/3 yr"
a* nj •<*
"tn-H *
Cr-< M
-« a a
n a
««g
2 u S
0) D,
W E O
n
.rt
^ ^ Ij
x x 3
Is >,
•* •*
s
es
S01 K
«2
•2>ic3
u S n
2 .0;
f |«
Ibl;
1
(3
«H
8
1
1
1
8
rH
C,
0
o>
1
OT
1
01
-H
S
T3
0)
-H
§•
0
£
X
&
"
W
M
"aT
M tn
Q)
Q) A
OT JJ
S°
sl
Applications (days)
(days)
s§
o) ij
5 V
ffl C
A 1-1
> JJ
t CU
ffl CU
S < o
>< l«
(OC O w « 3 M
n3 H tn 1 H -H OJ Q)
p •
c m
M
CM H
W
,_(
u a
w E^
O E-<
>^ o
S Z
it. 0
N CODES
LIQUID-RE
SOLUBLE 0
o
5l
05 S ^
£ OS W
iJ
(D
g.
•H
5
.W
O
o
rH
JQ
'in'
c
o
•H
AJ
S
V)
AJ
. -H
cu < tn c
2: OT o ,0 G
f.. ,,
•S
ct:
CQ
m s < OQ o
(< << 2 2; D
le, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part,
sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, --
a w
rd a
U £
S^
tO rH
•H -H
c.a
.
OT cn
J-t AJ
3 fl)
ja rH
rH
* 0)
tn a
Q) ^
3 M
CT AJ
SE
n
o
o
o
5
jj
§
•H
CD
OT
O
Ed
•"3"
i-l
8
(C
AJ
cn
c
-rH
T3 *H
CD O
AJ CD 1-1
td *U
rH (d AJ Q)
O Oi 3 ">?
rH O> -H rH X
O) (d >1 >1 01
O
Q O Q) Q) &
S -.H AJ AJ CO 0
C ftJ rH rH 01 —
flj rH 3 3 S
U 3 O O OT
CJ rH rH 13 0)
O
g," o
U rH X
3rd X
O O 1
Cu 2; AJ Ed
CU CJ O 3= C
< Q S S > 0 C
em.
ps, bogs, marshes, and potholes) .
u g
>t S
OT tfl
G
O M
(d td
Cn rH
•rH ' AJ
iH (D
JH 3
•H
M
iw o
0) 01
a -^
s _ §
>in3 O
C 0) JJ
(0 AJ
•§33
3 T5 U
o c i-H >
CJ rH rH rH
a a a
M S a a
S td t3 fd
rH AJ 0) AJ
E^ O ^ 0
Is Is
t-5 " " "
Ed vo co Ed
W -* in .<
D O U O
UNITS {HOURS, DAYS, ETC.) DESCRIBED IN THE LIMITATION.
S
M
CU
Ed
f> E^
M S
OI Cd
SI
c «
•H
S'u
tl CO
BlU
ui KO;
^* &4
^
•b HI
m
sz
u *
G C
•H --H
•rH i-H i-H
w a o o o
Q OTQ) crO"H(C-rH(dnJQ) rd
OidfdMtdtdfdGWOttgUcn -H
O£coidfO-'H"H(dOT o>o n c
UJ2g(OM^-H>iOTAJnJAJCtOt7l
|s^£G!8Srl«d£S€SI!S^
Issgggasasggagisg
-------
S
Q
8
M
K
g
W
g
|
S
— H
P
0) g
O M
tn 2
o •
e Q
i jq •~-~
1 SS2
• J-i ^co"
.5 i!) S1
M *—
M ^
w TJ i< Q)
' — QJ ^ >i
o) o "oT
tn c tn
O -H
in i-j p! f]i
• Q) QJ O iH
(0 C 4-) 0 >t
S 3 0 ^ 0
W 0) M
a-tJ to
a nJ Q)
x a CP '
• ^ O .H
^Q.^11
^ • . Q)
-H X X W
- W TJ ~-~
a o -H
< ty c s
JJ M
• ffl CO 0)
S iH O
(
c
I-H QJ ai
< S. § "s
M
• Q) M Q)
rj JJ r/i r;
H (d 0) OJ
a cd i-i o
"w
3
s is
"-" C
t-i O
r— )
uj td
— »!Q
SITE Application Type, Applicatior
Timing/ Application Equipment -
Surface Type (Antimicrobial onl^
cy Influencing Factor (Antimicrc
NON-FOOD/NON-FEED
CO
2
CO
CO
CO
• 2
CO
••'" S
X
\f
•"
^
<•
/ g
tj
^ "
X
••''
J
^ c
•* Q)
Basal bark and soil treatment., Wh
needed . , Backpack sprayer .
CO
CO
2
§
g
CO
2
g
^
S
^
o
CO
c
0)
Basal bark and soil treatment., Wh
needed., Knapsack sprayer.
i
i.
s
g
CO
2
g
u
g
^
s
g
Basal bark and soil treatment., Wh<
needed . , Power sprayer .
§
CO
2
W
2
i
g
CO
2
B
^
vJ
^x.
O
CO
Basal bark treatment.. Not on labe!
Backpack sprayer.
2§ggg iggggg
S^.sg'g giSigg
S-s.ggg^gggggg1
^
s^
&
SSg.S'g|gggggg
0
g
§gggglgggi-g
2§§iifg-gg§§§
= SSBs!gggg. BB
p.
^^
s
/
HJ.
s s g g g';g g g • g g g .
^^^^^''^^jjjj
«-««^,;;^^^.c?gg
;
•^ "~
®
& 13:
Q 0
i-3 O4 ••
^::-~^ccc~"~
1 1 1 1 1 ^ ^ S 1 1 I I
s i i i s : j .j j f : 1
^ 1 1 1 1 *r L L 1 I ° g
•3 S 3 S 3^ ^ nJtytOQJnj 2 2 S
^ ti £ ^ ^ S^a^a^^-J u oj
1 1 § | |aHwsm^Si § g
ini i !i I Hill; fi Si Si
^ Q, •" k ^ s a >, i s g-g § & §i 52 as as
« « « 1! k 1 I' I' 1} i| 1| I|
1! i! i! i! i! i If i! !! if I! if
-------
= 11
3 C*O
el £ D* ©
.§«_
fcwSS
n
!&
« W W W
M
td o
J-4 Ed M
i> J^ JJ
W O
X W
id -
i) >«
I
td
!
tl ffl
OJ H
H - ra-
ja • ft •
-------
0> H 13
W -H O
D JO
w o
S3
OS W ,C
0> JJ
S rH 0
o> w ai
C J-> M &
•H [0 CU JJ
S CirH O
jj i-j
i
(d
jj ^
^&
s^
ja o
a
r-i a
10 X
in o
S ^ B « B
rea
ayer
cn u
i« cd
00 CQ
(0 ,
M ftf
4J M
,&
' rO ^
^S
^H W
10 C
oa as
Jg 01 B
--i
« 3
i-l >i
fd 10
Ul M
« a
m w
-------
I
r-t
C
O
1
"3
a
•^
1
o
S
•a
JJ
13
r-l
3
r-t
S
§
XI
61
W
9
°
M
O.H
•o
"o "u
-1 O
A 0
01
S ti
-SL
Li M
SS
x-<
*«
ft r-t
§a
0i
s^
TJ *
£5
BJ.-4
rH ft
e e
o &
MS
(!)
rH fll
«»t W
«g
3|
0 M
JJ
8JJ
IS
r-l 01
a§
(0 «^
O (3
r-t O
cn*H
CrH
•rl ft
a &
U-l
s°
fl) .5
o p
1 1
0 B
ss
e
r-l d
M U
< sn ^
— * — »O (3
2 S S .s
-t a~t X i
o
u
ft
tS
CD — •
r-t W
C (3
Rj 01
G
0) 4J
O RJ •-*
* O W
>ȣ ^^
• C «
SO) >
G) U
0) "H Xt M
(/I rH
W ft rH >i
SQj. RJ M
O > JJ
X CJ Q) S
O W iJ
O C ^
0113 t-H O
•«-< JJ
« i 1^
S S -5 S
>*S s rt ^
m
5. *
(3 Cb
^1^« G §"o
§ r^ >JJ OC ft 01 g CO
Otsc o tn w 3 ti
r-tw-ai-i u*in-^a>(p
S-'g^^, &ioo'S-SjJ
Q) H JJ p
0 O C g
X JJ C W M
(00—40) O
SGSce; U^USCuO
M
..
o
o
I— 1
Xl
(/}
o
•H
tfl
JJ
M
JJ
•rl
G
o
•rH
JJ
(0
JJ
tn
JJ
'&
1
ft
JJ
•rH
(U
XI
JW
o
(—1
xt
JJ
•H
XI
"1
(p
rS
in
•rH
G
tn
'rH
o
i-H
o
tu
o
QJ
§
£
o
rH
CD
Xt
(0
t— 1
1
JS
CO
•a
3 • °
S 'S'o
k^ A (0
^, CO rH
ta rH
&« o
S C JJ
E O
:ON CODES
SOLUBLE CONCENT
?IONS
As Needed
Not Applicable
Not Specified (
Unconverted due
B S
S J u
OS ^-- CQ
o o to z < m c
•o ~
CO JJ
''d
w"
!S&
O H
(TJ JJ
ft
K QJ
OJ JJ
\jf_ Q)
S-3
D'l
%"
as!'
(TJ
^ JJ
01
O tji
rH (0
JJ
oT -
C tn
••H JJ
m o>
J-irH
rd
tii
(0 K
jj JJ
U Q)
(0 rH
0) X>
-.8
ft
o -
•Dtf
0) Q,
C *-t
Q) JJ
ft W
W
rH JJ
g w
•I-t -S
OS 0)
G nJ
0 JJ
O W
IH Q)
r-l -.-I
801
-. JJ"
rH Q)
•H Q>
8-S
Ul JJ
(U 0}
i?
r-l 0)
in en
- O
01 Q)
r-I W
tn -
ft en
Sft
E
SH
JJ rH
W rH
•H -H
G ft
U -
cn
cS
(d Q)
ty
jj
0
fO
rH
0
O
O
a
0
JJ
4J
G
CO
rH
ft
"3
0)
•r-t
•«*
O
CO
r*
8
U)
c
•H
o
s
o
g
&s
M
.s
M
1
Q
(H
U
Q
r— ,
B
a
w"
g
M
o:
8
M
ca
• s
M
EH
0
cc
Ed
g
£g
O -H (0 T3
ft rH (d J_J
o
(D
M
O
Q
s
M
J O
tu E
&j O
< Q
e .J- c=
<»53
.ago
S^^1
g
1
S
: No Calculation
: PPM calculated
: PPM Calculated
: Hundred Weight
: nn times (10 po
o
I-H
S
£*>
g
jj pa
1
eS
O CC
•rl CU
JJ W
ITATIONS CODES
roundwater restric
R IN PARENTHESES R
3
[d
S
O W
n Z
i-i
u *
-------
- m
•* m
12
S
Ed
S
O TH O ,H
O O U O
^EC ffi
[d - Cd ^
< — < —
o -* o -^
"H -
< ^
O •«*
CO g 13
01 -^ o
D J O
• !> in
SH >. l-t —-
^iiSi?
rSSSS
C 0)
-H JJ
s c •
-— 'O < Qj
« M
- Q) 01
x a, ai
• ItJ O rH
: a S o
! _ o >
O
g
s
:£B: co
I"
8 g
t* CO
2
1 ,
¥
in
$
v ^
-.^ J
"" to
'1
•i
, Aircraft.
1 g
/X i-H
£4 id
«
g jj
S w
:s3 (0
£> CJ
V 13
M (d
^ CQ
0
CO
2
CO
2
2
g
g
g
<
S
.0
tn
g
' J
*
13
C
I
, Low pressure
§
rH
rH
rt!
Broadcast
o
g
CO
2
CO
2
g
CO
2
to
2
Cd
XI
m
g
J
o
CO
, Aircraft.
j-i
•c
•H
rH
£
Broadcast
0
CO
2
g
CO
2
CO
2
g
g
<
<
ja
Ul
g
J
a
tJ
C
3
O
i-i
tn
, Low pressure
«
-H
rH
£
Broadcast
rH
O
CO
2
g
CO
2
CO
to
2
g
<
H
xi ,
in
c-a
<
j
o
CO
rest., Aircraft
jj
W
£
Broadcast
rH
0
CO
2
g
g
CO
•z.
g
CO
s
-1
g
x>
Lfl
(N
g
j
8
2
3
cn
LO
S
a
1
4J
cn
cu
(d
JH
jj
w
o
Cut
Broadcast
ground.
o
g
g
CO
•^
CO
2
CO
2
.g
<
J2
^
g
j
U
W
Uow., Sprayer.
£
jj
§
jj
O
S1
0
CO
2
g
g
CO
2
g
CO
2
D3
.Q
CM
rt '
,.1
8
Liar., Sprayer.
£
4J
C
o§
id
0)
M
JJ
jj
a
O
CO
CO
CO
2
g
g
CO
2
M
0
TH
g
ij
o
CO
M
1
stharvest., Spri
£
c
S
B
(d
2
JJ
jj
O
a
CO
r-i
0
CO
2
§
g
CO
2
2
CO
o
s
g
,T
C^
O
-H
3:
aent.f Foliar.,
(d
i-<
0)
a -
-H J-l
Wipe-on/w
applicato
g s « a
•^ 2 .3 2
td
.a
cra
roadca
I
-------
--
S ^? o 5*1 o ^
-
o ^
W - VD
<< ^- "31
CJ ^" D
3 - *O
!5T S
C5
B
a
o
S3
"a
c o >,
•^ -II t3
S C13
-31!
«
tx
' a w
I
V- JJ
-------
u •«* 5 5"
O 03 o u O 03
H -
<5 ,-.
O -<3l
Ed * Cd -
O ^ CJ ^
I
Cd M?"
S-^r.
u
u
S
•
g
S
R
D
g
S
• g
g
M
g
1
<
g
— M
jj p
rH H
en
"w to
SCD
w
U
£ Q
(d W
rH 5
7. o
bj p4
"gj
O H
0 5
o t<
rH °*
ttf C3
•H §
£ pfl
(U BJ
g«
¥.,
ro H
0 CO
o o
£«
VD (5
CTt
i!
APPENDIX A - C
ALL OP THESE USE
Date 08/04/94 - Time 09:53
Jin o
E rH
O rH
AJ tfl
(d -H
J-> Q
E
0
.c
a
IL
o cy
a S
o o
<
~°
• > M
IH >i SH ~
J-> in 0) S
M a-> aJ nj
0> C c •O
OS Cd M —
• M 7? .
C 0) >,
•H U ro
S C "0
h- 1 ' — '
"^C -^^ (0
" JJ "*" ^
< rH J3 M O
l§^^&
Ul 0) ^
a RJ CD
^ a QJ
• (0 O rH
i— 1 * - fl)
-H X « W
O 03 nj O
CO EH S Q
- IH -Cf ~
i— 1 CO JH
•H (0 tu jj
S Cd rH 0
"w"
i-I 1
O (fl . — •
tn 0 >,
s§
rH
<^f (0
o ' 5^
J-S AJ O -rH
?j G e
SITE Application Type, Applic
Timing, Application Equipme
Surface Type (Antimicrobial
cy Influencing Factor (Anti
wmmmfflmm
FOOD/FEED USES (con't)
M
X
g
g-
$
! §
%
^
«*, §
&•
>j
^
1 §
fs?
8* CQ
* B
f *
^ 0
I D
/
;>?
•. f
<
>-.
•• g
J
•^
~ K
f
$
> S
^' 3
. tn
J w
* I
Spot treatment., Foliar., Low
ground .
rH
TH
0
g
g
g
CO
2
g
g
*
«!
S
<
ja
rH
eg
£
J
\
O
CO
rH
R
r«
Spot treatment., Foliar., Spri
M
BB
03
2
g
g
i
g
CO
2
•X
B
g
rJ
^_
CJ
to
CD
S
iH
re
-H
Tree injection treatment., Fo!
injection equipment.
£
^
o
2 S
S o
g g
g g
g g
g g
g g
g g
* *
< 0
1
.a
rH
in
El g
J rJ
03 03
ti
a;
rH ii
•3 .S
as S
ti ij
(0 (0
Wipe-on/wiper treatment., Foli
Wipe-on/wiper treatment., Foli
applicator.
1
<•*.
£5
1
p-
S
rf
•K»
I
J^
^
a
»
^^>
f
Sf
J1"'
>
"$*
••>
<.•>•
* ->
i
•cH rH
O O
g 03
*z* **
03 01
2 2
O3 03
2 2
03 03
2 2
O3 CO
2 2
g g
* *
Ei] [x] J3 (a
' •?r'
rH rH %% ^H
^ _. tn LO r-t
J
'
2 S *" 3
•• J J trf j
^ *^« _5? "^
O U Q. O
co co Sr tn
"S. ^)
^S Cfl.
1 i s
Broadcast., Foliar., Aircraft.
Broadcast., Foliar., Ground.
Broadcast., When needed., Airc
^
iH
O
g g
2 g
g g
CO CO
CO CO
2 2
g g
* *
S? S?
rH rH
g g
rJ >J
^^ ^^
O CJ
CO CO
•a
a
o
a,
OJ ,
QJ
g
JJ
»
S
TJ
(0
!
TH
0
CO
g
CO
2
g
CO
2
g
*
5T
rQ
•1
^
O
w
0)
IH
pressu
Broadcast., When needed., Low-]
ground .
CO CO
g g
g g
g g
g g
03 03
2 2
* *
S? £j~
S <
.Q XI
rH rH
g ' g
O u
03 03
•O
OJ
•a n
Q) 0
a> ><
c 2
0) O?
High volume spray (dilute) . , Wl
High volume ground.
Spot treatment.. When needed.,
-------
§ 1
S S
Sr* «H T~*
' O O O
O O O • CS
Ii3 K) [d m Kl E!
S^ 8^" S^" S S^1 8
o w aw
S3
I
a o o
M c «
O —4
a « s
ao
o »-*
S p
>»—I i» (3
^5^
-< 3
t-» •. 0 «H
&wo»"
c « c
<-«„
SPS&
J
^^
o
•g
•a
s 2
CO CO
S(P
13 4J '
QJ -H -H
(1) -n-r-i
a a
•H fli
S 18
-------
Cn
ta
Cu
g
EH
u>
a
tn
_§
jj
cO
O
a
&
T
Inl
S
~ to
r-t TJ
O M
>i £ !-)
^-i -H a
d tox
O i-H CO
o
tn tn
e o -H
•^ t
>1 >i J-) to
w en x ^
tn ca o
•U JJ JJ CO O
•H -H -H JJ >,
tn tn tn to o
cS
CD CO QJ a
rH T-T ,-H OJ O
DJ Dl D) Dl 5-f
d d d to u
-H -H -H W
w tn , w o i
0 0 O 3 -H -§
jj jj jj g en — -
d d d X co tn
o o o 3 d
JJ JJ JJ Q) -rt
o u u to o 1o ~
•H -H -H = O W
r-Hi-Hr-HWS^CU.H^
a a ad >i-u ^ to
a a a o -H a'D
to fO fO -H r~t tn a ^^
cu co CD nJ ^P tfl r— i '
i— t i-i r-i O = d (
ooocoato^
•4-4 IW tM^McO >JJ
CD CO CDX1XCD COEi]
' cn tn tn s co tn -u
O O O D O d T3
'O Ti TJCW'O WQ)
•rH "Z)
s s ess so
I I il-.l I'd
c "3 -STJ'S^ c»
•/H 10 njioaiio -r* o)
S S S S >tS S « H
g
PS
w w _^
to1 tn tn -
0 CD >, AI •
l-j rH Q) (0 CU
§ •§ « n 3 <«
grH M „* S- > §2
O< < tn* rH << •— -J SO
w — * — ox d^tnco a)
§c,-Joj-5-Q^ 3^&^ gg-gl 2
S|.21o.|xe S.32M faiS5£5
Basoian — 3 >, idooffl-5jj
§ -S -3sa ~S5J1 gs^a^o
rfja-ua-uxfl; tnjJjJCt] x
aoaoco ood w
pi<; < £-*«: Q M* EH
O-CO-COrH- -CO-JJ J
I
-H ••
in t3 -
~ a'e
O m 3
o JJ ~
3 S &
43 £C tO
0 M
- tO JJ
— a
tn
'd -u JJ
O CO JJ
-H 24 CO
JJ U -H
JJ ii
•HO-
CO (0 CO
d co
O i-l -
•H 3 Cn
JJ rH (0
tO JJ
w oT -
•H (fl CD
CO
- .. Jj
X. tn
O tfl -
tO JJ JJ
a *-< CD
§r— i
.Q
-H ' CO
(0 - JJ
.M TJ (0
g ^
£ H .
xi CD a
0) -H
•H CO JJ
to a tn
XI 01
-•O i?
oJ o
•H x-H
CO J-i JJ
XI 0) W
d Cfl CO
O JJ
- u w
tn
jj - -
•H JH CD
d (0 ^
3 i— 1 -H
rH a
tn o tn
c u
O rH 0>
iH -H 0)
rH O .C
o o tn
14-1 01 Jj
o co en
en i-t
5s!
,C SH QJ
jj tfl tn
-H U
*• 0
S-) a) co
o »H tn
3
•» tn v
^- a tn
(DOE
XI D
(fl -. a
rH i-l
cu ••
C JJ rH
£ tn ,H
to in"
T3 - CD
Unconverted due to lack of
briquets, bursts, cake, can
parts/ pellets, piece, piec
g
•0
:ON RATE
Dosage Can Not be Calculate
No Calculation can be made
APPLICATI
DCNC :
No Calc ;
PPM calculated by weight
PPM Calculated by volume
Hundred Weight
jj
S t" O
j,
n
o
• o
o
s
Jj
§
rH
ffl
•H
&
CD
Ui
•H
_
O
1
&3
TH
= .
„
CD
U
3
tn
d
•H
(-1
0
4-1
JH
1
a
o
TH
Ul
0)
e
jj
d
d
I
ATIONS CODES
undwater restriction.
EH 0
s u
a o
§"
EH
EH
M
J
m
z
M
Q
ca
•H O
O W
_t-< [!]
JJ Q
a _
"Cf O
to w
w w
0> IM
•^ rf
i^ ^
S- 1
w tn
tn ^«
0
i! • W
- ^ . pH
>.§ S
W 0) >-i
O M Cu
-H >O O
to (0 as
Cn^n td
•H ^ m
n z
not apply through any type o
not apply directly to water c
day(s) pregrazing interval.
IN PARENTHESES REPRESENTS TH!
o o &.
o o a
m
~ " " §
^ m rt §
S o § *
C CODES
t of the Mississippi River
aii
GEOGRAPHI1
Oil : Wes
HI : Haw,
Mexico
ahoma
S rH
IS
-------
-------
APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
119
-------
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the ^registration for active
ingredients within the case 0096 covered by this Reregistration Eligibility Decision Document
It contains generic data requirements that apply to 0096 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 3V 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.
121
-------
-------
M
W
^
••H
fc
3
IH
5!
/—•>
O
0
S-
"3
E
03
s*
O
=
o
•1
Ui
•^n)
.52
*DJD
.
PM
0)
.s-
"3
. ^c
o
CO
03
"8
Q
II
§
o
1
IP
as
wi
S
H
P
O
K
: § o s s s s s
§ 3 3 § ^ 3 3
§ 8 § 8 § g 8
•g ^ ^ ^ -g ^ ^
*O • -o
&T ciT
0 U • .
^ii — * — < •— j —i — < —i
< < < «.* < <
cc
s
2 oa
j£j ,Qj
^ >> f 1 1 1 ts
aj .-S 2 -F '13 a 2
H -a * fi fl «*- 5
a 1 j * f 1 i
L^J ^^ ^^ «M L^ ^*
@ | 1 | | | 1
JTJ s *^ s s »s ^> t-i
8.a||!2B1'l
^UccfeCL,-U-«!3U
1
O ^ g
P^ i i i T* *"? *? *?
o-ivo\oSSSSS
SSS^gSgg
gg^z^^^^
s s § § § s §
"* "* •* Tf rf- Tfr T?
<<<<<<<<
+*
en
« g
1*3 S w
_S .a c w —
*^ O •« to H
2 «S <2 * | S
.§ s5 y> ^ 3 * •§
"S fe **3 -S *S »2 o o
I" 1 1 1 1 1 II
r?Tl
-------
O
w
CO
I
O
£
03
O
"3
o
.2
S-i
o
»n
en
oo
ON
«n
vo
en
oo
oo
i—<
VO
CM
o
o
oo
t-
o
ON
CM
vo
c-
o
ON
cs
o
o
en
oo
o
o
ON
ON
O
o
vo"
f-
o
ON
O
O
O
vo
0
o
•§
8
CO
a s
3 -S
••^ oo
co . t»
0
PL,
CO
8
co
ON ON ON
IT- l> tj
000
o
s
s
o o o o L o u o o o
PQ PQ PQ
PQ
PQ
L}^ U U
PQ PQ PQ
u
u
PQ pq pc pq
•a
I
C8
e
O
CUD
S
CTS
§
!
!
u
o>
j = s
w
«
£• ><
d Q
o o
-S
J3 -S gj
a ss d
5 § 'S
M
2 g
S H
t *? «? T
r-l rH' T-( i^H
00 00 00 90
-------
0
l/">
o
S-
ns
'3
o
=
ts
."2
WO
0)
*Ci
o
ce
la
0)
s
2
"3
cr1
o>
ft*
ta Supporting Guideline 1
cs
Q
I ^
£3
o
I
H
3S
1
3
S
£
pa
S
<— ' O ,—T yvT
is § §
v' *D r-J (-T\
^n vj ^ §
oo g 2
0 ^ • ^t ' 5-
U U O U O CJ CJ CJ CJ CJ U CJ Cj" Cj" U Cj"
pq" pcf pq eq cq pq pq ^ m" m" m" ffl- ^ ^ ^ ^
< •S^M^ ** »* , S
•a 55tsw^ cses1^^
1 S i | g i i ""115
"S , » V -3 '3 *S- ' ^^"SHg^
•ts .1, •» a S -s -S «' -"s .-a js « S «
^§tflll£ 1-S-§olgSBS
2 1 • • ? H H ^J-SS'^llSi
..1 J M u J, S» -g» « S H H & 3 | ^ =g
JiIII! till HN
1 Hit JHiff fill i!
vjvo^Sr^^S -<5M^W •
-------
o
tH
O
CO
I
1
O
O\
VO VO
t-- c-~
o\ • ON
VD
ON
CO I>
cs cs
Q Q
s
03
ON
t-
fi
O
fi
O
CN
.ON
r-
CN
12
.a
D£
O
O)
p
tj q_ o^ o^ x. u o
PQ ^o rn ro ^T.. PQ oo
«
o
«
« u
u" o" u" cj
« PQ « «
VO
cs
42
c
0}
s
9
CT
f§
CD
c
«^*<
13
2
£
.ff
i
i 1
3 S '•
1
•M
"3
1
1
i
Cn
**^
1
rt
«
S
1
MM
A
5
a
'c
en
O>
Q
§
1
1
t
1
I
-
*
!£ O
'•& OJ
« ft
w B*
OH O
§ *
fc^
o
p.
a
CO
2
•§ i
. 1 1
a fi
(3
-------
c
tr.
S
rs
"2
<
E
s
^o
V
p*^
cc
"So
0>
0)
I*
ew
1
0)
s
0>
t*
"3
a
c
••2
1
5
O
I
t*
o
IS
Q
t/
Jz;
h
"""^ T— <
-* o
ON Jn
O O O O O
00000
o o o o o
o«T of en" cs
a
-------
p
o
J™"<
o
s
IS
"D
<
2
JO
"o
s
Ci-<
O
c!
.2
1
•M
CO
'Eb
o
cu
P*
cu
•5
u
o
CM
•*->
i
0>
.«
"3
cr
o
tf
.1
""oS
TJ
O
w:
• »•«<
•s
0
d,
a.
3
CO
•*•»
Q
f— ^
ss
g
p
s
p~j
o
•5
a
FJ|
>
Qj 0)
r^ «
u «
^
1
r-(
_._ ** T— ( -^"^ T-H
o\ o 0s* o
§i ^i
^ en ~^ en
c 3 f"*s
*> ^ •> T^-
t> P^ i-- ft
VJD °° S °°
O o O o
f^> C^
<*""*> CD
i— < i— <
VO VO
en en
0 0
06" oo"
vo vo
r—4 T— <
vo vo
en en
80
CD
0 0
ro po
o
VO
0
o
o
T— t
vo
en
O
00
vo
T— {
VD
en
o
PQ
. £
BJ
gj
en
1
a>
1
1
PQ
•N ^ni.ij
Si
CN ^0
8^
•>
t^
'VO
o
o
•>
o
T— I
VD
en
o
CD
o
oo"
vo
T— t
VO
en
O
0
O
«
•J:
CS
en
a>
b£
«.
5
O
,** T^
f^ 0
oo oo
CN ^i")
CD
-
^
VD
O
O
0
vo
en
O
oo"
VO
r— 1
vo
en
o
0
CD
PQ
£
c3
•Js
en
1
I
i
0-vo"S g vg
5 fS xf w-> m
'-* vg oo oo oo
T~l "^ r~ o o
?^ ^^ CN CD CD
0 0 ^ °^ °m
^- _iT ^~l en en
2" ^T CD if) if)
O '— i vo t~~ t~-
2 oo P; ^ ^
^™^ ^"^ C*"^ ^^i C^
0 0 ^ ° °
.** »^_** T""<
ISi
88^
c^T CN"
vo oo
OO Tt
oo 'f""*
CD ^"^
*— ( T — 1
o o
O 0
pn . pQ
«
in -—
-O aj
sw S
U9 ^2
2 ^
0 S
P3
oo
CN
-------
o
en
o
en
u->
en
«n.
CN
o
e
T3
**•«
O
£
CS
fa
O
'S
c
O
on
o>
tf
01
cS
o\
cs
§
i
a
o>
S
"3
O
S
"S
o
o
a
a,
'S
•cc
cu
CO
i
AH
as
p
-------
-------
M
5
2
0
a
'§
a
o
ft.
o
t<
H
a
o
1
H
g
o
vo
^J-
ON
10
o
\o
*3-
ON
>n
o
o
«0
o
CO
S- 3
^O >y
^ -^
O\
u-i
0
o
o
CO
| |
S S
•
g
S
CN
5
CO
co
o
. cd
W
£
o
Q
>>
-G
ON
O
00
§
00
CN
"*
T-H
O
0
'$
O"
S
o>
"O
•>M
S
O
CUD
.a
%->
SH
O
a
cu
s
c«
Q
=? =S =3
CO
STR
E
P
Q
i
f!
s«
11
Che
cs
•g
s
1
CM
0
s
o
-5
•4^
«
1
O
fc:
.oa
*S
t
5
&
A
a
1
"33
£
fi
(A
*s
«M
O
1
-S
R
u
a
*-g
Ol
U
•e
J
•oS
o
a
cs
•4^
OD
o
1
£
3'3
s cu
« o ^
S w «
i § I
f * S i
1 I i I
•3 ^ .a ts
co > 'G O
o\
ffi
VO
-------
03
'S
a
1
CJ
1
03
Pk
O
W
I
I
DATA GAP
oo
CSCN
^H^_I
oooo
oooopoo
O
cs
o o
VO F-
\o r~
c- o
CO •*
en r-<
H
o
O'
£
CO
42
c
—s
o"
PQ"
O
PQ~
O
fff
O CJ
PQ PQ
O U
PQ" fff
CJ CJ
PQ PQ"
en
O>
^
P^
o
e
g G
CO
03
•4-J
-------
E
2
u
"B
••3-
o
O
en
T-< T3
O
O
q c; q o" q cJ
q t; cj q q q
CQ 0q fff PQ" ttf pq"
u
Q. « <
CO
crs
VI
"S
0)
I
cr
«u
K
-------
s Picloram
m
a
"3
c
C3
d.
O
o
H
o
o
*43
03
•4-1
.~
J- x-s
0 (^
cS^
"S
i
o
.«
"3
pporting Guideline Req
3
CO
1
Q
CITATION(S)
i
i
p
g
s
S
§
53
w
Waived
Picloram Acid
(U
o
CO
pq 3"
i— >
CJ O^
DQ CQ
«
•i^
u
CL,
Ground Water - Small Pros;
Ground Water - Small
Retrospective
vo vo
vo vo
r-( r-l
Not Applicable
Ground Water - Irrigated
Retrospective
S-
vo
CM PL,
o o
Q Q
1— > 1— >
u o"
pq" pq"
Droplet Size Spectrum
Drift Field Evaluation
3 S
<^> ^5
<^ r<
1
ctf
J3
O
£
4}
oo
pq^
CHEMISTRY
Nature of Residue - Plants
Ed
F* ^
P
LE£I] ^H
A~! f^s,
K r-l
Picloram Acid
Picloram Acid
fli fli
fll fli
oo en
PQ pq^
f
§
^TV a
Nature of Residue - Livestoc
Residue Analytical Method •
CQ o
T ^
r-t T-i
P f-
Picloram Acid
flX
(Jj)
-------
-------
-------
£
ce
__o
13
o
o
o
3
H
HH
U
"*• ^J- *-<
^ ° ^
ON OS OO
•sfr Tt- O
ON OS "3-
O O OO
x—t ^-i r*o
•***-*
42840804
•<*
O
oo
00
CM
^J-
42840804
•*
o
oo
§
oo
CM
Tfr
o
oo
o
•<*•
00
CM
PQ
(U
I
1
"3
cr
o>
1°
1
9
«
i*
o
fr.
a
d
KJ
O vo
^-i o
oo oo
o o
-^t- n-
OO 00
oo
o
oo
o
oo
CN
oo
• 00
5?
•*
O
oo
§
oo
CM
-*
en
05
og
O
O
O
STRY
H
&
U
H
U
g
i
P^
cal Identity
Che
a
CU
1
O
.1
«
F
o
EH
^>
03
-S
^>
=
fl
*P"(
s
^
i-
fi
j
«t-H
O
g
1
u
S
•rM
-s
a>
O
•es
1
§
-s
w
• *-T3
j>»
A
H
<3
.
0
"3
*-
s
co
oa
c
o
If
fl OH
O .,
U «
S3 .e*
£ o s
=§
PQ
•
11
O GO
a a w
« -S3 t> m
> Q o "a
PQ
vo SO
a s
VP
^>
•^
*»M
na
•s
•4^
05
W
T
m
VD
cc
H
U
a
a
^
g
o
0
>-3
0
U
H
-------
§
rH
VJ
0
S-
S
s
JD
s
0
0
CM
O
o
•43
03
£
O
0
f!
'S
e
0
*3
ff
o
g Guidelin
^a
t«
o
p-
3
CO
(S
ITATION(S)
CJ
1
p
I
1
o»
s
82, 00164726
40094602
ON
vo
es
o
o
0 O
W *M
SCJ)
S
^ s
« .^
« .a
*•"* V
p 1
ss H
1 -s
i
a
Q
O
a
H
i
w
a
^i
I
a'
«>
1
o
Jk
en
S
•"§
I
C3
O
1
S
-*->
CA
H
9
t-
I
8l
o
1
t^ oo
^D C5
ON ON
t~- f±
^3" IJT
o o
ON
O\
•<*
O
Q Q
o
VO
VO
vo
ON
O
VO
vo
en
vo
ON
cs
O
ON
vo
O
O O O
O O
O O
QO
en
• Mollusk
*?
Estuarine/Marine Toxic
-TEP
W
*?
£2
t
•e
CO
.***
Estuarine/Marine Toxic
-TEP
ta
?
1
3S
1
t
•<
"T
f2
.S
Seed Germination/Seedl
^
rn
TH
Emergence
Vegetative Vigor
TH
1
TH
1
1
r^
rn
TH
**
u
i
PQ
ffi
^
TH
^
TH
•s
o
o
nJ
0
u
>^
o
H
Pi
f
•g
1
rf
TH
OO
Acute Dermal Toxicity -
Rabbit/Rat
*?
TH
OO
.1
i
>>
Acute Inhalation Toxicil
*?
TH
00
1
^
Primary Eye Irritation •
•<*
TH
00
-------
o
rH
0
0
s
oj
13
o
o
&n
O
C
.2
1
M
'OJD
O>
»
5
1
"S
o>
s
o
"3
Supporting Guideline Reqi
-2
Q
^•^
C/5
s«^-
0
5
5
ii
z
1
SS
£>
H
9
1
g
40479411
40479412
>— > >-^>
0 0
IS fen
cs CW
Primary Dermal Irritation - R!
Dermal Sensitization - Guinea
r-l rH
00 CO
42297001
Waived
•—> >— s
0 0
90-Day Feeding - Rodent
90-Day Feeding - Non-rodent
< M
CO CO
42870701
Reserved
*i
^ — i
o
vo
c-
T— «
9
1— 1 H^
O U
•w
O»
i"^
21-Day Dermal - Rabbit/Rat
Chronic Feeding Toxicity - Rot
<5
CS i— 1
I 1
CO CO
Reserved
>— s
o
Chronic Feeding Toxicity -
Non-Rodent
M
rH
i
CO
Reserved
Reserved
>— 1 >— 5
0 0
Oncogenicity - Rat
Oncogenicity - Mouse
-3 M
fS C3
00 CO
• i
00 00
Reserved
42121106
0 0
rt
2-Generation Reproduction - R
Gene Mutation (Ames Test)
<
00 ' 00
42171602
O
Structural Chromosomal
Aberration
•4-
CO
42414001
42171603
r— 5 >— -j
o" o"
Other Genotoxic Effects
General Metabolism
3 S
CO GO
1
Q
U
si
p
c^
o
ft^
rl *
TIONAL/RESIDENTIAL I
Estimation of Dermal Exposure
Outdoor Sites
<
P
U rn
O 55
en
-------
°@
z
§ ^
o ^
o 0
Naa^
St
O
73
&
u
o
0
CO
I-H
CM
O
C
.2
Is
to
O H
^ £
CO
1
i
(U
t-t
Supporting Guideline Requi
— >
cT
cu
t.
Estimation of Inhalation Exposi
at Outdoor Sites
^MENTAL FATE
0
a
fe>.
§ I
vo o
en cj\
T— < 1— i
CO T-H
T— 1 OO
^ ^
cJ cJ
Hydrolysis
Photodegradation - Water
TH C*4
TH TH
vo vo
TH TH
*X3 ^~* *O *"O • 'Q ^c3 ^3 *T3 4^ '"O *^3 vli OO T3 TIJ
"3 g '3 g '3 g S '3 B 'S g 3 2 S S
-E2j>-t>-E3^HCjt/1^:: 4)
2^2 2- S^S^J^^Pi f^
0^0 0 0<<0 , >H
-------
2
o
u
o
o
sn
<*!•*
of
t-i
O>
05
I
I
u
Reserved
O
. -S
^ S
•§ |
§1
t- 0>
O «
|
%4
03
f 1
0 Q
SO
-------
-------
on g
S
2
o
.5
t/i
JS
"o
a
o
!
.a
OJD
O>
V
-c
CO
O
o
ON
ON
O
-O
CO
t^
O
oo
o
?p
ON
O
J3
3
O
e
o
. ON
ON
4>
fc
CH
CO
upporting Guide
rt
Q
T CHEMISTRY
O
e
ce
en
.W»
•SS *2
o
)1a
^
-------
CO
o
2
o
§
VO
T—(
O
o
vcf
g
vo
vo
o
03
o
"o
tD
CD
m w-> co
S S £
i—( r—I T—(
Tl- "3- V)
O O '-i
o o
o o
co~ co"
vo vo
o o
ON O\
O
O
o
o
"* CO
oo oo
h
r— I T— 1 C5
>O IO
r— ! T— 1 •<}
o
vo
CO
«M
O
os
vo
vo
CO
CN
O
rj-
ON
5?
CO
5?
o
C Q
o
vo
vo
S
CN "*
CO *-H
CO
W3
C3
o
o
O
e
o
.S3
0£
2
t;
pq"
o u o
«"• qq" «"
u u
03
o
CQ"
1
o
O
OJD
CO
«
0> -"S
_ ^
u
ty
ep -S -rt
111111
11 -1111
•< Q Q
« S
2 .S J3 -SS
^5 <53 : .S3
e
e
g
«
•S 5
H H « fc
e F
ate
Sfe -S
S 5 w
DJD
"2
o>
O3
S O
yf »r*
J I 1
cc
5 -S
e
8 »
S -^
•15 o>
O ^ ^3 S
p? -2 "•*
•g | a a
<1) C •
03 W
C3
"S «
•
>> -!
^OJD ^^ y
a -S
PQ
*J8
«
e
Q§ 5
rti fli *53
-S -*2 ^2
" "-S
<1 tf
-------
o
rH
O
0
^»^
E
es
J5
E
^
• M
%
W)
-2
"o
O
Si
o
1
00
'So
04
o>
•4-i
o
-2
c
o>
g
§
porting Guideline Requin
QI
5
BJ
•5
ft
g
^w'
1
B
g
U
Z
CH
S
H
as
H
Py^
i
1
p
$
§
Is
II ^™y
f^.
I—,
O
PQ
<
^imary Eye Irritation - Rabbit
Jf*
"T
So
V^ \D
^^ ^^
C*K CT\
'vj1 kj
*~1 *"~^
0 U
CQ pq
< <
•4^
2 BJD
Imary Dermal Irritation - Rab
armal Sensitization - Guinea Pi
*^ JT
i/p v«
So So
"2
1
|
i~>
u
pn
^^
§
:ute Delayed Neurotoxicity - H
Tj
t^.
T- f
«
1
•—»
u
PQ
<
'-Day Feeding - Rodent
^5
0\
^
r^
^'S^T3T3^0^
|1| f f f g |
o o o o
^ ^ ^
*~» •"» *— > »— i >— 1 1— n H- 5 H- ,
CJ U" U U EJ u" U (J
PQ PQ PQ fjQ PQ pQ pQ pn
<<<<<<<<
~s
"eS •§
1 « ' s 1 «
•3 tf J 5 1 '
? 1 « « ffl s ^ £
i A « W i i U U
4 a I j f f 1 !
Ill f Iff,
SoaflSg^^l
III! Ill if
l^? ^H ^^ «^> ^^ ^5 ^3 p£^ O
^?\ ^^ ^^ ^^\ ^^\ ^^N ^^ ^^J r^i
PM ^C fiu ^^ CQ
^"^ ^^ f^ ^^ ^^^ ^^^ ^H ^^
r^r'ifse^e^rJif'jrn
OO 00 OO OO QO OO OO Q^
CN T— (
O '0
CO CO
O\ Os
T— 1 r— 1
vo vo
^ 5h
u u
< <
icogenicity - Rat
tcogenicity - Mouse
0 0
^^ PQ
• ff) .i
00 00
CO T-l
0 0
wo wo
CM ON
oo vo
-3- ^?
t— <
o
CN
oo
CO
^
U O
OQ CO
•«r ^C
velopmental Toxicity - Rat
velopmental Toxicity - Rabbit
fli ^
Q 0
S S
f*s ?n
00 00
1— ( fX)
0 0
t~- C7\
OO WO
!>• 00
^^ T^-
C1^ i (
^ ^*
CJ O
pq" pq"
Jeneration Reproduction - Rat
ne Mutation (Ames Test)
^^ O
<4 O
-4
rn TT
oo oo
CN
CO
00
rj
^^
0\
i^T
uctural Chromosomal
J^
00 '
pq
•
oo
-------
O
_
•»— '
C3
o
"o
s
s
.2
CO
1
"o
CM
O
g
O
•43
CJ
.1
OJD
0
°2
tf
O
•*•»
t*
o
12
i
t_>
upporting Guideline Requii
CO
a
Q
®
^3
O
f— i
C/3 co
•d"
0)
>;
'3
3* o
ml ^
< <
Hydrolysis
Photodegradation - Water
T-l TH
VO VO
rH T-l
ucii *C_1 ^^^
O- O O
S 6 S
o o o
000
Pi PH Pi
-> -x -N
o> aj
?i
1— » >-5
c_T o^ u~
pA pT^ ^^,
<^^* ^C
"^C
Photodegradation - Soil
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
f*ji TH r^
*O VO VO
^ ^, ^ T-J ^
'3 '3 ^ •> 'o
^^ ^^ ^S ^{ ^^
t* C3 [^^ [^^ t2
c\^ c\j cci
o- o o
o o o
PH P-( P-i
fl2 Qi (U
OJ 0) U
C/3 C/3 C/D
""J. ""J. *~*
c_T cT pq pq cJ
OQ OO ^,^4 ^ft OA
f"^ r^ "^ ^Qj ^5j f^4
< a> o
C/2 00 OQ
"~5> r \ ""I
q °. c[
pA ^** . pn
-------
IT
S
09
11
11
6 £ S S
co cd csj cd
!-< 1-1
va
-5
"o
CM
O
O
1
•*->
o>
O)
c2
VI
"S
u
•\
pq
pq pq pq pq
a
en
O
Oil
o
.g
"3
T3
1
DJD
I
O
&
A
s
si
"S
Q
g
o
w
I I
• =
o
•-
1
1
•
vo
-
P!
-------
-------
APPENDIX C. Citations Considered to be Part of the Data
Base Supporting the Reregistration of Picloram
149
-------
-------
GUIDE TO APPENDIX C
CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Reregistration.Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor '
agencies in support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered
are included.
UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a
single study.
IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4(d)(4) below for further explanation). In a few
cases, entries added to the bibliography late in the review may be preceded by a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is needed.
FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When.no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
b.
Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
the date from the evidence contained in the document. When the date appears
151
-------
as (19??), the Agency was unable to determine or estimate the date of the
document.
Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the
following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit
number, petition number, or other administrative number associated
with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume
in which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for
"Company Data Library." This accession number is in turn followed by
an alphabetic suffix which shows the relative position of the study within
the volume.
152
-------
Picloram Acid - 005101
BIBLIOGRAPHY
MRID
CITATION
00022923
00026748
00026750
00026751
00026752
D. Turnbull and J.V. Rodricks (1985): Assessment of Possible Carcinogenic
Risk to Humans Resulting from Exposure to Di(2-ethylhexyl)phthalate (DEHP)
J. Am. Coll. Toxicol., 4(2), pp.111-145.
National Toxicology Program (1982): NTP Technical Report on the
carcinogenesis bioassay of di(2-ethylhexyl)phthalate (CAS No. 117-81-7) in
F344 rats and B6C3F1 mice (feed study) NIH Pub. No. 82-1773.
Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary Toxicities
of Environmental Pollutants to Birds: Special Scientific Report-Wildlife No.
191. (U.S. Dept. of the Interior, Fish and Wildlife Service, Patuxent Wildlife
Research Center; unpublished report) 00023105 Fisher, D.E.; St. John, L.E.,
Jr.; Guntenman, W.E.; et al. (1965) Fate of Banvel T, loxynil, Tordon and
Trifiuorilin in the dairy cow. Journal of Dairy Science 48(12):1711-1715,
(Also In unpublished submission received Apr 8, 1976 under 876-203;
submitted by Velsicol Chemical Corp., Chicago, 111.; CDL:235226-Y)
Leahy, J.S.; Taylor, T. (1966) Residues of Tordon in Treated Grain.
Undated method 1556/66/85. (Unpublished study received Nov 21, 1967 under
8F0660; prepared by Huntingdon Research Centre, submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:091151-1)00026749 Dow Chemical Company
(19??) Analytical Methods for Residues in Grain and Straw. Summary of
studies 091151-1 and 091151-K through 09115 l-O. (Unpublished study
received Nov 21, 1967 un- der 8F0660; CDL:09151-J)
Dow Chemical Company (1966) Determination of Residues of Tordon Acid in
Wheat Grain by Gas Chromatography. Method ACR 65.3R dated Feb 4, 1966.
(Unpublished study received Nov 21, 1967 under 8F0660; CDL:091151-K)
Dow Chemical Company (1965) Gas Chromatographic Method for the
Determination of Residues of Tordon Acid in Wheat Straw. Method ACR
65.4R dated Nov 15, 1965. (Unpublished study received Nov 21 1967 under
8F0660; CDL:091151-L)
Dow Chemical Company (1966) Determination of Residues of Tordon
Acid in Wheat Straw by Gas Chromatography. Method ACR 66.5 dated May
6,1966. (Unpublished study received Nov 21, 1967 under 8F0660-
CDL:091151-M)
153
-------
Pidoram Acid - 005101
BIBLIOGRAPHY
MRID
CITATION
00026753 Leahy, J.S.; Taylor, T, (1967) A gas-chromatographic determination of
residues in Picloram. Analyst 92(?/Jun):371-374. (Also In unpublished
submission received Nov 21, 1967 under 8F0660; submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:091151-O)
00027288 Dow Chemical Company (1967) Determination of Residues of Tordon Acid in
Barley Straw by Gas Chromatography. Method ACR 67.4 dated Jul 7, 1967.
(Unpublished study received Nov .21, 1967 under 8F0660; CDL:091151-N)
00035959 Riley, V.; Kutschinski, A.H. (1967) Residues of Tordon acid in Eggs and
Tissues from Chickens Fed the Herbicide. (Unpublished study received Jul 3,
1975 under 6F1653; submitted by Dow Chemical U.S.A., Midland, Mich.;
CDL:094501-E)
00036168 Bjerke, E.L.; Ervick, O.K.; Stymiest, C.; et al. (1973) A Residue Study of the
Disappearance of Picloram and 2,4-Dichlorophenoxyacetic acid in Small Grain
following Application of Tordon Her- bicide: GH-C 683. (Unpublished study
received Jul 3, 1975 under 6F1653; prepared in cooperation with South Dakota
State Univ and others, submitted by Dow Chemical Co., Indianapolis, Ind.;
CDL:094498-C)-
00036170 • Southwick, L.; Behrens, R.; Hartman, G.P. (1975) A Residue Study of
Picloram and 2,4-Dichlorophenoxyacetic acid in Wheat following One, Two
and Three Years Use of Picloram and 2,4-D (Tordon(R) 202 Mixture):
GHP-913. (Unpublished study received Jul 3, 1975 under 6F1653; prepared in
cooperation with Univ. of Minnesota and Univ. of Montana, submitted by Dow
Chemical Co., Indianapolis, Ind.; CDL:094498-E)
00036171 Bjerke, E.L.; Dietrich, I.; Baker, L.O.; et al. (1975) A Residue Study of
Picloram and 2,4-D in Wheat and Barley following Postemergence Application
of Tordon 22K Weed Killer plus Formula 40 Herbicide: GH-C 821.
(Unpublished study received Jul 3, 1975 under 6F1653; prepared in
cooperation with Univ. of Montana and Montana State Univ., submitted by-
Dow Chemical Co., Indianapolis, Ind.; CDL:094498-F)
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975) Toxicity of
Pesticides and Other Agricultural Chemicals to Honey Bees: Laboratory
Studies. By University of California, Dept. of Entomology. ?: UC,
Cooperative Extension. (Leaflet 2287; published study.)
154
-------
Picloram Acid - 005101
BIBLIOGRAPHY
MRID
CITATION
00037880
00041125
00041136
00045363
00045366
00045369
00045372
Meikle, R.W.; Williams, E.A.; Redemann, C.T. (1966) Metabolism of
Tordon herbicide (4-Amino-3,5,6-trichloropicorinic acid) in cotton and
decomposition in soil. Journal of Agricultural and Food Chemistry
14(4):384-387. (Also In unpublished submission received Jun 6, 1973 under
2F1265; submitted by Dow Chemical U.S.A., Midland, Mich •
CDL:092164-N)
Dow Chemical Company (1964) A Residue Study on Tissues from Beef Cattle
Fed Diets Containing Tordon Herbicide. (Unpublished study received Nov 6
1967 under OF0863; CDL:094525-AJ)
Bauriedel, W.R.; Neipert, N. (1965) The Fate of Labeled 14C-TriisoproPanol
amme Applied to Spring Wheat, (Unpublished study re- ceivedNov6 1967
under OF0863; submitted by Dow Chemical U.S.A., Midland Mich • '
CDL:094525-AX) '
Swann, R.L.; Pettyjohn, M.A.; Bjerke, E.L. (1972) Determination of Residues
of Picloram in Wheat, Barley and Oat Green Forage, Grain and Straw by Gas
Chromatography. Method ACR 72.7 dated May 12, 1972. (Unpublished
study received Jul 3, 1975 under .6F1653; prepared in cooperation with
International Research and Development Corp., submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:094500-A)
Bjerke, E.L. (1973) Determination of Residues of Picloram in Soil by Gas
Chromatography. Method ACR 73.3 dated May 21, 1973 (Unpublished study
received Jul 3, 1975 under 6F1653; submitted by Dow Chemical USA
Midland, Mich.; CDL:094500-D)
Bjerke, E.L.; Ervick, O.K. (1975) A Residue Study of Picloram and 2,4-D in
MiUed Wheat Fractions: GH-C 798. (Unpublished study received Jul 3 1975
under 6F1653; submitted by Dow Chemical U.S.A., Midland Mich • '
CDL:094501-B) . "
Kutschinski, A.H.; Stevenson, G.T. (1967) Residues of Tordon acid in Milk
from Cows Fed the Herbicide. (Unpublished study including experiment no
3-1400-5, received Jul 3, 1975 under 6F1653; submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:094501-F)
155
-------
Pidoram Acid - 005101
MRID
BIBLIOGRAPHY
CITATION
00045373 Dow Chemical U.S.A. (1967) Determination of Residues of Tordon acid in
Milk by Gas Chromatography. Method ACR 67.3 dated Jun 22, 1967.
(Unpublished study received Jul 3, 1975 under 6F1653; CDL:094501-G)
00045374 Kutschinski, A.H.; Riley, V. (1967) Residues of Tordon acid in Tissues from
Steers Fed the Herbicide. (Unpublished study received Jul 3, 1975 under
6F1653; submitted by Dow Chemical U.S.A., Mid- land, Mich.;
CDL:094501-H)
00045375 Dow Chemical U.S.A. (1967) Determination of Residues of Tordon acid
in Bovine Tissues by Gas Chromatography. Method ACR 67.2 dated Jun 21,
1967. (Unpublished study received Jul 3, 1975 under 6F1653; CDL:094501-I)
00045376 Bjerke, E.L.; Riley, V.; Bucek, O.C.; et al. (1969) Residues of Picloram in
Sheep Tissues. (Unpublished study received Jul 3, 1975 under 6F1653;
submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:094501-J)
00045409 Dow Chemical Company (1966) Determination of Residues of Tordon acid in
Grass by Gas Chromatography. Analytical method ACR 66.7 dated Jul 11,
• 1966. • (Unpublished study received Aug 4, 1969 under OF0863;
CDL:093160-G)
00059411 Redemann, C.T.; Meikle, R.W.; Hamilton, P.; et al. (1968) The fate of
4-Amino-3,5,6-trichloropicolinic acid in spring .wheat and soil. Bulletin of
Environmental Contamination & Toxicology 3 (2): 80-96. (Also In
unpublished submission received Sep 26, 1974 under 464-323; submitted by
Dow Chemical U.S.A., Midland, Mich.; CDL: 120353-B)
00062818 (1980) Determination of Residues of 3,6-Dichloropicolinic acid and Picloram in
Grass by Electron Capture Gas Chromatography. Method ACR 80.8 dated Jul
24, 1980. (Unpublished study received Nov 28, 1980 under 464-EX-67;
submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:099796-Q)
00069973 Dow Chemical Company (1964) Determination of Tordon Residues in Water
and Blood by Gas Chromatography. Tentative residue determination method
ACR 64.6 dated Nov 18, 1964. (Unpublished study received on unknown date
under unknown admin, no.; CDL: 130992-J)
156
-------
Picloram Acid - 005101
BIBLIOGRAPHY
MRID
CITATION
00073921
00073972
00073973
00073974
00078483
00085060
00098321
00098322
Higham, J.W. (1973) Cycocel(R): Cycocel Residues in Affined Raw Sugar
(Ewa and Hilo, Hawaii): Report No. C-370. Includes methods M-369 and
M-440. (Unpublished study received Jan 28, 1974 under 4G1461; submitted
by American Cyanamid Co., Prince- ton, N.J.; CDL:093894-R)
Dow Chemical Company (1967) Residue Determination Method: Determination
of Residues of Tordon Acid in Milk by Gas Chromatography. Method ACR
67.3 dated Jun 22, 1967. (Unpublished study received Mar 3, 1970 under
8F0660; CDL:090780-I)
Kutschinski, A.H.; Riley, V. (1967) Residues of Tordon Acid in Tissues from
Steers Fed the Herbicide. (Unpublished study received Mar 3, 1970 under
8F0660; submitted by Dow Chemical U.S.A., Midland Mich •
CDL:090780-J)
Dow Chemical Company (1967) Residue Determination Method: Determination
of Residues of Tordon Acid in Bovine Tissues by Gas Chromatography.
Method ACR 67.2 dated Jun 21, 1967. (Unpublished study received Mar 3
1970 under 8F0660; CDL:090780-K)
Dow Chemical Company (1967) Residue Determination Method: Determination
of Residues of Tordon(R) Acid in Chicken Eggs and Tissues by Gas
Chromatography. Method ACR 67.5 dated Sep 14, 1967. (Unpublished study
received on unknown date under 4E1489; submitted by Montana, Dept. of
Agriculture, Helena, Mont.; CDL: 093949-B)
Interregional Research Project Number 4 (1981) Summary of Residue
Chemistry Data: [Picloram]. (Compilation; unpublished study received Oct 20
1981 under 2E2585; CDL:070422-A)
Nolan, R.J.; Smith, F.A.; Muller, C.J.; et al. (1980) Kinetics of
14C-labeled Picloram in Male Fischer 344 Rats. (Unpublished study received
Apr 6, 1982 under 464-320; submitted by Dow Chem- ical U.S.A., Midland
Mich.; CDL:247156-H)
Mensik, D.C.; Johnston, R.V.; Pinkerton, M.N.; et al. (1976) The Cytogenetic
Effects of Picloram on the Bone Marrow Cells of Rats. (Unpublished study
received Apr 6, 1982 under 464-320; prepared in cooperation with Univ. of
157
-------
Picloram Acid - 005101
MRID
BIBLIOGRAPHY
CITATION
Texas, Medical Branch, submitted by Dow Chemical U.S.A., Midland, Mich.;
CDL:247156-I)
00108862 Dow Chemical Co. (1970) Residues of Picloram in Grass. (Compi lation;
unpublished study -received Apr 5, 1970 under OF0863; CDL:091493-A)
00108864 Dow Chemical Co. (1969) The Results of Tests on the Amount of Residue
Remaining Including a Description of the Analytical Methods Used: [Tordon].
(Compilation; unpublished study re ceived Apr 5, 1970 under OF0863;
CDL:091494-B)
00110534 Barna-Lloyd, T.; Taylor, H.; Swaim, L.; et al. (1982) Results of a Six-month
Dietary Toxicity Study of Picloram ..., Administered in the Diet to Male and
Female Beagle Dogs: Study TXT:K-038323 (28). Final rept. (Unpublished
study received Aug 23, 1982 under 464-502; submitted by Dow Chemical
U.S.A., Midland, MI; CDL:248162-A)
00110537 Gorzinski, S.; Johnson, K.; Campbell, R.; et al. (1982) Technical Grade
Picloram: Results of a 13-week Dietary Toxicity Study in Fischer 344 Rats:
Laboratory Report Code HET K-038323-(32). Final rept. (Unpublished study
received Aug 23, 1982 under 464 502; submitted by Dow Chemical U.S.A.,
Midland, MI; CDL: 248162-D)
00111404 Dow Chemical U.S.A. (1974) Residues: [Tordon 22K]. (Compilation;
unpublished study received Sep 26, 1974 under 464-323; CDL: 009845-A)
00111407 Dow Chemical Co. (1967) The Results of Tests on the Amount of Res idue
Remaining, Including a Description of the Analytical Method used: [Tordon].
(Compilation; unpublished study received Nov 21, 1967 under 8F0660;
CDL:090777-A)
00111470 Getzendaner, M.; Herman, J.; Van Giessen, B. (1969) Residues of 4
amino-3,5,6-trichloropicolinic acid in grass from applications of Tordon
herbicides. Agricultural and Food Chemistry 17 (6): 1251-1256. (Also In
unpublished submission received Sep 26, 1974 under 464-323; submitted by
Dow Chemical U.S.A., Midland, MI; CDL:120318-O)
00111473 Grover, R. (1971) Adsorption of picloram by soil colloids and various other
adsorbents. Weed Science 19(4):417-418. (Also In unpublished submission
158
-------
Picloram Acid - 005101
BIBLIOGRAPHY
MRID
CITATION
received Sep 26, 1974 under 464-323; sub mitted by Dow Chemical USA
Midland, MI; CDL: 120318-V)
00111482
00111527
00111557
00111560
00112016
00128714
00128947
Ervick, D.; Getzendaner, M. (1974) Residues of Picloram in Grass Treated
with Tordon 10K Pellets: GH-C 760. (Unpublished study received Oct 10,
1974 under 464-320; submitted by Dow Chemical U.S.A., Midland MI-
CDL: 120321-B) ' '
Maroder, H.; Prego, I. (1971) Transformation of picloram in prosopis
ruscifolia and diplotaxis tenuifolia. Weed Res. 11:193 195. (Also In
unpublished submission received Sep 26, 1974 under 464-323; submitted by
Dow Chemical U.S.A., Midland, MI; CDL:120317-T)
Bj'erke, E. (1975) A Residue Study of Picloram in Grass following Application
of M-3864 Herbicide: GH-C 805. (Unpublished study received Sep 10, 1976
under 464-541; submitted by Dow Chemical U.S.A., Midland MP
CDL:226133-A) '
Heitmuller, T. (1975) Acute Toxicity of Tordon 10K Pellets to Lar vae of the
Easter Oyster ..., Pink Shrimp ..., and Fiddler Crabs (Uca-pugilater).
(Unpublished study received Sep 10, 1976 under 464-541; prepared by
Bionomics-EG & G, Inc., submitted by Dow Chemical U.S.A., Midland MI-
CDL:226137-D)
Batchelder, T. (1974) Acute Fish Toxicity of Picloram-(Dry Tordon Acid).
(Unpublished study received Sep 10, 1976 under 464-541; submitted by Dow
Chemical U.S.A., Midland, MI; CDL:226137-C)
Dow Chemical U.S.A. (1983) Residue Chemistry: [Tordon K Salt Liq uor:
Grains and Animal Tissue]. (Compilation; unpublished study received Jun 20
1983 under 464-502; CDL:250508-A; 250509)
Bidlack, H. (1980) Determination of the Bioconcentration Factor for Picloram
in Bluegill Sunfish during Continuous Aqueous Exposure: GH-C 1384.
(Unpublished study received Jun 16, 1983 under 464-502; submitted by Dow
Chemical U.S.A., Midland, MI; CDL: 250517-A)
159
-------
Picloram Acid - 005101
BIBLIOGRAPHY
MRID
CITATION
00128976 McCaU, P.; Jeffries, T. (1978) Aerobic and Anaerobic Soil Degrada tion of
14C-picloram. Final rept. (Unpublished study received Jun 16, 1983 under
464-502; submitted by Dow Chemical U.S.A., Midland, MI; CDL:250518-A)
00129073 Heitmuller, T. (1975) Acute Toxicity of Tordon 22K to Larvae of the Eastern
Oyster (Crassostrea virginica), Pink Shrimp (Penaeus du orarum), and Fiddler
Crabs (Uca pugilator). (Unpublished study received Jun 24, 1983 under
464-502; prepared by Bionomics-EG & G, Inc., submitted by Dow Chemical
U.S.A., Midland, MI; CDL:250605-L)
00129076 Mayes, M.; Dill, D. (1982) The Toxicity of Picloram ... to Repre sentative
Freshwater Organisms: ES-561. (Unpublished study re ceived Jun 24, 1983
under 464-502; submitted by Dow Chemical U.S.A., Midland, MI;
CDL:250605-O)
00129078 McCarty, W.; Alexander, H.; Park, C. (1977) Comparative Toxicity of Three
Samples'of Technical Picloram Containing Various Amounts of
N"-(3,4,5,6-Tetrachloro-2-pyridinyi) Guanidine to BluegilL (Unpublished
study received Jun 24, 1983 under 464-502; submit ted by Dow Chemical
U.S.A., Midland, MI; CDL:250605-Q)
00129085 Woodward, D. (1979) Assessing the hazard of picloram to cutthroat trout.
Journal of Range Management 32(3):230-232. (Also In unpublished submission
received Jun 24, 1983 under 464-502; sub mitted by Dow Chemical U.S.A.,
Midland, MI; CDL:250605-Y)
00131364 Dow Chemical U.S.A. (1983) Residue Chemistry: [Tordon K Salt Liq our].
(Compilation; unpublished study received Aug 9, 1983 un der 464-502;
CDL:251037-A)
00132986 Dow Chemical U.S.A. (1980) Results of Tests on the Amount of Resi due
Remaining, Including a Description of the Analytical Methods Used:
[3,6-Dichloropicolinic Acid on Forage Grasses]. (Compilation; unpublished
study received Dec 7, 1983 under 464-EX-81; CDL:251919-C)
00141979 McCarty, W. (1977) Toxicity of 4-Amino-3,556-trichloropicolinic Acid,
Picloram, to Daphnids: Final Report. Unpublished study prepared by Dow
Chemical U.S.A. 8 p.
160
-------
Picloram Acid - 005101
BIBLIOGRAPHY
MRID
CITATION
00151783
00151784
00155940
00156366
00157171
00157173
00161306
00163216
00164725
f T t' • I n°? S' D'; MilaZZ°' D" (1984) The Acute and Chr°™ Toxicity
ot Technical Picloram (4-Amino-3,5,6-trichloropicolinic acid) to Daphnia
magna Straus: ES-690. Unpublished study pre pared by Dow Chemical USA.
Mayes M ; Dill. D.; Hopkins, D. (1984) The Toxicity of Technical Picloram
to the Embryo, Larval, and Juvenile Stages of the Rainbow Trout (Salmo
rgT^ ?/iChardS°n): ES'703' UnPubIished study prepared by Dow Chemical
UoA. 1 7 p.
Landry, T ; Johnson, K.; Cieszlak, F.; etal. (1986) Picloram: A Two-year
Dietary Chronic Toxicity-oncogenicity Study in Fischer 344 Rats. Unpublished
study prepared by Dow Chemical U.S.A. 1243 p.
Dow Chemical USA (1986) Results of Tests on the Amount of Residues
Remaining Including a Description of the Analytical Method of Picloram on
Crrassesa. Unpublished compilation. 300 p.
Bauriedel, W.; Miller, J. (1986) Metabolic Fate of Carbon- 14-picloram
Applied to Wheat: GH-C 1787. Unpublished study prepar ed by Dow
Chemical USA. 15 p.
Beavers J. (1983) An Acute Oral Toxicity Study in the Mallard with Picloram
w-Mrf^ Rep°rt: Pr°ject No' 103-221' Unpublished study prepared by
Wildlife International Ltd. 15 p.
Yackovich P.; Miller, J. (1986) The Fate of Carbon 14 Labeled Picloram Fed
to Laying Hens with Metabolism Study as Appendix. Unpublished study
prepared by Dow Chemical U.S.A. 64 P.
Yackovich, P.; Miller, J. (1986) The Fate of Carbon 14 Labeled Picloram Fed
to Lactating Goats. Unpublished study prepared by Dow Chemical USA in
cooperation with Analytical Bio-Chemistry Laboratories, Inc. 73 p.
Bjerke, E.; Majorski, S. (1986) Stability of Picloram in Grain, Straw Green
Forage and Grass Samples Stored Frozen: GH-C 1818. Unpublished study
prepared by Dow Chemical U.S.A. 9 p.
161
-------
Pidoram Acid - 005101
BIBLIOGRAPHY
MRID
CITATION
00164749 Woodburn, K. (1986) The Hydrolysis of Picloram Isooctyl Ester in Buffered,
Distilled Water: GH-C 1798. Unpublished study pre pared by Dow Chemical
U.S.A. 22 p.
•00164943 Woodburn, K.; Fontaine, D.; Bjerke, E. (1986) The Photolysis of Picloram in
Dilute Aqueous Solution: No. GH-C 1820. Unpublish ed study prepared by
Dow Chemical U.S.A. 58 p.
40054501 Weseloh, J. (1987) A Summary of Three Greenhouse Trials to Deter mine the
Effects of Picloram, 4-Amino-3,5,6-Trichloropicolinic Acid on Seed
Germination, Seedling Emergence, and upon Vegeta tive Vigor of Six
Dicotyledonae and Four Monocotyledbnae Crop Cultivars. Unpublished study
prepared by Dow Chemical U.S.A. 112 p.
40072601 Linscombe, V.; Gollapudi, B. (1987) Evaluation of Picloram in the Chinese
Hamster Ovary Cell/Hypoxanthine-guanine-phosphoribosyl Transferase
(CHO/HGPRT) Forward Mutation Assay: Final Report: File No. TXT:
K-038323-041. Unpublished study prepared by The Dow Chemical Co. 18 p.
40082701 Bjerke, E. (1987) Stability of Picloram in Grain Straw, Green Forage and
Grass Samples Stored Frozen: GH-C 1818: Addendum-15 Month Data.
Unpublished study prepared by Dow Chemical U.S.A. 3 p.
40094602 Johnson; W.; Finley, M. (1980) Handbook of Acute Tqxicity of Chemicals to
Fish and Aquatic Invertebrates: Resource Publication 137. US Fish and
Wildlife Service, Washington, D.C. 106 p.
40435601 Bjerke, E.; Majorski, S. (1987) Stability of Picloram in Grain, Straw, Green
Forage and Grass Samples Stored Frozen: Addendum-24 Month Data:
Laboratory Project ID GH-C 1818; Unpublished study prepared by Dow
Chemical U.S.A. 3 p.
40479413 Jeffrey, M. (1987) Picloram Acid (Picloram Technical): Acute Oral Toxicity
Study in Fischer 344 Rats: Final Rept.: K-038323-042A. Unpublished study
prepared by The Dow Chemical Co., Mammalian and Environmental
Toxicology Research Laboratory. 26 p. -
40479414 Jeffrey, M.; Schuetz, D.; Jersey, G. (1987) Picloram Acid (Picloram
Technical): Acute Dermal Toxicity Study in New Zealand White Rabbits: Final
162 .
-------
Picloram Acid - 005101
BIBLIOGRAPHY
MRID
CITATION
40479415
40479414
Kept.: K-038323-041D. Unpublished study prepared By The Dow Chemical
Co., Mammalian and Environmental Toxicology Research Laboratory. 17 p.
Streeter, C.; Battjes, J.; Johnson, K. (1987) Picloram Acid: An Acute Aerosol
Inhalation Study in Fischer 344 Rats: Final Rept.: K-038323-043 Unpublished
study prepared by The Dow Chemical Co., Mammalian and Environmental
Toxicology Research Laboratory. 21 p.
Jeffrey, M. (1987) Picloram Acid (Picloram Technical): Primary Eye Irritation
Study in New Zealand White Rabbits: Final Report: K 038323-042C
Unpublished study prepared by The Dow Chemical Co., Mammalian and
Environmental Toxicology Research Laboratory, lip.
Jeffrey, M. (1987) Picloram Acid (Picloram Technical): Primary Der mai
Irritation Study in New Zealand White Rabbits: Final Report: K-038323-042B
Unpublished study prepared by The Dow Chemical Co., Mammalian and
Environmental Tpxicology Research Laboratory. 10 p. ,
Jeffrey, M. (1987) Picloram Acid (Picloram Technical): Dermal Sen situation
Potential in the Hartley Albono Guinea Pig: Final Report: K-038323-042E
Unpublished study prepared by The Dow Chemical Co., Mammalian and '
Environmental Toxicology Research Laboratory. 13 p.
Bjerke, E. (1988) Stability of Picloram in Milk and Egg Whites Stored Frozen-
Proj. ID GH-C 2079. Unpublished study prepared by Dow Chemical USA
14 p. ' ' '
40479417
40479418
40731901
40834301
41069501
41092501
Young, J. (1988) Picloram: 12-Month Dog Chronic Dietary Toxicity Study-
Project Study ID: TXT:K-038323-040. Unpublished study prepared by Dow
Chemical Co. 154 p.
Breslin, W. (1989) Historical Control Data in New Zealand White Rabbits-
Picloram: Project ID: K-050731-003. Unpublished study prepared by Dow
Chemical U.S.A. 75 p.
Woodburn, E. (1989) Response to the Scientific Review of the Expo sure
Assessment Branch dated July 1, 1988 Associated with the Picloram
Registration Standard. Unpublished study prepared by Dow Chemical U.S.A
100 p.
163
-------
r
Picloram Acid - 005101
BIBLIOGRAPHY
MRID
CITATION
41094901 Baker, R. (1989) Product Chemistry: Picloram. Unpublished study prepared
by Dow Chemical U.S.A. 31 p.
41094902 Baker, R. (1989) Product Chemistry: Picloram. Unpublished study prepared
by Dow Chemical U.S.A. 73 p.
41094903 Baker, R. (1989) Product Chemistry: Picloram. Unpublished study prepared
' by Dow Chemical U.S.A. 5 p.
41209601 Racke, K. (1989) An Adsorption/Desorption Study of Picloram: Proje ct ID
GH-C 2218: Protocol No. 88129. Unpublished study prepared by Dow
Chemical Co. 61-p.
41209602 Reitz, R.; Dryzga, M.; Helmer, D.; et al. (1989) Picloram: General
Metabolism Studies in Female Fischer 344 Rats: Project ID K-038-323-044.
Unpublished study prepared by Dow Chemical Co. 57 p.
41260101 Racke, K.; McGovern, P.; Shepler, K.; et al. (1989) Photodegrada tion of
Picloram-isooctyl Ester on Soil by Natural Sunlight: PTRL Report No.
157W-1: PTRL Project No. 157W. Unpublished study prepared by Dow
Chemical U.S.A. 77 p.
41382502 Schroeder, R. (1990) A Teratogenicity Study in Rats with Picloram K Salt:
Final Report: Lab Project Number: 89-3459. Unpublished study prepared by
Bio/dynamics, Inc. 434 p.
41384901 Atkin, L.; Stott, W.; Stebbins, K. (1990) Picloram, Potassium Salt: 21-Day
Dermal Toxicity Study in New Zealand White Rabbits: Lab Project Study ID:
K-050731-008. Unpublished study prepared by Dow Chemical Co.,
Toxicology Research Laboratory, Health and Environmental Sciences. 160 p.
41395301 Knuteson, J.; Racke, K.; Woodburn, K.; et al. (1990) Picloram Fate in a
Coastal Plain Forest Ecosystem: Lab Project Number: GH-C 2299: Protocol
No.87115. Unpublished study prepared by Dow Blanco RSRA Analytical
Services, Inc and other laboratories. 210 p.
41442301 Bjerke, E. (1989) Stability of Picloram in Muscle and Liver Stored Frozen: Lab
Project ID: GH-C 2178: Protocol 88104. Unpublished study prepared by Dow
Chemical U.S.A., Agricultural Chemistry R&D Laboratories. 12 p.
164
-------
Picloram Acid - 005101
BIBLIOGRAPHY
MRID
CITATION
41485902
41549701
41905401
41976701
42037601
42078701
42380201
42494001
Samson, Y.; Gollapudi, B. (1990) Evaluation of Picloram in the Ames
Salmonella/Mammalian-microsome Bacterial Mutagenicity Assay Lab Project
Study I.D.: TXT:K-038323-046. Unpublished study prepared by The Dow
Chemical Co., Health and Environmental Sciences. 25 p.
McClintock, M.; Gollapudi, B. (1990)-Evaluation of Picloram in the Rat
Hepatocyte: Unscheduled DNA Synthesis (UDS) Assay: Lab Project Number:
TXT:K-038323-047. Unpublished study prepared by Dow Chemical Co.,
Health and Environmental Sciences-Texas. 45 p.
Dixon-White, H.; Ervick, D. (1991) Determination of Residues of Picloram
and Hexachlorobenzene in Rangeland Grasses Receiving Ground and Aerial
Applications of Tordon 22K Weed Killer: Lab Project Nos. GHC-2506.
Unpublished study prepared by North American Environmental Chemistry
Laboratories DowElanco and Harris Environmental Technologies. 42 p.
Bjerke, E. (1991) Response to: Memorandum (July, 1991) and Data Evaluation
Reports (...)- Review of Storage Stability Animal Commodities. Unpublished
study prepared by DowElanco. 5 p.
Dixon-White, H.; Ervick, D. (1991) Determination of Residues of Picloram
and Hexachlorobenzene in Rangeland Grasses Receiving Ground or Aerial
Applications of Grazon PC and Grazon P+D Herbicide: Lab Project Number:
90037. Unpublished study prepared by DowElanco and Harris Environmental
Technologies, Inc. 43 p.
Breslin, W.; Zielke, G.; Kociba, R. (1991) Picloram: Two-Generation on Diet
Reproduction Study in Sprague-Dawley Rats: Lab Project Number-
K-038323-057FO: K-038323-057F1W: K-038323-057FL Unpublished study •
prepared by The Toxicology Research Lab. & The Dow Chemical Co. 1225 p.
Phillips, A.; Bjerke, E.; Woods, J. (1992) Determination of Residues of
Picloram and Hexachlorobenzene in Wheat Receiving Ground and Aerial
Application of TORDON 22K Weed Killer: Lab Project Number: 90100.
Unpublished study prepared by DowElanco. 58 p.
Dixon-White, H.; Phillips, A.; Langer, W. (1992) Frozen Storage Stability of
Hexachlorobenzene in Green Grass and Hay: Lab Project Number: RES91015.
Unpublished study prepared by DowElanco. 44 p.
165
-------
Picloram Acid - 005101
BIBLIOGRAPHY
MRID
CITATION
42535301 Yackovich, P.; Byrne, S. (1992) Nature of the Residue of [carbon 14]-Labeled
Picloram in the Lactating Goat: Lab Project Number: MET92043.
Unpublished study prepared by DowElanco. 175 p.
42535302 Cryer, S.; Peterson, J.; Lacey, C.; et al. (1992) Picloram Fate in a Northern
Rangeland Ecosystem: Lab Project Number: ENV88088. Unpublished study
prepared by DowElanco. 227 p.
42579001 Petty, D.; Fontaine, D.; Harnick, B, (1992) Non-crop and Right-of-Way
Terrestrial Dissipation Study of Picloram in North Carolina: Lab Project
Number: 90094. Unpublished study prepared by DowElanco. 102 p.
42579002 Buttler, I.; Roberts, D.; Siders, L.; et al. (1992) Non-crop Right-of-way
Terrestrial Dissipation of Picloram in California: Lab Project Number:
ENV91020. Unpublished study prepared by DowElanco. 138 p.
42579003 Cryer, S.; Cooley, T.; Schuster, L. (1992) The Dissipation and Movement of
Picloram in Northern USA Forest Ecosystem: Lab Project Number:
ENV91088: PM91-2501. Unpublished study prepared by Pan-Agricultural
Labs, Inc. 376 p.
42579004 Stenner, S. (1992) Nature of the Residue in Wheat: (Carbon 14) Picloram:
Final Report: Lab Project Number: HWI 6397-111. Unpublished study
prepared by Hazleton Wisconsin, Inc. 243 p.
42619301 Stott, W.; Yano, B.; Haul, K.; et al. (1992) Picloram: Two-year Dietary
Oncogenicity Study in B6C3F1 Mice: Lab Project Number: K-038323-058.
Unpublished study prepared by The Dow Chemical Co. 919 p.
42619302 Cosse, P.; Stebbins, K.; Sames, K.; et al. (1992) Picloram: Two-year Dietary
Chronic Toxicity/Oncogenicity Study in Fischer 344 Rats: Lab Project Number:
K-038323-056. Unpublished study prepared by The Dow Chemical Co. 983 p.
42641801 Kimmel, E.; Aldcroft, K.; Ewing, A. (1993) A Confined Rotational Crop
Study with (carbon 14)-Picloram Using Turnips, 42641801 Mustard Greens,
Wheat, and Corn: Lab Project Number: 311W: MET9106. Unpublished study
prepared by PTRL-West, Inc. 257 p.
166
-------
Picloram Acid - 005101
MRID
BIBLIOGRAPHY
CITATION
42784401
42840802
43252301
Phillips, A. (1993) Determination of Residues of Picloram and
Hexachlorobenzene in Rangeland Grass Receiving Ground Applications of
Tordon 22K Herbicide (Supp): Lab Project Number: RES92031.01.
Unpublished study prepared by DowElanco in coop with A&L Great Lakes .
Labs, Inc. 48 p.
Krause, R. (1993) Picloram Acid Corrosiviry to Epoxy-modified-Phenolic
Resin Coated Steel Thirty Day 122 Degree F Storage Test Results: Lab Project
Number: FOR93078. Unpublished study prepared by DowElanco, Formulations
Science and Technology Lab. 9 p.
Krause, R.: Kinriunen, C.: Wallace, T. (1994) Storage Stability of Picloram
Acid One Year Ambient Temperature Storage Study Results: Lab Project
Number: FOR93079. Unpublished study prepared by DowElanco 14 p
167
-------
Triisopropanolamine Picloram - 005102
MRID CITATION
BIBLIOGRAPHY
41296501 Weseloh, J.; Stockdale, G. (1989) A Study To Determine the Effects of
Picloram on Seed Germination, Seedling Emergence and Vegetative Vigor: Lab
Project Number GH-P 1444; Protocol 89040. Unpublished study prepared by
Dow Chemical U.S.A. Midland Field Research Station. 170 p.
41366901 Hoxter, K.; Jaber, M. (1989) Tordon 101: An Acute Contact Toxicity Study
with the Honey Bee: Project No. 103-313. Unpublished study prepared by
Wildlife International Ltd. 16 p.
41381201 Berdasco, N.; Schuetz, D.; Jersey, G.; et al. (1989) Picloram Tri
isopropanolamine Salt: Acute Oral Toxicity Study in Fischer 344 Rats: Final
Report: Lab Project Study ID: K-049877-006A. Unpub lished study prepared
by The Dow Chemical Co., Toxicology Research Laboratory. 21 p.
41381202 Mizell, M.; Jersey, G.; Schuetz, D. (1989) Picloram TIPA: Acute Dermal
Toxicity Study in New Zealand White Rabbits: Final Report: Laboratory
Project Study ID: K-049877-006D. Unpublished study prepared by The Dow
Chemical Co., Toxicology Research Laboratory. 19 p.
41381203 Nitschke, K.; Lomax, L. (1989) Picloram Triisopropanolamine: Acute Aerosol
LC50 Study in Fischer 344 Rats: Final Report: Lab Project Study ID:
K-049877-007. Unpublished study prepared by The Dow Chemical Co.,
Toxicology Research Laboratory. 30 p.
41381204 Mizell, M. (1989) Picloram TIPA: Primary Eye Irritation Study in New
Zealand White Rabbits: Final Report: Lab Project Study ID: K-049877-006C.
Unpublished study prepared by The Dow Chemical Co., Mammalian and
Environmental Toxicology Research Laboratory. 12 p.
41381205 Mizell, M. (1989) Pieloram TIPA: Primary Dermal Irritation Study in New
Zealand White Rabbits: Final Report: Lab Project No. K-049877-006B.
Unpublished study prepared by The Dow Chemical Co., Mammalian and
Environmental Toxicology Research Laboratory, lip.
41381206 Berdasco, N.; Mizell, M. (1989) Picloram TIPA: Dermal Sensitization
Potential in the Hartley Albino Guinea Pig: Final Report: Lab Project Study
ID: K-049877-006E. Unpublished study prepared by Dow Chemical Co.,
Toxicology Research Laboratory. 15 p.
168
-------
Triisopropanolamine Picloram - 005102
-;--'- •'-:,- - _" ;» '.:<••* .
MRID CITATION
BIBLIOGRAPHY
41382504
41384902
41407701
41442701
41485901
41539701
41539702
41594601
41594602
Schroeder, R. (1990) A Teratogenicity Study in Rats with Picloram
Triisopropanolamine: Final Report: Lab Project Number: 89-3461.
Unpublished study prepared by Bio/dynamics, Inc. 472 p.
Atkin, L.; Stott, W.; Stebbins, K. (1990) Picloram, Triisopropanolamine Salt-
21-Day Dermal Toxicity Study in New Zealand White Rabbits: Lab Project
Study ID: K-049877-011. Unpublished study prepared by Dow Chemical Co
Toxicology Research Laboratory, Health and Environmental Sciences. 162 p.'
Hughes, J. (1990) The Toxicity of Tordon 101 to Selenastrum capricornutunr
Lab Project Number: 0460-04-1100-4. Unpublished study prepared by
Malcolm Pirnie, Inc. 33 p. ,
Szabo, J.; Grandjean, M. (1990) Picloram Triisopropanolamine: 13 Week
Dietary Toxicity Study in Fischer 344 Rats: Lab Project Study ID:
TXT:K-049877-009. Unpublished study prepared by Dow Chemical Co Lake
Jackson Research Center. 239 p.
Samson, Y.; Gollapudi, B. (1990) Evaluation of a Formulation Containing
Picloram Triisopropanolamine Salt in the Ames
Salmonella/Mammalian-microsome Bacterial Mutagenicity Assay Lab Project
Study I.D.: TXT:K-049877-003. Unpublished study prepared by The Dow
Chemical Co., Health and Environmental Sciences-Texas. 26 p.
McClintock, M.; Gollapudi, B. (1990) Evaluation of a Formulation Containing
Picloram Triisopropanolamine Salt in the Mouse Bone Marrow Micronueleus
Test: Lab Project Number: TXT:K-049877-005. Unpublished study prepared
by The Dow Chemical Co., Lake Jackson Research Center. 29 p.
McClintock, M.; Gollapudi, B. (1990) Evaluation of a Formulation Containing
Picloram Triisopropanolamine Salt (Picloram TIPA) in Rat Hepatocyte
Unschedule DNA Synthesis (UDS) Assay: Lab Project Number: TXT:K-
049877-004. Unpublished study prepared by The Dow Chemical Co. 41 p.
Baker, R. (1990) Product Chemistry: Picloram TIPA Concentrate.
Unpublished study prepared by DowElanco. 16 p.
Baker, R. (1990) Product Chemistry; Picloram TIPA Concentrate.
Unpublished study prepared by DowElanco. 17 p.
169
-------
Triisopropanolamine Picloram - 005102
MRID CITATION
BIBLIOGRAPHY
42343101 Domoradzki, J.; Hiser, M.; Bormett, G. et al. (1992) Picloram,
Triisopropanolamine Salt: Dissociation and Metabolism in Male Fisher 344
Rats: Lab Project Number: K-049877-013. Unpublished study prepared by. The
Dow Chemical Comp. 40 p.
42460901 Vedula, U.; Stebbins, K.; Breslin, W. (1992) Picloram Triisopropanolamine
Salt: Oral Gavage Teratology Study in New Zealand White Rabbits: Lab
Project Number: K-049877-015. Unpublished study prepared by The Dow
Chemical Co. 422 p.
42840803 Murphy, G. (1993) Determination of Color, Physical State, Odor, Melting
Point, Density, pH and Stability of Picloram Triisopropanolamine Salt (TIPA)
Technical Grade of Active Ingredient (TGAI): Lab Project Number:
FOR93046. Unpublished study prepared by DowElanco, Formulations Science
and Technology Lab. 10 p.
42840809 Reim, R. (1993) Determination of the Conditional Acid Dissociation Constant
of Picloram by Normal Pulse Polarography: Lab Project Number: ML-AL
89-040540R. Unpublished study prepared by The Dow Chemical Co. 10 p.
43027801 Murphy, G. (1993) Determination of Solubility of Picloram
Triisopropanolamine Salt (TIPA) Technical Grade of Active Ingredient (TGAI):
Lab Project Number: -FOR93048. Unpublished study prepared by DowElanco
Formulations Science and Technology Lab. 19 p.
43065001 Murphy, G. (1993) Response to Letter Written by Walter I. Waldrop (Received
12/3/93): Subject: Picloram Registration Standard: Lab Project Number:
GM122293A. Unpublished study prepared by DowElanco, Analytical and
Product Chemistry. 8 p.
43276601 Schwab, D. (1994) Evaluating the Effects of Picloram on the Germination,
Emergence, and Vegetative Vigor of Non-Target Terrestrial Plants: Final
Report: Lab Project Number: 41404. Unpublished study prepared by ABC
Laboratories, Inc. 137 p.
43307401 Baker, R.; Swayze, K. (1989) Aqueous Solubility of Picloram
Triisopropanolimine, Salt: Lab Project Number: GH/C/2264: 89045.
Unpublished study prepared by DowElanco. 15 p.
170
-------
Isooctyl/Ethylhexyl Picloram - 005103
MRID CITATION
BIBLIOGRAPHY
00131365
00164726
40094602
40178601
40479407
40479408
40479409
40479410
40479411
Hamaker, J. (1976) The Hydrolysis of Picloram in Buffered Distilled Water:
GS-1460. (Unpublished study received Aug 9, 1983 under 464-502; submitted
by Dow Chemical U.S.A., Midland, MI; CDL: 251038-A)
Grimes, J. (1986) Picloram Isooctyl Ester: A Dietary LC50 Study with the
Bobwhite: Final Report: WIL Project No. 103-249. Un published study
prepared by Wildlife International Ltd. 17 p.
Johnson, W.; Finley, M. (1980) Handbook of Acute Toxicity of Chemicals to
Fish and Aquatic Invertebrates: Resource Publi cation 137. US Fish and
Wildlife Service, Washington, D.C. 106 p.
LaskowsM, D. (1987) Aerobic Soil Degradation of Picloram Isooctyl Ester:
Laboratory Project ID: GH-C 1901. Unpublished study prepared bv Dow
Chemical U.S.A. 49 p.
Jeffrey, M.; Schuetz, D.; Eisenbrandt, D. (1987) Picloram Isooctyl Ester:
Acute Oral Toxicity Study in Fischer 344 Rats: Study No. K-041284-005A.
Unpublished study prepared by The Dow Chemical Co., Mammalian and
Environmental Toxicology Research Laboratory. 22 p.
Jeffrey, M.; Schuetz, D.; Yano, B. (1987) Picloram Isooctyl Ester: Acute
Dermal Toxicity Study in New Zealand White Rabbits: Study ID
K-041284-005D. Unpublished study prepared by The Dow Chemical Co.,
Mammalian and Environmental Toxicology Research Laboratory. 18 p.
Streeter, C.; Battjes, J.; Johnson, K. (1987) Picloram Isooctyl Ester: An Acute
Aerosol Inhalation Study in Fischer 344 Rats: K-041284-006. Unpublished
study prepared by The Dow Chemical Co., Mammalian and Environmental
Toxicology Research Laboratory. 21 p.
Jeffrey, M. (1987) Picloram Isoctyl Ester: Primary Eye Irritation Study hi New
Zealand White Rabbits: K-041284-005C. Unpublished study prepared by The
Dow Chemical Co., Mammalian and Environmental Toxicology Research
Laboratory, lip.
Jeffrey, M. (1987) Picloram Isooctyl Ester: Primary Dermal Irritation Study in
New Zealand White Rabbits: Final Rept.: K-041284005B. Unpublished study
171
-------
Isooctyl/Ethylhexyl Picloram - 005103
MRID CITATION
BIBLIOGRAPHY
prepared by The Dow Chemical Co., Mammalian and Environmental
Toxicology Research Laboratory. 12 p.
40479412 Jeffrey, M. (1987) Picloram Isooctyl Ester: Dermal Sensitization Potential in
the Hartley Albino Guinea Pig: Final Report: K041284-005E. Unpublished
study prepared by The Dow Chemical Co., Mammalian and Environmental
Toxicology Research Laboratory. 14 p.
41094904 Baker, R. (1989) Product Chemistry: Picloram Isooctyl Ester. Unpublished
study prepared by Dow Chemical U.S.A. 19 p.
41296501 Weseloh, J.; Stockdale, G. (1989) A Study To Determine the Effects of
Picloram on Seed Germination, Seedling Emergence and Vegetative Vigor: Lab
Project Number GH-P 1444; Protocol 89040. Unpublished study prepared by
Dow Chemical U.S.A. Midland Field Research Station. 170 p.
42121102 Vedula, U.; Jersey, G.; Breslin, W. (1991) 2-Ethylhexyl Ester of Picloram:
Oral Gavage Teratology Probe Study in Sprague-Dawley Rats: Lab Project
Number: DR-0044-1725-006/P. Unpublished study prepared by Dow Chemical
Co. 86 p.
42121103 Zablotny, C,; Stebbins, K.; Breslin, W. (1991) 2-Ethylhexyl Ester of Picloram:
Oral Gavage Teratology Probe Study in New Zealand White Rabbits: Lab
Project Number: DR-0044-1725-004. Unpublished study prepared by Dow
Chemical Co. 80 p.
42121104 Zablotny, C.; Stebbins, K,; Breslin, W. (1991) 2-Ethylhexyl Ester of Picloram:
Oral Gavage Teratology Study in New Zealand White Rabbits: Lab Project
Number: DR-0044-1725-008. Unpublished study prepared by Dow Chemical
Co. 260 p.
42121106 Samson, Y.; Gollapudi, B. (1991) Evaluation of Picloram EHE in the Ames
Salmonella/Mammalian Bacterial Mutagenicity Assay.: Lab Project Number:
DR-0044-1725-001. Unpublished study prepared by Dow Chemical Co. 30 p.
42121107 Hoxter, K.; Lynn, S. (1991) Picloram 2-EHE: An Acute Contact Toxicity
Study with the Honey Bee: Lab Project Number: 103-367: ESDR-0044-1725-2.
Unpublished study prepared by Wildlife International, Inc. 18 p.
172
-------
hooctyl/Ethylhexyl Picloram - 005103
t ' ''."•-
MRID CITATION
BIBLIOGRAPHY
42121108
42171601
42171602
42171603
42296901
42297001
42414001
42625901
Woodburn, K.; Hansen, S.; Ball, T. (1991) Picloram 2-EthylHexyl Ester:
Bioconcentration in Rainbow Trout, Oncorhynchus mykiss: Lab Project
Number: ES-DR-0044-1725-1. Unpublished study prepared by Dow Chemical
Co. 71 p.
Lockwood, D.; Szabo, J. (1991) Picloram 2-Ethylhexyl Ester (Picloram EHE):
Probe and 21-Day Dermal Toxicity Studies in New Zealand White Rabbits- Lab
Project Number: DR-0044-1725-005. Unpublished study prepared by Dow
Chemical Co.' 123 p.
Samson, Y.; Gollapudi, B. (1991) Evaluation of Picloram EHE in the Mouse
Bone Marrow Mieronucleus Test: Lab Project Number: DR-0044-1725-003.
Unpublished study prepared by Dow Chemical Co. 32 p.
Domoradzki, J.; Brzak, K.; Bormett, G.; et al. (1991) Picloram 2Ethylhexyl
Ester: Hydrolysis in vitro and in vivo in Fixcher 344 Rats: Lab Project
Number: DR-0044-1725-009. Unpublished study prepared by The Dow
Chemical Co. 55 p.
Vedula, U.; Stebbins, K.; Breslin, W. (1991) 2-Ethylhexyl Ester of Picloram:
Oral Gavage Teratology Study in Sprague-Dawley Rats: Lab Project Number:
DR-0044-1752-007. Unpublished study prepared by Dow Chemical. Co. 193 p.
Barna-Lloyd, T.; Szabo, J.; and Davis, N. (1991) Picloram 2-Ethylhexyl Ester
(Picloram EHE): Subchronic Dietary Toxicity Study in Fischer 344 Rats: Lab
Project Number: DR-0044-1725-002. Unpublished study prepared by The Dow
Chemical Co. 213p.
Cifone, M. (1992) Mutagenicity Test on Picloram-2-ethylhexyl Ester in the
CHO/HGPRT Forward Mutation Assay: Lab Project Number:
DR-0044-1725-010;14880-0-435DR. Unpublished study prepared by Hazleton
Washington, Inc. (Vienna and Kensington). 40 p.
Hoxter, K.; Bernard, W.; Smith, G. (1992) Access Herbicide: An Acute
Contact Toxicity Study with the Honey Bee: Lab Project Number: ES-2602:
103-389. Unpublished study prepared by Wildlife International Ltd. 20 p.
173
-------
Isooctyl/Ethylhexyl Picloram - 005103
MRID CITATION
BIBLIOGRAPHY
42645901 Hughes, J.; Williams, T. (1993) The Toxicity of Access Herbicide Formulation
to Selenastrum capricornutum: Lab Project Number: ES-2587: B460-152-1.
Unpublished study prepared by Malcolm Pirnie, Inc. 35 p.
42811901 Batzer, F.; LubinsM, R. (1993) Aqueous Photolysis of Piclorarn-IOE: Lab
Project Number: ENV93003. Unpublished study prepared by DowElanco
North American Chemistry Lab. 56 p.
42840804 Murphy, G. (1993) Determination of Color, Physical State, Odor, Melting
point, Density, pH and Stability of Picloram 2-Ethylhexyl Ester (2-EHE)
Technical Grade od Active Ingredient (TGAI): Lab Project Number:
FOR91114. Unpublished study prepared by Dow Blanco, Formulations Science
and Technology Lab. 10 p.
42840806 Chakrabarti, A. (1989) Vapor Pressure of the 2-Ethylhexyl Ester of Picloram
Measured by the Knudsen-Effusion/Weight Loss Method: Lab Project Number:
89-020121R. Unpublished study prepared by The Dow Chemical Co. 11 p.
42840807 Nicholson, L. (1989) Determination of the Octanol/Water Partition Coefficient
for Picloram 2-Ethylhexyl Ester Using Generator Column Technology: Lab
Project Number: ML-AL 89-080239. Unpublished study prepared by The Dow
Chemical Co. 25 p.
42840808 White-Henson, K. (1989) Determination of Water Solubility for Picloram
2-Ethylhexyl Ester Using Generator Column Technology: Lab Project Number:
ML-AL 89-080193. Unpublished study prepared by The Dow Chemical Co.
24 p.
42840810 Murphy, G. (1993) Determination of Solubility of Picloram 2-Ethylhexyl Ester
(2-EHE) Technical Grade of Active Ingredient (TGAI): Lab Project Number:
FOR91120. Unpublished study prepared by DowElanco, Formulation Science
and Technology Lab. 22 p.
42840811 Murphy, G. (1993) Response to Letter Written by Lois A. Rossi (1/22/93)
Subject: Picloram's Product Chemistry Review: Lab Project Number:
GM070993B. Unpublished study prepared by DowElanco, Analytical and
Product Chemistry, lip.
174
-------
Isooctyl/Ethylhexyl Picloram - 005103
MRID CITATION
BIBLIOGRAPHY
42870701
43276601
Bond, D. (1993) Picloram 2-Ethylhexyl Ester (Picloram EHE): Probe and
21-Day Dermal Toxicity Studies in New Zealand White Rabbits: Supplement to
MRID 42171601: Lab Project Number: DR-0044-1725-005. Unpublished
study prepared by DowElanco. 34p.
Schwab, D. (1994) Evaluating the Effects of Picloram on the Germination,
Emergence, and Vegetative Vigor of Non-Target Terrestrial Plants: Final
Report: Lab Project Number: 41404. Unpublished study prepared by ABC
Laboratories, Inc. 137 p.
175
-------
Potassium Picloram - 005104
MRID
BIBLIOGRAPHY
CITATION
00041475 Alexander, H.C.; Batchelder, T.L. (1965) Results of a Study on the Acute
Toxicity of Tordon(R) Herbicide to Three Species of Fish. (Unpublished study
received Nov 6, 1967 under OF0863; submitted by Dow Chemical U.S.A.,
Midland, Mich.; CDL:094524-H)
00098321 Nolan, R.J.; Smith, F.A.; Mullet, C.J.; et al. (1980) Kinetics of 14C-labeled
Picloram in Male Fischer 344 Rats. (Unpublished study received Apr 6, 1982
under 464-320; submitted by Dow Chemical U.S.A., Midland, Mich.;
CDL:247156-H)
00098322 Mensik, D.C.; Johnston, R.V.; Pinkerton, M.N.; et al. (1976) The Cytogenetic
Effects of Picloram on the Bone Marrow Cells of Rats. (Unpublished study
received Apr 6, 1982 under 464-320; prepared in cooperation with Univ. of
Texas, Medical Branch, submitted- by Dow Chemical U.S.A., Midland, Mich.;
CDL:247156-I)
00110534 Barna-Lloyd, T.; Taylor, H.; Swaim, L.; et al. (1982) Results of a Six-month
Dietary Toxicity Study of Picloram ..., Administered in the Diet to Male and
Female Beagle Dogs: Study TXT:K-038323(28). Final rept. (Unpublished
study received Aug 23, 1982 under 464-502; submitted by Dow Chemical
U.S.A., Midland, MI; CDL:248162-A)
00110537 Gorzinski, S.; Johnson, K.; Campbell, R.; et al. (1982) Technical Grade
Picloram: Results of a 13-week Dietary Toxicity Study in Fischer 344 Rats:
Laboratory Report Code MET K-038323-(32). Final rept. (Unpublished study
received Aug 23, 1982 under 464502; submitted by Dow Chemical U.S.A.,
Midland, MI; CDL: 248162-D)
**
00129063 Cope, O. (1966) Sport Fishery Research. Denver, CO: USDI. (Quarterly
progress reports, Sep 30; also In unpublished submission received Jun 24, 1983
under 464-502; submitted by Dow Chemical U.S.A., Midland, MI;
CDL:250605-B)
00151783 Gersich, F.; Hopkins, D.; Milazzo, D. (1984) The Acute and Chronic Toxicity
of Technical Picloram (4-Amino-3,5,6-trichloropicolinic acid) to Daphnia
magna Straus: ES-690. Unpublished study prepared by Dow Chemical USA.
16 p.
176
-------
Potassium Picloram - 005104
BIBLIOGRAPHY
MRID
CITATION
00151784
00155940
00157174
00164726
00164727
40479401
40479402
40479403
40479404
Mayes, M.; Dill. D.; Hopkins, D. (1984) The Toxicity of Technical Picloram
to the Embryo, Larval, and Juvenile Stages of the Rainbow Trout (Salmo
gairdneri Richardson): ES-703. Unpublished study prepared by Dow Chemical
USA. 17 p.
Landry, T.; Johnson, K.; Cieszlak, F.; et al. (1986) Picloram: A Two-year
Dietary Chronic Toxicity-oncogenicity Study in Fischer 344 Rats. Unpublished
study prepared by Dow Chemical U.S.A. 1243 p.
Beavers, J. (1985) Picloram Potassium Salt: An Acute Oral Toxicity Study with
the Mallard: Final Report: Project No. 103-245. Unpublished study prepared
by Wildlife International Ltd, 17 p. .
Grimes, J. (1986) Picloram Isooctyl Ester: A Dietary LC50 Study with the
Bobwhite: Final Report: WIL Project No. 103-249. Unpublished study
prepared by Wildlife International Ltd. 17 p.
Beavers, J. (1986) Picloram Potassium Salt: A Dietary LC50 Study with the
Bobwhite: Final Report: WIL Project No. 103-244. Unpublished study
prepared by Wildlife International Ltd. 17 p.
Jeffrey, M.; Battjes, J.; Yano, B. (1987) Tordon K Salt Liquor: Acute Oral
Toxicity Study in Fischer 344 Rats: Final Report: K050731-004A.
Unpublished study prepared by The Dow Chemical Co. Mammalian and
Environmental Toxicology Research Laboratory. 26p.
Jeffrey, M.; Phillips, J.; Lomax, L. (1987) Tordon K Salt Liquor: Acute
Dermal Toxicity Study in New Zealand White Rabbits: Final Rept.:
K-050731-004D. Unpublished study prepared by The Dow Chemical Co.,
Mammalian and Environmental Toxicology Research Laboratory. 18 p.
Streeter, C.; Battjes, J.; Yano, B. (1987) Tordon K Salt Liquor: An Acute
Aerosol Inhalation Study in Fischer 344 Rats: Final Rept.: K-050731-005.
Unpublished study prepared by The Dow Chemical Co., Mammalian and
Environmental Toxicology Research Laboratory. 20 p.
Jeffrey, M. (1987) Tordon K Salt Liquor: Primary Eye Irritation Study in New
Zeland White Rabbits: Final Rept.: K-050731-004C. Unpublished study
177
-------
Potassium Picloram - 005104
BIBLIOGRAPHY
MRID
CITATION
prepared by The Dow Chemical Co., Mammalian and Environmental
Toxicology Research Laboratory. 12 p.
40479405 Jeffrey, M. (1987) Tordon K Salt Liquor: Primary Dermal Irritation Study in
New Zealand White Rabbits: K-050731-004B. Unpublished study prepared by
The Dow Chemical Co., Mammalian and Environmental Toxicology Research
Laboratory. 10 p.
40479406 Jeffrey, M. (1987) Tordon K Salt Liquor: Dermal Sensitization Potential in the
Hartley Albino Guinea Pig: K-050731-004E. Unpublished study prepared by
The Dow Chemical Co., Mammalian and Environmental Toxicology Research
Laboratory. 13 p.
40834301 "Young, J. (1988) Picloram: 12-Month Dog Chronic Dietary Toxicity Study:
Project Study ID: TXT:K-038323-040. Unpublished study prepared by Dow
Chemical Co. 154 p.
41069501 ' Breslin, W. (1989) Historical Control Data in New Zealand White Rabbits:
Picloram: Project ID: K-050731-003. Unpublished study prepared by Dow
Chemical U.S.A. 75 p.
41094907 Baker, R. (1989) Product Chemistry: Tordon K Salt Liquor. Unpublished
study prepared by Dow Chemical U.S.A. 17 p.
41094908 Baker, R. (1989) Product Chemistry: Tordon K Salt Liquor. Unpublished
study prepared by Dow Chemical U.S.A. 21 p.
41094909 Baker, R. (1989) Product Chemistry: Tordon K Salt Liquor. Unpublished
study prepared by Dow Chemical U.S.A. 5 p.
41209602 Reitz, R.; Dryzga, M.; Helmer, D.; et al. (1989) Picloram: General
Metabolism Studies in Female Fischer 344 Rats: Project ID K-038323-044.
Unpublished study prepared by Dow Chemical Co. 57 p.
41366902 Hoxter, K.; Thompson, M.; Jaber, M. (1989) Picloram (4-Amino-3,5,
6-trichloropicoMnic Acid) K Salt (Technical): An Acute Contact Toxicity Study
with the Honey Bee: [Amended Report]: Lab Project No. 103-305.
Unpublished study prepared by Wildlife International Ltd. 18 p.
178
-------
Potassium Picloram - 005104
BIBLIOGRAPHY
MRID
CITATION
41382501
41382502
41384901
41407702
41485902
41549701
42078701
42619301
42619302
Schroeder, R. (1990) A Range-finding Study to Evaluate the Toxicity of
Picloram K Salt in the Pregnant Rat: Final Report: Lab Project Number:
89-3460. Unpublished study prepared by Bio/dynamics, Inc. 136 p.
Schroeder, R. (1990) A Teratogenicity Study in Rats with Picloram K Salt-
Final Report: Lab Project Number: 89-3459. Unpublished study prepared by
Bio/dynamics, Inc. 434 p.
Atkin, L.; Stott, W.; Stebbins, K. (1990) Picloram, Potassium Salt: 21-Day
Dermal Toxicity Study in New Zealand White Rabbits: Lab Project Study ID:
K-050731-008. Unpublished study prepared by Dow Chemical Co.,
Toxicology Research Laboratory, Health and Environmental Sciences. 160 p.
Hughes, J. (1990) The Toxicity of Picloram, Potassium Salt to Selenastram
capricornutum: Lab Project Number: 0460-04-1100-2. Unpublished study
prepared by Malcolm Pirnie, Inc. 33 p.
Samson, Y.; Gollapudi, B. (1990) Evaluation of Picloram in the Ames
Salmonella/Mammalian-microsome Bacterial Mutagenicity Assay Lab Project
Study I.D.: TXT:K-038323-046. Unpublished study prepared by The Dow
Chemical Co., Health and Environmental Sciences. 25 p.
McClintock, M.; Gollapudi, B. (1990) Evaluation of Picloram in the Rat
Hepatocyte: Unscheduled DNA Synthesis (UDS) Assay: Lab Project Number:
TXT:K-038323-047. Unpublished study prepared by Dow Chemical Co.,
Health and Environmental Sciences-Texas. 45 p.
Breslin, W.; Zielke, G.; Kociba, R. (1991) Picloram: Two-Generation on Diet
Reproduction Study in Sprague-Dawley Rats: Lab Project Number
K-038323-057FO: K-038323-057F1W: K-038323-057F1. Unpublished study
prepared by The Toxicology Research Lab. & The Dow Chemical Co. 1225 p.
Stott, W.; Yano, B.; Haut, K.; et al. (1992) Picloram: Two-year Dietary
Oncogenicity Study in B6C3F1 Mice: Lab Project Number: K-038323-058.
Unpublished study prepared by The Dow Chemical Co. 919 p.
Cosse, P.; Stebbins, K.; Sames, K.; et al. (1992) Picloram: Two-year Dietary
Chronic Toxicity/Oncogenicity Study in Fischer 344 Rats: Lab Project Number:
K-038323-056. Unpublished study prepared by The Dow Chemical Co. 983 p.
179
-------
Potassium Picloram - 005104
BIBLIOGRAPHY
MRID
CITATION
42840801 Murphy, G. (1993) Determination of Color, Physical State, Odor, Melting
Point, Density, pH and Stability of Picloram Potassium Salt (K) Technical
Grade of Active Ingredient (TGAI): Lab Project Number: FOR93047.
Unpublished study prepared by DowElanco, Formulations Science and
Technology Lab. 10 p.
42840809 Reim, R. (1993) Determination of the Conditional Acid Dissociation Constant
of Picloram by Normal Pulse Polarography: Lab Project Number: ML-AL
89-040540R. Unpublished study prepared by The Dow Chemical Co. 10 p.
42978101 Murphy, G. (1993) Determination of Solubility of Picloram Potassium Salt (K)
Technical Grade of Active Ingredient (TGAI): Lab Project Number:
FOR93049. Unpublished study prepared by DowElanco, Formulations Science
Technology Lab. 17 p.
43065001 Murphy, G. (1993) Response to Letter Written by Walter I. Waldrop (Received
12/3/93): Subject: Picloram Registration Standard: Lab Project Number:
GM122293A. Unpublished study prepared by DowElanco, Analytical and
Product Chemistry. 8 p.
43276601 Schwab, D. (1994) Evaluating the Effects of Picloram on the Germination,
Emergence, and Vegetative Vigor of Non-Target Terrestrial Plants: Final
Report: Lab Project Number: 41404. Unpublished study prepared by ABC
Laboratories, Inc. 137 p.
180
-------
APPENDIX D. List of AvaOable Related Documents
181
-------
-------
The following is a list of available documents related to Picloram acid and its
derivatives (Case # 0096). 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
Picloram acid and its derivatives and are included in the EPA's Office of Pesticide Programs
Public Docket.
1.
2.
3.
4.
5.
Health and Environmental Effects Science Chapters
Detailed Label Usage Information System (LUIS) Report
Picloram RED Fact Sheet
PR Notice 86-5 (included in this appendix)
PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
183
-------
-------
APPENDIX E. PR Notices 86-5 and 91-2
185
-------
-------
PR Notice 86-5
187
-------
-------
jSCteosn
A
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
July 29,1986
PR NOTICE 86-5
OHEICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
Attention:
Subject:
I. Purpose
NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Persons responsible for Federal registration of pesticides .
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).
J? reqilirl^taxi0 I36 submitted to the Environmental Protection Agency (EPA) in a
format ° Pr°VideS additi°nal guidance about' andlUustratioS of, the
Applicability
This PR Notice applies to all data that are submitted to EPA to satisfy data
rai?ng °r mai ntai?ing Pesticide registrations, experimental use permits,
FS^s^E???? uTn^r certain provisions of FIFRA and FFDCA.^These data
;nf ^ § tyty' Thls ^otlc& ^ not *&?& to commercial, financial, or
informatlon' which are, and must continue to lie, submitted differently under
separate cover.
III. Effective Date
This notice is effective on November 1, 1986. Data formatted according to this notice
Sbdtt° ** 6ff?Ctive date" A£ of the effective date' ^bmirgi daS p
to these requirements may be returned to the submitter for necessary
.
IV. Background
(dQ FR w .26', I98t' EPA published proposed regulations in the Federal Register
(49 FR 37956) which include Requirements for Data Submission (40 CFR §158 32) and
%%**?£*** CJr^ Conufid.entiality of Data (40 CFR §158.33). These regulationT
specify the format for data submitted to EPA under Section 3 of FIFRA and Sections 408 and
?nnf£Ln? i£ ' ^d P^fdures which must be followed to make and substantiate claims of
?egulation^r by 8 *° confidentiality *™ changed, either by the proposed
T?PP^S ^^^ these requirements mandatory through this Notice to gain resource-
oenefits from their use before the entire proposed regulation becomes final. Adequate
lead time is being provided for submitters to comply with the new requirements
189
-------
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 parry. 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-
Text Example
Page Page
17
A. Organization of the Submittal Package T 3
B. Transmittal Document 4 11
C. Individual Studies ' 4
C. 1 Special Considerations for Identifying Studies 5
D. Organization of each Study Volume 6 17
D. 1 Study Title Page 7 12
D. 2 Statement of Data Confidentiality Claims
(based on FIFRA §10(d)(l)) .8 13
D. 3 Confidential Attachment 8 15
D. 4 Supplemental Statement of Data Confidentiality
190
-------
i^ c9Pnis,^0JherthanthosebasedonFIFRA§10(d)(l)) & 14
D. 5 Good Laboratory Practice Compliance Statement r. . '. '. '. i; '.'.'.'.'.'.'.'.'.'.'.[. 9 [I
E. Reference to Previously Submitted Data ................. o
F. Physical Format Requirements & Number of Copies ................... 9
G. Special Requirements for Submitting Data to the Docket ...............
10
A- Organization of Submittal Package
ASulmital
consists of all studies submitted at the same time for review in
1^ With a * ansmittai document and ome? refS
of support statement, EPA Forms 8570-1, 8570-4,
transmittnH °.rganiz? each submittal package as described in this Notice. The
transmittal and any other administrative material must be grouped together in the first nhvsiral
volume. Each study included in the submittal package must then be found separately P Y
Submitters sometimes provide additional materials that are intended to clarify
°r C°mment l° MP Pr°duCt Managers and reviewers bettef understand
studySUCh materials relate to one study' they should be included as an appendix to that
Pa°
- 1° more than one study (as for example a summary of all
ne) or to the submittal m general, they must be included in the
y
page and statement of confidentiaUty
B. Transmittal Document
ea,fh submittal package must be a transmittal document. This
?ubm"ter. or all joint submitters; the regulatory action in support of
^ appliSation, petition, expe?Pmen?al
trnl ,,.-,' (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^ata rlquirement(s)
dsed by each one. The EPA-assigned number for the regulatory actfon ™ me
' ance petltl0n number> should be Eluded In the transmittel
SeeA«achmentlforanexampleofan ,
The list of included studies in the transmittal of a data
. eivided by discipiine-
^
191
-------
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.
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 title page as page 1.
The total number of pages in the com-plete study must be shown on the study title page. In
addition (to ensure that inadvertently separated pages can be reassociated with the proper study
during handling or review) use either of the following:
- Include the total number of pages in the complete study on each page (i.e., 1 of 250,
2 of 250, ...250 of 250).
- Include a company name or mark and study number on each page of the study, e g ,
Company Name-1986-23. Never reuse a study number for marking the pages of
subsequent studies.
When a single study is extremely long, binding it in mul-tiple 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 ot an end-use product produced from registered manufacturing-use
products should be bound as a single study under a single title page.
Product chemistry data submitted in support of a technical product, other
manufacturing-use product, an experimental use permit, an import tolerance petition, or an
end-use product produced from unregistered source ingredients, should be bound as a single
study for each Guideline series (61, 62, and 63) for conventional pesticides, or f9r the
equivalent subject range lor biorational pesticides. The first of the three studies in a complete
192
-------
K°d?f chemistry submittal for a biochemical pesticide would cover Guidelines 151-10
151-11, and 151-12; the second would covexGuidelineUS.l-lS, 151-15, and 151-16- the third
rn^rC°Vei^nellAei W'17^^ S?1 s&^ for a ™&°tid pesticide would cover
?£ f£ fh ^-i0' 15,V21' and ^l-?2; 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
h33S Infrm^on as defined in FIFRA §l(f(d)(l)(A), (B), or (C), and if so rZt be
handled as described in section D. 3. of this notice.
, . .
-------
of Data Confidentiality
Claims
claimed on a basis other than
FIFRA §10(d)(l)(A), (B), or (C)
D.I. Title Page
„, . A.title page is always required for each submitted study, published or unpublished.
The title page must aiways t,e freei[y reieasable to requestors; DO NOT INCLUDE CBI ON
££US 'ITl'JLE 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. rr .
b- Data requirement addressed. Include on the title page the Guideline number(s) of the
specific requirements; 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 periormed 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, inciuae on tne rme 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 suDmittea 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 ail relevant tacts 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 title 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).
194
-------
D.3. Confidential Attachment
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
hm the b°dy °f the Study at the P°int from which *e passTwS
. ?he ? onfldential Attachment to a study must be identified by a cover sheet fullv
6 ant and ""f £e clearlv marked "Confidential Attachment. "An
P10?^ of ?e P3*61* study title Pa§e may be used as this cover
wih naai nf entiaf Attachment separately from the body of the study, beginning
with page 1 of X on the title page. Each passage confined to the Confidential Attachmlnt
s£eciflcfcross reference to the page(s) in the main body of th? study
of '
D . 4. Supplemental Statement of Data Confidentiality Claims (See
Attachment 4)
A AIf y?u wi-lh ^mfeS claim of confidentiah'ty for any portion of a submitted studv
other than described by FIFRA §10(d) (1)(A), (B), or (C), fee 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
on™' 14 P°mtS t0 address in such a statement is included in Attachment 4
- 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 m 48 CFR 160. Samples of these statements are shown in Attachment
E- Reference to Previously Submitted Data
FOR ANO^T A,STISX THAI ^ PREVIOUSLY BEEN SUBMITTED
ninftirS?!^11 PJJRP.P1SE un e?s ERA 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 "culdieiy
S^T/ °t Kendmig ^r? C?pies of ^e study- References to previously submitted studies
should not be included in the transmittal document, but should be incorporated into the
statemenTof the method of support for the application. i*»«iuxi
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
195
-------
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 pi
"Public Docket Material - contains no information claimed as confidential"
•hrase
196
-------
V. For Further Information
Progr ^
/s/
James W. Akerman
Acting Director,
Registration Division
Attachment 1.
Attachment 2.
Attachment 3.
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
197
-------
1.
ATTACHMENT 1
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
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:
Signature
Name
Name
Phone
198
-------
ATTACHMENT!
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
Study Title
(Chemical name) - Magnitude of Residue on Corn
Data Requirement
Guideline 171-4
Author
John C. Davis
Study Completed On
January 5, 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Project ID
ABC 47-79
Page 1 of X
(X is the total number of pages in the study)
199
-------
-------
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 th-i s
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
mat 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 OPP
implements this policy by returning submitted analytical methods, for which confidentiality
claims have been made, to the submitter, to obtain the confidentiality waiver before thev can
be processed.
201
-------
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
which you claim confidentiality.
and line number(s) each portion 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.
202
-------
ATTACHMENTS
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 PHRASEL Ethylene Glycol
PAGE LINES REASON FOR THE DELETION
REFERENCE
6
28
100
14
25
19
Identity of Inert Ingredient
FIFRA
§10(d)(C)
Example 2. (Confidential paragraph(s) that have been deleted from the study)
CROSS REFERENCE NUMBER 5
DELETED PARAGRAPH(S):
This cross reference number is used in the study in place of the
following paragraph^) at the indicated volume and page
references.
PAGE
20.
Reproduce die deleted paragraphs) here
LINES REASON FOR THE DELETION
2-17 Description of the quality control process
FIFRA REFERENCE
Examples. (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
35-41.
REASON FOR THE DELETION FIFRA REFERENCE
Description of product manufacturing process §10(d)(l)(A)
203
-------
-------
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.
Submi tt er •
205
-------
-------
ATTACHMENT 7.
FORMAT OF THE SUBMITTAL PACKAGE
Transmittal Document
Related Administrative Materials .
(e.g. Method of Support Statement, etc.)
Other materials about the submittal
(e.g., summaries of groups of studies
to aid in their review).
Studies submitted as unique
to the format below.
FORMAT OF SUBMITTED STUDIES
Study title page.
Statement of Confidentiality Claims.
GLP and flagging* statements - as appropriate.
Body of the study, with English
language translation if required.
Appendices to the study.
Title Page of the Confidential
{-•—" " Attachment.
-: :__ —Confidential Attachment.
! ..-•—•> ] Supplemental Statement
'•-—;-"" 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.
LEGEND
207
-------
-------
PR Notice 91-2
209
-------
-------
A
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION. PESTICIDES
AND TOXIC SUBSTANCES
PR NOTICE 91-2
NOTICE TO
ATTENTION: Persons Responsible for Federal Registration of Pesticide Products.
SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement
I. PURPOSE:
°f M! notice is to ?larify ^ Office of Pesticide Program's policy with
statement of percentages in a pesticide's label's ingredient statement.
11 (Percent by weight) of ingredient(s) specified in the ingredient
nra'i^^Sr^A*6 "rt81 c°^entra*°* of soch ingregdient(s), as that
£ 158-153(i). Accordingly, the Agency has established the nominal
produc acceptable label claim for the amount of active ingredient in the
II. BACKGROUND
?£r S°me ?me .the Agency has accepted two different methods of identifying on the
fiK??880 "l^ med for *S mFedient(s) contained in a pesticide. Som! applicants
aPercentafe wtoch represented a level between the upper and the lower certified
,K Was re5erred to as the npminal concentration. Other applicants claimed the lower
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. Unfortunatelyf this led to a great deal of
confusion among the regulated industry, the regulators, and the consumer! as to exactly how
Z^ntLfglVen !?Sredient .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
be as
to encompass
lower certi?ed Mmits' which must be proposed in connection with a
-, ™ i> rePresent the amounts of an ingredient that may legally be present 40
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 nominal concenttation
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
211
-------
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).
HI. 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
significance(i.e., upper limit(s) only) and on a case by case basis as specified by EPA. These
limits are to be set Ibased 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:
(1) Beginning July 1, 1991, all new product registrations submitted to the Agency
are to comply with the requirements of this Notice.
istrants having products subject to reregistration under FIFRA section 4(a)
are to comply with the requirements of this Notice when specific products are
(2) Registrants
are to coim;
called in by the Agency under Phase V of the Reregistration Program.
212
-------
(3) All other products/applications that are not subject to (1) and (2) above will
have until July 1, 1^7, 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)
213
-------
-------
APPENDIX F. Combined Generic and Product Specific
Data Call-in
215
-------
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
.PESTIC
UBSTANCES
GENERIC AND PRODUCT SPECIFIC
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
reSuirf. y°Au and other registrants of pesticide products containing the
tnc efn*fied "i Attachment A of this Notice, the Data Call-in Chemical Sfcrtus
* S* °f Th d^ aS n°ted herein t0 the U'S- Environmental Protection Agency
Agen9y)- i yese data are necessary to maintain the continued registration of vour
tr cSntaininf thl,s ac^ve ingredient. Within 90 days after you receive this Notice you
must respond as set forth in Section IE below. Your response must state:
How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 7; or
1 .
believe you are exempt from the requirements listed in this Notice and
in Attachment 3 (for both generic and product specific data), the Requirements
Status and Registrant's Response Form, (see section HI-B); or — -
3 . Why you believe EPA should not require your submission of data in the manner
. specified by this Notice (see section HI-D).
«rith ;telf Y°* d° n°.t resP°nd 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 oT
your produces) subject to this N9tice wit be subject to suspension. We have prolkied a Ust of
all of your products subject to this Notice in Attachment 2 All products are listed on both the
generic ancf product specific Data Call-in Response Forms. Also include? is a Hst of aS
registrants who were sent this Notice (Attachment b). -
A r, Jhe.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). Col ection of Sis
, ... .
2070 n9mnn- * Pa5erw?rl Reduction Act by OMBApproval No
2070-0107 and 2070-0057 (expiration date 3-31-96).
This Notice is divided into six sections and seven Attachments. The Notice itself
contains information and instructions applicable to all Data Call-In Notices. The Attachments
contain specific chemical information and instructions. The six sections of the Notice are:
Section I
Section II
Section El
Section IV
Section V
Section VI
Why You are Receiving this Notice
Data Required by this Notice
Compliance with Requirements of this Notice
Consequences of Failure to Comply with this Notice
Registrants ' Obligation to Report Possible Unreasonable Adverse Effects
Inquiries and Responses to this Notice
217
-------
The Attachments to this Notice are:
Data Call-in Chemical Status Sheet
1-
2-
3-
4-
5-
6-
7-
uenenc uata uaii-in and Product Specific Data Call-in Response Forms with
instructions *
Generic Data Call-In and Product Specific Data Call-In Requirements Status
ana Registrant's Response frorms with instructions
Jtfatcning or. Jbnd-Use Froclucts for Meeting Acute Toxicology Data
Requirements tor Keregistration
br A Acceptance unteria ~
Ust ot Registrants Receiving This Notice
Uost Snare and Data Compensation Forms
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient(s) and reevaluated the
data needed to support continued registration of the subject active ingredient(s). This
reevaluation identified additional data necessary to assess the health and safety of the continued
use of products containing this active ingredient(s). You have been sent this Notice because
you have produces) containing the subject active ingredients.
SECTION n. DATA REQUIRED BY THIS NOTICE
n-A. DATA REQUIRED
The data required by this Notice are specified in the Requirements Status and
Registrant's Response Forms: Attachment 3 (for both generic and product specific data
requirements;. Depending on the results of the studies required in this Notice, additional
studies/testing may be required.
n-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified
in the Requirements Status and Registrant's Response Forms (Attachment 3). within the
timeframes provided. ~~~
n-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test
standards outlined in the Pesticide Assessment Guidelines for those studies for which
guidelines have been established.
These EPA Guidelines are available "from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (Telephone number:
703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD recommended test standards conform to those
specified in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the
OECD protocols, they should be modified as appropriate so that the data generated by the
study will satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend
deadlines for complying with data requirements when the studies were not conducted in
accordance with acceptable standards. The OECD protocols are available from OECD, 2001 L
218
-------
- 2°°36
number 202-785-6323; Fax telephone
Mntw ™;e;T' -Studies ^nd Proposed protocols submitted in response to this Data Call-in
Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES ISSUED
Unless otherwise noted herein, this Data Call-in does not in any way supersede or
the requirements of any previousTJata Call-ln(sj, oTanyather agreements entered into
. J Agency pertaining to sucn prior JNotice. Registrants must comply with the
rroductT Notlces to avoicf issuance of a Notice of Intent to Suspend their affected
SECTION m. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
„ '+L. +L--
witn tne
xw,v ™ must usf *he cornet forms and instructions when completing your response to this
Notice. The type of Data Call-in you must comply with (Generic 01 Product Specific) is
specified m item number 3 on the four Data Call-in forms (Attachments 2 and 3)
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
^ifi aPProffiate responses initiaUy required by this Notice for generic and product
ecific 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 '
SSi^^NnT^1111?11^9,8118?6^ (NOEXaflteting 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
IH-B. OPTIONS FOR RESPONDING TO THE AGENCY
1- Generic Data Requirements
The options for responding to this Notice for generic data requirements are- (a)
voluntary. cancellation, (b) delete use(s), (c) claim generic data exemption, (d) agree to satisfy
the generic data requirements imposed by this Notice or (e) request a data waiver(s).
r^w. £ djs^uss|.on of how to respond if you choose the Voluntary Cancellation option, the
Delete Use(s) option or the Generic Data Exemption option is presented below. A discussion
of the various options^vailable for satisfying the generic data requirements of this Notice is
contained in Section ffl-C. A discussion of options relating to requests for data waivers is
contained, in oection Ill-D.
Two forms apply to generic data requirements, one or both of which must be used in
responding to the Agency, depending upon your response. These two forms are the
Data-Call-in Response Form, and the Requirements Status and Registrant's Response Form
(contained in Attachments 2 and 3, respectively). - - ~ - ^===-'
x, ,. IJf Data Call-in Response Forms must be submitted as part of every response to this
Notice. The Requirements status ancTRegistrant's Response Forms also must be submitted if
you do not qualify for a generic uata exemption or are not requesting voluntary cancellation
of your registration^) Please note that the. company's authorized representative is required to
sign the first page of both Data Call-in Response Forms and the Requirements Status and
Registrant s Response Forms ur tms form is required! and initial any subsequent pages The
rorms contain separate detailed instructions on the response options. Do not "alter the printed
219
-------
material. If you have questions or need assistance in preparing your response, call or write the
contact person(s) identified in Attachment 1.
a. Voluntary Cancellation -
You may avoid the requirements of this Notice by requesting voluntary cancellation of
your product(s) containing the active ingredient that is the subject of this Notice. If you wish
to voluntarily cancel your product, you must submit completed Generic and Product Specific
Data Call-in Response Forms (Attachment 2), indicating your election of this option.
Voluntary cancellation is item number 5 on both Data Call-in Response Form(s). If you
choose this option, these are the only forms that you are required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice, which are contained in Section IV-C.
b.
Use Deletion -
You may avoid the requirements of this Notice by eliminating the uses of your product
to which the requirements apply. If you wish to amend your registration to delete uses, you
must submit the Requirements Status and Registrant's Response Form (Attachment 3), a
completed application lor amendment, a copy ot your proposed amended labeling, and all
other information required for processing the application. Use deletion is option number 7
under item 9 in the instructions for the Requirements Status and Registrant's Response Forms.
You must also complete a Data Call-in Response Form by signing the certification, item
number 8. Application forms tor amending registrations may be obtained from the
Registration Support Branch, Registration Division, Office of Pesticide Programs, EPA, by
catting (703) 308-8358.
If you choose to delete the use(s) subject to this Notice or uses subject to specific data
requirements, further sale, distribution, or use of your product after one year from the due
date of your 90 day response, is allowed only if the product bears an amended label.
c. Generic Data Exemption -
Under section 3(c)(2)(D) of FIFRA, an applicant for registration of a product is
exempt from the requirement to submit or cite generic data concerning an active ingredient if
the active ingredient in the product is derived exclusively from purchased, registered pesticide
products containing the active ingredient. EPA has concluded, as an exercise of its discretion,
that it normally will not suspend the registration of a product which would qualify and
continue to qualify for the generic data exemption in section 3(c)(2)(D) of FIFRA. To qualify,
aU of the following requirements must be met:
(i). The active ingredient in your registered product must be present solely because of.
incorporation of another registered product which contains the subject active ingredient
and is purchased from a source not connected with you;
(ii). Every registrant who is the ultimate source of the active ingredient in your
product subject to this DCI must be in compliance with the requirements of this Notice
and must remain in compliance; and
(iii). You must have provided to EPA an accurate and current "Confidential Statement
of Formula" for each of your products to which this Notice applies.
220
-------
~ To apply for the Generic Data Exemption you must submit a completed Data Call-In
Response Form Attachment 2 and all supporting documentation. The Generic Data Exemption
is item number 6a on the Data Call-in Response Form. If you claim a generic daSexempS
KLn,Xe *°VeSulred50 comP^te the Requirements Status and Registrant's Response Form
(jenenc Data Exemption cannot be selected as an option tor responding to product specitic
tlatd.
granted- a Generic Data Exemption, you rely on the efforts of other persons
™e>CI W"h *6 ^red data. F the registrant(s) who have committed to
generate and submit the required dka fail to take appropriate steps to meet requirements or are
no longer in compliance with this Data Call-in Notice, the Agency will consider that both mev
nf hS,Uv?e not,QomPliance and will normally initiate. proceedings to suspend the registrations '
of both our and their product®, unless you commit to submit and do submit the required
SdaS.
d- Satisfying the Generic Data Requirements of this Notice
^various options available to satisfy the generic data requirements of this
e 9lscussed in Section m-C.l. of this Notice and comprise options 1
^^^ £* the Requirements Status and Registrant's Res
ra on- the Data Call-in Response Form it von choose nem hh (agrPp m
e generic data requirements j, you must submit the Data Call-In Response Form and the
Requirements Status and Registrant's Response Form as well as any other information/data
?oe^fmlrE^°T?Mpp?A°S?n>0 addres£ ^ d*** re
-------
separate detailed instructions on the response options. Do not alter the printed material. If you
have questions or need assistance in preparing your response, call or write the contact
person(s) identified in Attachment 1.
a. Voluntary Cancellation
You may avoid the requirements of this Notice by requesting voluntary cancellation of
your produces) containing the active ingredient that is the subject of this Notice. If you wish
to voluntarily cancel your product, you must submit a completed Data Call-In Response Form,
indicating your election ofthis option. Voluntary cancellation is item number r> on both the
Generic and Product Specific Data Call-In Response Forms. If you choose this
option, you must complete bom Data Call-in response rorms. These are the only forms that
you are required to complete.
If you choose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
b. Satisfying the Product Specific Data Requirements of this Notice.
There are various options available to satisfy the product specific data requirements of
this Notice. These options are discussed in Section in-C.2. of this Notice and comprise
options 1 through 6 of item 9 in th$ instructions for the product specific Requirements Status
and Registrant's Response Form and item numbers 7a and To (agree to satisfy the product
specmc data requirements tor an MUP or EUP as applicable) on the product specific Data
Call-in Response Form. Note that the options available for addressing product specific data
requirements dirter slightly from those options for fulfilling generic data requirements.
Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
groduct specific data requirements. It is important to ensure that you are using the correct
rorms and instructions when completing your response to the Reregistration Eligibility
Decision document.
• c. Request for Product Specific Data Waivers.
Waivers for product specific data are discussed in Section HI-D.2. of this Notice and
are covered by option 7 of item 9 in the. instructions for the Requirements Status and
Registrant's Response Form. If you choose this option, you must submit the Data Uall-in
Response Form and tfte Requirements Status and Registrant's Response Form as well as any
otner mtormation/data pertaining to the option chosen to address the data requirement. Your
response must be on the forms marked "PRODUCT SPECIFIC" in item number 3.
in-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
1. Generic Data
If you acknowledge on the Generic Data Call-In Response Form that you agree to
satisfy the generic data requirements (i.e. you select item number 6b), then you must select
one of the six. options on the Generic Requirements Status and Registrant's Response Form
related to data production for each data requirement. Your option selection snould be entered
under item number 9, "Registrant Response." The six options related to data production are
the first six options discussed under item 9 in the instructions for completing the Requirements
Status and Registrant's Response Form. These six options are listed
immediately below with information in parentheses to guide you to additional instructions
provided in this Section. The options are:
222
-------
(1)
(2)
(3)
(4)
(5)
(6)
I will generate and submit data within the, specified timeframe (Developing
I have entered int9 an agreement with one or more registrants to develop data
jointly (Cost Sharing) • v
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 partiallv
acceptable and upgradeable (Upgrading a Study)
V? ^A^ fisting study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agencv (Citing an
Existing Study) . 3 ^ &
Option 1. Developing Data
rf~,/™«
deadlines
Ch-?!?Se.i!0 ^op the ^quired data it must be in conformance with Agency
with other Agency requirements as referenced herein and in the attachments All
pro™ a£d submitted must ™mPl? with the Good Laboratory Practice (GLP) rule (40
CFR Part 160), be conducted according to the Pesticide Assessment Guidelines (PAG) and be
? Oc°nformance wifi the requirements of PR Notice 86-5. In addition, certain studies require
Agency approval of test protocols in advance of study initiation. Those studies for which a
protocol must be submitted have been identified in the Requirements Status and Registrant's
Response Form and/or footnotes to the form. If you wish to use a protocol which littStrom
flJopTIons^ussed in Section II-C of this Notice, you must submit a detailed [description rf
?5r52^i P0^1^ y°ur.reasonfor. wishing to use it. The Agency may choose to reject
™Prifi J ?9 not- specified in Section II-C If the Agency rejects your protocol you will be
notified in writing, however, you should be aware that rejection of a proposed protocol will
not be a basis for extending the deadline for submission of data.
A progress report must be submitted for each study within 90 days from the date vou
are required to commit to generate or undertake some other means to address that studv
requirement such as making an offer to cost share or agreeing to share in the cost of
iS^te^ ^ S^ y' JhlS 90u"day Pr°Fess reP°rt must include me date the study was or will
be initiated and, for studies to be started within 12 months of commitment, the name and
address of the laboratories) or individuals who are or will be conducting the study.
In addition, if the time frame for submission of a final report is more than 1 vear
interim reports must be submitted at 12 month intervals from the date you are required to
fnT™1,1-0 generate or otherwise address the requirement for the study. In addition to the other
£tSa^noSSe£ ? In *? P,receding paragraph at a minimum, a brief description of current
activity on and the status of the study must be included as well as a full
description of any problems encountered since the last progress report.
*• A. The ^roe £amAes in th? Requirements Status and Registrant's Response Form are the
time frames that the Agency is allowing tor the submission of completed study reports or
protocols. The noted deadlines run from the date of the receipt of this Notice by the registrant
If the data are not submitted by the deadline, each registrant is subject to receipt of a Notice of
Intent to Suspend the affected registration(s).
. If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements (s), you must submit a request to
the Agency which includes: (1) a detailed description of the expected difficulty and (2) a
proposed schedule including alternative dates for meeting such requirements on a step-by-step
basis. You must explain any technical or laboratory difficulties and provide documentation
rrom the laboratory performing the testing. While EPA is considering your request the
223
-------
original deadline remains. The Agency will respond to your request in writing. If EPA does
not grant your request, the original deadline remains. Normally, extensions can be requested
only in cases of extraordinary testing problems beyond the expectation or control of the
registrant. Extensions will not be given in submitting the 90-day responses. Extensions will
not be considered if the request for extension is not made in a timely fashion; in no event shall
an extension request be considered if it is submitted at or after the lapse of the subject
deadline.
Option 2. Agreement to Share in Cost to Develop Data
If you choose to enter into an agreement to share in the cost of producing the required
data but will not be submitting the data yourself, you must provide the name of the registrant
who will be submitting the data. You must also provide EPA with documentary evidence that
an agreement has been formed. Such evidence may be your letter offering to join in an
agreement and the other registrant's acceptance of your offer, or a written statement by the
parties that an agreement exists. The agreement to produce the data need not specify all of the
terms of the final arrangement between the parties or the mechanism to resolve the terms.
Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the agreement they
may resolve their differences through binding arbitration.
Option 3. Offer to Share in the Cost of Data Development
If you have made an offer to pay in an attempt to enter into an agreement or amend an
existing agreement to meet the requirements of this Notice and have been unsuccessful, you
may request EPA (by selecting this option) to exercise its discretion not to suspend your
registrations), 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
registrants) developing the data has refused to accept the offer. To qualify for this option, you
must submit documentation to the Agency proving that you have made an offer to another
registrant (who has an obligation to submit data) to share in the burden of developing that
data. You must also submit to the Agency a completed EPA Form 8570-32, Certification of
Offer to Cost Share in the Development of Data, Attachment 7. In addition, you must
demonstrate that the other registrant to whom the offer was made has not accepted your offer
to enter into a C9St-sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that offer (such as a certified mail receipt). Your offer must, in addition
to anything else, offer to share in the burden of producing the data upon terms to be agreed to
or, failing agreement, to be bound by binding arbitration as provided by FIFRA section
3(c)(2)(B)(iii) and must not qualify this offer. The other registrant must also inform EPA of its
election of an option to develop and submit the data required by this Notice by submitting a
Data Call-In Response Form and a Requirements Status and Registrant's Response Form
committing to develop ana submit the data required by this JNotice.
In order for you to avoid suspension under this option, you may not withdraw your
offer to share in the burden of developing the data. In addition, the other registrant must fulfill
its commitment to develop and submit the data as required by this Notice. If the other
registrant fails to develop the data or for some other reason is subject to suspension, your
registration as well as that of the other registrant normally will be subject to initiation of
suspension proceedings, unless you commit to submit, and dp 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.
224
-------
Option 4. Submitting an Existing Study
? subP!? an existing study in response to this Notice, you must
t , ,^ Satiffies the recrements 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
r Wlth tlis N3tice' ^ormally without an extension?? toe'
d Uoe pd gen°y may determme at anv time that a stud[y * not valid
Notice for submitting an existing study'
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
P JfffT16^8 °/-thex??^clLall?ratory Practice (GLP) regulation, 40 CFR
Part 160. As stated m 40 CFR 160.3 'Raw data1 means any laboratory
worksheets, records, memoranda, notes, or exact copies thereof, that are the
result of original observations and activities of a study and are necessary for the
reconstruction and evaluation of the report of that study. In the event that exact
transcripts of raw data have been prepared (e.g., tapes which have been
transcribed verbatim, dated, and verified accurate by signature), the exact CODV
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 mstruments." The term "specimens", according to 40 CFR
160. 3, means any material derived from a test system for examination or
analysis.
Health and safety studies completed after May 1984 also must also contain all
GLP-reqmred quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants also must certify at the time of
submitting the existing study that such GLP information is available for post
May 1984 studies by including an appropriate statement on or attached to the
study signed by an authorized official or representative of the registrant.
You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Registration Phase 3
1 echmcal 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
^ny fco3^ mue-els the PurJP°se of *e PAG. The registrant is referred to 40
L.FK ips. /O 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 anv
supporting information or data. It has been the Agency's experience that studies
completed prior to January 1970 rarely satisfied toe purpose of toe PAG and
that necessary raw data usually are not available for such studies
225
-------
If you submit an existing study, you must certify that the study meets all requirements
of the criteria outlined above.
If EPA has previously reviewed a protocol for a study you are submitting, you must
identify any action taken by the Agency on the protocol and must indicate, as part of your
certification, the manner in which all Agency comments, concerns, or issues were addressed
in the final protocol and study.
If y9U know of a study pertaining to any requirement in this Notice which does not
meet the criteria outlined above but does contain factual information regarding unreasonable
adverse effects, you must notify the Agency 9f such a study. If such study is m the Agency's
files, you need only cite it along with the notification. If not in the Agency's files, you must
submit a summary and copies as required by PR Notice 86-5.
Option 5. Upgrading a Study
If a study has been classified as partially acceptable and upgradeable, you may submit
data to upgrade that study. The Agency will review the data submitted and determine if the
requirement is satisfied. If the Agency decides the requirement is not satisfied, you may still
be required to submit new data normally without any time extension. Deficient, but
upgradeable studies will normally be classified as supplemental. However, it is important to
note that not all studies classified as supplemental are upgradeable. If you have questions
regarding the classification of a study or whether a study may be upgraded, call or write the
contact person listed in Attachment 1. If you submit data to upgrade an existing study you
must satisfy or supply information to correct all deficiencies in the study identified by EPA.
You must provide a clearly articulated rationale of how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA. Your submission must also
specify the MRID number(s) of the study which you are attempting to upgrade and must be in
conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option also should be used to cite data that has been previously submitted to
upgrade a study, but has not yet been reviewed by the Agency. You must provide the MRID
number of the data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to
all data submissions intended to upgrade studies. Additionally, your submission of data
intended to upgrade studies must be accompanied by a certification that you comply with each
of those criteria, as well as a certification regarding protocol compliance with Agency
requirements.
Option 6. Citing Existing Studies
If you choose to cite a study that has been-previously submitted to EPA, that study
must have been previously classified by EPA as acceptable, or it must be a study, which has
not yet been reviewed by the Agency. Acceptable toxicology studies generally will have been
classified as "core-guideline" or "core-minimum." For ecological effects studies, the
classification generally would be a rating of "core." For all other disciplines the classification
would be "acceptable." With respect to any studies for which you wish to select this option,
you must provide the MRID number of the study you are citing and, if the study has been
reviewed by the Agency, you must provide the Agency's classification of the study.
If you are citing a study of which you are not the original data submitter, you must
226
-------
2. Product Specific Data
^ o ri If £°U ac^owkdge on the product specific Data Call-in Response Form that you aaree
to satisfy the product specific data requirements (i.e. you select option /a or 7b) then you
must setect one of the six options on the Requirement^ Status amTReoistSmt' Resnnn
related to data production for each data requirement. Your option selection should be T
under item number 9 "Registrant Response. " The six options SaSSfStoSSS
1? ^H™ the inst™ctions ?* completing ffe Re?ui?ementS
Form. These six options are listed immediately below with
g registrants to additional instructions provided inthis
• . . . ..
Sec ™n -The
(1)
(2)
(3)
(4)
(5)
(6)
Data) generate and submit data within the sPecified time-frame (Developing
jointiy (cSf Sharing agreement with one or more registrants to develop data
I have made offers to cost-share (Offers to Cost Share)
1 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) y
EPA has classified as acceptable or an existing
submitted but not reviewed by the Agency (Citing an Existing Study)
" The- requirements for developing product specific data are the
m-c '>
in
., t0 Share in Cost to DeveJQP Data - If you enter into an agreement to cost
hare me same requirements apply to product specific data as to generic dlta (see Section
in C.I Option 2). However, registrants may only choose this option for acute toxicity data
±HSTHef?f ^ data ^ °nly,if EPA has **&*** ^ *e attached data Sblefthat yoS?
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
- 1 the Pr-oduct for, w¥ch da4 will be submftted must be noted
agreement to cost snare by the registrant selecting this option. -
Shafe ,in.the. £ost of Data Development -The same requirements for
°^» ^ aPP^ ">
SF COI| 5'(SinnaMn?n^|SttdTh" Thf- "T re^em&nts described for generic data (see Section
in. i_ . l . , Option 3) apply to this option for product specific data.
llffife Existing Studies - The same requirements described for generic data (see
iii.u.1., uption oj apply to this option for product specific data.
A ..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
227
-------
Requirements Status and Registrant's Response Form, and in the generic data requirements
section (lULU.l.), as appropriate.
m-D REQUESTS FOR DATA WAIVERS
1. Generic Data
There are two types of data waiver responses to this Notice. The first is a request for a
low volume/minor use waiver and the second is a waiver request based on your belief that the
data requirements) are not appropriate for your product.
a.
Low Volume/Minor Use Waiver
Option 8 under item 9 on the Requirements Status and Registrant's Response
Form. Section 3(c)(2)(A) of FIFRA requires JtiFA to consider the appropriateness of
requiring data for low volume, minor use pesticides. In implementing this provision,
EPA considers low volume pesticides to be only those active ingredients whose total
production volume for all pesticide registrants is small. In determining whether to grant
a low volume, minor use waiver, the Agency will consider the extent, pattern and
volume of use, the economic incentive to conduct the testing, the importance of the
pesticide, and the exposure and risk from use of the pesticide. If an active ingredient is
used for both high volume'and low volume uses, a low volume exemption will not be
approved. If all uses of an active ingredient are low volume and the combined volumes
for all uses are also low, then an exemption may be granted, depending on review of
other information outlined below. An exemption will not be granted if any registrant of
the active ingredient elects to conduct the testing. Any registrant receiving a low
volume minor use waiver must remain within the sales figures in their forecast
supporting the waiver request in order to remain qualified for such waiver. If gra'nted a
waiver, a registrant will be required, as a condition of the waiver, to submit annual
sales reports. The Agency will respond to requests for waivers in writing.
To apply for a low volume, minor use waiver, you must submit the following
information, as applicable to your product(s), as part of your 90-day response to this
Notice:
(i).' Total company sales (pounds and dollars) of all registered product(s)
containing the active ingredient. If applicable to the active ingredient, include foreign
sales for those products that are not registered in this country but are applied to sugar
(pane or beet), coffee, bananas, cocoa, and other such crops. Present the above
information by year for each of the past five years.
(ii) Provide an estimate of the sales (pounds and dollars) of the active
ingredient for each major use site. Present the above information by year for each of
the past five years.
(iii) Total direct production cost of product(s) containing the active ingredient
by year for the past five years. Include information on raw material cost, direct labor
cost, advertising, sales and marketing, and any other significant costs listed separately.
(iv) Total indirect production cost (e.g. plant overhead, amortized plant and
equipment) charged to product(s) containing the active ingredient by year for the past
five years. Exclude all non-recurring costs that were directly related to the active
ingredient, such as costs of initial registration and any data development.
228
-------
(v) A list of each data requirement for which you seek a waiver Indicate the
type of waiver sought and the estimated cost to -you (listed separately for each data
of °onductinS & testing "eeSed t
anH th A,U? of fach data requirement for which you are not seeking any waiver
and the estimated cost to you (listed separately for each data requirement and associated
test) of conducting the testing needed to fulfill each of these datrrequkements
/ A *-viil ?°£ ea?h of the next ten years> a year-by-year forecast of comoanv sales
(pounds and dollars) of the active ingredient, direct production costs of SrXtfs)
containing the active ingredient (following the parameters in item 2 ?£ovS indirect
SSSf°n 9°S? ° Wuct{s) containing the active ingredient (following &e
SSredient " }' C°StS °f data devel°Pment pertaining to the active
A ^cription °f the importance and unique benefits of the active
tou rSV Dlscuss t1^ use patterns and the effectiveness of the active
ctro • c tou registered alternative chemicals and non-chemical control
strategies. Focus on benefits unique to .the active ingredient, providing information that
vour SffiS^ftS,^1?-!? y°U d°-n0t hT Dative Sato upol whicTto basf*
S^??w 'r£? • PrelenEthe ^o^S used to denve your estimates. To assist the
Agency in determining the degree of importance of the active ingredient in terms ofits
benefits, you should provide information on any of the folio wine factors as
i
Integrated Pest Management, (b) description of the beneficial impacts on the
environment of use of the active ingredient, as opposed to its registered alternatives
(c) information on the breakdown of the active ingredient after use and on its
(d) descriPtion of its use^^s against a pest(s) of
re^rdinS mit f^1" information for the Agency to make a determination
regarding a request for a low volume/minor use waiver will result in denial of the
request for a waiver. ^wiuoj. v± me
b- Request for Waiver of Data
?' Under ltem 9i °? the Requkements Status and Registrant's Response
tl°n
nnv h be-US6d lf y°u beve that a parUculai data requirement should
not apply because the requirement is inappropriate. You must submit a rationale
SftfS? y y?^ Kel,^Te ?e data re^ments should not apply. You also must
^™ the current label(s) of your pro5uct(s) and, if a current copy of your
Confidential Statement .of Formula is not already on file you must submit a current
You will be informed of the Agency's decision in writing. If the Agencv
determines that the data requirements of this Notice are not appropriate to your
rdU
j 4.x \ -11 i ^ «™*.i..u wj. u.u.0 iiuuAyv/ u aays or your receipt ot tfte Agency's wntten decision, you must
revised Requirements Status and Registrant's Response Form indicating the
suDmit a
option chosen.
229
-------
2. Product Specific Data
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request including
technical reasons, data and references to relevant EPA regulations, guidelines or
policies. (Note: any supplemental data must be submitted in the format required by PR
Notice 86-5). This will be the only opportunity to state the reasons or provide
information in support of your request. If the Agency approves your waiver request,
you will not be required to supply the data pursuant to section 3(c)(2)(B) of FIFRA. If
the Agency denies your waiver request, you must choose an option for meeting the data
requirements of this Notice within 30 days of the receipt of the Agency's decision.
You must indicate and submit the option chosen on the product specific Requirements
Status and Registrant's Response Form. Product specific data requirements tor product
cnemistry, 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 submittecTwithout adequate
supporting rationale will be denied and the original due date will remain in force.
SECTION IV.
CONSEQUENCES OF FAILURE TO COMPLY WITH THIS
NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due
to failure by a registrant to comply with the requirements of this Data Call-in Notice, pursuant
to FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent
to Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of
this Notice.
2. Failure to submit on the required schedule an acceptable proposed or final
protocol when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a
study as required by this Notice.
» ^^
4. Failure to submit on the required schedule acceptable data as required by this
Notice.
5. Failure to take a required action or submit adequate information pertaining to •
any option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task
Forces, failure to comply with the terms of an agreement or arbitration
concerning joint data development or failure to comply with any terms of a data
waiver).
6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section ni-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
230
-------
« i ' re§lstrant to whom you have tendered an offer to share in the cost
of developing data and provided proof of the registrant's receipt of such offer
or failure of a registrant on whom you rely for a generic data exemption either
on ?& rfiATnf p?ent t0 ievelop ^d ?,ubm^ the data ^quired by this Notice
Res omJeForm P°nse Form and a Requirements States and Registrant's
commitment to devel°P and submit the data as required by this
appropriate stePs to meet the requirements stated in this
unless you commit to submit and do submit the required data in the specified
time irame.
steps- not
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STTIDY TS
~
The Agency may determine that a study (even if submitted within the r
f^-6 a"d f 3ST6S a basisvf^ isi*ance of a Notice of InlB^sS
for suspension include, but are not limited to, failure to meet any of the foUowing:
in the Data Call-in Notice or other documents
c-e (Deluding, as applicable, EPA Pesticide Assessment
-RePortin,g Guidelmes, and GeneTox Health Effects Test Guidelines)
SSViSSSf' ahd rep^ng °f required S-tudies- Such requirements *
ut 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.
2nnrt- EPA^ requirements regarding the reporting of data, including the manner of
reporting, the completeness of results, andthe adequacy of any required supporting (or
raw) data, including, but .not .limited to, requirements referenced or includedm thif
Notice or contained^ PR 86-5 All studies must be submitted in the form of a finS
report; a preliminary report will not be considered to fulfill the submission
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
?at? ??tutorv authority to permit continued sale, distribution and use of existing
S°
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B)1data request if outstanding ^genef all^would
SiSSiSS^SSS,?* ?6 Af J-TO0868- Accordingly,^ Agency anticipates grSig
registrants permission to sell, distribute, or use existing stocks of suspended product(s) only in
231
-------
exceptional circumstances. If ypu believe such disposition of existing stocks of your product(s)
which may be suspended for failure to comply with this Notice should be permitted, you have
the burden of clearly demonstrating to EPA that granting such permission would be consistent
with the Act. You also must explain why an "existing stocks" provision is necessary, including
a statement of the quantity of existing stocks and your estimate of the time required for their
sale, distribution, and use. Unless you meet this burden, the Agency will not consider any
request pertaining to the continued sale, distribution, or use of your existing stocks after
suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice
and your product is in fuU compliance with all Agency requirements, you will have, under
most circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use
such existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has
particular risk concerns will be determined on a case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required
by this Notice will not result in the agency granting any additional time to sell, distribute, or
use existing stocks beyond a year from the date the 90 day response was due, unless you
demonstrate to the Agency that you are in full compliance with all Agency requirements,
including the requirements of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3-year study is scheduled to be submitted, all progress
reports and other information necessary to establish that you have been conducting the study in
an acceptable and good faith manner must have been submitted to the Agency, before EPA
will consider granting an existing stocks provision.
SECTION V.
EEGISTRANTS' OBLIGATION TO REPORT PQSSIKLE
UNREASON ABJLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
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.
232
-------
/At, i, responses to *1S Notice must include; completed Data Call-in Response Forms
(Attachment 2)and completed Requirements .Status and Registrant's Response Forms -
ht £f?M.? )j / bi? TJiguneri£ a?d ffoduct specie data) and any other documents required
by this Notice, and should be submitted to the contact person(s) identified in Attachment 1 If
PrUnSnsS2iSnrSatlpnn0T gDneric data exemption option is chosen, only the Generic and
Froduct Specific Data Call-In Response Forms need be submitted.
Notice
u (Oc).of .the Office of Enforcement and Compliance
' Wl11 be monitoring the data being generated in response to this
Sincerely yours,
Lois Rossi, Division Director
Special Review and
Keregistration Division
Attachments
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 " uenenc Data uau-in ana product Specific Data Call-In Response Forms with
Inetrnftinno " ~——
3-
4-
5-
6-
7-
Instructions
Generic Data Call-In and Product Specific Data Call-In Requirements Status
and Registrant's Response Forms with instructions
EfA Jjatcnmg ot tma-use Froducts for Meeting Acute Toxicology Data
Kequirements tor Keregistration
&FA Acceptance Criteria
List ot Registrants Receiving This Notice
uonnaentiai statement of Formula, Cost Share and Data Compensation Forms
233
-------
-------
Attachment 1. Chemical Status Sheets
235
-------
-------
PICLQRAM GENERIC DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
containilg^ramTndt dlrivatS
y°U
i!lS
Data dl"In
Sheet contains an overview of data
°°5taCt tor-mclmries Pertaining to the reregistration of
nir! Up6d m co%unctTA ^ (D the Generic Data Call-In
Data Call-In Response. Form (Attachment 2), (3) the Requirements
hP POP™ (Attaf m^nt 2), (4) a list of registrants receiving tSFs DC?
the EPA Acceptance Cntena (Attachment 5), and (6) the Cost Share and
S d
DATA REQUIRED BY THIS NOTICE
~~ ihe aaaitional data requirements needed to complete the generic database for Picloram
are contained m the Requirements Status and Registrants Response, Attachment C The
H Jf!°Z ^t^°;?(;lu
-------
PICLORAM PRODUCT SPECIFIC DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have
product(s) containing Picloram and its derivatives.
This Product Specific Data Call-in Chemical Status Sheet, contains an overview of data
required by tnis notice, and point ot contact tor inquiries pertaining to the reregistration of
Picloram. This attachment is to be used in conjunction with (1) the Product Specific Data
Call-In Notice, (2) the Product Specific Data Call-in Response Form (Attachment 2), (3) the
Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA •
Acceptance Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6)
and (7) the Cost Share and Data Compensation Forms in replying to this Picloram 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 Picloram are
contained in the Requirements Status and Registrant's Response, Attachment 3. The Agency
has concluded that additional data on .ficloram are needed tor 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 Picloram products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of Picloram, please contact .
Venus Eagle at (703) 308-8045.
If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Emily Mitchell at (703) 308-8583.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Emily Mitchell
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Picloram
238
-------
Attachment 2. Combined Generic and Product Specific
Data Call-In Response Forms (Form A inserts) Plus
Instructions
239
-------
-------
Instructions For Completing The "Data Call-in Response Forms" For The Generic And
Product Specific Data Call-In
INTRODUCTION
part
KPply '-0 the Generic and Product Specie "Data Call-in Response Forms"
f ?StrT t0 resp°nd * generic and product specific Dat? Call-l£s™s .
stration Program under the Federal Insecticide, Fungicide, and
™™; plf?? ^ anfnd-uf Product registrant only and have been sent this DCI
tetter as part of a RED document you have been sent just the product specific "Data Call-in
SSS?6 F°T- °ft r^!lstra^ responsible for generic data have been sent the generic
data response fojm The lype of Data Call-in (generic or product specific) is indicated in
item number 3 ("Date and Type of DCI") on each form. i«"«w maicatea m
£,form is ^ sam-eJ°r both generic and product specific data, instructions for
S are dlfferent' please read these instructions careMly before filling
EPA has developed these forms individually for each registrant, and has preprinted these
forms with a number of items. DO NOT use these forms for any
out
Items 1 through 4 have been preprinted on the form. Items 5 through 7 must be completed
%$3S?££fl?&-jS thr°Ugh " must * mm^ b? *e registrantPbeet
The public reporting burden for this collection of information is estimated to average 15
minutes per response including time for reviewing instructions, searching existing data
!SSS?' gating and maintaining the data needed, and completing and reviewing the
SS TrolWt^111 fT-mt ?toon- Sen4 comments regarding the burden estimate or any other aspect of
Snfnr^? °P ¥ m§rmaS°n5 including suggestions for reducing this burden, to Chief, P
Information Policy Branch Mail Code 2136^ U.S. Environmental Protection Agency, 401 M
St., S.W. Washington D.C. 20460; and to the Office of Management and Budget,
Paperwork Reduction Project 2070-0107, Washington, D.C 20503
241
-------
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Uenenc and Product specific Data (JaiFIn
Item l.ON BOTH FORMS: This item identifies your company name, number and address.
Item 2. ON BOTH FORMS: This item identifies the case number, case name, EPA chemical
number and chemical name.
Item 3.ON BOTH FORMS: This item identifies the type of Data Call-in. The date of
issuance is date stamped.
Item 4.ON BOTH FORMS: This item identifies the EPA product registrations relevant to
the data call-in. Please note that you are also responsible for informing the Agency of your
response regarding any product that you believe may be covered by this Data Call-in but that
is not listed by the Agency in Item 4. You must bring any such apparent omission to the
Agency's attention within the period required for submission of this response form.
Item 5.ON BOTH FORMS: Check this item for each product registration you wish to cancel
voluntarily. If a registration number is listed for a product for which you previously requested
voluntary cancellation, indicate in Item 5 the date of that request. Since this Data Call-in
requires both generic and product specific data, you must complete.item 5 on both Data Call-
in response forms. You do not need to complete any item on the Requirements Status and
Registrant's Response Forms.
Item 6a.ON THE GENERIC DATA FORM: Check this Item if the Data Call-in is for
generic data as indicated in Item 3 and you are eligible for a Generic Data Exemption for the
chemical listed in Item 2 and used in the subject product. By electing this exemption, you
agree to the terms and conditions of a Generic Data Exemption as explained in the Data
Call-in Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA registration Number
of each registered source of that active ingredient that you use in your product.
Typically, if you purchase an EPA-registered product from one or more other producers
(who, with respect to the inc9rporated product, are in compliance with this ana any other
outstanding Data Call-In Notice), and
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
(jenenc and Product specific Data (JajJFIn
incorporate that product into all your products, you may complete this item for all products
listedfon this form. If, however, you produce the active ingredient yourself, or use any
unregistered product (regardless of the fact that some of your sources are registered), you may
not claim a Generic Data Exemption and you may not select this item.
Item 6b.ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is for
generic data as indicated in Item 3 and if you are agreeing to satisfy the generic data
requirements pf this Data Call-In. Attach the Requirements Status and Registrant's Response
Form that indicates how you will satisfy those requirements.
NOTE: Item 6a and 6b are not applicable for Product Specific Data.
242
-------
S?ECIFIC DATA FORM: For each manufacturing use
mai-am reglStra*°n' y°U must a^ee to satisfy *e data
t eaC?- efnd use,Product (EUP) for which you wish to maintain registration you
must agree to satisfy the data requirements by responding "yes. "
FOR BOTH MUP and EUP products
* rlsp°nd >s" t°Jthis item (7a for MUP'S and Tb for EUP's) if your product
to another product and you qualify for a data exemption. You must provSe the
mberS °f "* " 1° ^complete me RequiremSJ; fSs and
equrem s an
' ?^a^ple5 °f such Products include repackaged products and
products tion 24c) products which are identical to federally registered
If you are requesting a data waiver, answer "yes" here; in addition, on the "Requirements
£LatffofeffillRfeSP°!;?^ f0m Undei ^Item 9> you must respond with o^TcWai
Kequest; tor each study for which you are requesting a waiver.
NOTE: Item 7a and 7b are not applicable for Generic Data.
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
uenenc and Product specific Data Call-in -- - -
Item 9. ON BOTH FORMS: Enter the date of signature.
J?nI?J-(?J-BOTH FORMS: This certification statement must be signed by an authorized
representative of your company and the person signing must include his/her title. Additional
resp°nse must be ininalled anl dated in the space provided for the
EPA
Item 1 1 . ON BOTH FORMS: Enter the phone number of your company contact.
— ^^^^^^^^^^^^^^••^^••^^^^^^M
Note: You may provide additional information that does not fit on this form in a signed letter that accompanies your response. For example you
may wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled this
product. For these cases, please -supply all relevant details so that EPA can ensure that its records are correct
243
-------
-------
l-f • 1
m I
^ A 1
O o I
om co
H*-O 41
oo 2:
o) I eel
& 2 SS "•
Pi < o S
_ ae o
O JC &
u- O •«
^
o
c
O
.S*
"*
:ates Environmental Protection
Washington, D.C. 20460
DATA CALL-IN RESPONSE
+-•
W
•0
Q)
4J
•H
»3
i
i
c
I
i
E
to
4^
S
~n
•M
CO
1
§
1
0
fr
c
JC
**
i1
7f
lo
1
**
o
**
g
]
cu
•jc
4-*
_>.
IS
*4-
2
CO
o
•g
01
i_
s
s
s
c
c
l_
4J a
= s
t- cu
a. u
, Si
o
I?
** SI
1
~~ ^
J— L-
CO
Q_
5 uu
o OO
^B
o
J.
& u
^3 Ctf
i w
t»
?J &3
S o
m
E
(0
J-l
O ; ,
H g
!«i
li|
So 5
S
«
1
1 g -g
U *• I ••
2 -g
X
0 C
2^
li
e eg
5 cu
E CO
S
J
I
o
o
•
1
CO
CO
u
1
to
4J
-|
Q.
•
*""
CO
(0
o
Is
• w
C9
•
1L"8'8
^3 o C
Ul CU 4J S *
g« "i c
^^_f^ D" j_
**5 ^^ *
** ^M O ~ *CD
a « -p cu
5 co *
— CO « CO
Tyr _• JJ" ty
4-» 4-» O ~ O)
o a "Do
f<0 05 V tf
0 C J "g =,
a. glj a cs
^ll-sll
C9 • V O 4J (U
N.— «-•*. cn ae
o-p
••- WTJ
I S«
V •** *^
"211=.
ob. I agree to satisf
Data requirements as
on the attached form
"Requirements Status
Registrant's Response
I*!]?-8
flj CD •»— «S +*
— •*— di
= C 4-* o C.
- O U t_ Of
> Q-OI ™-
• ca i. t- ca
in o Q.*J +*
v
r c
"8 °
a. co
S to
LU •*"
-
v
J
v
-
.
»
•
'
• Of I .
06 1 ' °
i
J
cu
eg
v
• c
•M e
cu 2
and all attachments are true, accurate, and compl
ding statement may be punishable by fine, impriso
esentat ive
CO L.
£ cu a.
fl 9"
Ic o •-
ai o
§^2 1
cu<2 <
•a
3 >• CO
D> ^»
CO C • C
*"— I CO
C X CO Q.
CO >~ J3 H-
•w C CO O
a) co o
.C CO CL 4^
c «j= S •-
E 4J ** " *~
•• a a> e- -n
o jc o> .— ' 3 cu
- '4^ c5 5
y c- -^ o co
J
-------
-------
H <0
ON
'
•4 **">
O n
-1 om co
*— O CU
OO L.
» i lit
^ t- CMCM
TS OL • "co
Xj < o >
1 i 1
U- O «£
o
c
Q)
Cn
c
o
-H
•P o
O vo
Q) ^ W
-P 0 CO
2°; g
6 w
H W
ro * Ctf
0) - H
C O t-3
° ^ tji
•H fi U
C fi rtj
W W S
(0 rtj
W S P
<0
-P
ri
-P
w
Q)
4J
-H
C
*L3
•
|
I
»
i
'
E
t_
o
H-
to
C
o
TJ
4J
co
CU
cr
CU
c.
c
o
E
O
"c
CU
JC
4J
^
Q.
§•
CO
CO
o
id instruct
u
CO
M
CO
CU
4->
3
*f-
CU
CD
O
TJ
CD
(U
Please r
c
c •
4-1 CD
C CO
— CO
J- *-» e to
OI CU 4-* CD •»
X: (D C_ 4-»
C 4J .r- C
CO O U CO
>>JT D" £_
••-CO C^ CO
•>- C = *r-
4J 4-» O D)
U CO "DO
3 co co a> a:
73 4^ — »
O O C 4-» "D S
t_ 4-» CD «f— c »
Q. £ 4-> CD CU
CU CU C CO
X CU t- CU CO C
£ S- M- U O
D) 3 E 4-» Q.
• CD D" t_ (D CO
-O (U O 4-* CU
r^- •-. L- H- to a;
T3
TJ CU CO
C CL J= 4--
CD ZD O C
y nj Q)
Q. 4-» E CO
~~i Q) 4-* CU •*
E -C CD t_ 4J
+-» — C
CD CU =f CO
X^ D- t_
CO H- +J CU 4-»
••-co o: co
•- c = ••-
4J 4-» • O O)
O CO TJ CU
U CO CO * CU
LJ ..— CU CO ~.
H- Q)
CO CO E CO CO
- CD £ D C
•M O 4-> O
4^ CO
CTJ CO CU
o cu cu a:
4-* E -C CO
CU O 4-> CO
tu c- co c -
1 •*- 4-» CU 4-1
t- 3 4J E C
D) O" CO CU CD
CO 0) t- L.
L. O •— 4->
— • JC 3 CO
CD 4J CT-—
• 4-» CU O)
JO tO C O£ CU
>o a o = 02
4-1 •
O C 3
•- CU 1 O
t- .— CO —
CU — TJ •— CU
c cu ro_a
tu cu t- t- TJ
_ 3 C CU
CO CO •— «£ 4-»
U O. CO
p cu at uj •—
- •¥— CU
§4-* U £-
o t- tu
•— CD 3 _a
4-* O E
tCU CO 3
4-* 0}
X -C C
UJ C 4-> O
CO CO S 4-»
4-* 4-* O CO
CO -£t t- I_
O O M- 4-»
CO C
0 — U
•M g) D> — •
'•— CU O
-C JZ i- >
CO 4-»
•»~* +-• C •
3 — 0 0 >.
CD t3 '*— •—*
^-« O *U +•» —
C O CO C.
• CD t- L. CD
ir» o Q. +-»+->
4-*
0
II
C_ -M
a. co
£_
* CO
"co >»
4-> •>- 3 CO
c 3 eo Q.
QJ O — • E
EC O
^ -Q H-
4^ C CD O
tfl CD U
— o
-C CO CL 4J
C 4J -C Q. -^
O 4-* CD f—
M CO O t- TJ
CO -C D) CU C
O 4-> TJ TJ CO
— CU C
- £"3 3 2
-> •— 0 J= 3
C_ 4-» C 4J 4-*
tt) I- -^ O CO
J HI 0 -O C
O CD CD
• t_ ••—
a -• —• o at
£_
CU
§
CU
c
0
O-
^-!
4J
O
CO
C
o
CO
&
o
u
4-
O
CO
2
O
c—
-------
-------
Attachment 3. Generic and Product Specific Requirement
Status and Registrant's Response Forms (Form B inserts)
and Instructions
245
-------
-------
Instructions For Completing
The •
Statas aQd Registrant's Response Forms"
ror Ine Genenc and Product Specific Data Call-in
INTRODUCTION
?6f riC a^Product SPecif* "Requirements Status and
and are to be used by registrants to resoond to penerir anH
30 miT.,Sf S1™?501^ fUI-n ^br-t5is coU?cti.°n of information is estimated to average
30 minutes per response, including time for reviewing instructions, searching existing data
J3E?* gT?ring an<^ nM^lanmw the data needed, and completing and reSlwSc ?&
§d8^^nUrfSS±-tiSen4 crnmentS regar^ing fe burd^n es^mate or any ofher aspect of
this collection of information including suggestions for reducing this burden to Chief
Inform^ion Policy Branch Mail Code 2136, U.S. Environment Protection Agency 401 M
St., S.W. Washington D.C. 20460; and to the Office of Management and
Paperwork Reduction Project 2070-0107, Washington, D C 20503
247'
-------
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS""
Generic ana .Product specinc Data UalFIh
Item 1. ON BOTH FORMS: This item identifies your company name, .number and
address.
Item 2. ON THE GENERIC DATA FORM: This item identifies the case number,
case name, EPA chemical number and chemical name.
ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the
case number, case name, and the EPA Registration Number of the product for
which the Agency is requesting product specific data.
Item 3. ON THE GENERIC DATA FORM: This item identifies the type of Data
CaJl-In. The date of issuance is date stamped.
ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the type
of Data Call-in. The date of issuance is also date stamped. Note the unique
identifier number (1D#) assigned by the Agency. This ID number must be used
in the transmittal document for any data submissions in response to this Data
Call-In Notice.
Item 4. ON BOTH FORMS: This item identifies the guideline reference number of
studies required. These guidelines, in addition to the requirements specified in
the Data Call-in Notice, govern the conduct of the required studies. Note that
series 61 and 62 in product chemistry are now listed under 40 CFR 158.155
through 158.180, Subpartc.
Item 51 ON BOTH FORMS: This item identifies the study title associated with the
guideline reference number and whether protocols and 1, 2, or 3-year progress
reports are required to be submitted in connection with the study. As noted in
Section HI of the Data Call-in Notice, 90-day progress reports are required for
all studies.
If an asterisk appears in Item 5, EPA has attached information relevant to this
guideline reference number to the Requirements Status and Registrant's
Response Form.
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS""
Generic ana Product specific Data uail-ln
Item 6. ON BOTH FORMS: This item identifies the code associated with the use
pattern of the pesticide. In the case of efficacy data (product specific
requirement), the required study only pertains to products which have the use
sites and/or pests indicated. A brief description of each code follows:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
248
-------
Item 7.
Item 8.
D
E
F
G
H
I
J
K
L
M
N
O
Aquatic food
Aquatic non-food outdoor
Aquatic non-food industrial
Aquatic non-food residential
Greenhouse food
Greenhouse non-food crop
Forestry
Residential
Indoor food
Indoor non-food
Indoor medical
Indoor residential
EUP
MP
MP/TGAI
PAI
PAI/M
PAI/PAIRA
PAIRA
PAIRA/M
PAIRA/PM
TEP
TEP %
*:; £°T? FOR11?S: This ite™ identifies the code assigned to the substance
that must be used for testing. A brief description of each code follows:
End-Use Product
Manufacturing-Use Product
Manufacturing-Use Product and Technical Grade Active
Ingredient
Pure Active Ingredient
Pure Active Ingredient and Metabolites
Pure Active Indredient or Pute Active
Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled and Metabolites
Pure Active Ingredient Radiolabelled and Plant
Metabolites
Typical End-Use Product
Typical End-Use Product, Percent Active Ingredient
Specified
Typical End-Use Product and Metabolites
Typical End-Use Product or Pure Active Ingredient and
Metabolites
Technical Grade Active Ingredient
Technical Grade Active Ingredient or Pure Active
Ingredient
Technical Grade Active Ingredient or Pure Active
Ingredient Radiolabelled
Technical Grade Active Ingredient or Typical End-Use
Product
Metabolites
Impurities
Degradates
See: guideline comment
This item completed by the Agency identifies the time frame allowed for
submission of the study or protocol identified in item 5.
TEP/MET
TEP/PAI/M
TGAI
TGAI/PAI
TGAI/PAIRA
TGAI/TEP
MET
IMP
DEGR
The *" frame
ftom
°f
ON THE PRODUCT SPECIFIC DATA FORM: The due date for
submisswn of product specific studies begins from the date stamped on the letter
transmitting the Reregistration Eligibility Decision document, and not from the
249
-------
date of receipt. However, your response to the Data Call-in itself is due 90
days from the date of receipt.
Item 9. ON BOTH FORMS: Enter the appropriate Response Code or Codes to show
how you intend to comply with each date requirement. Brief descriptions of
each code follow. The Data Call-in Notice contains a fuller description of each
of these options.
Option 1. ON BOTH FORMS: (Developing Data) I will conduct a'new study and
submit it within the time frames specified in item 8 above. By indicating
that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as
outlined in the Data Call-in N9tice and that I will provide the protocols
and progress reports required in item 5 above.
Option 2, ON BOTH FORMS: (Agreement to Cost Share) I have entered into an
agreement with one or more registrants to develop data jointly. By
indicating that I have chosen this option, I certify that I will comply with
all the requirements pertaining to sharing in the cost of developing data
as outlined in the Data Call-In Notice.
However, for Product Specific Data, I understand that this
option is available for acute toxicity or certain efficacy data ONLY if
the Agency indicates in an attachment to this notice that my product is
similar enough to another product to qualify for this option. I certify that
another party in the agreement is committing to submit or provide the
requiredaata; if the required study is not submitted on time, my product
may be subject to suspension.
Options. ON BOTH FORMS: (Offer to Cost Share) I have made an offer to
enter into an agreement with one or more registrants to develop data
jointly. I am also submitting a completed "Certification of offer to Cost
Share in the Development of Data" form. I am submitting evidence that
I have made an offer to another registrant (who has an obligation to
submit data) to share in the cost of that data. I am including a copy of
my offer and proof of the other registrant's receipt of that offer. I am
identifying the party which is committing to submit or provide the
required data; if the required study is not submitted on time, my product
may be subject to suspension. I understand that other terms under Option
3 in the Data Call-in Notice apply as well.
However, for Product Specific Data, I understand that this
option is available only for acute toxicity or certain efficacy data and •
only if the Agency indicates in an attachment to this Data Call-in Notice
that my product is similar enough to another product to qualify for this
option.
Option 4. ON BOTH FORMS: (Submitting Existing Data) I will submit an
existing study by the specified due date that nas never before been
submitted to EPA. By indicating that I have chosen this option, I certify
that this study meets all the requirements pertaining to the conditions for
submittal of existing data outlined in the Data Call-in Notice and I have
attached the needed supporting information along with this response.
250
-------
Option 5. ON BOTH FORMS: (Upgrading a Study) I will submit by the
specified due date, or:will cite data to upgrade a study that EPA has
classified as partially acceptable and potentially upgradeable By
indicating that I have chosen this option, I certify that I have met all the
requirements pertaining to the conditions for submitting or citing
existing data to upgrade a study described in the Data Call-in Notice I
am indicating on attached correspondence the Master Record
Identification Number (MRID) that EPA has assigned to the data that I
am citing as well as the MRID of the study I am attempting to upgrade.
Option 6. ON BOTH FORMS: (Citing a Study) I am citing an existing study .
that has been previously classified Dy ttPA as acceptable, core, core
minimum, or a study that has not yet been reviewed by the Agency If
reviewed, I am providing the Agency's classification of the study.
However, for Product Specific Data, I am citing another
registrant s study. I understand that this option is available ONLY for
acute toxicity or certain efficacy data and ONLY if the cited study was
conducted on my product, an identical product or a product which the
Agency has grouped" with one or more other products for purposes of
depending on the same data. I may also choose this option if I am citing
my own data. In either case, I will provide the MRID or Accession
number (s). If I cite another registrant's data, I will submit a completed
Certification With Respect To Data Compensation Requirements'^
FOR THE GENERIC DATA FORM ONLY: The following three options
pumpers 7, s, ana y) are responses mat apply only to the ^Requirements Status
and Registrant's Response Form" for generic data.
Option 7. (Deleting Uses) I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
Option 8. (Low Volume/Minor Use Waiver Request) I have read the statements
concerning low volume-minor use data waivers in the Data Call-in
Notice and I request a low-volume minor use waiver of the data
requirement. I am attaching a detailed justification to support this waiver
request including, among other things, all information required to
support the request. I understand that, unless modified by the Agency in
writing, the data requirement as stated in the Notice governs.
Option 9. (Request for Waiver of Data) I have read the statements concerning data
waivers otner tnan lowvolume minor-use data waivers in the Data
Call-in Notice and I request a waiver of the data requirement. I am
attaching a rationale explaining why I believe the data requirements do
not apply. I am also submitting a copy of my current labels. (You must
also submit a copy of your Confidential Statement of Formula if not
already on file with EPA). I understand that, unless modified by the
Agency in writing, the data requirement as stated in the Notice governs.
FOR PRODUCT SPECIFIC DATA: The following option (number 7) is a
response that applies to the "Requirements Status and Registrant's Response
Form" for product specific data.
251
-------
Option 7. (Waiver Request) I request a waiver, for this study because it is
inappropriate lor my product. I am attaching a complete justification for
this request, including technical reasons, data and references to relevant
EPA regulations, guidelines or policies. [Note: any supplemental data
must be submitted in the format required by P.R. Notice 86-5]. I
understand that this is my only opportunity to state the reasons or
provide information in support of my request. If the Agency approves
my waiver request, I will not be required to supply the data pursuant to
Section 3(c) (2) (B) of FIFRA. If the Agency denies my waiver request,
I must choose a method of meeting the data requirements of this Notice
by the due date stated by this Notice. In this case, I must, within 30
days-of my receipt of the Agency's written decision, submit a revised
"Requirements Status" form specifying the option chosen. I also
understand that the deadline for submission of data as specified by the
original Data Call-in notice will not change.
Item 10. ON BOTH FORMS: This item must be signed by an authorized representative
of your company. The person signing must include his/her title, and must initial
and date all other pages of this form.
Item 11. ON BOTH FORMS: Enter the date of signature.
Item 12. ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response.
Item 13. ON BOTH FORMS: Enter the phone number of your company contact.
KOTE: You may provide additional information that does not fit on this form in a signed letter that accompanies this your response. For example,
you may wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled
.252
-------
r~
<^
c
r"
a
G
(C
0.
0>
M
o
I N-N.
1 oin to
•o ¥? £
^ 2 eg g-
2 as ^
a . -s
< o >
Z 0
E t_
t- CQ Q.
0 E Q.
u. 0 1 PJ
O CQ
C Si!
o o
t^ Pi
<| Q)
W
§ «
•H Q)
•P ••
U 0 g
Ll — CJ
rM ^^
ft 03
• H
r~> r i O
/rt ^"^ ivi
*O . H
T* f^ flj
-H g
r_-j •*** P*
S m
M S
0) * 03
-p &
rt g
-p S
w §
•C OS
0) H
-P 0
•H Ol
CD «
.
0
M-
co
-C
4->
C
o
"O
CU
4-*
CO
tu
3
1"
C
o
"^
4-»
(D
E
O
s-
c
••—
V
x:
.51
Q.
s-
CO
•D
c
to
a>
c
o
CO
c
I
to
4-*
CO
CU
.c
4-»
ri
13
C-
to
u
•D
01
C_
0
CO
to
CU
Q.
C
•S >.
t_
4J ID
C CO
•r- CO
S- CU
a. u
H-
o
Z CO
...
•';•;
CJ
o .-^
tu C—
^ u "
^ Pi
c m
to j"*
S H
g 0
ro
CN
O
H E
ID £
0 _°
gOo
S 'a.
" 0) 4)
O e tc
|-H i|
"5 ^ §"
m — • L.
.- CO Q.
% \O oo
H
-0 W i-^
c O S O
ra U O ft
g jzj H <;
^ W O H
g^ |S CO Q
S Q cr> H
c
to
c_
4-*
CO O
"- CO
OJ C
tu o
o: a.
CO
• CU
O* a?
.1 — CXJO—i
o
4-*
CO
LTV
CU
C 4J
•— C
CU E
T3 CU
C3 5 J3
.ff§
^r o: z
-•- •
tQ tQ M W. W
O O O O O
e g g g g
fM W M c
4J CO CO
CD ^ 0> — '
•~ *; g (> Q.
CO *rf CU 4-> U
E D> (0 •—
4J U CU D) 3
CO IB CU O rH H H
tu
4-*
to
Q
B
«-
JJ
CU CU
•>-> S
CU tU
CO 4^ >
to "—
— ' CO ID
to 4->
TO C
"DC CU
CO C.
E CU Q.
I • tu
O CO CC.
•~ f. 1
4-1 C_
CU O
C CO J=
O— • 4->
to 3
OH- <
«!_>• eo
"ro ^»
CO C • C
4-» ••- 3 to
C 3 to O.
CU O — ' H
EC 0
ID >.^2 s-
4-» C CO O
to to o
• V— tU
0 4-I-- .i
C JT CO Q_ 4->
o 4->jc e •—
•- 4J to I—
4-* 4^
CO ID CU t- *U
o -c ro cu c
— 4J"DT3 to
1- tu C
- >~ • D 0>
4J <*- 3 t-
£- «- O .C 3
CU 4-» C 4-» 4-*
cj t-^: o to
CU 0-Q C
• O CO D)
,— _ _ o w
c.
CU
z
CU
c
o
o.
(O
o
CO
I
(0
g-
o
u
**-
o
CU
E
CO
z
M
-------
H
3
o -• O
% vo 8 H
o en i in
co O o> O
S o 5 o
•z.
Ul
s
I
UJ
Ij
UJ
f-f
3
'Ci 'C -M
0) Q) C
T3 Q) 'CS (0
Q) T3 Q) r-H
0) 3 0) a
Clu< c 6 •'• '
Q) C Q) W • -H (d
M -H M a >i -PC
cd cd o (d (d 0)
w M xJ 3 (d
w a wo wxi
— o •• "ci • m o o
CM M W CM r-H rH
OOM OO.H Utd
HrHO) W-HQ) 4Jg
O p[ ^)j J.C^ f^ Q)
—na- cu a
K*"i a CD ^t g "* go
•H a >H o m -P -P
rH >i rH M <1) (dd)
G rH C -P M '(I)
OT3Q) OT3cd -P^J
-H -P &> O rH
•H (d •• -H Cd -P (0 *•
TJ g W T3 g -H Cd
TJcdQ) "o nJ •> MX!
4-> C (d -H
Q) td Q) O &>
• X! g • X! H
W O W Q) W (d
4JO-P -POg ,>iC
C 4J fi 4J M Cd g
Cd CO Q) & fl)
O Q)
Q) M rH 0) M 1 TJ •
>OO) >O- J->3g
-nag -nao xirHo
-HMO) -H M 3 -H ft cd
W 4-> W -P M-H-H
C Q) cd C Q) W TS
(U M 15 Q)Mcd VQ)
wo) m a) a >i w M
^ - ^ -P 0) 0)
-P Q) -P - -H XS -P
OO3OOO-HI3
g -H 4J g -H O X • X!
X! CO X! cd O "O w
M&cd MI3X! -PQ)QJ
o a o o o -P M
a - a >i a)
ooo oo- xl-Pcd
HMO H M W a
OOOOOCUQJ'O
S cd S O 0) X? C
W-H- w-na xgcd
w w in in in d) 3
•H C (!) -H G Q) W C71
gojo gcu'tf oa)cd
in 4J in 3 -P -H i
i5 cd "C r- 1 o in
Q) O O 0) O C 3 a--H
^ (w a S'H'H oinm
^—^ ^— ^
cd X!
H H CM
1 1 1
CO CO CO
CM CM CM
H H H
-------
-
«w ?;
_j N-l^
*^ oin to
T— CD CU
a) -g ?? i
& > h-r^ S"
flj O OO 111
(1, g. "^^ _,
S- d S
E = 2-
u- O <
rr s
H §
Q) O
&• Pi
< m
H
c cu
o
•H m
4J ™
^ 0 f
S S §
i; -* ^
O o K
V( fM E<
CM m
. H
1 \ * ^2
"*"^ O P5
§ a
^ c 1
§^ 2
^i &> ""
•H r; J3
> -H S
s
CO
CO
o
CL
c
•s £r
4J (Q
C CO
••- w
s. .
at ^^ CJ 4-»
o S 'I o
co O ^ o
5O cj «
ru
062719
E
CO
o co
co vo
0]
Q vo
1 I8
T* i i ff\ •
-S H t/j
5 > H
-a CO i-q
g O S3 O
E 1*— 4 l~l ^^
<2 < N S
i— 1 O
a: a.
CO
• CD
0 cu
E
'|H E
CD
. r
CO li-
CU
4,2
CO CD
0) 4->
-J3
• u
h- C/J
CO CD
Z3 4-»
• CO
-o a.
fO
CO
tn ,i\
t_ t.
D) 0 OJ
o a.
t- o
"~
QJKOl-OOO-J
CD
4-»
I—
t
tn
0
r £
•r- L. L.
D— 3 CN O3 Cs3 f\ CSJ CN CSJ CN £S] (\ Csl
t~i tH r~i tH rH tH rH j^ rH rH t~H tH
»
UUUOUOUOUOuo
^
.? / is
1 c- ui i o> R ^
— '*".*' <5 ^ °
cU'Co"w^'Cmo> 3.il"rn
^ .^- .^ .„ o j- g g- = _g.
"-•»-4J4->4-»4J tn ra04"*
OOCD CD*-sO-.!cc
g 'g- i Z T T ^ g .> °- .2 .2
Iliiiliiilils
^ J" *•
* * * * *
•Q *3 ^5 'O Q) ^ aJ >»— '^— * »
*^- — ^ «H tH CSJ
H H CM en r» ro -^ 1 i I
\l VN t>J O* OJ CN Oj O3 OJ O3 CO CO
"Xl* £*% f^fc f*Sfc ^S^ f^ ^^ _J _J ^J ^^ —^ I
flj
CO
o
.
V—
4->
• c •
Q) O
o c
— ' O
Q.CO
E •*-
O £-
1*
CO - •
a>
.-£
4-« M-
(0
-51-
U
o v
"i;
•» CD
d) j^
£_ -r-
a> Q.
ID O -
at
|§
rm and all attach
leading statement
epresentative
O CO Q£
«'E "S
Sfe .D!
4-» C.
CD O
C CO _C
O— • 4->
CD D
OS- <
eg X co
"ro >-
CO C • C
4J— 3 CD
SS.2 §-
S C 0
Q) -^ O O
CO >*J2 S—
4-> C CO O
CO CD O
.t-
§
CJ
^
CO
g-
s
4-
o
o
•
M
P™
-------
Qi
Cr
td
O
O
Q)
to
vo
O
en
td
(0
•P
CO
0)
o
•H
ft
o
rH z W
O -n H
% vo
ta O
•? in
in
ft
o
in
in to
Q) .3
o
a) in
tJ SJ
a)
in
ft
0)
td H
o a)
in
td G
g O
td H
Q]
fd
Q)
a)
C ft M
W
O
O 4J
-H
: in
d) c o
in
ft
o
in
in to
Q) X!
- E-t-3 - EH
O
td
o) in
ts M
0) i g -H >i g
4J X) O -P Xi O
-H 4J
•cs
(d C
1°
0) H CO)
(0
0)
a o a a o id
in >
H -H 0) -H -H CU
Q)
01
o
>i O0)>i -PC
td
td
(d td
td-
td
fi ft O 4J
a) -p in
Q) O
in ^ o
CN td i—i *•
U H in id
w g o) -P g
td Xi CO)
^ ^ (l) C
^•i O *• gO
rH rH 0) -P -P
td
Q)
0)
fO -
-H
Q) ^ -OCU- r-lX!
in cuxr
(0'
i W
O Q) O O Q) O -H
-P Q) 0)
-H -C! JJ
O
'cri
-P Q) Q)
O -P
>i Q)
Q)
QJ 4J
Q)
0)
in
o in
0) Q) O-
ftcH
O
tti
U
ft
(0
U
(0
ft
,*
O
(0
£1
Q)
0}
O
-H
iH
ft
ft
(tf
10
(d
0)
(U
Q)
g-PTi OCDtd Cg
SW-H SW-H QW
C C
Q) tP fl)
-p -H I -H ft -H ft
-P-H
(U
-------
H )0
o
o S
o
,-J N'|s-
r^ OlA W
cu *o i i •*—
fft O OO Ul
'y t- CM CM
14 a . -i
f 0 >
_ a: o
E i-
c5 i &
u. 0 «t
>i H
O CO
0) O
(7* Pi
8 "5
O^ "2
S) O 0 4J
CD (-) -C 0
CJ ° U 0.
CM
en
H
c-»
tN
vo
o
H
CO
CO
O CO
CO VO
Q VO
i " M
B H CO
5 > H
E ^H H f^
«! CE N S
^ W 0 H
lo n i
| Q CT> H
*~
jj
c.
CD
£_
CO O
•»- CO
CD C.
0) O
Cf. O.
CO
• O CM
O Q.
C. CD
a^ot— ocjo— i
CD
h-
t
4^
in
in
01
C 4J
•— c
— ' CD
CU S
T3 0)
••-£_£_
C3 5X1
• S"§
-to:z
t"r f-;:
tQ W U W W W
O Q O O O O
S S S S S £
03 03 CM fSl (N OJ
H H H H H H
r? rl r "~3 *~>
CQ ffl CQ 03 m pa
<; rfj rt; c o o
•M « ru
(0 0) *j (j ^ ^j
E -O) CO; *•— CO CO
3 "O OJ CO •— £
*-• 3 *J 4-J
CO <^ LU 1JJ
*****
•'""""*
— 'H H ra
CO 1 1 I
I co co co H fa
oa oj oj .
C CD
CU E
E
.C 4^
0 C
CO QJ
4J CD CD
CO 4J >
CD «^-
_j 4J 4J
— 'CO CD
CO 4->
•og S
ixT S
CO i-
E CD a.
I > Cl
o co a.
H- •»-
E T3
CO CU
f" Q .^.
4J t-
cu o
C CO J=
O — ' 4J
CO 3
-s*- •*
OT >- CO
col . ¥
4-> ••- ^ CO
c 3: to a.
IJ« §
•M '— '
(0 >.JD M-
•M C CO O
CO CO O
..- (0 1—
CO CO *— ' 3 O
*J N- 3 £-
I- •*- O .E 3
»-« O
-------
t-
c
t~
f
V
f
ft
^1
o
0)
tn
< 10
Q *5
**H •!$
In
n, *^ W
PJ
rH r J t/i
dJ ^"^ Pg
ij * S3
CJ ^"^ "*2
uT ^J
Q) „ S3
G C «
o R ^
ii "ji 69
•H r«
!>
a "^ O
•*< tQ pjj
g SB CO
"fd |fj
4J S
CO g
rrj O
Q) U
1 *
o
g
fd
o
rH
o
•H
•H
g in
fd in
M ffl td
o H = °
o H
a* CJV '^ in
to O fli O
3 o 5 o
z
§
3
z
j
U
^
§
4J
w >-i fd '
- Q) fd g - H
u in ,cj fd w a -4-)
HO)- J-| Q) ,: ;--' .-. 4J C r
O »CJ ^ O O O C d)
fd o fd 4J g a
TS -H g fd a -H
c»->ao s -ins
G
rtj4->o)fd fdi 4J a o c -H in
•^3^!n ^ O U) 3
W W O »• 4J 4J d
4J T! c a o a) in
GQ)O Q)O rHiH Ifl M
fd &>rH 5n O fd Q) JH o
H fd Q) fd -H .X O 4-1
PI g g Q) ("^ y | ij^ i \ frt
fd M }-) o o fd o
(D-OQ) Q)4-> fd^ O-H
> 4J & fd --H rH
•H Q) fd •> «-,Q rH a
4->,Q!3,c;w U.Q a a
•H 00) ix-r-i a fd
WO^-HO fd&i fd
C 4J Q) X! 4J IS -3
Ifl-OS 4J «tHG Gfd
a) 4-> in o o g rd
4j 4J w aa i o> • - 3 •H'Ofd'O'C
DO>O rH-OOO
J-ltd 4-1 -H >i C ^-i — --^.
U 0) X! -H 4J -H Q) M >-l
W^O MM -H4J 0) 0)
O4-iGa oofdxx
a x3 o> o -H u is -H -r-i
o •*• in M x Q) *G g g
ts ^! w o • o x! in
C?Q) J-i >i4-iEHO) rJ 5H
fd O OQ)fd O !H O O
W4-1 4HW4II 4J i •
IOMO -EHG ad) 0) Q)
(Noao fd 4-1 •£ j-i >-)
O w o) o««- ga)fd s ^
^ 'C *5 *^S W O 4^ 0"* Cj^
J>*H J3 CD }-i M •• Q) 0)
H 4-1 rH 'Q ^i Q) 4J Q) (1) J-| J-(
H *H O G *H a X & fd
QWG rC 3 a CD S n fd fd • '
S
-------
CO
ft 1
T-
1
1
1
ft
S
I
tA
to
N-N- °
oin to
*-o N-N- X
O OO Ul
t- CNJCXJ
Q. — •
5- o §
E Z 2
'-mo.
o s Q.
u. 5 <
>i H
O CQ
C %
Q) O
&> ft
< CQ
PL)
§ «
-H CO
-P 0 >.
O VD EH
•P o 3
O CM K
t t Cu
^1 C"
ft • CQ
U H
H O
CQ
-H C b
^ »_J tj
C A
-H a
c w
g1
C-
co
"~
^5
c
o
T!
.
^
J
j
3
O
J
>
u
)
1
1
^
•
"
; j^
c_
4-* CD
C CO
— CO
t- 0)
a. o
cu
. c
H-
£g
CU
CO
"CD
c
o
4-»
CD
•g a)
% vo
nj CT\ rf
co O ft
So S
CM
O
O
CQ 0
CQ 0
co W°
CO i" 1 |
5 I5 Q X
3 ft < X
1 0 EH
U W v
S H |x
CO ^ (% f}-f
c i-^ EH H
^•ft CQ U
CD S
|-< o o
S CQ S S
^~
C
ra
L.
01 CU
•*- to
CT C
cu o
CO
O a:
— QJ
• £_
CO u.
0)
CJ
4-> C
CO CD
CD 4-*
i— CO
-Q
• 3
1^" CO
a, E
CO CU
Z3 -M
4-»
• CO
•O Q.
to
CO
0) •)->
* t
O) O ^
o a.
*~
QJOl-OCJO-J
CU
*j
|
4-»
in
g+j
— s
O £
"D O
'5 -^ CU
W ^"i
• CD 3
"•d* C£ ^Z
^
••
^
oo o ooooooooo
« « s «g-gsggggg
COCO CO COeOCOCQCOCOCOCQCO
H H H H H
£lj f^J |^J j-J^ jrf|
EH EH EH EH EH
*3 "O TS *d T!
S 55 S C H H
*o (o (D td (0 rtj rtj
ftft ft ftftftft ft 5l.\
HW PL] pqfLJliIELlHHWHH
C^ P^ 0^ Pi p] P[ PJ rh r*i pj Tj) rh
gg g 'g g g g EH EH g EH EH
OO O OOOOOOOOO
gg g gggggggsg
ww ^ ^333^^*^
(-3 (-) S Mii-iMMr--iKi-5KK
II i iliiigili
88 | llllHpl
^
,
•
,
- '
••
•" '
•r* r* r*. n
rvj 10 xj* 4n
^^ ^ «-»-«- ^N
^^ «^ *^ v^ *^ *s
o *
z; ^
— ' — a >»-
S o *i- °
•= n. cu „ c co
g E *> c o <-< '"
g O E JtO 4J CO 'E
O0 tA- ^ E CO *^*
is ^ c E £ >. -a
CO >,>-.T- S
-MOW "->^ COO •
| o .5- ^ o So 3 'I ^ t; ' o 5"
tJ'^O°SoE"^'+J^''« °co
T! t- o ^2 "~ £ « c ^ S
g CL O 0 Q. U < «* Q,
a.
-
^
'
"
"*? S"
rH f>T oT tH'
11 I ill! 1
HH H ooojtNcn n
VD^O VD VOVOVDVO VO
•2
CD
Q
j:
4-»
• C
cu o
4-» E
01 C
— • o
Q-_co
O C-
"g-
cB
«r8
CO
3 "°
o o
CO — •*
* co
m _r~
3 CO
£_ i*-
4-* C
CD o
CD a>
.Q
CO
•^ 2r
C CD
CU E
E
r- ^j
0 C
CO (U
4_» Q Q
CO «^-
— * CO ID
CD 4V
O) C
TJ C
CO D
ro >. co
en >*
co C • c
•M •— 3 CD
c 2 CD a.
§0 — E
c o
4-* — •
CO >. J2 •*-
•M C CO O
CO CO O
tr -C CD Q- 4J
o -M ^: a. ••-
•- -M CD >—
B CD CU 1- *D
O ^ CD CU C
*- 4-» "O "O CD
" CU C
J S- It t_
jj •- 0 ^ 3
J £- ^£ O CD
u o xi c
• O CO CO
D t- —
£_
CU
1
z
.
c.
CD
Q.
O
4-
0
0)
CO
CM
r-
-------
CO
O
Q)
&>
(fl
Pi
o
t
•
1»N. 8
oo t.
"O i i **••
§» SS X
t 0 1
=5 0
E t-
!>« *ia
O CO
c a
Q) O
&> P<
*aj CO
§ §
-H CO
-p O ».
U) ^f S5
.p o a
VN P5
S-J S
P< • CO
U H
H O
ftf • W
4-> Q S
C
o> - Q
sea
Cn ^
O 4J
3E1 g
>-H |
United States Er
Wasr
REQUIREMENTS ST7
O
M-
J=
4-*
g
requested
information
JC
4-1
_>.
U>
1
-M
g
S
CI
J=
m
4-1
4-*
10
O
JC
4-«
£.
3
O
L.
U
^
(U
u
S
8
_>
Q.
•
.K
c
-£
4j a
c u
•«- w
c- o>
Q. 0
CI
o C
,,£
£~
4-> 0>
>w?
O 4J
0] 0>
0) JC
2 "
(/> C
o -2
O "T3
K 6J
C/> d)
53
a
a
u a
H a
ELI I
HI Q
"UK
0 W 1
•g PI a
gL03!
£fjg
^B§
0 Q
» O =fe
« PS Q
Q & H
M
a
a
a
a
a
a
a
a
s i
I s
M
o
H a
1 o
= P) tn
1 S
ID ft;
% vo
o, m <;
« O Pi
So H
rvi
O
O
CQ O
W 0
S » «
? a Q
2§QX
SP,<
c W CJ &H
c ,_q p^i u
g-Pi CO U
E Is*! O O
3 w s a
9. Registrant
Response
CD
CO ul
~ E
U ID
— M
JD
r^ co
c
O 1-
C/l O
="£
• d
^0 O_
ro
2t CM
C?§.
a. on
LO£OI— OCJO— I
4-»
f
f—r Cj
tr^ CT' "* CT*
Hf"1 ^ c"1 r^ r*
M -. «. % wv -, ^H %M >-<
rfl fl5 - ^ (0 fCf flJ
ft ' i, ?
oooooooooooo oo qooo
r^j «^ J"3 P^ r^j r^ r^ "^ *^J l^ H3 f~0 t"D ^tJ 'D- ^3 "U "3
HHHHMHHH>-{HHH -HfcS HtHHH
oooooooooo o o oo 0,000
WWHWJiiWWWWHWli-l W W £L) pi] ji} EL]
OQQQQ.QQQQQQQ " Q Ct Q Q O Q
O U O U O O OUOUOO UO OOOO
jCQ PQ pQ fQ p^ pQ fQ CQ pCt PQ (Q CO pT[ fQ pQ pQ 0^ pQ
<| <1 " ;
V %. W.J I '
•* ^ "• ** '.'.
* f\f ,e o«*. >K *"
v X '\ ^ ** ** "•
v N- *+
j%
f •*• ^ -•
C 0> -< ' iff -r-
O '' O) (U *— ^J
•*»T ' j"' *• (0 O . CO C
•»• ,t> ^ ^> O — •* £ ^ -K t- O
m y^ . ;^ -^-. O SJ *-• T*— I •*«-*
, x * .-w > ^ ca ' t> C +>
DJ .X' «1 U (- -M **- O jOJ
C *-?C i (OX— •»•* C
•- -«- , /v i-3: L. >* L.O-M-t-'O
•. ti a>o(D4J^H+>aj£*.*»-
n > >* 4^*D -^ "- •«-* 4-» ,t^ 4J
^ ;M , g -g 3 ^0 S Q T S
% -, U # ^— lUCU S *X ^J .,-* I_ — ^ —
f f f. J>*. "~ •->— (D >» ' O- 1 •• OT I »•* ID t- M
.^-— *+J^4J O — 'EXflJXflXC
>.O)— • -•«- w .>. ••- jC «- U
4J c; •«— -O •»-> — » O- t- *** t-^i>«»~c w
.^.-•-^icio-*-.^-^-*^ x o^0'»->*>.^jl
!5^i^£§'oS>-2'*'>^ ^^SS.^^E
n.»ou.a,«o>*yo,|g << -*^o
i.^ ' J$ j " 1 1
«*"' '''" fr'' si' ' 4 "?
^o^to^Vco^o'-H^' S -'; ?| ^' '••;
j i j i t i i i ? j „;, i ,r i.iii
XO VO V^ VD ^O VO VO VO VO ^D CO CO CO CO CO CO
O
4-*
a
a>
(0
u
:ation as to information on thi
is on page one).
1°
t- ro
o u
O '—
«4-
4-* 4-»
CD £-
U CD
K
O 4J
4J X
-------
o
N-P^ X
O OO LU
t. CMtM
n. — /
Q. • CD
< 0 >
Et_
CO
0 z:
u. o
O.
Q.
<
T
Of ft
vj
C 55
oj o
cy* ft
< CO
n 2
o
-H CO
4J 0 s
O VO Ej
CD «* 2
•P 0 ri
O 0) ft
•i
t
4
\
4
ft • W
O H
H CJ
nj • &
•P Q p:
C
0) ^ C
g C g
C O <
0 -P
1
1
)
M tr> CO
-H c C
C .Cj <3
W W EH
fd W
co S
0) CO
-P EH
(0 fe
-P g
to |
•C p:
Q) H
-P &
c S"
& S
O
*4«
£
*J
C
o
t>
•M
03
3
CT
« *^
' CO
•M
O
01
.£=
__
C
o
•£
CO
o
CO
=>
Jg
ol
H S
{X{ |
~ H Q
o W §
Q. p| ,
CO Q
ra PH Q
0 ft H
to
^
S
S
&
1
|
S
&
g S
O C)
H &
| 0
ra -H •
•a S
co p^
CD O^ ^^
co o HI
So H
OJ
0 ,
0
CO O
co o
H °
co ^^ PH
£ S Q
73 f£ Q >^
3 ft rtj x
-o S
C ^^ PT|
" O W -
O [V| S^
| W « EH
c J E-l H
£ft CO O
CO
•r- CO
O5 C
(U O
fv r>
e> o;
CD
Jo
1— E=
• L.
CO u_
O
U
+-» C
CO 03
CU -M
H- CO
• D
N- CO
CO (U
rs -M
4->
• CD
^3 Q-
to
<0
D) 0 ~
«-
Q£O1— OUO— I
a>
I
t/3
IA
2*-
= S
cu E
•^ £_ L.
3 ••- CD
• 4
^tj l~3 ^3
H H H
ffi K JxJ
O O O
ipQ CQ rQ
Vfc. rf-\ j^N-
irv «M jy>
T— ^- «T-
1:1
S "
o
:C: *«) Jj
— Q s
Q. o« ^
^ *- J "D
«> c •© ±!
^ij | ^,x
J3 M L. cu -*-
£- CD CU > . 4-» X
• -^ o ca o
1 L. (Q ftf t— +*
O '^- O CO O
>" +•» L. <»». Q_- ^i
a', "a « ^ i ^
^o g 0 to ej a.
£ ^ OJ
UJ £
.
1
rsi
CO tH
V "». V
tst 03
I i i
"^f ^ *^*
o\ cr> en
01
S.
CO
.c
c
o
c
.3
CO
o •
'o °
4-» OJ
D)
CO CO
CD CL
C C
0 0
4-* CO
CO "-
^ c
4- O
4-* 4->
I- CO
01 U
(J ••—
**-
CD IP-
CD s-
U O
P- O
O 4->
*-» X
CD
i-i — »
?^
C »fr-
-------
CM
O
H
W
CM
O
rt\
U/
S
CJ
O
•H
So
0) ID
•P *#
O o
(i 1^5
r"H IN
rH U
(fl
JJ .
nvironmen
ington, D
W43
u
Ifl Ctf
Q) !S
id
u
United
j*
H
H
1
M
Q
H
Q
H
8
Pt
?INITIONS
»lMf
Q
W
9
Q
'NOTES AN
w
O
P
W
0
M
O
H
O
•H
04
vo
tn
o
o
0)
1
(0
0)
u
u
o
*J CO
•«— 0)
u o •«•
•S «
t- 0
O 4-» 3
ill
E O Q.
3 Q. O
CO CO
CU 3
4^ JC 1
o 4-< -a
c c
c- a
•oo.
us-—*
o ca
coo
CO ••-
>. 3 a.
cu >-
jc >.*•
4-> C
ca u
cu *u a.
U IT Ul
t- ta i—
3
o •• •»
CO "D r-f
01 •
T3 Ul to
cu a u
t- JC — •
01 0 J3
4-» c. ca
en a> oi
0) CO JC — •
C_ •— 4, CU
CO +* C Q
a •— — •
c- CJ "O"
H- 4-> — C3
o s- t.
•S~0 C 4^"
4J t- O C
C O.T3 01
-0 Ql to O
QJ L. 4J t.
t. 01 C D)
I? t> E "-
C) L. O
4J t- CU O
o ai c. ta
10 J=
4-» eg r
C- O 4J O
•— cr co c.
01 O 73 3
o c ~
ai ca H
CO O
CD S), O t- O CO
CD 0)
"O T- O >
Ol £. •*-
•— CO O
> M 3 to
0 •-
c. * r
CL4J CU O
U O C.
.. 3 c- 3
4J T3 3 O.
"S ^-D "
t. a o> «-•
a. L,
a CLJC •—
"S T3 t- o
o o 3 ca
t, m Q.
a. ca cu
JC 0) JC
? i.s-'o
~- JC GJ "U
C- 4-1 CO CU
3 O c-
4J O JC O)
O 4J 4J
CD — >
M— ra E co
3 C O U
s 'c 4: 'c
ca c- u
|| 4J 01 01
L. S- 4->
n_ cu <*-
^ ^ "
>s-M 4, c i-
c.
O
o
•JJ
3 -•
o ca
TJ 4J
0 C
O CU
M- "O
O CO
C d)
O t-
••- 4-» t_
4-t CO O
CO d) O
S-fe?
— QJ
t, 0) 4J tJ
o t- ca ••—
D) t- 3 ui
3) cu cr o
CJ i i i
O «£ u. 1^
3
g
u
O
M-
111
CO
:z
0
a.
UJ
C£.
ta
i—
<£
1—
CO
CD
UJ
CO
n
g
CO
CO
1—
z
Ul
Ul
cu
3
o
UJ
Qi
o
JC
M-
o
01
t
CO
in
o
3
3
"o
O
referenced in
CO
CO
cu
4-r
8
m
c
i
"o
M-
01
t
••
(fl
(U
•P
O
1 \
o
1
1
w
g
U
CO
3
5?
Of
g
5
1
Q.
4J
C- C
' Q)
in t- o
^- H- O
CO Is- C
in S3 cu
ca o
CO * O
C CO
o «-
4J ^ CO
o > ^
" S *
D) ^x
3 to ca
O 01
_. o •-
— ' O ^^
O C. CM
v- a. >
rvj
CU O) >O
JC C *s
t- CO
C 3 4->
" O E
C- CD -t-
01 <*- — •
4J C H-
L. CD O
T,1.2
cu ca 4-*
— • ca
••- CO O
4-» ca H-
•a 'ct 4J
0) C-
01 4-> OJ
L. CD U
to m o
c.c-
o> 4J in
OJ 4J *^
C. CO CO
•— o *
° 1^-
o CL i
4J 'E >o
ca o v^
o to
L. O — >
01 M- CO
o c
in co
1^ £•
CO CO
- in C
'to -n -^
_j <0 CO
S .fc
ca CM
o co **"
••- in o
CO *- •
0 O CO
U CO
in •»
4-* 1
'ii ^c5
4!^ 'I
o ••-
3 C t_
•a o 3
S 'v °~
CL.ti .^
CO
o o «*-
D) O C
COO
'E T3 4J
•i~ C en
tl >. o
CL«p-
2 S; "°
c -a c
cu »- o
C
1
CO
c
§
t_
a.
CO
o
CO
-
3
£_
-S
c
3
T3
CD
QJ
C,
"to
4-«
S
to
(U
T3
O
4-1
0
0)
4-1
O
H-
CO
'S
S
U
L.
CL
C
O
4J
S
|
O-
ttl
JC
4^
M-
o
c
o
a.
c.
u
w
cu
"a
H-
01
SI
»O CD
E
O D)
"oJ 15
E
_» .^.
.s 1
>-^
— * o
ca co
ca <:
cvi
o — '
4-» CO • d)
O "O > CO
"° "~ S '-M C
4J _C 4-» O d)
+J CJ ••— ' CO "D
*E •»-* ^ CO O
3 v CO CO 3
4-» — ••- -M CO
C CO ^3 CO
co c d) TJ co
=5 " c, >.-
g *, 0 = =
.- CO > J3 •-
§.p- CO -Ct
4-> 4J CO
CD O CO 4J
C 4-> <£ CO
O C OJ C
••- 01 H- O> ••-
4J .r- O CO
C 73 t- 4->
CU CU 0) O U
4J t- T3 4J 3
C Ol CO CO T3
— C t- 0
g _ 0, _0 U
OJ — > 4-*
H- > CO ^»
O •— 0 'NO
C O E ^*
O < JC t-
•.-0 • - O
CO H- 01 T3
CO O *•* CU -
3 4-» "D
O CU OJ 4^ QJ
co -a jc •- 4->
._ ca 4-1 E o
-u L. j5 cu
ai s- 3 4J
ca o to cu
» ca 4-» cu
4J CJ C -Q 0)
JC -^ «J • <-
Dl C — ' • O CO
3 J= CD 0) 4->
° $ -| s "g 1
CO O~ — • ^t- CO
ly^ 4_( • 3 CO
4-1 4-» .* C CO O" I—
•*— CO CO 4-* d) CD
E - O E C t- CU
t_ 4J •.-•.- CO TD
d) O *-* t- >• ^o
c-cjoa. co**-^ —
X C- *r- Q. •«- ^ O E
CUCDCO X^^N—t-
o o co o ca CD o
cacEo co — ' — ' c
•*- O 3 -M d) CO O •—
T3 O TD 3 CO O
CC O _-T3d»— O
ca ca s- L. • *— c — ' x t-
o-Q.-d) • ~o3c:oo
C >. en 0) L. 4^ O34-*E
o Jet •*-* *^ c t- 3 c di t-
•r— C CO •r" 3 4^ d) -Q CO O. t. L.
4J "Q flj flj 4_» (Q • n) LLJ O O
0 OJE_QWCDI-(^.Ca O"D H-
3 OCO 4-*£-CO 4) C d) Q.— * d) CD CO O *J in
L. O4JCO"-Ed>Q_ca.r- .r- £4J c 3- "a ja d) — '
o caxt- EojitJco c ^-r,0*
O .->= TT (0 — O t- t5 "Et 5- "D S*--*-1
co 4-* co co t- c t- cr d> •*- co ^2 **- o
— » _C CO O i- -M CO — ' J!^.*- D~*"c04J
__* . 3: _< coca OJQCD co .— 13 t- D£
3d> ococ -rj-^'^CdJO — ' c *"-cr di
03 CL O •»- CO ••-••-•.- E -^ • "- -^ — ' "- * z:c3c_ o c o co T3 « 3x:a:
"O CO CO"" ' —• — ' t- CO O *— •— -^ (« O *J
d)"~cao£-crooo cococo"E'~co5 •
« t_ c co ••-••-••- co c c cu •—
J^ CO *^ O C _Q dldldJOCOCOO C33O4-*
f4-» d) j-ij-jj^.t^ c~4->*^ o_m tn~g_Q g t-
4Jcoc«. -oooocacc o ^g_
co c t. ••- cu ••- — »_>— » eo o o ••-••-•— Q. UJ cy o
o-Mi-3:GJcocoa3JD c_ L_
BC — tc t. c « co •£ •- •- « o o o o o « g ~ o
<0<0 CO ZICO.n.C.C4J"O~D'~OT3~O"i cylCO
^T3CO»r-r- «r- «^ «r- «r- >r- •*- ..- «P- H- 4-» ••-
t- 4-* O. O C •— 1* 1* CP fllCOOJdl QJ flJ^ o £^13 d3 c^c^cTc^c^c^aicocodicoCH-
3^-,4j|— CDOCJOlQiQJCaiQiCtfQiOSDSOtio:*'- O
ro >* tnsor^-cooo^-cMpn^a-inco
(0
u
'i
CO
s
c.
CO
p)
(V
1
_o
§
*~
OJ
I
-------
03
•
O
c
0)
£y
C
r>
tates Environmental Protectic
United S
1
i
Washington, D. C. 20460
CO
?"3
H
jrj
g
s
p*^
w S
KEY DEFINITIONS FOR GUIDELIN
ase # and Name: 0096 Piclor<
Q u
W
EH
O
O
cu
CO
"o
>
>.
J=
O)
-C
c_
o
CO
CO
en
CO
CO
""*
CO
• • c-
cu
CO
• E
CH co
O cu
4-i
^ s-
"~
M »
*1\
t_
O
CM
C
CO
4-)
CO
co
0)
CO
CO
£_
o
c
i
CO •
CO
0 4J
4-" O
CU
O S-
> s-
.— CU
CO
o c
t- o
O 4J
CJ CO
CO ••-
•r- L.
CD
C- CO
CU £
i-S
to"c
CO CO
4-*
S- |L
"* *"
CO CO
I_ .r-
'Is
CU 4J
t- O
a
0 4-
z o
OJ
•
o
4-»
CO
s
•*~
£_
CO
Q.
^
CO
o
£_
0)
CO
O
^
CO
CO
H
CD
S
•3
CO
o
•^*
CD
O
>
CO
CO
O)
D>
O
•-5 °
§S
CJ C
I- CO
-s g
§-°
cu
t_ t_
0 3
.8
•s s-
u
CO
CO CO
« i!
c cu
o -a
0
CJ 4-»
3 CO
"C CU
O Q.
c_ cu
a. i-
CU CO
.C CO
4-> CU
^1
TJ -a
CU CU
C_ £_
'5 '5
tr cr
cu cu
M •*
X
D)
CO O
CU —
•— TJ
O O
CO CU
Q-
c_ c
CU CO
4-» CO
o
TJ 0
c o
CO 4-J
CO 2
c- a.
o
s °
.E c
-I
cu o
eo — •
t_ >
cu cu
4-> T3
CO
CU C-
c o
.F- S_
O >.
^1 O
CJ C
C- D)
0) CO
4-1 CU
0 J=
t_
O _c
M— 4-*
•D ~3
CU
required for brganophospates, and may be requir
the visual system. Registrants should consult
I/or chronic) is
adversely affect
^ 0
CO 4-*
CJ" CO
'E 4J
O C •
i. CU CO
.n 4-> cu
0 O •*-
-Q Q.TJ
3 3
CO CO 4-»
CU CU *H*
4-» 4-» O
3 CD
O c- C
CD 4-» O
^ CO -~
C 4->
O) O CO
"-*»
CO C
CD CU —
4J >
CO O
CD
•^ r- c
000
0) .,— .^.
» O
E
C
O) ••-
•C TJ
CU ^
O
-g s.
3 CO
M- CU
0 •-
CO CU
4-* C_
3 — •
CO CD
CU •—
c- o
cu
O
is required if it can be reasonably anticipated
n 40 CFR 152.170(b) or the criteria for initiat
a. "~
CJ
cu
Q. CO
LU 3
CU O
4-t
C.
° '£
•^ ^
CO CO
cu cu
1— £-
N-
foliant
, Desiccant & De
S
I
.c
4J
3
O
U
1
Q.
«
-S
1»-
B CO
M S— CO
E W CO
•*- CO
4-» CO JQ
C CO
CD t- s CO
CO — ' - L.
3 O CO •*- CO
• C 3 -f-
O D" O)
• O CO CO
CO i- L.
C CO O -
CO O 4-» 4-»
- ^^ 3
0 TJ jr TJ
H- CU O) O
CU 4-» »r- U
TJ Q. £- Q.
CU
TJ 0 O CU
c o jr TJ
o
. x CO
c cu c. cu
CD E CU Q.
O E CO
o o cu >>
•s ° •- §
et> T3 >*
"D C O L.
CD C O
b rt* u_
cy data for herbicides, plant groeth regulators,
s when used in accordance with label directions
the determination of efficacy is based. The Ag<
f special reviews) submission of efficacy data 1
CD 3 O
o o x:
•— ••- 0 CO
H- O ••- CU
H- co jr co
O O 3 CO
•— O
4J H- C
•— V- 0 C
e o a.—
3 CU CD
CO t- CO 4-»
CO 4-» CO
O CO "D
4J CO T3
4-> CO
CO O 4-» 4-»
4J 3 C •—
C tJ CO H-
cu o > cu
E c- cu C
CU Q. — > CU
1_ fit o
••- CO L.
3 ••- t.
CTJ: cu o
cu .c «
C- 4-» 4-» CO >*
CO qi r
— • JZ C CO CO
— • 4-" •— 3 CO
CD CD CO
D) 4J 3 CU
"O C C CU O
CU •— ••- C 4-» CD C
••- CO E 4-»
CD CU C C
3 4^ T3 CD CU
c o .e
CO .C CO — 3
CO D) H-
^ 3 Q.-- C
O JI CU •*- 4-»
C 4-< > CO CO
CU CU C—
D) CU T3 > 4->
3 4-> D) •.—
CU CO CO '* O)
JC C 3 O CU
I— O E *-? C_
^~
CO
*7)
CO
CU
CO
o
1 •
>• TJ
t 4^
CU CO
CO £_
CD 4->
O CO
C
CO O
e;
C §
O "D
>. c
c S
CU -Q
D)
< CO
CU .c
4-> CU
o 2
4-* O
"a co
CU 0)
4-> 0-
_Q 4->
CO O
cu *"*
J2 CU
o
CO CO
3 4->
E CO
*O CO
c cu
CO C—
cu c
— • cu
H- 3
CO — •
- o
£ "S
CO — •
c_
to ^
5) >
CU 3 C
C. CU 0
CU > TJ
.c cu cu
•"-• t- _E
_c — ^5
" •<- CJ
TJ CJ
CU CU CO
C Q. 4J
••- CO CO
CO (U
c "o Q"
"S CO Ii
E CU CO
TJ CO £-
co o
CD H-
TJ
TJ C C1J
CU CD —»
Q. —
O CO H-
— • D3 •
CU C £L CO
> ••- O ^
CU TJ t- 4J
•D C 0 C
•*- CO
O ^^ • 4-* f
-O CU 4-*
4-> 0) CO
O CO t- ••-
4-» CU CO O>
C_ 4-» D~
TJ CU CU
cu 4-» c_ a;
t- C 0
» .^ s- cu
t-'^- v c.
CU "8 3 "~
I- 5--D TJ
CO CO
I- 0 C
CO O O —
4-> •*- CD
CD CU 4-*
TJ CO J2 C
CU "* TJ '5
c o "3
§3 O TJ
CO -C C
O CO " <°
H- CU CO TI
t- CO 4J CU
cu >. co a.
o =t cU O
CD 4-» — J
4J C CU
0 CO >. >
3 4-» CU
TJ 4J -^ TJ
o •— >
t_ H- .:- o
Q. CD 4J XI
^^ C '. ^^
CU CU CO O
••- ^N CU
4-" Ji£ CO TJ
t- — T3 t-
§L- *.- t^
C_ -Q O"
O O >. O
O H- ic az
CM ro in
-------
-------
Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
253
-------
-------
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
picioram the Agency considered batching products. This process involves grouping similar
products for purposes of acute toxicity. Factors considered in the sorting process include each
product s active and inert ingredients (identity, percent composition and biological activity)
type of formulation (e.g emulsifiable concentrate, aerosol, wettable powder, granular, etc )
and labeling (e.g., signal word, use classification, precautionary labeling, etc.) Note that the
Agency is not describing batched products as "substantially similar" since some products
within a batch may not be considered chemically similar or have identical use patterns
• * nl-available information, batching has been accomplished by the process described
in the preceding paragraph. Acute toxicity data on individuafproducts has frequently been
found to be incomplete. Notwithstanding the batching process, the Agency reserves the right
to require, at any time, acute toxicity data for an individual product should the need arise
Registrants of products within a batch may choose to cooperatively generate submit or
cite a single battery of six acute 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 toxicological studies for each of their own products. If a registrant chooses to
rely upon previously submitted acute toxicity data, he/she may do so provided that the data
base is complete and valid by today's standards (see acceptance criteria attached) the
formulation tested is considered by EPA to be similar for acute toxicity, and the formulation
has not been significantly altered since submission and acceptance of the acute toxicitv data
Regardless of whether new data is generated or existing data is cited, the registrant must
clearly identify the material tested by its 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
DC! 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
Matus 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 wilLprovide 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
255
-------
Table T li
Batch
No.
1
sts the single batch for picloram
EPA Reg.
No.
62719-6
62719-17
62719-181
% of Picloram
24.2
24.4
24.4
Formulation Type
liquid
liquid
liquid
Table n lists the products which could not be batched. For the purposes of acute
toxicity batching, these products were not considered similar, or their similarity could not be
determined with the information available. The registrants of these products are responsible
for meeting the acute toxicity data requirements specified in the data matrix for end-use
products.
Table n.
EPA Reg. No.
62719-5
62719-30
62719-31
62719-57
62719-179
62719-182
% of Picloram
& other Active Ingredients
10.2
2 , 4-Dichlorophenoxy acetic
acid: 39.6
34.7
5.4
2 , 4-Dichlorophenoxy acetic
acid: 20.9
17.1
Triclopyr: 32.5
72.0
10.2
Formulation Type
liquid
liquid
liquid
liquid
solid
liquid
256
-------
Attachment 5. EPA Acceptance Criteria
257
-------
-------
SUBDIVISION D
Guideline
Series 61
Series 62
Series 63
Study Title
Product Identity and C9mposition
Analysis and Certification of Product Ingredients
Physical and Chemical Characteristics
259
-------
61 Product Identify 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).
7.
8.
9.
e^ nominal concentration, and certified limits (upper and lower) for each active ingredient and each
intentionally-added inert ingredient.
Name and upper certified limit for each impurity or each group of impurities present at > 0.1 % by weight
and for certain lexicologically significant impurities (e.g., dioxins, nitrosamines) present at <0.1%.
Purpose of each active ingredient and each intentionally-added inert.
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 jnert.
Molecular, structural, and empirical formulas, molecular weight or weight range, and any company
assigned experimental or internal code numbers for each active ingredient.
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.
JDescription of manufacturing process.
Statement of whether batch or continuous process.
Relative amounts o_f 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.
_ 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).
260
-------
62 Analysis and Certification of Product Ingredients
g- ftSd
ACCEPTANCE CRITERIA
gfade °f ^ active ^redient bei°g reregistered. Use a table to present
Does your study meet the following acceptance criteria?
2.
3."
4.
5.'
6."
8.
9.
10.
°f batch process)
Degree or accountability or closure > ca 98% .
ingredient
H i Aviation) provided for eadyzed ingredient
active-ingredientPand intentionally adSSeSSg^it
^^^^
l methods (as discussed in #9) to verffy certified linfits vaUdated asto
261
-------
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
_ Reported in °C
Pressure under which B.P. measured reported
_ Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
_ Measured at about 20-25° C
_ Density of technical grade active ingredient reported in g/ml or the specific gravity of liquids reported with
reference to water at 20° C. [Note: Bulk density of registered products- may be reported in lbs/ft3 or
Ibs/gallon.]
63-8 Solubility
_ Determined in distilled water and representative jpolar 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
63-11 Octanol/water Partition Coefficient
_ Measured at about 20-25° C
_ Experimentally determined and description of procedure provided (preferred method-45 Fed. Register
_ 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
262
-------
Guideline
81-1
81-2
81-3
81-4
81-5
81-6
SUBDIVISION F
Study Title
Acute Oral Toxicity in the Rat
Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
Acute Inhalation Toxicity in the Rat
Primary Eye Irritation in the Rabbit
Primary Dermal Irritation Study
Dermal Sensitization in the Guinea Pig
263
-------
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.
264
-------
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. ''
5-_ Dosing'duration at least 24 hours.
°-* Vehicle control, only if toxicity of vehicle is unknown
»' Annft^f '-fU r enSto ^"nj116 ? toxicity category or a limit dose (2000 mg/kg)
§• Application site clipped or shaved at least 24 hoursWore dosing. mg'*g->-
9- Application site at least 10% of body surface area.
lU. ADDllCatinn site rrw^rp^ wntK o n/^^^ivn ««.—.:-_:*_*: r nf^,,^ -*. *•"*-*- *
13.
Observation period to last at least 14 days
Individual body weights.
. _ .
14. _ Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
-------
81-3 Acute Inhalation Toxicity in the Rat
'ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1.
2.
3.
4.
5.
6.
7.
8.
11.
12."
13.-
14.-
Identify material tested (technical, end-use product, etc).
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 /*m or less).
At least 5 young adult rats/sex/group.
Dosing, at least 4 hours by inhalation. .
Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
Chamber temperature, 22° C (+2°), relative humidity 40-60%.
Monitor rate of air flow/
Monitor actual concentrations of test material in breathing zone.
Monitor aerodynamic particle size for. aerosols.
Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of
respirable substance).
Individual observations at least once a day.
Observation period to last at least 14 days.
Individual body weights.
Gross necropsy on all animals.
266
-------
81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
!•_ _ Identify material tested (technical, end-use product etc)
L- _ atudy not required if material is corrosive., causes severe
dermal irritation or has a pH of < 2 or > 1 1 5
3. _ 6 adult rabbits. — —
4- _ Dosing, instillation into the conjunctival sac of one eve
per animal. J
i:— ^c?±£a^
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 fir, 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.
267
-------
81-5 Primary Dermal Irritation Study '
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a pH of <2or >11.5.
3. 6 adult animals.
4. Dosing, single dermal.
5. Dosing duration 4 hours.
6. Application site shaved or clipped at least 24 hours prior to dosing.
7. Application site approximately 6 cm1.
8. Application site covered with a gauze patch held in place with nonirritating tape.
9. Material removed, washed with water, without trauma to application site.
10. Application site examined and graded for irritation at 1, 24, 48 and 72 hr, then daily until normal or 14 days
(whichever is shorter).
11.* Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
268
-------
81-6 Dermal Sensitization in the Guinea Pig
. ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1.
2.
4.
_j material tested (technical, end-use product, etc)
Study not required if material is corrosive or has a
pH of < 2 or >11.5.
• One offfie following methods is utilized:
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehlertest
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig.
Complete description of test.
* Reference for test.
Test followed essentially as described in reference document
Positive control included (may provide historical data conducted within ihe last 6 months).
Criteria marked with an * are supplemental and may not be required for every study.
269
-------
-------
Attachment 6. List of All Registrants Sent This Data Call-in Notice
(insert)
271
-------
-------
(
<0
tj
CO
CM
0
C
Q)
tn
^
c
o
•H
-P
O 0
0) VO
•P •*
O 0
^ CNJ
PM
• -
r-t O
•P •
CQ
Q)
g -
C G
O O
M 4^
•H tP
> c
C-H
01
01 CO
CD ge
-P
cO .
-P
w
•o
0)
-P
__J
•n
JD
u
H
EH
g
S
H
Ji
3
o
|C^
g-l
rtj
Q
CO
S3
&^
CH
55
H
CQ
W
2
S
P
U
H
O
S
j|
1^
o
EH
CQ
a
^
0
H
O
•H
£4
VO
Ot
O
o
•*
0)
0
9
to
•o
sf^e
0)
u
u
&
-H
tfl
0)
4J
4J
CO
til
1?
•H
O
01
0)
0)
^
•0
•0
0)
1
^t
l~l
(0
c
O
•H
^j
•H
•o
•d
0)
CO
c1
a
0
o
S
0
o
S
Sj
»»
5
co :
o
Q-
«C
S
z
""
III
CO
S
§
III
^
•-
CO
o
•** .
M
Kl
^
8
§
S
a
1
-------
-------
Attachment 7. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions
273
-------
-------
gl
S
g
"c
UJ
o.
•
o
§
8
6
CO
O
1
i
Q.
o
u.
-^
(0
£!
0
c
•2
^•0
^
«|
u
CO
"*
c
§
i
c
1
!
s
to
03
C
o
tn
C
o
o
3
5
o
o
(0
"o
a
GO S.
C
O
.1 "i
'•5 p
3 O
i °
£ "S
.2 E
S 1
m <
an
*
*
0
.. ..
Ik
5
5
£C
3
>
}
|
1
l
)
f*
if
11
^ E
uiil
— ""
E
M -
if?
«^|
2 S
^
1
c S
o a*
C Cja
o o
o"5
^i§
«.sl
CO ^
o
z
di
cc
UJ
oi
v>
2
(0
D
O
u>
^-'
§4
i
i~
•
I
<—
0>
I
2
^
1
2
Q
"5
"f
re
s
j
6
c
I J
g ' I
1
,
i,
I
3
i
^
J
l
C
_
H i
n *•
^
a
g
7
1
J
c
"£
O
U
&
LJLJ
275
-------
-------
nstructions for Completing the Confidential Statement of Formula
All the blocks on the form must be filled in and answered completely.
. If any block is not applicable, mark it N/A.
The CSF must be signed, dated and the telephone number of the responsible party must be provided.
AlUpplicable information which is on the product specific data submission must also be reported on the
for s^olidshtS rep°rted Under item 7 must be in P°unds Per ^lon for ^ids and Pounds per cubic feet
Flashpoint must be in degrees Fahrenheit and flame extension in inches.
currently registered
J-
k.
1.
m.
n.
be
common
must be repolttd mder column 10
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 Mograms)
All the items under column 13. b. must total 100 percent.
All items under columns 14.a. and 14.b. for the active ingredients must represent pure active form.
The upper and lower certified limits for ail active and inert ingredients must follow the 40 CFR 158 175
10110118' exPlanatton must be provided if the proposed limits are different than standard certified
When new CSFs are submitted and approved, all previously submitted CSFs become obsolete for that
specitic lormulation,,
277
-------
-------
United states Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE SN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
Approval Expires 3-3J-9«
Public reporting burden for this collection of information is estimated to average 15 minutes
Send C°mmentS regardinS lhe burtfln estimate °r *<* other
p h » ™ ,- . Including suggestions for reducing this burden, to Chief, Information Policy
Branch. PM-223. U A Environmental Protection Agency, 401 M St., S.W , Washington, DC 20460 and o the Office
of Management and Budget, Paperwork Reduction Project (2070-0106). Washington. DC 2050?.
Please fill In blanks below.
Compan> Name ~~ ~~ ~ —
Company Nnmber
EPA Rej.No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
lnsectic.de, Fung,cide 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
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
Name of Flrm(s)
Date of Offer
Certification:
I certify that I am duly authonzed 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 i
misleading statement may be punishable by fine or imprisonment or both under applicable law
sor
Signature of Company'* Authorized Representative
Nama and Title (Please Typo or Print)
Date
279
-------
-------
United States Environmental Protection Agency
Washington, DC 2O46O
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Form Approved
OMB No. 2O7O-
0107,
2070-0057
Approval Expires
3-31-96
- J of information is estimated to average 15 minutes per response includinn timp for
20460; and to the Office of Management and Budget, Paperwork Reduction Project
Please fill in blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
I Certify that:
on the back «™s form or attached sheets, or indicated on the attached
"*"**** ^ SeCti°n 3(c)(1 )(F) °f FIFRA for the studies ' nave cited in support of registration or
Signature
Name and Title (Please Type or Print)
Date
Signature
Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
281
-------
-------
APPENDIX G. FACT SHEET
283
-------
-------
United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-95-018
August 1995
R.E.D. FACTS
Picloram
Pesticide All pesticides sold or distributed in the United States must be
Rereglstration registered by EPA, based on scientific studies showing that they can be used
without posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered years ago be reregistered to ensure that they meet
today's more stringent standards.
, In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
fact sheet summarizes the information in the RED document for
reregistration case 0096, picloram acid and its three derivatives,
triisopropanolarnine picloram (TIPA-salt), isooctyl/ethylhexyl picloram -
(IOE), and potassium picloram (K-salt), referred to collectively as
"picloram".
Use Profile
Picloram is a systemic herbicide used to control deeply rooted
herbaceous weeds and woody plants in rights-of-way, forestry, rangelands,
pastures, and small grain crops. It is applied in the greatest amounts to
pasture and rangeland, followed by forestry. Picloram acid is a
manufacturing use product with no end uses. The TIPA-salt and K-salt have
food and feed uses, and are applied pre- or post-emergence as a ground or
aerial broadcast or spot treatment. The IOE derivative is registered for non-
food uses only. Picloram products have no household or residential uses.
All picloram products are classified as Restricted Use pesticides based
on hazard to nontarget plants, and may be applied only by or under the
direct supervision of certified applicators. Use practice limitations for the
TIPA-salt include a prohibition against applying through any type of
irrigation system, observation of a 30-day preharvest interval for
forage/fodder, and observation of a 7-day pregrazing interval. The IOE
includes prohibitions against contaminating water intended for irrigation or
domestic purposes, application to snow or frozen ground, and application
-------
near desirable trees if injury from potential transfer through roots cannot be
tolerated. The K-salt includes prohibitions against application through any
type of irrigation system, grazing or feeding forage from treated areas for 2
weeks after treatment, or harvesting hay from treated grain fields.
Regulatory Picloram was first registered as a pesticide in the U.S. in 1964. EPA
History classified picloram as a Restricted Use pesticide in 1978 as a result of
recurring reports of phytotoxicity to economically important crops caused
by contamination of water supplies.
EPA issued a Registration Standard for picloram in March 1985
imposing a maximum level of the manufacturing impurity
hexachlorobenzene (HCB) in technical picloram of 200 ppm, and requiring
additional studies including testing for nitrosamines. The sole registrant
completed this testing; no nitrosamines were detected in picloram products,
and the level of HCB is certified to be less than 100 ppm. EPA issued a
picloram Final Reregistration Standard and Tolerance Reassessment
document in May 1988. Currently, two picloram manufacturing use
products and seven end-use products are registered.
Human Health
Assessment
Toxicity
In studies using laboratory animals, picloram generally has been
shown to be of moderate to low acute toxicity. Picloram and its derivatives
are only slightly toxic by the oral and dermal routes and have been placed in
Toxicity Categories III and IV (the lowest of four categories) for these
effects. However, picloram acid is highly toxic and the three derivatives
are moderately toxic by the inhalation route (Toxicity Categories I and II).
Picloram and derivatives cause moderate eye irritation (Toxicity Category
ET). Most are not skin irritants (Toxicity Category IV, except IOE in
Category El). The three derivatives are skin sensitizers while picloram acid
is not.
In a subchronic toxicity study using rats, picloram caused changes in
the liver. A dog dietary study resulted in decreases in body weight gain,
food consumption, liver weights and several enzymes. In two dermal
toxicity studies using rabbits, picloram caused skin irritation, redness, and
swelling. A study using rats resulted in increased liver and kidney weights.
A study using rabbits resulted in increases in levels of several blood
components. A study using rats resulted in liver effects, increased liver and
kidney effects, and decreased body weight gain.
A chronic toxicity study using dogs resulted in increased liver weight.
A chronic/carcinogenicity study using rats resulted in chronic toxicity in
males only and no evidence of carcinogenicity. A study using mice also
resulted in no evidence of carcinogenicity. Based on these studies, picloram
was classified as a "Group E" chemical—one showing evidence of non-
carcinogenicity for humans. Subsequently, picloram IOE was found to bear
-------
structural similarity to di(2-ethylhexyl)phthalate or DEHP, which has been
found to cause cancer in rodents. EPA included this information in
assessing picloram's risks.to workers.
There is no evidence that picloram and its salts and ester are
associated with significant reproductive or developmental toxicity. A study
using rabbits resulted in reduced maternal weight gain. In five studies using
rabbits and rats, there was no evidence of developmental toxicity at any dose
level, though some signs of maternal toxicity were observed. In a
reproduction study using rats, effects to the kidneys, urine, and body weight
gain were observed at the high dose. Picloram shows no evidence of
causing mutagenicity.
Dietary Exposure
People may be exposed to residues of picloram through the diet.
Existing tolerances or maximum residue limits which have been reassessed
and found adequate include grain, forage, and straw of barley, oats, and
wheat; milk; eggs; fat, meat, kidney, liver, and meat by-products of
cattle, goats, hogs, horses, and sheep; and fat, meat, and meat by-products
of poultry (please see 40 CFR 180.292). Sufficient data also are available
to determine the adequacy of established food/feed additive tolerances for
barley, oat, and wheat milled fractions (excluding flour) listed in 40 CFR
185.4850 and 40 CFR 186.4850.
In reassessing picloram tolerances, EPA has found that both an
existing tolerance for forage grasses and a proposed new tolerance for hay
grass need to be raised to a higher level. A tolerance must be proposed for
wheat grain dust, and established tolerances for flax seed and straw should
be revoked since this use is not registered. International Codex MRLs are
neither established nor proposed so compatibility with U.S. tolerances is not
an issue.
EPA has assessed dietary risks considering chronic dietary exposure
and risk to picloram per se, and to the impurity HCB. The exposure/risk
estimates for picloram are extremely low. The Anticipated Residue
Concentration (ARC) for the U.S. population as a whole represents only
0.5% of the Reference Dose (RfD), an amount believed not to cause adverse
effects if consumed daily over a 70-year lifetime. The most highly expose
subgroup, non-nursing infants less than one year old, has an ARC which
represents 1.9% of the RfD. This low fraction of the allowable RfD is
considered to be an acceptable dietary exposure risk.
The HCB upper-bound cancer exposure/risk estimate, performed only
for the U.S. population as a whole, produced an ARC risk estimate of 6.7 x
10'7. This level of risk, which is likely a substantial overestimate, generally
is considered negligible.
-------
OccupationaS and Residential Exposure
Based on current use patterns, handlers (mixers, loaders, and
applicators) may be exposed to picloram during applications in agriculture
and forestry, on pastures and rangelands, along rights-of-way, and in other
non-crop areas. Because of picloram1 s use patterns, post-application
activities and exposure generally are not expected. No picloram products
are registered for homeowner use or have residential applications.
Since there is an exposure risk for handlers of picloram via the dermal
and inhalation routes during normal use, EPA conducted an occupational
exposure assessment. For the twelve major exposure scenarios identified,
Margins of Exposure (MOEs) for workers range from 111 for
backpack/knapsack application to 42,000 for groundboom application. The
risk to picloram handlers, therefore, is considered minimal.
Due to the HCB impurity in picloram and the structural similarity of
the IOE to DEHP, EPA also conducted a cancer risk assessment for
picloram handlers. The estimated excess cancer risk to agricultural workers
from HCB based on picloram use patterns and exposure by the dermal and
inhalation routes is between 4.19 x 10"5 and 1.07 x 10"7. The excess cancer
risk for workers from exposure to the IOE is 8.6 x 10"5. These estimates
are considered worst-case; actual exposure and risk may be lower.
Although entry into treated areas soon after application is expected to
be rare given picloram's typical use patterns, EPA has determined that entry
should not be permitted immediately following application. The Agency
therefore is requiring a 12-hour restricted entry interval (REI) for picloram
uses that are within the scope of the Worker Protection Standard for
Agricultural Pesticides (WPS), and a prohibition on entry until sprays have
dried for uses outside'the scope of the WPS.
Also, the MOEs for handlers are acceptable in some use scenarios
only with chemical-resistant gloves. Therefore, the minimum, baseline
personal protective equipment (PPE) for all WPS and nonWPS uses of
picloram is chemical-resistant gloves.
Human Risk Assessment
Picloram generally is of moderate to low acute toxicity but causes
inhalation toxicity (Toxicity Category II). Picloram is classified as a
"Group E" chemical—one showing evidence of non-carcinogenicity for
humans. However, it contains the impurity HCB which is classified as a
"B2" probable human carcinogen. In addition, picloram IOE is structurally
similar to DEHP, which has been found to cause cancer in rodents. EPA
considered this information in assessing picloram's risks.
People may be exposed to residues of picloram through their diets
since a number of food and animal feed crop uses are registered. However,
dietary exposure and risk are extremely low. There is no reason for
concern regarding chronic dietary exposure to picloram at this time.
-------
Environmental
Assessment
Risks to picloram handlers (mixers/loaders/applicators) are considered
minimal, and worst-case cancer risks to workers are not unacceptable (in the
10'5 to 10"7 range). To minimize risks to handlers, EPA is requiring use of
minimal, baseline PPE (chemical-resistant gloves). To minimize potential
reentry exposure risks, EPA is establishing restrictions on entry to treated
areas.
The principal environmental risks of picloram relate to contamination
of surface and ground water, and damage to nontarget terrestrial plants
including crops adjacent to areas of application via runoff or drift. Such
damage to plants also may emanate from more distant areas where ground
water is used for irrigation or is discharged into surface water. Nontarget
plants adjacent to areas of application may be exposed to concentrations of
picloram many times the levels that have been associated with toxic effects.
In addition, EPA has concerns related to endangered terrestrial mammals
and endangered aquatic animals.
Environmental Fate
Picloram is highly soluble in water, resistant to biotic and abiotic
degradation processes, and mobile under both laboratory and field
conditions. It is stable to hydrolysis and anaerobic degradation, and
degrades very slowly with half-lives ranging from 167 to 513 days. Its
major route of dissipation appears to be leaching.
Although no ground water monitoring studies have been submitted to
EPA, available data indicate that picloram has very high potential to leach to
ground water in most soils. As of 1992, picloram had been detected in '
ground water in 10 states, at concentrations up to 30 ppb.
Picioram is extremely mobile. Nearly 100% of the chemical leached
but none of it degraded over a three-year period in a University of Arkansas
study. Given its high persistence, it appears unlikely that picloram will
degrade once it reaches ground water, even over a period of several years.
Environmental Fate Assessment
Picloram is among the most mobile of currently registered pesticides.
In some soils, it is nearly recalcitrant to all degradation processes. Picloram
has been detected in ground water in 10 states, to date. However, it
generally does not pose a threat to human health at the levels detected.
Concerns are related principally to effects on nontarget plants, which
may be exposed to picloram by drift or runoff from areas of application, or
by irrigation with contaminated surface or ground water. Aquatic plants
also may be exposed to picloram via runoff, drift, or discharge of
contaminated ground water into surface water.
EPA is concerned about degradation of water quality in picloram use
areas. Eventual contamination of ground water is virtually certain in areas
where picloram residues persist in the overlying soil. Once in ground
water, picloram is unlikely to degrade, even over a period of several years.
-------
Risk Mitigation
Picloram also has a high potential to contaminate surface water by
runoff from use areas. The EPA Office of Drinking Water's STORET
database indicates that picloram has been reported in 420 of 744 surface
water samples. EPA does not have data from monitoring of picloram in
surface water. However, picloram is regulated by the Safe Drinking Water
Act (SDWA) and water supply systems are required to sample for it.
Ecological Effects
Picloram and its derivatives are practically nontoxic to birds,
mammals, and honeybees on an acute oral basis. Picloram acid and the K-
salt are moderately toxic to freshwater fish and slightly toxic to freshwater
invertebrates. The TIPA salt is slightly toxic to freshwater fish and
marine/estuarine mollusks and practically nontoxic to marine crustaceans.
Picloram salt is slightly toxic to marine/estuarine mollusks and
invertebrates. Additional studies are required.
Picloram is extremely phytotoxic as well as persistent and prone to
leach to ground water in all soil types. A number of additional plant, fish,
invertebrate, and marine/estuarine effects studies are required as
confirmatory data.
Ecological Effects Risk Assessment
Picloram poses very significant risks to nontarget plants. Estimated
concentrations of picloram in the environment are hundreds to thousands of
times the "level of concern" at which 25% of seedlings fail to emerge.
Although data requirements are not fulfilled for aquatic plants or animals,
estimated picloram exposures exceed levels of concern for endangered fish
and mollusks. Endangered terrestrial mammals also encounter exposures
which are likely to exceed levels of concern.
To lessen risks of picloram to nontarget plants and ground and surface
water, EPA is requiring the following risk mitigation measures and
programs.
Application Modifications
o EPA is lowering application rates and imposing limits on the number and
frequency of applications for all use patterns —
• The broadcast rate for range and pasture use and the spot treatment
rate will be lowered.
• The forestry use rate and frequency will be lowered.
• The rights-of-way use rate will be lowered.
o Picloram will remain classified for Restricted Use and may be identified
as a candidate for State Management Plans.
o EPA is requiring spray drift mitigation language including an Aerial Drift
Reduction Advisory, as well as ground water, surface water, and
phytotoxicity advisory language on all picloram product labeling.
-------
Monitoring and Other Programs
° The registrant, DowElanco, has committed to conduct a state ground
water monitoring/surveillance plan; The results will determine whether
additional data are required or appropriate regulatory action is necessary.
° The registrant has committed to provide support to the Heritage programs
in six states with the highest use of picloram. These programs map and
monitor sensitive habitat in 48 states to help protect endangered species.
Registrant Stewardship
° The registrant has instituted a strict product distribution system which
includes a mandatory training program for all picloram distributors.
Benefits
° EPA conducted a cursory benefits analysis and found that picloram is an
extremely effective herbicide at relatively low rates. To achieve the same
control, a combination of alternatives would have to be used at higher rates.
Endangered Species Protection Program
o EPA will address picloram's risks to endangered plants, mammals, and
aquatic species through the Endangered Species Protection Program, when it
goes into effect.
Additional Data EPA is requiring the following types of additional generic studies for
Required picloram to confirm its regulatory assessments and conclusions. Please see
the RED document for a more detailed list.
• Toxicity to marine/estuarine fish, mollusk, and shrimp;
• Early life stage - fish;
• Bluegill and rainbow Acute LD50;
• Invertebrate toxicity (Daphnia magna);
• Aquatic plant growth (marine diatom, algae);
• Seed germination/emergence;
• Vegetative vigor;
• Estimation of dermal or inhalation exposure at outdoor sites for
mixer/loaders and applicators using the hand cannon or
backpack/knapsack equipment;
• Ground water surveillance/monitoring.
The Agency is also 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 picloram end-use products must comply with EPA's current
Changes Required pesticide product labeling requirements, and with the following labeling
requirements. For the complete text of labeling changes required, please
see the picloram RED document.
-------
Reduced Use Rates and Increased Intervals
Labels must be amended to reflect the following changes in maximum
application rates and treatment intervals:
° Broadcast rate for range and pasture is lowered from current maximum
of 2.0 Ib. to 0.5 acid equivalent per acre (ae/A) for control of broadleaf
weeds and woody plants. For control of noxious weeds, broadcast
application of up to 1.0 Ib. ae/A may be used annually. Spot treatment will
be lowered to a maximum of 1.0 Ib ae/A with no more than 50% of an acre
being treated. Spot treatments and broadcast treatments can be applied
during the same growing season only if the total amount applied does not
exceed 1.0 Ib. ae/A per annual growing season.
° Forestry use rate is lowered from maximum of 2.2 Ibs. ae/A to 1.0 Ib.
ae/A for spot and broadcast treatment. Use is allowed only once every 2
years.
° Rights-of-way use rate is lowered from a maximum of 2.2 Ibs. ae/A to 1
Ib. ae/A annually.
Personal Protective Equipment (PPE) for Handlers
The minimum (baseline) handler PPE for all WPS and nonWPS uses of
picloram is chemical-resistant gloves. Remaining PPE for handlers is to be
based on the toxicity of the end-use product.
Entry Restrictions for Occupational-Use Products (WPS Uses)
EPA is establishing a 12-hour restricted entry interval (REI).. PPE required
for WPS-permitted early entry into treated areas that involves contact with
anything that has been treated, such as plants, soil, or water, is: coveralls,
chemical-resistant gloves, socks, and shoes.
Entry Restrictions for Occupational-Use Products (NonWPS Uses)
For nonWPS uses of picloram, EPA is requiring the following:
"Do not enter or allow others to enter the treated area until sprays
have dried."
Application Restrictions
"Do not apply this product in a way that will contact workers or other
persons, either directly or through drift. Only protected handlers may
be in the area during application."
Engineering Controls
"When handlers use closed systems, enclosed cabs, or aircraft in a
manner that meets the requirements listed in the WPS..., the handler
PPE requirements may be reduced or modified as specified in the
WPS."
User Safety Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. If
no such instructions exist for washables, use detergent and hot water.
Iveep and wash PPE separately from other laundry."
-------
User Safety Recommendations
"Users should wash hands before eating, drinking, chewing gum,
using tobacco, or.using the toilet."
"Users should remove clothing immediately if pesticide gets inside.
Then wash thoroughly and put on clean clothing."
Precautionary Statements
Because picloram salts and ester are skin sensitizers, the following statement
is required in the "Hazards to Humans (and Domestic Animals)" section on
end-use product labeling:
"Prolonged or frequent repeated skin contact may cause allergic
reactions in some individuals."
Respirator
If the acute inhalation toxicity of the end-use product is in Category I or II,
a respirator is required for pesticide handlers. The following type of
respirator is appropriate to mitigate picloram inhalation concerns:
"A dust/mist filtering respirator (MSHA/NIOSH approval number
prefix TC-21Q."
Spray Drift Labeling
The following language must appear on the label of each product that can be
applied aerially:
"Avoiding spray drift at the application site is the responsibility of the
applicator. The interaction of many equipment-and-weather-related
factors determine the potential for spray drift. The applicator and the
grower are responsible for considering all these factors when making
decisions."
"The following drift management requirements must be followed to
avoid off-target drift movement from aerial applications to agricultural
field crops. These requirements do not apply to forestry applications,
public health uses or to applications using dry formulations.
1. The distance of the outer most nozzles on the boom must not
exceed 3/4 the length of the wingspan.
2. Nozzles must always point backward parallel with the air stream
and never be pointed downwards more than 45 degrees."
"Where states have more stringent regulations, they should be
observed."
"The applicator should be familiar with and take into account the
information covered in the Aerial Drift Reduction Advisory."
Aerial Drift Reduction Advisory
Please see the picloram RED document for the text of this Advisory, which
must be contained in product labeling.
-------
Ground Water Advisory Statements
The following ground water advisory language must be placed on all
picloram labels:
"This chemical is known to leach through soil into ground water under
certain conditions as a result of agricultural use. Use of this chemical
in areas where soils are permeable, particularly where the water table
is shallow, may result in groundwater contamination."
Surface Water Advisory Statements
The following surface water advisory language must be placed on all
picloram labels:
"This chemical can contaminate surface water through spray drift.
Under some conditions, picloram may also have a high potential for
runoff into surface water (primarily via dissolution in runoff water)
for several months post-application. These include poorly draining or
wet soils with readily visible slopes toward adjacent surface waters,
frequently flooded areas, areas over-laying extremely shallow ground
water, areas with in-field canals or ditches that drain to surface water,
areas not separated from adjacent surface waters with vegetated filter
strips, and areas over-laying tile drainage systems that drain to surface
water."
Phytotoxicity Advisory Statements
The following phytotoxicity advisory language must be placed on all
picloram labels:
"This pesticide is toxic to some plants at very low concentrations.
Non-target plants may be adversely affected if pesticide is allowed to
drift from areas of application."
Precautionary Hazard Statement
Labeling should include the following:
"Do not apply this product to water, or to areas where surface water is
present, or to intertidal areas below the mean high water mark."
Picloram and its derivatives can be used without causing unreasonable
adverse effects to humans or the environment. Therefore, all uses of
products containing picloram acid and its derivatives are eligible for
reregistration, conditional upon implementation of the mitigation measures
specified in the picloram RED document.
Picloram products will be reregistered once the required product-
specific data, revised Confidential Statements of Formula, and revised
labeling are received and accepted by EPA.
For More EPA is requesting public comments on the Reregistration Eligibility
Information Decision (RED) document for picloram during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register. To
10
Regulatory
Conclusion
-------
obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket, Public Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide Programs
(OPP), US EPA, Washington, DC 20460, telephone 703-305-5805.
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregistration Information System at
703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA.GOV, or using ftp 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 picloram 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 picloram RED, or reregistration of individual products containing
picloram, 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 8:00 pm Eastern Standard
Time, Monday through Friday.
-------
------- |