&EPA
United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA 738-R-95-032
June 1995
Reregistration
Eligibility Decision (RED)
Ancymidol
Recycled/Recyclable
Printed with Soy/Canola Ink on paper that
contains at least 50% recycled fiber
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United States
Environmental Protection
Agency __^__
Prevention, Pesticides
And Toxic Substances
(7508W).
EPA-738-F-95-027
June 1995
R.E.D. FACTS
Pesticide
Reregistration
Ancymidol
All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies -showing that they can be used
without posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered years ago be reregistered to ensure that they meet
today's more stringent standards. .
In evaluating pesticides for reregistration, EPA obtains and reviews 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 3017, ancymidol.
Use Profile
Ancymidol is a plant growth regulator registered for treating
container-grown herbaceous plants, ornamental woody shrubs, arid bedding
plants grown in greenhouses and other plant bedding areas for commercial
production. Growth regulator effects produced by ancymidol are the result
of inhibition of gibberellin biosynthesis. Since gibberellin promotes growth,
treatment with ancymidol induces a more compact growth form by
suppressing growth between nodes. The amount ot active ingredient
required for an optimum growth response depends on pot size, stage of
growth, method of application., season, and varietal response.
Regulatory
History
Ancymidol was first registered as a pesticide in the U.S. in 1973.
In 1993 the Agency issued a Data Call-in (DCI) to the registrant for
submission of additional data on ancymidol to support reregistration.
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Human Health
Assessment
Currently there are two registered products, a technical formulation
for manufacturing-use only and an end-use product containing 0.0264%.
ancymidol.
Toxicity .
Testing of ancymidol for acute toxicity on animals indicates that when
inhaled, ingested, or applied to eyes, ancymidol is considered slightly
acutely toxic (Toxicity category III). When applied to skin, it is practically
non-toxic (Toxicity category IV). A subchronic 21-day toxicity study, on
rabbits showed no dermal irritation or systemic toxicity at the limit dose
(1000 rrig/kg) when applied dermally. A developmental toxicity study in rats
did not indicate that ancymidol is a developmental toxicant. From that
study, a lowest observed effect level for non-developmental toxic effects
was determined to be 200 mg/kg/day, based on decreased body-weight gain
and food consumption; while the no-effect level was considered to be 50
mg/kg/day. Finally, a battery of mutagenicity studies were negative for
ancymidol. Long-term chronic toxicity testing of ancymidol has not been
conducted but is not required since it is not found in food and other potential
exposure to humans is very limited.
Dietary Exposure
No dietary exposure is expected from the pesticide uses of ancymidol
since no food or feed uses are registered.
Occupational and Residential Exposure
Since ancymidol is used as a plant growth regulator for commercial
purposes, there is potential exposure to pesticide handlers during use of the
chemical and to persons entering treated sites after application is complete.
At this time there are no products containing ancymidol intended for
residential use. Therefore, the Agency did not conduct a residential risk
assessment.
Human Risk Assessment
Since ancymidol has no food or feed uses, dietary risk is not expected.
An acute toxicity inhalation study in rats treated with ancymidol shows what
appeared to be neurotoxic effects. However, while spray applications may _
produce significant exposure, concentrations of ancymidol are low in
formulated products (0.0264% a.L), spray volatility is low, and current
usage is very small. In consideration of this, the Agency believes that the,
potential risk to applicators is insignificant.
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Ecological Effects Risk Assessment
Because environmental exposure to ancymidol is very limited and low
toxicity is cited in all of the submitted studies, the Agency expects minimal
adverse effects to birds, mammals, aquatic organisms and non-target plants:
Additional Data
Required
The Agency is requiring product-specific data including product
chemistry and acute toxicity studies, revised Confidential Statements of
Formula (CSFs), a'nd revised labeling for reregistratibn.
For More
Information
Product Labeling AU end-use products containing ancymidol must comply with EPA's
Chanqes Required current pesticide product labeling requirements. For a comprehensive list of
, labeling requirements, please see the ancymidol RED document.
Regulatory ' The use of currently registered products containing ancymidol in
Conclusion accordance witn approved labeling will not pose unreasonable risks or
i- adverse effects to humans or the environment. Therefore, all uses of these
products are eligible for reregistration.
Ancymidol products will be reregistered once the required product-
- specific data, revised Confidential Statements of Formula, and revised
labeling are received and accepted by EPA. - - -
EPA is requesting public comments on; the Reregistration Eligibility
Decision (RED) document for ancymidol during a 60-day time period, as.
announced in a Notice of Availability published in the Federal Register. To
obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket, Public Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide Programs
(QPP), 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.
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Following the comment period, the ancymidol 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 ancymidol RED, or reregistration of individual products containing
ancymidol, 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.
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\ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
i -..,"" - , , "
' WASHINGTON, D.C. ,20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXlC SUBSTANCES
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 Ancymidol.- The
enclosed Reregistration Eligibility Decision (RED) contains the, Agency's evaluation, of the
data base of these chemicals, its conclusions of the potential human health and environmental
risks of the current product uses, and its decisions and conditions under which these uses and
products will be eligible for reregistration. The RED includes the data and labeling
requirements for products for reregistration. It may also include requirements for additional
data (generic) on the active ingredients to confirm the risk assessments.
To assist you with a proper response, read the enclosed document entitled "Summary -
of Instructions for Responding to the RED". This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses. The first set of required responses are due 90 days from;
the date of this letter. The second set of required responses are due 8 months from the
date of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products. - '
If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative
Veronica Dutch at (703) 308-8585. Address any questions on required generic data to the :
Special Review and Reregistration Division representative Reiman Rhinehart (703) 308-8584.
Sincerely yours
Enclosures
Dis Rossi, Director
Special Review
and Reregistration Division
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1. DATA CALL-IN (PCI) OR "90-DAY RESPONSE"-If generic data are required for
_ reregistration, a.DCI letter will be enclosed describing such data. If product specific data
are required, another DCIletter will be enclosed listing such requirements. If both generic
and product specific data are required, a combined Generic and Product Specific letter will
be enclosed describing such data. Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each PCI within 90 days-of the date
of this letter (RED issuance date); otherwise, your product may be suspended.
, 2: TIME EXTENSIONS AND DATA WAIVER REQUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect-to actual data submissions. Requests for data waivers must be submitted as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response,
but certainly no later than the 8-month response date. All data waiver and time extension
, requests must be accompanied by a full justification. All waivers and time extensions must be
granted by EPA in order to go into effect. .
3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1) Use only an original
application form. . Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
- changes, or labeling changes not related to reregistration) separately. You may delete uses
which the RED says are ineligible for reregistration. For further labeling guidance, refer to
the labeling section of the EPA publication "General Information on Applying for Registration
in the U.S., Second Edition, August 1992" (available from the National Technical information
Service, publication #PB92-221811; telephone number 703-487-4650),
' c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (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
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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
sigh EPA form 8570-31 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOtlCE-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 REVIEWSEPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to, respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATIQN ELIGIBILITY DECISION
ANCYMIDOL
/ - ' -
^; ,: ; , LISTC '' '-. ; '
CASE 3017
ENVffiONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
ANCYMTOOL REREGISTRATION ELIGIBILITY DECISION TEAM . , ...... i
\ - -... ..''
EXECUTIVE SUMMARY . . . ..,.,..; ... .'.. ...... . . ;... . . .... ; . . '. ... ..-.'. . . . v
I. INTRODUCTION . . . . . . ..-/.., . . ..... ...... .... ......... 1
n. - ; CASE OVERVIEW .. ..'/...-.....'..,:,'..........-..,'.... .,'. v,..-... 2
A. Chemical Overview '..'...-.........' ....' . . 2
B. Use Profile ......................... ^ ... 2
C. ( Data Requirements 3,
D. Regulatory History . . . . .....;.................... 4
ffl. . SCIENCE ASSESSMENT '. '. :.' . . . .'. .' ; .... ..'..,. . /. ... 4
A. Physical Chemistry Assessment . . . . . . 4
B. Human Health Assessment . ........... 5,
1. Toxicology Assessment . 5
a. . Acute Toxicity .5
b. Subchronic Toxicity . . . . . ... . . . . . . .... . . ... . . . . . .7
c. Developmental Toxicity ....-.' '..-; .7
d. Mutagenicity '; ....... 8
e. Other Toxic Endpoints .....;..... 9
2. Exposure Assessment - Occupational and Residential . . 9
3. Risk Assessment - Occupational ....................... 9
C. Environmental Assessment ....... .... 10
1. Environmental Fate . '.'...- ',,. . . . ; . . 10
a. Environmental Fate Assessment ................ . . 10
b. Environmental Chemistry, Fate and Transport 10
2. Ecological Effects ..:..,....,. 11
a. Non-Target Bird Data 11
b. Aquatic Data 13
c. Terrestrial, Semi-Aquatic, and Aquatic Plant Data ..... 14
d. Non-Target Insects Data ........... i ............. 14
e. Non-Target Mammal Data .... ..... .... 15
3. Ecological Effects Risk Assessment . . . . ........../..... 15
a. Risk to Terrestrial Animals ..... .'_. . .... ....... . . 15
b. Risk to Aquatic Animals 15
c; Risk to Non-Target Plants .............. . . ..... 15
d. Risk to Endangered Species ................. . . ... 16
IV. RISK MANAGEMENT AND REREGISTRATION DECISION . 16
A. Determination of Eligibility r ............. 16
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1. Eligibility Decision 17
2. Eligible and Ineligible Uses . ;..... 17
B. Regulatory Position . 17
V. ACTIONS REQUIRED OF REGISTRANTS ..:....... ^ ......... ... 19
A. Manufacturing-Use Products . . 19
1. Additional Generic Data Requirements 19
2. Labeling Requirements for Manufacturing-Use Products 19
B. End-Use Products 20
1. Additional Product-Specific Data Requirements 20
2. Labeling Requirements for End-Use Products ............. 20
C. Existing Stocks 21
VI. APPENDICES . . . . ...- 23
APPENDIX A. Table of Use Patterns Subject to Reregistration ....... 24
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision ...... 26
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of ancymidol 30
APPENDIX D. Product Specific Data Call-In ...... 35
Attachment 1. Chemical Status Sheets 47
Attachment 2. Product Specific Data Call-In Response Forms (Form A
inserts) Plus Instructions .48
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions .......... 49
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration . ... 52
Attachment 5.vi List of All Registrants Sent This Data Call-In (insert)
Notice ". 54
Attachment 6. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions . 55
APPENDIX E. List of Available Related Documents 63
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ANCYMIDOL REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Steve Jarboe .
Eric Maurer ,
Environmental Fate and Effects Division
Linda Kutney
Renee Gostello
Mike Davy
George Tompkins
Health Effects Division
Paula Deschamp
Winston Dang
Sany vette WHIiams-Foy
Registration Division,
Bipin Gandhi
James Stone
Biological Analysis Branch
Economic Analysis Branch
Science Analysis and Coordination Staff
Science Analysis and Coordination Staff
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Chemical Coordination Branch
Occupational and Residential Exposure Branch
Toxicology Branch II
Registration Support Branch
Fungicide-Herbicide Branch
Special Review and Reregistration Division
Rieman Rhinehart
.Bruce Sidwell
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Office of General Counsel:
Kevin Lee
Pesticide Branch
Office of Compliance Monitoring
Amar Singh
Pesticide Enforcement Policy Branch
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11
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE Acid Equivalent
.a.i. . Active Ingredient
ARC Anticipated Residue Contribution . - '
CAS Chemical Abstracts Service ,
CI . Cation - J.- . ' .
CNS Central Nervous System , . .
CSF Confidential Statement of Formula , ; "
DFR Dislodgeable Foliar Residue
DRES Dietary Risk Evaluation System
DWEL 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.
EEC , Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
i such as a terrestrial ecosystem.
EP -... - End-Use Product , -
EPA U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodentieide Act ,
FFDCA Federal Food, Drug, and Cosmetic Act . . '','
FOB Functional Observation Battery '
GLC \ .- Gas Liquid Chrpmatography . . , .
GM Geometric Mean ''
GRAS . Generally Recognized as Safe as Designated by FDA ' *
HA . Health Advisory (HA) The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur. '
HOT Highest Dose Tested . ; ;' : : '
LCSO 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
volurneof water, air or-feed, e.g., mg/1, mg/kg orppm. '
LDSO Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50% of
, i 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. ,,
LDto Lethal Dose-low. Lowest Dose, at which lethality occurs
LEL Lowest Effect Level ' . ,
LOG Level of Concern
LOD Limit of Detection .'-.' ,
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration ' >
MCLG ' Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants m~drinking water under the Safe Drinking Water Act. '
ugVg Micrograms Per Gram ' ' .. ' ,
mg/L Milligrams Per Liter . . . -
MOB Margin of Exposure
MP , Manufacturing-Use Product
MPI ' Maximum Permissible Intake .
MRID , Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A Not Applicable
NOEC v No effect concentration . -. .
NPDES National Pollutant Discharge Elimination System -
NOEL . No Observed Effect Level ...
ill
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GLOSSARY OF TERMS AND ABBREVIATIONS
NOAEL No Observed Adverse Effect Level , ...
OP Organophosphate
OPP Office of Pesticide Programs , ,
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method .
PHED Pesticide Handler's Exposure Data
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice ,
Q'( The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC RedBloodCell
RED Reregistration Eligibility Decision ,
RBI Restricted Entry Interval , .
RfD Reference Dose ' .
RS Registration Standard , ,
SLN Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product ,
TGAI Technical Grade Active Ingredient ' .
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support .a column of mercury 1mm high under standard conditions.
FAO/WHO Food and Agriculture Organization/World Health Organization
WP Wettable Powder
WPS Worker Protection Standard < '
IV
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EXECUTIVE SUMMARY
, This Registration Eligibility Decision (RED) addresses the eligibility for reregistration
of pesticide products containing the active ingredient ancymidol (alpha-cyclopyl-alpha-(4-
methoxyphenyl) -5-pyrimldinemethanol). Ancymidol is a plant growth regulator used in
commercial production of ornamental plants. It is used to treat herbaceous plants and ornamental
woody shrubs and vines. It acts by inhibiting gibberellin biosynthesis. Two products containing
ancymidol are currently registered.
The Agency has completed its review of the target database for ancymidol and has
determined that the uses of ancymidol as labeled and specified in this RED will not cause
unreasonable risk to humans or the environment and these uses are eligible for reregistration. No
additional data on the generic active ingredient is needed to confirm this reregistration eligibility
decision. ^, ,
Before reregistering the products containing ancymidol, the Agency is requiring that
product specific data, revised Confidential Statements of Formula (CSF) and revised labeling be
submitted within eight months of the issuance of this document. These data include product
chemistry for each registration and acute toxicity testing. After reviewing these data and any
revised labels and finding them acceptable in accordance with Section 3(c)(5) of FIFRA, the
Agency will reregister, a product. 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. .
v ,
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I.
mTRODUCTION
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 reregistration" before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action.",Thus, reregistration involves a thorough review of the scientific data base underlying a
pestipide'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 ancymidol. The document consists of six sections. Section I is the
introduction. Section II describes ancymidol, its uses, data requirements and regulatory history.
Section IE discusses the human health and environmental assessment based on the data available
to the Agency. Section IV presents the reregistration decision for ancymidol. Section V discusses
the reregistration requirements for ancymidol. Finally, Section VI is the Appendices which
support this Reregistration Eligibility Decision. Additional details concerning the Agency's review
,of applicable data are available on request.
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H. CASE OVERVIEW
A. Chemical Overview
The following active, ingredient is covered by this .Reregistration Eligibility
Decision:
Common Name:
Ancymidol
Chemical Name: Alpha-cyclop ropy l-alpha-(4-methoxyphenyl) -5-
pyrimidinemethanol
CAS Registry Number: 12771-68-5
OPP Chemical Code: 108601
Empirical Formula: C15H16N2O2
Structural Formula:
9
OH
-0-CH3
Trade and Other Names: Ancymidol, "A-Rest
Basic Manufacturer: Sepro Corporation .
B. Use Profile
The following is information on the currently registered uses with an overview of
use sites and .application methods. A detailed table of these uses of ancymidol is in
Appendix A. , ,
' 2
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Ancymidol is a" plant growth regulator registered for treating container-grown
herbaceous plants, ornamental woody shrubs, and bedding plants grown in greenhouses
and, other plant bedding areas for primarily commercial production. Growth regulator
effects produced by ancymidol are the result of inhibition'of gibberellin biosynthesis. It
produces a more compact growth form by suppressing internode elongation. The amount
'of active ingredient required for an optimum growth response depends on pot size, stage
of growth, method of application, season, and varietal response.
Type of Pesticide: Plant growth regulator
> - ,
Use Sites: Terrestrial nonfood (greenhouses and other plant bedding areas.)
Container-grown ornamental herbaceous plants, ornamental woody shrubs
and bedding plants , , -' ,.'.''
Target Pests: none ,
Formulation Types Registered:
Single Active Ingredient (AI) Products
Soluble concentrate/liquid--0.0264%
Technical/solid-98'% '
Method and Rates of Application:
Soluble concentrate/liquid
At containerized stage, apply soil drench treatment at 15.6mg (0.0000344
, Ib) ai/gal to 4" pots (0.21 Ib ai/A of bench area) or 6" pots (0.19 Ib ai/gal
of bench area). At cutting, foliar, or plant bed; stage, spray by backpack or
tank-type sprayer at 0.0011 Ib ai/gal or 0.022 Ib ai/A. ,
Use Practice Limitations:
Do not apply through any type of irrigation system. ,
C. Data Requirements
The Agency required data to support reregistration through a Data Call-In Notice
(2/18/93) for ancymidol. Requirements included studies on ecological effects, product
chemistry, environmental fate, and toxicology.
- These date were required to assess me potential risk from uses identified oh current
labels. Appendix B includes all data requirements, identified by the Agency for currently
registered uses, needed to support reregistration.
3 .
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D. Regulatory History
The first pesticide product containing ancymidol as an active ingredient was
registered by the Agency in 1973. Currently, there are two registered products, a technical
formulation for manufacturing-use only and a 0.0264% end-use product. In 1993 the
Agency issued a Data Call-in requiring the registrant to provide appropiate chemistry,
lexicological and environmental fate data on this active ingredient to support
reregistration.
HI. SCIENCE ASSESSMENT
Below is a summary of the physical chemistry data bases reviewed by the Agency for the
purpose of determining the physical and chemical properties of ancymidol. The specific studies
reviewed for guidelines 61-1 through 63-13 are referenced in Appendix B.
A. Physical Chemistry Assessment
Color:
Physical State:
Odor:
Melting Point:
Boiling Point:
Density :
Solubility:
white to buff
crystalline granular
Slightly aromatic
111-112 °C.
Not Required for a Solid
Loose 0.418 g/ml
Settled 0.510 g/ml
Solvent
Water
Acetone
Acetonitrile
Benzene
Chloroform
Hexane
Methanol
Methyl Cellosolve
gms/100 ml
0.065
>25
7'
3.7
>50
0.019 ,
>25 '
>25
Vapor Pressure:
2 X 1Q-7 Torr at 25°C.
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OctanoI/Water Partition
Coefficient: Log K= 1.91
B.
pH:
Stability:
7.06 for 10% slurry in deionized water
Stable in glass or fiber drums
Human Health Assessment
Below is a summary of the toxicology and exposure data bases reviewed by
the Agency for the purpose of determining the potential risk to human health from
the use of ancymidol.
1. Toxicology Assessment ,
a. Acute -Toxicity
Table 1 describes the acute toxicity of ancymidol.
Table 1: ACUTE TOXICITY DATA
TEST" ' , ,, - \ ,
Oral LD50 - rat
Dermal LD50 - rabbit
Inhalation LCSO - rat
Ocular irritation - rabbit
Primary dermal irritation - rabbit
Dermal sensitization - guinea pig
itMOLTS
1721 mg/kg M; 1016 mg/kg F
LD50 = > 5000 mg/kg (limit dose)
LCSO = 0.59 mg/1 . :
mild irritant
Primary Irritation Index (P.I.I.) = 0.0
Non-sensitizer '
CAmSQ&Y <,
m
TV
m
in
rv
reregistration of the TGAI. These data are presented for informational purposes. . ' . '' ,.
In'an acute oral toxieity study [MRID#: 424806-01], male and
female Fischer 344 rats were administered ancymidol at doses of 0, 750,
1375, or 2500 mg/kg/day. The LD§0 for males and females was 1721 and
1016 mg/kg, respectively. Treatment-related signs included decreased
body weight gain,, hypoactivity, tremors, ataxia, lethargy,
chromodacryorrhea and a minimal decrease in testicular size. Based on
> these results, ancymidol was determined to "have an, acute oral Toxicity
Category of III. This study satisfies data requirements for an acute oral
' toxicity study in rats.
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The acute dermal toxicity (LD50) and primary dermal irritation
potential [MRID#: 419379-01] of ancymidol was evaluated in 5 male and
5 female New Zealand White rabbits. The "limit dose" of 5000 nig/kg was
applied topically and occluded for 24-hours after which it was removed.
The rabbits remained on study for 14 days and were sacrificed. There
were no treatment-related clinical findings upon observation of test ,
animals. All animals survived to the end of the study period. There was
no dermal irritation on-any animal. Based on the results of this study, the
dermal LD50 for ancymidol is >5000 mg/kg (limit dose) and the primary
irritation index (P.I.I.) = 0.0; ancymidol is not considered to be a dermal
irritant. Both acute dernial toxicity and primary dermal irritation studies
were determined to indicate a Toxicity Category of IV. This study satisfies
the requirements for an acute dermal (LD50) toxicity study 'and a primary
dermal irritation study in rabbits.
In an acute inhalation toxicity study [MRID# 42130801], groups of
Fischer 344 rats [10/sex/group] were exposed for a 4-hour "nose only"
period to a liquid droplet aerosol containing 7.5% ancymidol + acetone or
acetone alone. The total gravimetric exposure concentration was 0.63 mg/1
of air and the activity concentration was 0.59 mg ancymidol/L of air., The
mass median equivalent aerodynamic diameter (MMEAD) and the activity
median equivalent aerodynamic diameter (AMEAD) were 1.16 and 0.84,
respectively. Death occurred in 10/20 (50%) test animals treated with
ancymidol + acetone. Other signs of toxicity included: hypoactivity,
labored breathing, gasping, poor grooming, prostration, ataxia, and
kyphosis. Based on the results of this study, the median lethal
concentration (LC50) for a 4-hour exposure was estimated to be 0.59 mg
ancymidol/L of air "which places ancymidol in Toxicity Category III. This
study is classified as Core Supplementary and does not satisfy the
requirements for an acute inhalation toxicity study in rats. It may be
upgraded upon submission of missing clinical observations and pathology
information. This information has been requested from the registrant.
In a primary eye irritation study [MRID#41937902],' 63 mg (0,1
ml) of ancymidol was placed into the conjunctiva! sac of one eye of each
of 6 New Zealand white rabbits (three of each sex) for several seconds.
Within one hour post-treatment, iritis, conjunctivitis and slight corneal
dullness was observed in one rabbit. By Day 4, the irritation had cleared.
The remaining 5 animals developed very slight redness with 4/5 showing
very slight chemosis. These signs cleared by Day 3. Corneal damage in
' 3/6 test animals'was indicated by positive responses to the sodium
fluorescein stain 24 hours post-treatment. This had resolved by Day 4.
There were no adverse effects on body weight during the study. The results
of this study indicate that ocular irritation was cleared by Day 4 or less in
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all test animals. .Aricymidol was determined to be a mild ocular irritant
with a Toxicity Category of III. This study satisfies data requirements for
a primary eye irritation study in rabbits! ,
In a dermal sensitization study (modified Buehler method, 1965)
[MRID#: 419137-02], 12 female Hartley albino guinea pigs were exposed
to 50 mg doses of ancymidol at 6xhour intervals, three times a week for 2
weeks, then challenged with the same dose 10 days later. All test animals
survived to the end of the study period. Thqre were no adverse effects on
body weight during the study. Based on the results'of this study, dermal
sensitization or irritation was not evident in animals induced and challenged,
with ancymidol at a dose of 50 mg. This study satisfies the guideline
requirement for a dermal sensitization study in guinea pigs.
b. Subchronic Toxicity
In a 21-Day subchronic dermal toxicity study [MRID#: 421212-01],
the systemic toxicity and dermal irritation potential of ancymidol were
evaluated in 5 male and 5 female New Zealand White rabbits.' None of the
treated animals exhibited any dermal irritation or systemic toxicity after.
repeated exposure to 1000 mg/kg (limit dose) of ancymidol for 21 days.,
This study satisfies the requirement for, a repeat dose [21-day] dermal
toxicity study on the skin of rabbits. ,
c. Developmental Toxicity
In a developmental toxicity study [MRID#: 42480602], ancymidol
was administered to pregnant GD [Grl:CD (SD)] rats at doses of 0, 50,^
200, or 800 mg/kg/day on gestation days 6-17. Treatment-related maternal
findings included decreases in body weight gain* and food consumption at
200 mg/kg/day. The maternal no' observed effect level (NOEL) was 50
mg/kg/day. The maternal lowest observed effect level (LOEL) was
determined to be 200 mg/kg/day, based on decreased body weight gain and
food consumption.
Developmental toxicity findings worthy, of note included extra or
rudimentary thoracic ribs and increased number of presacral vertebrae. The
levels of extra or rudimentary thoracic ribs were outside of historical
control ranges and demonstrated a treatment:related response. It was
concluded that there was evidence of developmental alterations of rib
development (e.g., rudimentary cervical and thoracic ribs, extra ribs, wavy
ribs) with some vertebral changes (e.g., extra cervical vertebrae) at 800
mg/kg/day. Alterations in rib development (e.g., extra and rudimentary.
thoracic rib) were also seen at 200 mg/kg/day. The data suggested a dose
-------
'response in the incidence of rib anomalies, but this was not supported
statistically. Based on these findings, the no observed effect level (NOEL)
for developmental toxicity was determined to be 50 mg/kg/day and the
lowest observed effect level (LOEL) for developmental toxicity was
determined to be 200 mg/kg/day. This study satisfies the requirements for
a developmental toxicity study in rats. ,
d. Mutagenicity
Ancymidol was evaluated in a forward gene mutation study
[MRID#: 470105-08] at the thymidine kinase locus in mouse L5178Y TK+ "
cells in culture. The cells were exposed to ancymidol at concentrations of
10, 50, 100, 200, 400, 600, 800, or 1000 /ig/ml in the absence of
exogenous metabolic activation system and to 0.1, 1, 10, 100, 200, 400,
600 or 800 ptg/ml in the presence of an exogenous metabolic activation
system. Ancymidol was tested to a sufficiently high concentration based on
reduced cell growth in suspension. All cells were killed by 1000 ^g/ml in
the presence of S9 mix in the preliminary cytotoxicity assay. Positive and
solvent control values were, adequate. No evidence was seen of
mutagenicity at any concentration of ancymidol with or without exogenous
metabolic activation. This study is classified as an acceptable study that
satisfies the requirements for an in vitro mammalian cell gene mutation
study.
In a Salmonella/microsome plate incorporation assay '[MRID#:
470105-10] strains TA98, TA100, TA1535, TA1537, and TA1538 were
exposed to ancymidol at concentrations of 250, 500, 1000, 2500 or 5000
/Kg/plate, with and without exogenous metabolic activation. In the absence
of cytotoxicity or solubility limitations, ancymidol was tested to a
maximum concentration of 5000 /xg/plate. There was no evidence of
induced mutant colonies over background at any dose tested, either with or
without exogenous metabolic activation. This study satisfies the guideline
requirements for a gene mutation study. ,
In an unscheduled DNA synthesis (UDS) assay [MRID#: 470105-
12], cultures of primary hepatocytes from a male Fischer 344 rat were
exposed to ancymidol at concentrations of 0.5, 1,5, 10, 50, 100, 500 or
1000 jug/ml. Two assays were performed, each using hepatocytes from a
separate rat. The test compound was delivered in DMSO and the cells
exposed to the test material for 20 hours. Ancymidol was excessively.
cytotoxic in both assays at 1000 jag/ml, precluding evaluation of the cells
for UDS induction at this concentration. Some cytotoxicity was apparent
at 500 /ig/m!778778 but surviving cells were suitable for evaluation. All
other doses were non-cytotoxic. No induction of UDS occurred at any
,8
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concentration of ancymidol evaluated in either assay. This is an acceptable
, study for other genotoxic effects. > '
. ' ' - _ .''.-"-/'
e. Other Toxic Endpoints
Based on the use pattern for ancymidol as a non-food use pesticide,
the RfD Committee of the Office of Pesticide Programs decided riot to
establish an RfD for this chemical. There has been no,review by the Food
and Agricultural Organization/World Health Organization (FAO/WHO)
Joint Committee on Pesticide Residues (JMPR) for this pesticide. '
Exposure Assessment - Occupational and Residential
An occupational exposure assessment is required for an active
ingredient if (1) certain toxicological criteria are triggered and (2) there is
potential exposure to either handlers (mixers, loaders, applicators) during
use of the chemical or to persons entering treated sites after application is
complete. At this time there are no products containing ancymidol intended
for residential use. Therefpre, the Agency did^not conduct a residential
exposure assessment.
Mixer/Loader/Applicator Exposure
". - * ' '.. . > ,
Since ancymidol is used as a plant growth regulator for commercial
purposes, the potential exposure for handlers is significant. Based on the
pattern of use, several exposure scenarios are plausible depending on the
type of application equipment and procedures employed. The current label
(EPA. Reg.No. 67690-2) indicates that three kinds of application methods
are available: bench area sprays; soil drench treatments; and foliar spray
application methods. Handlers using open spray application methods (hand-
held and tank-type sprayers) have potential for respiratory, dermal, and eye
exposure when using ancymidol.
Post-Application Exposure's
Based on the existing use patterns of ancymidol, post-application
dermal (including contact with foliage) arid inhalation exposures exist.
Risk Assessment,- Occupational
The most appropriate endpoint for occupational exposure was
determined to be from the 21 day dermal toxicity study in rabbits (MRID
421212-01). However, since no systemic effects were seen at doses up to
-------
1000 mg/kg/day in that _study, no quantitative occupational or residential
risk assessment is necessary.
As noted in Section IILB^la, "Acute Toxicity", rats treated with
ancymidol in an acute inhalation study showed what appeared to be
neurotoxic effects. Without additional refined data (i.e., from an acute
inhalation neurotoxicity study) the Agency is not able to quantitatively
characterize potential risk of this effect from exposure. However, while
spray applications may produce significant exposure, concentrations of
ancymidol are low in formulated products (0.0264 % a.L), spray volatility
is low, and current^usage is very small. In consideration of this, the
Agency believes that submission of an acute inhalation neurotoxicity study
is unnecessary since the potential risk to applicators is insignificant.
C. Environmental Assessment
Because of the limited acreage anticipated, minor use sites (ornamental flowers and
shrubs), and low toxicity cited in all of the submitted studies, the Agency expects minimal
adverse effects to birds, mammals, aquatic organisms and non-target plants.
1. Environmental. Fate
At this time, all appropriate data requirements in the environmental fate
guidelines are fulfilled for ancymidol.
a. Environmental Fate Assessment
Based on the acceptable environmental fate data required (three data
requirements) for the limited use pattern, the major route of dissipation of
ancymidol in the soil is by microbial metabolism (aerobic half-life = 14.9
days). Based on an acceptable hydrolysis study, ancymidol was stable in
sterile aqueous buffer solutions at'pH 5.0, 7.0 and 9.0. In an acceptable
batch equilibrium study ancymidol was highly mobile with reported Kads
values ranging from 0.11 (sand soil) to 0.82 (clay loam soil). In an
acceptable leaching soil column study using a sandy loam soil, a total of
8.9 percent of the radioactivity applied to the column was recovered in the
combined leachate. ,
b. Environmental Chemistry, Fate and Transport
(1) Hydrolysis
Ancymidol was reported to be stable to hydrolysis in sterile
aqueous buffer solutions at pH 5.0, 7.0 and 9.0 at 25°C for 30
10
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days. The requirement for hydrolysis data has been satisfied
, (MRID ft 417235-03)
(2) Aerobic Soil Metabolism
Ancyrnidol, applied at 0.5 ppm, degraded with a half-life of
14.9 days.in a sandy loam soil incubated at 25°C. Six unidentified
degradates were detected at <; 0.01 ppm. Carbon dioxide increased
to a maximum of 44.89 percent of the applied by 61 days post
treatment and unextracted radioactivity increased to approximately
43 percent at 61 days post treatment. The aerobic soil metabolism
data requirement has been fulfilled. (MRID #420530-01)
(3) Leaching and Adsorption/Desorption
Ancymidol was highly mobile with reported Freundlich K^
values ranging from 0.11 (sandy soil) to 0.82 (clay loam soil)., In
a leaching soil column study, using a sandy loam soil, a.total of 8.9
percent of the radioactivity applied to the column was recovered in
the combined leachates during the 43 day leaching period; In the
original study, the cation exchange capacity was not provided for
one of the four soils and was requested. This requested information
was provided and was listed as 30.0 meq/100 g. This study is now
acceptable and the data requirements fulfilled for a leaching and
adsorption/desorptioii study. (MRID #s 417235 02 and 419137-01)
2. Ecological Effects
The ecotoxicological data base is adequate to characterize the toxicity of
ancymidol to nontarget terrestrial and aquatic organisms when used in greenhouses
and on limited terrestrial non-food sites.
a. Non-Target Bird Data
In order to establish the toxicity of ancymidol to birds, the
following tests may be required using, the technical grade material: one
avian single-dose oral (LD50) study on one species (preferably mallard or
bobwhite quail); two subacute dietary studies (LC5Q) on one species of
waterfowl (preferably the mallard duck) and one species of upland game
bird (preferably bobwhite quail). If the chemical is persistent in the
environment, the Agency may also require two avian reproduction studies
on mallard duck and bobwhite quail. In this case, due to the limited use
sites, only one study is necessary to be evaluated under this topic, the avian
.11
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sub acute dietary. The study summarized below is acceptable for use in
hazard assessment.
Wild mammal testing is required on a case-by-case basis, depending
on the results of the lower tier studies such as acute and subacute testing,
intended use pattern, and pertinent environmental fate characteristics. No
wild mammal testing is required for ancymidol.
(1) Avian Acute Toxicity
The requirement for avian acute oral toxicity has been
waived because of the low expected exposure to birds. Ancymidol
has very limited usage with use sites including greenhouses and
bedding areas. In addition, ancymidol was found to be practically
nontoxic in the dietary feeding study using bobwhite quail. For
these reasons the Agency believes it unnecessary to require avian
acute toxicity testing. ,
(2) Avian Subacute Dietary Toxicity
TaW*2: AS^^a^^^ii^^^&ytW^
Species
Bobwhite quail
% Test Material (TGAI)
99.9
LCs,
>5192ppm
,. , ,m^
Conclusions
practically nontoxic
These results show that ancymidol is practically nontoxic to
birds with an LC5o > 51?2 ppm. The guideline requirement for the
avian subacute dietary LC^ study is fulfilled. (MRID # 416706-02)
(3) Avian Reproduction
Avian reproduction studies are required when birds may be
exposed repeatedly or continuously through persistence,
bioaccumulation, or multiple applications, or if mammalian
reproduction tests indicate reproductive hazard. No avian
reproduction studies are required for the current use pattern of
ancymidol. .
1 12
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b. Aquatic Data
(1) Freshwater Fish Toxicity
In order to establish the toxicity of a pesticide to freshwater
, fish, the data which may be.required on the technical grade of the
active ingredient are two freshwater fish toxicity studies 1 One study
should use a coldwater species (preferably the rainbow trout), and
the other should use a warmwater species (preferably the bluegill
sunfish), and if persistent in the environment, ,the fish early life
stage study would be required. Based on the limited use sites, only
one study is necessary to be evaluated under this topic.
,fabfe3? , -\_% W^&^at^rgisfe.A«»tel^&ayPb 100 ppm
Conclusions
practically nontoxic
. The results of the rainbow trout 96-hour acute toxicity study
indicates that ancymidol is practically nqhtoxic to'cold water fish.
The guideline requirement for acute toxicity testing of the technical
on freshwater fish is fulfilled. (MRID # 416706-03)
(2) Freshwater Invertebrate Toxicity v
Testing which may be required to assess the hazard of a
pesticide to freshwater aquatic invertebrates is a test using
preferably first msta.* Daphnia magna or early instar amphipods,
stoneflies, mayflies, or midges. If the chemical is persistent in the
environment, an-aquatic invertebrate life cycle may be required.
Based on the limited use sites, only one study is necessary
to be evaluated under this topic.
; I^le4; - , " ":
Species
Daphnia magna
" " ^^^alerIffy«rtelSFate^&yie%16i»4B^ , c- - ,, -, ;- TO
% Test Material
(TGAI)
99.9
LC^
> 100 ppm
Conclusions
'..-"
practically nontoxic
There is sufficient information to characterize ancymidol as
practically nontoxic to aquatic invertebrates. The. guideline
requirement is fulfilled. (MRID #416706:01)
13
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(3) Estuarine/Marine Toxicity
Estuarine studies were not required or submitted for
evaluation under this topic since it is assumed that estuarine
exposure is minimal.
c. Terrestrial, Semi-Aquatic, and Aquatic Plant Data
In order to establish the toxicity to aquatic plants, an aquatic plant
growth study comprising of Selenastrum capricornutum, 'Lemna gibba,
Skeletonema costafum, Anabaena flos-aquae', and freshwater diatom may
be required using the technical grade material. In order to establish the
toxicity to terrestrial plants, the germination, seedling emergence and
vegetative vigor studies may be required using the technical grade material.
Because of the limited acreage anticipated, and minor use sites to
be treated (ornamental flowers and shrubs), only two non-target aquatic
plant studies using Selenastrum capricornutum and Lemna gibba-were
required. No non-target terrestrial plant toxicity data were required (also
because of limited acreage anticipated and minor use sites to be treated).
The non-target aquatic plant studies are summarized below and are
acceptable for use in hazard assessment.
tabfeSs
Species
% A.I.
Lemna gibba
99.8
0.29 ppm
Selenastrum capricornutum
99.8
26.9 ppm
When considering the environmental fate and ecotoxicological data
(Tier I and II effects) in combination with the application methods and
rates, the Agency concludes that ancymidol will represent minimal risk to
aquatic plant species. Both Tier I and II data requirements have been
fulfilled. (MRID # 431405-01 and 431405-02) , ,
d. Non-Target Insects Data
The minimum data required to establish the acute toxicity to honey
bees is an acute Contact LD50 study with the technical material. There is
sufficient information to characterize ancymidol as practically nontoxic to
bees. The guideline requirement is fulfilled. (MRID # 413405-04)
14
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Table 6:
Species
Apis mellifera
Nontarget insert Aciri* Contact Toiicity tradings
%Test
Material
99.8
LD^
> lOO/^g/bee
Conclusion
practically nontoxic
e. Non-Target Mammal Data
The available mammalian data indicate that ancymidol is slightly
toxic to small mammals on an acute basis. This study is discussed in the
Human Health Assessment, III, B, 1. a. and presented below (MRID
#424806-01)
Species
LD^ing/kg)
Conclusion
Rat (small mammal surrogate studies)
M = 1721 F = 1016
3. Ecological Effects Risk Assessment
a, Risk to Terrestrial Animals
The maximum expepted residues (ppm) on vegetation immediately
after one application of 0.4356 Ibs a.i,/A (based on Hoerger and Kenaga,
1972) would be 104 ppm. This would be well below the toxicity hazard to
birds of 5192 ppm and to mammals (LC50= 4500 ppm in the diet of female
rats, based on an oral LD50 of 1016 mg/kg and eonsumption of 31 % of
their weight in food). Minimal adverse effects are expected to birds and
mammals from the use of ancymidol. It also appears likely that there will
be minimal adverse effects to beneficial insects (LD5o > 100 #g/bee) since
it is practically nontoxic to honey bees. ' -
b. Risk to Aquatic Animals ' ' .
A direct application of 0,4356 Ibs a.i./A into an acre pond six feet
deep would have 27 parts per billion (ppb) of ancymidol. This is well
below the toxicity hazard of 100 ppm for'fish and aquatic invertebrates.
Minimal adverse effects are expected to aquatic animals from the use of
ancymidol. ,
c. Risk to Non-Target Plants
^ A direct application of 0.4356 Ibs a.i,/A into an acre pond six feet
deep would have 27 parts per billion (ppb) of ancymidol. This is well
below the toxicity hazard of 290 ppb for aquatic plants.
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Since current application rates and usage are very low and this
chemical is a growth regulator for height control of commercially produced
ornamental plants and shrubs, very little exposure to terrestrial plants is
anticipated. Therefore, minimal adverse effects are expected to terrestrial
plants from the labeled use of ancyrriidol.
d. Risk to Endangered Species
Endangered species are not expected to be affected from the labeled
use of ancymidol because of very limited exposure of the chemical to
endangered species sites and, triggers for endangered species were not
exceeded. , - .
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
- i ' r
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether products containing the active
ingredients are eligible for reregistration. The Agency has previously identified and
required the submission of the generic (i.e., active ingredient specific) data required to
support reregistration of products containing ancymidol as the active ingredient. The
Agency has completed its review of these generic data, and has determined that the data
are sufficient to suppprt reregistration of all products containing ancymidol. Appendix B
identifies the generic data .requirements that the Agency reviewed as part of its
determination of reregistration eligibility of ancymidol, and lists the submitted studies that
the Agency found acceptable.
The data identified in Appendix B are sufficient to allow the Agency to assess the
registered uses of ancymidol and to determine that ancymidol can be used without resulting
in unreasonable adverse effects to humans and the environment. The Agency therefore
finds that all products containing ancymidol as the active ingredient are, eligible for
reregistration. The reregistration of particular products is addressed in Section V of this
document. . , . ,
The Agency made its reregistration eligibility determination based upon the target
data base required for reregistration, the current guidelines for conducting acceptable
studies to generate such data, published scientific literature, etc. and the data identified in
Appendix B. Although the Agency has found that all uses of ancymidol are eligible for
reregistration, it should be understood that the Agency mayvtake appropriate regulatory
action, and/of require the submission of additional data to support the registration of
products containing ancymidol, if new information comes to the Agency's attention or if
the data requirements for registration (or the guidelines for generating such data) change.
16
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1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient
ancymidol, the Agency has sufficient information on the health effects of
ancymidol and on its potential for causing adverse effects in fish and wildlife and
the environment. The Agency concludes that products containing ancymidol for
,all uses are eligible for reregistratiori. the Agency has determined that ancyrriidol
products, labeled and used as specified in this Reregistration Eligibility -Decision,
will not pose unreasonable risks or adverse effects to humans or the environment.'
2. Eligible and Ineligible Uses
The Agency has determined that all uses of ancymidol are eligible for
reregistration.
B. Regulatory Position ;
The, following is a summary of the regulatory positions and rationales for
ancymidol. Where labeling revisions are imposed, specific language is set forth in Section
V of this document. .
Worker Protection Requirements
The 1992 Worker Protection Standard for Agricultural Pesticides (WPS)
established certain worker-projection requirements (personal protective equipment,
restricted entry .intervals, etc.) to be specified on the label of all products that contain uses
within the scope of the WPS. Covered uses 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, turfgrass, flowers, shrubs, ornamental/and
seedlings). These include uses on plants, and on the soil or planting medium the plants are
(or will be) grown in. Current use of ancymidol on commercially-grown ornamental plants
falls within the scope of the WPS. There are no residential uses of ancymidol.
Handler (Mixer, Loader, Applicator) Personal Protective Equipment
The potential for .exposure of handlers (mixer, loader, and applicator) to
ancymidol exists. For each end-use product, PPE requirements for pesticide handlers
will be set during reregistration in one of two ways:
1.
If EPA has no special concerns about the acute or other adverse effects of
an active ingredient, the PPE; for pesticide handlers will be established
based on the acute toxicity of the end-use product. For occupational-use
products, PPE will be established using the process described in PR Notice
93-7 or more recent EPA guidelines.
17
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2. If EPA has special concerns about an active ingredient due to very high ;
acute toxicity or to certain other adverse effects, such as allergic effects or
delayed effects (cancer, developmental toxicity, reproductive effects, etc):
In the RED for that active ingredient, EPA may establish minimum
,,or "baseline" handler PPE requirements that pertain to all or most
occupational end-use products containing that active ingredient.
. These minimum PPE requirements must be compared with the PPE
that would be designated on the basis of the acute toxicity of each
end-use product.
The more stringent choice for each type of PPE (i.e., body wear,
hand protection, footwear, eyewear, etc.) must be placed on the
label of the end-use product.
There no are special lexicological concerns about ancymidol that warrant the
establishment of active-ingredient-based PPE requirements. Therefore any PPE
requirements will be established based on the acute toxicity of the end-use product.
Post-application Entry Restrictions
Restricted Entry Interval - Under the Worker Protection Standard (WPS), interim
restricted entry intervals (REI) for all uses within the scope of the WPS are established
based on the acute toxicity of the active ingredient. The toxicity categories of the active
ingredient for acute dermal toxicity, eye irritation potential, and skin irritation potential
are used to determine the interim WPS REI. If one of more of the three acute toxicity
effects are in toxicity category I, the interim WPS REI is established at 48 hours. If none
of the acute toxicity effects are in category I, but one or more of the three is classified as
category II, the interim WPS REI is established at 24 hours. If none of the three acute
toxicity effects are in category I or II, as with ancymidol, the.interim WPS REI is
established at 12 hours. ,
The 12 hour interim restricted entry interval (REI) must be imposed for all uses
of ancymidol within the scope of the WPS, based on acute toxicity effects (Category III
and IV).
Early Entry PPE- 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 or two ways.
1. If EPA has no special concerns about the acute or other adverse effects of
an active ingredient, it establishes the early-entry PPE requirements based
18
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on the acute dermal toxicity, skin irritation potential, and eye irritation
potential of the active ingredient.
2. If EPA has special concerns about an active ingredient due to very high
acute toxicity or to certain other adverse effects, such as allergic effects or
delayed effects (cancer, development toxicity, reproductive effects, etc.),
it may establish early-entry PPE requirements that are more stringent than
would be established otherwise.
This minimum required early entry PPE appropriate to ancymidol consist of
coveralls, chemical-resistant gloves, and shoes plus socks.
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for thejeregistration
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 ancymidol for the
above eligible uses has been reviewed and determined to be substantially complete.
However, the Agency has required the registrant to submit missing clinical
observation and pathology information to upgrade the acute inhalation study in rats
or to conduct a new study.
2. Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing use products (MP)
labeling must be revised to comply with all current EPA regulations, PR Notices,
and applicable policies. The MP labeling must bear the following statement under
Directions for Use:
"Only for formulation into a herbicide/plant growth regulator for
the following use(s): (fill blank only with those uses that are being
supported by MP registrants)."
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 products 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
19
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has complied with U.S. EPA submission requirements regarding the
supported use(s).
(b) "this product may be used to formulate products for any additional
use(s) not listed on the MP label if the formulator, user group, or
grower has complied with U.S. EPA submission requirements
regarding the support of such use(s)."
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility has
been made. The product specific data requirements are listed in Appendix G, the
Product Specific Data Call-in Notice.
Registrants must review previous data submissions to ensure that they meet
current EPA acceptance criteria and if not, commit to conduct new studies. If a
registrant believes that previously submitted data meet current testing standards,
then study MRID numbers should be cited according to the instructions in the
Requirement Status and Registrants Response Form provided for each product,
2. Labeling Requirements for End-Use Products
The following label statements are required on all endTiise products:
a. "Do not apply directly to water or to areas where-surface
water is present or to intertidal areas below the mean high
water mark. Do not contaminate water when disposing of
equipment washwater or rinsate."
"Do not enter or allow worker entry into treated areas
during the restricted entry interval (REI) for 12 hours."
"PPE required for early entry to treated areas that is
permitted under the Worker Protection Standard and that
involves contact with anything that has been treated, such as
plants, .soil, or water, is coveralls, chemical-resistant
gloves, and shoes plus socks."
20
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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 ancymidol
products bearing old labels/labeling for 26 months from the date of issuance of this RED.
Persons other than thes registrant may distribute or sell such products for 50 months from
-the date of the 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
21
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22
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VI. APPENDICES
23
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GUIDE TO APPENDIX B
- ,. - ' - ''-'.-
.Appendix B contains listings of data requirements which support the teregistratipn for active
ingredients within the case ANCYMIDOL covered by this Registration Eligibility Decision
Document. It contains generic data requirements that apply to ANCYMIDOL 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 RoyaLRoad, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food /
"-...." B Terrestrial feed . ' '
C Terrestrial non-food
D ' Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food ,
I. Greenhouse non-food '.,-,'"'
;. J . Forestry
K Residential .--,..'
L Indoor food
M. Indoor non-food -
N Indoor medical
- O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this
column lists the identifying number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
26
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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. Dpcument date; The date of the study is taken directly from the document.
When the date is followed by a question mark., the bibliographer has deduced ;
the date from the evidence contained in the document. When the date appears
as (19??), the Agency was unable to determine or estimate the date of the
document.
30
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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.
31
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BIBLIOGRAPHY
MRID
, CITATION
00162638 Day, E. (1986) Ancymidol Technical Product Chemistry Data: Report No.
EWD8604. Unpublished study prepared by Lilly Research Laboratories, lip.
- 41670601 Murray, A.; Seacat, J.; Brown, G. (1990) The Acute Toxicity of An-cymidol
to Daphnia magna in a Static Test System: Lab ProjectNumber: C00690.
Unpublished study prepared by Lilly ResearchLaboratories. 35 p.
41670602 Murray, A.; Seacat, J.; Grothe, D. (1990) The Toxicity of Ancymi-dol to
-. '. Juvenile Bobwhite in a 5-Day Dietary Study: Lab ProjectNumber: A00790.
Unpublished study prepared by Lilly ResearchLaboratories. 40 p.
41670603 Murray, A:; Seacat, J,; Brown, G. (1990) The Acute Toxicity of An-cymidol
, to Rainbow Trout (Salmo gairdneri) in a Static TestSystem: Lab Project
Number: F02890. Unpublished study preparedby Lilly Research Laboratories.
38 p. " '' i - . .* ' . ' .. ' ..-' '-.
41723501 Kazee, B. (1990) Determination of Solubility of Ancymidol: Final Report: Lab
-; Project Number: SC900027." Unpublished study prepared by Battelle. 37 p.
41723502 Davis, M. (1990) Ancymidol: Adsorptkm/Desorption of CCarbon
141-Ancymidol on Soils by the Batch Equilibrium Method: Lab
ProjectNumber: SC900026. Unpublished study prepared by Battelle. 75p.
41723503 Kazee, B. (1990) Hydrolysis of Ancymidol in Water: Lab Project Num-ber:
SC900028. Unpublished study prepared by Battelle. 45 p.
i '. -.''..
41821201 Chakrabarti,, A. (1990) Vapor Pressure of Ancymidol Measured by the '>...
Knudsen-Effusion/Weight.Loss Method: Lab Project Number: ML-AL-
90-020336. Unpublished study prepared by Dow Chemical, Analytical Sciences
Div. 10 p. , ,
41913701 _ Zwick, T.; Saxena, A.; Marsh, S-. (1991) Mobility Study: Soil .
ColumnLeaching Study on a Soil Dosed With 14C-Ancymidol and Aged:
LabProject Number: SC900025. Unpublished study prepared by
BatelleMemorial Institute. 48 p. ,
41913702 Wright, F.; Rock, G.; Sites, D.; et al. '(1991) A Guinea Pig Sensit-ization
Study of Ancymidol: Lab Project Number: G02490. Unpub-lished study
prepared by Lilly Research Laboratories. 33 p.
41937901 Laska, D.; Rock, G.; Brown, G. ,(1991) The Acute Toxicity and Primary
Dermal Irritation of Ancymidol.in the new Zealand White Rabbit; Lab Project
Number: B13190. Unpublished study prepared by Lilly Research Labs. 29p.
32
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BIBLIOGRAPHY
MRBD
CITATION
41937902 Laska, D.; Rock, G.; Brown, G. (1991) The Acute Ocular Irritationof t
Ancymidol in the New Zealand White Rabbit: Lab Project Num-ber: B13090.
Unpublished study prepared by Lilly Research Labs.26 p.
42053001 Saxena, A.; Malik, N.; Lofthouse, T. (1991) Aerobic Soil Metabolismof
Ancymidol: Lab Project Number: SC900021.. Unpublished studyprepared by
Battelle Memorial Institute. 70 p.
42121201 Wright, F.; Glenn, R.; Sites, D.; et al. (1991) A 21-Day SubchronicDermal
Toxicity Study of Ancymidol (...) Administered Topicallyto New Zealand
White Rabbits: Lab Project Number: B11590. Un-published study prepared^ by
Lilly Research Labs. 270 p.
42130801 Wolff, R.; Allen, D.; Williams, G.; etal. (1991) The Acute Inhala-tion
Toxicity in the Fischer 344 Rat of Technical Ancymidol: Lab Project Number:
R25191. Unpublished study prepared by LillyResearch Labs. 39 p.
42480601 Wright, F.; Poulsen, R.; Clair, R. (1992) Acute Toxicity, ofAncymidol
(Compound 069231) Administered Orally to Fischer 344&ats: Lab Project
Number: R23391. Unpublished study preparedby Lilly Research Labs.' 37 p.
42480602 Wright, F.; Clair, R. (1992) A Developmental Toxicity Study ofAncymidol
(Compoud 069231) Administered Orally to CD Rats: LabProject Number:
R33191. Unpublished study prepared by LillyResearch Labs. 374 p.
43140501 Milazzo, D,; Servinski, M, ; Hugo, J.; et al. (1994) AncymidoliToxicity to the
Aquatic Plant, Duckweed, Lemna gibba L: LabProject Number:
DECO/ES/2725. Unpublished study prepared byThe Dow Chemical
Environmental Toxicology & Chemistry ResearchLab. 31 p.
43140502 Milazzo, D.; Servinski, M.; Hugo, J.; et al. (1994) Ancymidol:Toxicity to the
Green Alga, Selenastrum capricornutum Printz:Lab Project Number: ES/2724,
Unpublished study prepared by TheDow Chemical Environmental Toxicology
& Chemistry Research Lab.31 p.
43140504 Palmer, S.; Beavers, J. (1993) Ancymidol: An Acute ContactToxicity Study
with the Honey Bee: Lab Project Number: 103/402:ES/2687. Unpublished
study prepared by Wildlife InternatibnalLtd. 21.
43216301 Handy, P. (1994) Determination of the Stability of Ancymidol Technical to
Sunlight and Selected Metals and Metal Ions at Elevated Temperatures: Lab
Project Number: FOR93056. Unpublished study prepared by DowElanco. 13 p.
33
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BIBLIOGRAPHY
MRID
CITATION
47010508 (00155380) Bewsey, B. (1985) The Effects of Ancymidol (EL-531 Compound
69231) on the Induction of Forward Mutation at the Thymidine Kiriase Locus of
L5178Y Mouse Lymphoma Cells: Studies 850423MLA805 and
85051MLA805. Unpublished studies prepared by Lilly Research Labs. 38'p.\-
47010510 (00155382) Rexroat, M. (1985) The Effect of Ancymidol (EL-531 Compound
69231) on the Induction of Reverse Mutations in Salmonella Typhimurium
Using the Ames Test: Study 850325AMS805. Unpublished study prepared by
Lilly Research Labs. 32 p. ' . "
47010512 (00155384) Hill, L. (1985) The_Effect of Ancymidol (EL-531 Compound
69231) on the Induction of DNA Repair Synthesis in Primary Cultures of Adult
Rat Hepatocytes: Studies 850402UDS805 and 850409UDS805.
Unpiiblishedstudies prepared by Lilly Research Labs, 27 p.
34
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam: , ..",.',
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet, to
submit certain product specific data as noted herein to the U.S. Environmental Protection
Agency (EPA, the Agency). These data are necessary to maintain the continued registration of
your produces) containing this active ingredient. Within 90 days after you receive this Notice
you must respond as set forth hi Section III below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
'Attachments 1 through 6; or
'.'. K . ' "
2. Why you believe you are exempt from the requirements listed in this Notice and
in Attachment 3, Requirements Status and Registrant's Response Form, (see
section III-B); or ,
3. Why you believe EPA should not require your submission of product specific
data in the manner specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your produces) subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2, Data Call-In Response Form, as
well as a list of all registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-
0107 (expiration date 12-31-92 and 2070-0057 (expiration date 03-31-96), This Notice is
divided into six sections and six Attachments. The Notice itself contains information and
35
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instructions applicable to all Data Call-In Notices. The Attachments contain specific chemical
information and instructions. The six sections of the Notice are: '
Section. I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III- Compliance With Requirements Of This Notice
Section IV- Consequences Of Failure To Comply With This Notice .
, Section V- Registrants'Obligation To Report Possible Unreasonable Adverse
- ' '' '. '-, ' ' " 'Effects . " . '' ;" -. ,',,'-',
Section VI- Inquiries And Responses To This Notice
The Attachments to this Notice are: , «
1 -
2 -
3 -
4 -
5 -
6 -
Data Call-In Chemical Status Sheet
Product-Specific Data Call-In Response Fprm ,
Requirements Status and Registrant's Response Form ' ,
EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistratipn
List of Registrants,Receiving This Notice
Cost Share and Data Compensation Forms, and Product Specific Data Report
Form
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the
data needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional
generic data requirements are being imposed. You have been sent this Notice because you
have product(s) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
i . ' ' .' ' ' ..
II-A. DATA REQUIRED /
The product specific data required by.this Notice are specified in Attachment 3,
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional testing may be required. '
II-B. SCHEDULE FOR SUBMISSION OF DATA \ . ,
You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form,'within the time frames:
provided. , . , .
36
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II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD
protocols, they should be modified as appropriate so that the data generated by the study will
satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for
complying with data requirements when the studies were not conducted in accordance with
acceptable standards. The OECD protocols are available from OECD, 1750 Pennsylvania Avenue
N.W., Washington, D.C. 20006.
All new studies and proposed protocols submitted in response to this Data CalWn Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)]t .
H-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or change the
requirements of any previous Data Call-In(s), or any other agreements entered into wife the,
Agency pertaining to such prior Notice. Registrants must comply with the requirements of all
Notices to avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific data must
be submitted to the Agency within 90 days after your receipt of this Notice. Failure to adequately
respond to this -Notice within 90 days of your receipt will be a basis for issuing a Notice of Intent
to Suspend (NOIS) affecting your products. This and other bases for issuance of NOIS due to
failure to comply with this Notice are presented in Section IV-A and IV-B.
ffl-B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or
(c) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product specific
37
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data requirements of this Notice is contained in Section III-.C., A discussion of options relating to
requests for data waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used in your response to the Agency. These forms are the Data-Call-in
Response Form, and the Requirements Status and Registrant's Response Form, Attachment 2 and
Attachment 3. The Data Call-In Response Form must be submitted as part of every response to
this Notice. In addition, one copy of the Requirements Status and Registrant's Response Form
must be submitted for each product listed on the Data Call-In Response Form unless the voluntary
cancellation option is selected or unless the product is identical to another (refer to .the instructions
for completing the Data Call-In Response Form in Attachment 2). Please note that the company's
authorized representative is required to sign the firs,t page of the Data Call-in Response Form and
Requirements Status and Registrant's Response Form (if this form is required) and initial any
subsequent pages. The forms contain separate detailed instructions on the response options. Do
not alter the printed material. ,If you have questions or need assistance in preparing your
response, call or write the contact person(s) identified in Attachment 1.
1- Voluntary Cancellation - You may avoid the. requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must submit a completed Data Call-In
Response Form, indicating your election of this option. Voluntary cancellation is item number 5
on the Data Call-in Response Form. If you choose this option, this is the only form that you are
required to complete, v ,
. 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 jhe Existing Stocks
provisions of this Notice which are contained in Section IV-C. '."'.
2. Satisfying the Product Specific Data Requirements of this Notice There are various ''-'
options available to satisfy the product specific data requirements of this Notice. These options
are discussed in Section III-C of this Notice and comprise options 1 through 6 on the
Requirements Status and Registrant's Response Form and item numbers 7a and 7b on the Data
Call-in Response Form. Deletion of a use(s) and the low volume/minor use option are not valid
options for fulfilling product specific data requirements. »'
3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section III-D of this Notice and are covered by option 7 on the Requirements Status '
and Registrant's Response Form. If you choose one of these options, you must submit both forms
as well as any other information/data pertaining to the option chosen to address the data
requirement.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy the
product specific data requirements (i.e. you select item number 7a pr,7b), then you must select
one of the six options on the Requirements Status and Registrant's Response Form related to data
production for each data requirement. Your option selection should be entered under item
' '..' ' ' .
; " ' ' : 38 - - -'' - '-'/'..".
-------
number 9, "Registrant Response." the six options related to data production are the first six
options discussed under item 9 in the instructions for completing the Requirements Status and
Registrant's Response Form. These six options are listed immediately below with information in
parentheses to guide registrants to additional instructions provided in this Section. The options
are:
(1) I will generate and submit data within the specified time frame (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) * I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing :
Study)
Option 1. Developing Data If you choose to develop tha required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein and
in the attachments. All data generated and submitted must comply with the Good Laboratory
Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide Assessment
Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.
The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports. 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 registrations).
If you cannot submit the data/reports to the Agency in the time required by this Notice and
intend to seek additional time to meet the requirements(s), you must submit a request to the
Agency which includes: (1) a detailed description of the expected difficulty and (2) a proposed
schedule including alternative dates for meeting such requirements on a step-by-step basis. You
must explain any technical or laboratory difficulties and provide documentation from the
laboratory performing the testing. While EPA is considering your request, th'e original deadline
remains. The Agency will respo.nd to your- request in writing. If EPA does not grant your
request, the original deadline remains. Normally, extensions can be requested only in cases of
extraordinary testing problems beyond the expectation or control of the registrant. Extensions
will not be given in submitting the 90-day responses. Extensions will not be considered if the
request for extension is not made in a timely fashion; in no event shall an extension request be
considered if it is submitted at or after the lapse of the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data Registrants may only choose
this option for acute toxicity data and certain efficacy data and only if EPA has indicated in the
attached data tables that your product and at least one Other product are similar for purposes of
39 ' ' '. ' ' ' , ' " "
-------
depending on the same data. If this is the case, data may be generated for just one of the products
in,the group. The registration number of the product for which data will be;submitted must be
noted in the agreement, to cost share by the registrant selecting this option. If you choose 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 io 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 This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer
to pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration(s), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as, a general
policy, absent other relevant considerations, it will not suspend the registration of a product of a
registrant who has in good faith sought and continues to: seek to enter into a joint data
development/cost sharing program, but the other registrant(s) developing the data has refused to
accept your offer. To qualify for this option, you must submit documentation to the Agency
proving that you have made an offer to another registrant (who has an obligation to submit data)
to share in the burden of developing that data. You must also submit to the Agency .a completed
EPA Form 8570-32, Certification of Offer to Cost Share in the Development of Data, Attachment
6. In addition, you must demonstrate that the other registrant to .whom the offer was made has
not accepted your offer to enter into a cost sharing, agreement by including a copy of your offer
and proof of the other registrant's receipt of that offer (such as a certified mail receipt). Your
offer must, in addition to anything else, offer to share in the burden of producing the data upon
terms to be agreed or failing agreement to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii) and must not qualify this offer. The other registrant must also inform,EPA
of its election of an option to develop and submit the data required by this Notice by submitting a
Data Call-In Response Form and a Requirements Status and Registrant's Response Form
committing to develop and submit the data required by this Notice. ,
In order for you to avoid suspension under this option, you-may «Qt withdraw your offer
to share, in the burdens of developing the data. In addition, the other registrant must .fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant fails
to develop the data or for some other reason is subject to suspension, your registration as well as
that Of the other registrant will normally be subject ito initiation of suspension proceedings, unless
you commit to submit, and do submit the required data in the specified time frame. In such cases,'
the Agency generally will not grant a time extension for submitting the data.
Optipn 4, Submitting an Existing Study If you choose to submit an existing, study in
response to this Notice, you must determine that the study satisfies the requirements imposed by
this Notice. You, may only submita study that has not been previously submitted to the Agency
40
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or previously cited by anyone. Existing studies are studies which predate issuance of this Notice.
Do not use this option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid and
needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data
and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in accordance with the
requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160.
As stated in 40 CFR 160.3Q ", 'raw data' means any laboratory worksheets,
records, memoranda, notes, or exact copies thereof, that are the result of original ,
observations and activities of a study and are necessary for the reconstruction and
' evaluation of the report of that study. In the event that exact transcripts of raw
data have been prepared (e.g., tapes which have been transcribed verbatim, dated,
and verified accurate by signature), the exact copy or exact transcript may be
substituted for the original source as raw data. 'Raw data' may include --
photographs, microfilm or microfiche copies, computer printouts, magnetic media,
including dictated observations, and recorded'data from automated instruments."
The term "specimens", according to 40 CFR 160.3(k), means "any material ,
derived from a test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study
signed by an authorized official or representative of the registrant. ..',;
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according to the PAG may be/
submitted to the Agency for consideration if the registrant believes that the study
clearly meets the purpose of the PAG. The registrant is referred to 40 CFR 158.70
which states the-Agency's policy regarding acceptable protocols. If you wish to
submit the study, you must, in addition to certifying that the purposes of the PAG
are met by the study, clearly articulate the rationale why you believe the study
meets the purpose of the PAG, including copies of any supporting information or
data. It has been the Agency's experience that studies completed prior to January
41
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1970 rarely satisfied the purpose of the PAG and that necessary raw data are
usually not available for such studies.
' ' * " ' . . ~ - *
If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.
If you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable adverse.,
effects, you must notify the Agency of sucha study. If suc'h study is in the Agency's files, you
need only cite it along with the notification. If not in the Agency's files, you must submit a'
summary and copies as required by PR Notice 86-5.
Options, 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 L 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
conformancewith PR Notice 86-5.
Do not submit additional data for the purpose o'f upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
r
This option should also.be used to cite data that has been previously submitted to upgrade
a study, but has not yet been reviewed by the Agency. You must provide the MRID number of
the data submission as well as the MRID number of the study being upgraded. ;i
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 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. -
42
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If you are citing a study of which you are not the original data submitter, you must submit
a completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-in Response Form and the Requirements
Status and Registrant's Response Form, as appropriate.
m-D REQUESTS FOR DATA WAIVERS
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 ail
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 Requirements Status
and Registrant's Response Form. Product specific data requirements for.product chemistry, acute
toxicity and efficacy (where appropriate) are required for all products and the Agency would grant
a waiver only under extraordinary circumstances. You should also be aware that submitting a
waiver request will not automatically extend the due date for .the study in question. Waiver
requests submitted without adequate supporting rationale will be denied and the original due date
will remain in force.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a 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. .
43
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6.
l:
8.
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). v
Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section III-G of this Notice.
Withdrawal_pf an offer to share in the cost of developing required data.
s Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or
failure of a registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this Notice
on a Data Call-in Response Form and a Requirements Status and
Registrant's Response Form;
b. fulfill the commitment to develop and submit the data as required by this
Notice; or " .
c. otherwise take appropriate steps to,meet the requirements stated in this '
Notice, unless you commit to submit and do submit the required data in the
specified time frame. ,
Failure to take any required or appropriate steps', not mentioned above, at any time
following the issuance of this Notice. .
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS '
UNACCEPTABLE ~^-^~ ~ ; ' -.- ,. . - .
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance .of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents incorporated
by reference (including, as applicable;, EPA Pesticide Assessment Guidelines, Data '
Reporting Guidelines, and GeneTox Health Effects Test Guidelines) regarding the design,
conduct, and reporting of required studies. Such requirements include, but are not limited
to, those relating to test material, test procedures, selection of species, number of animals,
; sex and distribution of animals, dose and effect levels to be tested or attained, duration of
test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation
of any changes required by the Agency following review.
9.
44
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3. EPA requirements regarding the reporting of data, including the manner of reporting,
the completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or^
contained in PR 86-5. All studies must be submitted in the form of a final report; a
preliminary report will not be considered to fulfill the submission requirement:
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks.for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not
be consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional'
circumstances. If you believe such disposition of existing stocks of your product(s) which may be
suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act. You
must also explain why an "existing stocks" provision is necessary; including a statement of the
quantity of existing stocks and your estimate of the time required for their sale, distribution, and
use. Unless you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in foil 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, o.r 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 Ag&ncy has particular
risk concerns will be determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you demonstrate
to the Agency that you are in full compliance with all Agency requirements, including the
requirements of this Notice. For example, if you decide to voluntarily cancel your registration six
months before a 3 year study is scheduled to be submitted, all progress reports and other
information necessary to establish that you have been conducting .the study in an acceptable and
good faith manner must have been submitted to the Agency, before EPA will consider granting an
existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS -
45
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Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information to
the Agency. Registrants must notify the Agency of any factual information they have, from '
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency. ,
'.-.*- . ' ' '
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet.
f ' '
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-in Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for product
specific data) and any other documents required by this Notice, and should be submitted to the -
contact persbn(s) identified in Attachment 1. -If the voluntary cancellation or generic data " ;
exemption option is chosen, only the Data Call-in Response Form need be submitted.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
' .' - s
Lois Rossi, Division Director
Special Review and
Reregistration Division
Attachments'
' ... ' 1 -
1 -. '.2 -
3 -
4 -
5 -
6 -
Data Call-In Chemical Status Sheet
Product-Specific Data Gall-In Response Form
Requirements Status and Registrant's Response Form ' ,
EPA Batching of End-Use Products for Meeting Acute Toxicology Data '
Requirements for Reregistration
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms, and Product Specific Data Report Form
46
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ANCYMIDOL DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-in Notice because you have product(s)
containing ANCYMIDOL. ,
This Product Specific Data Call-in Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
Ancymidol. 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^), (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 Ancymidol 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 Ancymidol are
contained in.the Requirements Status and Registrant's Response, Attachment 3. The Agency has
concluded that additional data on Ancymidol are needed for specific products. These data are
required to be submitted to the Agency within the time frame listed. These data are needed to fully
complete the' reregistration of all eligible Ancymidol products,
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of Ancymidol, please contact
Rieman Rhinehart at (703) 308-8584.
If you have any questions regarding the product specific data requirements and procedures
established by this Notice, please contact Veronica Dutch at (703) 308r8585.
All responses to this Notice for the Product Specific data requirements should be submitted
to:
Veronica Dutch
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: ANCYMIDOL
47
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
PRODUCT SPECIFIC DATA
. Item 1-4. Already completed by EPA. *.
Item 5.
Item 6.
If you wish to voluntarily cancel your product, answer "yes." If you choose this
option, you will not have to provide the data required by the Data Call-In Notice and
you will not have to complete any other forms. Further .sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing
Stocks provision of the Data Call-In Notice (Section IV-C).
Not applicable since this form calls in product specific data only. However, if your
product is identical to another product and you qualify for a data exemption, you
must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide the
EPA registration numbers of your source(s); you would not complete the
"Requirements Status,and Registrant's Response" form. Examples of such' products
include repackaged products and Special Local Needs (Section 24c) products which
are identical to federally registered products. '
For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes." If you are
requesting a data ^raiver, answer "yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with Option
7 (Waiver Request) for each study for which you are requesting a waiver. See Item
6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
NOTE: " You may provide additional' information that does not fit on this form in a signed
letter that accompanies.this form. For example, you may wish to report that your
, product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct. .'',-'
Item 7a.
Item 7b.
48
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM FDR PRODUCT SPECIFIC DATA
Item 1-3
Item 4.
ItemS.
Item 6.
Item 7.
ItemS.
Item 9.
Completed by EPA. Note the unique identifier number assigned by EPA in Item
3. This number must be used in the transmittal document for any data
submissions in response to this Data Call-In Notice.
The guideline reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the requirements
specified in the Notice, govern the conduct of the required studies. Note that series
61 and 62 in product chemistry are now listed under 40 CFR 158^155 through
158.180, SubpartC.
The study title associated with the guideline reference number is identified.
The use pattern(s) of the pesticide associated with the product specific irequirements
is (are) identified. For most product specific data requirements, all use patterns'are
covered by the data requirements. In'the case of efficacy data, the required studies
only pertain to products which have the use sites and/or pests indicated. !
The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases. -
The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Document unless EPA
determines that a longer time period is necessary.
Enter only one of the following response codes for each data requirement to show
how you intend to comply with the data requirements listed in this table. Fuller
descriptions of each option are contained in the Data Call-In Notice. '
I will generate and submit data by the specified due date (Developing Data). By
indicating that I have chosen this option, I certify that I will comply with alHhe
requirements pertaining to the conditions for submittal of this study as outlined in the
Data Call-In Notice. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form (EPA
Form 8570-29) and (2) two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4).
I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing). I am submitting a copy of this agreement. I understand that this
option is available only for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this Notice that my product is similar enough to another
product to qualify for this option. I certify that another party in the agreement is
49
-------
committing to submit or provide the required data; if the required study is not
submitted on time, my product may be subject to suspension.. By the specified due
date, I will also submit: (1) a completed "Certification With Respect To Data
Compensation Requirements" form (EPA Form 8570-29) and (2) two completed
and signed copies of the Confidential Statement of Formula (EPA Form 8570-4).
f, -
3. I have made offers to share in the cost to develop data (Offers to Cost Share). I
understand that this option is available only for acute toxicity or certain efficacy data
and only if EPA indicates in an attachment to this Data Call-In Notice that my product
is similar enough to another product to qualify for this option. I am submitting,
evidence that I have made an offer to another registrant (who has an obligation to
submit data) to share in the cost of that data. I am also submitting a completed
"Certification of Offer to Cost Share in the Development Data" form. .1 am
including a copy of my offer and proof of the other registrant's receipt of that offer.
I am identifying the party which is committing to submit or provide the required data;
if the required study is not submitted on time, my product may be subject to
suspension. I understand that other terms under Option 3 in the Data Call-In Notice
(Section in-C.l.) apply as well. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
4. By the specified due date, I will submit an existing study that has not been submitted
previously to the Agency by anyone (Submitting an Existing Study). I certify that
this study will meet all the requirements for submittal of existing data outlined in
Option 4 in the Data Call-In Notice (Section-ffl-C.l.) and will meet the attached
acceptance criteria (for acute toxicity and product chemistry data). I will attach the
needed supporting information along with this response. I also certify that I have
determined that this study will fill the data requirement for which I have indicated this
choice. By the specified due date, I will also submit a completed "Certification With
Respect To Data Compensation Requirements" form (EPA Form 8570-29) to
show what data compensation option I have chosen. By the specified due date, I will
also submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed copies
of the Confidential Statement of Formula (EPA Form 8570-4).
5. By the specified due date, I will submit or cite data to upgrade a study classified by
the Agency as partially acceptable and upgradable (Upgrading a Study). I will
submit evidence of the Agency's review indicating that the study may be upgraded
and what information is required to do so. I will provide the MRID or Accession
number of the study at the due date. I understand that the conditions for this option
outlined Option 5 in the Data Call-In Notice (Section III-C.l.) apply. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
50
-------
Completed and signed copies of the Confidential Statement of Formula (EPA Form
8570-4), ' ,, -... ' - . I-'-.
6. By the specified due date, I will cite an existing study that the Agency has classified
as acceptable or an existing study that has been submitted but not reviewed by the
Agency (Citing an Existing Study). If I. am citing another registrant's study, I
understand that this option is available only for acute; toxiciry or certain efficacy data
and only if the cited study was conducted on my product, an identical product or;a
. - product which EPA has "grouped" with one or more other products for purposes of
depending on the same data. I, may also choose this option if I am citing my own
data. Ineither case, I will provide the MRID or Accession number(s) for the cited
data on a "Product Specific Data Report" form or in a similar format. By/the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies of the Confidential Statement of Formula (EPA Form
8570-4). ,
7, , I request a waiver for this study because it is inappropriate for my product (Waiver
Request). I am attaching a complete justification for this request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies.
[Note: any supplemental data must be submitted in the format required by P.R. Notice
86-5]. I understand that this is my only opportunity to state the reasons or provide
information in support of my request. If the Agency approves my waiver request; I
will not be required to supply the data pursuant to Section 3(c)(2)(B)"of FIFRA. If,
the Agency denies my waiver request, I must choose a method of meeting the data
requirements of this Notice by the due date stated by this Notice. In this case, I must,
within 30 days of my receipt of the Agency's written decision, submit a revised
"Requirements Status and Registrant's Response" Form indicating the option chosen.
I also understand that the deadline for submission of data as specified by the original
data call-in notice will not change. By the specified due date, I will also submit: (1)
a completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
Items 10-13. Self-explanatory. , . ,
NOTE: ' You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
. voluntarily canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
51
-------
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EPA'S DECISION NOT TO BATCH END-USE PRODUCTS CONTAINING ANCYMIDOL
FOR PURPOSES OF MEETING ACUTE TOXICITY DATA REQUIREMENTS FOR
REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxicity data requirements for reregistration of end-use products containing the active .
ingredient ancymidol, the Agency considered batching end-use 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.).
However, batching of end-use products containing ancymidol was not possible after
considering the available information described above. Table I lists all the end-use products
containing ancymidol. These products were either considered not to be similar for purposes of _
acute toxicity or the Agency lacked sufficient information,for decision making purposes.
Registrants of these products are responsible for meeting the acute toxicity data requirements for
each product.
Registrants must generate all the required acute toxicological studies for each of their
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 toxicity 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 DCI
Notice contains two response forms which are to be completed and submitted to the Agency
within 90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant
will meet the data requirements for each product. The second form, "Requirements Status and
Registrant's Response," lists the product specific data required for each product, including the;
standard six acute toxicity tests. A registrant 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). Since the end-use products containing
ancymidol could not be batched, registrants cannot choose from the remaining options: Cost
sharing (Option 2) or Offers to Cost Share (Option. 3).
52
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Table I. End-Use Products Containing Ancymidol
. EPA Reg. No. .'
% of ancymidol
Formulation TVDP
67690-2
67690-5
0.0264
98
Soluble Concentrate
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed
copies of the form are required. Following are basic instructions: -, ' . '
a. All the blocks "on the form must be filled in and answered completely.,
b. If any block is not applicable, mark it N/A. '
'C. The CSF must be signed, dated and the telephone number of the responsible party
must be provided. . . .
d. All applicable information which is on the.'productspecific data submission must
also be reported on the CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids. ,
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f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. . For all active ingredients, the EPA Registration Numbers for the currently
registered source products must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
common names for the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be
reported under column 10 and must be exactly the same as on the source product's
label.
j. All the weights ih columns 13.a. and 13.b. must be in pounds, kilograms, or
grams. In no case will volumes be accepted. Do not mix English and metric '
system units (i.e., pounds and kilograms). "
k. All the items under cJolumn 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must represent
pure active form. " . \ . , .
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m. The upper and lower certified limits for ail active and inert ingredients must follow
, the 40 CFR 158.175 instructions. An explanation must be provided if the proposed
limits are different than standard certified limits.
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n. When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific, formulation.
55
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8-EPA
United States (Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
207n-nflfi7
Approval Expires 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief. Information Policy
Branch, PMr223. U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to.the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503. '
Piease fill in blanks below. - '. ._
Company Name "" v ,
Product Name . ,
Corapimy Number
EPA Rc&No. ;
I Certify- that: -: '-''' ~ ."'.''
My company is willing to develop and submit the data required by EPA under the authority of the Federal
insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data. ' - .-'.:. / ' , ,-
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3{c)(2)(B)(iii) of FIFflA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s): ' ,,
Name of Flrm(»)
Oat* of Offer
Certification:
I certify (hat I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized flapreaentatlve
Date
Natna and Title (Please Type or Print)
EPA Form 8570-32 (S/91) Replaces UFA Form 858(1, which Is obsolete
59
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60
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Form Approved
OMB No. 2070-0107,
2070-0057 , - ;
' Approval Expires
3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including tirrie for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any.other aspect of this collection of information,
including suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, U.S. Environmental Protection
Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project
(2070-0106), Washington, DC 20503. .. , .
Please fill in blanks below. .
Company Name
Product Name
Company Number
EPA Reg. No. ,
I Certify that: ,
1. For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
data submitterto cite tftat study.
2. That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the
original data submitter, or I have obtained the written permission of the original data submitter, or I have notified jn writing the
cdmpany(ies) that submitted data I have cited and have offered to: (a) Pay compensation for those data in accordance with sections
3(c)(1)(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
requirement of FIFRA and the amount of compensation due, if .any. The companies I have notified are. (check one)
[ ] The companies who haVe submitted the studies listed on the back of this form or attached sheets, or indicated on the attac.ied
"Requirements Status and Registrants'Response Form," '-...
3. That I have previously complied with section 3(c)(1 )(F) of FIFRA for the studies I have cited in support of registration or
reregistration under FIFRA.
Signature
Date
Name and Title (Please Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the registration or
reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) arid 3(c)(2)(D).
Signature - .
Date
Name and Title (Please Type or Print)
trrt rUfm oo/U-o I i
61
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62
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The following is a list of available documents related to ancymidol. 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 ancymidol 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
Ancymidol 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 .
63
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