United States
Environmental Protection
Agency ^__
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738TF-96-005
December 1995
R.E.D. FACTS
Gibberellic Acid
Pesticide All pesticides sold or distributed in the United States must be
Reregistration registered by EPA, based on scientific studies showing that they can be used
without posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered before November 1, 1984, be reregistered to ensure
that they meet today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency develops
mitigation measures or regulatory controls needed to effectively reduce each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA explains the basis
for its decision in a Reregistration Eligibility Decision (RED) document.
This fact sheet summarizes the information in the RED document for
reregistration case number 4110, Gibberellic Acid. •"
Use Profile
For the purpose of this RED, the following compounds will be
considered collectively under the term "Gibberellic Acids": Gibberellic Acid
(GA3); related isomers known as Gibberellins (GA4+GA7); and th& salt of
the acid, Potassium Gibberellate.
Gibberellic Acids are naturally occurring plant hormones.
Gibberellic Acids are used in agriculture as plant regulators to stimulate
both cell division and cell elongation that affect leaves as well as stems
(eventually affecting fruit development and fruit set). Applications of
Gibberellic Acids can also hasten plant maturation and seed germination.
Because they are naturally occurring compounds and have a nontoxic mode
of action in target plants, Gibberellic Acid and related isomers have been
classified as biochemical pesticides.
Gibberellic Acids are applied to growing crops (field crops, small
fruits, vines and tree fruits), ornamental and shade tress, and ornamental
plants, shrubs and vines. The Agency has determined that the uses of
Gibberellic Acids, as currently registered, will not cause unreasonable risk
to humans or the environment. These uses are eligible for reregistration.
However, six of the uses currently on the labels are not covered by either
the exemption from tolerance (40 CFR 180.1098), or a numeric tolerance
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(40 CFR 180.224). The Agency plans to propose to exempt from tolerance
many plant regulators, including Gibberellic Acids, when used in low doses.
This exemption will apply only when application rates do not exceed 250
grams of ai/acre/year! The Agency believes this action does not present
unreasonable risks because it is based on Gibberellic Acid's low acute
mammalian toxicity, low use rates, naturally occurring exposure in the diet
from numerous plant sources, and minimal exposure in the diet derived
from consumption of treated commodities under the proposed maximum
label use rate.
Formulation Types Registered:
Formulations include tablets, soluble granules, and liquid concentrate.
Method and Rates of Application:
Gibberellic Acid (GA3) and Gibberellin Mixture (GAj-t-GA,):
Gibberellic Acid (GA3) and Gibberellin Mixtures (GA4+GA7)
may be applied by aircraft, irrigation systems, ground spray
equipment, seed treatment or soil incorporation.
Potassium Gibberellate:
Potassium Gibberellate may be applied by hand-held spray
equipment and as a seed treatment.
Regulatory
History
Use Practice Limitations
For terrestrial uses:
"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 apply through any type of irrigation system."
The plant regulator, Gibberellic Acid, was initially registered in
the United States in 1947 as PROVIDE GROWTH REGULATOR
SOLUTION (EPA Reg. No. 275-2) for applications to apple trees as a
means of controlling fruit russet fungus. Gibberellic Acids are naturally
occurring plant hormones that act as plant regulators, promoting cell
division and cell elongation leading to increased fruit set and crop yields.
During Phase 4 of the accelerated pesticide reregistration process, the
data base for Gibberellic Acids was evaluated and determined to be
inadequate in satisfying certain requirements for biochemical pesticides,
which include plant growth regulators. A DCI was issued in September
1993 to fill the outstanding data gaps.
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Human Health
Assessment
The biochemical data requirements for the reregistration of Gibberellic
Acids have been satisfied through the submission of data in response to the
1993 DCI. These data are adequate to support the registration of Gibberellic
Acids on all RAC's, as well as all of the currently registered uses. .
Toxicity
In studies using laboratory animals, Gibberellic Acids generally have
been shown to be of low acute toxicity. The acute dermal toxicity
(LD5o>2g/kg), acute inhalation (negative LC5() at 2.98mig/l and LC^
>5.9mg/l), eye irritation (all cleared in 7 days) place Gibberellic Acids in
Toxicity Category HI (the second lowest of four toxicity categories).
Gibberellic Acids acute toxicity (LD50>5g/kg), dermal irritation (mild to
slight), and dermal sensitization (mild sensitizer) place it in Toxicity
Category IV (the lowest of four toxicity categories).
[NOTE: For acute oral, dietary, mammalian/avian/aquatic toxicity:
Category I = very highly or highly toxic '.''..
Category n '— moderately toxic
Category HI <= slightly toxic '
Category IV = practically non-toxic]
Subchronic Toxicity
Two subchronic oral toxicity studies for Gibberellic Acids were
reviewed in connection with the RED process. In the first subchronic
dietary study there was a NOEL of 10,000 ppm and a LOEL of 50,000 ppm
based on the occurrence of soft stools hfboth sexes of rats and increased
BUN levels, liver and kidney weights in females. In the second study, there
was a NOEL of 10,000 ppm and a LOEL of 25,000 ppm based on
alterations in clinical chemistry, decreased food consumption, decreased
body weights, increases in relative organ weights (brain, kidney, testis) and
gross histopathological changes in the kidney.
Developmental Toxicity
Two developmental toxicity studies for,Gibberellic Acids were
reviewed for this RED. In the first study, rats were dosed at 0, 100, or
1,000 mg/kg/day for 8 weeks without significant chemical, hematological or
pathologic evidence of toxicity. The maternal toxicity NOEL was greater
than 1,000 mg/kg/day (HTD). In the second study, rabbits were dosed at 0,
300, or 1,000 mg/kg/day; the highest concentration caused increased
mortality, abortion rates, clinical signs of toxicity, and gross pathological
observations. The maternal and developmental NOELs were established at
300 mg/ig/day.
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Mutagenicity
Gibberellic Acid (GA3) Salmonella typhimurium test strains TA 98, TA
100, TA 1535, TA 1537, and TA 1538 at concentrations ranging from 0 to
10,000 ug/plate with negative test results up to limit dose of 5,000 and 10,000
ug/plate. The mutagenicity of Gibberellins (GA4+GA7) was tested in an Ames
assay with Salmonella typhimurium test strains TA 98, TA 100, TA 1535, TA
1537, and TA 1538 at concentrations ranging from 0 to 10,000 ug/plate. Test
results were negative up to 10,000 ug/plate in the standard set of five histidine
negative strains of Salmonella typhimurium LT2.
A mouse-micronucleus assay on Gibberellins (GA4+GA7) indicated that nol
increased incidence of micronucleated-polychromatic erythrocytes (m-PCE) werel
found at levels up to 1200 mg/kg.
An unscheduled DNA synthesis in rat hepatocytes conducted with
Gibberellins technical 90% (G^+GA,) was negative for induction of UDS up
1260 ug/ml, the limit of solubility (MRID 40261603). A second unscheduled
DNA synthesis in rat hepatocytes conducted with Gibberellins also was negative.
Dietary Exposure
People may be exposed to residues of Gibberellic Acids through the diet.
Tolerances or maximum residue limits have been established for Gibberellic Acic
(GA3) and Gibberellins (GA4+GA7)for the following commodities (refer to 40
CFR 180.224)'.
Gibberellic Acid (0.15 ppm)
Artichokes
Blueberries
Citrus fruits
Grapes
Hops
Leafy vegetables
Stone fruits
Sugarcane
Sugarcane fodder
Sugarcane forage
Gibberellin Mixture (0.5 ppm)
Apples
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An exemption from the requirement of a tolerance (40 CFR 180.1098). has
been established for Gibberellins (specifically GA3) when used as a plant regulator
at less than 20g ai/acre in or on the following RAC's:
Barley
Beans
Beets (sugar)
Broccoli
Brussels sprouts
Cabbage
Cauliflower
Corn (all)
Cotton
Cucumbers
Grapefruit
Lemons
Lettuce
Melons
Mints
Mustard greens
Oats
Onions
Oranges
Peanuts
Peppers
Potatoes
Rice
Hye
Sorghum (milo)
Soybean
Spinach
Strawberries
Squash
Sugarcane
Tomatoes
Turnips
Watercress
Wheat
The Agency plans to propose an exemption from the requirements of a
tolerance for certain Gibberellic Acids (specifically Gibberellic Acid (GA3), a
mixture of Gibberellins (GA4+GA7), and Potassium Gibberellate) for all RAC's
when treated with application rates under 250 g ai/acre/year. The Agency believes
this action does not present unreasonable risks because it is based on Gibberellic
Acids' low mammalian toxicity, low use rates, natural background dietary
exposure and minimal exposure in the diet derived from consumption of treated
commodities under the proposed use rates.
Occupational and Residential Exposure
Based on the application methods listed on the product labels, the potential
for eye, dermal, and Inhalation exposure to agricultural workers does exist.
However, the lack of acute toxicity (i.e., Gibberellic Acids are hi Toxicity
Categories HI and TV) does not trigger additional requirements for evaluation of
worker exposure over the existing precautionary labeling currently required under
the provisions of the Worker Protection Standards.
Human Risk Assessment ,
' ' . "• . • • f. :
Since exposures and subsequent risks from Gibberellic Acids are not
expected, any potential risks from exposures to treated plants will be mitigated by
use of baseline personal protective equipment required by the Worker Protection
Standards, supplemented by specific precautionary labeling required by this RED.
Post-application reentry workers are required to observe a 12 hour Restricted
Entry Interval. Because of Gibberellic Acid's low mammalian toxicity, however it
is a candidate for a reduced reentry interval from 12 hours to 4 hours.
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Environmental Based on a review of all available ecological data, exposure
Assessment information, and Gibberellic Acids non-toxic mode of action, the Agency
expects that applications of Gibberellic Acids will pose minimal risk to
nontarget wildlife and fish.
Environmental fete studies for biochemicals are not imposed unless
adverse effects are observed in ecological effects data. Since no adverse
effects are anticipated, the .Agency will not, at this time, impose any
environmental fete data requirements for the currently registered uses of
Gibberellic Acids.
Additional Data
Required
Product Labeling
Changes
Required
Regulatory
Conclusion
For More
Information
EPA is requiring the a revised Confidential Statement of Formula
(CSF) and revised product labeling for reregistration.
The Agency has reexamined the lexicological data base for
Gibberellic Acid s and concluded that the current precautionary labeling
(i.e., Signal Word , Statement of Practical Treatment, and other label
statements associated with mitigating risks) adequately mitigate any risks
associated with the use of this plant regulator.
Based on the reviews of the generic data for Gibberellic Acid, the
Agency has sufficient information on health effect and potential for causing
adverse effects to human s or the environment. Therefore, the Agency
concludes that the use of currently registered products containing
Gibberellic Acids in accordance with approved labeling will not pose
unreasonable risks or adverse effects to humans or the environment. Certain
uses of Gibberellic Acids that have neither a tolerance or an exemption from
tolerance requirements (i.e., food use/commodities not listed in 40 CFR
180.224 or 40 CFR 180.1098) will become eligible for reregistration when
the proposed tolerance exemption is issued as a final rule in 1996.
EPA is requesting public comments on the Reregistration Eligibility
Decision'(RED) document for [name] during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register. To
obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket, Public Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide Programs
(OPP), US EPA, Washington, DC 20460, telephone 703-305-5805.
Electronic copies of the RED and this feet 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 feet sheet can be obtained from EPA's
National Center for Environmental Publications and Information
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(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fex 513-489-8695.
Following the comment period, the Gibberellic Acid 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 Gibberellic Acid RED, or reregistration of individual products
containing Gibberellic Acid, please contact the Biopesticides and Pollution
Prevention Division (7501W), OPP, US EPA, Washington, DC 20460,
telephone 703-308-8712.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
free 1-800-858-7378, between 9:30 am and 7:30 pm Eastern Standard
Time, Monday through Friday. .
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
DEC 28 1995
CERTIFIED MAIL
Dear Registrant: , •
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on me biopestitide case Gibberellic Acid,
which includes Gibberellic Acid (GA3), related isomers known as Gibberellins (GA4+GA7),
and the salt of the acid, Potassium Gibberellate. 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. . •"•..'•
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. An Application for Reregistration is required to be
submitted eight months from the date of receipt of this letter. Complete and timely
responses will avoid the Agency taking the enforcement action of suspension against your
products.
If you have questions about our decision or the requirements set forth in this
document, please .contact the reregistration representative for/the Biopesticides and Pollution
Prevention Division, Richard King at (703) 308-8052.
Sincerely yours,
Janet Andersen, Acting Director
Biopesticides and Pollution
Prevention Division (75Q1W)
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1. DATA GALL-IN (DCfl OR "90-DAY RESPONSE"-if generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data
are required, a DCI letter will be enclosed listing such requirements. If both generic and
product specific data are required, a combined Generic and Product Specific DCI letter will
be enclosed describing such data. However, if you are an end-use product registrant only and .
have been granted a generic data exemption (GDE) by EPA, you are being sent only the
product specific response forms (2 forms) with the RED. Registrants responsible for generic
data are being sent response forms for both generic and product specific data requirements (4
forms); You must submit the appropriate response forms (following the instructions
provided) within 90 days of the receipt of this KED/DCI letter; otherwise, your product
may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER REQUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for time extensions for product specific data
should be submitted in the 90-day response. Requests for data waivers must be submitted as
part of the 90-day response. All data waiver and time extension requests must be accompanied
by a full justification. All waivers and time extensions must be granted by EPA in order to go
into effect.
3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
. and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may, but are not
required to, delete uses which the RED says are ineligible for reregistration. For further
labeling guidance, refer to the labeling section of the EPA publication "General Information
on Applying for Registration in the U.S., Second Edition, August 1992" (available from the
National Technical Information Service, publication #PB92-221811; telephone number 703-
487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies ~
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that; they meet
the Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
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of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.
e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4 COMMENTS ifr RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5 WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVDEWS-EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILrrY DECISION
Gibberellic Acid
LISTD
CASE 4110
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
BIOPESTICTOE AND POLLUTION
PREVENTION DIVISION
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TABLE OF CONTENTS
GIBBERELLIC ACID
REREGISTRATION ELIGIBILITY DECISION TEAM . . .' . . ... .......... 1
EXECUTIVE SUMMARY ......................... . . ., . . .... . . . . iv
A - . , • • .' ;.-.•.'. • •.
I. INTRODUCTION ..... . . . . . .... . ... .,,". . . . ... .... . . , 1
n. CASEOVERVIEW ... . . i,.'..' . . . . . . ..... . .... . . ... .2
A. Chemical Overview ............ . ... . . 2
B. UseProfile ..: ^ ..................:.. 2
C. Estimated Usage of Pesticide .......... ... . . . . . ........ ... ... 6
D. Data Requirements . . . . . . . . ........... .... ... . . . ..,.,. ... 8
E. Regulatory History .-.... . . .... .9
m. SCIENCE ASSESSMENT . . . ... /. ........;. ... , . .". . . . .-. .9
A. Physical Chemistry Assessment ... . . . . ...... . . . . . . . . 9
• B. Human Health Assessment . 10
1. Toxicology Assessment . i ...... 10
a. Mammalian Toxicity . . . . . ..... . . . . . . 10
b. Subchronic Toxicity . ..................... .-... . . 11
c. Developmental Toxicity ..... . . . . . ., . . ... . . 13
d. Mutagenicity 13
e. Immunotoxicity 14
2. Exposure Assessment .............................. 14
a. Dietary Exposure and Risk Assessment ............ 14
b. Occupational Exposure and Risk Assessment ......... 15
C. Environmental Assessment .... ....,.'.. . . . .... 15
1. Ecological Toxicity Data . . .•', ...................... . 15
2. Environmental Fate . . . ...... ... .... ; ............ . ;16
TV. RISK MANAGEMENT AND REREGISTRATION DECISION ... ... 16
A. Determination of Eligibility . .... ......... . . . . . . ... . ........ 16
1. Eligibility Decision . . . . . . . ... ........ ... .......... 17
2. Eligible Uses 17
B. Regulatory Position . .... ,. 19
1. Tolerance Reassessment . ....*..............;....... 19
2. i Endangered Species Statement ................ . . . . . . . 20
3. Labeling Rationale 20
V. ACTIONS REQUIRED OF REGISTRANTS . . . . . . . ... . . . . .... ... .22
A. Manufacturing-Use Products ............................. 22
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1. Additional Generic Data Requirements . . 22
2. Labeling Requirements for Manufacturing-Use Products .-22
B. End-Use Products . . '• • 22
1. Additional Product-Specific Data Requirements ............ 22
2. Labeling Requirements for End-Use Products 23
C. Existing Stocks ..24
VI. APPENDICES • • • • 25
APPENDIX A. fable of Use Patterns Subject to Reregistration ....... 26
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision • • • HI
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistratiion of Gibberellic Acid 115
APPENDIX D. List of Available Related Documents ... . 122
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GIBBERELLIC ACID
REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biopesticides and Pollution Prevention Division
Denise Greenway
Christina L. Hartman (IR-4)
Phillip Button
Richard King
J. Thomas McClintock
Sheryl Reilly
Robert I. Rose
William Schneider
RoySjoblad
JohnTice
Freshteh Toghrol
Robert Torlai.
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE Acid Equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution .
CAS Chemical Abstracts Service
CI Cation , ,
CNS Central Nervous System
CSF Confidential Statement of Formula .
DFR Dislodgeable Foliar Residue
DRES Dietary Risk Evaluation System
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,
such as a terrestrial ecosystem.
EP End-Use Product .
EPA U.S. Environmental Protection Agency
FDA Food and Drug Administration . . '• •
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act ,,
FFDCA Federal Food, Drug, and Cosmetic Act
FOB Functional Observation Battery ,
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
HDT Highest Dose Tested , •
LCjo Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test animals. It is usually expressed as the weight of substance
per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50%
of the test animals when administered by the route indicated (oral, dermal, inhalation). It is
expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LDte Lethal Dose-low. Lowest Dose at which lethality occurs.
LEL Lowest Effect Level
LOG Level of Concern
LODt 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 in drinking water under the Safe Drinking Water Act.
jig/g Micrograms Per Gram
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible Intake .
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A Not Applicable
NOEC No effect concentration .
NPDES National Pollutant Discharge Elimination System
LD
'50
11
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GLOSSARY OF TERMS AND ABBREVIATIONS
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake .
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method ,
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval "
ppb Parts Per Billion
PPE Personal Protective Equipment ,
ppm Parts Per Million •
PRN Pesticide Registration Notice
Q*, The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell ,
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose , . '•
RS Registration Standard
SLN Special Local Need "(Registrations Under Section 24 (c) of FIFRA) ,
TC Toxic Concentration^ The concentration at which a substance produces a toxic effect.
TJD Toxic Dose. The dose at which a substance produces a toxic effect. ' - «
TEP Typical End-Use Product ; >
TGAI Technical Grade Active Ingredient
TLC ' Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
FAO/WHO Food and Agriculture Organization/World Health Organization
WP Wettable Powder ..
WPS Worker Protection Standard
111
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EXECUTIVE SUMMARY
The Environmental Protection Agency has completed an assessment of the potential human
health and environmental risks associated with the pesticidal uses of Gibberellic Acid and its
related isomers. For the purposes of this reregistration eligibility decision, the following
compounds will be considered collectively under the term "Gibberellic Acids": Gibberellic Acid
(GAj); related isomers known as Gibberellins (GA^ and (GA7); and the salt of the acid, Potassium
gibberellate.
Gibberellic Acids are naturally occurring plant hormones. Gibberellic Acids are used in
agriculture as plant regulators to stimulate both cell division and cell elongation that affect leaves
as well as stems (eventually affecting fruit development and fruit set). Applications of Gibberellic
Acids can also hasten plant maturation and seed germination. Because they are naturally occurring
compounds and have a nontoxic mode of action in target plants, Gibberellic Acid and related
isomers have been classified as biochemical pesticides.
The Agency has determined that the uses of Gibberellic Acids, as currently registered, will
not cause unreasonable risk to humans or the environment. These uses are eligible for
reregistration. However, six of the uses currently on the labels are not covered by either the
exemption from tolerance (40 CFR 180.1098), or a numeric tolerance (40 CFR 180.224). The
Agency plans to propose to exempt from tolerance many plant regulators, including Gibberellic
Acids, when used in low doses. This exemption will apply only when application rates do not
exceed 250 grams of ai/acre/year. The Agency believes this action does not present unreasonable
risks. It is based on low acute mammalian toxicity, low use rates, naturally occurring exposure
in the diet from numerous plant sources, and minimal exposure in the diet derived from
consumption of treated commodities under the proposed maximum label use rate.
The interim Worker Protection Standard (WPS) Restricted-Entry Interval (REI) for
Gibberellic Acids was established at 12 hours, based on acute mammalian toxicity. However, the
Agency has determined that an interim REI of 12 hours may, in certain circumstances, be reduced
to 4 hours for pesticides with low acute mammalian toxicities in Toxicity Categories ffl and IV.
The Gibberellic Acids are candidates for reduced interim REI's due to their very low acute
toxicities (i.e., Toxicity Categories ffl and IV).
Before reregistering the products containing Gibberellic Acids, the Agency is requiring
that revised Confidential Statements of Formula (CSF) and revised product labeling be submitted
within eight months of the issuance of this document. After reviewing mis information and finding
it acceptable in accordance with Section 3(c)(5) of FIFRA, the Agency will reregister a product.
Those products that contain Gibberellic Acids in combination with other active ingredients will
be eligible for reregistration only when the other active ingredients are determined to be eligible
for reregistration.
IV
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I.
INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984. The amended Act provides a.schedule for the reregistration process to be completed in
nine years. There are five phases to the reregistration process. The first four phases of the process
focus on identification of data requirements to support the reregistration of an active ingredient
and the generation and submission of data to fulfill the requirements. The fifth phase is a review
by the U.S. Environmental Protection Agency (referred to as "the Agency") of all data submitted
to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregistration" before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review of the scientific data base underlying a
pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of Gibberellic Acids . The document consists of six sections. Section I is the
introduction. Section n describes Gibberellic Acids, their uses, data requirements and regulatory
history. Section HI discusses the human health and environmental assessment based on the data
available to the Agency. Section IV presents the reregistration decision for Gibberellic Acids.
Section V discusses the reregistration requirements for Gibberellic Acids. Finally, Section VI
contains the Appendices that 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 ingredients are covered by this Reregistration Eligibility
Decision:
• Common Name: Gibberellic Acid (GA3), Gibberellins (GA4) and (GA7),
Potassium Gibberellate
• Chemical Name: Gibberellic Acid (GA3), GibbereUins (GA4) and (GA7),
Potassium Gibberellate
• Chemical Family: Gibbane structure (from the fungus Gibberella fujikurot)
• CAS Registry Number:
Gibberellic Acid (GA3) and Gibberellins (GA4+GA7) - 77-06-5
Potassium gibberellate — 125-67-7
• OPP Chemical Code:
Gibberellic Acid (GA3) and Gibberellins (GA4+GA7) - 43801
Potassium gibberellate — 43802
Empirical Formula:
Gibberellic Acid (GA3)
Gibberllins (GA4+GA7)
Potassium Gibberellate
C,9H22O6
Qo^eOs +
C,9H21KO6
Trade and Other Names: ProGibb, Pro Vide, Activol, Grocel, and
Gibrel.
Basic Manufacturer:
Abbott Laboratories
AGTROL Chemical Products, Inc.
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 Gibberellic Acids may
be found Appendix A.
For Gibberellic Acid and related isomers:
-------
Type of Pesticide: Plant regulator
Use Sites:
Gibberefflc Acid:
TERRESTRIAL FOOD CROP: Artichoke; blueberry; broccoli;
Brussels sprouts; cabbage; carrot (including tops); cauliflower;
celery; cherry; cucumber; lettuce; melons; melons, cantaloupe;
melons, honeydew; melons, water; peach; pepper; prune; rhubarb;
spinach; squash (all or unspecified); strawberry. ,
TERRESTRIAL FOOD + FEED CROP: Apple; barley; beans;
beans, dried-type; beans, mung; beans, succulent (lima); beans,
succulent (snap); citrus fruits; corn, field; corn, sweet; corn, pop;
cotton, (unspecified); grapefruit; grapes; hops; lemon; lime;
mustard; oats; orange; peanuts (unspecified); peas, field; potato,
white/Irish; rice; rye; sorghum; sorghum (unspecified); soybeans
(unspecified); sugarbeet; sugarcane; tangelo; tomato; turnip; wheat
TERRESTRIAL FEED CROP: Sugar beets (including tops)
i-, , _• i
TERRESTRIAL NONFOOD CROP: Golf course turf;
ornamental herbaceous plants; ornamental lawns and turf;
ornamental woody shrubs and vines
TERRESTRIAL NONFOOD H- OUTDOOR RESIDENTIAL:
Ornamental and/or shade trees, ornamental herbaceous plants,
ornamental lawns, ornamental woody shrubs and vines
GREENHOUSE FOOD CROP: Rhubarb
GREENHOUSE NONFOOD CROP: Ornamental woody shrubs
and vines
Gibberellin Mixture (GAd + GA7);
TERRESTRIAL FOOD CROP: Spinach (seed crop only; SLN,
WA)
TERRESTRIAL FOOD+FEED CROP: Apple
3
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TERRESTRIAL NON-FOOD CROP: Cherry, Pear
TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL:
Ornamental herbaceous plants
Potassium Gibberellate:
TERRESTRIAL FOOD CROP: Artichoke, Blueberry, Celery,
Cherry, Cucumber (seed crop only), Lettuce (seed crop only),
Prune , .
TERRESTRIAL FOOD+FEED CROP: Grapes, Hops, Lemon,
Orange, Potato, white/Irish ("seed" crop only), Tangelo
TERRESTRIAL NON-FOOD CROP: Tobacco
TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL:
Ornamental and/or shade trees, Ornamental herbaceous plants,
Ornamental nonflowering plants, Ornamental woody shrubs and
vines
GREENHOUSE FOOD CROP: Rhubarb
INDOOR RESIDENTIAL: Ornamental herbaceous plants
Target: Higher Plants.
Formulation Types Registered: Tablets, soluble granules, liquid concentrate.
Method and Rates of Application:
Gibberellic Acid (GAa) and Gibberellin Mixture (GA4+GA7):
Types of treatment:
Band treatment, Broadcast, Chemigation, Commercially grown nursery
grass sod treatment, Dip treatment, Drench, High volume spray (dilute),
Low-volume spray (concentrate), Seed treatment, Soil in-farrow treatment,
Soil incorporated treatment, Soil sidedress treatment, Soil treatment, Spot
treatment, Spray
-------
Equipment:
Airblast, Aircraft, Center pivot irrigation, Dropper, Fixed-wing aircraft,
Ground, hand held sprayer, Hand move irrigation, High volume ground
sprayer, Mist-type seed treater, Moving wheel irrigation, Seed treater,
Solid set irrigation, Sprayer
Timing:
At first squaring, At pegging, At planting, August, Bare root, Bloom,
Crown, December, Dormant, Early bloom, Early spring, Early tillering>
Fall, Foliar, Fruiting, January, Nonbearing, November, October, Petal
fall, Postemergence, Postharvest, Posttransplant, Prebloom through foliar,
Prebloom, Preemergence, Preharvest, Pretransplant, Seed pieces Seed,
September, Transplant, When needed
Application Rates: ., .
Refer to Appendix A.
Potassium GibbereUate:
Types of Treatment:
Dip treatment; spray
Equipment:
aerosol can; sprayer
Timing:
Bloom; crown; December; fall; foliar; November; October; preharvest;
"seed" (potatoes) • ' , . .
/ ..„-., • > , • • , -
Application Rates:
Refer to Appendix A.
Use Practice Limitations:
For terrestrial uses:
. ' ' . 1 . .
Do not apply directly to water or to areas where surface water is present or to
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intertidal areas below the mean high water mark.
Do not apply through any type of irrigation system. -
Do not apply within 7 to 40 days of harvest, depending on crop.
C. Estimated Usage of Pesticide
This section summarizes the best estimates available for the pesticide uses of
Gibberellic Acids. These estimates are derived from a variety of published and
proprietary sources available to the Agency. The data, reported on an aggregate and site
(crop) basis, reflect annual fluctuations in use patterns as well as the variability hi using
data from various information sources.
' The table below summarizes the pesticides use by site.
ESTIMATED ANNUAL'U.S. USAGE OF GIBBERELLIC AGIOS FOR 1990-1993
Site Acres Grown
FIELD CROPS
Cotton
Hops-
-OR
-WA
Potatoes, Irish
Rice
Tobicco
FRUrrS&NUTS
Blueberries, bearing —
-MI
Citrus Fruit —
- Grapefruit
-Lemons
-CA
-Oranges
Oranges, CA
Temples, bearing, FL
- Tangelos, bearing, FL
- Tangerines, bearing
FL
(000)
12,269-14,047
40-40
7-7
28-28
1,329-1,401
2,865 - 3,023
703 - 754
33-36
15-16
173 - 192
67-69
48-49
791 - 819
188-191
7-8
8-11
27-27
14-14
Acres
. Treated
(000)
0- 374
1.4- 1.4
0.8 - 0.8
0.6- 0.6
0-3
0-5
0-4
0.7-1.0
*-0.5
1-4
2-10
2-4
34-50
32-40
» . *
*-0.6
1.3-1.3
0.7-0.7
Site
Treated
(%)
0- 3
3-3
11-11
2-2
0- <1
0- <1
0-<1
2-3
*-3
1-2
3-14
4-9
4-6
17-21
* . *
*-6
4-4
5-5
• Lbs A.I. Applied •
Total
(000)
0- 0.29
0.02- 0.02
0.01 - 0.01
0.01 r 0.01
0- 0.44
0 - 0.28
0-0.11
0.15-0.18
* - 0.08
* - 0.22
0.19-0.45
0.19-0.21
2.0 - 3.4
2.0-3.4
* _ *
*-0.05
0.15-0.19
0.10-0.10
Applic Rate
(Ibs a.i./A)
0.001 - 0.001
0.01 - 0.01
<_ 0.02 -0.02
_< 0.02-0.02
0.15-0.15
0.01 - 0.06
0.03-0.03
0.10-0.17
0.17-0.17
0.03 - 0.04
0.03 - 0.06
<0.06-0.10
0.04-0.06
0.06-0.10
na-na
0.04 - 0.04
0.05-0.05
0.05-0.05
ESTIMATED ANNUAL U.S. USAGE OF GIBBERELLIC ACIDS FOR 1990-1993(CONT'D)
Site
Acres Grown
Acres
Treated
Site
Treated
CA
(000)
8-8
(000)
0.6-0.6
8-8
— Lbs A.I. Applied —
Total Applic Rate
(000)
0.05 - 0.09
(Ibs a.i./A)
<0.06 - 0.08
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Grapes, bearing —
- AZ
-CA
-NY
- OR
Pecans, bearing
Pome Fruit —
Apples,' bearing.
-MD
-MI
-OR
-PA "'
-WA
Pears
Stone Fruit —
- Cherries , < .
.Sweet, bearing
-CA
-OR
-WA
Tart, bearing
-MI
- Peaches, bearing
- Plunis/Pmnes
- Other Stone Fruit
.760 - 765
5-5
637-656
33-33
4-5
na-na
446-460
4-4
53-56>
8-10
22-24
139 - 147
; 82-83
136-140
/ 45-46
11-11
10-10
14-14
47 - 50
. 33-34
175 - 179
142-147
183-186
112-337
2.5-215
107-332.
*-0.3
0-0.1
'* _ *
77 - 124
"l-l
1-1
.3-4
1-1
61-85
1-2
20-26
9-10
0,2 - 0.4
3-3
4-6
11-11
9-9
*-0.5
.1-1
0-1
\ 15-44
50 - 50
16-52
*'-!-
0-3
: * .* •"•
17 - 27
. 18-18
2-2.
41-37
6-5
44-58
<1 -2
> . . • . •
14-19
19-21
2-3
27-32
26-42'
23-24
26-28
*-
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ESTIMATED ANNUAL U.S. USAGE OF GIBBERELLIC ACIDS FOR
1990-1993(CONTD) ,
Site
Acres Grown
(000)
Acres
Treated
(000)
Site
Treated
— Lbs A.I. Applied —
Total ApplicRate
(000)
(Ibs a.i./A)
NON-AGRICULTURE
Nursery/Greenhouse —
- Greenhouse, CA
Cut Flowers/Greens
Container Plants
Transplant Material, etc
- Outdoor, CA
Cut Flowers/Greens
Container/Field Plants
Transplant Material, -etc
SUM OF ABOVE (©)
500-500
2-2
2-2
na-na
,
10-10
27-27
na-na
21,699-23,905
na-na
0.01-0.02
0.02-0.02
< 0.01 -0.03
0.01 - 0.01
0.03 - 0.03
<0.01 -<0.01
259-959
<1- <1
<1 - 1
1- 1
na-na
<1 - <1
<1 - <1
na-na
na-na
< 0.30 - <0.30 na - na
<0.001 -<0.001
0.003-0.006
<0.001-0.001
<0.001 - 0.001
0.002-0.003
< 0.001 -< 0.001
<15-59
< 0.03-0.04
_< 0.13-0.25
< 0.04-0.04
<0.03 - 0.05
_< 0.10-0.11
<0.06 - 0.06
na - na
* USDA indicated some usage, but survey reports were not sufficient to estimate usage, which probably
was relatively small.
© Each summation excludes data for sub-categories if there are data for the corresponding higher-
level category (e.g., excluding bearing sweet and tart cherries separately because total cherries
is included). In the summations, "*" and "na" count as zeroes.
NOTE1: na «« not available or not applicable. *
NOTE 2: Ranges result from different sources and/or years.
SOURCES-
- Anderson & Gianessi, Agricultural Pesticide Use in CA, 1990 & 1991
- CA EPA, Pesticide Use Report, Annual 1990
- Gianessi & Anderson, Pesticide Use in U.S. Crop Production, National Summary Report, 2/95
- Gianessi & Anderson, Pesticide Use in U.S. Crop Production, National Data Report, 2/95
-USDcpt. of Commerce, 1992 Census of Agriculture, CA . ,
- US EPA 1990-93 proprietary sources
- USDA/NASS, Agricultural Chemical Usage, 1990, Vegetables Summary
- USDA/NASS, Agricultural Chemical Usage, 1991 Fruits & Nuts Summary
-USDA/NASS, Agricultural Chemical Usage, 1990-93 Field Crops Summaries
- USDA/NASS, Agricultural Chemical Usage, 1993 Fruits Summary
- USDA/NASS, Agricultural Chemical Usage, Vegetables, 1992 Summary
-USDA/NASS, Citrus Fruits, 1991-93 Summaries .
- USDA/NASS; Crop Production, 1990-93 Summaries
- USDA/NASS, Noncitrus Fruits & Nuts, 1993-94 Preliminaries
-USDA/NASS, Vegetables, 1992-94Summaries
D. Data Requirements
In Phase 4 of the Reregistration Process, data gaps for Gibberellic Acids were
identified and a DCI was issued in September of 1993 for studies relating to product
chemistry and ecologicial effects. These data were required to support the uses of products
containing the active ingredients Gibberellic Acid, Gibberellins, and Potassium
Gibberelate. Appendix B includes all data requirements identified that are needed to
8
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'support reregistration for currently registered uses. . '
E. Regulatory History
The plant regulator, Gibberelllc Acid, was initially registered in the United States
in 1947 as PROVIDE GROWTH REGULATOR SOLUTION (EPA Reg. No. 275-2) for
applications to apple trees as a means of controlling fruit russet fungus. Gibberellic Acids
are naturally occurring plant hormones that act as plant regulators, promoting cell division
and cell elongation leading to increased fruit set and crop yields.
During Phase 4 of the Reregistration Process, the data base for Gibberellic Acids
was evaluated and determined to be inadequate in Satisfying certain requirements for
biochemical pesticides, which include plant growth regulators. The following were
identified as outstanding data gaps and a DCI was issued in September 1993:
Guideline No.
151B-17g
151B-17i
151B-17J
151B-17p
154B-11
Solubility
pH
Stability
Octanol/water partition coefficient
Non-target insect
The biochemical data requirements for the reregistrationi of Gibberellic Acids have
been satisfied through the submission of data in response to the 1993 DCI. These data are
adequate to support the registration of Gibberellic Acids on all RAG's, as well as all of
the currently registered uses specified in Section IV.
This Reregistration Eligibility Decision reflects a reassessment of all data that were
submitted in response to the Reregistration Process. . •
HI. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Gibberellic Acid is a plant hormone that was first isolated in 1938 from cultures
of Gibberetta jujikuroi (Sawada) and Fusarium moniliforme, the causative agents for
Bakanae disease in rice. More than 60 Gibberellins are known; however, only three,
Gibberellic Acid (GA3), Gibberellins — a mixture of QA and GA , and Potassium
Gibberellate, are registered as biopesticides in the United States.
Gibberellic Acid is an odorless, fine, white powder at 23°C. It has a melting point
of 223-226°C and a bulk density of 600 mg/ml at 23.8?C. Gibberellic Acid is soluble in
water (460 mg/ml), while its sodium, potassium, and ammonium salts are very soluble in
-------
water (5g/l of water). Gibberellic Acids have a shelf Me of at least 2 years under normal
conditions in unopened containers. Potassium Gibberellate has a pH of 5.5- 6.5 while
Gibberellic Acid has a pH of 4.
B. Human Health Assessment
1. Toxicology Assessment
Adequate mammalian toxicology data on Gibberellic Acids are available
and will support a Reregistration Eligibility Decision (RED).
a. Mammalian Toxicity
Certain mammalian toxicity studies conducted with Gibberellic
Acids have been submitted and adequately satisfy the requirements as set
forth in 40 CFR 158.690 - Biochemical Pest Control Agents.
10
-------
0-'
TABLE H: ACUTE MAMMALIAN TOXICITY REQUIREMENTS
FOR GIBBERELLIC ACIDS
Guideline
152B-10
Acute oral tox.
(rat)
152B-11
Acute dermal tox.
(rabbit)
152B-12
Acute inhalation . ,
(rat)
152B-13*
Eye irritation
(rabbit)
152B-14*
, Dermal irntation
(rabbit)
152B-15*
Dermal
sensitization
152B-16*
Hypersensitivity
Test Material
GA4+GA7,90%
GA3, 7.5%
GA4+GA7, 90%
GA3, 7.5%
GA4+GA7, 90%
GA3, 7.5%
GA4+GA7,90%
GA3, 7.5% '.
GA4+GA7, 90%
GA3, 7.5%
GA4+GA7, 90%
GA3, 10%
All products
Results
LD 50 ( 5g/kg
,LD 50 > 5g/kg (combined)
LD50(cf&?) > 2g/kg
LD 50 > 2 g/kg (combined)
LC50 negative at 2.98mg/l;
maximum attainable exposure.
LC50 > 5.9 mg/1 (combined)
PEIS ranged from 19.3 at 1 hr. to
4. 7 at 96 hrs. All irritation cleared
by 7 days.
Eye irritation clearing in 7 days or
less.
P.I.S. =0
Mild or slight irritant.
Reported as mild sensiti^er
Not a contact dermal sensitizer.
All incidents must be reported to the
Agency.
Toxicity
'Category
IV
rv
ffl
ra
ra
m
m,
m
TV
IV
rv
rv
MRID
40873201
41591103
40873202
41591104
40873203
41501105
4Q873204
41591106
40873205
41591107
40873206
41560406
* Not required for TGAI.
In the evaluation of the toxicology data base for the reregistration eligibility
decision for Gibberellic Acids, the Agency reeyaluated the primary eye irritation
study conducted with Gibberellins (TGAI mixture of GA4+GA7) (MRID ''
40873204) and concluded that the eye irritation potential is more appropriately
reclassified as Toxicity Category m rather than Toxicity Category n as initially
classified. , •-,"'.
b. Subchronic Toxicity
Two subchronic oral toxicity studies for Gibberellic Acids were
reviewed in connection with the RED process. In the first subchronic
dietary study (MRID 41617501), rats of both sexes were fed diets
containing Gibberellic Acid (GA3, purity 88.5%) at concentrations of 0,
11
-------
1,000, 10,000, or 50,000 ppm for 13 weeks. A group of control animals
and high-dose animals were fed regular rodent diet for an additional 4-week
recovery period. The consumption of test material was 53-117, 550-1178,
or 2994-5786 mg/kg/day (males) and 67-130, 730-1283, or 3872-6241
mg/kg/day (females). The only treatment-related clinical sign of toxicity
was a low incidence of soft stools in both sexes receiving the highest dose.
Very slightly decreased body weight gains were observed in mid-dose
males and high dose animals of both sexes. Slightly increased total food
consumption hi all treated groups were observed. Evidence suggestive of
a compound-related effect on kidney function included significantly
increased blood urea nitrogen levels (BUN) and increased relative kidney
weights in female rats hi the high-dose group. BUN levels and kidney
weights were comparable to controls at the end of a 4-week recovery
period, indicating reversibility of renal effects. Other effects observed hi
high-dose males included decreased globulin levels at termination of the
study and decreased glucose levels (p^O.05) at the end of the 4-week
recovery period- Increased relative liver weights were observed in males
at 50,000 ppm and in females at 10,000 ppm and 50,000 ppm. At the end
of the recovery period, increased relative liver weights were still evident
in females (11%), but hot hi males. In the absence of clinical chemistry
correlates and gross and microscopic hepatic abnormalities, the liver weight
changes are considered compensatory rather than a toxic effect of .the test
material. Under the conditions of this study, the NOEL is 10,000 ppm; the
LOEL is 50,000 ppm, based on the occurrence of soft stools in both sexes,
and increased BUN levels, h'ver and kidney weights in females.
In the second study (MRID 41616601), rats were fed diets
containing 0, 1,000, 10,000 or 25,000 ppm Gibberellins (GA4+GA7,
purity 85.5%) for 13 weeks. Additional groups of 10 control and 10 high-
dose animals were held for a 4-week recovery period. The 25,000 ppm
exposure group was fed a diet containing 50,000 ppm during the first 14
, days of the study; however, due to low weight gain and clinical signs the
dosage was reduced for the duration of the study. The average calculated
doses for the 1,000, 10,000, and 25,000 ppm groups, the latter corrected
for exposure to 50,000 ppm, were 67, 704, and 2238 mg/kg/day for males
and 85, 814, and 2403 mg/kg/day for females. No treatment-related effects
were observed at the 1,000 or 10,000 ppm dietary levels. One male in the
25,000 ppm treatment group died during the third week of the study.
Compared to controls, treatment of rats of both sexes at 25,000 ppm had
significant effects on clinical signs, food consumption (during the first 5
weeks of the study), body weight, organ-to-body weight ratios,
hematology, clinical chemistry and gross microscopic pathology. Clinical
signs hi the high-dose groups included hunched posture, thin rough coat,
a bloody crust on the nose and urine stains. Body weights for males and
12
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females were significantly lower than controls throughout the study,
including the recovery phase. There was a marked increase in body Weights
when the treatment was reduced from 50,000 to 25,000 ppm after 14 days,,
and by the end of the recovery period at week 17, body weights were
within 91% of control groups for both sexes.
Males had significantly decreased hemoglobin and hematocrit values
and significantly lower total bilirubin, cholesterol, and alkaline phosphatase
values. Females had signicandy lower total protein, albumin and calcium
values and significantly higher globulin, total bilirubin, cholesterol and
alkaline phosphatase values. Both sexes had significantly increased relative
brain weights and males had significantly increased relative kidney and
testis weights. Gross pathological changes in the kidneys (rough surfaces
and depressed areas in the cortex) were present in both sexes.
Histologically, chronic tubular nephritis, tubular dilation, and focal loss of
nephrons were observed. Histological changes in the liver were marginal
in incidence and severity. Under the conditions of the study, the NOEL is
10,000 ppm; the LOEL is 25,000 ppm based on alterations in clinical
chemistry, decreased food consumption, decreased body weights, increases
in relative organ weights (brain, kidney, and testis), and gross and
histopathological changes in the kidney.
c. Developmental Toxicity
Gibberellic Acid (GA3) was administered to rats at doses of 0, 100
or 1,000 mg/kg/day for 8 weeks without significant clinical, hematological
or pathologic evidence of toxicity. The maternal toxicity NOEL was
greater than 1000 mg/kg/day (HTD))(MRID 40155201).
In a separate study, artificially inseminated rabbits were treated with
Gibberellins (GA4+GA7) by oral gavage at 0, 100, 300, or 1000
mg/kg/day (MRID 41143201). The highest concentration caused increased
mortality, abortion rates, clinical signs of toxicity and gross pathological
observations. The maternal and developmental NOELs were established at
300 mg/kg/day.
d. Mutagenicity
Gibberellic Acid (GA3) (MRID 40261601) was tested in an Ames
assay with Salmonella typhimuriwn test strains TA 98, TA 100, TA 1535,
TA 1537, and TA 1538 at concentrations ranging from 0 to 10,000
ug/plate with negative test results up to limit dose of 5,000 and 10,000
ug/plate. The mutagenicity of Gibberellins (GA4+GA7) (MRID 40873207)
was tested in an Ames assay with Salmonella typhimurium test strains TA
13
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2.
98, TA 100, TA 1535, TA 1537, and TA 1538 at concentrations ranging
from 0 to 10,000 ug/plate. Test results were negative up to 10,000 ug/plate
in the standard set of five histidine negative strains of Salmonella
typhimuriumUn. _
A mouse-micronucleus assay oh Gibberellins (GA4+GA7) indicated
that no increased incidence of micronucleated-polychromatic erythrocytes
(m-PCE) were found at levels up to 1200 mg/kg (MRTO 40873208).
. An unscheduled DNA synthesis in rat hepatocytes conducted with
Gibberellins technical 90% (GAt+GA,) was negative for induction of UDS
up to 1260 ug/ml, the limit of solubility (MRID 40261603). A second
unscheduled DNA synthesis in rat hepatocytes with Gibberellins also was
negative (MRTO 40873209). .
e. Immunotoxicity .
The guideline requirement for immunotoxicity was waived based
on the results of a residue study (no detectable residue noted with a
detection limit of 1 ppm), low application rates, and nominal potential
human exposure. ,
Exposure Assessment
a. Dietary Exposure and Risk Assessment
Tolerances (40 CFR 180.224) for Gibberellins (specifically (GA3),
and the mixture of Gibberellins (GA4 and GA7)) have been established for
(1) residues of Gibberellic Acid on the following RAC's, and (2) for the
combined residues of the gibberellin mixture (GA4 and G^.) on the
following RAC's:
Gibberellic Acid (0.15 ppm) Gibberellin Mixture (0.5 ppm)
Artichokes
Blueberries
Citrus fruits
Grapes
Hops
Leafy vegetables
Stone fruits
Sugarcane
Sugarcane fodder
Sugarcane forage
Apples
An exemption from the requirement of a tolerance (40 CFR
14
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180.1098) has been established for Gibberelfins (specifically GA3) when
used as a plant regulator at less than 20g ai/acre in or on the following
RAC's: _
Barley
Beans
Beets (sugar)
Broccoli
Brussels sprouts
Cabbage
Cauliflower
.Corn (all)
Cotton
Cucumbers
Grapefruit
Lemons
Lettuce
Melons
Mints
Mustard greens
Oats
Onions
Oranges
Peanuts
Peppers
Potatoes ;
Rice
Rye
Sorghum (milo)
Soybean
Spinach
Strawberries
Squash,
Sugarcane
Tomatoes
Turnips
Watercress
Wheat
The Agency plans to propose an exemption from the, requirements
of a tolerance for certain Gibberellic Acids (specifically Gibberellic Acid
(GA3), a mixture of Gibberellins (GA4+GA7) and Potassium Gibberelate)
for ail RAC's When treated with application rates under 250 g ai/acre/year.
The Agency believes this action does not present unreasonable risks
because it is based on Gibberellic Acids'low mammalian toxicity, low use
rates, natural background dietary exposure and minimal exposure in the
diet derived from consumption of treated commodities under the proposed
use rates.
b. Occupational Exposure and Risk Assessment
Based on the application methods listed on the product labels, the
potential for eye, dermal, and inhalation exposure to agricultural workers
does exist. However, the lack of acute toxicity (i.e., Gibberellic Acids are
in Toxicity Categories m and IV) does not trigger additional requirements
for evaluation of worker exposure over the existing precautionary labeling
currently required under the provisions of the Worker Protection Standards
discussed in Section V.
C. Environmental Assessment
There are no outstanding data requirements. Sufficient data have been provided for
an environmental fate and effects assessment.
1. Ecological Toxicity Data
All of the ecological effects data requirements for Gibberellic Acids have
been adequately fulfilled. These data indicate that Gibberellic Acids are not likely
to cause adverse effects in npntarget avian, aquatic, and insect species.
15
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TABLE IV: ENVIRONMENTAL EXPRESSION - TIER I GUIDELINE
REQUIREMENTS FOR GIBBERELLIC ACIDS
Guideline
No.
154B-6
154B-7
154B-8
154B-9
154B-IO
154B-11
Study
Avian acute oral
Avian acute dietary
Fish Toxichy -
Rainbow Trout
Invertebrate toxicity
Nontarget Plants
Nontarget Insects
Results
Gibberellic Acid is practically non-toxic to Bobwhite
Quail. The ID,,, is > 2250 mg a.i./kg. The NOEL
> 2250 mg a.i./kg (HTD).
Gibberellic Acid is practically non-toxic to Bobwhite
Ouail. LC« is > 4640 ppm (HTD).
The LCjo of Gibberellic Acid is > 150 ppm.
Gibberellic Acid is practically non-toxic to coldwatcr
fish. The NOEL > 150 ppm (HTD).
The LCM of Gibberellic Acid is > 143 ppm.
Gibberellic Acid is practically non-toxic to aquatic
invertebrates. The NOEL > 143 ppm (HTD).
Waived because Gibberellic Acid is a growth
stimulator that is naturally produced in plants.
Gibberellic Acid is classified as relatively non-toxic
to honey bees.
MRID
42084401
121075
42167401
42084402
43370201
2. Environmental Fate
Environmental fate studies are not required for biochemical pesticides
unless adverse effects on nontarget species are observed as a result of acute testing
(Tier I) for ecological effects. No adverse effects are suggested by the data as
described in Table IV above.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(AJ 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 Gibberellic Acids as their active ingredients.
The Agency has completed its review of these generic data, and has determined that the
data are sufficient to support reregistration of all products containing Gibberellic Acids.
Appendix B identifies the generic data requirements that the Agency reviewed as part of
its determination of reregistration eligibility of Gibberellic Acids, and lists the submitted
studies that the Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess the
currently registered uses of Gibberellic Acids and to determine that Gibberellic Acids can
16
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be used without resulting in unreasonable adverse effects to humans and the environment.
The Agency therefore finds that products containing Gibberellic Acids as the active
ingredients 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 certain currently registered uses of
Gibberellic Acids are eligible for reregistration, it should be understood that the Agency
may take appropriate regulatory action, and/or require the submission of additional data
to support the registration of products containing Gibberellic Acids, if new information
comes to the Agency's attention or if the data requirements for registration (or the
guidelines for generating such data) change.
1. Eligibility Decision
Based on the reviews of the generic data for thb active ingredients
Gibberellic Acids, the Agency has sufficient information on the health effects of
Gibberellic Acids and on its potential for causing adverse effects in fish and
wildlife and the environment. The Agency has determined that products containing
Gibberellic Acids, when labeled and used as specified in this Reregistration
Eligibility Decision, will not pose unreasonable risks or adverse effects to humans
or the environment. Therefore, the Agency .concludes that products containing
Gibberellic Acids for certain uses are eligible for reregistration.
2. Eligible Uses
The Agency has determined that certain uses of Gibberellic Acids are
eligible for reregistration.
TERRESTRIAL FOOD CROP: Artichoke; blueberry; broccoli;
Brussels sprouts; cabbage; carrot (including tops); cauliflower;
celery; cherry; cucumber; lettuce; melons; melons, cantaloupe;
melons, honeydew; melons, water; peach; pepper; prune; rhubarb;
spinach; squash (all or unspecified); strawberries.
TERRESTRIAL FOOD + FEED CROP: Apple; barley; beans;
beans, dried-type; beans, mung; beans, succulent (lima); beans,
succulent (snap); citrus fruits; corn, field; corn, sweet; corn, pop;
cotton, (unspecified); grapefruit; grapes; hops; lemon; lime;
mustard; oats; orange; peanuts (unspecified); peas, field; potato,
white/Irish; rice; rye; sorghum; sorghum (unspecified); soybeans
. (unspecified); sugarbeet; sugarcane; tangelo; tomato; turnip; wheat
17
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TERRESTRIAL FEED CROP: Sugar beets (including tops)
TERRESTRIAL NONFOOD CROP: Golf course turf,
ornamental herbaceous plants, ornamental lawns, ornamental woody
shrubs and vines
\ 7™
TERRESTRIAL NONFOOD + OUTDOOR RESIDENTIAL:
Ornamental and/or shade trees, ornamental herbaceous plant*;,
ornamental lawns, ornamental woody shrubs and vines
GREENHOUSE FOOD CROP: Rhubarb
/
GREENHOUSE NONFOOD CROP: Ornamental woody shrubs
and vines
Gibberellin Mixture (GA. + GA7);
TERRESTRIAL FOOD CROP: Spinach (seed crop only; SLN,
•WA)
TERRESTRIAL FOOD+FEED CROP :Apple
TERRESTRIAL NON-FOOD CROP: Cherry
*.. i . '
TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL:
Ornamental herbaceous plants
Potassium Gibberellate;
TERRESTRIAL FOOD CROP: Artichoke, Blueberry, Celery,
Cherry, Cucumber (seed crop only), Lettuce (seed crop only),
Prune .
TERRESTRIAL FOOD+FEED CROP: Grapes, Hops, Lemon,
Orange, Potato, white/Irish ("seed" crop only), Tangelo
TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL:
Ornamental and/or shade trees, Ornamental herbaceous plants,
Ornamental nonflowering plants, Ornamental woody shrubs and
vines
GREENHOUSE FOOD CROP: Rhubarb
18
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INDOOR RESIDENTIAL: Ornamental herbaceous plants
1 ' ' ' ' . •: ' .•• ••'.'••'
. * * - " . a
The following uses of Gibberellic Acids do not have a tolerance (40 CFR
180.224) or an exemption from tolerance (40 CFR 180.1098). The Agency plans
to propose such an exemptionln the Winter of 1996 and, pending public comment,
issue a final rule in the,Sping of 1996.
Carrots
Peas
Cucurbits*
* Certain specific crops are currently covered by 40 CFR 180.1098.
Pears
Small grains*
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for
Gibberellic Acids. Where labeling revisions are imposed, specific language is set forth
in Section V of this document.
1. Tolerance Reassessment
The Agency plans to propose to exempt many plant growth regulators from
the requirement of a tolerance including Gibberellic Acids [i.e., Gibberellic Acid
(GA3), Gibberellins (a mixture of GA4+GA7), and Potassium Gibberellate] in the
Winter of 1996. This proposed tolerance exemption will exempt the; plant
regulators from the requirements of a tolerance when applied to growing crops (all
RACs) at application rates not exceeding 250 grams a.i./acre/year. This proposed
exemption is based on the plant regulator's low use rate, natural exposure in the
diet from numerous plant food sources, minimally anticipated increase in dietary
exposure over the naturally occurring exposure in the diet when using the
maximum label rates, and low mammalian toxicity. Pending public comment, the
Agency anticipates issuing a final rule regarding this tolerance exemption in the
Spring of 1996.
2. Endangered Species Statement
Based on the current use patterns, the potential for adverse effects to
endangered plant and animal species from applications of Gibberellic Acids is not
expected.
3. Labeling Rationale
• , - • - .'•'."*
Precautionary Labeling:
The Agency has reexamined the lexicological data base for Gibberellic
19
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Acids and concluded that the current precautionary labeling (i.e. Signal Word,
Statement of Practical Treatment, and other label statements associated with
mitigating risks) adequately mitigate the risks associated with the use of this plant
regulator.
Workers Protection Requirements:
The 1992 Worker Protection Standards for Agricultural Pesticides (WPS)
established certain worker-protection requirements (personal protective equipment,
restricted entry intervals, etc.) to be specified on the label of all products that
contain uses within the scope of WPS, Uses within the scope of the WPS include
all commercial (non-homeowner) and research uses on farms, forests, nurseries,
and greenhouses that produce agricultural plants (including food, feed, and fiber
plants, trees, turf grasses, flowers, shrubs, ornamental, and seedlings). Uses within
the scope include not only uses on plants, but also uses on soil or planting medium
that the plants are (or will be) grown in.
At this time some of the registered uses of Gibberellic Acids are within the
scope of the WPS. Those that are outside the scope of WPS include use:
* on plants grown for other than commercial or research purposes, which
may include plants in habitations, home fruit and vegetable gardens, and
home greenhouses,
* on plants that are in ornamental gardens, parks golf courses, and public or
private lawns grounds and that are intended only for decorative or
environmental benefit. (However, pesticides used on sod farms ARE
covered by WPS).
* in a manner not directly related to the production of agricultural plants,
including, for example; control of vegetation along rights-of-way, in
hedgerows and fencerows and other noncrop areas.
Any product whose labeling reasonably permits use in the production of an
agricultural plant on any farm, forest, nursery, or greenhouse must comply with
the labeling requirements of PR Notice 93-7, "Labeling Revisions Required by the
Worker Protection Standards WPS)". The labeling statements required by PR
Notice 93-7 and .93-11 are to be on the product label exactly as instructed in those
notices.
On April 25,1995, the Agency established a policy that allows registrants
to reduce the interim WPS restricted entry interval (REI) from 12 hours to 4 hours
for certain low risk pesticides. This policy identifies the Gibberellic Acids as
•candidates eligible for a reduced WPS REI. The procedures for requesting a
2p
-------
reduction in me REI are outlined in Section V.
Personal Protective Equipment (PPE);
All PPE labeling requirements for products containing Gibberellic Acids
were established using.the process described in PR Notice 93-7 br more recent
EPA guidelines.
At mis time some of the registered use of Gibberellic Acids are within the
scope of WPS while others are not. The PPE requirements will pertain to both the
WPS and non-WPS uses, because the potential exposure for WPS and non-WPS
uses are similar. This RED will not impose any changes to the PPE WPS labeling
requirements established in PR Notices 93-7 and 93-11.
Restricted-Entry Intervals (REI):
Under the WPS, interim RET s for all uses within the spope of the WPS
were established on the basis of the acute mammalian toxicity of the active
ingredient. The toxicity categories of the active ingredient for acute dermal
toxicity, eye irritation potential, and skin irritation potential were used to
determine the interim WPS REI. If one or more of the active ingredient's toxicity
categories is classified as toxicity category I, the interim WPS REI is established
at48 hours. If none of the acute toxicity effects are in category I, but one or more
of the three is classified as category n, the interim WPS REI is established at 24
hours. If none of the three acute toxicity effects are in category I or n, the interim
WPS REI is established at 12 hours. The interim WPS REI for Gibberellic Acids
is 12 hours, since the acute mammalian toxicity is in Toxicity Categories HI and
IV. In certain instances, the Agency has determined that the interim REI of 12
hours may be reduced to 4 hours for pesticides with low acute toxicities (i.e.
products with acute mammalian toxicities in categoriesm and IV.). ,
The interim Worker Protection Standard (WPS) Restricted-Entry Interval
(REI) for Gibberellie Acids was established at 12 hours, based on acute
mammalian toxicity. However, the Agency has determined that an interim REI of
12 hours may, in certain circumstances, be reduced to 4 hours for pesticides with
low acute mammalian toxicities in Toxicity Categories HI and IV. The Gibberellic
Acids are candidates for reduced interim REI's due to their very low acute
toxicities (i.e., Toxicity Categories HE and IV). The procedure for requesting a
reduction hi the REI is specified in Section V.
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistration
21
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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 Gibberellic Acids for
the above eligible uses has been reviewed and determined to be substantially
complete. At this time no additional data are being required. However, the Agency
is requiring that a revised Confidential Statement of Formula (CSF) and revised
product labeling be submitted within eight months of the issuance of this document
for all products.
* 2. Labeling Requirements for-Manufacturing-Use Products
At this time, no additional labeling requirements are being
imposed on manufacturing use products containing Gibberellic
Acids as an active ingredient.N
B. End-Use Products
1. Additional Product-Specific Data Requirements
4 -
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 data base supporting the reregistration of the above eligible end
uses of Gibberellic Acids is substantially complete, and no additional product
specific data is being required at this time. However, the Agency is requiring that
a revised CSF arid revised product labeling be submitted within 8 months of the
issuance of this document for all products.
2. Labeling Requirements for End-Use Products
Worker Protection Standard: -
Personal Protective Equipment (PPE):
Using the tests in PR Notices 93-7 and 93-11 that establish minimum
(baseline) requirements for PPE, your product label must bear the appropriate
precautionary language relating to PPE. Because some of the registered uses of
Gibberellic Acids are within the scope of the WPS and some are not, the minimum
(baseline) requirements will pertain to both the WPS and nonWPS uses, because
die potential exposure is similar. .
22
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Restricted-Entry Interval (RET): ,
The interim WPS REI for Gibberellic Acids is 12 hours, which is based on
the acute mammalian toxicity. The Agency has determined that the interim REI of
12 hours may, in certain circumstances, be reduced to 4 hours for pesticides with
low acute mammalian toxicities (i.e. products with acute mammalian toxicities in
Categories HI and" IV),.
Registrants of products containing Gibberellic Acids who wish their
product to be considered a candidate for a REI reduction from 12 hours to 4
hours must notify the Agency. For each product, the following information
must be submitted:
1. An application for Reregistration (EPA Form 8570-1).
2. One copy of the current product label, clearly marked to highlight the
, interim WPS REI. . .
' *,.„./ , .'':. ' , . ' - .
3. Two copies of the revised label, clearly marked to highlight the revised
WPS REI.
4. The following certification statement:
"I certify that this notification is complete in accordance with the provisions
of the Agency's reduced REI Policy and that no other changes have been
made to the labeling or confidential statement of formula of this product.
I further understand that if this notification does not comply with the terms
of the Agency' s reduced RET Policy, this product may be in violation of the
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and I may be
subject to enforcement action and penalties under Sections 12 and 14 of
FIFRA. I understand that the Agency may direct a change in the REI of a
product if the Agency determines that a change is appropriate, and that
products may be subject to regulatory and enforcement action if the
appropriate changes are not made."
Notifications should be sent to:
ByUoS.Mail:
Document Processing Desk (WPS:95-1)(BPPD)
Office of Pesticide Programs (7504W)
- Environmental Protection Agency
401 M Street, S.W.
Washington, DC 20460-0001
23
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By Express:
Document Processing Desk (WPS:95-1)(BPPD)
Office of Pesticide Programs (7504W)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
C. 'Existing Stocks
I L""1 • ' i
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 on a 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 Gibberellic
Acids products bearing old labels/labeling for 26 months from the date of issuance of this
RED. Persons other than the registrant may distribute or sell such products for 50 months
from the date of the issuance of this RED. Registrants and persons other than registrants
remain obligated to meet pre-existing Agency imposed label changes and existing stocks
requirements applicable to products they sell or distribute.
24
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VI. APPENDICES
25 .
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case Gibberellic Acid covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to Gibbereliic Acid in all products,
including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in which
they appear in 40 CFR Part 158. the reference numbers accompanying each test refer to the test
protocols set in the Pesticide Assessment Guidelines, which are available from the National
Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial nonfood
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
I Forestry
K Residential
L Indoor food
M Indoor non-food ',-.','•
N Indoor medical
Q Indoor residential
1 > • ' • •. ' ' .'•'-.'.'-.
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.
Ill
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PHYSICAL AND CH
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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 loan article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. 'The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a
single study. .
IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six^digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4(d)(4) below for further explanation). In a few
cases, entries added to the bibliography late in the review may be preceded by a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is needed.
FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description.of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
''-„ .first submitter as the author.
b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
the date from the evidence contained in the document. When the date appears
as (19??*), the Agency was unable to determine or estimate the date of the
document.
c. Titie. In some cases, it has Seen necessary for the Agency bibliographers to
create or enhance a document tide. Any such editorial insertions are contained
'••'•••.'. . : - - •• 115 . , :':.' ..-"'- ' '• '.'-'
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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.
116
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BIBLIOGRAPHY
MRBD
CITATION
00121075 Fink, R.; Reno, F. (1973) Eight-day Dietary LCSO-Bobwhite Quail:
Gibbereffic Acid: Project No. 375-126. Final rept. (Unpub-
lished study received May 22, 1974 under 275-12; prepared by
Hazleton Laboratories, Inc., submitted by Abbott Laboratories,
North Chicago, IL; CDL:023029-A)
40155201 Lehrer, S. (1986) Evaluation of the Effects of Orally Administered
Gibberellic Acid on the Embryonic and Fetal Development of the
Rat (Segment H, TFR): Laboratory Project ID: TA86-014. Unpub-
lished study prepared by Abbott Laboratories. 61 p.
40261601 Diehl, M. (1987) SalmoneUa/Mammalian Microsome Mutagenicity Test
(Ames Test) of Gibberellic Acid: Lab Project ID: T87-109. Un- ..
published study prepared by Abbott Laboratories, Pharmaceutical
Products R&D. 27 p.
40261603 Cifone, M. (1986) Evaluation of Gibberellic A3 (Acid Gibberellic)
in the Rat Primary Hepatocyte Unscheduled DNA Synthesis Assay:
Lab Project ID: 20991. Unpublished study prepared by Hazleton
Biotechnologies Co. 27 p.
40746801 Lehrer, S. (1986) Evaluation of the Effects of Orally Administered
Gibberellic Acid on the Embryonic and Fetal Development of the
Rat: Supplemental Volume: Laboratory Project ID TA86-014. Unpu-
bh'shed study prepared by Abbott Laboratories. 96 p.
x - ' . p
40779301 Kenney, D. (1988) Gibberellic Acid (GAS): Product Chemistry:
Project ID. 8/88-03. Unpublished study prepared by Abbott
Laboratories, Inc. 15 p.
40872801 Terrill, J. (1988) Acute Inhalation Toxicity Study with Gibberellic
Acid (GA3) in the Rat: Project ID: HLA Study No. 375-140. Unpu-
blished study prepared by Hazleton Laboratories America, Inc.
34p. <
40872802 Glaza, S. (1988) Primary Eye Irritation Study of Gibberellic Acid
(GAS) in Rabbits: Project ID: HLA 80602321. Unpublished study
prepared by Hazleton Laboratories America, Inc. 32 p.
40872803 Glaza, S. (1988) Primary Dermal Irritation Study of Gibberellic
Acid (GAS) in Rabbits: Project ID: HLA 80602322. Unpublished
study prepared by Hazleton Laboratories America, Inc. 23 p.
117
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BIBLIOGRAPHY
MRID
CITATION
- 40873201 Glaza, S. (1988) Acute Oral Toxicity,Study of Gibberellins A4A7
(GA4A7) in Rats: Project ID: HLA 80602323. Unpublished study
prepared by Hazleton Laboratories America, Inc. 25 p.
- 40873202 Glaza, S. (1988) Acute Dermal Toxicity Study of Gibbereliins A4A7
(GA4A7) in Rabbits: Project No. HLA 80602324. Unpublished study
prepared by Hazleton Laboratories America, Inc. 28 p.
- 40873203 Terrill, J. (1988) Acute Inhalation Toxicity Study with Gibbere-
llins A4A7 (GA47A) hi the Rat: Project No. HLA Study No.
375-141. Unpublished study prepared by Hazleton Laboratories
America, Inc. 33 p.
- 40873204 Glaza, S. (1988) Primary Eye Irritation Study of Gibberellins A4A7
(GA4A7) in Rabbits: Project ID: HLA 80602326. Unpublished study
prepared by Hazleton Laboratories America, Inc. 32 p.
- 40873205 Glaza, S. (1988) Primary Dermal Irritation Study of Gibberellins
A4A7 (GA4A7) in Rabbits: Project ID: HLA 80602325. Unpublished
study prepared by Hazleton Laboratories America, Inc. 23 p.
- 40873206 Glaza, S. (1988) Dermal Sensitization Study of Gibberellins A4A7
(GA4A7) hi Guinea Pigs (Maximization Test): Project ID: HLA
80602327. Unpublished study prepared by Hazleton Laboratories
America, Inc. 38 p.
- 40873207 Lawlor, T. (1988) Salmonella/Mammalaian-Microsome Plate Incorpora-
tion Mutagenicity Assay (Ames Test) with Confirmatiry Assay.
Unpublished study prepared by Microbiological Associates, Inc.
62 p.
- 40873208 Putman, D. (1988) Micronucleus Cytogenetic Assay in Mice: Gibberel-
lins: Project No. T8201.122. Unpublished study prepared by
Microbiological Associates, Inc. 28 p.
- 40873209 Curren, R. (1988) Unscheduled DNA Synthesis Assay in Rat Primary
Hepatocytes with a Confirmatory Assay: Project ID: T8201.380009.
Unpublished study prepared by Microbiological Associates, Inc.
33p.
- 40917601 Kenney, D. (1988) Gibberellic Acid (GA3): Product Chemistry. Un-
published study prepared by Abbott.LabOratories. 149 p.
- 40917602 Kenney, D. (1988) Gibberellic Acid (GAS): Product Chemistry. Un-
118
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BIBLIOGRAPHY
MRID
CITATION
• • • '
published study prepared by Abbott Laboratories. 147 p.
41143201 Kenwood, S. (1989) Teratology Study with Gibberellins A4A7 (GA4 A7)
in Rabbits: Project ID: HLA 6161-111. Unpublished study pre-
pared by Hazleton Laboratories America, Inc. 172 p.
41560406 Kreuzmann, J. (1990) Delayed Contact Hypersensitivity Study in
Guinea Pigs of: Pro-Gibb 10%: Lab Project Number: 90-4049-21.
Unpublished study prepared by Hill Top Biolabs, Inc. 63 pi
41591103 Shults, S. (1990) Acute Oral Toxicity Study in Rats with ABG-3123:
Lab Project Number: 90-0142. Unpublished study prepared by Ri-
cerca, Inc. 29 p.
• - • i- % • " ' . '.'.-•'
' r * ' - "
41591104 Shults, S. (1990) Acute Dermal Toxicity Study in Albino Rabbits
with ABG-3123: Lab Project Number: 90-0143. Unpublished study
prepared by Ricerca, Inc. 24 p.
41591105 Biesemeier, J. (1990) Acute Inhalation Toxicity Study of ABG-3123
in Sprague-Dawley Rats: Lab Project Number: 90.0002.006. Unpub-
lished study prepared by Food and Drug Research Laboratories.
67 p.
41591106 Shults, S. (1990) Primary Eye Irritation Study in Albino Rabbits
with ABG-3123: Lab Project Number: 90-0144. Unpublished study
prepared by Ricerca, Inc. 29 p.
41591107 Shults, S. (1990) Primary Dermal Irritation Study in Albino Rabbits
with ABG-3123: Lab Project Number: 90-0145. Unpublished study
prepared by Ricerca, Inc. 21 p.
41605803 Glaza, S. (1989) Primary Eye Irritaion Study of GIB Technical in
Rabbits: Final Report: Lab Project Number: HLA 90305642. Unpub-
lished study prepared by Hazleton Laboratories America, Inc. 30
41605804 Glaza, S. (1989) Primary Dermal Irritation Study of GIB Technical
in Rabbits: Final Report: Lab Project Number: HLA 90305640. Un-
published study prepared by Hazleton Laboratories America, Inc.
22 p.
41616601 MacKenzie, K. (1990) 13-Week Dietary Toxicity Study with Gibbere-
llins A4A7 in Rats: Lab Project Number: HLA 6161/114. Unpub-
lished study prepared by Hazleton Laboratories America, Inc.
457 p.
' . • . • - . - (
' .'••"" ..-•' 119 -' . ...;. "-. ,
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MRID
BIBLIOGRAPHY
CITATION
41617501 Auletta, C. (1990) A Subchronic (3 Month) Oral Toxicity Study in
the at with Gibberellic Acid (GA 3) via Dietary Admixture: Lab
Project Number: 89-3472. Unpublished study prepared by Bio/-
dynamics Inc. 591 p.
42084401 Campbell, S. (1991) Gibberellic Acid Technical Material Code 33690
(Encapsulated) An Acute Oral Toxicity Study with the Northern
Bobwhite: Lab Project Number: 161-121. Unpublished study pre-
pared by Wildlife International, Ltd. 19 p.
42084402 Ward, T. (1991) Acute Toxicity of Gibberellic Acid to the Daphnid,
Daphnia magna: Lab Project Number: 91139-A. Unpublished study
prepared by EnviroSystems Division of Resource Analysts, Inc.
and FLI Environmental Services. 37 p.
42167401 Boeri, R. (1991) Acute Toxicity of Gibberellic Acid to the
Rainbow Trout, Oncorhynchus mykiss: Lab Project Number:
91138-A. Unpublished study prepared by Resource Analysts, Inc.
41 p.
42250901 Shults, S. (1991) Acute Oral Toxicity Study in Rats with
Gibberellic Acid Technical Material: Lab Project Number:
90-0329: 3680-90-0329-TX-002. Unpublished study prepared by
Ricerca, Inc. 39 p.
42250902 Shults, S. (1991) Acute Dermal Toxicity Study in Albino Rabbit
with Gibberellic Acid Technical Material: Lab Project Number:
90-0330. Unpublished study prepared by Ricerca, Inc. 23 p.
• 43045601 Rosebery, G. (1993) Product Chemistry for Green Sol 48: Lab
Project Number: GS48PC/1: GS48/PC/1. Unpublished study
prepared by International Regulatory Consulting. 67 p.
• 43370201 Palmer, S.; Beavers, J. (1994) Gibberellic Acid: An Acute
Contact Toxicity Study with the Honey Bee: Final Report: Lab
Project Number: 393-101. Unpublished study prepared by
Wildlife International Ltd. 14 p.
\
- 43376601 Rojas, F. (1994) Physical and Chemical Properties: Stability
of Gibberellic Acid Technical Grade Active Ingredient and
End-use Material: Addendum to Report 18-593-62: Lab Project
Number: 87-2559-62. Unpublished study prepared by Abbott Labs.
17 p.
120
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BIBLIOGRAPHY
MRID
CITATION
43376602 Palmer, S.; Beavers, J. (1994) Gibberellin A3: An Acute Contact
Toxicity Study with the Honey Bee: Lab Project Number: 161-127.
Unpublished study prepared by Wildlife International, Ltd. 19
'• p • ' •. • '"- .- •" •• ' •- -; •
43401201 Rojas, F. (1994) Analysis of Five Lots of Gibberellic Acid
Technical Grade Active Ingredient and End-use Material: Lab
Project Number: 92-2668-62: 18-593-62. Unpublished study
prepared by Abbott Laboratories. 37 p.
94280022 Cozzi, E. (1990) Abbott Laboratories Phase 3 Summary of MRID
40261603. Genotoxicity Study (Unscheduled DNA Synthesis Assay)
with Gibberellic Acid (GAS) Hazleton Project No. 20991.
Prepared by Hazleton Biotechnologies, Inc. 9 p.
94280023 Cozzi, E. (1990) Abbott Laboratories Phase 3 Summary of MRID
40873207. Genotoxicity Study (Ames Salmonella Assay) with
Gibberellins A4A7 (GA4A7): MBA Study No. T8201.501014. Prepared
, by Microbiological Associates, Inc. 8 p.
94280024 Cozzi, E. (1990) Abbott Laboratories Phase 3 Summary of MRID
40873208. Genotoxicity Study (Mouse Micronucleus Assay) with
Gibberellins A4A7 (GA4A7): MBA Study "No. T8201.122. Prepared by
Microbiological Associates, Inc. 8 p.
94280025 Cozzi, E. (1990) Abbott Laboratories Phase 3 Summary of MRID"
40873209. Genotoxicity Study (Unscheduled DNA Synthesis Assay)
with Gibberellins A4A7 (GA4A7): MBA Study No. T8201.380009.
Prepared by Microbiological Associates, Inc. 8 p.
121
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The following is a list of available documents for Gibberellic Acid that my farther assist you
in responding to this Reregistration Eligibility Decision document.. These documents may be
obtained by the following methods:
Electronic
File format:
1.
Portable Document Format (.PDF) Requires Adobe® Acrobat or compatible
reader: Electronic copies 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.GOVr or using WWW (World Wide Web) on
WWW.EPA.GOV., or contact at (703)-.
PR Notice 86-5. ,'..'"'
2. PR Notice 91-2 (pertains to the Label Ingredient Statement).
3. A full copy of this RED document.
4. A copy of the fact sheet for Gibberellic Acid.
The following documents are part of the Administrative Record for Gibberellic Acid
and may included in the EPA's Office of Pesticide Programs Public Docket. Copies of these
documents are not available electronically, but may be obtained by contacting the person listed
on the Chemical Status Sheet.
1.Health and Environmental Effects Science Chapters.
2.Detailed Label Usage Information System (LUIS) Report.
The following Agency reference documents are not available electronically, but may be
obtained by contacting the person listed on the .Chemical Status Sheet of mis RED document.
1. The Label Review Manual.
2. EPA Acceptance Criteria
122
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