United States
Environmental Protection
Agency
Prevention, Pesticides
And.Toxic Substances
(7508W)
EPA-738-F-96-016
August 1996
R.E.D. FACTS
Cryolite
Pesticide
Reregistration
Use Profile
Regulatory
History
All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can be
used without posing unreasonable risks to people or the environment.
Because of advances in scientific knowledge, the law requires that
pesticides which were first registered 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
any 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 0087, cryolite.
Cryolite is an insecticide used on many fruits, vegetables and
ornamental crops to protect against leaf eating pests. Currently, the
predominant uses are on grapes, potatoes and citrus. Cryolite is formulated
as dusts, wettable powders and water dispersable granulars and can be
applied by ground or air equipment. Multiple applications at high rates are
typical. The highest single application rate is 30 Ibs/acre on citrus and
ornamentals; the highest seasonal rate from multiple applications is 154
Ibs/acre on lettuce. Cryolite is a naturally occurring mineral that is also
synthetically produced.
Cryolite was first registered as a pesticide in the U.S. in 1957. EPA
issued a 1983 Guidance Document and a superseding 1988 Registration
Standard requiring environmental, toxicological and residue data needed to
determine cryolites reregistration eligibility. A 1990 Data Call-in required
additional product-specific data.
Currently, four cryolite products are registered.
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Human Health
Assessment
Toxicity
Li studies using laboratory animals, cryolite generally has been shown
to be slightly to practically non-toxic on an acute basis. The acute dermal
LD50 in rats is 2.1 g/kg, placing cryolite in Toxicity Category m (the
second lowest of four categories) for this effect. Cryolite is considered a
moderate irritant based on eye irritation studies and classified in Toxicity
Category IV for acute oral exposure, acute inhalation and skin irritation.
Cryolite is classified as a non-sensitizer based on dermal sensitization tests
conducted with Guinea pigs.
Cryolite has been classified as a Group "D" chemical, "not classifiable
as to human carcinogenicity". It has been the subject of a comprehensive
review by the National Research Council (National Academy of Sciences
Subcommittee of Health Effects of Ingested Fluoride) who concluded that
"...the available data are insufficient to demonstrate a carcinogenic effect of
fluoride in animals." and that "..the weight-of-evidence from more than 50
epidemiological studies does not support the hypothesis of an association
between fluoride exposure and increased cancer risk in humans." The
Agency is in agreement with the conclusion reached by the National
Academy of Sciences.
Dietary Exposure
People may be exposed to residues of cryolite through the diet.
Tolerances or maximum residue limits have been established for the
fluorine compounds cryolite and synthetic cryolite in or on raw agricultural
commodities. These include a regional registration tolerance for kiwi-fruit
and a time-limited tolerance to expire May 6, 1996, on potatoes. EPA has
reassessed the cryolite tolerances and found that some are acceptable,
others must be revoked because the registrants have chosen not to support
the uses; and based on new data, tolerances will be proposed/established for
cabbage, citrus, collards, eggplant, lettuce (head and leaf), peaches,
potatoes and tomatoes. Food additive tolerance increases must be proposed
for raisins and tomato paste, and data must be submitted to determine
appropriate food additive tolerance levels for prunes. The Agency has
completed its review of the data needed to establish a permanent tolerance
for potatoes. The Agency will propose in the Federal Register permanent
tolerances for potatoes at 2 ppm and potato waste at 22 ppm.
EPA has assessed the dietary risk posed by cryolite. A qualitative
dietary risk assessment was performed to include the daily intake of
fluoride from other sources, i.e. fluorinated public water sources. The
Agency concluded that levels of fluoride in/on food from the agricultural
use of cryolite plus fluoride levels in U.S. drinking water supplies results in
a high-end daily dietary intake of fluoride of approximately 0.085
mg/kg/day. This is less than the Agency's determined Maximum
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Environmental
Assessment
Additional Data
Required
Product Labeling
Changes
Required
Regulatory
Conclusion
Concentration Limit Goal (MCLG) of 4.0 mg/L [0.114 mg/kg/day], a level
which provides no known or anticipated adverse health effects. The MCLG
has been reviewed and is supported by the Surgeon General.
Acute risk is not expected to birds, mammals, aquatic organisms or
beneficial insects from exposure to cryolite. Chronic ecological risk also is
not expected because, in the presence of sufficient water, cryolite is quickly
converted to near natural background levels of simple inorganic compounds
containing its constituent elements (sodium, aluminum, fluorine). Once
cryolite dissolves and penetrates to shallow depths in soil or is transported
to natural waters, any minor chemical imbalances caused by its insecticidal
application are offset by the mineral buffering capacity of the environment
and/or self-correcting agricultural practices (such as calcium applications
and pH adjustments to the soil). Ground or surface water effects should be
negligible.
EPA is requiring the following additional generic studies for cryolite
to confirm its regulatory assessments and conclusions: Magnitude of the
residue in field grown cranberries and plums. Before determining the
eligibility of cryolite for use on strawberries EPA is requiring a generic
study on the magnitude of the residue in field grown strawberries. The
Agency also is requiring product-specific data including product chemistry
and acute toxicity studies, revised Confidential Statements of Formula
(CSFs), and revised labeling for reregistration.
All cryolite end-use products must comply with EPA's current
pesticide product labeling requirements. Some of the required labeling are:
Worker Protection restrictions that include 12 hour restricted entry intervals
and the minimal early entry personal protective equipment requirements;
user safety recommendations; environmental hazards statement prohibiting
application or contamination of water or intertidal areas; spray drift
precautions. For a comprehensive list of labeling requirements, please see
the cryolite RED document.
EPA has determined that the following uses of cryolite have been
supported and are eligible for reregistration: broccoli, Brussels sprouts,
cabbage, cauliflower, citrus fruits, collards, cranberries, cucumbers,
eggplant, grapes, kohlrabi, lettuce (leaf and head), melons, peaches,
peppers, plums (fresh prunes), pumpkins, squash (winter and summer),
tomatoes, kiwi, potatoes, ornamental herbaceous plants, ornamental
nonflowering plants, ornamental woody shrubs and vines and shade trees.
The use on strawberries is being supported but there are no residue data at
this time upon which to base an eligibility decision. The Agency will
evaluate the eligibility of this use after the data are submitted and reviewed.
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The use of eligible cryolite products in accordance with labeling specified
in this RED will not pose unreasonable adverse effects to humans or the
environment. These products will be reregistered once the required product
specific data, CSFs, and revised labeling are received and accepted by EPA.
Products which contain active ingredients in addition to cryolite will be
reregistered when all of their other active ingredients also are eligible for
reregistration.
There are several currently registered uses for cryolite that are not
being supported and their tolerances are being proposed for revocation:
apples, apricots, beans, beets (roots and tops), blackberries, boysenberries,
carrots, corn, dewberries, kale, loganberries, mustard greens, nectarines,
okra, peanuts, pears, peas, quinces, radishes (roots and tops), turnips (roots
and tops) and youngberries.
For More
Information
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for cryolite 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 fact sheet can be downloaded
from the Pesticide Special Review and Reregistration Information System
at 703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPAGOV, or using ftp onFTP.EPA.GOV, or using
WWW (World Wide Web) on WWW.EPA.GOV.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fax 513-489-8695.
Following the comment period, the cryolite 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 cryolite RED, or reregistration of individual products containing
cryolite, please contact the Special Review and Reregistration Division
(7508W), OPP, US EPA, Washington, DC 20460, telephone
703-308-8000.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
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free 1-800-858-7378, between 9:30 am and 7:30 pm Eastern Standard
Time, Monday through Friday.
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I
\
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES AND
TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
J 0 1996
I am pleased to announce that the Environmental Protection Agency has
completed its reregistration eligibility review and decisions on the pesticide chemical
case #0087 which includes the active ingredient cryolite. The enclosed Rereaistration
Eligibility Decision (RED) contains the Agency's evaluation of the data base of this
chemical, its conclusions of the potential human health and environmental risks of the
current product uses, and its decisions and conditions under which these uses and
products will be eligible for reregistration. The RED includes the data and labeling
requirements for products for reregistration. It also includes requirements for
additional data (generic) on the active ingredient to confirm the risk assessments.
To assist you with a proper response, read the enclosed document entitled
"Summary of Instructions for Responding to the RED." This summary also refers to
other enclosed documents which include further instructions. You must follow all
instructions and submit complete and timely responses. The first set of required
responses is due 90 days from the date of receipt of this letter. The second set of
required responses is due 8 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.
Please note that this RED was finalized and signed prior to August 3, 1996. On
that date, the Food Quality Protection Act of 1996 ("FQPA") became effective,
amending portions of both the pesticide law (FIFRA) and the food and drug law
(FFDCA). This RED does not address any issues raised by FQPA, and any tolerance-
related statements in the RED did not take into account any changes in tolerance
assessment procedures required under FQPA. To the extent that this RED indicates
that a change in any tolerance is necessary, that determination will be reassessed by
the Agency under the standards set forth in FQPA before a proposed tolerance is
issued. To the extent that the RED does not indicate that a change in a tolerance is
necessary, that tolerance too will be reassessed in the future pursuant to the
requirements of FQPA.
Recycled/Recyclable • Printed with Vegetable Oil Based Inks on 100% Recycled Paper (40% Postconsumer)
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If you have questions on the product specific data requirements or wish to meet
with the Agency, please contact the Special Review and Reregistration Division
representative Jeff Biliinglea at (703) 308-8004. Address any questions on required
generic data to the Special Review and Reregistration Division representative Dana
Lateuiere at (703) 208-8044.
Sincerely yours,
Lois Rossi, Director
Special Review
and Reregistration Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1. DATA CALL-IN (DO) OR "90-DAY RESPONSE"-If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data
are required, a DCI letter will be enclosed listing such requirements. If both generic and
product specific data are required, a combined Generic and Product Specific DCI letter will
be enclosed describing such data. However, if you are an end-use product registrant only and
have been granted a generic data exemption (GDE) by EPA, you are being sent only the
product specific response forms (2 forms) with the RED. Registrants responsible for generic
data are being sent response forms for both generic and product specific data requirements (4
forms). You must submit the appropriate response forms (following the instructions
provided) within 90 days of the receipt of this RED/DCI letter; otherwise, your product
may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER REQUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for time extensions for product specific data
should be submitted in the 90-day response. Requests for data waivers must be submitted as
part of the 90-day response. All data waiver and time extension requests must be accompanied
by a full justification. All waivers and time extensions must be granted by EPA in order to go
into effect.
3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPQNSE"-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 hi 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).
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d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.
e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOHCE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5. WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
ByU.S.Mail;
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
Cryolite
CASE 0087
LIST A
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
CRYOLITE REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
H. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Estimated Usage of Pesticide 3
D. Data Requirements 5
E. Regulatory History 5
HI. SCIENCE ASSESSMENT 6
A. Physical Chemistry Assessment 6
B. Human Health Assessment 7
1. Toxicology Assessment 7
a. Acute Toxicity 7
b. Subchronic Toxicity 8
c. Chronic toxicity/Carcinogenicity 9
d. Developmental Toxicity 11
e. Reproductive Toxicity 13
f. Mutagenicity 13
g. Metabolism 14
h. Dose Response Assessment 14
i. Reference Dose 14
2. Exposure Assessment 17
a. Dietary Exposure 18
b. Occupational and Residential 26
3. Risk Characterization 27
a. Dietary .: 27
b. Occupational 29
C. Environmental Assessment 29
1. Ecological Toxicity Data 29
a. Toxicity to Terrestrial Animals 29
b. Toxicity to Aquatic Animals 31
c. Toxicity to Plants 33
2. Environmental Fate 34
a. Environmental Fate Assessment 34
b. Environmental Fate and Transport 34
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3. Exposure and Risk Characterization 39
a. Ecological Exposure and Risk Characterization. 39
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 43
A. Determination of Eligibility 43
B. Determination of Eligibility Decision. 44
1. Eligibility Decision 44
2. Eligible and Ineligible Uses 44
C. Regulatory Position 45
1. Tolerance Reassessment 45
2. Tolerance Revocations and Import Tolerances 48
3. Restricted Use Classification 48
4. Reference Dose and Cancer Classification 49
5. Endangered Species Statement 49
6. Spray Drift Advisory 50
7. Environmental/Ecological Effects 50
8. Occupational/Residential Labeling Rationale/Risk Mitigation .. 50
V. ACTIONS REQUIRED OF REGISTRANTS 52
A. Manufacturing-Use Products 52
1. Additional Generic Data Requirements 52
2. Labeling Requirements for Manufacturing-Use Products 53
B. End-Use Products 54
1. Additional Product-Specific Data Requirements 54
2. Labeling Requirements for End-Use Products 54
a. Occupational/Residential Protection 54
b. Other Labeling Requirements 56
c. Spray Drift Labeling 57
C. Tolerance Revocation and Import Tolerances 59
D. Existing Stocks 60
VI. APPENDICES 61
APPENDIX A. Table of Use Patterns Subject to Registration 62
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 88
APPENDIX C. Citations Considered to be Part of the Data Base Supporting
the Reregistration of Cryolite 95
APPENDIX D. Combined Generic and Product Specific Data Call-in .. 108
Attachment 1. Chemical Status Sheets 130
Attachment 2. Combined Generic and Product Specific Data Call-In
Response Forms (Form A inserts) Plus
Instructions 132
Attachment 3. Generic and Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and
Instructions 137
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Attachment 4.
Attachment 5.
Attachment 6.
APPENDIX E.
EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 144
List of All Registrants Sent This Data Call-in (insert)
Notice 147
Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions.... 148
List of Available Related Documents 157
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CRYOLITE REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Assessment
William Gross
Gabe Patrick
Eric Maurer
Biological Analysis Branch
Biological Analysis Branch
Economic Analysis Branch
Environmental Fate and Effects Assessment
Karen Angulo
Alex Clem
Allen Vaughan
Health Effects Assessment
William Greear
Stephen Funk
John Leahy
Tom Myers
Brian Steinwand
Risk Management Assessment
Marilyn Mautz
Peg Perreault
Dana Lateulere
Science Analysis and Coordination Staff
Environmental Fate and Groundwater Branch
Ecological Effects Branch
Toxicology Branch I
Reregistration Support Chemistry Branch
Occupational and Residential Exposure Branch
Risk Characterization and Analysis Branch
Science Analysis Branch
Insecticide-Rodenticide Branch
Insecticide-Rodenticide Branch
Reregistration Branch
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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
FAO/WHO Food and Agriculture Organization/World Health Organization
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.
HOT Highest Dose Tested
LC50 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.
LDJO 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.
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs.
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
ug/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
ill
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GLOSSARY OF TERMS AND ABBREVIATIONS
NPDES National Pollutant Discharge Elimination System
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 .
RUP , Restricted Use Pesticide
SLN Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect:
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
ug/L Micrograms per liter
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
The U. S. Environmental Protection Agency has completed its reregistration eligibility
decision of the pesticide cryolite. This decision includes a comprehensive reassessment of the
required target data and the use patterns of currently registered products. Cryolite is an
insecticide used on many fruits, vegetables and ornamental crops to protect against leaf eating
pests. Currently, the predominant uses are on grapes, potatoes and citrus. Cryolite is formulated
as dusts, wettable powders, granulars and water dispersable granulars and can be applied by
ground or air equipment. The Agency has concluded that all supported uses, except strawberries,
as prescribed in this document, will not cause unreasonable risks to humans or the environment
and therefore, are eligible for reregistration. Additional residue data are required to confirm the
Agency's risk assessment and conclusions. Additional residue data are required before an
eligibility decision can be made for the use of cryolite containing products on strawberries.
Cryolite was first registered as a pesticide in the U.S. in 1957. EPA issued a 1983
Guidance Document and a superseding 1988 Final Registration Standard and Tolerance
Reassessment (FRSTR) requiring environmental, toxicological and residue data needed to
determine cryolites reregistration eligibility. A 1990 Data Call-in (DCI) required additional
ecological effects, toxicological, residue and product chemistry data.
In studies using laboratory animals, cryolite generally has been shown to be slightly to
practically non-toxic on an acute basis. The acute dermal LD50 in rats is 2.1 g/kg, placing cryolite
in Toxicity Category HI (the second lowest of four categories) for this effect. Cryolite was
considered a moderate irritant in eye irritation studies. Cryolite was classified in Toxicity
Category IV for acute oral exposure, acute inhalation and skin irritation. Cryolite was classified
as a non-sensitizer after dermal sensitization tests were conducted with Guinea pigs.
People may be exposed to residues of cryolite through their diet. Tolerances or maximum
residue limits have been established for the fluorine compounds cryolite and synthetic cryolite
in or on raw agricultural commodities. These include a regional registration tolerance for kiwi-
fruit and a time-limited tolerance to expire May 6, 1996 on potatoes. EPA has reassessed the
cryolite tolerances and found that some are acceptable, others must be revoked because the
registrants have chosen not to support the uses, and new tolerances must be established for
cabbage, citrus, collards, eggplant, lettuce (head and leaf), peaches and tomatoes. Food additive
tolerance (FAT) increases must be established for raisins and tomato paste and data must be
submitted to determine appropriate FAT levels for prunes. The Agency has completed its review
of the data needed to establish a permanent tolerance for potatoes. The Agency will propose in
the Federal Register permanent tolerances for potatoes at 2 ppm and potato waste at 22 ppm.
EPA has assessed the dietary risk posed by cryolite. A qualitative dietary risk assessment
was performed to include the daily intake of fluoride from other sources, i.e. fluorinated public
water sources. The Agency concluded that levels of fluoride in/on food from agricultural use of
cryolite plus fluoride levels in U.S. drinking water supplies results in a high-end daily dietary
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intake of fluoride of approximately 0.085 mg/kg/day. This is less than the Agency's determined
Maximum Concentration Limit Goal (MCLG) of 4.0 mg/L [0.114 mg/kg/day], a level which
provides no known or anticipated adverse health effects. The MCLG has been reviewed and is
supported by the Surgeon General.
Cryolite has been classified as a Group "D" chemical, "not classifiable as to human
carcinogenicity". It has been, the subject of a comprehensive review by the National Research
Council (National Academy of Sciences Subcommittee of Health Effects of Ingested Fluoride)
who concluded that "...the available data are insufficient to demonstrate a carcinogenic effect of
fluoride in animals." and that "..the weight of evidence from more than 50 epidemiological
studies does not support the hypothesis of an association between fluoride exposure and increased
cancer risk in humans." The Agency is in agreement with the conclusion reached by the National
Academy of Sciences.
Acute risk is not expected to birds, mammals, aquatic organisms or beneficial insects from
exposure to cryolite. Chronic ecological risk is also not expected because in the presence of
sufficient water, cryolite is quickly converted to near natural background levels of simple
inorganic compounds containing its constituent elements (sodium, aluminum, fluorine). Once
cryolite dissolves and penetrates to shallow depths in the soil or is transported to natural waters,
any minor chemical imbalances caused by its insecticidal application are offset by the mineral
buffering capacity of the environment and standard agricultural practices (i.e., calcium
applications, pH adjustments to the soil). Ground or surface water effects are expected to be
negligible.
EPA is requiring the following additional generic studies for cryolite to confirm its
regulatory assessments and conclusions: Residue crop field trials for cranberries and plums. The
Agency also is requiring product-specific data including product chemistry and acute toxicity
studies, revised Confidential Statements of Formula (CSFs), and revised labeling for
reregistration. Residue field trials are needed to determine the eligibility of cryolite use on
strawberries.
VI
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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 cryolite. The document consists of six sections. Section I is the
introduction. Section n describes cryolite, its uses, data requirements and regulatory history.
Section M discusses the human health and environmental assessment based on the data available
to the Agency. Section IV presents the reregistration decision for cryolite. Section V discusses
the reregistration requirements for cryolite. Finally, Section VI is the Appendices which support
this Reregistration Eligibility Decision. Additional details concerning the Agency's review of
applicable data are available on request.
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H. CASE OVERVIEW
A. Chemical Overview
The following active ingredient(s) are covered by this Reregistration Eligibility
Decision:
• Common Name: Cryolite
Chemical Name:
Sodium aluminofluoride or sodium aluminum fluoride or
sodium hexafluoroaluminate
Chemical Family: Inorganic fluorine compound.
CAS Registry Number: 15096-52-3
OPP Chemical Code: 75101
Empirical Formula: Na3AlF6
Trade and Other Names: Kryocide®, Prokil®, Cryolite
Basic Manufacturers: Gowan Company and Elf Atochem North America
Inc.
Use Profile
The following is information on the currently registered uses with an
overview of use sites and application methods. A detailed table of the current uses
.of cryolite is in Appendix A. Cryolite is registered for use on Terrestrial Food,
Terrestrial Food and Feed and Terrestrial Non-food sites. Cryolite is
predominantly used by commercial growers and is not registered for greenhouse
use.
Type of Pesticide: Fluorine Insecticide
Use Sites: Terrestrial Food Crops - Cucurbits (melons, cantaloupe, water melon,
pumpkins, all types of squash), fruiting vegetables (eggplant, pepper, broccoli,
Brussels sprouts, cabbage, cauliflower, collards, head and leaf lettuce, kohlrabi),
kiwi (in California only), pears, radish, cranberry and peaches.
Terrestrial Food and Feed Crops - grapefruit, lemon, lime, orange, tangelo,
tangerines, tomatoes, apples, potatoes, beans and grapes.
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Terrestrial Non-food Crops - Ornamental herbaceous plants, ornamental
nonflowering plants, ornamental woody shrubs and vines, ornamental and/or
shade trees.
Target Pests: Cabbage looper, cutworms, corn earworm, spotted cucumber
beetle, diamondback moth, flea beetles, imported cabbage worms, yellow-striped
armyworm, melonworm, pickleworm, citrus cutworm, fruit-tree leafroller, Fuller
rose beetle, garden tortrix, katydids, orange tortrix, orangedog, variegated
cutworm, blue-green citrus root weevil, omnivorous leafroller, grape leaffolder,
Western grapeleaf skeletonizer, grape berry moth, armyworm, tobacco budworm,
pepper weevil, Colorado potato beetle, blister beetles, tomato pinworm, codling
moth, gypsy moth and plum curculio.
Formulation Types Registered:
END USE PRODUCTS
Granular 20.0%
The granular formulation is registered only for Special Local Need uses [24(c)'s]
and is applied as a "mulch-like" bait.
Dust
Wettable powder/dust
Water Dispersable Granules
96.0%
93.0 and 96.0%
93%
Method and Rates of Application: Cryolite products may be applied by
hydraulic ground sprayers and/or aircraft. The maximum single application rate
is 30 Ibs ai/A, applied as a liquid to citrus and ornamentals; the maximum seasonal
application rate from multiple applications is 154 Ibs ai/A, applied as a liquid to
lettuce. See Appendix A for required rates and restrictions.
Timing: For most crops cryolite is applied during the early part of the growing
season when insects are first seen, or their presence is impending. Potato
applications are usually made mid to late season. Grapes are predominantly
treated pre-bloom through the early part of the season. Grape vines may also be
treated post-harvest.
C. Estimated Usage of Pesticide
This section summarizes the best estimates available for the pesticide uses of
cryolite. These estimates are derived from a variety of published and proprietary sources
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available to the Agency. The data, reported on an aggregate and site (crop) basis, reflect
annual fluctuations in use patterns as well as the variability in using data from various
information sources.
The table below summarizes the percent of various U.S. crops treated annually
with cryolite, 1992 - 1994:
Site/1
Apples
Cabbage
Cantaloupes
Cauliflower
Cucumbers
Grapes
Kiwi
Lemons
Lettuce
Oranges
Peaches
Peppers
Potatoes
Squash
Strawberries
Tangerines
Tomatoes
Watermelons
Totals
Acres
Grown/2
(xOOO)
457.1
99.4
111.2
55.3
172.4
757.4
7.1
62.4
269.4
646.2
176.4
118.4
1,379.5
69.0
49.7
23.5
449.7
246.1
Acres
Treated
CxOOO)/3
1-2
1-1
1-1
1-1
1-1
250-475
1-1
1-1
1-4
5-10
1-1
1-1
40-100
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Note: All other sites had either no known usage or no available data. Where data typically exist, there are n o
known usage on beans, broccoli, eggplant, grapefruit, limes, ornamentals, pears, and tangelos; those with
no available data include collards, cranberries, mustard, radishes, and turnip.
D. Data Requirements
Data to support the continuing registration of cryolite were required in the 1983
Registration Standard and in the superseding 1988 Final Registration Standard and
Tolerance Reassessment (FRSTR). Data were required on ecological effects,
environmental fate, residue chemistry, chronic toxicity, oncogenicity and reproduction,
as well as product-specific product chemistry and acute toxicity for both natural and
synthetic cryolite. A 1990 DCI required additional ecological effects, acute and chronic
toxicity, residue and product chemistry data. These data were required to support those
uses listed in the 1983 and 1988 Registration Standards. Appendix B includes all data
requirements identified by the Agency needed to support reregistration of currently
registered uses.
E. Regulatory History
.Cryolite has been registered in the United States since 1957 for use as an
insecticide. A Registration Standard was issued in June 1983 for all pesticide products
containing the active ingredient, cryolite. This document identified the additional generic
data required to support the continued registration of cryolite for terrestrial outdoor food
and non-food uses. The 1983 Registration Standard also specified the product-specific
product chemistry and acute toxicity data required for manufacturing use products. At
the time the 1983 Registration Standard was issued, the Agency's data base for cryolite
was extremely poor and extensive data gaps existed in all disciplines.
The Agency reviewed all of the data submitted in response to the data
requirements outlined in the 1983 Registration Standard and subsequently issued a Final
Registration Standard and Tolerance Reassessment (FRSTR) in April 1988. In the 1988
Registration Standard, the Agency concluded that additional data were required to make
a full assessment regarding the continued registration of all uses of cryolite. Existing data
gaps resulted from a determination that certain submitted studies were unacceptable, and
changes in data status from "reserved" to "required" based on results of lower tier studies,
and/or expanded CFRPart 158 data requirements. A Data Call-in (DCI) for cryolite was
issued in 1990 which required ecological effects and toxicological data and additional
residue data to reassess current tolerances for cryolite.
In response to the DCI and Product and Residue Chemistry Update, the basic
registrants chose not to support certain registered food uses. On March 12, 1996, a
Generic Data Exemption (GDE) revocation letter was sent to the remaining end-use
product registrant, who also opted not to support those same registered food uses.
Amended labels showing the removal of these unsupported uses are required to be
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submitted within sixty days from the date of issuance of this Reregistration Eligibility
Document. The supported and unsupported food uses are listed in Table 17 of this
document This Reregistration Eligibility Decision reflects a reassessment of all data
submitted in response to the Registration Standards for cryolite, as well as assessments
of data recently submitted in response to the DCI and Product and Residue Chemistry
Update.
Eff. SCEENCE ASSESSMENT
A. Physical Chemistry Assessment
Cryolite (sodium aluminum fluoride, sodium aluminofluoride or sodium
hexafluoroaluminate) is a fluorine insecticide which is a naturally occuring inorganic
mineral that can also be produced synthetically. [The human and environmental science
assessments that follow deal predominantly with the effects of fluoride as it was found to
be the main component of concern.]
Structural Formula of Cryolite:
F
3-
(Na\
Empirical Formula:
Molecular Weight:
CAS Registry No.:
OPP Chemical Code:
209.97
15096-52-3
075101
IDENTIFICATION OF ACTIVE INGREDIENT
Natural cryolite is a white, black, purple, or violet crystalline solid with a melting
point of 1009 C; synthetic cryolite is a white crystalline solid with a melting point ranging
from 960-1027 C. Cryolite was found to be soluble in water at a range of 400 - 1200 ppm
(at 25 C), insoluble in alcohol and to decompose in basic (alkaline) environments.
Cryolite's insecticidal mode of action is predominantly as a stomach poison. Cryolite is
formulated as a dusl, water dispersable granule or wettable powder and applied as a liquid
spray or dust. There is also a mulch-like granular formulation applied as a bait for use in
two Special Local Need (SLN) registrations.
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MANUFACTURING-USE PRODUCTS
The Cryolite Reregistration Standard Update (5/16/91) identified two 96%
technical products registered to Elf Atochem North America, Inc. (previously Pennwalt
Corporation; EPAReg. No. 4581-116) and Gowan Company (EPAReg. No. 10163-41).
These products are currently registered as end-use products (EPs). A list of registered
cryolite EPs is presented in Table 1.
Table 1. Registered cryolite
Formulation
96% wettable powder/dust
96% dust
93% wettable powder/dust
93% water-dispersible granules
20% granular/bait
products.
EPA Reg. No.
4581-116
10163-41
5481-132
10163-185
OR95000800
WA95001800
Registrant
Elf Atochem North. America, Inc. a
Gowan Company
Amvac Chemical Corporation
Gowan Company
Gowan Company
a The name of the registrant has changed from Pennwalt Corporation to Elf Atochem North America, Inc. without
change in company number.
B. Human Health Assessment
1. Toxicology Assessment
The available toxicological database for cryolite is adequate and supports
a reregistration eligibility determination for the currently registered uses.
Although fluoride (a component of cryolite) is accumulated at all dose levels in
several subchronic and chronic animal studies, the accumulation itself is not
considered an adverse effect. The LOEL in these studies is based on the biological
effects resulting from the fluoride accumulation.
a. Acute Toxicity
Results of the acute toxicity studies conducted with technical
cryolite are summarized below in Table 2:
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Table 2. Acute Toxicity Values of Technical Cryolite.
Route
Oral1
Dennalb
Inhalation0
Eye Irritation"1
Skin Irritation6
Dermal Sensitizationf
Species
Rat
Rabbit
Rat
Rabbit
Rabbit
Guinea Pig
Results
LD50: >5 g/kg
LD,n: 2.1 g/kg
LC50 >2.06 mg/L
and < 5.03 mg/L
Moderate Irritant
No Effects
Non sensitizer
Toxicity Category
IV
III
IV
III
IV
N/A
•MRID No. 00138096.
* MRID No. 00128107.
< MRID No. 00128107.
'MRID No. 00128106. Not required for TGAI, however, presented here for informational purposes.
* MRID No. 00128106. Not required for TGAI, however, presented here for informational purposes.
*MRID No. 00138097. Not required for TGAI, however, presented here for informational purposes.
Dental fluorosis is noted as an endpoint in several toxicology studies.
Dental fluorosis is defined as a cosmetic mottling of tooth enamel caused by
fluoride or its compounds and is not considered an adverse health effect.
b. Subchronic Toxicity
In a 3-month feeding study in rats, cryolite (96%) was administered to
groups of 40 male and 40 female Charles River Crl:CD(SD)BR rats in the diet at
levels of 0, 50, 5000 or 50,000 ppm (corresponding to 0, 3.8, 399.2 and 4172.3
mg/kg/day in males and 0,4.5,455.9 and 4758.1 mg/kg/day in females). At 5000
ppm and above, the stomachs of male and female rats exhibited thickened walls,
dark contents, raised focal areas, glandular thickened walls, non-glandular light
focal areas, glandular dark focal areas and red glandular areas of the stomach at
necropsy. Histological examination revealed submucosal lymphoid foci,
epidermal hyperplasia, hyperkeratosis/acanthosis, erosion/ulcerations, mucosal
atrophy and chronic submucosal inflammation. Male and female rats at 50,000
ppm exhibited reduced body weights and decreases in hemoglobin and hematocrit
The NOEL is 50 ppm (3.8 mg/kg/day) for effects other than fluoride
accumulation. The LOEL is 5000 ppm (399.2 mg/kg/day) based on lesions
observed in the stomach. Fluoride accumulated at all dose levels (MRID
00158000).
In a 28-day subchronic feeding study, groups of 5 Sprague-Dawley rats/sex
were administered cryolite (97.6%) at dose levels of 0, 250, 500, 1000, 2000,
4000,10,000,25,000 or 50,000 ppm in the diet (representing approximately 0, 25,
50,100, 200, 400, 1000, 2500 and 5000 mg/kg/day). The teeth were whiter and
the enamel became soft and granular at all dose levels and there was a dose-
8
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response relationship. A NOEL was not determined. The LOEL is 250 ppm (25
mg/kg/day) based on dental fluorosis (MRID 00128109).
In a 3-month feeding study in dogs, cryolite (97.3%) was administered to
groups of 7 male and 7 female dogs at 0, 500, 10,000 or 50,000 ppm
(corresponding to 0, 17, 368 and 1692 mg/kg/day). One male and one female
dog/group were interim sacrificed at 45 days. At 50,000 ppm, 'there was decreased
food consumption, body weight, body weight gain and red blood cells (RBC),
hemoglobin (Bgb), hematocrit (HCT), mean corpuscular volume (MCV) and
mean corpuscular hemoglobin (MCH). Fluoride accumulated in bone at all dose
levels. The NOEL is 10,000 ppm (368 mg/kg/day). The LOEL is 50,000 ppm
(1692 mg/kg/day) for effects other than fluoride accumulation. Fluoride
accumulation occurred at all dose levels (MRID 00157999).
In a 21-day subchronic dermal toxicity study, cryolite (96% a.i.) was
administered dermally to 5 New Zealand White Rabbits/sex at dose levels of 0,25,
250, or 1000 mg/kg/day. Exposure was for 6 hours per day, 5 days per week. The
following signs were probably due to inadvertent oral exposure (rabbits were
observed licking their fur during the study). Signs of toxicity included: mortality
in males (3/5) and females (1/5) at 1000 mg/kg/day; clinical signs of toxicity (thin
appearance, hypoactivity); actual decreases in absolute body weight (up to 400
gms) throughout the study; anemia and changes in several clinical chemistry
parameters. At 250 mg/kg/day, body weight was only decreased on day 5 with
weight gain returning to normal for the duration of the study. The systemic LOEL
and NOEL due to dermal exposure can not be determined. Signs and mortality
were probably due to oral exposure (MRID 41224801).
This 21-day subchronic dermal toxicity study is unacceptable because there
is a high possibility that cryolite was ingested during the study. Given the extreme
sensitivity of the rabbit to oral doses of cryolite and the observations of oral
exposure, it is likely that the toxicity observed was due to oral ingestion. It does
not satisfy the guideline requirement for a 21-day subchronic dermal study (82-2).
However this guideline requirement (82-2) is waived and an additional study is not
required on the technical. An additional study in the rat or rabbit is not necessary.
Based on its chemical/physical properties, cryolite would not be absorbed through
the skin to an appreciable extent to justify requiring an additional study.
c. Chronic toxicity/Carcinogenicity
The National Toxicology Program (NTP) conducted a 2-year rat
carcinogenichy study with sodium fluoride (99%) 80, 50, 50, 50 and 80 F344/N
rats/sex/group at dose levels of 0,0 (paired control), 25, 100 or 175 ppm in water,
-------
representing 0, 0, 1.3, 5.2 and 8.6 mg/kg/day in males and 0, 0, 1.3, 5.5 and 9.5
mg/kg/day in females (HED DOC NO. 009682; NTP, 1990).
Animals in the 100 and 175 ppm groups exhibited attrition, deformity,
discoloration, and mottling of the teeth. Animals in the 25 ppm groups exhibited
only mottling of the teeth. Serum, urine, and bone fluoride levels were increased
in all treated animals. The fluoride levels showed a dose-response relationship.
OsteoscleTosis was increased in females in the 175 ppm group. Dentine incisor
dysplasia was increased in males and females in all treated groups. Incisor
odontoblast degeneration was increased in males in all treated groups and in
females in the 175 ppm group. Incisor ameloblast degeneration was increased in
males in all treated groups and in females in the 100 and 175 ppm groups.
Osteosarcoma of the bone was only observed in one male in the 100 ppm group
and in three males in the 175 ppm group. NTP considers this to be equivocal
evidence of carcinogenicity in male F344/N rats. Other tumors present were
squamous cell neoplasms of the epithelium of the oral mucosa, follicular cell
adenomas and carcinomas and benign tumors arising from stratified squamous
epithelium. The occurrence of these tumors was not associated with
administration of the test material. The NOEL is less than 25 ppm (1.3
mg/kg/day). The LOEL is 25 ppm (1.3 mg/kg/day) based on mottling of teeth,
dentine incisor dysplasia, increased serum, urine and bone fluoride levels in males
and females and incisor odontoblast and incisor ameloblast degeneration in males.
There was "equivocal evidence" of carcinogenic activity in male rats and "no
evidence" of carcinogenic activity in female rats.
NTP conducted a 2-year mouse carcinogenicity study with sodium fluoride
(99%) in groups of 80, 50, 50, 50 and 80 B6C3Ti mice/sex at dose levels of 0, 0
(paired control), 25,100 or 175 ppm in water, representing 0, 0, 2.4, 9.6 and 16.7
mg/kg/day in males and 0,0,2.8,11.3 and 18.8 mg/kg/day in females (HED DOC
NO. 009682; NTP,1990).
Attrition of the teeth ("grinding down by friction") was increased in
females in the 175 ppm group and in all treated male groups. The incidence of
discoloration and mottling ("spotted tooth enamel caused by excessive fluorides
during the time teeth are calcifying") of the teeth was increased in all male and
female treated groups. Alkaline phosphatase was increased in females in the 175
ppm group when compared to controls. Bone fluoride levels were increased in
males and females in all NaF treated groups. The incidence of dentine dysplasia
was increased in males in the 175 ppm group. It was concluded by NTP that there
was "no evidence" of carcinogenic activity in male or female mice administered
sodium fluoride in drinking water for 2 years. The NOEL is less than 25 ppm (2.4
mg/kg/day). The LOEL is 25 ppm (2.4 mg/kg/day) based on attrition of the teeth
10
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in males, discoloration and mottling of the teeth in males and females and
increased bone fluoride in both sexes.
Cryolite (97.3-97.4%) was tested in a one-year chronic feeding study in
beagle dogs (4/sex/group) at dose levels of 0, 3000, 10,000 or 30,000 ppm,
representing 0, 95, 366 and 1137 mg/kg/day in males and 0, 105,387 and 1139
mg/kg/day in females. In terms of fluoride the doses are 0, 51, 198, or 614 mg
F/kg/day for males and 0, 57, 209 or 615 mg F/kg/day for females (MRID
42575101).
At 3000 ppm, there were slight increases .in the incidence of emesis
(vomiting; white and yellow froth in both males and females), nucleated red cells
in males, and renal lesions (regeneration of the tubular epithelium, interstitial
fibrosis, tubular dilation, interstitial infiltration with lymphocytes) in 1-2 males
and/or females. Females also showed a decrease in specific gravity of the urine.
At 10,000 ppm, decreased red cell count, hemoglobin, hematocrit, mean
corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin
concentration, and platelets, and increased incidence of abnormal red cells
(anisokaryocytes, microcytes, macrocytes, target cells, hypochromic cells,
nucleated red cells, basophilic stippling, and Howell-Jolly bodies), hematopoiesis
in the liver and spleen, megakaryocytosis in the spleen, and myelofibrosis in the
bone marrow were observed in males and/or females. Also, increased leukocytes
(primarily segmented neutrophils and eosinophils) were observed in females.
Dilation of Bowman's space was observed in one male and one female at this dose.
Clinical chemistry showed a decrease in total serum protein in males and in serum
albumin in females. In addition, decreased serum calcium was observed in males.
Body weight gain was increased in males at 30,000 ppm. Increased lactate
dehydrogenase was observed in both males and females and decreased blood
sodium was observed in males. The NOEL (in terms of Cryolite) is less than 3000
ppm (95 mg/kg/day in males and 105 mg/kg/day in females). The LOEL is 3000
ppm (95 mg/kg/day) based on increases in emesis, nucleated cells in males, renal
lesions and a decrease in urine specific gravity in females.
d. Developmental Toxicity
Cryolite was tested by gavage in a developmental toxiciry study in
Sprague-Dawley derived fBR Simonsen albino rats (30/group) at dose levels of
0, 750, 1500 or 3000 mg/kg/day during gestation days 6-15 inclusive. At 3000
mg/kg/day, well above the limit dose, the only observation was whitening of the
teeth of dams. The NOEL for maternal toxicity is 3000 mg/kg/day. The LOEL
11
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is greater than 3000 mg/kg/day. The NOEL for developmental toxicity is 3000
mg/kg/day. The LOEL is greater than 3000 mg/kg/day (MRID 00128112).
Cryolite (97.3%) was tested by gavage in a developmental toxicity study
in female CD-I mice (25/group) at dose levels of 0, 30, 100 or 300 mg/kg/day.
There was increased mortality at 300 mg/kg/day. The glandular portion of the
stomach was red beginning at 100 mg/kg/day. In addition, females in the 300
mg/kg/day group exhibited dark red contents of the stomach. The NOEL for
maternal toxicity is 30 mg/kg/day and the LOEL is 100 mg/kg/day based on the
occurrence of dark red contents of the stomach. Fetuses at 300 mg/kg/day
exhibited bent ribs and bent limb bones. The NOEL for developmental toxicity
is 100 mg/kg/day. The LOEL is 300 mg/kg/day based on an increase in bent ribs
and bent limbs (MRID 42297902).
Cryolite (97.3%) was tested by gavage in a range-finding developmental
toxicity study in female New Zealand White rabbits (5/group) at dose levels of 0,
10,30,100,300 or 1000 mg/kg/day. Mortality was increased in the 30,100, 300
and 1000 mg/kg/day groups. Toxic signs including decreased defecation,
decreased urination, soft stool and black colored feces were increased in the
treated groups when compared to controls. Food consumption was decreased in
all treated groups. Most animals studied in the 30, 100, 300 and 1000
mg/kg/group exhibited dark red areas, dark red contents and/or reddened mucosa
of the stomach. The NOEL for maternal toxicity is 10 mg/kg/day and the LOEL
is 30 mg/kg/day based on an increased incidence of soft stool and dark colored
feces and decreased defecation and urination. The NOEL for developmental
toxicity is 30 mg/kg/day. .The LOEL could not be assessed due to excessive
toxicity at dose levels of £ 30 mg/kg/day (MRID 42297901).
This study is unacceptable and will not satisfy the guideline requirement
for a non-rodent developmental study. This study suggested that severe maternal
toxicity occurred at lower doses than external developmental toxicity. However,
following an extensive literature evaluation, the National Research Council
(National Academy of Sciences Subcommittee of Health Effects of Ingested
Fluoride) (NAS) has determined the following:
"There have been reports of adverse effects on reproductive outcomes associated with high levels
of fluoride intake in many animal species. In most of the studies, however, the fluoride
concentrations associated with adverse effects were far higher than those encountered in drinking
water....
"Based on these findings, the subcommittee concludes that the fluoride concentrations associated
with adverse reproductive effects in animals are far higher than those to which human populations
are exposed. Consequently, ingestion of fluoride at current concentrations should have no adverse
effects on human reproduction."
12
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A new rabbit developmental study is not required at this time since there
are two acceptable rodent developmental studies (rat and mouse) showing no
specific adverse developmental effects. In addition, the NAS report supports this
decision. It is unlikely that an additional rabbit developmental study would alter
the risk evaluation for Cryolite.
e<, Reproductive Toxicity
In a two-generation reproduction study, Sprague-Dawley rats (30 per
group) were administered cryolite (96%) in the diet at dose levels of 0, 200, 600,
or 1800 ppm (representing 0, 14, 42, and 128 mg/kg/day for males and 0, 16, 49,
and 149 mg/kg/day for females, respectively, during premating). Compound-
related systemic toxiciry was observed in a dose related manner among both sexes
and generations at all dose levels as evidenced by clinical signs of dental fluorosis.
Whitening of the upper and/or lower incisors was observed in most treated animals
of both generations. Beveled anterior edge of the lower incisor was observed in
^67% of animals from both generations at 1800 ppm. Mottled appearance of
lower incisor was noted at dose levels k600 ppm in 6%-40% of Fx animals;
however, this sign was not dose related. The NOEL was not determined. The
LOEL for systemic toxiciry was 200 ppm (15 mg/kg/day) based on dental
fluorosis.
Reproductive toxiciry was observed at 1800 ppm as evidenced by
significantly decreased pup body weights during lactation days 7, 14, and 21
(82%-88% of control in Fx offspring) and days 4, 7, 14, and 21 (74%-89%) of
control in F2 offspring). Gross findings were also observed in pups at 1800 ppm
by the time of weaning. They were manifested as pale kidneys, pale livers and
enlarged hearts and were considered to be compound related. No effects were
observed on parental reproductive performance. The NOEL and LOEL for
reproductive toxiciry were 600 and 1800 ppm, respectively (46 and 138
mg/kg/day) based on decreased pup body weights (MRID 43387501).
f. Mutagenicity
Cryolite was tested in an (Ames) reverse mutation test using Salmonella
tvphimurium with and without activation at dose levels of 167, 500, 1670, 5000,
7500 and 10000 //g/plate. The results were negative (MRID 41838401).
Cryolite produced negative results when tested at 100, 500 and 1000 //g/ml
with and without activation in an in vitro chromosomal aberration study using
human lymphocytes (MRID 4183 8402).
13
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Cryolite was negative for inducing unscheduled DNA repair in primary rat
hepatocytes at dose levels up to and including 50 fj.g/m.1 (MRID 41838403).
g-
Metabolism
A general metabolism study is not required. It has been demonstrated that
lexicologically, cryolite behaves as free fluoride. There are numerous references
in the literature on the metabolism of cryolite and other fluoride salts. The
National Research Council, in their 1993 report on fluoride concluded that fluoride
is readily absorbed by the gut and rapidly becomes associated with teeth and
bones. The remaining fluoride is eliminated almost exclusively by the kidneys
with the rate of renal clearance related directly to urinary pH.
h. Dose Response Assessment
The OPP's Health Effects Division's RfD/Peer Review Committee
(document dated December 22,1995) concluded the following for cryolite:
For acute dietary exposure, no endpoint of concern could be found from •
which an acute dietary risk assessment (1 day) should be conducted. There was
no endpoint for acute dietary exposure since acute toxicity in animal studies is
absent until very high doses of cryolite were used.
Based upon review of the toxicology database for cryolite there are no
short-term (1-7 days) or intermediate-term (7-90 days) occupational or residential
endpoints identified or risk assessments required.
Cryolite has been classified as a Group "D" chemical, "not classifiable as
to human carcinogenicity". It has been the subject of a comprehensive review by
the National Research Council (National Academy of Sciences Subcommittee of
Health Effects of Ingested Fluoride) who concluded that "... the available
laboratory data are insufficient to demonstrate a carcinogenic effect of fluoride in
animals." and that"... the weight of evidence from more than 50 epidemiological
studies does not support the hypothesis of an association between fluoride
exposure and increased cancer risk in humans." The Agency is in agreement with
the conclusions reached by the National Academy of Sciences (NAS).
i.
Reference Dose
The OPP's Health Effects Division's RfD/Peer Review Committee
(document dated December 22,1995) determined that a weight-of-the-evidence
risk assessment for chronic dietary exposure to fluoride residues as a result of
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agricultural uses of cryolite would be more appropriate than a traditional RfD
approach for the following reasons:
• National and International regulatory organizations (U.S. EPA Office of
Water, U.S. Department of Health and Human Services (DHHS), the
Canadian Government, and the World Health Organization) have assessed
potential health risks from exposure to fluoride. The endpoints and
estimated effect levels documented by these organizations are similar.
• The U.S. Surgeon General (Koop, 1984 and Elders, 1994) has
recommended a guideline level of exposure that should provide an
adequate "margin of safety" based on a large amount of human data,
including epidemiology studies.
• Animal data considered by the RfD Committee are consistent with human
data with respect to dose related skeletal effects.
Regulatory Background
Fluoride levels in public drinking water are regulated under the Safe
Drinking Water Act. The Agency has established a Maximum Concentration
Limit Goal (MCLG) at 4.0 mgfL [0.114 mg/kg/day; note that all conversions from
mg/L of fluoride in drinking water to mg/kg body weight/day are based on 70 kg
body weight and 2 L/day water consumption as taken from Drinking Water
Criteria Document on fluoride, October 21, 1985] to protect against crippling
skeletal fluorosis, Federal Register (FR) 11396 (Vol. 51, No. 63, 4/2/86). The
MCLG established on 4/2/86 finalizes interim regulations set in FR47142 (Vol.
50, No. 220, 11/14/85) and proposed in FR20164 (Vol. 50, No. 93, 5/14/85). In
addition, these FR notices established a Secondary Maximum Contaminant Level
(SMCL) at 2.0 mg/L [0.057 mg/kg/day] for cosmetic effects (objectionable dental
fluorosis) which are not considered to be adverse health effects. The MCLG has
been reviewed and is supported by the Surgeon General.
The Agency's Office of Drinking Water issued a Drinking Water Criteria
Document on Fluoride (October 21, 1985) which presents summaries of
experimental and clinical data on the health effects of fluoride in animals and
humans. In general, the health effects of fluoride include dental fluorosis and
skeletal fluorosis.
Dental fluorosfc is a mottling of tooth enamel. The relationship between
fluoride intake and the incidence of dental fluorosis has been demonstrated in both
animals and humans.
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"At the request of the Agency, the U.S. Surgeon General examined the
relationship of fluoride in drinking water and the aspects of dental fluorosis. The
results of that evaluation (Koop 1982, Albertini et al. 1982) led to the general
conclusions that, while not considered an adverse health effect, the undesirable
cosmetic effects to teeth could be minimized by limiting the fluoride concentration
to twice the optimum for the reduction of dental caries. The Surgeon General
encouraged communities to limit water to twice optimum (about 2 mg F/L [0.057
mg/kg/day]) to provide this protection for children up to age nine, but emphasized
that there is no sound evidence to indicate that adverse effects on general or dental
health (dental fluorosis was not judged to be an adverse effect) are associated with
concentrations of fluoride that are naturally found in U.S. public water supplies."
(Water Criteria Document p. IX-13).
Skeletal fluorosis results from the incorporation of excessive fluoride into
bone. Skeletal fluorosis increases in severity with both dose and duration of
exposure to fluoride. In its mildest form, it is characterized by an increase in bone
density (osteosclerosis) that is detectable only through X-ray examination. The
most severe form (crippling skeletal fluorosis) is characterized by irregular bone
deposits.
"At the request of the Agency, the U.S. Surgeon General examined the nondental
health aspects associated with fluoride in drinking water. An ad hoc advisory
committee met in April, 1983 inBethesda, MD and provided their report (Shapiro
1983) and a later formal response from the Surgeon General (Koop 1984) to EPA.
The Surgeon General concluded that he did not consider changes in bone density
to be an adverse health effect and that adverse effects (arthralgias) are not likely
to occur at human dose levels below 20 mg F/day (10 mg F/L for an adult
consuming 2 L water/day [0.29 mg/kg/day]). The ad hoc committee concluded
that four times the optimal fluoride concentration (approximately 4 mg F/L [0.114
mg/kg/day]) in drinking water should provide an adequate margin of safety for
preventing adverse health effects which were not documented to occur in the U.S.
population below 8 mg F/L [0.23 mg/kg/day]." (Water Criteria Document p. TK-
21).
Other Regulatory Assessments
Canada Environmental Protection Act (CEPA) (1993) concluded that
inorganic fluorides are not present in the environment at levels that may result in
adverse effects to human health.
"Based on available information, the estimated average daily intakes of inorganic
fluoride are less than the level at which adverse effects upon the skeleton (the
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end-point considered most sensitive on the basis of available data) are anticipated
(i.e. >200 ug/kg/bw/day fluoride [0.2 mg/kg/day]."
The 1993 World Health Organization (WHO) Guidelines for Drinking-
Water Quality addresses fluoride exposure and concludes the following:
"There is no evidence to suggest that the guideline value of 1.5 mg/L set in 1984
needs to be revised. Concentrations above this value carry an increasing risk of
dental fluorosis, and much higher concentrations lead to skeletal fluorosis. The
value is higher than that recommended for artificial fluoridation of water
supplies."
2. Exposure Assessment
Cryolite (sodium aluminofluoride, fluorine expressed as elemental—50 percent),
is an insecticide formulated as a wettable powder or dust containing 93% or 96% active
ingredient, a 20% granular bait and as a water dispersible granular containing 93% active
ingredient. Cryolite is applied by aerial equipment and ground sprayers. Depending on
the crop and insect situation, applications are made from one to several times per season.
Tolerances are established for combined residues of the insecticidal fluorine
compounds cryolite and synthetic cryolite in/on the following raw agricultural
commodities (RACs): broccoli, cabbage, cauliflower, brussels sprouts, kohlrabi,
cucumber, squash, cantaloupe, watermelon, grapefruit, grapes, kiwi (in California only),
lettuce head, lettuce leaf, peppers, potatoes, tomatoes, eggplant, cranberries, collards, and
peaches. [Source: 40 CFR§ 180.145 (a), (b), and (c)]. All RAC tolerances are currently
set at 7 ppm, except 15 ppm in/on kiwifruit and 2 ppm in/on potatoes (time-limited
tolerance to expire on 5/6/96). There are no tolerances for residues in animal products.
A feed additive tolerance (FAT), time-limited to expire on 5/6/96, is established for potato
waste, process (wet or dry) [40 CFR §186.3375] at 22.0 ppm. The Agency has completed
its review of the data needed to establish a permanent tolerance for potatoes. The Agency
will propose in the Federal Register permanent tolerances for potatoes at 2 ppm and
potato waste at 22 ppm.
Cryolite was the subject of a Registration Standard Guidance Document (6/83),
a Final Registration Standard and Tolerance Reassessment (FRSTR) Residue Chemistry
Chapter (1/22/88), and a Reregistration Standard Update dated (5/16/91). These
documents summarized the regulatory conclusions of available residue chemistry data and
specified what additional data were required for reregistration.
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a. Dietary Exposure
GLN 171-3: Directions for Use
As of 12/95 there were three cryolite end-use products (EPs) with
food/feed uses registered to Gowan Company and Elf Atochem, the primary
registrants. These EPs are presented below in Table 3.
Table 3. Cryolite End-Use Products registered by Basic Producers
Registrant Reg. No.
Gowan Co.
10163-41
10163-185
OR95000800
WA95001800
Elf Atochem Inc
4581-116
Most Recent Label
Acceptance Date
August 17, 1995
March 11, 1994
March 24, 1995
March 28, 1995
November 12, 1995
Formulation Class
96% Dust
93% WDG
20% G
20% G
96% WP/D
Product Name
Prokil Cryolite 96
Prokil Cryolite WDG
Gowan Cryolite Bait
Gowan Cryolite Bait
Kryocide Insecticide
The conclusions listed below regarding the reregistration eligibility of cryolite
food/feed uses are based on the use patterns registered by the basic producers, Gowan
Company and Elf Atochem North America, Inc.; all data to support the food/feed uses
were based on the above registered label rates and restrictions. All end-use product labels
which rely on these data must be amended such that they are consistent with the basic
producers labels.
GLN 171-4 (a): Plant Metabolism
The qualitative nature of the residue in plants is adequately understood. Uptake
and translocation of cryolite from soil is unlikely owing to the low water solubility of
cryolite. Plant residues are inorganic surface residues of cryolite. The residues of
concern are cryolite fluoride residues.
GLN 171-4 (b): Animal Metabolism
The requirement for animal metabolism studies was waived, as the Agency
determined that cryolite metabolism in animals manifests itself as free fluorine. The
qualitative nature of the residue in animals is adequately understood. Total fluoride is the
residue of concern.
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GLN 171-4 (c) and (d): Residue Analytical Methods - Plants and Animals
Adequate methodology is available for data collection and tolerance enforcement.
Atochem methods BR-006-02 for plant residues and BR-010-00 for animal tissues have
undergone successful Agency validation and will be published in PAM, Vol. H Using
these methods, total fluoride is determined using a pH/ion meter with a fluoride-specific
electrode. The limit of quantitation is 0.05 ppm. Because cryolite is an inorganic ionic
compound, recovery of residues using FDA Multiresidue Protocols is not expected and
the requirement for such data is waived.
GLN 171-4 (e): Storage Stability in Plant and Animal Commodities
Storage stability is not of concern as cryolite is a naturally occurring mineral and
breakdown (ionization or dissolution) of residues in plant or animal tissues is not
expected.
GLN 171-4 (k): Magnitude of the Residue in Plants
Pending required label amendments and/or revised tolerances (as prescribed in this
document or previous Agency correspondence), reregistration data requirements are
fulfilled for broccoli, Brussels sprouts, cabbage, cauliflower, citrus fruit, collards,
cucumbers, eggplant, grapes, kiwifruit, kohlrabi, lettuce, melons, peaches, peppers,
potatoes, pumpkins, squash (winter and summer), and tomatoes.
Additional residue data are required for cranberries, plums and strawberries. There
are no registered uses on apricots, beets, carrots, caneberries (blackberries, boysenberries,
dewberries, loganberries, youngberries), corn, nectarines, okra, peanuts, peas, quinces,
and rutabagas; these tolerances are proposed for revocation. The registrants intend to
cancel the registered uses on apples, beans, kale, mustard greens, pears, radishes, and
turnips; these tolerances are proposed for revocation.
Data to support the tolerances for cryolite on blueberries, raspberries and
strawberries are being generated by Interregional Research Project No. 4 (IR4), but are
currently not available. These tolerances will not be proposed for revocation at this time.
The reregistration eligibility for the use of cryolite on strawberries will be determined
when the data are reviewed and found acceptable. There are currently no registered uses
for cryolite on blueberries and raspberries, therefore, these uses are not subject to a
reregistration decision. The Agency will make a decision regarding the registration of the
blueberry and raspberry uses when the data are made available.
A summary of the available data and reregistration data requirement status by crop
group are summarized below. (See Section IV for the tolerance reassessment summary,
recommendations and proposed revocations).
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Root and Tuber Vegetables Group
Beets, carrots, radishes, rutabagas, turnips: There are no registered uses on beets, carrots,
and rutabagas. The registrants have proposed to cancel uses on radishes and turnips. The
Agency will propose to revoke these tolerances.
Potatoes: The tolerance for cryolite residues in/on potatoes is time-limited to expire
5/6/96. A petition for permanent tolerance is pending. A label (10163-41) has been
approved (08/17/95) for foliar application to potatoes at up to 11.5 Ibs. a.i/acre, with a
maximum seasonal application of 92 Ibs. a.i./acre. The PHI is 0 days. The Agency has
reviewed the data needed to establish a permanent tolerance for potatoes and will be
proposing a permanent tolerance of 2 ppm in the Federal Register.
Leaves of Root and Tuber Vegetables Group
Beet tops, radish tops, rutabaga tops, turnip tops: There are no registered uses on beets
and rutabagas. The registrants have proposed to cancel uses on radishes and turnips. The
Agency will propose to revoke these tolerances.
Leafy Vegetables Group
Lettuce (head): Residue data on head lettuce were reviewed in the 1991 Update. Cryolite
residues were 8.12-174.87 ppm in/on head lettuce with wrapper leaves and 1.1-3.66 ppm
in/on head lettuce without wrapper leaves harvested 14 days following the last of eight
applications of the 96% WP/D formulation using ground and aerial equipment at 19.2 Ib
ai/A/application (Ix the maximum single application rate). The data indicate that the
established 7 ppm tolerance is too low and that a tolerance of 180 ppm would be
appropriate. The Agency will propose a tolerance of 180 ppm for cryolite residues in/on
head lettuce.
Lettuce (leaf): Residue data on leaf lettuce were reviewed in the 1991 Update. Cryolite
residues were 27.1-36.8 ppm in/on untrimmed leaf lettuce and 11.6-17.5 ppm in/on
trimmed leaf lettuce harvested 14 days following the last of eight applications of the 96%
WP/D formulation using ground and aerial equipment at 19.2 Ib ai/A/application (Ix the
maximum single application rate). The data indicate that the established 7 ppm tolerance
is too low and that a tolerance of 40 ppm would be appropriate. The data support the
proposed use pattern (4581-116, 08/95) of 8 - 20 Ibs. a.i./acre/application, 160 Ibs.
a.i./acre/year, 14 day PHI. The Agency will propose a tolerance of 40 ppm for cryolite
residues in/on leaf lettuce.
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Brassica Leafy Vegetables Group
Broccoli: Residue data on broccoli were reviewed in the 1988 FRSTR. Cryolite residues
were 0.5-6.0 ppm in/on broccoli harvested 7 or 14 days following the last of six
applications of the 96% WP/D formulation at 15.4 Ib ai/A/application (1.3x the maximum
single application rate). The available data support the established 7 ppm tolerance for
cryolite residues in/on broccoli.
Brussels sprouts: Residue data on Brussels sprouts and broccoli were reviewed in the
1988 FRSTR. Cryolite residues were 2.9-5.7 ppm in/on Brussels sprouts harvested 7 or
14 days following the last of six applications of the 96% WP/D formulation at 16 Ib
ai/A/application (1.3x the maximum single application rate). The available data,
including data on broccoli support the established 7 ppm tolerance for cryolite residues
in/on Brussels sprouts.
Cabbage: Residue data on cabbage were reviewed in the 1991 Update. Cryolite residues
were 1.56-40.52 ppm in/on cabbage with wrapper leaves and 0.52-2.76 ppm in/on
cabbage without wrapper leaves harvested 14 days following the last of eight or nine
applications of the 96% WP/D formulation using ground and aerial equipment at 16 Ib
ai/A/application (Ix the maximum single application rate). The data indicate that the
established 7 ppm tolerance is too low and that a tolerance of 45 ppm would be
appropriate. The Agency will propose a tolerance of 45 ppm for cryolite residues in/on
cabbage.
Cauliflower: Residue data on cauliflower and broccoli were reviewed in the 1988
FRSTR. Cryolite residues were 3.9-5.2 ppm in/on cauliflower harvested 7 or 14 days
following the last of eight applications of the 96% WP/D formulation at 15.4 Ib
ai/A/application (1.3x the maximum single application rate). The available data,
including data on broccoli support the established 7 ppm tolerance for cryolite residues
in/on cauliflower.
Collards: Residue data on collards were reviewed in the 1991 Update. Cryolite residues
were 0.46-34.47 ppm in/on collards harvested 14 days following the last of six
applications of the 96% WP/D formulation using ground and aerial equipment at 15.4 Ib
ai/A/application (Ix the maximum single application rate). The data indicate that the
established 7 ppm tolerance is too low and that a tolerance of 35 ppm would be
appropriate. The Agency will propose a tolerance of 35 ppm for cryolite residues in/on
collards.
Kohlrabi: No field residue data are available for kohlrabi. However, the Cryolite Update
concluded that no data are required for reregistration purposes as the existing data for
broccoli can be used to support the tolerance for kohlrabi. The registered use patterns for
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the 96% WP/D formulation are identical for broccoli and kohlrabi. The available data for
broccoli indicate that the established 7 ppm tolerance is acceptable.
Kale, mustard greens: The registrants propose to cancel uses on kale and mustard greens.
The Agency will propose to revoke these tolerances.
Legume Vegetables Group
Beans and peas: There is no registered use on peas. The registrants propose to cancel
uses on beans. The Agency will propose to revoke these tolerances.
Fruiting Vegetables (except Cucurbits) Group
Eggplant: Data reviewed in the FRSTR indicate that cryolite residues were 2.7 and 3.9
ppm in/on eggplant harvested on the day of the last of four foliar spray applications of the
96% WP/D formulation at 11.5 Ib ai/A (Ix the maximum single application rate). These
data must be supplemented by the translation of tomato residue data, including cherry
tomatoes, to support the proposed label for the WP/D (4581-116): 15.4 Ibs.
a.i7acre/application, 61.4 Ibs. a.i./acre/season, 14 day PHI. The tomato data indicate that
the existing tolerance of 7 ppm is inadequate, and that a tolerance of 30 ppm is required
(see tomato).
Peppers: Cryolite residues were 2.0-5.8 ppm in/on peppers harvested 14 days following
the last of two applications at 7- to 9-day intervals of the 96% WP/D formulation at 11.5
Ib ai/A/application (Ixthe maximum single application rate). The available data support
the established 7 ppm tolerance for cryolite residues in/on peppers.
Tomatoes: Cryolite residues were 1.22-6.06 ppm in/on tomatoes and 1.87-27.39 ppm
in/on cherry tomatoes harvested 14 days following the last of four applications of the 96%
WP/D formulation using ground and aerial equipment at 15.4 Ib ai/A/application (Ix the
maximum single application rate). The data indicate that the established 7 ppm tolerance
would be adequate if all pertinent labels specify a restriction on cherry tomatoes.
However, in order to alleviate the need for this restriction the registrant has agreed to the
Agency proposing in the Federal Register a tolerance of 30 ppm for cryolite residues in/on
all tomatoes.
Cucurbit Vegetables Group
Cucumbers: Data indicate that cryolite residues were 0.3-5.2 ppm in/on cucumbers
harvested 7 days following the last of three to five applications of the 96% WP/D
formulation at 7.7-15.5 Ib ai/A/application (>lx the maximum single application rate).
The available data support the established 7 ppm tolerance for cryolite residues in/on
cucumbers.
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Melons: Data reviewed in the Update indicate that cryolite residues were 1.7-2.56 ppm
in/on melons harvested 14 days following the last of four or five applications of the 96%
WP/D formulation using ground and aerial equipment at 15.4 Ib ai/A/application (Ix the
maximum single application rate). The available data support the established 7 ppm
tolerance for cryolite residues in/on melons.
Pumpkins: Data on melons will be translated to pumpkins.
Squash (winter): Data on melons will be translated to winter squash.
Squash (summer): Data reviewed in the Update indicate that cryolite residues were 1.73-
5.41 ppm in/on summer squash harvested 7 days following the last of four applications
of the 96% WP/D formulation using ground and aerial equipment at 15.4 Ib
ai/A/application (Ix the maximum single application rate). The available data support the
established 7 ppm tolerance for cryolite residues in/on summer squash.
Citrus Fruits Group
Data reviewed in the Update indicate that cryolite residues were 1.3-30.39 ppm
in/on grapefruit harvested 14-16 days following the last of three or six foliar applications
of the 96 WP/D formulation made with ground equipment at 28.8 Ib ai/A (Ix the
maximum registered single application rate). Residues were 0.74-38.45 ppm in/on
lemons harvested 13-16 days following the last of three or six foliar applications of the
96 WP/D formulation made with ground equipment at 28.8 Ib ai/A (Ix the maximum
registered single application rate). Residues were 0.81-93.18 ppm in/on oranges
harvested 15 days following the .last of three foliar applications of the 96 WP/D
formulation made with ground equipment at 28.8 Ib ai/A (Ix the maximum registered
single application rate). The data indicate that the established 7 ppm tolerance is too low
and that a tolerance of 95 ppm would be appropriate. The Agency will propose a
tolerance of 95 ppm for cryolite residues in/on citrus fruit.
Pome Fruits Group
Apples, pears, quinces: There is no registered use on quinces. The registrants propose
to cancel uses on apples and pears. The Agency will propose to revoke these tolerances.
Stone Fruits Group
Apricots, nectarines, plums (fresh prunes^): There are no registered uses on apricots,
nectarines, and plums (fresh prunes) although a tolerance of 7 ppm is currently
established; the registrants do not support the apricot and nectarine use. Cryolite residues
were <0.5-1.4 ppm in/on plums harvested 45 days following two applications of a 96%
WP/D formulation using ground equipment at 12 Ibs. a.i./A/application. The four trials
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were conducted in California; additional trials are required before an adequate tolerance
can be determined for plums (fresh prunes).
Peaches: Cryolite residues were 4.84-8.90 ppm in/on peaches harvested 45 days
following the two applications of the 96% WP/D formulation using ground equipment at
11.5 Ib ai/A/application (Ix the maximum single application rate). The data indicate that
the established 7 ppm tolerance is too low and that a tolerance of 10 ppm would be
appropriate. The Agency will propose a tolerance of 10 ppm for cryolite residues in/on
peaches.
Small Fruits and Berries Group
Blackberries, boysenberries. dewberries, loganberries, raspberries, voungberries: There
are currently no registered uses on caneberries; however, there is an established tolerance
of 7 ppm for each of these crops. IR4 is generating the data to support the tolerances for
blueberry and raspberry use in the Pacific Northwest and may also conduct field trials in
other regions around the country to support the uses nationally. These uses are not
subject to a reregistration decision; when the data are available, the Agency will make a
registration decision.
Blueberries (huckleberries): There is no registered use on blueberries; however, see note
above for caneberries.
Cranberries: There are no data to support the currently registered use: 9.6 - 11.5 Ibs.
a.i./acre/application, 35 Ibs. a.i./acre/season maximum, 30 day retreatment interval and
30 day PHI. Data must be submitted for five trials [region 1 (2), region 5 (2), region 12
(1)] conducted at the maximum label rate and minimum PHI. Currently IR4 is generating
the necessary data to support this use. An interim report from IR4 showed there was
sufficient varietal and geographically representative field trial data to show that fluoride
from cryolite residues are not expected to exceed the established 7 ppm tolerance when
Gowan Bait is used as directed. The studies in progress will support both the wettable
powder and bait formulation use of cryolite on cranberries.
Grapes: Data reviewed in the FRSTR indicate that cryolite residues were 0.6-5.5 ppm
in/on grapes harvested 31 days following one or two applications of the 96% D
formulation at 9.6 Ib ai/A (spray) or 15.4 Ib ai/A (dust). Labels specify an additional
postharvest application may be made to grape vines at a rate of 7.7 Ibs. a.i./acre. The
combined seasonal application rate may not exceed 27 Ibs. a.i./acre. These data support
the established tolerance of 7 ppm for residues in/on grapes.
Sfrawberries: The current tolerance for strawberries is 7 ppm. IR4 is generating the data
to support the tolerance for cryolite on strawberries in the Pacific Northwest and may also
conduct field trials in other regions around the country to support the use nationally.
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When the data are available, the Agency will reassess the tolerance and make an
eligibility decision for the use of cryolite on strawberries.
Cereal Grains Group
Corn: There is no registered use on corn. The Agency will propose to revoke this
tolerance.
Miscellaneous Commodities
Kiwifruit (CA): Residues were 2.7-10.6 ppm in/on kiwifruit harvested 29 days following
four foliar spray applications of the 96% WP/D at 9.6 Ib ai/A/application (Ix the
maximum rate). These data support the established 15 ppm tolerance for residues in/on
kiwifruit grown in California.
Okra: There is no registered use on okra. The Agency will propose to revoke this
tolerance.
Peanuts: There is no registered use on peanuts. The Agency will propose to revoke this
tolerance.
GLN 171-4 (I): Magnitude of the Residue in Processed Food/Feed
Reregistration data requirements for processing studies are satisfied for citrus
fruits, grapes, potatoes, and tomatoes. As registered uses on apples are to be canceled,
processing studies are not required for this commodity. A summary of cryolite processing
studies is presented below.
Potatoes: An acceptable potato processing study has been submitted and reviewed. This
study indicates that cryolite residues concentrated llx in potato peels/potato waste
processed from potatoes treated at a 6.7x exaggerated rate. These data support the
established food additive tolerance (FAT) for cryolite in potato waste, provided that the
time-limited tolerance for residues on potatoes is sustained or a permanent tolerance is
established. The Agency will propose the establishment of a permanent tolerance for
potatoes. Residues did not concentrate in potato chips, flakes, or granules; no FAT is
required for any of these commodities.
Tomatoes: An acceptable tomato processing study was reviewed in the Update. This
study indicates that residues concentrated in tomato paste (1.6X). A food additive
tolerance of 45 ppm will be proposed for tomato paste.
Citrus fruit: An acceptable orange processing study was reviewed in the Update. Cryolite
residues did not concentrate in pulp, oil, or juice processed from oranges treated at 5x the
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maximum registered rate.
Grapes: Acceptable processing studies were reviewed in the FRSTR. Fluorine residues
from cryolite concentrated lOx in raisins processed from grapes bearing measurable
residues. The registrants have proposed a food additive tolerance for cryolite residues in
raisins. The Agency ruled favorably on the proposed FAT, 70 ppm. However, under the
modified procedure for calculating food/feed additive tolerances, the appropriate FAT is
55 ppm, the product of the maximum average field trial residue and the average
processing factor. [Memo S. Irene to D. Barolo, OPP, 9/12/95; re: Update to Subdivision
O, Residue Chemistry Guidelines.]
Plums: A processing study is not required in this particular case because cryolite does not
metabolize or degrade and is not systemic; also, there is only one product of processing,
which is prunes. The processing represents a loss of water, and cryolite would be stable
under such conditions. Prunes are a ready-to-eat food, and a food additive tolerance is
required. A value of 7 ppm may be appropriate, but additional field trials must be
evaluated.
GLN 171-4 (j): Magnitude of the Residue in Meat, Milk, Poultry, and Eggs
The Agency has concluded that there is no reasonable expectation of finite fluoride
residues in ruminant or poultry tissues as a result of livestock ingestion of cryolite. As
this situation falls under 40 CFR §180.6 (a) (3), tolerances for cryolite residues in meat,
milk, poultry, and eggs are not required.
GLN 165-1: Confined Rotational Crops
The requirement for data on confined rotational crops was waived. The residue
available to rotational crops is expected to be negligible with respect to the amount of free
fluorine occurring naturally in soil.
b. Occupational and Residential
An occupational and/or residential exposure assessment is required for an active
ingredient if (1) certain toxicological criteria are triggered and (2) there is potential
exposure to handlers (mixers, loaders, applicators, etc.) during use or to persons entering
treated sites after application is complete.
Occupational-use products and homeowner-use products
At this time no products containing cryolite are intended primarily for homeowner
use; all product are intended primarily for occupational use.
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Handler (Mixers. Loaders. Applicators') Exposures and Assumptions
The Agency has determined that there is a potential for exposure to mixers,
loaders, applicators, or other handlers resulting from usual use-patterns associated with
cryolite. There are potential exposures to: mixer/loaders supporting ground and aerial
applications of wettable powder, dusts, granular and water-dispersible granular
formulations; applicators using ground and aerial equipment to apply sprays; and fiaggers
participating in aerial applications.
However, an exposure assessment was not performed because there were no
toxicological endpoints identified for cryolite.
Post-Application Exposures and Assumptions
The Agency has determined that there is potential exposure to persons entering
treated sites after application is complete. Post-application exposures may occur to
agricultural workers following applications to registered food and ornamental crops
during hand-labor tasks and other crop-production activities. Post-application exposures
may also occur to residential workers following applications on plants that are in
ornamental gardens, parks, golf courses, and public or private lawns and grounds and that
are intended only for decorative or environmental benefit.
However, a post-application exposure assessment was not performed because there
were no toxicological endpoints identified for cryolite.
3. Risk Characterization
a. Dietary
Cryolite is an inorganic fluoride-containing insecticide. Plant residues are
inorganic surface residues of cryolite which are measured as total fluoride using a pH/ion
meter with a fluoride-specific electrode. The residues of toxicological concern are
fluoride residues.
Fluoride occurs at low levels in food and air as well as in drinking water
(FR20167, Vol. 50, No. 93, 5/14/85). Atmospheric levels of fluoride contribute relatively
little to the average level of dietary fluoride exposure and are not further considered in this
exposure estimate. Incidental dietary exposures to fluoride as a toothpaste additive or as
a dental treatment are also not included in this exposure estimate. This exposure is
regulated by the Food and Drug Administration and is expected to be negligible.
As a part of the Reregistration Eligibility Decision for Cryolite, the Agency
recently (2/96) conducted a chronic exposure analysis using the Dietary Risk Evaluation
27
-------
System (ORES). This analysis was performed using recommended tolerance increases
and raw agricultural commodity (RAC) tolerance revocations. Percent crop treated data
were used to calculate the anticipated residue concentration. The results are summarized
below in Table 4.
Table 4. Dietary Exposure Evaluation for Cryolite.
Population Subgroup
U.S. Population
Children 1-6
Children 7-12
Females 13+ years, nursing
Exposure of Fluoride
(mg/kg/day)
Food from agricultural use of Cryolite1
0.020
0.024
0.015
0.028
analysis based on reassessed tolerances and %crop treated.
Weight-of-the-Evidence Dietary Risk Assessment
A weight-of-the-evidence dietary risk assessment for cryolite has been conducted
as recommended by the RfD Committee.
• "... There exists no directly applicable scientific documentation of adverse medical
effects at levels of fluoride below 8 mg/L [0.23 mg/kg/day]. (FR20166, Vol. 50,
No. 93, 5/14/85)
• Less than 0.4% of the U.S. population (on public water supplies) is exposed to
greater than 2 mg/L fluoride [0.057 mg/kg/day] in the public water supply. (Water
Criteria Document, pg. IV-3, Table IV-1.)
• Dietary exposure estimates using reassessed tolerances and percent of crops
treated are approximately 0.020 mg/kg/day for the U.S. population and 0.028
mg/kg/day for the highest exposed subgroup (females 13 years and older and
nursing).
[Note: Dietary exposures from food sources are high-end estimates, since
tolerance values (which estimate high-end values on treated crops) were used in
the residue estimate.]
28
-------
Therefore, it can be concluded that levels of fluoride in/on food from the
agricultural use of cryolite plus fluoride levels in U.S. drinking water supplies results in
a high-end daily dietary intake of fluoride of approximately 0.085 mg/kg/day. This is less
than the MCLG of 4.0 mg/L [0.114 mg/kg/day], a level which provides no known or
anticipated adverse health effects. The MCLG has been reviewed and is supported by the
Surgeon General.
b. Occupational
Although occupational exposure to cryolite is expected, an occupational
quantitative risk assessment is not required because there were no toxicological endpoints
of concern identified for cryolite.
C. Environmental Assessment
1. Ecological Toxicity Data
At present, the available ecological toxicity database is adequate to assess
the hazard of cryolite to nontarget terrestrial organisms.
a. Toxicity to Terrestrial Animals
(1) Birds, Acute and Subacute
In order to establish the toxicity of cryolite to birds, the following tests are
required using the technical grade material: one avian single-dose oral (LDSO)
study on one species (preferably mallard or bobwhite quail); two subacute dietary
studies (LCjo) on one species of waterfowl (preferably the mallard duck) and one
species of upland game bird (preferably bobwhite quail).
^mm$f A mg/kg
>2150
£ ' *v
MRID No.
Author/Year
00152375
Fletcher, 1984
^ ^
Toxicity
Category
Practically
nontoxic
^-v*fc,,,x
Fulfills Guideline
Requirement
Yes
29
-------
Species
Northern Bobwhite
Mallard
M|p4i\s^s;s-sS s-5,
^IweJrftv 1PlfMH»<
% A.I.
96
96
m-"" "¥-ss>
g\^»n is%fe
LCS, ppm
>10,000
>10,000
1 ,s ^Xs^s^iss1 - *
5 % ™.« ••
MRIDNo.
Author/Year
00084001
Fink, 1975
00084002
Fink, 1975
, WijVi -
Toxicity
Category
Practically
nontoxic
Practically
non-toxic
^'/-\ %,-*A,*
Fulfills Guideline
Requirement
Yes
Yes
These results indicate that cryolite is practically nontoxic to avian species
on an acute oral (TABLE 5) and subacute dietary (TABLE 6) basis. The guideline
requirements are fulfilled (MRIDs 00152375, 00084001, and 00084002).
(2) Birds, Chronic
Avian reproduction studies are required when birds may be exposed
repeatedly or continuously through persistence, bioaccumulation, or multiple
applications, or if mammalian reproduction tests indicate reproductive hazard.
Many uses of cryolite allow for multiple applications. However, due to the
physicochemical properties (naturally occurring mineral, readily soluble in water),
and the relative lack of acute toxicity to birds, avian reproduction studies are not
required for this chemical.
(3) Mammals
Wild mammal testing is required on a case-by-case basis, depending on the
results of the lower tier studies such as acute and subacute testing, intended use
pattern, and pertinent environmental fate characteristics. In most cases, however,
an acute oral LD^ from the Agency's OPP Health Effects Division (HED) is used
to determine toxicity to mammals. This LDSO is reported below.
.- xABtS 7s MamniallaB AfaitCOffSKf^xmty SiwMt
Species
Rat (small mammal surrogate)
RS '.....$..¥..... ;..^f.ff,^.t'f <...
LD.mg/kg
>1500
- V'^ , f ' „' ' -
MRID#
00071392
rfYTft < '.V
Toxicity Category
Slightly toxic
The available mammalian data (TABLE 7) indicate that cryolite is no more
than slightly toxic to small mammals on an acute oral basis (MRJD 00071392).
30
-------
(4) Insects
A honey bee acute contact LD50 study is required if the proposed use will
result in honey bee exposure.
Species
Honey Bee
.11
Technical
ec4A«i»OOTto.«i3
*«-*.
>217
'«Kfc^mujto«spfe />;- -
MRID No. Author/Year
00036935 - Atkins, 1975
'i'l™ ' /' $ ' ' '',', /,'/ '
ToricMy Category
Practically nontoxic
"/.,
Fulfills Guideline
Requirement
Yes
There is sufficient information to characterize cryolite as practically
nontoxic to bees (TABLE 8). The guideline requirement is fulfilled (MRID
00036935).
be Toxicity to Aquatic Animals
(1) Freshwater Fish
In order to establish the toxicity of a pesticide to freshwater fish, the
minimum data required on the technical grade of the active ingredient are two
freshwater fish toxicity studies. One study should use a coldwater species
(preferably the rainbow trout), and the other should use a warmwater species
(preferably the bluegill sunfish).
:, ?JiBLE'#s fb&sfafafax 38sk'
Species
Rainbow trout
Rainbow trout
Bluegill sunfish
Bluegill sunfish
,'- '^
% A.I.
96
98
96
98
&«&&&* f
LC.n ppm a.i
47
>100
>400
>100
"^.. - >"*
MRID No.
40094602
Johnson & Finley,
1980
00147306
Bailey, 1984
40094602
Johnson & Finley,
1980
00147306
Bailey, 1984
/if,'-,,,;, ,,,,^ ^ ,^ 'I''';.'. ^ •. '-.'" ^ .. '
Toxicity Category
Slightly toxic
Practically nontoxic
Practically nontoxic
Practically nontoxic
Fulfills Guideline
Requirement
Yes
Yes
Yes
Yes
31
-------
TAB1»B tOt FtonsJa&ti Jfia
Spedes
Riinbowtrout
Bluegill suafish
% A.I.
50
50
^7 ""'"; t'A
LQ, ppnt a.i.
42.5
>100
^
MRIDNo.
00073803
McCann, 1971
00073804
McCann, 1972
"""'"' •, f
Toxicity Category
Slightly toxic
Practically nontoxic
' ' ^<:,,,; :'
Fulfills Guideline
Requirement
Yes
Yes
The results of the 96-hour acute toxicity studies (TABLES 9 and 10)
indicate that cryolite is no more than slightly toxic to fish. The guideline
requirements are fulfilled (MRIDs 40094602, 00147306, 00073803, and
00073804).
Data from fish early life-stage tests may be required if the product is
applied directly to water or is expected to be transported to water from the
intended use site, and when certain other conditions apply. Registered uses of
cryolite do not fulfill these conditions, therefore, data from these studies are not
required.
The fish life-cycle test is required when an end-use product is intended to
be applied directly to water or is expected to transport to water from the intended
use site, when any of the following conditions apply: the estimated environmental
concentration (EEC) is equal to or greater than one-tenth of the NOEL in the fish
early life-stage or invertebrate life-cycle test, or if studies of other organisms
indicate the reproductive physiology offish may be affected. Registered uses of
cryolite do not fulfill these conditions, therefore, data from this study are not
required.
(2) Freshwater Invertebrates
The minimum testing required to assess the hazard of a pesticide to
freshwater invertebrates is a freshwater aquatic invertebrate toxicity test,
preferably using first mstarDqphnia magna or early instar amphipods, stoneflies,
mayflies, or midges.
32
-------
>. IgABltBll? &res|rwajf«r Im<«rte1j^ieV«xlci:y JttecUsss -
Species
Simocephalus
Daphnia pulex
% A.I.
96
96
EC,, (ppm ai)
5.0
10.0
x;:'Lr^__
MRID NO. Author/Year
40094602 - Johnson and
Finley, 1980
40094602 - Johnson and
Finley, 1980
,,,,.,., , ' ^Iv-ssTJ
Toxicity
Category
Moderately toxic
Moderately toxic
£,,;.,,/' ' 7,
Fulfills Guideline
Requirement
No; supplemental
study1
Yes
IQCu iCSt SpCClCS.
There is sufficient information to characterize cryolite as moderately toxic
to aquatic invertebrates (TABLE 11). The guideline requirement is fulfilled
(MRID 40094602).
Data from an aquatic invertebrate life-cycle test may be required if the
product is applied directly to water or is expected to be transported to water from
the intended use site, and when certain other conditions apply. In view of the
environmental fate conclusions (see 2(a)(2), Exposure and Risk to Nontarget
Aquatic Animals, below), data from this study are not required for cryolite.
The following Daphnia life-cycle study was submitted and reviewed:
..UABkB-^i;. SPresirws
Species
Daphnia magna
tterlisveriBfaa
% A.I.
96.0
(feTflxidtyFiaaiHgs % '"
MATC (ppm ai)
>5.1, <9.9 for survival
^_vv?r::X *»«-
MRID NO.
Author/Year
41207701 Battelle, 1989
' ^\Z*'f< -\ -i* V
Fulfills Guideline
No; supplemental studj^
1. inis study was determined to be supplemental because M ATC's for reproduction and growth were not established.'
(3) Estuarine and Marine Animals
Acute toxicity testing with estuarine and marine organisms is required
when an end-use product is intended for direct application to the marine/estuarine
environment or is expected to reach this environment in significant concentrations.
In view of the environmental fate conclusions (see 3(a)(2), Exposure and Risk to
Nontarget Aquatic Animals), data from these studies are not required for cryolite.
The usual requirements under this category include a 96-hour LCSO for an
estuarine fish, a 96-hour LC50 for shrimp, and either a 48-hour embryo-larvae
study or a 96-hour shell deposition study with oysters. The following shrimp study
was submitted and reviewed:
33
-------
'•'*ABL&**kta«ftft^
Species
Pink Shrimp
% A.I.
96
HCtbfJ&BiSltg*; v'' ?
LC5/ECM (ppm ai)
>,4
Si ' '*• «•«•
MRID No. Author/Year
00073805 -Heftmuller,
1975
',
Torictty
Category
Slightly toxic
^ ,
Fulfills Guideline
Requirement . ,
No; supplemental
study1
Study wta conducted to tat the limits of solubility, actual EC50 was not determined.
There is sufficient information to characterize cryolite as no more than
slightly toxic to estuarine/marine shrimp (TABLE 13). (MRID 00073805).
c. Toxicity to Plants
(1) Terrestrial
Terrestrial plant testing (seedling emergence and vegetative vigor) is
required for herbicides that have terrestrial non-residential outdoor use patterns
and appear to move off site of application through volatilization (vapor pressure
>1.0 x 10"5mm Hg at 25C) or drift (aerial or irrigation), and/or that may have
endangered or threatened plant species associated with the site of application. The
above conditions do not apply for cryolite, therefore, plant data are not required.
(2) Aquatic
Aquatic plant testing is required for any herbicide or fungicide that has
outdoor non-residential terrestrial uses that may move off-site of application by
runoff (solubility >10 ppm in water), by drift (aerial or irrigation), or is applied
directly to aquatic use sites (except residential). The above conditions do not apply
for cryolite, therefore, aquatic plant data are not required.
2.
Environmental Fate
a.
Environmental Fate Assessment
Cryolite is a naturally occurring inorganic substance; however, most
present day supplies of cryolite are synthetically produced. The Agency primarily
based its assessment of the environmental fate of cryolite on various published
sources of information on its chemical constituents and fundamental chemistry.
In addition, two studies submitted by the registrant contained some useful
information on hydrolysis and leaching/adsorption. Because cryolite is an
inorganic substance, the complement of environmental fate studies normally
required for organic chemicals are not appropriate. However, enough is known
about is chemical nature from the open literature and the two studies submitted by
the registrant to complete the fate assessment without requiring additional testing.
34
-------
The Agency believes that once cryolite dissolves and penetrates to shallow
depths in soil solution (which is likely to occur as a result of watering of crops) or
is transported to natural waters, its constituent ions (Al and F) will rapidly reach
or be quickly converted to near background levels of numerous solvated or
complex ions containing aluminum and/or fluorine, or into insoluble minerals such
as fluorite and gibbsite. Standard agricultural practices to maintain soil fertility,
particularly pH regulation and maintenance of sources of readily available calcium
and other minerals, insure that the extreme excursions in the amounts of aluminum
or fluorine species present in some natural environments do not occur. Therefore,
the use of cryolite should have negligible impacts on ground and surface water
quality and there should be no difference in the accumulation of aluminum or
fluorine moieties in plants or animals.
b. Environmental Fate and Transport
Two laboratory studies were submitted to the Agency by the registrants.
The study containing hydrolysis information served only to show that "free"
fluoride concentrations increase with pH, and that in pure or laboratory buffered
water, less than half of the total fluorine is usually available in the form of free
fluoride ion. In the hydrolysis study, aluminum speciation with fluoride or
hydroxide was not determined, equilibrium constants were not measured, and the
results were not compared with those expected from the chemical literature. The
Agency interprets the study on leaching and adsorption as being consistent with
precipitation of fluoride. In addition to the information given in the two studies,
the Agency also used information reported in scientific journals and published in
standard references and textbooks in order to determine the fate of cryolite in soils.
No additional data are required at this time.
Environmental Chemistry
Cryolite's crystal lattice is composed of sodium ions (Na+) and
hexafluoroaluminate ions (A1F/-). When dissolved in soil solution, many
different aqueous species are possible and their relative concentrations depend
greatly on pH and on the presence and concentration of other soil ions or ligands.
Sodium ion will not be discussed here because it is well-known that it exchanges
freely in the environment and is considered non-toxic at concentrations far above
those that would result from cryolite application. This assessment, therefore,
considers the principal simple and complex solvated ions or neutral species
derived from the dissociation and hydrolysis of the hexafluoroaluminate ion, and
their chemical reactions with other ubiquitous environmental species.
In order to determine the fate of the hexafluoroaluminate ion, the
relationships and interactions of the ion with naturally occurring soil chemicals
35
-------
must be considered. Forms of the elements aluminum, calcium, and fluorine are
naturally abundant in the earth's soils, and their relative concentrations are subject
to considerable natural variation. These elements occur principally as insoluble
minerals with but a small fraction available for soil solution.
Fluoride. In the presence of calcium ion, fluoride is precipitated as
calcium fluoride (the insoluble mineral fluorite). This precipitation equilibrium
shifts such that the more dissolved calcium that is available, the less fluoride will
be in solution. Other even less soluble minerals (e.g., fluorapatite,
fluorphlogopite) and complexation with aluminum or other ions can further
depress fluoride. All processes depend on pH, prevailing mineral composition,
and even the presence of organic matter. Various literature sources suggest that
levels of calcium in natural soil solution are between 8 to 300 ppm. Simple
Agency calculation shows that for a soil with calcium ion at the lowest
concentration of 8 ppm, fluoride is limited by calcium fluoride solubility to a
maximum concentration range of approximately 4 to 16 ppm.
The Agency's calculations indicate that the natural soil background
equilibrium concentrations of fluoride would be approached if the fluoride from
cryolite, when cryolite is applied at the maximum yearly application rate of
172 kg/ha (154 Ib/acre), were to penetrate the soil to a maximum depth of around
40 to 50 cm (15 to 20 inches) (these calculations assumed that the soil has a
uniform horizon and a bulk density of 1.5 g/cm3, and half of the fluorine from
cryolite was conservatively complexed and the other'half "free" fluoride). Soil
factors such as inhomogeneous wetting or preferential flow would allow relatively
deeper movement. These calculated values for concentration and leaching depth
compare well with the four registrant-tested soils for which background (control)
fluoride content varied from about 2 to 14 ppm and leaching depth after cryolite
addition was well within the expected range.
Aluminum. An analysis of aluminum ions conducted by the Agency
indicates that aluminum ions or complexes are generally considered much less
toxic than fluoride. The aqueous amphoteric aluminum ion (A1(H2O)63H') strongly
and actively complexes with numerous other ions, including "free" fluoride (F~~)
and hydroxide (OH~~). These components are always present in soils, with or
without the application of cryolite. Concentrations of aluminum ions or
complexes are generally more stringently restricted by natural processes and by
less soluble clays and other minerals (for example, gibbsite, a form of aluminum
hydroxide) than those for calcium or fluorine.
Conclusion. The theoretically possible slight increases in equilibrium
concentrations of exchangeable aluminum or fluorine species in natural soils or
waters due to insecticidal application of cryolite are insignificant when compared
36
-------
to the existing background concentrations and the buffering capacity of the
environment for these specific minerals. In addition, any potential increase in
environmental concentrations may be offset by standard agricultural practices
(e.g., calcium applications, pH adjustments).
(1) Dissociation in Water
Hydrolysis. Synthetic cryolite (N^AlFg, sodium hexafluoroaluminate,
97.3% pure) at an initial concentration of 200 ppm yielded "free" fluoride ion
concentrations (as measured by a fluoride ion specific electrode) of 16.8, 40.0, and
47.0 ppm at pH's 5, 7, and 9, respectively. These concentrations correspond to
approximately 15.5, 37 and 43% of the total available fluorine.
Speciation (identification) of aluminum and fluorine complexes was not
attempted. No equilibria were measured or discussed (MRID 00142836).
(2) Mobility
The Agency interprets the leaching and adsorption study submitted by the
registrant as being consistent with precipitation of fluoride ion as calcium fluoride
(CaFj), rather than sorption in the usual sense. This interpretation is based upon
Agency calculations using the registrant's data and the properties that they gave
for four soils (mainly cation exchange capacity). Simple assumptions,
approximations, and use of controlling equilibria enable a good estimate of the
range of fluoride concentrations that could be expected in soil solution in field
situations.
Column Leaching, In a column leaching study using four different soils
with cryolite at an equivalent application rate of 16 Ib/acre, fluoride (the only
species monitored) showed little mobility. A fluoride ion specific electrode was
used for quantitation. Background fluoride concentrations from the control soils,
which varied from about 2 to 14 ppm, were subtracted from the treated soils.
Most fluoride remained within the top 24 cm of the columns. Some extraneous
leaching did occur to a maximum depth interval of 36-42 cm, but was probably
an artifact of method limitations and/or natural soil variation. No fluoride was
detected in the leachate of the 42 cm columns. For comparison, sodium fluoride,
which was run through equivalent soil columns at equivalent fluoride
concentration, showed virtually the same leaching profile for fluoride as cryolite
(MRID 00142837).
Adsorption. A batch equilibrium adsorption study was conducted for the
fluoride ion from cryolite with the same four soils used for column leaching
above. Desorption was not investigated. Cryolite soil treatment rates were 5, 10,
37
-------
20 and 50 ppm. A fluoride ion specific electrode was again used for quantitation.
Only simple sorption coefficients were calculated, not Freundlich coefficients.
The data show two striking features. First, there are large soil-dependent
differences in sorption, with "apparent" simple Kd's ranging from 1 to 53 in
standard units (calculated range of apparent Koc's is from approximately 600 to
6400). Second, there is a pronounced, regular concentration-dependent spread of
Kd values within three of the four individual soils. For these three soils the higher
the concentration, the lower the Kd. For example, in Lakeland sand with 5 ppm
of cryolite, the Kd is 6.6, but at 50 ppm of cryolite, the Kd is only 1.4.
These features prompted the Agency to conduct a Freundlich analysis
using the registrant's data. Results yielded exponents (1/n values) of
approximately 1/2 for three soils (exponents of 0.56, 0.49, and 0.69 for sand,
sandy loam, and silt loam soils, respectively). The exponent of about 1/2, the
seeming approach to "saturation" of fluoride, and the apparent lack of correlation
with organic matter in these soils suggested that the mineral precipitation with a
divalent cation is responsible for the observed behavior.
As calcium is usually a dominant exchangeable cation in soils, and also
forms insoluble calcium fluoride, the Agency tested the precipitation hypothesis
using registrant adsorption data, the solubility product constant for calcium
fluoride (the mineral fluorite), and the assumptions that approximately half of the
fluorine in cryolite is available as fluoride and that exchangeable calcium ion in
many soils usually accounts for about 0.1 to 0.2 of the maximum CEC (the
registrants did not report individual exchangeable cations). Calculations using the
various measured Kd's and water to soil ratios showed fluoride concentrations
consistent with those predicted.
Unlike the other three soils, the fourth soil (Aguila clay loam) had uniform
sorption coefficients for all four of the tested concentrations. Kd's averaged
approximately 8.9 ± 1.3 in standard units, the pH is 8.0, and its CEC is given as
43.6 meq/100 g. These high values are typical of a calcarious soil and require
special interpretation. With a large reserve of calcium, small changes in its
equilibrium concentration due to precipitation with fluoride are offset, and the soil
is far from being saturated with fluoride. Additional calcium ion available from
equilibrium with abundant solid carbonate opposes any shifts in dissolved calcium
concentration. Thus, the observed sorption behavior is again explainable if
calcium fluoride precipitation occurs (MRID 00142837).
38
-------
3. Exposure and Risk Characterization
a. Ecological Exposure and Risk Characterization
Explanation of the Risk Quotient (RQ) and the Level of Concen
(LOG): The Levels of Concern are criteria used to indicate potential risk to
nontarget organisms. The criteria indicate that a chemical, when used as directed,
has the potential to cause undesirable effects on nontarget organisms. There are
two general categories of LOG (acute and chronic) for each of the four nontarget
faunal groups and one category (acute) for each of two nontarget floral groups.
In order to determine if an LOG has been exceeded, a risk quotient must be
derived and compared to the LOC's. A risk quotient is calculated by dividing an
appropriate exposure estimate, e.g. the estimated environmental concentration,
(EEC) by an appropriate toxicity test effect level, e.g. the LCS0. The acute effect
levels typically are:
-EC25 (terrestrial plants),
-ECSO (aquatic plants and invertebrates),
-LC50 (fish and birds), and
-LDSO (birds and mammals)
The chronic test results are the:
-NOEL (sometimes referred to as the NOEC) for avian and mammal reproduction
studies, and either the NOEL for chronic aquatic studies, or the Maximum
Allowable Toxicant Concentration (MATC), the geometric mean of the NOEL and
the LOEL (sometimes referred to as the LOEC) for chronic aquatic studies.
When the risk quotient exceeds the LOG for a particular category, risk to that
particular category is presumed to exist. Risk presumptions are presented along
with the corresponding LOC's.
39
-------
Levels of Concern (LOC) and associated Risk Presumption
Mammals, Birds
IF THE
acute RQ>
acute RQ>
acute RQ>
chronic RQ>
Fish, Aquatic invertebrates
IP THE
acute RQ>
acute RQ>
acute RQ>
chronic RQ>
Plants
LOC
0.5
0.2
0.1
1
RQ>
RQ>
0.5
0.1
0.05
1
LOC
1
1
PRESUMPTION
High acute risk.
Risk that may be mitigated through
restricted use.
Endangered species may be affected
acutely.
Chronic risk, endangered species
may be affected chronically.
PRESUMPTION
High acute risk.
Risk that may be mitigated through
restricted use.
Endangered species may be affected
acutely.
Chronic risk, endangered species
may be affected chronically.
PRESUMPTION
High risk.
Endangered plants may be affected.
Currently, no separate criteria for restricted use or chronic effects for plants exist.
(1) Exposure and Risk to Nontarget Terrestrial Animals
(a) Birds
Residues found on dietary food items following cryolite application may
be compared to LCSO values to predict hazard. The maximum concentration of
residues of cryolite that may be expected to occur on selected avian or mammalian
dietary food items following a single application rate is provided in TABLE 14
below:
40
-------
mmH4r12Mna-&4 -B&favama^'
Food items
Range Grasses (short)
Fruit/Vegetable Leaves (other than
legumes)
Seeds
Fruits
!! f f / s •* "^' * ' *• •. :
SjjM^Htentlonssn Avian waA MamBiaJJan BlefcaryJSoo^ Items 'in. 3PPIV
EEC
6960
2079-2592
144-435
144-435 ,
RQ
0.696
0.208-0.259
0.014-0.043
0.014-0.043
Based on TABLE 14 above, the maximum expected residue (6960 ppm)
would occur on the short grass cover in citrus groves. The acute RQ for this use
(0.696) exceeds the LOC of 0.5, indicating acute risk to birds. Residues on fruit
and vegetable leaves (2079-2592 ppm) provide RQ's of 0.208-0.259, which
exceed the LOC of 0.2 for risk that may be mitigated through restricted use.
However, acute risk to birds is not expected from any registered use of
cryolite. It is unlikely that birds would receive significant dietary exposure.
Although many bird species will eat grasses, they generally provide a relatively
poor quality food when compared with the other potential food items listed in
TABLE 10. A more reasonable "worst case" scenario for cryolite ingestion by
birds is exemplified by contaminated grapes. This residue level is much less than
10% of the avian LC50 value (i.e., the criterion for concern about endangered
species). Therefore, it is unlikely that cryolite use poses any significant acute risks
to avian species, including those designated as endangered.
Avian reproduction data are not available for cryolite. Ordinarily, any
pesticide with multiple applications generates a concern for chronic risk to birds.
Although most cryolite uses allow for multiple applications, chronic risk is not a
concern in this case for the following reasons:
1) Cryolite is soluble in water (400 - 1200 ppm).
2) Cryolite is not persistent.
In view of the above, it is unlikely that cryolite residues will accumulate
on foliage. Any significant rainfall or irrigation would also serve to decrease the
probability of accumulation on foliage.
(b) Mammals
Small mammal exposure is addressed using acute oral LDSO values
converted to estimate a LCSO value for dietary exposure. The estimated LC50 is
derived using the following formula:
41
-------
LD«i x body weight
food consumption per day (g)
These estimated LC50s are shown in TABLE 15, below.
TAKE*****
Small Mammal
Meadow vole
Adult field mouse
VfaramatFooiJ ConHjasqrffi
Body Weight in Grams
46 gms
13 gms
aa'iaKhfls-QSiHwS on arei^e- «ni
% of Weight Eaten Per Day
61%
16%
,,'' " ^ - a- •. •. '
Food Consumed Per Day
in Grams
28.1 gms
2.1 gms
-- 5
Estimated LQ,
Per Day in PPMs
>2456 ppm
>9286 ppm
The above table is based on information contained inPrinciples of Mammalogvbv D. E. Davis and F. Golly, published by Reinhol
Corporation, 1963.
The estimated LC50 is then compared to the residues listed in TABLE 14
to calculate a risk quotient (EEC/LC^. TABLE 16 below shows the risk quotients
for each of the following application rates:
•TABU* <:S^S "^
Small Mammal
Meadow vole consuming range grasses
Adult field mouse consuming seeds
Application Rates in Ibs. a.i/A
15.4 (vegetables)
0.846
0.224
29 (citrus, ornamentals)
2.843
0.750
Figures from the above table indicate that RQ's will exceed LOC's for small
mammals. It should be noted, however, that these calculations are estimates based
on the value LD50> 1500 mg/kg, which is the "lowest" value available. The data
also show longer studies (28-day and 3-month) with rats, with no mortality at
levels as high as 50,000 ppm in the diet. Based on all the available information,
acute risk to small mammals is not expected from the use of cryolite.
For the same reasons listed above in the discussion on birds, chronic risk
to mammals is not expected from the use of cryolite.
(c) Insects
With an acute contact LD50 of >217 micrograms per bee, cryolite is
considered practically nontoxic to honey bees. Risk to honey bees is not expected.
42
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IV.
(2) Exposure and Risk to Nontarget Aquatic Animals
Expected Aquatic Concentrations. Cryolite displays only slight acute
toxieity to freshwater fish. Acute toxicity to Daphnia and shrimp is no more than
moderate.
Because of the unique nature of cryolite, and the fact that it is a naturally
occurring mineral, the standard EEC calculations are not appropriate for this
pesticide. This conclusion is based upon the fact that in the presence of sufficient
water, cryolite is quickly converted to near natural background levels of its
constituents. Once cryolite dissolves and penetrates to shallow depths in soil
solution or is transported to natural waters, any minor chemical imbalances caused
by its insecticidal application are offset by the specific mineral buffering capacity
of the environment and self-correcting agricultural practices. Ground or surface
water effects should be negligible, and no significant difference in the
accumulation of aluminum or fluoride moieties in plants or animals is expected to
occur. Therefore, the use of cryolite is not expected to present significant risk to
aquatic organisms.
(3) Exposure and Risk to Nontarget Plants
No data were required to support a nontarget plant risk assessment for
cryolite.
(4) Endangered Species
No risks to endangered species have been identified.
RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether products containing the active
ingredients are eligible for reregistration. The Agency has previously identified and
required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing cryolite as the active ingredient. The
Agency has completed its review of these generic data, and has determined that the data
are sufficient to support reregistration of products containing cryolite. Appendix B
identifies the generic data requirements that the Agency reviewed as part of its
determination of reregistration eligibility of cryolite, and lists the submitted studies that
the Agency found acceptable.
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The data identified in Appendix B were sufficient to allow the Agency to assess
the registered uses of cryolite and to determine that cryolite can be used without resulting
in unreasonable adverse effects to humans and the environment. The Agency therefore
finds that all products containing cryolite as the active ingredient, labeled and used as
specified in this document, are eligible for reregistration. The reregistration of particular
products is addressed in Section V of this document.
The Agency made its reregistration eligibility determination based upon the target
data base required for reregistration, the current guidelines for conducting acceptable
studies to generate such data, published scientific literature, etc. and the data identified
in Appendix B. Although the Agency has found that all of the supported uses of cryolite,
except strawberries, 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 cryolite, if new information comes to
the Agency's attention or if the data requirements for registration (or the guidelines for
generating such data) change. The reregistration eligibility for the use on strawberries
will be determined when the appropriate data are submitted and reviewed.
B. Determination of Eligibility Decision
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient cryolite,
the Agency has sufficient information on the health effects of cryolite and on its
potential for causing adverse effects in fish and wildlife and the environment. The
Agency has determined that cryolite products, labeled and used as specified in this
Reregistration Eligibility Decision, will not pose unreasonable risks or adverse
effects to humans or the environment Therefore, the Agency concludes that
products containing cryolite that are labeled for those uses that have been
supported, except strawberries, are eligible for reregistration. The eligibility for
the use on strawberries will be determined when the data are available and
reviewed.
2. Eligible and Ineligible Uses
The Agency has determined that the following supported uses of cryolite
are eligible for reregistration: broccoli, Brussels sprouts, cabbage, cauliflower,
citrus fruits, collards, cranberries, cucumbers, eggplant, grapes, kohlrabi, lettuce
(leaf and head), melons, peaches, peppers, plums (fresh prunes), pumpkins, squash
(winter and summer), tomatoes (except cherry), kiwi, potatoes, ornamental
herbaceous plants, ornamental nonflowering plants, ornamental woody shrubs and
vines and shade trees. The use on strawberries is being supported by IR4 but the
data are not currently available to reassess the eligibility. The use on blueberries
44
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and raspberries is not subject to a reregistration decision because these uses have
never been registered, although tolerances were historically set for these
commodities. 1R4 has indicated that they will be conducting the field trial data in
1996 to support the existing tolerances for the strawberries, blueberries and
raspberries.
Uses that are not being supported and for which tolerances will be revoked
include: apples, apricots, beans, beets, blackberries, boysenberries, carrots, corn,
dewberries, kale, loganberries, mustard greens, nectarines, okra, peanuts, pears,
peas, quinces, radish (roots and tops), rutabaga, turnips, and youngberries.
C. Regulatory Position
The following is a summary of the regulatory positions and rationales for cryolite.
Where labeling revisions are imposed, specific language is set forth in Section V of this
document.
1.
Tolerance Reassessment
Tolerances Listed Under 40 CFR 6180.145(a1: Tolerances listed in 40 CFR §180.145 are
for the combined residues of the insecticidal fluorine compounds cryolite and synthetic
cryolite. A summary of cryolite tolerance reassessments is presented in Table 17. The
established tolerances for broccoli, Brussels sprouts, cauliflower, cucumbers, grapes,
kohlrabi, melons, peppers, pumpkins, and squash are adequate. The following tolerance
proposals are pending approval with the Agency: increase for cabbage (45 ppm), citrus
fruit (95 ppm), collards (35 ppm), peaches (10 ppm) and potatoes (2 ppm); separate
tolerances proposed for head (180 ppm) and leaf lettuce (40 ppm). The established
tolerances for tomatoes and eggplant must be increased to 30 ppm. Additional data are
required to confirm the appropriate tolerance for cranberries and plums. Data are required
to determine the appropriate tolerance for strawberries.
Tolerance Listed Under 40 CFR S180.145ftA: The established tolerance for kiwifruit is
adequate.
Tolerances Listed Under 40 CFR S180.145fc): A petition for a permanent tolerance for
potatoes has been submitted and the Agency has reviewed the data. The Agency will
propose the establishment of a permanent tolerance for potatoes at the same level as the
current 2.0 ppm time-limited tolerance.
Tolerances Listed Under 40 CFR $186.3375 (time-limited tolerances): The current 22
ppm tolerance for potato waste is adequate, pending establishment of a permanent
tolerance on potatoes.
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Tolerances Needed Under 40 CFR §185.3375: Food additive tolerances are needed for
prunes, raisins (55 ppm) and tomato paste (45 ppm).
Table 17. Tolerance Reassessment Summary
Commodity
Current Tolerance
(ppm)
Tolerance
Reassessment (ppm)
Comment/Correct Commodity
Definition
Tolerances listed under 40 CFR 180.145(a):
Apples
Apricots
Beans
Beets, roots
Beets, tops
Blackberries
Blueberries (huckleberries)
Boysenberries
Broccoli
Brussels sprouts
Cabbage
Carrots
Cauliflower
Citrus fruits
Collards
Com
Cranberries
Cucumbers
Dewberries
Eggplant
Grapes
Kale
Kohlrabi
Lettuce
Loganberries
Melons
Mustard greens
Mectarines
Okra
7
7
7
7
7
7
7
7
7
7
7
7
7
7
7
7
7
7
7
7
7
7
7
7
7
7
7
7
7
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
TBDb
Revoke
7
7
45
Revoke
7
95
35
Revoke
TBDa
7
Revoke
30
7
Revoke
7
180
40
Revoke
7
Revoke
Revoke
Revoke
Not supported
Not supported
Not supported
Not supported
Not supported
Not supported
Data are required.
Not supported
New field trial data
Not supported
New field trial data
New field trial data
Not supported
Additional data are required.
Not supported
New field trial data
Not supported
Lettuce, head. New field trial
data
Lettuce, leaf. New field trial
data
Not supported
Not supported
Not supported
Not supported
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Commodity
Peaches
Peanuts
Pears
Peas
Peppers
Plums (fresh prunes)
Pumpkins
Quinces
Radish, roots
Radish, tops
Raspberries
Rutabaga, roots
Rutabaga, tops
Squash (winter)
Squash (summer)
Strawberries
Tomatoes
Turnip, roots
Turnip, tops
Youngberries
Current Tolerance
(ppm)
7
7
7
7
7
7
7
7
7
7
7
7
7
. 7
7
7
7
7
7
7
Tolerance
Reassessment (ppm)
10
Revoke
Revoke
Revoke
7
TBD"
7
Revoke
Revoke
Revoke
TBD"
Revoke
Revoke
7
7
TBDa
30
Revoke
Revoke
Revoke
Comment/Correc/ Commodity
Definition
New field trial data
Not supported
Not supported
Not supported ,
Additional data are required
Not supported
Not supported
Not supported
Data are required.
Not supported
Not supported
Data are required.
New field trial data
Not supported
Not supported
Not supported
Tolerances listed under 40 CFR 180.145(b):
Kiwifruit
1
Tolerances listed under 40 CFR 180.145(c)
Potatoes
2.0
(Time-limited to
expire on 5/6/96)
2.0
A permanent tolerance is
pending.
Tolerances needed under 40 CFR 185.3375
Prunes
Raisins
Tomato paste
none
None
None
TBD"
55
45
Additional data are required
Processing study
Processing study
Tolerances listed under 40 CFR 186.3375
Potato waste, process (wet or
dry)
22.0
(Time-limited to
expire on 5/6/96)
22.0
A permanent tolerance petition
has been submitted./
Potatoes, -waste from
processing
TBD = to be determined;
TBD = to be determined;
additional residue data are required.
additional residue data are required. Not currently a registered use.
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CODEX HARMONIZATION
No Codex Maximum Residue Limits (MRLs) for fluorine compounds
(Cryolite) exist. Therefore, there are no questions of compatibility with respect
to Codex MRLs and U.S. tolerances.
2. Tolerance Revocations and Import Tolerances
As part of the Agency's reregistration eligibility decision for cryolite,
several food uses will be voluntarily canceled. Once a pesticide use is no longer
registered in the United States, the related pesticide residue tolerance and/or
food/feed additive regulation generally is no longer needed. It is the Agency's
policy to propose revocation of a tolerance, and/or food/feed additive regulation,
following the deletion of a related food use from a registration, or following the
cancellation of a related food-use registration. The Agency has the responsibility
under the Federal Food, Drug and Cosmetic Act (FFDCA) to revoke a tolerance
on the grounds that the Agency cannot conclude the tolerance is protective of the
public health.
The Agency recognizes, however, that interested parties may want to retain a
tolerance and/or food/feed additive regulation in the absence of a U.S. registration,
to allow legal importation of food into the U.S. To assure that all food marketed
in the U.S. is safe, under FFDCA, the Agency requires the same technical
chemistry and toxicology data for such import tolerances (tolerances without
related U.S. registrations) as are required to support U.S. food use registrations
and any resulting tolerances. In addition, the Agency requires residue chemistry
data (crop field trials) that are representative of growing conditions in exporting
countries in the same manner that the Agency requires representative residue
chemistry data from different U.S. regions to support domestic use of the pesticide
and the tolerance and/or regulation.
Parties interested in supporting an existing cryolite tolerance as an import
tolerance should ensure that all of the data noted above are available to the
Agency, so that the Agency may determine whether maintenance of the tolerance
and/or regulation would be protective of the public health.
3.
Restricted Use Classification
Cryolite is not a Restricted Use pesticide and the Agency is not requiring
a change in this classification.
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4. Reference Dose and Cancer Classification
A weight-of-the-evidence dietary risk assessment for cryolite has been
conducted as recommended by the Agency's OPP Reference Dose (RfD)
Committee.
• "... There exists no directly applicable scientific documentation of adverse
medical effects at levels of fluoride below 8 mg/L [0.23 mg/kg/day].
(FR20166, Vol. 50, No. 93, 5/14/85)
• Less than 0.4% of the U.S. population (on public water supplies) is
exposed to greater than 2 mg/L fluoride [0.057 mg/kg/day] in the public
water supply. (Water Criteria Document, pg. IV-3, Table IV-1.)
• Dietary exposure estimates using reassessed tolerances and percent of
crops treated are approximately 0.020 mg/kg/day for the U.S. population
and 0.028 mg/kg/day for the highest exposed subgroup (females 13 years
and older and nursing). [Note: Dietary exposures from food sources are
high-end estimates, since tolerance values (which estimate high-end values
on treated crops) were used in the residue estimate.]
Therefore, it can be concluded that levels of fluoride in/on food from the
agricultural use of cryolite plus fluoride levels in U.S. drinking water supplies
results in a high-end daily dietary intake of fluoride of approximately 0.085
mg/kg/day. This is less than the MCLG of 4.0 mg/L [0.114 mg/kg/day], a level
which provides no known or anticipated adverse health effects. The MCLG has
been reviewed and is supported by the Surgeon General.
Cryolite has been classified as a Group "D" chemical, "not classifiable as
a human carcinogen". It has been the subject of a comprehensive review by the
National Research Council (National Academy of Sciences Subcommittee of
Health Effects of Ingested Fluoride) who concluded that "... the available
laboratory data are insufficient to demonstrate a carcinogenic effect of fluoride in
animals." and that"... the weight of evidence from more than 50 epidemiological
studies does not support the hypothesis of an association between fluoride
exposure and increased cancer risk in humans." The Agency is in agreement with
the conclusions reached by the National Academy of Sciences (NAS).
5. Endangered Species Statement
Currently, the Agency is developing a program ("The Endangered Species
Protection Program") to identify all pesticides whose use may cause adverse
impacts on endangered and threatened species and to implement mitigation
49
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measures that will eliminate the adverse impacts. The program would require use
restrictions to protect endangered and threatened species at the county level.
Consultations with the Fish and Wildlife Service may be necessary to assess risks
to newly listed species or from proposed new uses. In the future, the Agency
plans to publish a description of the Endangered Species Program in the Federal
Register. Because the Agency is taking this approach for protecting endangered
and threatened species, it is not imposing label modifications at this time through
the RED. Rather, any requirements for product use modifications will occur in the
future under the Endangered Species Protection Program.
6. Spray Drift Advisory
The Agency has been working with the Spray Drift Task Force, EPA
Regional Offices and State Lead Agencies for pesticide regulation to develop the
best spray drift management practices. The Agency is now requiring interim
measures that must be placed on product labels/labeling as specified in Section V.
Once the Agency completes its evaluation of the new data base submitted by the
Spray Drift Task Force, a membership of U.S. pesticide registrants, the Agency
may impose further refinements in spray drift management practices to further
reduce off-target drift and risks associated with this drift.
7. Environmental/Ecological Effects
The Agency has determined that it is unlikely that cryolite use poses any
significant acute risks to avian or mammalian species, including those designated
as endangered. Although most cryolite uses allow for multiple applications, avian
and mammalian chronic risks are not a concern in this case because cryolite is not
persistent and assuming any significant rainfall or irrigation during the application
interval (7-30 days), cryolite residues will not accumulate on foliage. Because of
the unique nature of cryolite, in the presence of sufficient water it is quickly
converted to near natural background levels of its constituents. Ground or surface
water effects are expected to be negligible, and no significant difference in the
accumulation of aluminum or fluoride moieties in plants or animals is expected to
occur. Therefore, the use of cryolite is not expected to present significant risk to
aquatic organisms.
8. Occupational/Residential Labeling Rationale/Risk Mitigation
All cryolite products are intended primarily for occupational use. There
are currently no cryolite products intended primarily for homeowner use.
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The Worker Protection Standard fWPSl
On August 21,1992 the Agency issued worker protection regulations effecting all
pesticide products whose labeling reasonably permits use in the production of agricultural
plants on any farm, forest, nursery or greenhouse. In general, products within the scope
of the Worker Protection Standard (WPS) had to bear complying labeling when sold or
distributed by the registrant after April 21, 1994.
The WPS labeling requirements pertaining to personal protective equipment
(PPE), restricted entry interval (REI) and notification are interim. The interim WPS
handler PPE requirements are based solely on the acute dermal and inhalation toxiciry and
skin and eye irritation potential of the end-use product. The interim WPS restricted-entry
intervals for agricultural workers are based solely on the acute dermal toxiciry and skin
and eye irritation potential of the active ingredient. The interim WPS "double"
notification requirement is imposed if the active ingredient is classified as toxicity
category I for acute dermal toxiciry or skin irritation potential. "Double" notification is
the statement on the labels of some pesticide products requiring employers to notify
workers about pesticide-treated areas orally as well as by posting of the treated areas.
These requirements are to be reviewed and revised, as appropriate during reregistration
and other Agency review processes. During reregistration, the Agency reviews risks
resulting from WPS uses as well as from all other occupational and residential uses.
Personal Protective Equipment for Handlers (Mixers, Loaders, Applicators, etc).
EPA has determined that occupational handler exposures and risks generally are
the same for WPS and nonWPS uses of cryolite. Therefore, occupational handler
exposures and risks are evaluated jointly. As a result of the reregistration evaluation of
the acute and other adverse effects of cryolite, the Agency has determined that risks to
handlers do not warrant the establishment of active-ingredient-based minimum personal
protective equipment or engineering-control requirements that would apply to all cryolite
end-use products. Handler PPE requirements for cryolite are to be based solely on the
acute toxicity of individual end-use products.
Entry Restrictions
As a result of the reregistration evaluation of the acute and other adverse effects
of cryolite, the Agency has determined that the risks from post-application exposures to
cryolite by workers warrant the minimum WPS REI of 12 hours. Furthermore, since EPA
has determined that the risks from adverse effects are minimal, EPA is establishing the
minimum WPS early-entry PPE of coveralls, chemical resistant gloves, shoes and socks.
Post- application exposures associated with non-WPS outdoor uses generally
involve less substantial, and briefer exposures than those associated with WPS uses.
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Therefore, the Agency generally uses a different standard for reentry into treated areas
following such uses. For nonWPS uses of cryolite, the Agency is requiring that reentry
be prohibited following liquid applications until sprays have dried and following dry
applications until dusts have settled. No PPE for nonWPS uses is specified since reentry
is prohibited until sprays have dried and dusts have settled.
Worker Notification
Cryolite is not classified as toxicity category I for select acute dermal toxicity or
skin irritation potential and is not classified as a severe skin sensitizer. EPA has no
special concerns about cryolite for adverse effects where a single exposure can trigger the
effect. EPA has not established an unusually long restricted-entry interval for cryolite.
Therefore, at this time, EPA is not requiring a WPS "double" notification statement on the
labeling of cryolite end-use products.
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistration
of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The following generic data are required before an eligibility decision can be made
for the use of cryolite on strawberries:
171-4(k) Magnitude of Residue in Strawberries.
The generic data base supporting the reregistration of cryolite for the eligible uses
has been reviewed and determined to be substantially complete for all uses. The
following data are required on a confirmatory basis.
Product Chemistry
All TGAI data requirements are satisfied for the Gowan synthetic cryolite alternate
formulations of the 96% EP/MP, except that data concerning the stability of the TGAI of
alternate formulation 3 remain outstanding. Additional product-specific (MP) data are
outstanding concerning both synthetic cryolite alternate formulations of the Gowan 96%
EP/MP. Provided that the registrants submit the data required for the 96% EP/MPs, and
either certify that the suppliers of beginning materials and the manufacturing processes
for the cryolite TGAIs have not changed since the last comprehensive product chemistry
52
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review or submit complete updated product chemistry data packages cryolite is eligible
for reregistration with respect to product chemistry data requirements.
Residue Chemistry
171-3 Directions For Use - all end-use product labels (e.g., MAI labels, SLNs,
and products subject to the generic data exemption) must be amended such that
they are consistent with the basic producer labels.
171-4(k) Magnitude of Residue.in Plants:
Cranberries - Additional data are required to support the currently registered use:
9.6 - 11.5 Ibs. a.i./acre/application, 35 Ibs. a.i./acre/seasoii maximum, 30 day
retreatment interval and 30 day PHI. Data must be submitted for three trials
conducted at the maximum label rate and minimum PHI.
Plums - Additional field trials are required to support the tolerance and proposed
use patterns. Three additional trials are required, one each in regions 5, 11, and
12.
2. Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing use product (MP)
labeling must be revised to comply with all current EPA regulations, PR Notices
and applicable policies. The MP labeling must bear the following statement under
Directions for Use:
"Only for formulation into an [fill blank with Insecticide, Herbicide or the
applicable term which describes the type of pesticide use(s)] for the
following use(s) [fill blank only with those uses that are being supported
by MP registrant."
An MP registrant may, at his/her discretion, add one of the following statements
to an MP label under
"Directions for Use" to permit the reformulation of the product for
a specific use or all additional uses supported by a formulator or
user group:
(a) "This product may be used to formulate products for specific use(s)
not listed on the MP label if the formulator, user group, or grower
has complied with U.S. EPA submission requirements regarding
support of such use(s)."
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(b) "This product may be used to formulate products for any additional
use(s) not listed on the MP label if the formulator, user group, or
grower has complied with U.S. EPA submission requirements
regarding support of such use(s)."
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility
has been made. The product specific data requirements are listed in Appendix G,
the Product Specific Data Call-in Notice.
Registrants must review previous data submissions to ensure that they meet
current EPA acceptance criteria (Appendix F; Attachment E) and if not, commit
to conduct new studies. If a registrant believes that previously submitted data
meet current testing standards, then study MRID numbers should be cited
according to the instructions in the Requirement Status and Registrants Response
Form provided for each product.
2. Labeling Requirements for.End-Use Products
The labels and labeling of all products must comply with EPA's current
regulations and requirements as specified in 40 CFR 156.10 and other applicable
notices. All end-use product labels [e.g. multiple active ingredient (MAI) labels,
SLN's, and products subject to generic data exemption] must be amended such
that they are consistent with the basic producer labels. See Appendix A for
appropriate rates and restrictions for those supported uses.
a. Occupational/Residential Protection
PPE/Engineering Control Requirements for Pesticide Handlers
For sole-active-ingredient end-use products that contain cryolite, the handler
personal protective equipment requirements set forth in this section must be incorporated
on all cryolite product labels. Any conflicting PPE requirements on current labeling must
be removed. There are currently no multiple-active-ingredient end-use products that
contain cryolite.
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Products Intended Primarily for Occupational Us
-------
Placement in labeling:
If WPS uses are also on label, follow the instructions in PR Notice 93-7 for
establishing a Non-Agricultural Use Requirements box and place the appropriate nonWPS
entry restriction in that box. If no WPS uses are on the label add the appropriate nonWPS
entry restriction in the Directions-For-Use section on the end-use-product labeling.
b. Other Labeling Requirements
The Agency is requiring the following labeling statements to be located on all end-
use products containing cryolite that are intended primarily for occupational use:
Application Restrictions
"Do not apply this product in a way that will contact workers or other persons,
either directly or through drift. Only protected handlers may be in the area during
application."
User Safety Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such
instructions for washables, use detergent and hot water. Keep and wash PPE
separately from other laundry."
User Safety Recommendations
• "Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet."
• "Users should remove clothing immediately if pesticide gets inside. Then
wash thoroughly and put on clean clothing."
« "Users should remove PPE immediately after handling this product. Wash
the outside of gloves before removing. As soon as possible, wash
thoroughly and change into clean clothing."
Environmental Hazard Statement
The labels of all cryolite end-use products must be revised to bear the following under the
Environmental Hazard Section:
56
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• "Do not apply directly to water, or to areas where surface water is present or to
intertidal areas below the mean high-water mark. Do not contaminate water when
disposing of equipment wash water or rinsate."
c. Spray Drift Labeling
The following language must be placed on each product label that can be applied aerially:
Avoiding spray drift at the application site is the responsibility of the applicator.
The interaction of many equipment-and-weather-related factors determine the
potential for spray drift. The applicator and the grower are responsible for
considering all these factors when making decisions.
The following drift management requirements must be followed to avoid off-target
drift movement from aerial applications to agricultural field crops. These
requirements do not apply to forestry applications, public health uses or to
applications using dry formulations.
1. The distance of the outer most nozzles on the boom must not exceed 3/4
the length of the wingspan or rotor.
2. Nozzles must always point backward parallel with the air stream and never
be pointed downwards more than 45 degrees.
Where states have more stringent regulations, they should be observed.
The applicator should be familiar with and take into account the information
covered in the Aerial Drift Reduction Advisory Information.
The following aerial drift reduction advisory information must be contained in the
product labeling:
[This section is advisory in nature and does not supersede the mandatory
label requirements.]
INFORMATION ON DROPLET SIZE
The most effective way to reduce drift potential is to apply large droplets. The
best drift management strategy is to apply the largest droplets that provide
sufficient coverage and control. Applying larger droplets reduces drift potential,
but will not prevent drift if applications are made improperly, or under
unfavorable environmental conditions (see Wind, Temperature and Humidity, and
Temperature Inversions).
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CONTROLLING DROPLET SIZE
* Volume - Use high flow rate nozzles to apply the highest practical spray
volume. Nozzles with higher rated flows produce larger droplets.
• Pressure - Do not exceed the nozzle manufacturer's recommended
pressures. For many nozzle types lower pressure produces larger droplets. When
higher flow rates are needed, use higher flow rate nozzles instead of increasing
pressure.
• Number of nozzles - Use the minimum number of nozzles that provide
uniform coverage.
• Nozzle Orientation - Orienting nozzles so that the spray is released parallel
to the airstream produces larger droplets than other orientations and is the
recommended practice. Significant deflection from horizontal will reduce droplet
size and increase drift potential.
• Nozzle Type - Use a nozzle type that is designed for the intended
application. With most nozzle types, narrower spray angles produce larger
droplets. Consider using low-drift nozzles. Solid stream nozzles oriented straight
back produce the largest droplets and the lowest drift.
BOOM LENGTH
For some use patterns, reducing the effective boom length to less than 3/4 of the
wingspan or rotor length may further reduce drift without reducing swath width.
APPLICATION HEIGHT
Applications should not be made at a height greater than 10 feet above the top of
the largest plants unless a greater height is required for aircraft safety. Making
applications at the lowest height that is safe reduces exposure of droplets to
evaporation and wind.
SWATH ADJUSTMENT
When applications are made with a cross-wind, the swath will be displaced
downward. Therefore, on the up and downwind edges of the field, the applicator
must compensate for this displacement by adjusting the path of the aircraft
upwind. Swath adjustment distance should increase, with increasing drift potential
(higher wind, smaller drops, etc.)
58
-------
WIND
Drift potential is lowest between wind speeds of 2-10 mph. However, many
factors, including droplet size and equipment type determine drift potential at any
given speed. Application should be avoided below 2 mph due to variable wind
direction and high inversion potential. NOTE: Local terrain can influence wind
patterns. Every applicator should be familiar with local wind patterns and how
they affect spray drift.
TEMPERATURE AND HUMIDITY
When making applications in low relative humidity, set up equipment to produce
larger droplets to compensate for evaporation. Droplet evaporation is most severe
when conditions are both hot and dry.
TEMPERATURE INVERSIONS
Applications should not occur during a temperature inversion because drift
potential is high. Temperature inversions restrict vertical air mixing, which causes
small suspended droplets to remain in a concentrated cloud. This cloud can move
in unpredictable directions due to the light variable winds common during
inversions. Temperature inversions are characterized by increasing temperatures
with altitude and are common on nights with limited cloud cover and light to no
wind. They begin to form as the sun sets and often continue into the morning.
Their presence can be indicated by ground fog; however, if fog is not present,
inversions can also be identified by the movement of smoke from a ground source
or an aircraft smoke generator. Smoke that layers and moves laterally in a
concentrated cloud (under low wind conditions) indicates an inversion, while
smoke that moves upward and rapidly dissipates indicates good vertical air
mixing.
SENSITIVE AREAS
The pesticide should only be applied when the potential for drift to adjacent
sensitive areas (e.g. residential areas, bodies of water, known habitat for
threatened or endangered species, non-target crops) is minimal (e.g. when wind
is blowing away from the sensitive areas).
C. Tolerance Revocation and Import Tolerances
The use of cryolite on apples, apricots, beans, beets, blackberries, boysenberries,
carrots, com, dewberries, kale, loganberries, mustard greens, nectarines, okra, peanuts,
pears, peas, quinces, radish (roots and tops), rutabaga, turnips, and youngberries is being
59
-------
voluntarily canceled as part of the Agency's reregistration eligibility decision regarding
this pesticide. It is the Agency's policy to propose revocation of a tolerance, and/or
food/feed additive regulation, following the deletion of a related food use from a
registration, or following the cancellation of a related food-use registration. As a result,
any parties interested in supporting the tolerance/regulation for import purposes in the
absence of a registered U.S. use should notify the Agency as soon as possible.
Li responding, the Agency will provide detailed information on the outstanding
data requirements for these tolerances and/or regulations. The Agency will consider
commitments made to generate data to support such tolerances/regulations and the
timeliness of data submissions in its assessment of whether the tolerances/regulations
should be retained. Persons interested in establishing a new tolerance for import purposes
only, or retaining a current tolerance for import purposes following cancellation of the
related use, must submit a petition, along with the appropriate supporting data.
D. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling
for 26 months from the date of the issuance of this Reregistration Eligibility Decision
(RED). Persons other than the registrant may generally distribute or sell such products for
50 months from the date of the issuance of this RED. However, existing stocks time
frames will be established case-by-case, depending on the number of products involved,
the number of label changes, and other factors. Refer to "Existing Stocks of Pesticide
Products; Statement of Policy"; Federal Register. Volume 56, No. 123, June 26,1991.
The Agency has determined that registrants may distribute and sell cryolite
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.
60
-------
VI. APPENDICES
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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 Cryolite covered by this Reregistration Eligibility Decision
Document It contains generic data requirements that apply to Cryolite 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 CFRPart 158. the reference numbers accompanying each test refer to the test
protocols set in the Pesticide Assessment Guidelines, which are available from the National
Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this
column lists the identifying number of each study. This normally is the Master Record
Identification (MR3D) number, but may be a "GS" number if no MRED number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
88
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GUIDE TO APPENDIX C
CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere
in the Reregistration Eligibility Document. Primary sources for studies in this
bibliography have been the body of data submitted to EPA and its predecessor agencies
in support of past regulatory decisions. Selections from other sources including the
published literature, in those instances where they have been considered, are included.
UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case
of published materials, this corresponds closely to an article. In the case of unpublished
materials submitted to the Agency, the Agency has sought to identify documents at a level
parallel to the published article from within the typically larger volumes in which they
were submitted. The resulting "studies" generally have a distinct title (or at least a single
subject), can stand alone for purposes of review and can be described with a conventional
bibliographic citation. The Agency has also attempted to -unite basic documents and
commentaries upon them, treating them as a single study.
IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique to
the citation, and should be used whenever a specific reference is required. It is not related
to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4(d)(4) below for further explanation). In a few cases,
entries added to the bibliography late in the review may be preceded by a nine character
temporary identifier. These entries are listed after all MRID entries. This temporary
identifying number is also to be used whenever specific reference is needed.
FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a. Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the Agency
has shown an identifiable laboratory or testing facility as the author. When no
author or laboratory could be identified, the Agency has shown the first submitter
as the author.
b. 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. Title. In some cases, it has been necessary for the Agency bibliographers to create
or enhance a document title. Any such editorial insertions are contained between
square brackets.
95
-------
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following
elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the word
"under" is the registration number, experimental use permit number,
petition number, or other administrative number associated with the
earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume in
which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for "Company
Data Library." This accession number is in turn followed by an alphabetic
suffix which shows the relative position of the study within the volume.
96
-------
BIBLIOGRAPHY
MRID
CITATION
U.S. Department of Health and Human Services, National Institute of Health
(1990). Technical Report Series No. 393. Toxicology and Carcinogenesis Studies
of Sodium Fluoride (CAS No. 7681-49-4) in F344/N Rats ands B6C3F! Mice
(Drinking Water Studies). National Toxicology Program, Reserach Triangle Park,
NC. NTH Publiction No. 91-2848.
00036395 Atkins, EX.; Greywood, E.A.; Macdonald, R.L. (1975) Toxicity of Pesticides and
Other Agricultural Chemicals to Honey Bees: Laboratory Studies. By University
of California, Dept of Enotomology: UC, Cooperative Extension. (Leaflet 2287;
published study).
00073805 Heitmuller, T. (1975) Acute Toxicity of Kryocide to Pink Shrimp (-Penaeus
duorarum-) and Fiddler Crabs (~Uca pugilator-). (Unpublished study received
Mar 4, 1975 under 1202-297; prepared by Bionomics~EG & G, Inc., submitted
by Puregro Co., Los Angeles, Calif.; CDL:222201-A)
00073803 McCann, J.A. (1971) Cryolite 50 Dust: Rainbow Trout: Test No. 416. (U.S.
Agricultural Research Service, Pesticides Regulation Div., Animal Biology
Laboratory; unpublished study; CDL:104869-A)
00073804 McCann, J.A. (1972) Cryolite 50 Dust: Bluegill (Lepomis macrochirus): Test No.
443. (U.S. Agricultural Research Service, Pesticides Regulation Div., Animal
Biology Laboratory; unpublished study; CDL:129759-A)
00084001 Fink, R. (1975) Final Report: Eight-day Dietary LC50--Bobwhite Quail: Project
No. 110-103. (Unpublished study received Mar 4,1975 under 1202-297; prepared
by Truslow Farms, Me., submitted by Puregro Co., Los Angeles, Calif.;
CDL:222203-A)
00084002 Fink, R. (1975) Final Report: Eight-day Dietary LC50-~Mallard Ducks: Project
No. 110-104. (Unpublished study received Mar 4, 1975 under 1202-297; prepared
by Truslow Farms, Inc., submitted by Puregro Co., Los Angeles, Calif.;
CDL:222203-B)
00102979 Pennwalt Corp. Agchem Div. (1980) Lettuce: (Efficacy of Kryocide).
(Unpublished study received Apr 19, 1982 under CA 81/90; CDL:
CDL:247554-A)
00128106 Ralston Purina Co. (1981) Acute Oral Toxicity-Method, Summary, Pathology;
Primary Dermal Irritation—Method, Summary; Primary Eye Irritation—Method,
Summary: 0Kryocide Insecticide NB 84-146-2B: Rats, Rabbits |: RT Lab No.
880531. (Unpublished study received Feb 10,1983 under 4581-116; submitted
by Agchem Div., Pennwalt Corp., Philadelphia, PA; CDL:071392-A)
97
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BIBLIOGRAPHY
MRID
CITATION
00128107 Hansen, K.; Mills, V.; Beck, L.; et al. (1981) Acute Dermal Toxicity Study:
Kiyocide Lisecticide (N.B. 84-146-2B): Rabbits: Project No. 1685-C; Project No.
1136. Rev. rept. (Unpublished study received Feb 10, 1983 under 4581-116;
prepared by Elars Bioresearch Laboratories, Inc. and Westpath Laboratories, Inc.,
submitted by Agchem Div., Pennwalt Corp., Philadelphia, PA; CDL: 071392-B)
00128112 Harris, S.; Holson, J.; Barnett, W.; et al. (1983) Final Report for a Teratology
Study of Kryocide Insecticide in Albino Rats: PNW/ S Al 1182008. (Unpublished
study received Feb 10,1983 under 4581-116; prepared by Science Applications,
Inc., submitted by Agchem Div., Pennwalt Corp., Philadelphia, PA;
CDL:071392-H)
00130741 Gowan Co. (1981) Study-Residue: Flourine on Grapes and Raisins. (Compilation;
unpublished study received Aug 9, 1983 under 10163-41; CDL:251073-A)
00138096 Hazleton Laboratories America, Inc. (1983) Acute Oral Toxicity-Method,
Summary, Pathology-Raw Data Attached: Kryocide: RT Lab No. 814515.
(Unpublished study received Dec 29,1983 under 4581-116; submitted by Agchem
Div., Pennwalt Corp., Philadelphia, PA; CDL:252071-A)
00138097 Hazleton Laboratories America, Inc. (1983) Dermal Sensitization Study in Guinea
Pigs-Closed Patch Technique: Kryocide: RT Lab No. 814516. (Unpublished
study received Dec 29, 1983 under 4581-116; submitted by Agchem Div.,
Pennwalt Corp., Philadelphia, PA; CDL:252071-B)
00142836 Dykeman, R. (1985) The Hydrolysis of Synthetic Cryolite (Kryocide Insecticide):
Project No. WT-5-85. Unpublished study prepared by Agchem Div. Pennwalt
Corp. 16 p.
00142837 Dykeman, R. (1985) The Leaching of Synthetic Cryolite (Kryocide Insecticide)
in Soil Columns: Project No. WT-4-85. Unpublished study prepared by Agchem
Div. Pennwalt Corp. 32 p.
00147306 Bailey, H. (1984) Static Acute Studies on Kryocide Insecticide with Rainbow
Trout (Salmo gairdneri), Bluegill Sunfish (Lepomis macrochirus and Daphnia
magna): Project LSC-7632. Unpublished study prepared by SRI International.
25 p.
00149815 Nigh, E. (1985) Letter sent to W. Miller dated January 22, 1985: Cryolite on
grapes. Prepared by Gowan Co. 2 p.
00152192 Gowan Co. (1983) Chemical and Physical Properties of the Active Ingredient
Sodium Fluoaluminate. Unpublished compilation. 17 p.
98
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BIBLIOGRAPHY
MRID
CITATION
00152375 Fletcher, D. (1984) Acute Oral Toxicity Study with Kryocide Insecticide in
Bobwhite Quail: Final Report to Pennwalt Corporation: BLAL No. 83 QD 42.
Unpublished study prepared by Bio-Life Associates, Ltd. 19 p.
00157999 Hagen, C.; Strouse, J. (1986) 90-Day Dietary Study in Dogs with Kryocide: Final
Report: Project No. WIL-75007. Unpublished study prepared by WIL Research
Laboratories, Inc. 563 p.
00158000 Weltman, R. (1985) Subchronic Toxicity Study with Kryocide Insecticide in Rats:
Final Report: Study No. 6120-100. Unpublished study prepared by Hazleton
Laboratories America, Inc. 684 p.
00158001 Carlson, R.; Keckemet, O. (1986) Results of Tests on the Amounts of Residue
Occurring in Crops and Animal Products from Use of Kryocide Brand Synthetic
Cryolite. Unpublished study prepared by Pennwalt Corp. 276 p.
40094602 Johnson, W.W.; Finley, M.T. (1980) Handbook of acute toxicity of chemicals to
fish and aquatic invertebrates. USFWS Publications No. 137.
40193801 Wada, T. (1987) Prokil Cryolite 96: Product Chemistry: Product Identity and
Composition. Unpublished compilation prepared by Central Glass Co., Ltd. 17
P-
40635601 Markle, G.; Archer, T.; Beutel, J. (1988) Cryolite-Magnitude of Residue on
Kiwifruit: IR-4 PR No. 2709. Unpublished study prepared by IR-4 Western
Region Analytical Laboratory, Univ. of CA. 28 p.
40692001 Plebankiewicz, A. (1987) Product Chemistry: Product Identity and Composition:
Prokil Cryolite 96: Project ID: Minex. Unpublished study prepared by Siarkopol
Sulfur Plant, Poland. 10 p.
40692002 Plebankiewcz, A. (1987) Product Chemistry: Analysis and Certification of Product
Ingredients: Prokil Cryolite 96: Project ID: Minex. Unpublished study prepared
by Siarkopol Sulfur Plant, Poland. 38 p.
40705101 Hellburg (1988) Product Chemistry: Product Identity and Composition: Prokil
Cryolite 96. Unpublished study prepared by KaliChemie Aktiengesellschaft. 8
P-
40705102 Hellburg (1987) Product Chemistry: Analysis and Certification of Product
Ingredients: Prokil Cryolite 96. Unpublished study prepared by KaliChemie
Aktiengesellschaft. 12 p.
99
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BIBLIOGRAPHY
MRID
CITATION
40705103 Hellburg (1988) Product Chemistry: Physical and Chemical Characteristics: Prokil
Cryolite 96. Unpublished study prepared by KaliChemie Aktiengesellschaft. 5
P-
41014701 Skjoldager, S. (1989) Prokil Cryolite 96: Product Chemistry: Project ID: Crydata.
Unpublished study prepared by Kryolitselskabet Oresund A/S. 6 p.
41021201 Freedlander, R. (1988) Kryocide Magnitude of the Residue in Potato: Project No.
BR-88-21-1; Pennwalt Study No. 70-88. Unpublished study prepared by
McKenzie Laboratories, Inc. 356 p.
41021202 Freedlander, R. (1988) Kyrocide Magnitude of the Residue in Processed Potato
Fractions: Project No. BR-88-22-1; Pennwalt Study No. 69-88. Unpublished
study prepared by McKenzie Laboratories Inc. 176 p.
41022901 Dahl, G. (1989) Kryocide Insecticide: Product Chemistry: Laboratory Project ID:
PW-120. Unpublished compilation prepared by Pennwalt Corp. 14 p.
41022902 DeSavigny, C. (1989) Kryocide Insecticide: Product Chemistry: Laboratory
Project ID: PW-122. Unpublished study prepared by Pennwalt Corp. 6 p.
41116701 Dahl, G. (1989) Kryocide Insecticide: Analysis of Samples: Laboratory Project ID
PW-127. Unpublished study prepared by Onada Chemical Industry Co., Ltd. 8
P-
41170001 Takeuchi, Y.; Tomita, T.; Codrea, E. (1989) Prokil Cryolite 96: Central...: Product
Chemistry...(Supplemental Information): Project ID Toyomenka SF. Unpublished
study prepared by Central Glass Company, Ltd. in cooperation with Gowan
Company. 30 p.
41200801 Skjoldager, S.; Gardner, W. and Codrea, E. (1989) Prodil Cryolite 96: Product
Chemistr: Analysis and Certification of Product Ingredients: Proj ect ID Crydata.
Unpublished study prepared by Kryolitselskabet Oresund A/S. 21 p.
41207701 Mclntyre, D. (1989) Chronic Toxicity of Cryolite (...) to the Freshwater
Invertebrate, Daphniamagna: Proj. No. PN-001. Unpublished study prepared by
Battelle Columbus Laboratories. 88 p.
41224801 Wilkinson, G.; Tosca, P.; Singer, A. et. al. (1989) 21-Day Repeated Dose Dermal
Toxicity Study of Cryolite in the Rabbit: BCD Study No. N4900-2001.
Unpublished study prepared by Battele Columbus Division. 167 p.
100
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BIBLIOGRAPHY
MRID
CITATION
41229101 Dahi, G. (1989) Kiyocide Insecticide: Product Chemistry: Project ID PW-128.
Unpublished study prepared by Onada Chemical Industry Co., Ltd. 7 p.
41235501 Codrea, E. (1989) Prokyl Cryolite 96: Product Chemistry: Dissociation Constant:
Project ID Toyomenka SF. Unpublished study prepared by Gowan Co. 4 p.
41239301 Codrea, E. (1989) Prokil Cryolite 96: Product Chemistry (Dissociation Constant):
Project ID Crydata. Unpublished study prepared by Gowan Co. 4 p.
41260901 Kroeger, H. (1989) Product Chemistry: Prokil Cryolite 96: Supplemental
Information: Project ID Kalichem. Unpublished study prepared by KaliChemie
Aktiengesellschaft. 63 p.
41287201 Codrea, E. (1989) Product Chemistry: Dissociation Constant: Prokil Cryolite 96:
Lab Project ID: KALICHEM. Unpublished study prepared by KaliChemie
Aktiengesellschaft. 4 p.
41380601 Pitt, J. (1989) Kryocide: Magnitude of the Residue in Collard: Lab Project
Number: BR-88-64; Pennwalt Study No. 61-88. Unpublished study prepared by
Pennwalt Corp. and McKenzie Laboratories, Inc. 178 p.
41380602 Pitt, J. (1989) Kryocide: Magnitude of the Residue in Cantaloupe: Lab Project
Number: BR-88-63: Pennwalt Study No. 64-88. Unpublished study prepared by
Pennwalt Corp. and McKenzie Laboratories, Inc. 175 p.
41380603 Pitt, J. (1989) Kryocide: Magnitude of the Residue in Squash: Lab Project
Number: BR-88-67; Pennwalt Study No. 65-88. Unpublished study prepared by
Pennwalt Corp. and McKenzie Laboratories, Inc. 232 p.
41380604 Pitt, J. (1989) Kryocide: Magnitude of the Residue in Grapefruit: Lab Project
Number: BR-88-26-1; Pennwalt Study No. BR-88-26. Unpublished study
prepared by Pennwalt Corp. and McKenzie Laboratories, Inc. 239 p.
41380605 Pitt, J. (1989) Kryocide: Magnitude of the Residue in Lemon: Lab Project
Number: BR-88-11. Unpublished study prepared by Pennwalt Corp. and
McKenzie Laboratories, Inc. 225 p.
41380606 Pitt, J. (1989) Kryocide: Magnitude of the Residue in Orange: Lab Project
Number: BR-88-25. Unpublished study prepared by Pennwalt Corp. and
McKenzie Laboratories, Inc. 242 p.
101
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BIBLIOGRAPHY
MRID
CITATION
41380607 Pitt, J. (1989) Kiyocide: Magnitude of the Residue in Processed Orange Fractions:
Lab Project Number: BR-88-24-1; Pennwalt Study No. 75-88. Unpublished study
prepared by Pennwalt Corp. and McKenzie Laboratories, Lie. 171 p.
41380608 Pitt, J. (1989) Kiyocide: Magnitude of the Residue in Tomato: Lab Project
Number: BR-88-68; Pennwalt Study No. 66-88. Unpublished study prepared by
Pennwalt Corp. and McKenzie Laboratories, Inc. 272 p.
413 80609 Pitt, J. (1989) Kiyocide: Magnitude of the Residue in Processed Tomato Fractions:
Lab Project Number: BR-88-69: Pennwalt Study No. 67-88. Unpublished study
prepared by Pennwalt Corp. and McKenzie Laboratories, Inc. 96 p.
41380610 Pitt, J. (1989) Kryocide: Magnitude of the Residue in Cabbage: Lab Project
Number: BR-88-62; Pennwalt Study No. 62-88. Unpublished study prepared by
Pennwalt Corp. and McKenzie Laboratories, Inc. 267 p.
41380611 Pitt, J. (1990) Kryocide: Magnitude of the Residue in Lettuce: Lab Project
Number: BR-88-65: Pennwalt Study No. 60-88. Unpublished study prepared by
Pennwalt Corp. and McKenzie Laboratories, Inc. 194 p.
41419301 Michalak, Z.; Broomberg, S.; Gardner, W. (1990) Prokil Cryolite 96 (...):
Proposed Alternate Technical Source Produced by Siarkopol Sulfur Plant, Poland:
Product Chemistry: Supplemental: Lab Project Number: Minex. Unpublished
study prepared by Siarkopol Sulfur Plants and Gowan Co. 23 p.
41429801 Pitt, J. (1990) Kryocide Magnitude of the Residue in Processed Potato Fractions:
Addendum: Lab Project Number: BR-89-44-1. Unpublished study prepared by
McKenzie Laboratories, Inc. 43 p.
41613101 Dahl, G. (1990) Kiyocide Insecticide: Analysis of Samples: Lab Project Number:
PW-127. Unpublished study prepared by Onoda Chemical Industry Co., Ltd. 24
P-
41694101 Craine, E. (1990) A Feeding Study with Dairy Cows Using Kryocide (Synthetic
Cryolite): Addendum to the Final Report: Lab Project Number: 262373.
Unpublished study prepared by WIL Research Laboratories, Inc. 16 p.
41694102 Craine, E. (1990) A Feeding Study with Dairy Cows Using Kryocide (Synthetic
Cryolite): Amendment I to the Final Report: Lab Project Number: WIL-75011.
Unpublished study prepared by WIL Research Laboratories, Inc. 10 p.
102
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BIBLIOGRAPHY
MRID
CITATION
41694103
41694104
41694105
41694106
41694107
41694108
41782101
41838401
41838402
41838403
42067901
Craine, E. (1990) A Feeding Study with Dairy Cows Using Kiyocide (Synthetic
Cryolite):. Amendment II to the Final Report: Lab Project Number: WIL-75011.
Unpublished study prepared by WIL Research Laboratories, Inc. 9 p.
Craine, E. (1990) A Feeding Study with Dairy Cows Using Kryocide (Synthetic
Cryolite): Amendment II to the Final Report: Lab Project Number: WIL-75011.
Unpublished study prepared by WIL Research Laboratories, Inc. 16 p.
Craine, E. (1990) A Feeding Study with Chickens Using Kryocide (Synthetic
Cryolite): Amendment I to the Final Report: Lab Project Number: WIL-75012.
Unpublished study prepared by WIL Research Laboratories, Inc. 12 p.
Craine, E. (1990) A Feeding Study with Chickens Using Kryocide (Synthetic
Cryolite): Amendment I to the Final Report: Lab Project Number: WIL-75012.
Unpublished study prepared by WIL Research Laboratories, Inc. 10 p.
Craine, E. (1990) A Feeding Study with Chickens Using Kryocide (Synthetic
Cryolite): Amendment n to the Final Report: Lab Project Number: WIL-75012.
Unpublished study prepared by WIL Research Laboratories, Inc. 9 p.
Craine, E. (1990) A Feeding Study with Chickens Using Kryocide (Synthetic
Cryolite): Amendment m to the Final Report: Lab Project Number: WIL-75012.
Unpublished study prepared by WIL Research Laboratories, Inc. 10 p.
Lamprecht, M.; Codrea, E. (1991) Prokil Cryolite 96: Product Chemistry
Supplemental Information. Unpublished Study prepared KaliChemie AG &
Gowan Co. 26 p.
StankowsM, L. (1991) Ames/Salmonella Plate Incorporation Assay on Kryocide:
Lab Project Number: PH 301-ANA-001-90. Unpublished study prepared by
Pharmakon Research International, Inc. 64 p.
San Sebastian, J. (1991) In vitro Chromosome Aberration Analysis of Kryocide
in Human Lymphocytes: Lab Project Number: PH 324-ANA001-90. Unpublished
study prepared by Pharmakon Research International, Inc. 75 p.
San Sebestian, J. (1991) Rat Hepatocyte Primary Culture/DNA Repair Test on
Kryocide: Lab Project Number: PH 311-ANA-001-90. Unpublished study
prepared by Pharmakon Research International, Inc. 76 p.
Pitt, J. (1991) Kryocide: Magnitude of the Residue in Potato: Lab Project Number:
BR-90-28-1. Unpublished study prepared by McKenzie Labs, Inc. 239 p.
103
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BIBLIOGRAPHY
MRID
CITATION
42126401 Pitt, J.; Wright, M.; Freedlander, R.; et al. (1991) Registrants Response to
Questions Raised by EPA in its June 14,1991 Memorandum Titled "PP#9F3739
Cryolite on Potatoes. Evaluation of the November 8, and 30, 1990, Amendment
(...): Lab Project Number: BR-91-40. Unpublished study prepared by Atochem
North America, Inc., in cooperation with Ussary Scientific Services. 81 p.
42215901 Pitt, J.; Wright, M.; Freedlander, R.; et al. (1992) Registrants' Response to
Questions Raised by EPA in its July 2, 1991 Memorandum Titled "PP#9F3739
Cryolite on Potatoes. Evaluation of the November 8, and 30, 1990, Amendments
(...): Addendum Ito the Final Report: Lab Project Number: BR-91-40: SPONSOR.
Unpublished study prepared by Atochem North America, Inc., and Ussary
Scientific Services. 26 p.
42297901 Nemec, M. (1992) A Range-Finding Developmental Toxicity Study of Kryocide
in Rasbbits: Final Report: Lab Project Number: WJL-160001. Unpublished study
prepared by WIL Research Labs., Inc. 255 p.
42297903 Wright, M. (1991) Cryolite Confined Rotational Study: Final Report: Phase I
Preliminary Investigations: Lab Project Number: BR-90-13: 3 8653. Unpublished
study prepared by Analytical Biochemistry Labs., Inc. 181 p.
42575101 Tompkins, E. (1992) One Year Dietary Toxicity Study in Dogs with Kryocide:
Final Report: Lab Project Number: WJJL-75033. Unpublished study prepared by
WIL Research Labs, Inc. 969 p.
42630001 Pitt, J. (1992) Elf Atochem Method Number BR-010-0: Kryocide Insecticide
Analytical Fluoride Electrode Method for Cryolite in Tissue Samples by
Microdifrusion: Lab Project Number: BR-92-55. Unpublished study prepared by
Elf Atochem North America, Inc. 17 p.
42656901 Pitt, J. (1992) Kryocide: Magnitude of the Residue in Tomato: Lab Project
Number: BR-90-29-1: BR-90-29. Unpublished study prepared by McKenzie
Labs., Inc. 215 p.
42659301 Pitt, J. (1993) Kryocide: Magnitude of the Residue in Pepper: Lab Project
Number: BR-91-07-1: BR-91-07. Unpublished study prepared by McKenzie
Labs., Inc. 540 p.
42751701 Pitt, J. (1993) Addendum 1 to Atochem Study Number 60-88, Kryocide:
Magnitude of the Residue in Lettuce (MRID 41380611): Lab Project Number:
BR-88-65: 60-88. Unpublished study prepared by McKenzie Labs, Inc. 41 p.
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BIBLIOGRAPHY
MRID
CITATION
42751702
42751703
42751704
42751705
42751706
42751707
42751708
42751709
42751710
42751711
Pitt, J. (1993) Addendum 1 to Atochem Study Number 61-88, Kryocide:
Magnitude of the Residue in Collard (MRID 41380601): Lab Project Number:
BR-88-64: 61-88. Unpublished study prepared by McKenzie Labs, Inc. 31 p.
Pitt, J. (1993) Addendum 1 to Atochem Study Number 62-88, Kryocide:
Magnitude of the Residue in Cabbage (MRID 41380610): Lab Project Number:
BR-88-62: 62-88. Unpublished study prepared by McKenzie Labs, Inc. 82 p.
Pitt, J. (1993) Addendum 1 to Atochem Study Number 64-88, Kryocide:
Magnitude of the Residue in Cantaloupe (MRID 41380602): Lab Project Number:
BR-88-63: 64-88. Unpublished study prepared by McKenzie Labs, Inc. 21 p.
Pitt, J. (1993) Addendum 1 to Atochem Study Number 65-88, Kryocide:
Magnitude of the Residue in Squash (MRID 41380603): Lab Project Number:
BR-88-67: 65-88. Unpublished study prepared by McKenzie Labs, Inc. 31 p.
Pitt, J. (1993) Addendum 1 to Atochem Study Number 66-88, Kryocide:
Magnitude of the Residue in Tomato (MRID 41380608): Lab Project Number:
BR-88-68: 66-88. Unpublished study prepared by McKenzie Labs, Inc. 26 p.
Pitt, J. (1993) Addendum 1 to Atochem Study Number 67-88, Kryocide:
Magnitude of the Residue in Processed Tomato Fractions (MRID 41380609): Lab
Project Number: BR-88-69: 67-88. Unpublished study prepared by McKenzie
Labs, Inc. 29 p.
Pitt, J. (1993) Addendum 1 to Atochem Study Number 75-88, Kryocide:
Magnitude of ihe Residue in Processed Orange Fractions (MRID 41380607): Lab
Project Number: BR-88-24-1: 75-88. Unpublished study prepared by McKenzie
Labs, Inc. 70 p.
Pitt, J. (1993) Addendum 1 to Atochem Study Number BR-88-11, Kryocide:
Magnitude of the Residue in Lemon (MRID 41380605): Lab Project Number:
BR-88-11. Unpublished study prepared by McKenzie Labs, Inc. 110 p.
Pitt, J. (1993) Addendum 1 to Atochem Study Number BR-88-26, Kryocide:
Magnitude of the Residue in Grapefruit (MRID 41380604): Lab Project Number:
BR-88-26: BR-88-26-1. Unpublished study prepared by McKenzie Labs, Inc. 49
P-
Pitt, J. (1993) Addendum 1 to Atochem Study Number BR-88-25, Kryocide:
Magnitude of the Residue in Orange (MRED 41380606): Lab Project Number:
BR-88-25. Unpublished study prepared by McKenzie Labs, Inc. 48 p.
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BIBLIOGRAPHY
MRID
CITATION
42830201 Dahl, G. (1993) Supplemental Submission: Registrant Response to the Cryolite
Registration Standard Update: Lab Project Number: CRYO-PCRSU01.
Unpublished study prepared by Onoda Chemical. 13 p.
42854501 Codrea, E. (1993) Cryolite Product Chemistry-Supplemental Data. Unpublished
study prepared by Gowan Co. 19 p.
43077601 Ourisson, P. (1993) Prokil Cryolite 96: Magnitude of the Residue on Stone Fruit:
Lab Project Number: 560-501: GC9201. Unpublished study prepared by Hulst
Research Farm Services, Inc., McKenzie Laboratories and Quality Associates Inc.
167 p.
43387501 Schroeder, R. (1994) A Two-generation Dietary Reproduction Study in Rats with
Kryocide (Cryolite): Revised Final Report: Lab Project Number: 90-3633.
Unpublished study prepared by Pharmaco LSR, Inc. Toxicology Services North
America. 1352 p.
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BIBLIOGRAPHY
MRID
CITATION
43769301 Samoil, K. (1995) Magnitude of Residue: Cyrolite on Cranberry: (Interim Report):
Lab Project Number: 05416: 05416.94-MA-04: 05416.94-WA-59. Unpublished
study prepared by McKenzie Labs, Inc. 214 p.
43867501 Pitt, J. (1994) Kryocide Insecticide: Magnitude of the Residue in Cucumber: Lab
Project Number: BR-93-12-1: BR-93-12:12A-93. Unpublished study prepared by
Elf Atochem North America. 489 p.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
GENERIC AND PRODUCT SPECIFIC
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the
active ingredient identified in Attachment A of this Notice, the Data Call-in Chemical Status
Sheet to submit certain data as noted herein to the U.S. Environmental Protection Agency
(EPA, the Agency). These data are necessary to maintain the continued registration of your
produces) containing this active ingredient. Within 90 days after you receive this Notice you
must respond as set forth in Section m below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 7; or
2. Why you believe you are exempt from the requirements listed in this Notice
and in Attachment 3 (for both generic and product specific data), the
Requirements Status and Registrant's Response Form, (see section IH-B); or
3. Why you believe EPA should not require your submission of data in the
manner specified by this Notice (see section ffl-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2. All products are listed on both the
generic and product specific Data Call-in Response Forms. Also included is a list of all
registrants who were sent this Notice (Attachment 5).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
andRodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
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information is authorized under the Paperwork Reduction Act by OMB Approval No.
2070-0107 and 2070-0057 (expiration date 3-31-96).
This Notice is divided into six sections and seven Attachments. The Notice itself
contains information and instructions applicable to all Data Call-Li Notices. The Attachments
contain specific chemical information and instructions. The six sections of the Notice are:
Section I
Section IE
Section HI
Section IV
Section V
Section VI
Why You are Receiving this Notice
Data Required by this Notice
Compliance with Requirements of this Notice
Consequences of Failure to Comply with this Notice
Registrants' Obligation to Report Possible Unreasonable Adverse
Effects
Inquiries and Responses to this Notice
The Attachments to this Notice are:
1- Data Call-in Chemical Status Sheet
2- Generic Data Call-in and Product Specific Data Call-in Response Forms with
Instructions (Form A)
3 - Generic Data Call-In and Product Specific Data Call-in Requirements Status
and Registrant's Response Forms with Instructions (Form B)
4- EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5- List of Registrants Receiving This Notice
6 - Confidential Statement of Formula. Cost Share and Data Compensation Forms
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient(s) and reevaluated the
data needed to support continued registration of the subject active ingredient(s). This
reevaluation identified additional data necessary to assess the health and safety of the
continued use of products containing this active ingredient(s). You have been sent this Notice
because you have product(s) containing the subject active ingredients.
SECTION ILDATA REQUIRED BY THIS NOTICE
H-A. DATA REQUIRED
The data required by this Notice are specified in the Requirements Status and
Registrant's Response Forms: Attachment 3 (for both generic and product specific data
requirements). Depending on the results of the studies required in this Notice, additional
studies/testing may be required.
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n-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements
specified in the Requirements Status and Registrant's Response Forms (Attachment 3) within
the timeframes provided.
n-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test
standards outlined in the Pesticide Assessment Guidelines for those studies for which
guidelines have been established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (Telephone number:
703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD recommended test standards conform to those
specified in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the
OECD protocols, they should be modified as appropriate so that the data generated by the
study will satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend
deadlines for complying with data requirements when the studies were not conducted in
accordance with acceptable standards. The OECD protocols are available from OECD, 2001
L Street, N.W., Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone
number 202-785-0350).
All new studies and proposed protocols submitted in response to this Data Call-In
Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160].
H-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3fcV2>>rBVNQTICES ISSUED
BY THE AGENCY
Unless otherwise noted herein, this Data Call-in does not in any way supersede or
change the requirements of any previous Data Call-InfsX or any other agreements entered into
with the Agency pertaining to such prior Notice. Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of Intent to Suspend their affected
products.
SECTION HI.
COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
You must use the correct forms and instructions when completing your response to
this Notice. The type of Data Call-In you must comply with (Generic or Product Specific) is
specified in item number 3 on the four Data Call-In forms (Attachments 2 and 3).
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ffl-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for generic and product
specific data must be submitted to the Agency within 90 days after your receipt of this Notice.
Failure to adequately respond to this Notice within 90 days of your receipt will be a basis for
issuing a Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for
issuance of NOIS due to failure to comply with this Notice are presented in Section IV-A and
IV-B.
m-B. OPTIONS FOR RESPONDING TO THE AGENCY
1. Generic Data Requirements
The options for responding to this Notice for generic data requirements are: (a)
voluntary cancellation, (b) delete use(s), (c) claim generic data exemption, (d) agree to satisfy
the generic data requirements imposed by this Notice or (e) request a data waiver(s).
A discussion of how to respond if you choose the Voluntary Cancellation option, the
Delete Use(s) option or the Generic Data Exemption option is presented below. A discussion
of the various options available for satisfying the generic data requirements of this Notice is
contained in Section m-C. A discussion of options relating to requests for data waivers is
contained in Section DI-D.
Two forms apply to generic data requirements, one or both of which must be used in
responding to the Agency, depending upon your response. These two forms are the
Data-Call-in Response Form, and the Requirements Status and Registrant's Response Form.
(contained in Attachments 2 and 3, respectively).
The Data Call-in Response Forms must be submitted as part of every response to this
Notice. The Requirements Status and Registrant's Response Forms also must be submitted if
you do not qualify for a Generic Data Exemption or are not requesting voluntary cancellation
of your registration(s). Please note that the company's authorized representative is required to
sign the first page of both Data Call-in Response Forms and the Requirements Status and
Registrant's Response Forms (if this form is required) and initial any subsequent pages. The
forms contain separate detailed instructions on the response options. Do not alter the printed
material. If you have questions or need assistance in preparing your response, call or write the
contact person(s) identified in Attachment 1.
a.
Voluntary Cancellation -
You may avoid the requirements of this Notice by requesting voluntary cancellation of
your product(s) containing the active ingredient that is the subj ect of this Notice. If you wish
to voluntarily cancel your product, you must submit completed Generic and Product Specific
Data Call-in Response Forms (Attachment 2), indicating your election of this option.
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Voluntary cancellation is item number 5 on both Data Call-In Response FormfsX If you
choose this option, these are the only forms that you are required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with -the Existing Stocks
provisions of this Notice, which are contained in Section IV-C.
b. Use Deletion -
You may avoid the requirements of this Notice by eliminating the uses of your product
to which the requirements apply. If you wish to amend your registration to delete uses, you
must submit the Requirements Status and Registrant's Response Form (Attachment 3), a
completed application for amendment, a copy of your proposed amended labeling, and all
other information required for processing the application. Use deletion is option number 7
under item 9 in the instructions for the Requirements Status and Registrant's Response Forms.
You must also complete a Data Call-in Response Form by signing the certification, item
number 8. Application forms for amending registrations may be obtained from the
Registration Support Branch, Registration Division, Office of Pesticide Programs, EPA, by
calling (703) 308-8358.
If you choose to delete the use(s) subject to this Notice or uses subject to specific data
requirements, further sale, distribution, or use of your product after one year from the due date
of your 90 day response, is allowed only if the product bears an amended label.
c. Generic Data Exemption -
Under section 3(c)(2)(D) of FIFRA, an applicant for registration of a product is
exempt from the requirement to submit or cite generic data concerning an active ingredient if
the active ingredient in the product is derived exclusively from purchased, registered pesticide
products containing the active ingredient EPA has concluded, as an exercise of its discretion,
that it normally will not suspend the registration of a product which would qualify and
continue to qualify for the generic data exemption in section 3(c)(2)(D) of FIFRA. To qualify,
all of the following requirements must be met:
(i). The active ingredient in your registered product must be present solely because of
incorporation of another registered product which contains the subject active
ingredient and is purchased from a source not connected with you;
(ii). Every registrant who is the ultimate source of the active ingredient in your
product subject to this DCI must be in compliance with the requirements of this Notice
and must remain in compliance; and
(iii). You must have provided to EPA an accurate and current "Confidential Statement
of Formula" for each of your products to which this Notice applies.
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To apply for the Generic Data Exemption you must submit a completed Data Call-In
Response Form, Attachment 2 and all supporting documentation. The Generic Data
Exemption is item number 6a on the Data Call-in Response Form. If you claim a generic data
exemption you are not required to complete the Requirements Status and Registrant's
Response Form. Generic Data Exemption cannot be selected as an option for responding to
product specific data requirements.
If you are granted a Generic Data Exemption, you rely on the efforts of other persons
to provide the Agency with the required data. If the registrants) who have committed to
generate and submit the required data fail to take appropriate steps to meet requirements or
are no longer in compliance with this Data Call-In Notice, the Agency will consider that both
they and you are not compliance and will normally initiate proceedings to suspend the
registrations of both your and their product(s), unless you commit to submit and do submit the
required data within the specified time. In such cases the Agency generally will not grant a
time extension for submitting the data.
d. Satisfying the Generic Data Requirements of this Notice
There are various options available to satisfy the generic data requirements of this
Notice. These options are discussed in Section DI-C.l. of this Notice and comprise options 1
through 6 of item 9 in the instructions for the Requirements Status and Registrant's Response
Form and item 6b on the Data Call-In Response Form. If you choose item 6b (agree to satisfy
the generic data requirements), you must submit the Data Call-In Response Form and the
Requirements Status and Registrant's Response Form as well as any other information/data
pertaining to the option chosen to address the data requirement. Your response must be on
the forms marked "GENERIC" in item number 3.
e. Request for Generic Data Waivers.
Waivers for generic data are discussed in Section HI-D.l. of this Notice and are
covered by options 8 and 9 of item 9 in the instructions for the Requirements Status and
Registrant's Response Form. If you choose one of these options, you must submit both forms
as well as any other information/data pertaining to the option chosen to address the data
requirement.
2. Product Specific Data Requirements
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this
Notice or (c) request a data waiver(s).
A discussion of how to respond if you choose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product
specific data requirements of this Notice is contained in Section m-C.2. A discussion of
options relating to requests for data waivers is contained in Section IE-D.2.
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Two forms apply to the product specific data requirements one or both of which must
be used in responding to the Agency, depending upon your response. These forms are the
Data-Call-in Response Form, and the Requirements Status and Registrant's Response Form.
for product specific data (contained in Attachments 2 and 3, respectively). The Data Call-In
Response Form must be submitted as part of every response to this Notice. In addition, one
copy of the Requirements Status and Registrant's Response Form also must be submitted for
each product listed on the Data Call-In Response Form unless the voluntary cancellation
option is selected. Please note that the company's authorized representative is required to sign
the first page of the Data Call-in Response Form and Requirements Status and Registrant's
Response Form (if this form is required) and initial any subsequent pages. The forms contain
separate detailed instructions on the response options. Do not alter the printed material. If you
have questions or need assistance in preparing your response, call or write the contact
person(s) identified in Attachment 1.
a. Voluntary Cancellation
You may avoid the requirements of this Notice by requesting voluntary cancellation of
your product(s) containing the active ingredient that is the subject of this Notice. If you wish
to voluntarily cancel your product, you must submit a completed Data Call-Li Response
Form, indicating your election of this option. Voluntary cancellation is item number 5 on both
the Generic and Product Specific Data Call-In Response Forms. If you choose this
option, you must complete both Data Call-In response forms. These are the only forms that
you are required to complete.
If you choose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
b. Satisfying the Product Specific Data Requirements of this Notice.
There are various options available to satisfy the product specific data requirements of
this Notice. These options are discussed in Section ffl-C.2. of this Notice and comprise
options 1 through 6 of item 9 in the instructions for the product specific Requirements Status
and Registrant's Response Form and item numbers 7a and 7b (agree to satisfy the product
specific data requirements for an MUP or EUP as applicable) on the product specific Data
Call-in Response Form. Note that the options available for addressing product specific data
requirements differ slightly from those options for fulfilling generic data requirements.
Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
product specific data requirements. It is important to ensure, that you are using the correct
forms and instructions when completing your response to the Reregistration Eligibility
Decision document.
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c. Request for Product Specific Data Waivers.
Waivers for product specific data are discussed in Section IH-D.2. of this Notice and
are covered by option 7 of item 9 in the instructions for the Requirements Status and
Registrant's Response Form. If you choose this option, you must submit the Data Call-in
Response Form and the Requirements Status and Registrant's Response Form as well as any
other information/data pertaining to the option chosen to address the data requirement. Your
response must be on the forms marked "PRODUCT SPECIFIC" in item number 3.
m-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
1.
Generic Data
If you acknowledge on the Generic Data Call-in Response Form that you agree to .
satisfy the generic data requirements (i.e. you select item number 6b), then you must select
one of the six options on the Generic Requirements Status and Registrant's Response Form
related to data production for each data requirement. Your option selection should be entered
under item number 9, "Registrant Response." The six options related to data production are
the first six options discussed under item 9 in the instructions for completing the
Requirements Status and Registrant's Response Form. These six options are listed
immediately below with information in parentheses to guide you to additional instructions
provided in this Section. The options are:
(1) I will generate and submit data within the specified timeframe (Developing
Data)
(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an
existing study that has been submitted but not reviewed by the Agency (Citing
an Existing Study)
Option 1. Developing Data
If you choose to develop the required data it must be in conformance with Agency
deadlines and with other Agency requirements as referenced herein and in the attachments.
All data generated and submitted must comply with the Good Laboratory Practice (GLP) rule
(40 CFRPart 160), be conducted according to the Pesticide Assessment Guidelines (PAG)
and be in conformance with the requirements of PR Notice 86-5. In addition, certain studies
require Agency approval of test protocols in advance of study initiation. Those studies for
which a protocol must be submitted have been identified in the Requirements Status and
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Registrant's Response Form and/or footnotes to the form. If you wish to use a protocol which
differs from the options discussed in Section II-C of this Notice, you must submit a detailed
description of the proposed protocol and your reason for wishing to use it. The Agency may
choose to reject a protocol not specified in Section II-C. If the Agency rejects your protocol
you will be notified in writing, however, you should be aware that rejection of a proposed .
protocol will not be a basis for extending the deadline for submission of data.
A progress report must be submitted for each study within 90 days from the date you
are required to commit to generate or undertake some other means to address that study
requirement, such as making an offer to cost share or agreeing to share in the cost of
developing that study. This 90-day progress report must include the date the study was or
will be initiated and, for studies to be started within 12 months of commitment, the name and
address of the laboratory(ies) or individuals who are or will be conducting the study.
In addition, if the time frame for submission of a final report is more than 1 year,
interim reports must be submitted at 12 month intervals from the date you are required to
commit to generate or otherwise address the requirement for the study. In addition to the other
information specified in the preceding paragraph, at a minimum, a brief description of current
activity on and the status of the study must be included as well as a full description of any
problems encountered since the last progress report.
The time frames in the Requirements Status and Registrant's Response Form are the
time frames that the Agency is allowing for the submission of completed study reports or
protocols. The noted deadlines run from the date of the receipt of this Notice by the registrant.
If the data are not submitted by the deadline, each registrant is subject to receipt of a Notice of
Intent to Suspend the affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements(s), you must submit a request to
the Agency which includes: (1) a detailed description of the expected difficulty and (2) a
proposed schedule including alternative dates for meeting such requirements on a step-by-step
basis. You must explain any technical or laboratory difficulties and provide documentation
from the laboratory performing the testing. While EPA is considering your request, the
original deadline remains. The Agency will respond to your request in writing. If EPA does
not grant your request, the original deadline remains. Normally, extensions can be requested
only in cases of extraordinary testing problems beyond the expectation or control of the
registrant. Extensions will not be given in submitting the 90-day responses. Extensions will
not be considered if the request for extension is not made in a timely fashion; in no event shall
an extension request be considered if it is submitted at or after the lapse of the subject
deadline.
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Option 2. Agreement to Share in Cost to Develop Data
If you choose to enter into an agreement to share in the cost of producing the required
data but will not be submitting the data yourself, you must provide the name of the registrant
who will be submitting the data. You must also provide EPA with documentary evidence that
an agreement has been formed. Such evidence may be your letter offering to join in an
agreement and the other registrant's acceptance of your offer, or a written statement by the
parties that an agreement exists. The agreement to produce the data need not specify all of the
terms of the final arrangement between the parties or the mechanism to resolve the terms.
Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the agreement they
may resolve their differences through binding arbitration.
Option 3. Offer to Share in the Cost of Data Development
If you have made an offer to pay in an attempt to enter into an agreement or amend an
existing agreement to meet the requirements of this Notice and have been unsuccessful, you
may request EPA (by selecting this option) to exercise its discretion not to suspend your
registration(s), although you do not comply with the data submission requirements of this
Notice. EPA has determined that as a general policy, absent other relevant considerations, it
will not suspend the registration of a product of a registrant who has in good faith sought and
continues to seek to enter into a joint data development/cost sharing program, but the other
registrant(s) developing the data has refused to accept the offer. To qualify for this option,
you must submit documentation to the Agency proving that you have made an offer to
another registrant (who has an obligation to submit data) to share in the burden of developing
that data. You must also submit to the Agency a completed EPA Form 8570-32, Certification
of Offer to Cost Share in the Development of Data, Attachment 7. In addition, you must
demonstrate that the other registrant to whom the offer was made has not accepted your offer
to enter into a cost-sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that offer (such as a certified mail receipt). Your offer must, in addition
to anything else, offer to share in the burden of producing the data upon terms to be agreed to
or, failing agreement, to be bound by binding arbitration as provided by FIFRA section
3(c)(2)(B)(iii) and must not qualify this offer. The other registrant must also inform EPA of its
election of an option to develop and submit the data required by this Notice by submitting a
Data Call-in Response Form and a Requirements Status and Registrant's Response Form
committing to develop and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your
offer to share in the burden of developing the data. In addition, the other registrant must fulfill
its commitment to develop and submit the data as required by this Notice. If the other
registrant fails to develop the data or'for some other reason is subject to suspension, your
registration as well as that of the other registrant normally will be subject to initiation of
suspension proceedings, unless you commit to submit, and do submit, the required data in the
specified time frame. In such cases, the Agency generally will not grant a time extension for
submitting the data.
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Option 4. Submitting an Existing Study
If you choose to submit an existing study in response to this Notice, you must
determine that the study satisfies the requirements imposed by this Notice. You may only
submit a study that has not been previously submitted to the Agency or previously cited by
anyone. Existing studies are studies which predate issuance of this Notice. Do not use this
option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid
and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly Met:
a. You must certify at the time that the existing study is submitted that the raw
data and specimens from the study are available for audit and review and you
must identify where they are available. This must be done in accordance with
the requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR
Part 160. As stated in 40 CFR 160.3 "Raw data1 means any laboratory
worksheets, records, memoranda, notes, or exact copies thereof, that are the
result of original observations and activities of a study and are necessary for the
reconstruction and evaluation of the report of that study. In the event that exact
transcripts of raw data have been prepared (e.g., tapes which have been
transcribed verbatim, dated, and verified accurate by signature), the exact copy
or exact transcript may be substituted for the original source as raw data. 'Raw
data1 may include photographs, microfilm or microfiche copies, computer
printouts, magnetic media, including dictated observations, and recorded data
from automated instruments." The term "specimens", according to 40 CFR
160.3, means "any material derived from a test system for examination or
analysis."
b. Health and safely studies completed after May 1984 also must also contain all
GLP-required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants also must certify at the time of
submitting the existing study that such GLP information is available for post
May 1984 studies by including an appropriate statement on or attached to the
study signed by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the
Guideline relevant to the study provided in the FIFRA Accelerated
Reregistration Phase 3 Technical Guidance and that the study has been
conducted according to the Pesticide Assessment Guidelines (PAG) or meets
the purpose of the PAG (both available from NTIS). A study not conducted
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according to the PAG may be submitted to the Agency for consideration if the
registrant believes that the study clearly meets the purpose of the PAG. The
registrant is referred to 40 CFR 158.70 which states the Agency's policy
regarding acceptable protocols. If you wish to submit the study, you must, in
addition to certifying that the purposes of the PAG are met by the study, clearly
articulate the rationale why you believe the study meets the purpose of the
PAG, including copies of any supporting information or data. It has been the
Agency's experience that studies completed prior to January 1970 rarely
satisfied the purpose of the PAG and that necessary raw data usually are not
available for such studies.
If you submit an existing study, you must certify that the study meets all requirements
of the criteria outlined above.
If EPA has previously reviewed a protocol for a study you are submitting, you must
identify any action taken by the Agency on the protocol and must indicate, as part of your
certification, the manner in which all Agency comments, concerns, or issues were addressed
in the final protocol and study.
If you know of a study pertaining to any requirement in this Notice which does not
meet the criteria outlined above but does contain factual information regarding unreasonable
adverse effects, you must notify the Agency of such a study. If such study is in the Agency's
files, you need only cite it along with the notification. If not in the Agency's files, you must
submit a summary and copies as required by PR Notice 86-5.
Option 5. Upgrading a Study
If a study has been classified as partially acceptable and upgradeable, you may submit
data to upgrade that study. The Agency will review the data submitted and determine if the
requirement is satisfied. If the Agency decides the requirement is not satisfied, you may still
be required to submit new data normally without any time extension. Deficient, but
upgradeable studies will normally be classified as supplemental. However, it is important to
note that not all studies classified as supplemental are upgradeable. If you have questions
regarding the classification of a study or whether a study may be upgraded, call or write the
contact person listed in Attachment 1. If you submit data to upgrade an existing study you
must satisfy or supply information to correct all deficiencies in the study identified by EPA.
You must provide a clearly articulated rationale of how the deficiencies have been remedied
or corrected and why the study should be rated as acceptable to EPA. Your submission must
also specify the MRID number(s) of the study which you are attempting to upgrade and must
be in conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
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This option also should be used to cite data that has been previously submitted to
upgrade a study, but has not yet been reviewed by the Agency. You must provide the MR3D
number of the data submission as well as the MRDD number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to
all data submissions intended to upgrade studies. Additionally, your submission of data
intended to upgrade studies must be accompanied by a certification that you comply with
each of those criteria, as well as a certification regarding protocol compliance with Agency
requirements.
Option 6. Citing Existing Studies
If you choose to cite a study that has been previously submitted to EPA, that study
must have been previously classified by EPA as acceptable, or it must be a study which has
not yet been reviewed by the Agency. Acceptable toxicology studies generally will have been
classified as "core-guideline" or "core-minimum." For ecological effects studies, the
classification generally would be a rating of "core." For all other disciplines the classification
would be "acceptable." With respect to any studies for which you wish to select this option,
you must provide the MRID number of the study you are citing and, if the study has been
reviewed by the Agency, you must provide the Agency's classification of the study.
If you are citing a study of which you are not the original data submitter, you must
submit a completed copy of EPA Form 8570-31, Certification with Respect to Data
Compensation Requirements.
2. Product Specific Data
If you acknowledge on the product specific Data Call-in Response Form that you
agree to satisfy the product specific data requirements (i.e. you select option 7a or 7b), then
you must select one of the six options on the Requirements Status and Registrant's Response
Form related to data production for each data requirement. Your option selection should be
entered under item number 9, "Registrant Response." The six options related to data
production are the first six options discussed under item 9 in the instructions for completing
the Requirements Status and Registrant's Response Form. These six options are listed
immediately below with information in parentheses to guide registrants to additional
instructions provided in this Section. The options are:
(1) I will generate and submit data within the specified time-frame (Developing
Data)
(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
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(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an
existing study that has been
submitted but not reviewed by the Agency (Citing an Existing Study)
Option 1. Developing Data ~ The requirements for developing product specific data are the
same as those described for generic data (see Section IH.C.l, Option 1) except that normally
no protocols or progress reports are required.
Option 2. Agree to Share in Cost to Develop Data — If you enter into an agreement to cost
share, the same requirements apply to product specific data as to generic data (see Section
ULC.l, Option 2). However, registrants may only choose this option for acute toxiciiy data
and certain efficacy data and only if EPA has indicated in the attached data tables that your
product and at least one other product are similar for purposes of depending on
the same data. If this is the case, data may be generated for just one of the products in the
group. The registration number of the product for which data will be submitted must be noted
in the agreement to cost share by the registrant selecting this option.
Option 3. Offer to Share in the Cost of Data Development —The same requirements for
generic data (Section IH.C.I., Option 3) apply to this option. This option only applies to acute
toxiciiy and certain efficacy data as described in option 2 above.
Option 4. Submitting an Existing Study — The same requirements described for generic data
(see Section m.C.l., Option 4) apply to this option for product specific data.
Option 5. Upgrading a Study — The same requirements described for generic data (see
Section ffl.C.1., Option 5) apply to this option for product specific data.
Option 6. Citing Existing Studies — The same requirements described for generic data (see
Section ffl.C.1., Option 6) apply to this option for product specific data.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-in Response Form and the
Requirements Status and Registrant's Response Form, and in the generic data requirements
section (Tfl.C.1.), as appropriate.
m-D REQUESTS FOR DATA WAIVERS
1.
Generic Data
There are two types of data waiver responses to this Notice. The first is a request for a
low volume/minor use waiver and the second is a waiver request based on your belief that the
data requirement(s) are not appropriate for your product.
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a.
Low Volume/Minor Use Waiver
Option 8 under item 9 on the Requirements Status and Registrant's Response Form.
Section 3(c)(2)(A) of FIFRA requires EPA to consider the appropriateness of requiring data
for low volume, minor use pesticides. In implementing this provision, EPA considers low
volume pesticides to be only those active ingredients whose total production volume for all
pesticide registrants is small. In determining whether to grant a low volume, minor use
waiver, the Agency will consider the extent, pattern and volume of use, the economic
incentive to conduct the testing, the importance of the pesticide, and the exposure and risk
from use of the pesticide. If an active ingredient is used for both high volume and low volume
uses, a low volume exemption will not be approved. If all uses of an active ingredient are low
volume and the combined volumes for all uses are also low, then an exemption may be
granted, depending on review of other information outlined below. An exemption will not be
granted if any registrant of the active ingredient elects to conduct the testing. Any registrant
receiving a low volume minor use waiver must remain within the sales figures in their
forecast supporting the waiver request in order to remain qualified for such waiver. If granted
a waiver, a registrant will be required, as a condition of the waiver, to submit annual sales
reports. The Agency will respond to requests for waivers in writing.
To apply for a low volume, minor use waiver, you must submit the following
information, as applicable to your produces), as part of your 90-day response to this
Notice:
(i). Total company sales (pounds and dollars) of all registered produces)
containing the active ingredient. If applicable to the active ingredient, include foreign
sales for those products that are not registered in this country but are applied to sugar
(cane or beet), coffee, bananas, cocoa, and other such crops. Present the above
information by year for each of the past five years.
(ii) Provide an estimate of the sales (pounds and dollars) of the active
ingredient for each major use site. Present the above information by year for each of
the past five years.
(iii) Total direct production cost of produces) containing the active ingredient
by year for the past five years. Include information on raw material cost, direct labor
cost, advertising, sales and marketing, and any other significant costs listed separately.
(iv) Total indirect production cost (e.g. plant overhead, amortized plant and
equipment) charged to produces) containing the active ingredient by year for the past
five years. Exclude all non-recurring costs that were directly related to the active
ingredient, such as costs of initial registration and any data development.
(v) A list of each data requirement for which you seek a waiver. Indicate the
type of waiver sought and the estimated cost to you (listed separately for each data
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requirement and associated test) of conducting the testing needed to fulfill each of
these data requirements.
(vi) A list of each data requirement for which you are not seeking any waiver
and the estimated cost to you (listed separately for each data requirement and
associated test) of conducting the testing needed to fulfill each of these data
requirements.
(vii) For each of the next ten years, a year-by-year forecast of company sales
(pounds and dollars) of the active ingredient, direct production costs of product(s)
containing the active ingredient (following the parameters in item 2 above), indirect
production costs of product(s) containing the active ingredient (following the
parameters in item 3 above), and costs of data development pertaining to the active
ingredient.
(viii) A description of the importance and unique benefits of the active
ingredient to users. Discuss the use patterns and the effectiveness of the active
ingredient relative to registered alternative chemicals and non-chemical control
strategies. Focus on benefits unique to the active ingredient, providing information that
is as quantitative as possible. If you do not have quantitative data upon which to base
your estimates, then present the reasoning used to derive your estimates. To assist the
Agency in determining the degree of importance of the active ingredient in terms of its
benefits, you should provide information on any of the following factors, as applicable
to your product(s): (a) documentation of the usefulness of the active ingredient in
Integrated Pest Management, (b) description of the beneficial impacts on the
environment of use of the active ingredient, as opposed to its registered alternatives,
(c) information on the breakdown of the active ingredient after use and on its
persistence in the environment, and (d) description of its usefulness against a pest(s) of
public health significance.
Failure to submit sufficient information for the Agency to make a
determination regarding a request for a low volume/minor use waiver will result in
denial of the request for a waiver.
b.
Request for Waiver of Data
Option 9, under Item 9, on the Requirements Status and Registrant's Response
arm. This option may be used if you believe that a particular data requirement should
not apply because the requirement is inappropriate. You must submit a rationale
explaining why you believe the data requirements should not apply. You also must
submit the current label(s) of your product(s) and, if a current copy of your
Confidential Statement of Formula is not already on file you must submit a current
copy.
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You will be informed of the Agency's decision in writing. If the Agency
determines that the data requirements of this Notice are not appropriate to your
product(s), you will not be required to supply tne data pursuant to section 3(c)(2)(B). If
EPA determines that the data are required for vour productfsl you must choose a
method of meeting the requirements of this Notice within the time frame provided bv
this Notice. Within 30 days of your receipt of the Agency's written decision, you must
submit a revised Requirements Status and Registrant's Response Form indicating the
option chosen.
2. Product Specific Data
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request including
technical reasons, data and references to relevant EPA regulations, guidelines or
policies. (Note: any supplemental data must be submitted in the format required by PR
Notice 86-5). This will be the only opportunity to state the reasons or provide
information in support of your request. If the Agency approves your waiver request,
you will not be required to supply the data pursuant to section 3(c)(2)(B) of FIFRA. If
the Agency denies your waiver request, you must choose an option for meeting the
data requirements of this Notice within 30 days of the receipt of the Agency's decision.
You must indicate and submit the option chosen on the product specific Requirements
Status and Registrant's Response Form. Product specific data requirements for product
chemistry, acute toxicity and efficacy (where appropriate) are required for all products
and the Agency would grant a waiver only under extraordinary circumstances. You
should also be aware that submitting a waiver request will not automatically extend the
due date for the study in question. Waiver requests submitted without adequate
supporting rationale will be denied and the original due date will remain in force.
SECTION IV.
IV-A NOTICE OF INTENT TO SUSPEND
CONSEQUENCES OF FAILURE TO COMPLY WITH THIS
NOTICE
The Agency may issue a Notice of Intent to Suspend products subject to this Notice
due to failure by a registrant to comply with the requirements of this Data Call-in Notice,
pursuant to FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice
of Intent to Suspend include, but are not limited to, .the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of
this Notice.
2. Failure to submit on the required schedule an acceptable proposed or final
protocol when such is required to be submitted to the Agency for review.
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3. Failure to submit on the required schedule an adequate progress report on a
study as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this
Notice.
5. Failure to take a required action or submit adequate information pertaining to
any option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task
Forces, failure to comply with the terms of an agreement or arbitration
concerning joint data development or failure to comply with any terms of a data
waiver).
6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section EI-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost
of developing data and provided proof of the registrant's receipt of such offer or
failure of a registrant on whom you rely for a generic data exemption either to:
i. Inform EPA of intent to develop arid submit the data required by this Notice
on a Data Call-in Response Form and a Requirements Status and Registrant's
Response Form.
ii. Fulfill the commitment to develop and submit the data as required by this
Notice; or
iii. Otherwise take appropriate steps to meet the requirements stated in this
Notice,
unless you commit to submit and do submit the required data in the specified
time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any
time following the issuance of this Notice.
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IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The
grounds for suspension include, but are not limited to, failure to meet any of the following:
1) EPA requirements specified in the Data Call-in Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines)
regarding the design, conduct, and reporting of required studies. Such requirements
include, but are not limited to, those relating to test material, test procedures, selection
of species, number of animals, sex and distribution of animals, dose and effect levels
to be tested or attained, duration of test, and, as applicable, Good Laboratory Practices.
2) EPA requirements regarding the submission of protocols, including the
incorporation of any changes required by the Agency following review.
3) EPA requirements regarding the reporting of data, including the manner of
reporting, the completeness of results, and the adequacy of any required supporting (or
raw) data, including, but not limited to, requirements referenced or included in this
Notice or contained in PR 86-5. All studies must be submitted in the form of a final
report; a preliminary report will not be considered to fulfill the submission
requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding generally would
not be consistent with the Act's purposes. Accordingly, the Agency anticipates granting
registrants permission to sell, distribute, or use existing stocks of suspended produces) only in
exceptional circumstances. If you believe such disposition of existing stocks of your
produces) which may be suspended for failure to comply with this Notice should be
permitted, you have the burden of clearly demonstrating to EPA that granting such permission
would be consistent with the Act. You also must explain why an "existing stocks" provision is
necessary, including a statement of the quantity of existing stocks and your estimate of the
time required for their sale, distribution, and use. Unless you meet this burden, the Agency
will not consider any request pertaining to the continued sale, distribution, or use of your
existing stocks after suspension.
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If you request a voluntary cancellation of your product(s) as a response to this Notice
and your product is in full compliance with all Agency requirements, you will have, under
most circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use
such existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has
particular risk concerns will be determined on a case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required
by this Notice will not result in the agency granting any additional time to sell, distribute, or
use existing stocks beyond a year from the date the 90 day response was due, unless you
demonstrate to the Agency that you are in full compliance with all Agency requirements,
including the requirements of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3-year study is scheduled to be submitted, all progress
reports and other information necessary to establish that you have been conducting the study
in an acceptable and good faith manner must have been submitted to the Agency, before EPA
will consider granting an existing stocks provision.
SECTION V.
REGISTRANTS* OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the
information to the Agency. Registrants must notify the Agency of any factual information
they have, from whatever source, including but not limited to interim or preliminary results of
studies, regarding unreasonable adverse effects on man or the environment. This requirement
continues as long as the products are registered by the Agency.
SECTION VI.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by
this Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status
Sheet.
All responses to this Notice must include completed Data Call-fa Response Forms
(Attachment 2)and completed Requirements Status and Registrant's Response Forms
(Attachment 3), for both (generic and product specific data) and any other documents
required by this Notice, and should be submitted to the contact person(s) identified in
Attachment 1. If the voluntary cancellation or generic data exemption option is chosen, only
the Generic and Product Specific Data Call-in Response Forms need be submitted.
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The Office of Compliance (OC) of the Office of Enforcement and Compliance
Assurance (OECA), EPA, will be monitoring the data being generated in response to this
Notice.
Sincerely yours,
*J> •
Lois Rossi, Division Director
Special Review and
Reregistration Division
Attachments
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2- Generic Data Call-In and Product Specific Data Call-in Response Forms with
Instructions
Generic Data Call-in and Product Specific Data Call-In Requirements Status
and Registrant's Response Forms with Instructions
EPA Batching of End-Use Products for Meeting Acute Toxicology Data
3-
4-
5-
6-
Requirements for Reregistration
List of Registrants Receiving This Notice
Confidential Statement of Formula. Cost Share and Data Compensation Forms
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CRYOLITE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-in Notice because you have produces)
containing Cryolite.
This Product Specific Data Call-In Chemical Status Sheet contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
Cryolite. This attachment is to be used in conjunction with (1) the Product Specific Data Call-in
Notice, (2) the Product Specific Data Call-in Response Form (Attachment 2), (3) the
Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) a list of registrants
receiving this DCI (Attachment 5) and (7) the Cost Share and Data Compensation Forms in
replying to this Cryolite Product Specific Data Call-in (Attachment 6). Instructions and guidance
accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for Cryolite are
contained in the Requirements Status and Registrant's Response. Attachment 3. The Agency has
concluded that additional data on Cryolite are needed for specific products. These data are
required to be submitted to the Agency within the time frame listed. These data are needed to
fully complete the reregistration of all eligible Cryolite products.
INOUnUES AND RESPONSES TO THIS -NOTICE
If you have any questions regarding this product specific data requirements and
procedures established by this Notice, please contact Jeff Billingslea at (703) 308-8004.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
JeffBillingslea
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch (7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Cryolite
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CRYOLITE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have produces)
containing Cryolite.
Thj8 Generic Data Call-in Chemical Status Sheet contains an overview of data required
by this notice, and point of contact for inquiries pertaining to the reregistration of Cryolite. This
attachment is to be used in conjunction with (1) the Generic Data Call-In Notice, (2) the Generic
Data Call-In Response Form (Attachment 2), (3) the Requirements Status and Registrant's Form
(Attachment 3), (4) a list of registrants receiving this DCI (Attachment 5), (5) the Cost Share and
Data Compensation Forms in replying to this Cryolite Generic Data Call In (Attachment D).
Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for Cryolite are
contained in the Requirements Status and Registrant's Response. Attachment 3. The Agency has
concluded that additional product chemistry data on Cryolite are needed. These data are needed
to fully complete the reregistration of all eligible Cryolite products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Dana Lateulere at (703) 308-8044.
All responses to this Notice for the generic data requirements should be submitted to:
Dana Lateulere, Chemical Review Manager
Reregistration Branch
Special Review and Reregistration Division (7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Cryolite
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Instructions For Completing The "Data Call-in Response Forms" For The Generic And
Product Specific Data Call-In
INTRODUCTION
These instructions apply to the Generic and Product Specific "Data Call-In Response
Forms" and are to be used by registrants to respond to generic and product specific Data Call-ins
as part of EPA's Reregistration Program under the Federal Insecticide, Fungicide, and
Rodenticide Act If you are an end-use product registrant only and have been sent this DCI letter
as part of aRED documentyou have been sent just the product specific "Data Call-in Response
Forms." Only registrants responsible for generic data have been sent the generic data response
form. The type of Data Call-In (generic or product specific) is indicated in item number 3
("Date and Type of DCI") on each form.
Although the form is the same for both generic and product specific data, instructions for
completing these forms are different. Please read these instructions carefully before filling out
the forms.
EPA has developed these forms individually for each registrant, and has preprinted these
forms with a number of items. DO NOT use these forms for any other active ingredient.
Items 1 through 4 have been preprinted on the form. Items 5 through 7 must be completed
by the registrant as appropriate. Items 8 through 11 must be completed by the registrant before
submitting a response to the Agency.
The public reporting burden for this collection of information is estimated to average 15
minutes per response, including time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing the collection of
information. Send comments regarding the burden estimate or any other aspect of this collection
of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, Mail Code 2136, U.S. Environmental Protection Agency, 401 M St., S.W., Washington,
D.C. 20460; and to the Office of Management and Budget, Paperwork Reduction Project
2070-0107, Washington, D.C. 20503.
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-in
Item 1.
Item 2.
ItemS.
Item 4.
Item 5.
Item 6a.
ON BOTH FORMS This item identifies your company name, number and
address.
ON BOTH FORMS: This item identifies the case number, case name, EPA
chemical number and chemical name.
ON BOTH FORMS: This item identifies the type of Data Call-in. The date of
issuance is date stamped.
ON BOTH FORMS: This item identifies the EPA product registrations relevant
to the data call-in. Please note that you are also responsible for informing the
Agency of your response regarding any product that you believe may be covered
by this Data Call-in but that is not listed by the Agency in Item 4. You must bring
any such apparent omission to the Agency's attention within the period required
for submission of this response form.
ON BOTH FORMS: Check this item for each product registration you wish to
cancel voluntarily. If a registration number is listed for a product for which you
previously requested voluntary cancellation, indicate in Item 5 the date of that
request. Since this Data Call-In requires both generic and product specific data,
you must complete item 5 on both Data Call-In response forms. You do not need
to complete any item on the Requirements Status and Registrant's Response
Forms.
ON THE GENERIC DATA FORM:Check this Item if the Data Call-in is for
generic data as indicated in Item 3 and you are eligible for a Generic Data
Exemption for the chemical listed in Item 2 and used in the subject product. By
electing this exemption, you agree to the terms and conditions of a Generic Data
Exemption as explained in the Data Call-In Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA
registration Number of each registered source of that active ingredient that you use
in your product.
Typically, if you purchase an EPA-registered product from one or more other
producers (who, with respect to the incorporated product, are in compliance with
this and any other outstanding Data Call-In Notice), and incorporate that product
into all your products, you may complete this item for all products listed on this
form. If, however, you produce the active ingredient yourself, or use any
unregistered product (regardless of the fact that some of your sources are
registered), you may not claim a Generic Data Exemption and you may not select
this item.
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-Li
Item 6b. ON THE GENERIC DATA FORM: Check this Item if the Data Call-Li is .for
generic data as indicated in Item 3 and if you are agreeing to satisfy the generic
data requirements of this Data Call-in. Attach the Requirements Status and
Registrant's Response Form that indicates how you will satisfy those requirements.
NOTE: Item 6a and 6b are not applicable for Product Specific Data.
Item 7a. ON THE PRODUCT SPECIFIC DATA FORM: For each manufacturing use
product (MUP) for which you wish to maintain registration, you must agree to
satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes."
FOR BOTH MUP and EUP products
You should also respond "yes" to this item (7a for MUP's and 7b for EUP's) if
your product is identical to another product and you qualify for a data exemption.
You must provide the EPA registration numbers of your source(s); do not
complete the Requirements Status and Registrant's Response form. Examples of
such products include repackaged products and Special Local Needs (Section 24c)
products which are identical to federally registered products.
If you are requesting a data waiver, answer "yes" here; in addition, on the
"Requirements Status and Registrant's Response" form under Item 9, you must
respond with option 7 (Waiver Request) for each study for which you are
requesting a waiver.
NOTE: Item 7a and 7b are not applicable for Generic Data.
134
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-in
Item 8.
Item 9.
Item 10.
ON BOTH FORMS: This certification statement must be signed by an
authorized representative of your company and the person signing must include
his/her title. Additional pages used in your response must be initialled and dated
in the space provided for the certification.
ON BOTH FORMS: Enter the date of signature.
ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response.
Item 11. ON BOTH FORMS: Enter the phone number of your company contact.
Note: You may provide additional information that does not fit on this foimia a signed tetter that accompanies your response. For example, you
may wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled this
product. For these cases, please supply all relevant details so that EPA can ensure that its records are correct.
135
-------
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Instructions For Completing The "Requirements Status and Registrant's Response
Forms" For The Generic and Product Specific Data Call-In
INTRODUCTION
These instructions apply to the Generic and Product Specific "Requirements Status and
Registrants Response Forms" and are to be used by registrants to respond to generic and product
specific Data Call-in's as part of EPA's reregistration program under the Federal Insecticide,
Fungicide, and Rodenticide Act. If you are an end-use product registrant only and have been
sent this DCI letter as part of a RED document you have been sent just the product specific
"Requirements Status and Registrants Response Forms." Only registrants responsible for generic
data have been sent the generic data response forms. The type of Data Call-In (generic
-------
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-in
Item 1.
Item 2.
Item 3.
Item 4.
ItemS.
ON BOTH FORMS: This item identifies your company name, number and
address.
ON THE GENERIC DATA FORM: This item identifies the case number, case
name, EPA chemical number and chemical name.
ON THE PRODUCT SPECIFIC DA^ FORM: This item identifies the case
number, case name, and the EPA Registration Number of the product for which
the Agency is requesting product specific data.
ON THE GENERIC DATA FORM? This item identifies the type of Data
Call-In. The date of issuance is date stamped.
ON THE PRODUCTSPECIFIC DATA FORM: This item identifies the type
of Data Call-in. The date of issuance is also date stamped. Note the unique
identifier number (ID#) assigned by the Agency. This ID number must be used
in the transmittal document for any data submissions in response to this Data Call-
in Notice.
ON BOTH FORMS: This item identifies the guideline reference number of
studies required. These guidelines, in addition to the requirements specified in the
Data Call-in Notice, govern the conduct of the required studies. Note that series
61 and 62 in product chemistry are now listed under 40 CFR 158 155 through
158.180, Subpartc.
ON BOTH FORMS: This item identifies the study title associated with the
guideline reference number and whether protocols and 1, 2, or 3-year progress
reports are required to be submitted in connection with the study. As noted in
Section m of the Data Call-in Notice, 90-day progress reports are required for all
studies.
If an asterisk appears in Item 5, EPA has attached information relevant to this
guideline reference number to the Requirements Status and Registrant's Response
Form.
137
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In
Item 6. ON BOTH FORMS: This item identifies the code associated with the use pattern
of the pesticide. In the case of efficacy data (product specific requirement), the
required study only pertains to products which have the use sites and/or pests
indicated. A brief description of each code follows:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
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 crop
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
Item 7. ON BOTH FORMS: This item identifies the code assigned to the substance that
must be used for testing. A brief description of each code follows:
EUP
MP
MP/TGAI
PAI
PALM
PAMPAIRA
PAIRA
PAIRA/M
PAIRA/PM
TEP
TEP %
TEP/MET
End-Use Product
Manufacturing-Use Product
Manufacturing-Use Product and Technical Grade Active
Ingredient
Pure Active Ingredient
Pure Active Ingredient and Metabolites
Pure Active Indredient or Pute Active
Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled and Metabolites
Pure Active Ingredient Radiolabelled and Plant Metabolites
Typical End-Use Product
Typical End-Use Product, Percent Active Ingredient
Specified
Typical End-Use Product and Metabolites
138
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Item 8.
Item 9.
TEP/PAI/M
TGAI
TGAI/PAI
TGALOPAIRA
TGAI/TEP
MET
IMP
DEGR
Typical End-Use Product or Pure Active Ingredient and
Metabolites
Technical Grade Active Ingredient
Technical Grade Active Ingredient or Pure Active
Ingredient
Technical Grade Active Ingredient or Pure Active
Ingredient Radiolabelled
Technical Grade Active Ingredient or Typical End-Use
Product
Metabolites
Impurities
Degradates
See: guideline comment
This item completed by the Agency identifies the time frame allowed for
submission of the study or protocol identified in item 5.
ON THE GENERIC DATA FORM: The time frame runs from the date of your
receipt of the Data Call-in notice.
ON THE PRODUCT SPECTFE DATA FORM: The due date for submission
of product specific studies begins from the date stamped on the letter transmitting
the Reregistration Eligibility Decision document, and not from the date of receipt.
However, your response to the Data Call-In itself is due 90 days from the date of
receipt.
ON BOTH FORMS: Enter the appropriate Response Code or Codes to show
how you intend to comply with each data requirement. Brief descriptions of each
code follow. The Data Call-in Notice contains a fuller description of each of these
options.
Option 1. ON BOTH FORMS: (Developing Data^ I will conduct a new study and
submit it within the time frames specified in item 8 above. By indicating
that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as
outlined in the Data Call-in Notice and that I will provide the protocols and
progress reports required in item 5 above.
Option 2. ON BOTH FORMS: (Agreement to Cost Shared I have entered into an
agreement with one or more registrants to develop data jointly. By
indicating that I have chosen this option, I certify that I will comply with
all the requirements pertaining to sharing in the cost of developing data as
outlined in the Data Call-In Notice.
139
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However, for Product Specific DataJ understand that this option
is available for acute toxicity or certain efficacy data ONLY if the Agency
indicates in an attachment to this notice that my product is similar enough
to another product to qualify for this option. I certify that another party in
the agreement is committing to submit or provide the required data; if the
required study is not submitted on time, my product may be subject to
suspension.
Option 3. ON BOTH FORMS: (Offer to Cost Shared I have made an offer to enter
into an agreement with one or more registrants to develop data jointly. I
am also submitting a completed "Certification of offer to Cost Share in the
Development of Data" form. I am submitting evidence that I have made
an offer to another registrant (who has an obligation to submit data) to
share in the cost of that data. I am including a copy of my offer and proof
of the other registrant's receipt of that offer. I am identifying the party
which is committing to submit or provide the required data; if the required
study is not submitted on time, my product may be subject to suspension.
I understand that other terms under Option 3 in the Data Call-In Notice
apply as well.
However, for Product Specific Data,I understand that this option
is available only for acute toxicity or certain efficacy data and only if the
Agency indicates in an attachment to this Data Call-in Notice that my
product is similar enough to another product to qualify for this option.
Option 4. ON BOTH FORMS: (Submitting Existing Data) I will submit an
existing study by the specified due date that has never before been
submitted to EPA. By indicating that I have chosen this option, I certify
that this study meets all the requirements pertaining to the conditions for
submittal of existing data outlined in the Data Call-In Notice and I have
attached the needed supporting information along with this response.
Option 5. ON BOTH FORMS; (Upgrading a Study) I will submit by the specified
due date, or will cite data to upgrade a study that EPA has classified as
partially acceptable and potentially upgradeable. By indicating that I have
chosen this option, I certify that I have met all the requirements pertaining
to the conditions for submitting or citing existing data to upgrade a study
described in the Data Call-in Notice. I am indicating on attached
correspondence the Master Record Identification Number (MRID) that
EPA has assigned to the data that I am citing as well as the MRID of the
study I am attempting to upgrade.
Option 6. ON BOTH FORMS: (Citing a Study) I am citing an existing study that
has been previously classified by EPA as acceptable, core, core minimum,
140
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or a study that has not yet been reviewed by the Agency. If reviewed, I am
providing the Agency's classification of the study.
However, for Product Specific Data, I am citing another
registrant's study. I understand that this option is available ONLY for
acute toxicity or certain efficacy data and ONLY if the cited study was
conducted on my product, an identical product or a product which the
Agency has "grouped" with one or more other products for purposes of
depending on the same data. I may also choose this option if I am citing
my own data. In either case, I will provide the MRID or Accession number
(s). If I cite another registrant's data, I will submit a completed
"Certification With Respect To Data Compensation Requirements" form.
FOR THE GENERIC DATA FORM ONLY The following three options (Numbers
7, 8, and 9) are responses that apply only to the "Requirements Status aid
Registrant's Response Form "for generic data.
Option 7.
tion 8-
°Ption 9-
(Deleting Uses^ I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
(Low Volume/Minor Use Waiver Request I have read the statements
concerning low volume-minor use data waivers in the Data Call-in Notice
and I request a low-volume minor use waiver of the data requirement. I am
attaching a detailed justification to support this waiver request including,
among other things, all information required to support the request. I
understand that, unless modified by the Agency in writing, the data
requirement as stated in the Notice governs.
(Request for Waiver of Datal I have read the statements concerning data
waivers other than lowvolume minor-use data waivers in the Data Call-in
Notice and I request a waiver of the data requirement I am attaching a
rationale explaining why I believe the data requirements do not apply. I am
also submitting a copy of my current labels. (You must also submit a copy
of your Confidential Statement of Formula if not already on file with
EPA). I understand .that, unless modified by the Agency in writing, the data
requirement as stated in the Notice governs.
FORPRODUCT SPECIFIC BATA The following option (number 7) is a response
that applies to the "Requirements Status and Registrant's Response Form" fo
product specific data.
Option 7. (Waiver Request I request a waiver for this study because it is
inappropriate for my product. I am attaching a complete justification for
this request, including technical reasons, data and references to relevant
EPA regulations, guidelines or policies. [Note: any supplemental data must
141
-------
Item 10.
Item 11.
Item 12.
be submitted in the format required by P.R. Notice 86-5]. I understand that
this is my only opportunity to state the reasons or provide information in
support of my request. If the Agency approves my waiver request, I will
not be required to supply the data pursuant to Section 3(c) (2) (B) of
FBFRA. If the Agency denies my waiver request, I must choose a method
of meeting the data requirements of this Notice by the due date stated by
this Notice. In this case, I must, within 30 days-of my receipt of the
Agency's written decision, submit a revised "Requirements Status" form
specifying the option chosen. I also understand that the deadline for
submission of data as specified by the original Data Call-in notice will not
change.
ON BOTH FORMS: This item must be signed by an authorized representative
of your company. The person signing must include his/her title, and must initial
and date all other pages of this form.
ON BOTH FORMS:Enter the date of signature.
ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response.
Item 13. ON BOTH FORMS:Enter the phone number of your company contact.
NOTE: You may provide additional information that does not fit on this form in a signed letter that accompanies this your response. For example, you
may wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled this
142
-------
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EPA'S BATCHING OFCRYOLITE PRODUCTS FOR MEETING REREGISTRATION
ACUTE TOXICITY DATA REQUIREMENTS
In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregistration of products containing Cryolite as the active
ingredient, the Agency has batched products which can be considered similar for purposes of
acute toxicity. Factors considered in the sorting process include each product's active and inert
ingredients (identity, percent composition and biological activity), type of formulation (e.g.,
emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal
word, use classification, precautionary labeling, etc.). Note that the Agency is not describing
batched products as "substantially similar" since some products within a batch may not be
considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described
in the preceding paragraph. Not with-standing the batching process, the Agency reserves the
right to require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute toxicological studies to represent all the products within that
batch. It is the registrant's option to participate in the process with all other registrants, only some
of the other registrants, or only their own products within a batch, or to generate all the required
acute toxicological studies for each of their own products. If a registrant chooses to generate the
data for a batch, he/she must use one of the products within the batch as the test material. If a
registrant chooses to rely upon previously submitted acute toxicity data, he/she may do so
provided that the data base is complete and valid by today's standards (see acceptance criteria
attached), the formulation tested is considered by EPA to be similar for acute toxicity, and the
formulation has not been significantly altered since submission and acceptance of the acute
toxicity data. Regardless of whether new data is generated or existing data is referenced,
registrants must clearly identify the test material by EPA Registration Number. If more than one
confidential statement of formula (CSF) exists for a product, the registrant must indicate the
formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow
the directions given in the Data Call-in Notice and its attachments appended to the RED. The DCI
Notice contains two response forms which are to be completed and submitted to the Agency
within 90 days of receipt. The first form, "Data Call-in Response," asks whether the registrant
will meet the data requirements for each product. The second form, "Requirements Status and
Registrant's Response," lists the product specific data required for each product, including the
standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide
whether he/she will provide the data or depend on someone else to do so. If a registrant supplies
the data to support a batch of products, he/she must select one of the following options:
Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing
Study (Option 5) or Citing an Existing Study (Option 6). If a registrant depends on another's data,
143
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he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or Citing
an Existing Study (Option 6). If a registrant does not want to participate in a batch, the choices
are Options 1,4,5 or 6. However, a registrant should know that choosing not to participate in a
batch does not preclude other registrants in the batch from citing his/her studies and offering to
cost share (Option 3) those studies.
PRS identified Federal Registration and Special Local Need (SLN) uses for batching
purposes. The products in bold print represent Federal Registrations and the SLN uses are not
in bold print.
Kryocide Insecticide 96.0% a.i. EPA Reg. No. 4581-116
Kryocide Insecticide 96.0% a.i. EPA SLN No. CA77016700
Kryocide Insecticide 96.0% a.i. EPA SLN No. CA79012100
Kryocide Insecticide 96.0% a.i. EPA SLN No. CA80008100
Kryocide Insecticide 96.0% a.i. EPA SLN No. NJ90000-800
Prokil Cryolite 96 96.0% a.i.
Prokil Cryolite 96 96.0% a.i.
Prokil Cryolite 96 96.0% a.i.
Prokil Cryolite 96 96.0% a.i.
Prokil Cryolite 96 96.0% a.i.
Prokil Cryolite 96 96.0% a.i.
Cryolite 93 93.0% a.i.
EPA Reg. No. 10163-0041
EPA SLN No.
EPA SLN No.
EPA SLN No.
EPA SLN No.
EPA SLN No.
DE93000-300
MI93 00-500
NJ93000-600
NJ90000-700
PA93000-500
EPA Reg. No. 5481-132
Prokil Cryolite WDG 93.0% a.i. EPA Reg. No. 10163-185
Prokil CryoliteWDG 93.0% a.i. EPA Reg. No. NJ94000-800
Gowan Cryolite Bait 20.0% a.i.
Gowan Cryolite Bait 20.0% a.i.
EPA SLN No. OR95000-800
EPA SLN No. WA95001-800
Sixteen products were found which contain Cryolite as an active ingredient. Fourteen
products were placed in Batch 1 and two products were placed in Batch 2 (see graphs below).
144
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Batch
CA77016700
CA79012100
CA80008100
NJ90000800
10163-41
DE93000300
MI93000500
NJ90000700
NJ93000600
PA93 000500
5481-132
10163-00185
NJ94000800
—
EPA Reg. Number
IM^HMHMI
OR95000800
WA95001800
96
96
96
96
96
96
96
96
96
96
93
93
% of active
ingredient
MB
20
20
powder
powder
powder
powder
powder
powder
powder
powder
powder
powder
powder
powder
jowder
Formulation Type
mm^mum
powder
powder
Data from the HED Chapter on the technical can be used in support of all Batch 1 products.
The HED Chapter indicates that all the acute tox studies are Category m and/or IV;
therefore, data on the technical can be bridged to support Batch 2 products.
New acute tox studies are not required since existing data on the technical may be used
directly (Batch 1) and/or bridged (Batch 2) to all of the above listed products.
145
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed
copies of the form are required. Following are basic instructions:
a.
b.
c.
d.
e.
f.
g-
h.
i.
k.
1.
m.
n.
All the blocks on the form must be filled in and answered completely.
If any block is not applicable, mark it N/A.
The CSF must be signed, dated and the telephone number of the responsible party
must be provided.
All applicable information which is on the product specific data submission must
also be reported on the CSF.
All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids.
Flashpoint must be in degrees Fahrenheit and flame extension in inches.
For all active ingredients, the EPA Registration Numbers for the currently
registered source products must be reported under column 12.
The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
common names for the trade names must be reported.
For the active ingredients, the percent purity of the source products must be
reported under column 10 and must be exactly the same as on the source product's
label.
All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or
grams. In no case will volumes be accepted. Do not mix English and metric
system units (i.e., pounds and kilograms).
All the items under column 13 .b. must total 100 percent.
All items under columns 14.a. and 14.b. for the active ingredients must represent
pure active form.
The upper and lower certified limits for ail active and inert ingredients must follow
the 40 CFR 158.175 instructions. An explanation must be provided if the proposed
limits are different than standard certified limits.
When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific formulation.
147
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149
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wEPA
United States Environmental Protection Agency
Washington: DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Farm Approved
OMB No. 2070-0106
2070-0057
Approval Expires 3-31-96
EmfLTlT? • , nSfthlS C0"e2!0n °f infomiatfon * estimated to average 15 minutes per response, including
tune for reviewing instructions, searching existing data sources, gathering and maintaining the dateVwedwTand
SSSClS^B
t££L PM £ ffS x ^nuation^nclucfing suggestions for reducing this burden, to Chief. Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W.. Washington, DC 20460; and to the Office
of Management and Budget. Paperwork Reduction Project (2070-0106). Washington, DC 20503?
Please fill in blanks below.
Company Number
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
lnsecte.de, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
SS.^ ?1? y a?!lratrun d?ClSi°n Undef seclion SfeHSMBX") of F'F*A if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s): a
Mimo of Flrm(«)
Date of Offer
Certification:
s rePresent tne company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Rapre*antttiv«
Date
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Form Approved
OMB No. 2070-0107,
2070-0057
Approval Expires
3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response i
revising instructions searching existing data sources, gathering and maintaining the data needed ..no lm
col ec ton of information. Send comments regarding the burden estimate or any other aspect of this collection of information
tIO?wr wdUhin9 tthiS n^en t0' Chi6f lnf°rmation P°licy Branch' PM'233- U'S- Bivlronm«l?P^5So? '
), Washington^cloloT' ' "* t0 *" ^ °f Management and Bud9et- Paperwork Reduction Project
the
Please fill in blanks below.
Company Name
Product Name
I Certify that:
Company Number
EPA Reg. No.
StUdy C',ted.in suPP°rt °f registration or reregistratiion under the Federal Insecticide, Fungicide and Rodenticide Act
y'am original data submitteri or'have obtained the wriiten permission
in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the
btamed the written permission of the original data submitter, or I have notified in writing the
<»M/i vpV«nrf QM/ovn\ * nm A w/u^ and have offered to: (a) Pay compensation for those data in accordance with sections
3(c)(1)(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
requirement of FIFRA and the amount of compensation due, if any. The companies I have notified are. (check one)
0, . , _ . t I'tted the studies listed on the back of this form or attached sheets, or indicated on the attached
Status and Registrants' Response Form,"
3. That I have previously complied with section 3(c)(1)(F) of FIFRA for the studies I have cited in support of registration or
reregistration under FIFRA.
Signature
Date
Name and Title (Please Type or Print)
GENERAL. OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the registration or
reregistration of my products, to the extent required by FIFRA section 3(c)(1 )(F) and 3(c)(2)(D).
Signature
Date
Name and Title (Please Type or Print)
A Form 8570-31 (4-96)
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APPENDIX E - LIST OF AVAILABLE RELATED DOCUMENTS
The following is a list of available documents for Cryolite that may further assist you in
responding to this Reregistration Eligibility Decision document. These documents may be
obtained by the following methods:
Electronic
File format:
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.GOV, or using WWW (World Wide Web) on WWW EPA GOV or
contact Jeff Billingslea at (703)-308-8004.
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 Cryolite.
The following documents are part of the Administrative Record for Cryolite 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.
2.
Health and Environmental Effects Science Chapters.
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 this RED document.
1. The Label Review Manual.
2. EPA Acceptance Criteria
155
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