United States Prevention, Pesticides EPA 738-R-95-004
Environmental Protection And Toxic Substances January 1995
Agency (7508W)
4>EPA Reregistration
Eligibility Decision (RED)
Fosamine ammonium
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case fosamine
ammonium. The enclosed Reregistration 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 may also include requirements for
additional data (generic) on the active ingredients to confirm the risk assessments.
To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED". This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses. The first set of required responses are due 90 days from
the date of this letter. The second set of required responses are due 8 months from the
date of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.
If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative
Frank Rubis at (703) 308-8184. Address any questions on required generic data to the Special
Review and Reregistration Division representative Shanaz Bacchus at (703) 308-8065.
Sincerely yours,
Louis P. True, Jr., Acting 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 (PCI) OR "90-DAY RESPONSE" If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data
are required, another DCI letter will be enclosed listing such requirements. If both generic
and product specific data are required, a combined Generic and Product Specific letter will
be enclosed describing such data. Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of the date
of this letter (RED issuance date); otherwise, your product may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER REQUESTS No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for data waivers must be submitted as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response,
but certainly no later than the 8-month response date. All data waiver and time extension
requests must be accompanied by a full justification. All waivers and time extensions must be
granted by EPA in order to go into effect.
3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE" You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may delete uses
which the RED says are ineligible for reregistration. For further labeling guidance, refer to
the labeling section of the EPA publication "General Information on Applying for Registration
in the U.S., Second Edition, August 1992" (available from the National Technical Information
Service, publication #PB92-221811; telephone number 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
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limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.
e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5. WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
Fosamine Ammonium
LISTB
CASE 2355
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
FOSAMINE AMMONIUM REREGISTRATION ELIGIBILITY DECISION TEAM . . i
EXECUTIVE SUMMARY vi
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Data Requirements 4
D. Regulatory History 4
III. SCIENCE ASSESSMENT 5
A. Physical Chemistry Assessment 5
B. Human Health Assessment 6
1. Toxicology Assessment 6
a. Acute Toxicity 6
b. Subchronic Toxicity 8
c. Developmental Toxicity 10
d. Mutagenicity 10
e. Reference Dose 12
2. Exposure Assessment 12
a. Dietary Exposure 12
b. Occupational and Residential 12
3. Risk Assessment 15
a. Dietary 15
b. Occupational and Residential 15
C. Environmental Assessment 15
1. Environmental Fate 15
a. Environmental Chemistry, Fate and Transport 16
b. Environmental Fate Assessment 19
2. Ecological Effects 21
a. Ecological Effects Data 21
(1) Terrestrial Data 21
(2) Aquatic Data 23
(3) Non-Target Insects Data 25
(4) Non-Target Plants Data 26
b. Ecological Effects Risk Assessment 27
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 32
A. Determination of Eligibility 32
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1. Eligibility Decision 33
2. Eligible and Ineligible Uses 33
B. Regulatory Position 33
1. Tolerance Reassessment 34
2. Labeling Rationale/Risk Mitigation Measures 34
3. Endangered Species Statement 36
V. ACTIONS REQUIRED BY REGISTRANTS 37
A. Manufacturing-Use Products 37
1. Additional Generic Data Requirements 37
2. Labeling Requirements for Manufacturing-Use Products 38
B. End-Use Products 39
1. Additional Product-Specific Data Requirements 39
2. Labeling Requirements for End-Use Products 39
C. Spray Drift Label Advisory 41
D. Existing Stocks 41
VI. APPENDICES 43
APPENDIX A. Table of Use Patterns Subject to Reregistration 45
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 51
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of 2355 61
APPENDIX D. List of Available Related Documents 73
APPENDIX E 77
PR Notice 86-5 79
PR Notice 91-2 97
APPENDIX F. Generic Data Call-in 103
Attachment 1. Chemical Status Sheet 119
Attachment 2. Generic DCI Response Forms Inserts (Form A) plus
Instructions 123
Attachment 3. Requirements Status and Registrants' Response Forms
Inserts (Form B) plus Instructions 127
Attachment 4. List of Registrant(s) sent this DCI (Insert) 133
APPENDIX G. Product Specific Data Call-in 135
Attachment 1. Chemical Status Sheet 149
Attachment 2. Product Specific Data Call-in Response Forms (Form A
inserts) Plus Instructions 151
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions 157
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 161
Attachment 5. EPA Acceptance Criteria 165
Attachment 6. List of All Registrants Sent This Data Call-in (insert) Notice
179
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Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 181
APPENDIX H. FACT SHEET 191
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FOSAMINE AMMONIUM REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
John Faulkner
George Keitt
Steve Jarboe
Environmental Fate and Effects Division
Janice King Jensen
Joanne Edwards
Jim Hetrick
Health Effects Division
Andy Rathman
Flora Chow
Arliene Aikens
Pam Hurley
Laura Morris
Registration Division
Joanne Miller
Jesse Mayes
Tom Ellwanger
Mary Waller
Bipin Gandhi
Special Review and Reregistration Division
Kathy Davis
Shanaz Bacchus
Economic Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Science Analysis and Coordination Staff
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Tolerance Support Chemistry Branch
Chemical Coordination Branch
Chemical Coordination Branch
Toxicology Branch I
Occupational and Residential Exposure Branch
Fungicide-Herbicide Branch
Fungicide-Herbicide Branch
Registration Support Branch
Registration Support Branch
Registration Support Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Office of Research and Development :
Vivian Williams Science, Planning and Regulatory Evaluation
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Office of General Counsel:
Kevin Lee
Office of Compliance :
Beverley Updike
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE Acid equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
DRES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium
specific (i.e. drinking water) lifetime exposure at which adverse, non
carcinogenic health effects are not anticipated to occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration
in an environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
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
in
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GLOSSARY OF TERMS AND ABBREVIATIONS
LC
50
LD
50
LDlo
LEL
LOG
LOEL
MATC
MCLG
mg/L
MP
MPI
MOE
MRID
N/A
NPDES
NOEL
Median Lethal Concentration. A statistically derived concentration of a
substance that can be expected to cause death in 50% of test animals. It is
usually expressed as the weight of substance per weight or volume of water, air
or feed, e.g., mg/1, mg/kg or ppm.
Median Lethal Dose. A statistically derived single dose that can be expected to
cause death in 50% of the test animals when administered by the route indicated
(oral, dermal, inhalation). It is expressed as a weight of substance per unit
weight of animal, e.g., mg/kg.
Lethal Dose-low. Lowest Dose at which lethality occurs
Lowest Effect Level
Level of Concern
Lowest Observed Effect Level
Maximum Acceptable Toxicant Concentration
Maximum Contaminant Level Goal (MCLG) The MCLG is used by the
Agency to regulate contaminants in drinking water under the Safe Drinking
Water Act.
Micrograms Per Gram
Milligrams Per Liter
Manufacturing-Use Product
Maximum Permissible Intake
Margin Of Exposure
Master Record Identification (number). EPA's system of recording and
tracking studies submitted.
Not Applicable
National Pollutant Discharge Elimination System
No Observed Effect Level
IV
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GLOSSARY OF TERMS AND ABBREVIATIONS
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
PAM Pesticide Analytical Method
PPE Personal Protective Equipment
ppb Parts Per Billion
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*! The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer
Risk Model
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TC Toxic Concentration. The concentration at which a substance produces a toxic
effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TMRC Theoretical Maximum Residue Contribution
TLC Thin Layer Chromatography
WPS Worker Protection Standard
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EXECUTIVE SUMMARY
The Agency has conducted risk assessments of the current uses of fosamine ammonium
pesticide products and has determined that those uses of fosamine ammonium, as specified in
this document, will not cause unreasonable risk to humans or the environment, and are eligible
for reregistration.
Fosamine ammonium is a herbicide/plant growth regulator that is used for
brush control of nonagricultural rights-of-way (e.g., highways, railroads, and utilities),
industrial sites, and fencerows. The pesticide can be applied once from spring to early fall by
aircraft, backpack or handwands. It is prohibited from use in irrigation systems. When the
pesticide is applied in one year, its brush control effects are achieved by inhibiting bud growth
the year following the application. Fosamine ammonium is not registered for application to
croplands and soils treated with this herbicide cannot be converted to food/feed croplands
within one year of treatment. According to the current label, fosamine ammonium is not
registered for sale or use in California and Arizona. A product registered for forest planting
sites has been canceled (June 22, 1994), and the current uses on aquatic sites are being
voluntarily deleted from the sole product registration.
The health and environmental effects data bases indicate a low level of toxicity of this
pesticide. Fosamine ammonium is not very persistent and degrades rapidly in most soils.
Data provided to support estimates of acute and chronic exposure and risks to mammalian
species, other vertebrates and invertebrates are sufficient for reregistration purposes.
Fosamine ammonium is currently classified as a Toxicity Category II chemical on the
basis of acute dermal toxicity studies in mammalian species. Adequate data have been
submitted in support of worker exposure. There are no special toxicological concerns for this
plant growth regulator which warrant the establishment of minimum or baseline active-
ingredient-based personal protective equipment (PPE) for handlers.
The Agency is requiring the submission of additional generic data to confirm its
scientific conclusions for fosamine ammonium. These confirmatory data requirements include
(i) method validation for a worker exposure study; (ii) certification of limits of the technical
grade active ingredient; (iii) a cytogenetics assay; (iv) spray drift characterization; (v) an avian
reproduction study in mallards; and (v) data or further information to clarify effects on non-
target plants.
Before reregistering the products containing fosamine ammonium, the Agency is
requiring that product specific data, revised Confidential Statements of Formula (CSF) and
revised labeling be submitted within eight months of the issuance of this document. These data
include product chemistry for each registration and acute toxicity testing. After reviewing
these data and any revised labels and finding them acceptable in accordance with Section
3(c)(5) of FIFRA, the Agency will reregister a product. Those products which contain other
active ingredients will be eligible for reregistration only when the other active ingredients are
VI
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determined to be eligible for reregistration.
vn
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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 fosamine ammonium. The document consists of six sections. Section I is
the introduction. Section II describes fosamine ammonium, its uses, data requirements and
regulatory history. Section III discusses the human health and environmental assessment based on
the data available to the Agency. Section IV presents the reregistration decision for fosamine
ammonium. Section V discusses the reregistration requirements for fosamine ammonium.
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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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Decision document:
Common Name:
fosamine-ammonium
Chemical Name:
ammonium ethyl carbamoylphosphonate
Chemical Family:
organophosphonate subclass of organophosphate
CAS Registry Number: 25954-13-6
OPP Chemical Code: 106701
Empirical Formula:
Structural Formula:
C3HU04N2P
0 0
t I
CH3-CH2-0-P-C-NH2
Molecular Weight:
170.11
Basic Manufacturer:
E. I. Du Pont de Nemours and Co., Inc.
Trade Name:
Krenite®
B. Use Profile
The following is information on the current registered uses with an overview of use
sites and application methods. A detailed table of these uses of fosamine ammonium is in
Appendix A.
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Type of Pesticide: brush control agent, plant growth regulator.
Use Sites:
Terrestrial nonfood crop
Nonagricultural uncultivated areas (campgrounds; industrial areas,
outdoor)
Nonagricultural rights-of-way (highway, railroad, pipeline, utility)
Aquatic nonfood industrial
ditch banks, areas adjacent to and surrounding domestic water
supply, reservoirs, supply streams, lakes and ponds
All data in support of these aquatic nonfood industrial sites are
analyzed in this RED document, and all outstanding data to support
the continued registration of these sites are listed in this RED
document. The Agency is processing the registrant's request to
amend the label to delete these use sites. If, in the future, the
registrant wishes to register aquatic sites, the registrant will have to
resubmit all data to support those uses.
Target Pests: control of undesirable brush/herbaceous plant species, which include
american elder, basswood, bigleaf maple, birch, blackberry, black cherry,
blackgum, black locust, bracken, Chinese tallow, chokecherry, eastern cottonwood,
eastern pine, elm, field bindweed, hawthorn, hickory, leafy spurge, loblolly pine,
multiflora rose, persimmon, pin cherry, quaking aspen, red alder, red maple, red
oak, salmonberry, slippery elm, sassafras, sourwood, sumac, sweetgum,
sycamore, thimbleberry, tree-of-heaven, tuliptree, vine maple, Virginia pine, water
oak, white ash, white oak, wild grape, wild plum, winged elm, and willow.
Formulation Types Registered: Water-soluble liquid
Method and Rates of Application:
Equipment - open pour, mix/load, high pressure handwand,
backpack, aerial, ultra low-volume equipment.
Method and Rate - Open pour, mix/load; 6 Ib ai/A to 24 Ib ai/A
Timing - Applied during period from full leaf in spring to
first fall coloration.
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Use Practice Limitations: Do not apply directly to water, or areas where
surface water is present, or to intertidal areas below
the mean high water mark. Do not contaminate
water when disposing of equipment washwaters.
Do not use on food crops. If areas previously
treated with fosamine ammonium are converted to
cropland, do not plant food crops or graze livestock
within 1 (one) year of treatment. However,
nonfood/feed plants such as wild flowers and native
grasses, may be planted at any time after treatment
on the sites listed above.
Do not apply through irrigation system.
Do not cut treated brush until stems are dead, or
sprouting may occur.
Not registered for sale or use in California and
Arizona on the current registered label.
C. Data Requirements
Data required in the Data Call-in (DCI) Notice (9/30/91) for fosamine ammonium
included studies on ecological effects, environmental fate, product chemistry, toxicology
and occupational and residential exposure. These data were required to support the
registered uses. Appendix B includes all data requirements identified by the Agency for
currently registered uses needed to support reregistration.
D. Regulatory History
Fosamine ammonium was first registered on July 7, 1975, under EPA Registration No.
352-376 (Du Pont Krenite® Brush Control Agent). It was registered for non-cropland
(non-food) use areas such as railroads, pipeline, utility and highway right-of-ways,
reforestation areas, drainage ditch banks, storage areas, industrial plants sites, and other
similar sites. However, the registrant requested voluntary cancellation of this product
which was effective on June 22, 1994.
A second product, (EPA Reg. No. 352-395), was registered on May 2, 1980.
Currently, this product is registered under two trade names, Du Pont Krenite® S Brush
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Control Agent and Du Pont Krenite® UT Brush Control Agent. This formulated product
also contains 41.5% active ingredient, ammonium salts of fosamine. The uses, except for
forest planting sites, are the same as for the original product.
On August 23, 1994, Du Pont filed an Application for Amended Registration,
requesting voluntary cancellation of direct applications to water, ditchbanks, and to other
sites which are adjacent to and surrounding domestic water, supply reservoirs, supply
streams, lakes and ponds. The Agency is processing this request, which includes
publishing a Notice of Intent to delete these uses in the Federal Register. There will be
a ninety (90) day comment period. Because there are no other current registrants and
there are outstanding environmental data requirements to support continued registration
of these uses, the Agency does not anticipate Du Pont or any other party choosing to retain
these uses. Therefore, the Agency presumes that these sites will be deleted from the
current label by late 1994.
For this reason and the fact that there are outstanding data requirements for these
sites, the Agency has excluded the risk assessment of aquatic sites in its decision to
reregister fosamine ammonium. Consideration of the aquatic uses for future registration
must include all applicable data requirements.
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Fosamine ammonium is a monoammonium salt of phosphonic acid containing an
aminocarbonyl group and a monoethyl ester. It is formulated as a soluble concentrate
liquid end-use product (EP) containing 41.5% of the active ingredient (a.i.). Technical
fosamine ammonium exhibits the following characteristics:
Color white
Physical State crystalline solid
Odor alcoholic
Melting Point 173-175°C (decomposition)
Density, Bulk density
or specific gravity 1.24 g/ml at 25°C
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Solubility
Vapor pressure
Octanol/water partition
coefficient
Stability
completely miscible in water;
less than 1 ppm in methylene chloride, ether,
hexane, toluene
1 ppm in acetone
2 ppm in acetonitrile.
17 g/100 ml in methanol.
4x 106mmHgat25°C
Kow = 0.0012
5.79 for 1% solution (w/v) at 25°C
stable at 25°C and 55°C, stable in the presence of
metal (iron) and metal ions (ferric chloride) and to
sunlight for at least two weeks.
B. Human Health Assessment
Below is a summary of the toxicology and occupational and residential
exposure data bases reviewed by the Agency for the purpose of determining the
reregistration eligibility of fosamine ammonium. Data bases for chronic feeding
studies, carcinogenic, metabolic and reproductive toxicological endpoints are
conditionally required for the current use pattern of the pesticide, under conditions
specified in 40 CFR §158.340.
1. Toxicology Assessment
a. Acute Toxicity
Acute studies for oral, dermal, and inhalation endpoints, which
were based on a 42% technical grade active ingredient (TGAI),
demonstrated low potential toxicity for fosamine ammonium. For the
RED, oral, dermal and inhalation exposures were evaluated on the basis of
the Toxicity Categories IV, II and IV, respectively, as shown in Table I.
Similarly, studies with the 42% formulation indicated low potential for
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primary dermal irritation and primary eye irritation. Fosamine ammonium
does not appear to be a dermal sensitizer. All data requirements for acute
oral, dermal, inhalation, dermal irritation and eye irritation toxicological
endpoints are satisfied.
There were no clinical signs of acute delayed neurotoxicity observed
in hens at doses of 2000 mg/kg/day. However, there were some perineural
lymphoid proliferations of the tibial nerve in both the positive control and
treated group, but not in the vehicle control group. Although these
proliferations may be unrelated to the degenerative changes observed in the
positive control group, their presence in both treated and control groups
indicates equivocal results (MRID 42934801).
In an acute mammalian neurotoxicity study, rats were dosed by
gavage with 0, 500, 1000 or 2000 mg/kg/day of fosamine ammonium. The
systemic NOEL from this study was considered to be 500 mg/kg, while the
LEL, based on diarrhea, was 1000 mg/kg. Possible neurotoxic effects
were observed, but not statistically significant at 1000 and 2000 mg/kg.
These were slight palpebral closure, irregular respiration, both observed
in the open arena. Ample positive control data were provided on
amphetamine, acrylamide, carbaryl and DDT.
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Table 1; Acute Toxicity
TEST
Acute Oral
Acute Dermal
Acute Inhalation
Primary Eye
Irritation
Primary Dermal
Irritation
Dermal
Sensitization
Acute delayed
neurotoxicity
Acute mammalian
neurotoxicity
MRID
00075735
00026825
00075733
00030774
00075734
00078990
00075738
00075733
00026826
00075737
42934801
42946501
RESULTS
LD50 (rat): 24,400 mg/kg
LD,n (rabbit): >1682 mg/kg (HOT)
LC50 (rat): >56.6mg/L air (male),
>42.0 mg/L air (female)
Low potential (rabbit)
Low potential (rabbit)
Not a sensitizer under conditions of study
Perineural lymphoid proliferations. Results
equivocal until resolved.
NOEL: 500 mg/kg; LEL 1000 mg/kg.
Increases in palpebral closure (non-
statistical), irregular respiration.
CATEGORY
IV
II
IV
-
-
-
-
-
b. Subchronic Toxicity
Subchronic oral studies
Subchronic feeding data are only conditionally required for the
fosamine ammonium use pattern if the intended use is expected to result in
human exposure to the product via the oral route and if the expected
exposure is over a limited portion of the human lifespan, yet is significant
in terms of the frequency of exposure, magnitude of exposure, or the
duration of exposure. Due to concern for potential drinking water
contamination from the use of fosamine ammonium around reservoirs,
subchronic feeding data in two species were required. Both subchronic
feeding studies in rodents (MRID 00075736) and nonrodents (MRID
42867001) deviate somewhat from the guidelines. However, the combined
data from the two studies are sufficient to fulfill the regulatory requirement
for subchronic feeding data.
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Fosamine ammonium was tested in a 90-day feeding study in rats
at 0, 200, 1000 or 5000/10000 ppm in the diet (0, 10, 50, 250 or 500
mg/kg/day). At the highest dose level, the animals received 5000 ppm for
8 weeks and then 10000 ppm for weeks 9 through 13. The NOEL is 200
ppm. The LOEL is 1000 ppm based on: (a) swollen deep proximal
convoluted tubules of the kidney in males at 1000 ppm and above, and (b)
on vacuolated and degeneratively affected deep proximal convoluted tubules
of the kidney, epithelial hyperplasia of the urinary bladder and slight
decreases in body weight, body weight gain and food consumption in males
at 5000/10000 ppm. The biological meaning of the kidney effects is
unknown. Although this study was accepted, it was considered incomplete
because of (i) the lack of data on dietary analyses; (ii) lack of individual
animal data for clinical signs, body weight, food consumption and organ
weights; (iii) the small number of tissues microscopically examined; and
(iv) the lack of adequate examination of the low- and mid-dose animals
(MRID 00075736).
In another subchronic feeding study, fosamine ammonium was fed
to dogs for 6 months at 0, 200, 1000 or 5000/7500/10000 ppm (0, 5, 25
and 125 or 187.5 or 250 mg/kg/day). At the highest dose level, the dogs
received 5000 ppm for the first week and 7500 ppm for the second and
third weeks. Beginning at the fourth week, the dogs received 10000 ppm
in the diet. Four males and four females were tested at each dose level.
There was a statistically significant increase in serum glucose in high-dose
female dogs when compared to controls at 2 and 6 months. This increase
was attributed to the values from one dog in the group. No other
treatment-related effects were observed. The NOEL is 5000/7500/10000
ppm (HDT). Although this study was accepted, it is considered somewhat
incomplete because the dogs were 14-16 months old at the start of the
study, rather than 4-9 months old, and therefore, the effects on young
animals could not be evaluated in the study (MRID42867001).
Nevertheless, results from these two studies are sufficient to characterize
the potential subchronic toxicity from mammalian oral exposure to the
pesticide.
Subchronic Dermal
An acceptable 21-day dermal study is available. In this study,
fosamine ammonium was tested in male and female rabbits at 0, 50, 500
or 1500 mg/kg/day. The test material was applied as a paste in deionized
water for 6 hours/day for 21 or 22 consecutive days. Intermittent minimal
dermal irritation was observed in all groups in both male and female
rabbits. Although mild erythema was observed more often in the test
9
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groups than in the controls, it was not clearly related to exposure to the test
material. The NOEL is therefore considered to be 1500 mg/kg/day (HDT)
(MRID 41998101).
Subchronic mammalian neurotoxicity
In a subchronic mammalian neurotoxicity study in rats, fosamine
ammonium was tested at 0, 5000, 10000 or 20000 ppm in the diet for 96-
98 days (calculated to be 299, 604 or 1193 mg/kg/day for males and 398,
779 or 1567 mg/kg/day for females). The NOEL for systemic effects is
below 299 mg/kg/day. The LEL is 299 mg/kg/day, based on diarrhea in
males at all dose levels and in females at 1567 mg/kg/day in females.
There were no neurotoxic effects at any dose level. Ample positive control
data were provided on amphetamine, acrylamide, carbaryl and DDT.
These data were considered acceptable (MRID 42946502).
c. Developmental Toxicity
Fosamine ammonium was tested in Crl:CD®BR rats at the following
dose levels: 0, 50, 350, 1000 or 3000 mg/kg/day. The test material was
administered by gavage on days 7-17 of gestation. The maternal NOEL is
1000 mg/kg/day and the maternal LEL is 3000 mg/kg/day based on clinical
signs of toxicity (diarrhea) and on decreases in body weight gain and food
consumption during the dosing period. The developmental NOEL is 3000
mg/kg/day (HDT) (MRID 42320901).
d. Mutagenicity
Mutagenicity studies include: (1) gene mutation assay in S.
typhimurium (MRID 41891601); (2) CHO/HGPRT assay for gene mutation
(MRID 00148267); (3) in vivo bone marrow cytogenetic assay in rats
(MRID 00147636); (4) in vitro assay for chromosome aberrations in
Chinese hamster ovary~(CHO) cells (MRID 00147635); and (5)
unscheduled DNA synthesis/rat hepatocytes in vitro (MRID 00147634).
All of the studies were classified as acceptable except for the
unscheduled DNA synthesis study (UDS) in rat hepatocytes, which was not
tested at high enough dose levels. The in vitro assay for chromosome
aberrations in CHO cells was strongly positive, whereas all the other four
assays were negative. Although the UDS study was classified as
unacceptable, according to the new mutagenicity testing requirements, the
basic regulatory requirement for a mutagenicity battery is satisfied by the
10
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studies that were conducted. The new battery consists of the following
studies: a gene mutation assay in S. typhimurium, an in vivo bone marrow
cytogenetic assay, and a mouse lymphoma assay or a CHO/HGPRT assay
for gene mutation in conjunction with an in vitro assay for chromosomal
aberrations in Chinese hamster ovary (CHO) cells. These studies have
already been conducted. The basic mutagenicity study battery requirements
are fulfilled. However, clastogenic (chromosome breakage) effects in the
Tier I studies trigger the need for additional confirmatory data. Based on
the strong clastogenic effect in the cultured CHO cells, the Agency requires
additional testing with germ cells as a follow-up, confirmatory study. This
testing requirement can be satisfied with such assays as an in vivo
cytogenetics assay in spermatogonia/spermatocytes or a micronucleus assay
with spermatids.
(i) Gene mutation assay in S. typhimurium
Fosamine ammonium was tested for the potential to induce reverse
mutations in Salmonella typhimurium strains TA97, TA98, TA100 or
TA1535 using the plate incorporation assay, both with and without
metabolic activation. The dose levels selected ranged from 10 to 5000
jig/plate. The results were negative.
(ii) CHO/HGPRT assay for gene mutation
Krenite (41.5% formulation) was tested for the potential to induce
forward mutations in Chinese hamster ovary cells (CHO/HGPRT assay) up
to levels of cytotoxicity, both with and without metabolic activation.
Krenite was not mutagenic in this assay.
(iii) Cytogenetic assay
Single oral doses of Krenite (0, 1, 3 or 10 grams/kg) were
administered by gavage in rats in an in vivo bone marrow study. Krenite
did not induce an increase in the frequency of chromosomal aberrations at
any dose level.
Chromosome aberrations in Chinese hamster ovary (CHO) cells
In an in vitro assay for chromosome aberrations in Chinese hamster
ovary (CHO) cells, Krenite was tested at levels up to cytotoxicity.
Statistically significant, dose-related increases in structural chromosome
11
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aberrations were observed at 16.7 and 33.3 jiL/ml Krenite in nonactivated
cultures, as well as at 15, 30 or 33.3 jiL/ml in S-9 supplemented cultures.
Under the conditions of the assay, Krenite was clastogenic both with and
without metabolic activation. Chromosome breakage was observed at final
concentrations (v/v, in medium) of Krenite equivalent to:
1.4%, 2.8%, or 5.7% (with metabolic activation);
1.6% or 3.2% (without metabolic activation)
Unscheduled DNA synthesis/rat hepatocytes in vitro.
To determine unscheduled DNA synthesis, the EP was tested in an
in vitro assay in rat hepatocytes at 8 halflog concentrations ranging from
1 x 10 5 mM to 10 mM. There was no positive response in two separate
trials for induction of unscheduled DNA (repair) synthesis as judged by a
net increase of 5 silver grains or more per nucleus. In these assays, the EP
tested negatively for UDS induction in rat hepatocytes. However, 10 mM
(the highest dose tested) is equivalent to 1.7 mg product/ml or 0.88 mg
a.i./ml. The limit dose for this assay is 5 mg ai/ml. Therefore, the study
was not conducted at a sufficiently high dose level for an adequate negative
result.
e. Reference Dose
There is no food use pattern for fosamine ammonium. For potential
future food use, the Reference Dose (RfD) is 0.01 mg/kg/day, based on the
NOEL of 10 mg/kg/day from the rat subchronic study with an uncertainty
factor of 1000.
2. Exposure Assessment
a. Dietary Exposure
Since there are no registered food uses for fosamine ammonium, no
dietary exposure is expected. Dietary exposure data are not required.
b. Occupational and Residential
There is a potential for handler exposure to the herbicide during
open/pour mixing and loading, and applications by air, backpack and high
pressure/volume hand wands. Fosamine ammonium is a Toxicity Category
II chemical for acute dermal exposure (LD50 > 1682 mg/kg). The other
12
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toxicological endpoint which was used in this assessment is Toxicity
Category IV for acute inhalation toxicity (see Table 1).
Mixer/Loader/Applicator (Handler) Exposure:
Chemical specific mixer/loader/applicator data have been submitted
to EPA. Estimates of the units of daily dermal and inhalation handler
exposure were obtained from MRID No. 42598101 and the Pesticide
Handlers Exposure Database (PHED ver. 1.01). Exposure scenarios are
presented in Table 2 along with the corresponding exposure assessment.
M/L/A exposure estimates are based on the use of the fosamine ammonium
end-use-products (EP) at the maximum label rates.
The daily maximum acreages treated are assumed to be: 2 acres by
backpack, 10 acres by high pressure handwand, and 350 acres by air.
Worker exposure estimates are based on the assumption that workers wear
long pants, long sleeve shirt, shoes, and socks, and no gloves, except for
workers using backpacks (Scenario V) who are assumed to wear chemical
resistant gloves.
The major route of worker exposure is dermal which is estimated
to range from 0.3 mg/kg to 9.0 mg/kg during an eight hour work day.
Inhalation exposure for the same time frame is estimated to be negligible.
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Table 2. Worker Exposure Values for Fosamine Ammonium
Exposure Scenario
(Scen,f)
Dermal
Exposure"
(mg/lb a.i.)
Inhalation
Exposure1"
Cug/lb a,i.)
Maximum
Label
Application
Rate
(Ib a.i,/Acre)
Daily Dermal
Exposure'
(mg/kg/day) . .
Daily
Inhalation
Exposure
•(mg/kg/day)
Mixer/Loader Exposure
Open Mixing Liquids,
High Pressure Handwand
Application (I-a)
Open Mixing Liquids,
Fixed-Wing Aerial
d-b)
0.15
0.15
0.4
0.4
24
12
0.5
9.0
0.001
0.02
Applicator Exposure
High Pressure Handwand
Application4 (II)
Fixed-Wing Aerial6 (III)
Backpackf(IV)
0.8 (avg.)
0.005
1.3
6.2 (avg)
0.2
30
24
12
12
2.7
0.3
0.4
0.02
0.01
0.01
a Dermal unit exposures are reported as the best fit mean, unless noted. The best fit mean is the composite
total dermal exposure based on using the geometric mean for lognormal distributed data, arithmetic mean
for normal distributed data, and the median for all other distribution types.
b Inhalation exposure values are reported as geometric means (lognormal distributions).
0 Daily Exposure (mg/kg/8 hr day) =
Exposure (mg/lb a.i.) X Max. Appl. Rate (Ib a.i./acre) X Max. Treated
70kg
d Rights-of-way, high pressure handwand sprayer at 100 to 300 psi.
e All cab types.
f Two gallon knapsack
Postapplication Exposure
Postapplication/reentry and residue dissipation data are not required
in support of the current fosamine ammonium use patterns.
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3. Risk Assessment
a. Dietary
There are no registered food uses for fosamine ammonium. A
dietary risk assessment is not required for the current fosamine ammonium
use pattern.
b. Occupational and Residential
Fosamine ammonium is considered to be in Toxicity Category IV
for acute oral and inhalation toxicity, and Category II for acute dermal
toxicity. The dermal effects observed in rabbits and guinea pigs after acute
or subchronic dermal exposure at the highest doses tested were either
intermittent dermal irritation or at most mild erythema. Currently, there
are no toxicity concerns for short term (1 to 7 days) or intermediate term
(1 week to several months) occupational exposure. The NOELs identified
in the rat acute neurotoxicity study (500 mg/kg), the developmental toxicity
study (3000 mg/kg/day) and the 21 day dermal study (1500 mg/kg/day)
were very high and thus trigger no risk concern based on expected
exposure.
For this use pattern of fosamine ammonium, the estimated exposure
of commercial mixer/loader/applicators is likely to reflect the worse case
scenario. However, there are no known significant acute or chronic
toxicological endpoints that warrant the establishment of risk mitigation
measures to any category of handlers of the pesticide. Clothing as
described in the exposure assessment will provide adequate protection to
handlers.
C. Environmental Assessment
1. Environmental Fate
Available environmental fate data support a qualitative environmental fate
assessment of fosamine ammonium. Fosamine ammonium dissipation is
predominantly dependent on rapid, microbial mediated degradation. Major
degradates of fosamine ammonium are carbamoylphosphonic acid (CPA),
carboxylphosphonic acid (ING-3003), and carbon dioxide (C02). However, no
definitive environmental fate data are available for CPA and ING-3003.
Additionally, this environmental fate assessment excludes the aquatic sites, due to
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the lack of applicable data, namely aerobic aquatic and aquatic field dissipation
studies, and the registrant's desire to remove them from the product label.
a. Environmental Chemistry, Fate and Transport
(1) Hydrolysis
Fosamine ammonium is stable to hydrolysis. Radiolabeled fosamine
ammonium, at 9.2 to 10.3 jig/ml, did not hydrolyze in sterile, buffer solutions at
pH 5,7, and 9 (MRID 40133701).
(2) Photodegradation in water, soil and air
Radiolabeled fosamine ammonium also did not photodegrade in irradiated
pH 9 buffer solution and Keyport silt loam soil. The requirements for
photodegradation in water and soil have been satisfied. The data to support the
photodegradation in air were waived because fosamine ammonium volatilization
from soil does not appear to be a major route of dissipation. Fosamine ammonium
also has a low vapor pressure of 4.6 x 106 mm Hg as reported in MRIDs
40133702 and 40133703.
(3) Aerobic and anaerobic soil metabolism
Fosamine ammonium dissipation is predominantly dependent on rapid,
microbial-mediated degradation. Radiolabeled fosamine ammonium, at 10 |ig/g,
had a first-order degradation half-life of 0.5 days (k= 1.441 days *) in an aerobic
Delaware silt loam soil. Supplemental soil metabolism data indicate fosamine
ammonium had a half-life of 1.2 weeks in aerobic silt loam and sandy loam soil.
Degradates of fosamine ammonium were CPA (94 percent of applied immediately
posttreatment), IN-G3003 (26 percent of applied 1 month posttreatment), and C02
(33 percent of applied).
Radiolabeled fosamine ammonium had a half-life of 4 days in anaerobic
sediment and pond water from Meyersville, Maryland. Radiolabeled fosamine
ammonium was stable in sterile, anaerobic sediment and water samples.
Degradates of fosamine ammonium were CPA (59 percent of applied at 14 days
posttreatment), ING-3003 (43 percent of applied at 9 months posttreatment), and
C02 (7.6 percent of applied) (MRIDs 42060601, 42724301, 42060602,
42680701).
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(4) Anaerobic aquatic metabolism
Data indicate fosamine ammonium degradation in anaerobic environments
is a rapid, microbial-mediated process. Anaerobic aquatic studies provide
marginally acceptable data on the metabolism of fosamine ammonium in anaerobic
aquatic environments.
As described above in the section on anaerobic soil metabolism,
radiolabeled fosamine ammonium, at 10 |ig/g, had a half-life of 4 days (k = 0.156
days1) in Meyersville, MD sandy loam sediment and pond water. Fosamine
ammonium was stable in sterile sediment and pond water. Radiolabeled residues
in sediment extracts were parent fosamine ammonium (104 percent of applied
immediately posttreatment), carbarnoylphosphonic acid (59 percent of applied
fosamine ammonium at 14 days posttreatment), and carboxylphosphonic acid (43
percent of applied fosamine ammonium at 9 months posttreatment). Radiolabeled
residues in the potassium hydroxide traps were identified as C02 (7.6 percent of
applied fosamine ammonium at 12 months posttreatment). Radiolabeled residues
were also detected (less than 15 percent of applied fosamine ammonium) in
nonextractable sediment organic matter. The anaerobic aquatic metabolism data
requirement is satisfied (MRIDs 42060602 and 42680701).
(5) Leaching and adsorption/desorption
Based on limited data, fosamine ammonium appears to be very mobile in
sandy loam soil. A batch equilibrium study provides acceptable data on the
binding affinity of fosamine ammonium in sandy loam soil. The reported data
indicate that fosamine ammonium should be very mobile in sandy loam soil, with
a Freundlich adsorption coefficient of 0.066 ml/g (l/n = 0.8603; Koc = 8.087
ml/g). A simple desorption coefficient (Kdes) was greater than 16 ml/g.
Although the unaged portion of the batch equilibrium/soil column leaching
is not fulfilled at this time, the weight of evidence from acceptable and
supplemental mobility data indicate that fosamine ammonium has a very low
binding affinity to sandy loam and silt loam textured soils. No additional mobility
data are needed to assess the mobility of fosamine ammonium (parent) at this time.
The aged residues portion of the Guideline 163-1 data requirement, to address
mobility of the individual degradates, has not been satisfied (MRIDs 42492401,
42492301).
(6) Field volatility
Fosamine ammonium has a low vapor pressure (4.6 x 106 mm Hg).
Therefore, the data requirement for a field volatility study (Guideline 163-3) was
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waived because fosamine ammonium volatilization from soil does not appear to be
a major route of dissipation.
(7) Terrestrial field dissipation
Fosamine ammonium rapidly dissipates in the field. Acceptable field
dissipation data indicate fosamine ammonium, at 24 Ibs a.i./A in 0-15 cm surface
soil, had a half-life of 1 day (Lexington, TN), 1 day (Newark, DE) and 5 days at
Fayetteville, NC. Fosamine ammonium was detected (0.4 ppm) immediately
posttreatment in 15-30 cm soil samples at the Fayetteville, NC site. These
detections were considered to be sample contamination because there was no
detection of fosamine ammonium at later sampling periods.
Supplemental field dissipation data from small microplots indicate fosamine
ammonium, at 11 kg/ha in 0-2 inch soil depth, had a calculated half-life of 1.1
weeks in a Delaware Keyport silt loam soil, 0.79 weeks in an Illinois Flanagan silt
loam, 0.55 weeks in a Florida Leon Immokalee fine sandy loam soil. The
degradate CPA was detected at 26.7 percent of recovered radioactivity in the
Delaware silt loam (6 weeks), 40 percent of the recovered radioactivity in the
Illinois silt loam (6 weeks), and 83 percent of the recovered radioactivity in
Florida sandy loam (2 weeks). Radiolabeled residues were detected (0.6 to 5.1
percent of applied radioactivity) to a depth of 15 inches soil samples after 3 to 12
months post fosamine ammonium application. The majority of radiolabeled
residues were not identified as fosamine ammonium and CPA (less than 1 percent
of recovered radioactivity at depths greater than 2 inches). Cumulative rainfall for
the studies was 64.95 inches (12 months) at the Delaware site, 26.85 inches at the
Illinois site (6 months), and 15.91 inches at the Florida site (6 months). Soil
samples were not taken deeper than 15 inches.
Radiolabeled fosamine ammonium, at 12 Ibs a.i/A applied to microplots
planted with fescue, grass, red clover, and pin oak, was not detected (less than
0.05 ppm) in underlaying 0-3 inch soil samples between 1 to 12 months
posttreatment. Radiolabeled residues in soil were CPA (1.3 to 8.6 ppm at 1 month
to 0.5 to 1.1 ppm at 7 months) and unextractable residues (ratio of CPA:
unextractable residues (1:1)). Radiolabeled fosamine ammonium was detected
(381-481 ppm immediately posttreatment to 0.05 ppm at 3 months posttreatment)
on plant foliage. The degradate CPA and carboxyphosphonic acid also were
detected on plant foliage.
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Field dissipation studies indicate that fosamine ammonium degrades rapidly
(t1/2 less than 5 days) in soil under typical use conditions. Although fosamine
ammonium is a mobile compound, there is little evidence to indicate leaching is a
major route of dissipation. In addition, supplemental studies indicate that CPA
dissipation does not appear to be dependent on leaching. However, unidentified
residues were detected at a depth of 15 inches (MRID 40955701).
(8) Fish bioaccumulation
Marginally acceptable accumulation in fish data indicate fosamine
ammonium at 1 ppm did not bioaccumulate in bluegill sunfish tissues.
Bioconcentration factors for fosamine ammonium could not be estimated because
of analytical limitations. Average concentrations of 14C-fosamine ammonium were
0.334 mg/kg in fillet tissues, 0.337 mg/kg in whole fish, and 0.348 mg/kg in
viscera. The Kow of fosamine ammonium also is low (less than 0.0012). These
data indicate fosamine ammonium residues should not accumulate in fish tissues.
However, a nine percent fish mortality was observed in the accumulation in fish
study. Data requirements for Guideline 165-4 are satisfied. (MRID 42587601).
(9) Droplet size spectrum and field drift studies
Droplet size spectrum (Guideline 201-1) and field drift studies (Guideline
202-1) are needed to support ground spray and aerial spray application methods for
fosamine ammonium. These data requirements have been imposed on the
registrant who has chosen to satisfy them through participation in the industry
Spray Drift Task Force. Spray Drift data from the Task Force are due June 30,
1995. If the new data suggest substantially different drift potential for the use
patterns of fosamine ammonium, the Agency will reassess its impact on the
associated environmental risks.
b. Environmental Fate Assessment
Based on supplemental and acceptable environmental fate data, fosamine
ammonium dissipation is predominantly dependent on rapid, microbial-mediated
degradation (t1/2 0.5 to 11 days). Fosamine ammonium is also mobile (Kad less
than 1 and Rf greater than 0.98) in mineral soils.
Degradates of fosamine ammonium are carbamoylphosphonic acid (CPA),
carboxylphosphonic acid (ING-3003), unidentified polar compounds and C02.
Supplemental soil column leaching studies indicate fosamine ammonium residues
are relatively immobile. The mobility and persistence of individual degradates
(CPA, ING-3003, and unidentified polar degradates) are unknown at this time.
Field dissipation studies confirm laboratory data for fosamine ammonium.
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Fosamine ammonium rapidly dissipated, with a half-life of less than 5 days from
the surface field soils. Leaching does not appear to be a major route of dissipation
for fosamine ammonium and CPA in field studies. However, unidentified,
radiolabeled polar residues were detected at a depth of 15 inches in confined field
dissipation studies.
The environmental fate data indicate fosamine ammonium should be very
mobile in mineral soils. However, fosamine ammonium should not pose a threat
to groundwater or surface waters because it rapidly degrades in aerobic and
anaerobic environments. The mobility of CPA, ING-3003 and individual polar
degradates has not been adequately quantified at this time.
Ground water. Fosamine ammonium (parent) has a low probability to
impact ground-water quality. Although the chemical is highly soluble in water and
mobile in various soils, fosamine ammonium (parent) is not persistent in soil under
aerobic or anaerobic conditions. The rapid degradation of fosamine ammonium
reduces the likelihood that the chemical will move through the aerobic soil layer
without any degradation. There are inadequate data to assess the environmental
fate and transport of the degradates of fosamine ammonium, namely
carbamoylphosphonic acid (CPA) and carboxylphosphonic acid (ING-3003).
However, due to the lack of toxicological concern for these compounds, the
Agency is not requiring further definitive fate and transport data for them.
Surface water. Fosamine ammonium could move to surface water through
spray drift and to a lesser extent in surface water runoff. There is a low
probability that fosamine ammonium will be found in most runoff waters because
it degrades rapidly in aerobic and anaerobic environments (t1/2 less than 4 days)
through microbial-mediated processes. However, fosamine ammonium may be
found in surface waters with low microbiological activities or long hydrological
residence times. The Agency has no data on the concentrations of fosamine
ammonium in surface waters. The available data on major degradates of fosamine
ammonium are insufficient to assess their runoff potential or persistence in surface
waters. However, available data indicate that fosamine ammonium will not
significantly impact the quality of surface waters.
Drinking Water. No MCLs or drinking water health advisories have been
established for fosamine ammonium or its degradates. Consequently, the Agency
is not recommending at this time any mandated monitoring of drinking water
derived from surface water sources for fosamine ammonium or its degradates.
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2. Ecological Effects
The ecotoxicological data base is sufficient to characterize the toxicity of
fosamine ammonium to nontarget terrestrial and aquatic organisms when used on
noncropland for control of undesirable brush/herbaceous plant species.
a. Ecological Effects Data
(1) Terrestrial Data
(a) Avian Acute Toxicity
The minimum data required to evaluate the acute toxicity of fosamine
ammonium to birds is an avian single-dose oral LD50 test with technical material
utilizing either a waterfowl or upland game-bird species. The minimum data
required to evaluate fosamine ammonium's subacute toxicity are two avian dietary
LC50 tests with technical material, utilizing a waterfowl and upland game-bird
species. The minimum data required to evaluate chronic toxicity are two avian
reproduction studies with technical material, utilizing a waterfowl and an upland
game-bird species.
Data from the avian single-dose studies indicate that technical fosamine
ammonium is practically nontoxic to avian species on the basis of acute oral
toxicity. LD50s for a 99.4% TGAI fosamine ammonium in both the mallard duck
and the bobwhite quail are greater than 5000 mg/kg which was the highest dose
tested (MRIDs 00093715 and 00130225).
(b) Avian Subacute Dietary Toxicity
Data in support of avian subacute dietary toxicity indicate that technical
fosamine ammonium is practically nontoxic to avian species (mallard, bobwhite
quail). The LC50s (> 10000 and 5620 ppm, see Table 3) are estimated to be
greater than the highest dose tested (MRIDs 00093716, 41891602, and 41891603).
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Table 3. Avian Subacute Dietary Studies Using Fosamine Ammonium
Species
Mallard
Bobwhite quail
%ai
99.4
97.7
97.7
LC50
(ppm)
> 10000
>5620
>5620
Conclusions
practically non-toxic
practically non-toxic
practically non-toxic
(c) Avian Reproduction/Chronic Effects
Suggestive evidence for reproductive effects to avian species was
demonstrated in a laboratory study sponsored by the U.S. Fish and Wildlife
Service. This study examined the embryotoxic and teratogenic effects of various
solutions of the end-use product (EP: equivalent to 1.5 percent, 6.5 percent and
30 percent a.i.) on mallard and bobwhite quail eggs following a 10 second dipping.
An embryotoxic response was seen in eggs treated with the 6.5 percent and 30
percent EP solutions. The solutions were more embryotoxic to the mallard than
to the bobwhite quail. While this study is not a guideline study and is classified
as supplemental, it reflects a more representative exposure associated with direct
spray application to eggs.
In an avian reproduction study utilizing bobwhite quail, no reproductive
effects were noted at any of the dose levels tested (250, 1000, or 4000 ppm). As
shown in Table 8 below, the estimated environmental concentrations (EEC) of
fosamine ammonium on different avian and mammalian food items range from 18
ppm to 5760 ppm at the typical and maximum application rates. Because the
highest dose level tested, 4000 ppm, is below the maximum EEC of 5760 ppm on
short-grass, this study is classified as supplemental, but is adequate to perform a
risk assessment on avian species (MRID 42948301).
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Table 4. Avian Reproduction/Chronic Effects
Species
Bobwhite Quail
Mallard
Bobwhite Quail
and Mallard
%ai
Fosamine
ammonium
97.7
97.7
41
Effect Level
no effects noted at highest dose level tested (4000 ppm)
scientifically unsound study, ambiguous results
embryotoxic response seen at 6.5% and 30% a.i.
solution application to eggs
Conclusions
not tested at
maximum EEC
Not applicable
not guideline
study
There is some indication of potential chronic avian reproduction effects in
another study utilizing mallard species fed 99.7% fosamine ammonium in the diet.
However, this study deviated from the protocol and was not considered
scientifically sound. While there was a statistically significant decrease in numbers
of eggs laid at the lowest concentration, 250 ppm (Williams test), no statistically
significant effects were noted at the highest dose level, 4000 ppm (MRID
42948302). These results were considered ambiguous and were not used to assess
the risk to avian species.
Given the ambiguous nature of the data from these studies, the Agency is
requiring a new mallard duck reproduction study for confirmatory purposes.
There appears to be no indication of reproductive effects in bobwhite quail based
on the concentrations (up to 4000 ppm) tested, therefore the Agency is not
requiring any additional data for the bobwhite quail.
(d) Toxicity to Nontarget Mammals
An LD50 value was derived from acceptable rat acute oral toxicity tests
submitted to EPA. The rat LD50 of formulated fosamine ammonium (43 percent)
is 24400 mg/kg. This value characterizes the acute toxicity to mammals as
practically nontoxic (MRIDs 00075735, 00026835).
(2) Aquatic Data
(a) Freshwater Fish Toxicity
Two 96-hour LC50 fish toxicity tests utilizing the technical material are the
minimum data required to evaluate the acute toxicity of fosamine ammonium to
freshwater fish. One test is for warmwater fish, preferably bluegill sunfish, and
the other is for coldwater fish, preferably rainbow trout. The minimum data
required to evaluate the acute toxicity to estuarine/marine species are a fish 96-
23
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hour LC50 test using either a marine or estuarine species, a mollusc 96-hour EC50
shell deposition study or 48-hour EC50 on oyster embryolarvae, and a shrimp 96-
hour LC50 test using either a marine or estuarine species. The minimum data
required to evaluate chronic toxicity are from a fish early life stage study.
Table 5. Freshwater Fish LC50 Studies
Species
Rainbow
trout
Bluegill
Coho Salmon
% ai fosamine
ammonium
98.6
98.6
unknown
LCSO
(ppm)
377
590
>200
Conclusions
practically non-
toxic
Data from fish acute toxicity studies indicate that fosamine ammonium is
practically nontoxic to coldwater and warmwater fish (MRIDs 41607103,
41607102 and 00129075).
(b) Freshwater Invertebrate Toxicity
The minimum data required to establish the acute toxicity of fosamine
ammonium to freshwater invertebrates is a 48-hour LC50 test utilizing the technical
material. At a minimum chronic toxicity to aquatic invertebrates is evaluated by
an early life stage study. These data indicate that technical fosamine ammonium
(99% ai) is practically nontoxic to freshwater invertebrates, such as Daphnia (LC50
1524 ppm) (MRIDs 00143492 and 92086005). No further data are required.
(c) Estuarine/Marine Toxicity
Fosamine ammonium (41.5% a.i.) is practically nontoxic to estuarine
species as suggested by the results from the following studies (MRIDs 42715101,
42715103, and 42715102). No further data are required.
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Table 6. Estuarine/Marine LC50/EC50 Studies
Species
Sheepshead
Minnow
Mysid Shrimp
Eastern Oyster
%ai
97.7
97.7
97.7
LC50/EC50
(ppm)
>128
>136
>122
Conclusions
practically
nontoxic
For the current use patterns of fosamine ammonium, a fish early life stage
and an invertebrate life cycle study could have been triggered under certain
conditions:
(i) if actual or estimated environmental concentrations in water resulting
from the use is less than 0.01 of any EC50 or LC50 value determined in
required testing; and
(ii) the pesticide is persistent in water (e.g., half-life in water greater than
4 days).
The Agency's assessment of fosamine ammonium for this RED document
indicates a half-life of less than 4 days in soil based on acceptable aerobic and
anaerobic soil metabolism studies. Supplemental data show somewhat higher half-
life values (up to 1.2 weeks). The half-life reported in the anaerobic aquatic
metabolism study (t1/2 = 4) is a combined half-life in sediment and soil. Because
fosamine ammonium has a low binding affinity to sediment/soil, a similar half-life
in water is expected. Based on these acceptable fate studies, showing a half-life
of less than 4 days in soil and a similar expected half-life in water, neither a fish-
early life stage study nor an invertebrate life cycle study is required for fosamine
ammonium.
(3) Non-Target Insects Data
A 48-hour LD50 test utilizing the technical material is the minimum
requirement to establish the acute toxicity of fosamine ammonium to nontarget
insects. The test organism is the honey bee (Apis mellifera). In such a study
technical fosamine ammonium (95% a.i.) was shown to be practically nontoxic to
the honey bee. The estimated LD50 is considered to be greater than 200 pig/bee
(MRID 41215802).
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(4) Non-Target Plants Data
(a) Terrestrial, Semi-Aquatic, Aquatic Plant Data
The minimum data required to establish the phytotoxicity of fosamine
ammonium are seed germination/seedling emergence testing for terrestrial plants
and aquatic plant testing. For the aquatic plant testing, the following species were
required to be tested for fosamine ammonium: Selenastrum capricornutum, Lemna
gibba, Skeletonema costatum, Anabaena flos-aquae, and a freshwater diatom.
Eight aquatic plant studies were submitted and found acceptable.
Table 7: Nontarget Aquatic Plant Testing Data
Species
Selenastrum capricornutum
Selenastrum capricornutum
Anabaena flos-aquae
Skeletonema costatum
Navicula pelliculosa
Lemna gibba
%ai
64
98.3
98.3
98.3
98.3
97.7
Results
(mg/1)
NOEC >1000 (the highest level tested)
EC50>18
NOEC =18
EC50>17
NOEC = 17
EC50>15
NOEC =15
EC50>19
NOEC =19
NOEC < 21
The terrestrial plant studies which were submitted (MRID 42647601) are
classified as supplemental. Data for four of the ten species tested (corn, sugar
beet, pea and cucumber) were determined to be inadequate, because the seeds had
been pretreated with a fungicide and/or insecticide. These studies need to be
repeated using seeds that have not been pretreated with a fungicide and/or
insecticide. Alternatively, these studies may be accepted if the registrant can
successfully demonstrate that the pretreatment pesticide was surface active and
non-systemic, and not antagonistic to, or synergistic with fosamine ammonium.
These studies may be upgraded when acceptable Tier I seed germination, complete
Tier II seedling emergence and complete Tier II vegetative vigor studies are
submitted (MRIDs 41215804, 42902901, 42902902, 42902904, 42902903, and
42587602).
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b. Ecological Effects Risk Assessment
(1) Risk to Avian and Mammalian Species
Characterizing risk to avian and mammalian species is a function of
ecotoxicological hazard and environmental exposure. The Agency characterizes
risk in part by calculating risk quotients, and compares them to levels of concern
(LOCs). A risk quotient is derived by dividing exposure (EEC) by an appropriate
toxicity endpoint (e.g. generally the LC50 or LD50 of the most sensitive species).
The risk quotient is compared to the LOCs. LOCs for birds and mammalian
species are: 0.5 for acute High Risk (HR); 0.2 for acute Restricted Use (RU); 0.1
for acute Endangered Species (ES); and 1.0 for chronic risk. When the risk
quotient exceeds the LOG for a particular category, then risk to that category is
presumed to exist.
The Agency obtained estimates of expected environmental concentrations
(EECs) on various food items consumed by birds and mammalian species by using
the monograph of Hoerger and Kenaga (1972). These estimates were used in
assessing risk, because actual field study residue data were lacking. Hoerger and
Kenaga describe both "maximum" and "typical" EECs. Maximum EECs are those
values representing the most extreme, and, probably infrequent, residue scenarios.
Typical EECs are those values representing environmental conditions which are
likely to occur. For purposes of the fosamine ammonium risk assessment both
"typical" and "maximum" EEC values are used. Expected "typical" and
"maximum" EECs resulting from application of fosamine ammonium at the typical
and highest application rates are listed below. Application rates on the labels of
currently registered products range from 6 Ib a.i./A to 24 Ib a.i./A.
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Table 8. Maximum and Typical EECs After Application of Fosamine
Ammonium on Different Avian/Mammalian Food Items
Substrate
Short Grass
Long Grass
Leaves and Leafy Crops
Forage, (alfalfa) Insects
Pods Containing Seeds
Fruit
Typical/Maximum Residues
(ppm)
12 Ib a.i./A
1500/2880
1104/1320
420/1500
396/696
36/144
18/84
Typical/Maximum Residues
(ppm)
24 Ib a.i./A
3000/5760
2208/2640
840/3000
1188/1392
72/288
36/168
(2)
Avian Acute Oral and Chronic Risks
The Agency's Guidelines for Avian Dietary LC50 Testing specify that a
study may demonstrate that the actual LC50 is greater than 5000 ppm in lieu of
demonstrating an actual LC50. Both bobwhite quail and mallard studies included
tests up to the maximum 5000 ppm level and no indications of toxicity were noted
in either species. Therefore, the Agency has determined it is reasonable to assume
that the levels of concern for acute effects will not be exceeded if fosamine
ammonium is used as labeled.
The avian reproductive effects via chronic ingestion of fosamine ammonium
are not as clearly defined as the avian acute oral effects. While some data suggest
potential sensitivity to mallards, no effects were observed in bobwhite quail at the
highest dose tested (4000 ppm). The data which are indicative of avian
reproductive effects, however, are either ambiguous or do not meet guideline
requirements.
Additional non-guideline data were provided by the U.S. Fish and Wildlife
Service. These studies indicated that 6.5 percent and 30 percent end-use product
solutions containing fosamine ammonium produced a statistically greater
embryotoxic response in mallard ducks than bobwhite quail eggs.
Because of the ambiguity associated with the mallard duck reproduction
study, the Agency is relying on the bobwhite guideline reproduction study and the
U.S. Fish and Wildlife Service data for the risk assessment. A conservative
quantitative estimation of risk using the maximum application rate of 24 Ib a.i./A
was performed for this risk assessment using only bobwhite quail reproductive
data. The risk quotient for chronic effects using the bobwhite quail data (5760
28
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ppm/4000 ppm) is 1.4 which exceeds the Agency's level of concern for avian
chronic risk (LOG = 1). Therefore based on a conservative estimation of risk, the
use of fosamine ammonium may present a potential for chronic risk to avian
species.
However, in order to determine whether there are actual reproductive
effects associated with chronic exposure to fosamine ammonium, the Agency is
requiring the registrant to conduct a new confirmatory mallard duck reproduction
study. The Agency has determined that the bobwhite quail study is adequate for
purposes of this risk assessment. In addition, the registrant has provided to the
Agency some initial risk mitigation measures which may help reduce the avian
exposure to fosamine ammonium and thereby reduce the potential reproductive
risk. The risk mitigation measures are discussed in Sections IV and V below.
(3) Mammalian Acute Oral and Chronic Risks
Using the rat as a small mammal surrogate, fosamine ammonium is
expected to be practically non-toxic to small mammalian species. The rat LD50 of
formulated fosamine ammonium (43%) is 24,400 mg/kg. Acute oral and subacute
dietary risks to non-endangered and endangered non-target mammals are not
expected to result from present label uses of fosamine ammonium.
The results of an acceptable developmental toxicity study, in which sexually
mature rats were gavaged for an eleven day period with fosamine ammonium at
levels up to 3000 mg/kg/day, showed no mortality (3000 mg/kg/day equates to
about 30000 ppm). No mortality was seen at the highest dose tested, 20000 ppm,
in an acceptable 90-day neurotoxicity study. Given that the highest exposure case
EEC for fosamine ammonium is 5760 ppm, and comparing this value to actual
mammalian data showing no acute/longer term effects at levels up to 30000 ppm,
there would be no expected acute or chronic mammalian effects to occur.
(4) Risks to Aquatic Animals
Exposure to nontarget aquatic organisms can result from spray drift and
runoff from treated areas. Characterizing risk to aquatic species is a function of
ecotoxicological hazard and environmental exposure. It is performed in a manner
similar to that for birds and small mammals. The exception is that the EECs are
calculated differently. The Agency calculates risk quotients (EEC/LC50 or LD50
of the most sensitive species), and then compares these to levels of concern
(LOCs). LOCs for aquatic species are: 0.5 for acute High Risk (HR); 0.1 for
acute Restricted Use (RU); 0.05 for acute Endangered Species (ES); and 1.0 for
chronic risk. When the risk quotient exceeds the LOG for a particular category,
then risk to that category is presumed to exist.
29
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Estimated Environmental Concentrations (EECs) were calculated using the
Agency's Hazard Evaluation Division's Standard Evaluation Procedure for
Ecological Risk Assessment (EPA-540/9-85-001). These estimates were used in
assessing risk, because actual field study residue data were lacking. The Agency
generally employs the highest application rate permitted on the label and calculates
the EEC resulting from direct application, from spray drift, and from runoff of the
pesticide into a 6-foot deep 1-acre pond, and the EEC resulting from runoff of the
pesticide into a 6-inch deep 1-acre pond. For purposes of this risk assessment, the
typical (12 Ib a.i./A) and highest (24 Ib a.i./A) application rates were employed.
The EECs resulting from direct application, spray drift, and runoff of
fosamine ammonium applied at 12 and 24 Ib a.i./A application rates into 6 inch
and 6 foot deep one acre ponds are listed in 4 below. This table also provides a
comparison of acute risk quotients to the Agency's levels of concern (LOCs). The
LC50 for rainbow trout (96-hr LC50 of 377), the most sensitive freshwater aquatic
organism tested, was used in risk quotient calculations.
Table 9. Risk Quotients and LOCs for Pond Scenarios (Rainbow Trout LCfn = 377 ppm)
Use Site
Rights of Way, Non-
cropland, Industrial
Sites
Rights of Way, Non-
cropland, Industrial
Sites
Application
Rate
12 Ibs ai
24 Ibs ai
EEC (ppm)
Runoff (6') = 0.366
Drift (6') = 0.256
Direct (6')= 0.73
Runoff (6")= 4.4
Drift (6") = 3.08
Direct (6")= 8.8
Runoff (6') = 0.732
Drift (6') = 0.5 12
Direct (6')= 1.46
Runoff (6") = 8. 8
Drift (6") =6.16
Direct (6") = 17.6
Risk
Quotient
(EEC/LCJ
0.001
0.002
0.012
0.008
0.023
0.002
0.001
0.004
0.023
0.016
0.047
Level of Concern (LOQ
High Risk 0.5
Restricted Use 0.1
Endangered Species 0.05
High Risk 0.5
Restricted Use 0.1
Endangered Species 0.05
The acute risk quotients do not exceed any level of concern. Therefore, the
Agency concludes that acute effects to freshwater fish and aquatic invertebrates are
not expected as a result of the normal use of fosamine ammonium.
In the absence of an actual LC50 or EC50, the Agency did not estimate an
acute risk quotient for estuarine species. However, the highest dose levels tested
in each of the three estuarine species tested resulted in no mortalities (sheepshead
minnow 96-hr LC50 > 128 ppm; mysid shrimp 96-hr LC50 > 136 ppm; and eastern
oyster 96-hr EC50 > 122 ppm). Therefore, the Agency assumes that acute hazards
30
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to estuarine species are not expected as a result of the use of fosamine ammonium
as labeled.
Additional information which supports this conclusion are: (i) there is only
one seasonal application of fosamine ammonium; (ii) acute toxicity values are
greater than 1 ppm, (iii) EECs in water are less than 0.01 of individual acute
toxicity values; and (iv) environmental fate data (anaerobic aquatic metabolism)
indicate a half life of 4 days under certain conditions. The Agency also believes
that it is reasonable to assume that there are no chronic risks to aquatic organisms.
(5) Risks to Aquatic Plants
Exposure to nontarget aquatic plants can result from spray drift from
treated areas, surface runoff, or wind blown soil particles. Estimated
Environmental Concentrations (EECs) were calculated using the Agency's Hazard
Evaluation Division Standard Evaluation Procedure for Ecological Risk
Assessment (see under Risks to Aquatic Organisms). The Agency's LOG for
aquatic plants is 1. There are no separate LOCs for restricted use, endangered
species, or chronic risks. If the EEC _>_ EC25, the Agency presumes a high risk
and endangered plants may be affected. The risk quotient is derived using the
most conservative EC25 value for aquatic plants, greater than 15 mg/1 (the highest
level tested for Skeletonema costatum).
Table 10. Nontarget Aquatic Plant Risk Quotients and LOG of Fosamine
Ammonium based on EC25 greater than 15
Use Site
Rights of Way, Non-
cropland, Industrial Sites
Rights of Way, Non-
cropland, Industrial Sites
Application Rate
121bsai
24 Ibs ai
EEC (water
depth)
0.366 ppm
(6')
4.4 ppm (6")
0.732 ppm (6')
8.8 ppm
(6")
Risk Quotient
(EEC/LC,n)
0.02
0.29
O.05
0.59
LOC
1
1
None of the acute risk quotients exceed the LOC. Therefore, the Agency
concludes that no acute effects to aquatic plants are expected as a result of the use
of the registered uses of fosamine ammonium. A chronic risk assessment to
aquatic plants cannot be performed because data are not available. However, the
registrant is not supporting any aquatic sites. Data in support of chronic risks to
aquatic plants will be required if, in the future, the registrant wishes to register
such sites.
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(6) Risk to Terrestrial Plants
A terrestrial nontarget plant risk assessment cannot be conducted until all
Tier I and II data requirements have been fulfilled. Data are outstanding for corn,
sugar beet, pea and cucumber. Because results of the most sensitive terrestrial
plant species tested are needed in order to conduct an acute risk assessment, a risk
assessment cannot be performed. Any movement of this herbicide from the
treatment site via spray drift, surface runoff, or wind blown soil particles has the
potential to adversely affect nontarget and endangered/threatened plants. Direct
applications to rights-of-way are a special concern, because of the large numbers
of endangered plants growing in rights-of-way areas.
Applications of fosamine ammonium at the registered rates may pose a
significant risk to endangered plant species inhabiting treated rights-of-way. EPA
has been working with the U.S. Fish and Wildlife Service and other federal and
state agencies to develop a program to avoid jeopardizing the continued existence
of listed endangered species from the use of pesticides. The Endangered Species
Protection Program is expected to become final in 1995. Limitations on the use
of fosamine ammonium may be required to protect endangered and threatened
species, but these limitations have not yet been defined, and they may be
formulation-specific. The Agency anticipates that consultation with the U.S. Fish
and Wildlife Service will be conducted in accordance with the species-based
priority approach described in the Program. After completion of the consultation,
registrants will be informed if any required label modifications are necessary.
Such modifications would most likely consist of the generic label statement
referring pesticide users to use limitations contained in county Bulletins.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether products containing the active
ingredients are eligible for reregistration. The Agency has previously identified and
required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing fosamine ammonium 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 fosamine ammonium
for certain sites as specified in this document. The registrant has voluntarily requested
cancellation of the aquatic sites as discussed previously. Appendix B identifies the generic
data requirements that the Agency reviewed as part of its determination of reregistration
eligibility of fosamine ammonium, and lists the submitted studies that the Agency found
acceptable.
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The data identified in Appendix B for fosamine ammonium were sufficient to allow
the Agency to assess its registered uses, except for aquatic sites. The Agency has
determined that fosamine ammonium can be used for registered sites, except the aquatic
sites, as specified in this document, without resulting in unreasonable adverse effects to
humans or the environment. The Agency is requiring risk mitigation measures for non-
target animal species. The reregistration requirements of fosamine ammonium products
are addressed in this Section and in Section V below.
The Agency made its reregistration eligibility determination based upon the target
database required for reregistration, the current guidelines for conducting acceptable
studies to generate such data, the registrant's request for voluntary cancellation of aquatic
sites and the data identified in Appendix B. The Agency has found that certain uses of
fosamine ammonium, as discussed in this document, are eligible for reregistration, under
the conditions specified herein. However, it should be understood that the Agency may
take appropriate regulatory action, and/or require the submission of additional data to
support the reregistration of products containing fosamine ammonium, if new information
comes to the Agency's attention or if the data requirements for reregistration (or the
guidelines for generating such data) change.
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient, fosamine
ammonium, the Agency has sufficient information on the health effects of fosamine
ammonium and on its potential for causing adverse effects in fish and wildlife and
the environment. The Agency has determined that fosamine ammonium products,
labeled and used on sites as specified in this Reregistration Eligibility Decision
document, will not pose unreasonable risks of adverse effects to humans or the
environment, and are therefore eligible for reregistration.
2. Eligible and Ineligible Uses
The Agency has determined that all currently registered uses of fosamine
ammonium, except for aquatic sites, as described in this document, are eligible for
reregistration. The registrant has voluntarily requested cancellation of those
aquatic sites. The Agency is not including those sites in its eligibility decision,
because of the inadequate environmental data for those sites and the impending
deletion of those uses from all current registrations.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for fosamine
ammonium. Where labeling revisions are imposed, specific language is set forth in
Section V of this document.
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1. Tolerance Reassessment
Tolerances are not currently established for the herbicide fosamine
ammonium since there is no registered food or feed use.
2. Labeling Rationale/Risk Mitigation Measures
a. Personal Protection Equipment (PPE) Requirements
The current registered uses of fosamine ammonium do not include uses
associated with the production of an agricultural plant on/in any farm, forest,
nursery, or greenhouse. Sites on which this herbicide/plant growth regulator is
used are limited to utility rights-of-way, outdoor industrial areas, campgrounds,
storage areas and noncropland. These uses and the single registered product do not
fall under the scope of PR Notice 93-7, "Labeling Revisions Required by the
Worker Protection Standard (WPS)," and PR Notice 93-11, "Supplemental
Guidance for PR Notice 93-7". The Agency's labeling regulations for worker
protection statements (40 CFR 156, subpart K) are not applicable to fosamine end-
use products at this time.
For each end-use product, PPE requirements for pesticide handlers will be
set in one of two ways:
1. If EPA has no special concerns about the acute or other adverse
effects of an active ingredient, the PPE for pesticide handlers will
be established based on the acute toxicity of the end-use product.
For occupational-use products, PPE will be established using the
process described in PR Notice 93-7 or more recent EPA
guidelines.
2. If EPA has special concerns about an active ingredient due to very
high acute toxicity or to certain other adverse effects, such as
allergic effects, cancer, developmental toxicity, or reproductive
effects, the following conditions apply:
o In the RED for that active ingredient, EPA may establish
minimum or "baseline" handler PPE requirements that
pertain to all or most occupational end-use products
containing that active ingredient.
o These minimum PPE requirements must be compared
with the PPE that would be designated on the basis of the
acute toxicity of each end-use product.
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o The more stringent choice for each type of PPE (i.e.,
bodywear, hand protection, footwear, eyewear, etc.) must
be placed on the label of the end-use product.
There are no special toxicological concerns about fosamine ammonium that
warrant the establishment of baseline or minimum active-ingredient based
PPE for handlers (mixer/loader/applicators). Therefore, the PPE for
pesticide handlers will be established based on the acute toxicity of the end-
use product.
The Agency is establishing the following entry restrictions for the
occupational uses of fosamine ammonium end-use products:
For liquid applications:
"Do not enter or allow others to enter the treated area until
sprays have dried."
Other Labeling Requirements
The Agency is requiring labeling statements concerning application
restrictions and user safety recommendations to be located on all end-use
products containing fosamine ammonium that are intended primarily for
occupational use. See Chapter V for the actual statements.
b. Spray-Drift Label Advisory
In order to inform the user of best management practices that would
minimize spray drift from the target site, the Agency is currently preparing
spray drift statements. This future labelling may be required for all
fosamine products that may be applied aerially.
c. Avian Risk Mitigation
The Agency has determined that there is a potential for adverse effects on
avian reproduction with the use of fosamine ammonium. The data indicative of
such effects are not conclusive as discussed earlier (Section III). Briefly, the U.S.
Fish and Wildlife data suggest that reproduction in avian species may be adversely
affected when eggs are directly exposed to sprays of the end-use product (EP). By
way of contrast, the data from the bobwhite quail reproduction study shows no
effects at any dose levels. The Agency, therefore, thought it prudent to regulate
fosamine ammonium based on the weight of evidence supporting the reregistration
of fosamine, the low toxicity profile of the herbicide and the following
considerations.
35
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Information provided by Agency use experts suggests that fosamine
ammonium is not typically applied at the permitted maximum application rate of
24 Ib a.i./A. Rather, users and the registrant suggest that as much as 80 percent
of the use of fosamine ammonium is at the rate of 12 Ib a.i. to 16 Ib a.i. per acre.
Based on these more typical use rates, the estimated EECs for avian species would
be approximately 33 percent to 50 percent lower than for the 24 Ib a.i. rate. In
addition, less than one percent of the sites are treated with fosamine ammonium,
and application is limited to once per year. Furthermore, the sites treated are
narrow strips of land, rather than vast acreages of cropland. These factors further
decrease the potential for exposure to nesting birds.
The registrant has voluntarily submitted label amendments to allow
applications during the period after spring growth has hardened to the development
of fall coloration on deciduous species, and to restructure maximum rates of
application. These label amendments reduce the maximum application rate to 16
Ib a.i./A for low shrubs/brush (floor work), which constitute 80 percent of the use
of the herbicide. Applications to a maximum of 24 Ib a.i./A are proposed only for
tall dense wood species with very heavy foliage (side trim work). Prior to this
modification, all applications were permitted up to the 24 Ib a.i./A.
Additionally, submission of a new mallard duck reproduction study should
resolve any question of the potential for fosamine ammonium to cause reproductive
effects in this avian species. The Agency may require further risk mitigation
measures depending on the results of the required study.
3. Endangered Species Statement
The Agency has concerns about the exposure of threatened and endangered
avian species to fosamine ammonium as discussed above in the Section IIIC.
Currently, the Agency is developing a program ("The Endangered Species
Protection Program") to identify all pesticides whose use may cause adverse
impacts on endangered and threatened species and to implement mitigation
measures that will eliminate the adverse impacts. The program would require use
modifications or a generic product label statement, requiring users to consult
county-specific bulletins. These bulletins would provide information about specific
use restrictions to protect endangered and threatened species in the county.
Consultations with the Fish and Wildlife Service will be necessary to assess risks
to newly listed species or from proposed new uses.
The Agency plans to publish a description of the Endangered Species
Program in the Federal Register in 1995 and have enforceable county-specific
bulletins available. Because the Agency is taking this approach for protecting
endangered and threatened species, it is not imposing label modifications at this
36
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time through the RED. Rather, any requirements for product use modifications
will occur in the future under the Endangered Species Protection Program.
V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistration
of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
While there is currently no registered manufacturing-use product, the generic data
base supporting the reregistration of fosamine ammonium for the above eligible
uses has been reviewed and determined to be substantially complete except for the
following confirmatory data requirements:
• Guideline 62-2: Certification of limits. The registrant must provide information
to certify that the limits are within the standards required by 40 CFR §158.120.
Guideline 71-4b: Avian reproduction (mallards). Data are required to confirm
that the chronic avian reproductive risk does not exceed the Level of Concern at
the Estimated Environmental Concentration.
Guideline 84-2a: An in-vivo cytogenetics assay on spermatogonia/spermatocytes
to satisfy Guideline 84-2a requirements for toxicology mutagenicity.
Guideline 201-1, Guideline 202-1: Droplet size spectrum, and field drift data are
needed to evaluate off-target movement of spray applied fosamine ammonium.
These data requirements are being fulfilled by the registrant through their
participation in the Spray Drift Task Force. These data are scheduled for
submission by June 30, 1995.
Guidelines 231, 232: Method validation data for worker exposure study, MRID
42598101.
Guidelines 122-1 and 123-1: Terrestrial plant testing data requirements. Four of
the ten terrestrial plant testing studies for corn, sugarbeet, pea, and cucumber,
need to be repeated. Alternatively, the registrant can provide documentation to
demonstrate that the compounds used for pretreatment of seeds do not interfere
with the fosamine ammonium results in these studies. The other studies may be
upgraded when acceptable Tier I seed germination, complete Tier II emergence
and complete Tier II vegetative vigor studies are submitted.
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Guidelines 164-2 and 162-4. Aerobic aquatic metabolism and aquatic field
dissipation data would be required to support future use patterns of an aquatic site.
Assuming that the aquatic sites will be deleted from the current registration, the
Agency does not expect to receive these data. In the future, if the registrant wishes
to register any aquatic uses, these and all data in support of those sites must be
resubmitted.
2. Labeling Requirements for Manufacturing-Use Products
Effluent Discharge Labeling Statements
While there is no currently registered manufacturing-use product, these
requirements are appropriate for future registrations of fosamine ammonium.
All manufacturing-use or end-use products that may be contained in an
effluent discharged to the waters of the United States or municipal sewer systems
must bear the following revised effluent discharge labeling statement.
Within Environmental Hazards section of the Precautionary Statement of the label:
"Do not discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans or other waters unless in accordance with the requirements of a
National Pollutant Discharge Elimination System (NPDES) permit and the
permitting authority has been notified in writing prior to discharge. Do not
discharge effluent containing this product to sewer systems without previously
notifying the local sewage treatment plant authority. For guidance contact your
State Water Board or Regional Office of the EPA."
All affected products distributed or sold by registrants and distributors
(supplemental registrants) must bear the above labeling by October 1, 1995. All
products distributed or sold by persons other than registrants or supplemental
registrants after October 1, 1997 must bear the correct labeling. Refer to PR
Notice 93-10 or 40 CFR 152.46(a)(l) for additional information.
38
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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.
(a) Within Environmental Hazards section of the Precautionary Statement of the
label:
"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 washwaters or rinsate."
(b) To reduce environmental loading and potential exposure to non-target species,
the product label must include language to limit use as outlined below:
(i) the end-use product can be applied only once annually during the period
after spring growth has hardened to the development of fall coloration in
deciduous species, and
(ii) the maximum application rate for low shrubs/brush is 16 Ib a.i./A, and
for tall dense woody species with very heavy foliage can be 24 Ib a.i./A.
(c) The end-use product labels cannot include directions for applications to aquatic
sites. The current, sole registrant has submitted an application for amended
registration to delete these uses from its product registration. Future submissions
of appropriate data to support registration for these uses will be considered by the
Agency.
39
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(d) The Agency is requiring the following labelling statements to be located on all
end-use products containing fosamine ammonium:
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 applications."
Entry restrictions
The Agency is establishing the following entry restrictions for the
occupational uses of fosamine ammonium end-use products:
For liquid applications:
"Do not enter or allow others to enter the treated area until
sprays have dried."
Other Labelling Requirements
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 clothing immediately after
handling this product. If gloves are worn, wash the
outside of gloves before removing. As soon as
possible, wash thoroughly and change into clean
clothing."
These statements must be included on the labels, as they are
appropriate, after PPE requirements are set by the Agency.
40
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C. Spray Drift Label Advisory
In order to inform the user of best management practices that would minimize
spray drift from the target site, the Agency is currently preparing spray drift labelling
statements. This future labelling may be required for all fosamine ammonium products
that may be applied aerially.
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 fosamine
ammonium 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.
41
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42
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VI. APPENDICES
43
-------
44
-------
APPENDIX A. Table of Use Patterns Subject to Reregistration
45
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46
-------
Date 8/11/94
Time 14:37
APPENDIX A
CASE 2355, [Fosamine ammonium] Chemical 106701 [Ammonium ethyl carbamoylphosphonate
Page 1
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON- FEED
DRAINAGE SYSTEMS
High volume spray (dilute) ., When needed.,
High volume ground.
Low volume spray (concentrate) . , When
needed., Airblast.
Low volume spray (concentrate) . , When
needed., Backpack mist blower.
Spray., When needed., Aircraft.
INDUSTRIAL AREAS (OUTDOOR)
High volume spray (dilute) ., When needed.,
High volume ground.
Low volume spray (concentrate) . , When
needed., Airblast.
Low volume spray (concentrate) . , When
needed., Backpack mist blower.
Spray., When needed., Aircraft.
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. /crop /year otherwise) /A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
NA
NA
NA
NA
NA
NA
NA
NA
NONAGRICULTURAL RIGHTS -OF-WAY/FENCEROWS/HEDGEROWS
High volume spray (dilute) ., When needed.,
High volume ground.
Low volume spray (concentrate) . , When
needed., Airblast.
Low volume spray (concentrate) . , When
needed., Backpack mist blower.
Spray., When needed., Aircraft.
SC/L
SC/L
SC/L
SC/L
NA
NA
NA
NA
Use Group: AQUATIC NON- FOOD INDUSTRIAL
24 Ib A * NS NS NS NS NS NS
24 Ib A * NS NS NS NS NS NS
24 Ib A * NS NS NS NS NS NS
12 Ib A * NS NS NS NS NS NS
Use Group: TERRESTRIAL NON- FOOD CROP
24 Ib A * NS NS NS NS NS NS
24 Ib A * NS NS NS NS NS NS
24 Ib A * NS NS NS NS NS NS
12 Ib A * NS NS NS NS NS NS
Use Group: TERRESTRIAL NON- FOOD CROP
24 Ib A * NS NS NS NS NS NS
24 Ib A * NS NS NS NS NS NS
24 Ib A * NS NS NS NS NS NS
12 Ib A * NS NS NS NS NS NS
AZ, CA C46, C93
AZ, CA C46, C93
AZ, CA C46, C93
AZ, CA C46, C93
AZ, CA C46, C93
AZ, CA C46, C93
AZ, CA C46, C93
AZ, CA C46, C93
AZ, CA C46, C93
AZ, CA C46, C93
AZ, CA C46, C93
AZ, CA C46, C93
NONAGRICULTURAL UNCULTIVATED AREAS/SOILS
High volume spray (dilute)., When needed., SC/L NA
High volume ground.
Low volume spray (concentrate)., When SC/L NA
needed., Airblast.
Low volume spray (concentrate)., When SC/L NA
needed., Backpack mist blower.
Use Group: TERRESTRIAL NON-FOOD CROP
24 Ib A * NS NS NS NS NS
24 Ib A * NS NS
24 Ib A * NS NS
NS NS NS
NS NS NS
AZ, CA
AZ, CA
AZ, CA
C46, C93
C46, C93
C46, C93
-------
Date 08/11/94
Time 14:37
APPENDIX A
CASE 2355, [Fosamine ammonium] Chemical 106701 [Ammonium ethyl carbamoylphosphonate
Page 2
SITE Application Type, Application
Timing, Application Equipment
Form(s) Min. Appl.
Rate (AI un-
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
less noted
otherwise)
Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
unless noted Max. /crop /year otherwise)/A] (days) Interv
otherwise) Dose cycle /crop /year [day(s)]
cycle
Codes
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
NONAGRICULTURAL UNCULTIVATED AREAS/SOILS (con't)
Spray., When needed., Aircraft. SC/L NA
RECREATIONAL AREAS
High volume spray (dilute)., When needed., SC/L NA
High volume ground.
Low volume spray (concentrate)., When SC/L NA
needed., Airblast.
Low volume spray (concentrate)., When SC/L NA
needed., Backpack mist blower.
Spray., When needed., Aircraft. SC/L NA
Use Group: TERRESTRIAL NON-FOOD CROP (con't)
12 Ib A * NS NS NS NS NS
Use Group: TERRESTRIAL NON-FOOD CROP
24 Ib A * NS NS NS NS NS
24 Ib A * NS NS
24 Ib A
12 Ib A * NS NS
NS
NS NS
AZ, CA
AZ, CA
AZ, CA
AZ, CA
AZ, CA
C46, C93
C46, C93
C46, C93
C46, C93
C46, C93
-------
Date 08/11/94 - Time 14:37 APPENDIX A - CASE 2355, [Fosamine ammonium] Chemical 106701 [Ammonium ethyl carbamoylphosphonate LUIS 1.5 - Page 3
HEADER ABBREVIATIONS
Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Microbial claims only.
noted otherwise)
Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.
noted otherwise)
Soil Tex. Max. Dose : Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
Max. # Apps ® Max. Rate : Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3
years" is expressed as "4/3 yr"
Max. Dose [(AI unless : Maximum dose applied to a site over a single crop cycle or year. System calculated.
noted otherwise)/A]
Min. Interv (days) : Minimum Interval between Applications (days)
Restr. Entry Interv (days) : Restricted Entry Interval (days)
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C : Coarse
M : Medium
F : Fine
O : Others
FORMULATION CODES
SC/L : SOLUBLE CONCENTRATE/LIQUID
ABBREVIATIONS
AN : As Needed
NA : Not Applicable
NS : Not Specified (on label)
UC : Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet,
briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part,
parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, --
APPLICATION RATE
DCNC : Dosage Can Not be Calculated
No Calc : No Calculation can be made
W : PPM calculated by weight
V : PPM Calculated by volume
cwt : Hundred Weight
nnE-xx : nn times (10 power -xx); for instance, "1.234E-04" is equivalent to ".0001234"
USE LIMITATIONS CODES
C46 : Do not apply through any type of irrigation system.
C93 : Do not apply directly to water.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
GEOGRAPHIC CODES
AZ : Arizona
CA : California
-------
50
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APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
51
-------
52
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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 2355 covered by this Reregistration Eligibility Decision Document.
It contains generic data requirements that apply to 2355 in all products, including data
requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in
which they appear in 40 CFR Part 158. the reference numbers accompanying each test refer
to the test protocols set in the Pesticide Assessment Guidelines, which are available from the
National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703)
487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
0 Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files,
this column lists the identifying number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
53
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54
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Fosamine Ammonium
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-15
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
Coefficient
PH
Stability
Flammability
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
41607104
41607104
41607104
41607105
required
41607105
41607106
41607106
41607106
41607106
41607106
41607106
41215803
41607106
00164989
41607106
41607106
41687501
55
-------
Data Supporting Guideline Requirements for the Reregistration of Fosamine Ammonium
REQUIREMENT
63-16
63-17
63-18
63-20
63-21
Explodability
Storage Stability
Viscosity
Corrosion characteristics
Dielectric Breakdown Voltage
USE PATTERN
All
All
All
All
All
CITATION(S)
41687501
00094669
41687501
41687501
Waived
ECOLOGICAL EFFECTS
71-1A
71-2A
71-2B
72-1C
72-2A
72-3A
72-3B
72-3C
122-2
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Acute Avian Diet- Duck
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Estu/Marine Tox. Fish
Estu/Marine Tox. Mollusk
Etsu/Marine Tox. Shrimp
Aquatic Plant Growth
CF
CF
CF
CF
CF
CF
CF
CF
CF
00093715
00130225
41891603, 00093716
41891602
41607103
00143492
42715101
42715102
42715103
42902901,42902902, 42902903,
141-1
Honey Bee Acute Contact
CF
42902904, 41215804
41215802
56
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Data Supporting Guideline Requirements for the Reregistration of Fosamine Ammonium
REQUIREMENT USE PATTERN CITATION(S)
TOXICOLOGY
81-1 Acute Oral Toxicity - Rat
81-2 Acute Dermal Toxicity -
Rabbit/Rat
81-3 Acute Inhalation Toxicity - Rat
81-4 Primary Eye Irritation - Rabbit
81-5 Primary Dermal Irritation - Rabbit
81-6 Dermal Sensitization - Guinea Pig
81-7 Acute Delayed Neurotoxicity
Screen
81-8ss Acute Neurotoxicity
82-1A 90- Day Feeding-rodent
82-IB 90-day Feeding nonrodent
82-2 21-day Dermal Rabbit
82-7ss 90 day Neurotoxicity Screen
83-3A Teratogenicity-Rat
84-2A Gene Mutation (Ames Test)
84-2B Structural Chromosomal
Aberration
84-4 Other Genotoxic Effects
CF
CF
CF
CF
CF
CF
CF
CF
CF
CF
CF
CF
CF
CF
CF
CF
00026825, 00075735
00075733
000789990, 00075734, 00000774
00075738
00026826, 00015733
00075737, 00097289
42934801
42946501
00075736
42867001
41998101
42946502
42320901
41891601, 00148267
00147636, 00147635
147634
57
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Data Supporting Guideline Requirements for the Reregistration of Fosamine Ammonium
REQUIREMENT
USE PATTERN
CITATION(S)
86-1 Domestic Animal Safety
ENVIRONMENTAL FATE
161-1 Hydrolysis
161-2 Photodegradation in Water
161-3 Photodegradation in Soil
161-4 Photodegradation in Air
162-1 Aerobic Soil Metabolism
162-2 Anaerobic Soil Metabolism
162-3 Aerobic Aquatic Metabolism
162-4 Aerobic Aquatic Metabolism
163-1 Leaching/Adsorption/Desorption
163-2 Lab Volatility
163-3 Field Volatility
164-1 Terrestrial Field Dissipation
164-2 Aquatic Field Dissipation
164-3 Forest Field Disipation
165-1 Confined Roatational Crops
165-4 Bioaccumulation in Fish
201-1 Droplet Size Spectrum
202-1 Drift Field Evaluation
CF
CF
CF
CF
CF
CF
CF
CF
F
CF
F
CF
CF
CF
F
CF
CF
CF
CF
92086999
40133701
40133702
40133703
Waived
42060601, 42724301
42060602, 42680701, 257323
42060602, 42680701
00257323, 42492401
42492401, 40133704, 00257323
42492401, 42492301
42492401
40955701, 00257323
Required
Waived
Waived
42587601
Required
Required
58
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Data Supporting Guideline Requirements for the Reregistration of Fosamine Ammonium
REQUIREMENT USE PATTERN CITATION(S)
OCCUPATIONAL AND RESIDENTIAL EXPOSURE
231 Estimation of Dermal Exposure at CF 42598101
outdoor sites
232 Estimation of Inhalation Exposure CF 42598101
at outdoor sites
59
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60
-------
APPENDIX C. Citations Considered to be Part of the
Data Base Supporting the Reregistration of 2355
61
-------
62
-------
GUIDE TO APPENDIX C
1. 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.
2. 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.
3. 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.
4. 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
63
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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.
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.
64
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BIBLIOGRAPHY
MRID
CITATION
00026825 E.I. du Pont de Nemours & Company (1979) Du Pont Krenite® S Brush
Control Agent: Oral LD50 Test: Report No. 426-79. (Unpublished study
received Dec 13, 1979 under 352-395; CDL: 241515-C)
00026826 Ferenz, R.L.; Dashiell, O.L.; (1979) Du Pont Krenite® S Brush Control Agent:
Skin Irritation Test on Rabbits: Report No. 42979. (Unpublished study
received Dec 13, 1979 under 352-395; submitted by E.I. du Pont de Nemours
& Co., Wilmington, Del.; CDL:241515-D)
00027291 Ferenz, R.L.; Dashiell, O.F. (1979) Du Pont Krenite® S Brush Control Agent:
Skin Absorption LD50 in Male and Female Rabbits: Report No. 420-79.
(Unpublished study received Dec 13, 1979 under 352-395; submitted by E.I. du
Pont de Nemours & Co., Wilmington, Del.; CDL:241515-E)
00030774 Brown, R.H. (1973) Du Pont Krenite® Brush Control Agent: Acute Inhalation
Toxicity: Haskell Lab. Report No. 6-73. (Unpublished study received Feb 15,
1980 under 352-395; submitted by E.I. du Pont de Nemours & Co.,
Wilmington, Del.; CDL:241801-B)
00073557 Carroll, K.S. (1972) Oral LD50 Test: Haskell Laboratory Report No. 462-72.
(Unpublished study received Jan 13, 1975 under 352376; submitted by E.I. du
Pont de Nemours & Co., Wilmington, Del.; CDL:110907-D)
00075733 McAlack, J.W. (1973) Skin Toxicity and Irritancy Test: Haskell Laboratory
Report No. 118-73. (Unpublished study received Jan 13, 1975 under 352-376;
submitted by E.I. du Pont de Nemours & Co., Wilmington, Del.;
CDL:110907-F)
00075734 Brown, R.H. (1973) Acute Inhalation Toxicity~0ne Hour Exposure-Male Rats:
Haskell Laboratory Report No. 6-73. (Unpublished study received Jan 13,
1975 under 352-376; submitted by E.I. du Pont de Nemours & Co.,
Wilmington, Del.; CDL:110907-G)
00075735 Miles, E.N.; Sherman, H. (1968) Ten-dose Subacute Oral Test: Haskell
Laboratory Report No. 248-68. (Unpublished study received Jan 13, 1975
under 352-376; submitted by E.I. du Pont de Nemours & Co., Wilmington,
Del.; CDL:110907-H)
00075736 Holsing, G.C.; Busey, W.M. (1969) Final Report: Three-month Dietary
65
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BIBLIOGRAPHY
MRID
CITATION
Feeding with One-generation Reproduction Study—Rats: Project No. 201-234;
HLO 362-69. (Unpublished study received Jan 13, 1975 under 352-376;
prepared by TRW, Inc., submitted by E.I. du Pont de Nemours & Co.,
Wilmington, Del.; CDL: 110907-1)
00075737 Hood, D.B. (1968) Skin Irritation and Sensitization Tests: Haskell Laboratory
Report No. 260-68. (Unpublished study received Jan 13, 1975 under 352-376;
submitted by E.I. du Pont de Nemours & Co., Wilmington, Del.;
CDL:110907-J)
00078990 Brittelli, M.R.; Wylie, C.N. (1981) Inhalation LC50-(Head-only, Modified
EPA Proposed Guidelines): Haskell Laboratory Report No. 241-81.
(Unpublished study received May 20, 1981 under 352395; submitted by E.I. du
Pont de Nemours & Co., Wilmington, Del.; CDL:245116-A)
00093715 Reno, F.E.; Moore, S.C.; Hinkle, S. (1979) Final Report: Acute Oral LD50 in
Mallard Ducks: Project No. 201-517. (Unpublished study received Feb 1, 1979
under unknown admin, no.; prepared by Hazleton Laboratories America, Inc.,
submitted by E.I. du Pont de Nemours & Co., Inc., Wilmington, Del.;
CDL:246600-A)
00093716 Piccirillo, V.J.; Carr, S.B. (1978) Final Report: Subacute Dietary LC50 in
Mallard Ducks: Project No. 201-518. (Unpublished study received Feb 1, 1979
under unknown admin, no.; prepared by Hazleton Laboratories America, Inc.,
submitted by E.I. du Pont de Nemours & Co., Inc., Wilmington, Del.;
CDL:246601-A)
00129075 Lorz, H.; Glenn, S.; Williams, R.; et al. (1979) Effects of Selected Herbicides
on Smelting of Coho Salmon. By Oregon, Dept. of Fish and Wildlife,
Research and Development Section and U.S. Forest Service, Pacific Northwest
Forest and Range Experiment Station. Corvallis, OR: US EPA.
(EPA-600/3-79-071; Grant #R804283; pages i,iv-x,1,6-14,40-50,83-85,92
only; also In unpublished submission received Jun 24, 1983 under 464-502;
submitted by Dow Chemical U.S.A., Midland, MI; CDL:250605-N)
00130225 Reno, F.; Moore, S.; Hinkle, S. (1979) Final Report: Acute Oral LD50 in
Bobwhite Quail: Project No. 201-515. (Unpublished study received Feb 1,
1979 under unknown admin, no.; prepared by Hazleton Laboratories America,
Inc., submitted by E.I. du Pont de Nemours & Co., Inc., Wilmington, DE;
CDL:246603-A)
66
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BIBLIOGRAPHY
MRID
CITATION
00143492 Goodman, N. (1979) 48-Hour LC50 in Daphnia magna: Report No. 55379.
Unpublished study prepared by Haskell Laboratory for Toxicology and
Industrial Medicine. 2 p.
00147634 McCooey, K. (1982) Unscheduled DNA Synthesis/Rat Hepatocytes in vitro
with Krenite: Report No. 680-82. Unpublished report prepared by Haskell
Laboratory 4 p.
00147635 E.I. du Pont de Nemours and Co., Inc. (1982) In vitro Assay for Chromosome
Aberrations in Chinese Hamster Ovary (CHO) Cells: Report No. 683-82.
Unpublished report prepared by Haskell Laboratory. 12 p.
00147636 Farrow, M. (1982) In vivo Bone Marrow Cytogenetic Assay in Rats with H#
14,506: Final Report: Project No. 201-572. Unpublished report prepared by
Hazleton Laboratories America, Inc. 20 p.
00148267 Loving, J.; Fitzpatrick, K. (1982) CHO/HGPRT Assay for Gene Mutation:
Report No. 676-82. Unpublished report prepared by Haskell Laboratory. 15
P-
00164989 Berus, J.; Breaux, E. (1986) Octanol/Water Partition Coefficient (Kow) of
Fosamine Ammonium: Document No. AMR-605-86. Unpublished study
prepared by E. I. du Pont de Nemours & Co., Inc. 26 p.
40133700 E.I. du Pont de Nemours & Co., Inc. (1987) Submission of Environmental
Studies in Support of Fosamine Ammonium. Transmittal of 4 studies.
40133701 Koeppe, M. (1986) Hydrolysis of [Carbonyl-14C]-Fosamine Ammonium:
Laboratory Project ID: AMR-567-86. Unpublished study prepared by E.I. du
Pont de Nemours & Co., Inc. 41 p.
40133702 Koeppe, M. (1986) Photodegradation of [Carbonyl-14C]-Fosamine Ammonium
in pH 9 Aqueous Buffer: Laboratory Project ID: AMR-566-86. Unpublished
study prepared by E.I. du Pont de Nemours & Co., Inc. 50 p.
40133703 Scott, M. (1986) Photodegradation of [Carbonyl-14C]-Fosamine Ammonium on
Soil: Laboratory Project ID: AMR-560-86. Unpublished study prepared by
E.I. du Pont de Nemours & Co., Inc. 39 p.
40133704 Priester, T.; Sheftic, G. (1987) Batch Equilibrium (Adsorption/Desorption) and
67
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BIBLIOGRAPHY
MRID
CITATION
Soil Thin-layer Chromatography Studies with [Carbonyl-14C]-Fosamine
Ammonium: Laboratory Project ID: AMR-632-86. Unpublished study
prepared by E.I. du Pont de Nemours & Co., Inc. 43 p.
40955701 Eble, J. (1989) Report of the Field Dissipation Study of Krenite S Brush
Control Agent: Laboratory Project ID AMR-1064-88. Unpublished study
prepared by E.I. du Pont de Nemours and Co., Inc. 135 p.
41215802 Meade, A. (1989) Acute contact LD50 Study of Krenite (INR 1108-10) on
Honey Bees (apis Mellifera L.): Laboratory Project ID ABM-854.
Unpublished study prepared by E. I. Du Pont de Nemours and Co. 10 p.
41215804 Douglas, M.; Handley, J. (1988) The Algistatic Activity of Fosamine
Technical: Project ID DPT 171(u)/88719. Unpublished study prepared by
Huntingdon Research Centre, Ltd. 21 p.
41607102 Baer, K. (1990) Static Acute 96-Hour LC50 of in Rl 108-76 to Bluegill Sunfish,
Lepomis macrochirus: Fosamine Ammonium: Lab Project Number: 374-90.
Unpublished study prepared by E.I. du Pont de Nemours and Co., Inc., Haskell
Lab. 19 p.
41607103 Baer, K. (1990) Static Acute 96-Hour LC50 of IN Rl 108-76 to Rainbow Trout,
Oncorhychus mykiss: Fosamine Ammonium: Lab Project Number: 375-90.
Unpublished study prepared by E.I. du Pont de Nemours and Co., Inc., Haskell
Lab. 19 p.
41607104 Tseng, P. (1990) Product Identity and Composition of Fosamine Ammonium:
Lab Project Number: AMR-1821-90. Unpublished study prepared by E.I. du
Pont de Nemours and Co. 50 p.
41607105 Tseng, P. (1990) Analysis and Certification of Product Ingredients of Fosamine
Ammonium: Lab Project Number: AMR-1822-9. Unpublished study by
prepared by E.I. du Pont de Nemours and Co. 1 p.
41607106 Cadwgan, G. (1990) Physical and Chemical Characteristics of Fosamine
Ammonium: Lab Project Number: AMR-1823-90. Unpublished study prepared
by E.I. du Pont de Nemours and Co., Agric. Dept. 27 p.
41891601 Reynolds, V. (1991) Mutagenicity Testing of DPX-R1108-100 (Fosamine
Ammonium) in the Salmonella typhimurium Plate Incorporation Assay: Lab
68
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BIBLIOGRAPHY
MRID
CITATION
Project Number: 221-91: 4581-865: 500. Unpublished study prepared by E.I.
du Pont de Nemours and Co. 26 p.
41891602 Beavers, J.; Grimes, J.; Long, R.; et al. (1991) H #18642: A Dietary LC50
Study with the Mallard: Lab Project Number: 112-251: 153-91. Unpublished
study prepared by Wildlife International Ltd. 26 p.
41891603 Beavers, J.; Grimes, J.; Long, R.; et al. (1991) H #18642: A Dietary LC50
Study with the Northern Bobwhite: Lab Project Number: 112-250: 154-91.
Unpublished study prepared by Wildlife International Ltd. 26 p.
41998101 McKenzie, S. (1991) Repeated Dose Dermal Toxicity: 21-Day Study with
DPX-R1108-100 (Fosamine Ammonium) in Rabbits: Lab Project Number:
431-91. Unpublished study prepared by E.I. du Pont de Nemours and Co.,
Haskell Lab. 199 p.
42060601 Spare, W. (1991) Aerobic Soil Metabolism of Carbon 14-Fosamine
Ammonium: Lab Project Number: 1710: AMR-1793-90. Unpublished study
prepared by Agrisearch Inc. 64 p.
42060602 Spare, W. (1991) Anaerobic Soil Metabolism of Carbon 14-Fosamine
Ammonium: Lab Project Number: 1711: AMR-1794-90. Unpublished study
prepared by Agrisearch Inc. 77 p.
42320901 Alvarez, L. (1992) Developmental Toxicity Study of DPX-R1108-100 in Rats:
Lab Project Number: 9147-001. Unpublished study prepared by E.I. du Pont de
Nemours and Co. 165 p.
42492301 Spare, W. (1992) Adsorption/Desorption of Fosamine Ammonium in One Soil:
Lab Project Number: 1718: AMR 2326-92. Unpublished study prepared by
Agrisearch Inc. 44 p
42492401 Priester, T.; Sheftic, G. (1992) Batch Equilibrium (Adsorption/Desorption) and
Soil Thin-Layer Chromatography Studies with [Carbonyl-14C]-Fosamine
Ammonium: Revised: Lab Project Number: AMR 632-86. Unpublished study
prepared by E.I. du Pont de Nemours and Co. 89 p.
42587601 Blasberg, J.; Hicks, S.; Stuerman, L. (1992) Flow-through Bluegill
Bioconcentration Study for (Carbon 14)-Fosamine Ammonium: Lab Project
Number: 40286. Unpublished study prepared by ABC Labs, Inc. 64 p.
69
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BIBLIOGRAPHY
MRID
CITATION
42587602 Hughes, J.; Balcom, P. (1992) Fosamine Ammonium: Toxicity to Lemna gibba
G3: Lab Project Number: B382-155-1. Unpublished study prepared by
Malcolm Pirnie, Inc. 26 p.
42598101 Jensen, M.; Merricks, D. (1992) Fosamine Ammonium Worker Exposure
Study during Application of Krenite S Brush Control Agent to Right-of-way
Areas: Lab Project Number: 1716: AMR 2314-92. Unpublished study
prepared by Agrisearch Inc. 81 p.
42647601 Carski, T. (1993) Influence of Fosamine Ammonium on Seed Germination,
Seedling Emergence, and Vegetative Vigor of Several Terrestrial Plants: Lab
Project Number: AMR 2301-92. Unpublished study prepared by DuPont
Haskell Research Center. 229 p.
42680701 Spare, W. (1993) Anaerobic Aquatic Metabolism of 14C-Fosamine Ammonium:
Final Report Amendment (Supplement No. 1): Lab Project Number: 1711:
1794-90. Unpublished study prepared by Agrisearch Incorporated. 42 p.
42715101 Ward, T.; Magazu, J.; Boeri, R. (1993) Acute Toxicity of DPX-R1108-100
(Fosamine Ammonium) to the Sheepshead Minnow, Cyprinodon variegatus:
Lab Project Number: MR-9581-031: 169-93: 121-DU. Unpublished study
prepared by T.R. Wilbury Labs, Inc. 31 p.
42715102 Ward, T.; Magazu, J.; Boeri, R. (1993) Acute Flow-through Mollusc Shell
Deposition Test with DPX-R1108-100 (Fosamine Ammonium): Lab Project
Number: 9581-031: 249-93: 122-DU. Unpublished study prepared by T.R.
Wilbury Labs, Inc. 33 p.
42715103 Ward, T.; Magazu, J.; Boeri, R. (1993) Acute Toxicity of DPX-R1108-100
(Fosamine Ammonium) to the Mysid, Mysidopsis bahia: Lab Project Number:
MR-9581-031: 168-93: 120-DU. Unpublished study prepared by T.R. Wilbury
Labs, Inc. 32 p.
42724301 Spare, W. (1993) Aerobic Soil Metabolism of 14C-Fosamine Ammonium
Supplement No. 1: Final Report Amendment: Lab Project Number: 1710:
AMR 1793-90. Unpublished study prepared by Agrisearch Inc. 38 p.
42867001 Cox, L. (1993) Subchronic Oral Toxicity: Six-Month Study with
DPX-R1108-76 (Fosamine Ammonium) Feeding Study in Dogs: Revisions No.
1: Lab Project Number: 406-78: 2763-001. Unpublished study prepared by Du
70
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BIBLIOGRAPHY
MRID
CITATION
Font's Haskell Laboratory for Toxicology and Industrial Medicine. 391 p.
42902901 Thompson, S.; Swigert, J. (1993) Fosamine Ammonium: A 5-day Toxicity Test
with the Freshwater Alga, Selenastrum capricornutum: Final Report: Lab
Project Number: 112A-116: AMR 2642-93. Unpublished study prepared by
Wildlife International Ltd. 30 p.
42902902 Thompson, S.; Swigert, J. (1993) Fosamine Ammonium: A 5-Day Toxicity
Test with the Freshwater Alga, Anabaena flos-aquae: Final Report: Lab Project
Number: 112A-115A: AMR 2643-93. Unpublished study prepared by Wildlife
International Ltd. 30 p.
42902903 Thompson, S.; Swigert, J. (1993) Fosamine Ammonium: A 5-Day Toxicity
Test with the Freshwater Diatom, Navicula pelliculosa: Final Report: Lab
Project Number: 112A-117: AMR 2644-93. Unpublished study prepared by
Wildlife International Ltd. 30 p.
42902904 Thompson, S.; Swigert, J. (1993) Fosamine Ammonium: A 5-Day Toxicity
Test with the Marine Diatom, Skeletonema costatum, Final Report: Lab Project
Number: 112A-118: AMR 2645-93. Unpublished study prepared by Wildlife
International Ltd. 29 p.
42934801 Fletcher, D. (1993) H-18642: 21-Day Acute Delayed Neurotoxicity Study in
Mature White Leghorn Hens: Lab Project Number: 124-001-13: 9324: HLO
434-93. Unpublished study prepared by Bio-Life Associates, Ltd. in
cooperation with E.I. DuPont de Nemours and Co. Haskell Lab. 116 p.
42942201 MacKenzie, S. (1993) Cholinesterase Inhibition Study with DPX-R1108-100
(Fosamine Ammonium) in Rats: Lab Project Number: 9618-001: 599-93.
Unpublished study prepared by E.I. du Pont de Nemours and Co., Haskell Lab.
55 p.
42946501 Christoph, G. (1993) Acute Neurotoxicity of DPX-R1108-100 (Fosamine
Ammonium) in Rats: Lab Project Number: 431-93: 9326-001: HLR 431-93.
Unpublished study prepared by Du Font's Haskell Lab for Toxicology and
Industrial Medicine. 496 p.
42946502 Christoph, G. (1993) Subchronic Neurotoxicity of DPX-R1108-100 (Fosamine
Ammonium) in Rats: Lab Project Number: 438-93: 9327-001: HLR 438-93.
Unpublished study prepared by Du Font's Haskell Lab for Toxicology and
71
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BIBLIOGRAPHY
MRID CITATION
Industrial Medicine. 534 p.
42948301 Fletcher, D.; DuCharme, D. (1993) H-18642 (DPX-R1108-100; Fosamine
Ammonium): Toxicity and Reproduction Study in Bobwhite Quail: Lab Project
Number: 124-004-07: 9324: HLO 527-93. Unpublished study prepared by
Bio-Life Associates, Ltd.; Haskell Lab for Toxicology and Industrial Medicine.
409 p.
42948302 Fletcher, D.; DuCharme, D. (1993) H-18642 (DPX-R1108-100; Fosamine
Ammonium): Toxicity and Reproduction Study in Mallard Ducks: Lab Project
Number: 124-005-08: 9324: HLO 526-93. Unpublished study prepared by
Bio-Life Associates, Ltd.; Haskell Lab for Toxicology and Industrial Medicine.
472 p.
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APPENDIX D. List of Available Related Documents
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The following is a list of available documents related to fosamine ammonium. It's
purpose is to provide a path to more detailed information if it is needed. These accompanying
documents are part of the Administrative Record for fosamine ammonium and are included in
the EPA's Office of Pesticide Programs Public Docket.
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Information System (LUIS) Report
3. Fosamine ammonium RED Fact Sheet
4. PR Notice 86-5 (included in this appendix)
5. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
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76
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APPENDIX E. PR Notices 86-5 and 91-2
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78
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PR Notice 86-5
79
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80
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
tpno1 WASHINGTON, D.C. 20460
July 29, 1986
OFFICE OF
PR NOTICE 86-5 PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Attention: Persons responsible for Federal registration of pesticides.
Subject: Standard format for data submitted under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and certain provisions of the
Federal Food, Drug, and Cosmetic Act (FFDCA).
I. Purpose
To require data to be submitted to the Environmental Protection Agency (EPA) in a
standard format. This Notice also provides additional guidance about, and illustrations of, the
required formats.
II. Applicability
This PR Notice applies to all data that are submitted to EPA to satisfy data
requirements for granting or maintaining pesticide registrations, experimental use permits,
tolerances, and related approvals under certain provisions of FIFRA and FFDCA. These data
are defined in FIFRA §10(d)(l). This Notice does not apply to commercial, financial, or
production information, which are, and must continue to oe, submitted differently under
separate cover.
III. Effective Date
This notice is effective on November 1, 1986. Data formatted according to this notice
may be submitted prior to the effective date. As of the effective date, submitted data packages
that do not conform to these requirements may be returned to the submitter for necessary
revision.
IV. Background
On September 26, 1984, EPA published proposed regulations in the Federal Register
(49 FR 37956) which include Requirements for Data Submission (40 CFR §158.32), and
Procedures for Claims of Confidentiality of Data (40 CFR §158.33). These regulations
specify the format for data submitted to EPA under Section 3 of FIFRA and Sections 408 and
4139 of FFDCA, and procedures which must be followed to make and substantiate claims of
confidentiality. No entitlements to data confidentiality are changed, either by the proposed
regulation or by this notice.
OPP is making these requirements mandatory through this Notice to gain resource-
saving benefits from their use before the entire proposed regulation becomes final. Adequate
lead time is being provided for submitters to comply with the new requirements.
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V. Relationship of this Notice to Other OPP Policy and Guidance
While this Notice contains requirements for organizing and formatting submittals of
supporting data, it does not address the substance of test reports themselves. "Data reporting"
guidance is now under development in OPP, and will specify how the study objectives,
protocol, observations, findings, and conclusions are organized and presented within the study
report. The data reporting guidance will be compatible with submittal format requirements
described in this Notice.
OPP has also promulgated a policy (PR Notice 86-4 dated April 15, 1986) that
provides for early screening of certain applications for registration under FIFRA §3. The
objective of the screen is to avoid the additional costs and prolonged delays associated with
handling significantly incomplete application packages. As of the effective date of this Notice,
the screen will include in its criteria for acceptance of application packages the data formatting
requirements described herein.
OPP has also established a public docket which imposes deadlines for inserting into the
docket documents submitted in connection with Special Reviews and Registration Standards
(see 40 CFR §154.15 and §155.32). To meet these deadlines, OPP is requiring an additional
copy of any data submitted to the docket. Please refer to Page 10 for more information about
this requirement.
For several years, OPP has required that each application for registration or other
action include a list of all applicable data requirements and an indication of how each is
satisfied—the statement of the method of support for the application. Typically, many
requirements are satisfied by reference to data previously submitted—either by the applicant or
by another party. That requirement is not altered by this notice, which applies only to data
submitted with an application.
VI. Format Requirements
A more detailed discussion of these format requirements follows the index on the next
page, and samples of some of the requirements are attached. Except for the language of the
two alternative forms of the Statement of Data Confidentiality Claims (shown in Attachment 3)
which cannot be altered, these samples are illustrative. As long as the required information is
included and clearly identifiable, the form of the samples may be altered to reflect the
submitter's preference.
- INDEX-
Text Example
Page Page
A. Organization of the Submittal Package 3 17
B. Transmittal Document 4 11
C. Individual Studies 4
C. 1 Special Considerations for Identifying Studies 5
D. Organization of each Study Volume 6 17
D. 1 Study Title Page 7 12
D. 2 Statement of Data Confidentiality Claims
(based on FIFRA §10(d)(l)) 8 13
D. 3 Confidential Attachment 8 15
D. 4 Supplemental Statement of Data Confidentiality
Claims (other than those based on FIFRA §10(d)(l)) 8 14
D. 5 Good Laboratory Practice Compliance Statement 9 16
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E. Reference to Previously Submitted Data 9
F. Physical Format Requirements & Number of Copies 9
G. Special Requirements for Submitting Data to the Docket 10
A. Organization of Submittal Package
A "submittal package" consists of all studies submitted at the same time for review in
support of a single regulatory action, along with a transmittal document and other related
administrative material (e.g. the method of support statement, EPA Forms 8570-1, 8570-4,
8570-20, etc.) as appropriate.
Data submitters must organize each submittal package as described in this Notice. The
transmittal and any other administrative material must be grouped together in the first physical
volume. Each study included in the submittal package must then be bound separately.
Submitters sometimes provide additional materials that are intended to clarify,
emphasize, or otherwise comment to help Product Managers and reviewers better understand
the submittal.
- If such materials relate to one study, they should be included as an appendix to that
study.
- If such materials relate to more than one study (as for example a summary of all
studies in a discipline) or to the submittal in general, they must be included in the
submittal package as a separate study (with title page and statement of confidentiality
claims).
B. Transmittal Document
The first item in each submittal package must be a transmittal document. This
document identifies the submitter or all joint submitters; the regulatory action in support of
which the package is being submitted--i.e., a registration application, petition, experimental
use permit (EUPj, §3(c)(2j(B) data call-in, §6(aj(2) submittal, or a special review; the
transmittal date; and a list of all individual studies included in the package in the order of their
appearance, showing (usually by Guideline reference number) the data requirement(s)
addressed by each one. The EPA-assigned number for the regulatory action (e.g. the
registration, EUP, or tolerance petition number) should be included in the transmittal
document as well, if it is known to the submitter. See Attachment 1 for an example of an
acceptable transmittal document.
The list of included studies in the transmittal of a data submittal package supporting a
registration application should be subdivided by discipline, reflecting the order in which data
requirements appear in 40 CFR 158.
The list of included studies in the transmittal of a data submittal package supporting a
petition for tolerance or an application for an EUP should be subdivided into sections A, B,
C,.... of the petition or application, as defined in 40 CFR 180.7 and 158.125, (petitions) or
Pesticide Assessment Guidelines, Subdivision I (EUPs) as appropriate.
When a submittal package supports a tolerance petition and an application for a
registration or an EUP, list the petition studies first, then the balance or the studies. Within
these two groups of studies follow the instructions above.
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C. Individual Studies
A study is the report of a single scientific investigation, including all supporting
analyses required for logical completeness. A study should be identifiable and distinguishable
by a conventional bibliographic citation including author, date, and title. Studies generally
correspond in scope to a single Guideline requirement for supporting data, with some
exceptions discussed in section C.I. Each study included in a submittal package must be
bound as a separate entity. (See comments on binding studies on page 9.)
Each study must be consecutively paginated, beginning from the title page as page 1.
The total number of pages in the com-plete study must be shown on the study title page. In
addition (to ensure that inadvertently separated pages can be reassociated with the proper study
during handling or review) use either of the following:
- Include the total number of pages in the complete study on each page (i.e., 1 of 250,
2 of 250, ...250 of 250).
- Include a company name or mark and study number on each page of the study, e g ,
Company Name-1986-23. Never reuse a study number for marking the pages of
subsequent studies.
When a single study is extremely long, binding it in mul-tiple volumes is permissible
so long as the entire study is pag-inated in a single series, and each volume is plainly identified
by the study title and its position in the multi-volume sequence.
C.I Special Considerations for Identifying Studies
Some studies raise special problems in study identification, because they address
Guidelines of broader than normal scope or for other reasons.
a. Safety Studies. Several Guidelines require testing for safety in more than one
species. In these cases each species tested should be reported as a separate study, and bound
separately.
Extensive supplemental reports of pathology reviews, feed analyses, historical control
data, and the like are often associated with safety studies. Whenever possible these should be
submitted with primary reports of the study, and bound with the primary study as appendices.
When such supplemental reports are submitted independently of the primary report, take care
to fully identify the primary report to which they pertain.
Batteries of acute toxicity tests, performed on the same end use product and covered by
a single title page, may be bound together and reported as a single study.
b. Product Chemistry Studies. All product chemistry data within a submittal package
submitted in support of an end-use product produced from registered manufacturing-use
products should be bound as a single study under a single title page.
Product chemistry data submitted in support of a technical product, other
manufacturing-use product, an experimental use permit, an import tolerance petition, or an
end-use product produced from unregistered source ingredients, should be bound as a single
study for each Guideline series (61, 62, and 63) for conventional pesticides, or for the
equivalent subject range for biorational pesticides. The first of the three studies in a complete
product chemistry submittal for a biochemical pesticide would cover Guidelines 151-10,
151-11, and 151-12; the second would cover Guidelines 151-13, 151-15, and 151-16; the third
would cover Guideline 151-17. The first study for a microbial pesticide would cover
Guidelines 151-20, 151-21, and 151-22; the second would cover Guidelines 151-23 and
151-25; the third would cover Guideline 151-26.
Note particularly that product chemistry studies are likely to contain Confidential
Business Information as defined in FIFRA §10(d)(l)(A), (B), or (C), and if so must be
handled as described in section D.3. of this notice.
c. Residue Chemistry Studies. Guidelines 171-4, 153-3, and 153-4 are extremely
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broad in scope; studies addressing residue chemistry requirements must thus be defined at a
level below that of the Guideline code. The general principle, however, of limiting a study to
the report of a single investigation still applies fully. Data should be treated as a single study
and bound separately for each analytical method, each report of the nature of the residue in a
single crop or animal species, and for each report of the magnitude of residues resulting from
treatment of a single crop or from processing a single crop. When more than one commodity
is derived from a single crop (such as beet tops and beet roots) residue data on all such
commodities should be reported as a single study. When multiple field trials are associated
with a single crop, all such trials should be reported as a single study.
D. Organization of Each Study Volume
Each complete study must include all applicable elements in the list below, in the order
indicated. (Also see Page 17.) Several of these elements are further explained in the following
paragraphs. Entries in the column headed "example" cite the page number of this notice
where the element is illustrated.
Element
Study Title Page
Statement of Data
Confidentiality
Claims
Certification of Good
Laboratory Practice
Flagging statements
Body of Study
Study Appendices
Cover Sheet to Confi-
dential Attachment
When Required
Always
One of the two alternative
forms of this statement
is always required
If study reports laboratory
work subject to GLP require-
ments
For certain toxicology studies (When
flagging requirements are finalized.)
Always - with an English language
translation if required.
At submitter's option
If CBI is claimed under FIFRA
, (B),or(C)
Example
Page 12
Page 13
Page 16
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
If CBI is claimed under FIFRA
(B),or(C)
Only if confidentiality is
claimed on a basis other than
FIFRA§10(d)(l)(A), (B), or (C)
Page 15
Page 14
D.I. Title Page
A title page is always required for each submitted study, published or unpublished.
The title page must always be freely releasable to requestors; DO NOT INCLUDE CBI ON
THE TITLE PAGE. An example of an acceptable title page is on page 12 of this notice.
The following information must appear on the title page:
a. Study title. The study title should be as descriptive as possible It must clearly identify
the substance (s) tested and correspond to the name of the data requirement as it appears in the
Guidelines.
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b. Data requirement addressed. Include on the title page the Guideline number (s) of the
specific requirement(s) addressed by the study.
c. Author (s). Cite only individuals with primary intellectual responsibility for the content
of the study. Identify them plainly as authors, to distinguish them from the performing
laboratory, study sponsor, or other names that may also appear on the title page.
d. Study Date. The title page must include a single date for the study. If parts of the
study were performed at different times, use only the date of the latest element in the study.
e. Performing Laboratory Identification. If the study reports work done by one or more
laboratories, include on the title page the name and address of the performing laboratory or
laboratories, and the laboratory's internal project number (s) for the work. Clearly distinguish
the laboratory's project identifier from any other reference numbers provided by the study
sponsor or submitter.
f. Supplemental Submissions. If the study is a commentary on or supplement to another
previously submitted study, or if it responds to EPA questions raised with respect to an earlier
study, include on the title page elements a. through d. for the previously submitted study,
along with the EPA Master Record Identifier (MRID) or Accession number of the earlier
study if you know these numbers. (Supplements submitted in the same submittal package as
the primary study should be appended to and bound with the primary study. Do not include
supplements to more than one study under a single title page).
g. Facts of Publication. If the study is a reprint of a published document, identity on the
title page all relevant facts of publication, such as the journal title, volume, issue, inclusive
page numbers, and publication date.
D.2. Statements of Data Confidentiality Claims Under FIFRA §10(d)(l).
Each submitted study must be accompanied by one of the two alternative forms of the
statement of Data Confidentiality Claims specified in the proposed regulation in §158.33 (b)
and (c) (See Attachment 3). These statements apply only to claims of data confidentiality
based on FIFRA §10(d)(l)(A), (B), or (C). Use the appropriate alternative form of the
statement either to assert a claim of §10(d)(l) data confidentiality (§158.33(b)) or to waive
such a claim (§158.33(c)). In either case, the statement must be signed and dated, and must
include the typed name and title of the official who signs it. Do not make CBI claims with
respect to analytical methods associated with pet-itions for tolerances or emergency
exemptions (see NOTE Pg 13).
D.3. Confidential Attachment
If the claim is made that a study includes confidential business information as defined
by the criteria of FIFRA §10(D)(1)(A), (B), or (C) (as described in D.2. above) all such
information must be excised from the body of the study and confined to a separate
study-specific Confidential Attachment. Each passage of CBI so isolated must be identified by
a reference number cited within the body of the study at the point from which the passage was
excised (See Attachment 5).
The Confidential Attachment to a study must be identified by a cover sheet fully
identifying the parent study, and must be clearly marked "Confidential Attachment." An
appropriately annotated photocopy of the parent study title page may be used as this cover
sheet. Paginate the Confidential Attachment separately from the body of the study, beginning
with page 1 of X on the title page. Each passage confined to the Confidential Attachment
must be associated with a specific cross reference to the page(s) in the main body of the study
on which it is cited, and with a reference to the applicable passage(s) of FIFRA §10(d)(l) on
which the confidentiality claim is based.
D.4. Supplemental Statement of Data Confidentiality Claims (See
Attachment 4)
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If you wish to make a claim of confidentiality for any portion of a submitted study
other than described by FIFRA §10(d) (1)(A), (B), or (C), the following provisions apply:
- The specific information to which the claim applies must be clearly marked in the
body or the study as subject to a claim of confidentiality.
- A Supplemental Statement of Data Confidentiality Claims must be submitted,
identifying each passage claimed confidential and describing in detail the basis for the
claim. A list of the points to address in such a statement is included in Attachment 4
on Pg 14.
- The Supplemental Statement of Data Confidentiality Claims must be signed and dated
and must include the typed name and title of the official who signed it.
D.5. Good Laboratory Practice Compliance Statement
This statement is required if the study contains laboratory work subject to GLP
requirements specified in 40 CFR 160. Samples of these statements are shown in Attachment
6.
E. Reference to Previously Submitted Data
DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it. A copy of the title page
plus the MRID number (if known) is sufficient to allow us to retrieve the study immediately
for review. This prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study. References to previously submitted studies
should not be included in the transmittal document, but should be incorporated into the
statemenTof the method of support for the application.
F. Physical Format Requirements
All elements in the data submittal package must be on uniform 8 1/2 by 11 inch white
paper, printed on one side only in black ink, with high contrast and good resolution. Bindings
for individual studies must be secure, but easily removable to permit disassembly for
microfilming. Check with EPA for special instructions before submitting data in any medium
other than paper, such as film or magnetic media.
Please be particularly attentive to the following points:
• Do not include frayed or torn pages.
• Do not include carbon copies, or copies in other than black ink.
• Make sure that photocopies are clear, complete, and fully readable.
• Do not include oversize computer printouts or fold-out pages.
• Do not bind any documents with glue or binding tapes.
• Make sure that all pages of each study, including any attachments or
appendices, are present and in correct sequence.
Number of Copies Required - All submittal packages except those associated with a
Registration Standard or Special Review (See Part G below) must be provided In three
complete, identical copies. (The proposed regulations specified two copies; three are now
being required to expedite and reduce the cost of processing data into the OPP Pesticide
Document Management System and getting it into review.)
G. Special Requirements for Submitting Data to the Docket
Data submittal packages associated with a Registration Standard or Special Review
must be provided in four copies, from one of which all material claimed as CBI has been
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excised. This fourth copy will become part of the public docket for the RS or SR case. If no
claims of confidentiality are made for the study, the fourth copy should be identical to the
other three. When portions of a study submitted in support or an RS or SR are claimed as
CBI, the first three copies will include the CBI material as provided in section D of this
notice. The following special preparation is required for the fourth copy.
• Remove the "Supplemental Statement of Data Confidentiality Claims".
• Remove the "Confidential Attachment".
• Excise from the body of the study any information you claim as confidential,
even if it does not fall within the scope of FIFRA §10(d)(l)(A), (B), or (C).
Do not close up or paraphrase text remaining after this excision.
• Mark the fourth copy plainly on both its cover and its title page with the phrase
"Public Docket Material - contains no information claimed as confidential".
V. For Further Information
For further information contact John Carley, Chief, Information Services Branch,
Program Management and Support Division, (703) 305-5240.
/S/
James W. Akerman
Acting Director,
Registration Division
Attachment 1. Sample Transmittal Document
Attachment 2. Sample Title Page for a Newly Submitted Study
Attachment 3. Statements of Data Confidentiality Claims
Attachment 4. Supplemental Statement of Data Confidentiality Claims
Attachment 5. Samples of Confidential Attachments
Attachment 6. Sample Good Laboratory Practice Statements
Attachment 7. Format Diagrams for Submittal Packages and Studies
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ATTACHMENT 1
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
1. Name and address of submitter (or all joint submitters**)
+ Smith Chemical Corporation Jones Chemical Company
1234 West Smith Street -and- 5678 Wilson Blvd
Cincinnati, OH 98765 Covington, KY 56789
+ Smith Chemical Corp will act as sole agent for all submitters.
2. Regulatory action in support of which this package is submitted
Use the EPA identification number (e.g. 359-EUP-67) if you know it. Otherwise describe the
type of request (e.g. experimental use permit, data call-in - of xx-xx-xx date).
3. Transmittal date
4. List of submitted studies
Vol 1. Administrative materials - forms, previous corres-pondence with Project
Managers, and so forth.
Vol 2. Title of first study in the submittal (Guideline No.)
Vol n Title of nth study in the submittal (Guideline
No.)
* Applicants commonly provide this information in a tran-smittal letter. This
remains an acceptable practice so long as all four elements are included.
* Indicate which of the joint submitters is empowered to act on behalf of all joint
submitters in any matter concerning data compensation or subsequent use or
release of the data.
Company Official: Name
Signature
Company Name
Company Contact:
Name Phone
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ATTACHMENT 2
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
Study Title
(Chemical name) - Magnitude of Residue on Corn
Data Requirement
Guideline 171-4
Author
John C. Davis
Study Completed On
Januarys, 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Project ID
ABC 47-79
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Page 1 of X
(X is the total number of pages in the study)
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ATTACHMENT 3
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under FIFRA §10(d)(l)(A),(B), or (C).
STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
No claim of confidentiality is made for any information contained in this
study on the basis of its falling within the scope of FIFRA
6§10(d)(1)(A), (B), or (C).
Company
Company Agent: Typed Name Date:
Title Signature
2. Claim of confidentiality under FIFRA §10(d)(l)(A), (B), or (C).
Information claimed confidential on the basis of its falling within the
scope of FIFRA §10(d)(1)(A), (B), or (C) has been removed to a
confidential appendix, and is cited by cross-reference number in the body
of the study.
Company:
Company Agent: Typed Name Date:
Title Signature
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
NOTE: Applicants for permanent or temporary tolerances should note that it is OPP policy
that no permanent tolerance, temporary tolerance, or request for an emergency exemption
incorporating an analytical method, can be approved unless the applicant waives all claims of
confidentiality for the analytical method. These analytical methods are published in the FDA
Pesticide Analytical Methods Manual, and therefore cannot be claimed as confidential. OPP
implements this policy by returning submitted analytical methods, for which confidentiality
claims have been made, to the submitter, to obtain the confidentiality waiver before they can
be processed.
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ATTACHMENT 4
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described by FIFRA §10(d)(l)(A), (B),
or (C), but for which you claim confidential treatment on another basis, the following
information must be included within a Supplemental Statement of Data Confidentiality Claims:
• Identify specifically by page and line number (s) each portion of the study for
which you claim confidentiality.
• Cite the reasons why the cited passage qualifies for confidential treatment.
• Indicate the length of time—until a specific date or event, or permanently—for
which the information should be treated as confidential.
• Identify the measures taken to guard against undesired disclosure of this
information.
• Describe the extent to which the information has been disclosed, and what
precautions have been taken in connection with those disclosures.
• Enclose copies of any pertinent determinations of confidentiality made by EPA,
other Federal agencies, of courts concerning this information.
• If you assert that disclosure of this information would be likely to result in
substantial harmful effects to you, describe those harmful effects and explain
why they should be viewed as substantial.
• If you assert that the information in voluntarily submitted, indicate whether you
believe disclosure of this information might tend to lessen the availability to
EPA of similar information in the future, and if so, how.
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ATTACHMENT 5
EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
Example 1. (Confidential word or phrase that has been deleted from the study)
CROSS REFERENCE NUMBER 1 This cross reference number is used in the study in place of the
following paragraph (s) at the indicated volume and page
references.
DELETED WORDS OR PHRASE: Ethylene Glycol
PAGE LINES REASON FOR THE DELETION FIFRA
REFERENCE
6 14 Identity of Inert Ingredient §10(d)(C)
28 25
100 19
Example 2. (Confidential paragraph(s) that have been deleted from the study)
CROSS REFERENCE NUMBER 5 This cross reference number is used in the study in place of the
following paragraph (s) at the indicated volume and page
references.
DELETED PARAGRAPH(S) :
( )
( Reproduce the deleted paragraph (s) here )
PAGE LINES REASON FOR THE DELETION FIFRA REFERENCE
20. 2-17 Description of the quality control process § 1 0 (d) ( 1) (C)
Example 3. (Confidential pages that have been deleted from the study)
CROSS REFERENCE NUMBER 7 This cross reference number is used in the study in place of the
following paragraph (s) at the indicated volume and page
references.
DELETED PAGES(S): are attached immediately behind this page
PAGES REASON FOR THE DELETION FIFRA REFERENCE
35-41. Description of product manufacturing process § 10 (d) (1) (A)
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ATTACHMENT 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
This study meets the requirements for 40 CFR Part 160
Submitter
Sponsor
Example 2.
This study does not meet the requirements of 40 CFR Part 160, and
differs in the following ways:
1.
2.
3.
Submitter
Sponsor
Study Director_
Example 3.
The submitter of this study was neither the sponsor of this study nor
conducted it, and does not know whether it has been conducted in
accordance with 40 CFR Part 160.
Submitter
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ATTACHMENT 7.
FORMAT OF THE SUBMITTAL PACKAGE
Transmittal Document
Related Administrative Materials
(e.g. Method of Support Statement, etc.)
Other materials about the submittal
(e.g., summaries of groups of studies
to aid in their review).
Studies submitted as unique
to the format below.
FORMAT OF SUBMITTED STUDIES
• Study title page.
Statement of Confidentiality Claims.
GLP and flagging* statements - as appropriate.
Body of the study, with English
language translation if required.
Appendices to the study.
Title Page of the Confidential
Attachment.
Confidential Attachment.
Supplemental Statement
of Confidentiality Claims
When flagging requirements
are finalised.
Documents which must be submitted as
appropriate to meet established requirements.
Documents submitted at submitter's option.
LEGEND
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PR Notice 91-2
97
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98
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, B.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
PR NOTICE 91-2
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDES
ATTENTION: Persons Responsible for Federal Registration of
Pesticide Products.
SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement
I. PURPOSE:
The purpose of this notice is to clarify the Office of
Pesticide P^gram's P9licy with respect to the statement of
percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(s)
specified in the ingredient statement on the label must be stated
as the nominal concentration of such ingredient(s), as that term
is defined in 40 CFR 158.153(1). Accordingly, the Agency has
established the nominal concentration as the only acceptable
label claim for the amount of active ingredient in the product.
II. BACKGROUND
For some time the Agency has accepted two different methods
9f identifying on the label what percentage is claimed for the
ingredient(s) contained in a pesticide. Some applicants claimed a
percentage which represented a level between the upper and the
lower certified limits. This was referred to as the nominal
concentration. Other applicants claimed the lower limit as the
percentage of the ingredient(s) that would be expected to be
present in their product at the end of the product's shelf-life.
Unfortunately, this led to a great deal of confusion among the
regulated industry, the regulators, and the consumers as to
exactly how much of a given ingredient was in a given product.
The Agency has established the nominal concentration as the only
acceptable label claim for the amount of active ingredient in the
product.
Current regulations require that the percentage listed in
the active ingredient statement be as precise as possible
reflecting go9d manufacturing practices 40 CFR 156.10(g)(5). The
certified limits required for each active ingredient are intended
to encompass any such "good manufacturing practice" variations 40
CFR 158.175(c)(3).
The upper and lower certified limits, which must be proposed
in connection with a product's registration, represent the
amounts of an ingredient that may legally be present 40 CFR
158.175. The lower certified limit is used as the enforceable
lower limit for the product composition according to FIFRA
section 12(a)(1)(C), while the nominal concentration appearing on
the label would be the routinely achieved concentration used for
calculation of dosages and dilutions.
The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual
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product compositi9n because the nominal concentration would be
the amount of active ingredient typically found in the product.
It is imp9rtant for registrants to note that certified
limits for active ingredients are not considered to be trade
secret information under FIFRA section 10(b). In this respect the
certified limits will be routinely provided by EPA to States for
enforcement purposes, since the nominal concentration appearing
on the label may not represent the enforceable composition for
purposes of section 12(a)(1)(C).
III. REQUIREMENTS
As described below under Unit V. " COMPLIANCE SCHEDULE," all
currently registered products as well as all applications for new
registration must comply with this Notice by specifying the
nominal C9ncentrati9n expressed as a percentage by weight as the
label claim in the ingredient(s) statement and equivalence
statements if applicable (e.g., elemental arsenic, metallic zinc,
salt of an acid). In addition, the requirement for performing
sample analyses of five or more representative samples must be
fulfilled. C9pies of the raw analytical data must be submitted
with the nominal ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR
158.170. All products are required to pr9vide certified limits
for each active, inert ingredient, impurities of toxicological
significance(i. e., upper limit(s) 9nly) and on a case by case
basis as specified by EPA. These limits are to be set based on
representative sampling and chemical analysis(i.e., quality
control) of the product.
The format of the ingredient statement must conform to 40
CFR 156-Labeling Requirements For Pesticides and Devices.
After July 1, 1997, all pesticide ingredient Statements must
be changed to nominal concentration.
IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lower then the minimum
level to achieve efficacy. This is extremely important for
products which are intended to C9ntrol pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 153.640.
In those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make
the registration process more uniform and more manageable for
both the agency and the regulated community. It is the Agency's
intention to implement the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority programs, i.e., reregistration, new chemical, or
fast track (FIFRA section 3(c)(3)(B). Therefore,
applicants/registrants are expected to comply with the
requirements of this Notice as follows:
(1) Beginning July 1, 1991, all new product registrations
submitted to the Agency are to comply with the
requirements of this Notice.
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(2) Registrants having products subject to reregistration
under FIFRA section 4(a) are to comply with the
requirements of this Notice when specific products are
called in by the Agency under Phase V of the
Reregistration Program.
(3) All other products/applications that are not subject to
(1) and (2) ab9ve will have until July 1, 1997, to
comply with this Notice. Such applications should note
"Conversion to Nominal Concentrations on the
application form. These types Or amendments will not be
handled as "Fast Track" applications but will be
handled as routine requests.
VI. FOR FURTHER INFORMATION
Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.
/s/
Anne E. Lindsay, Director
Registration Division (H-7505C)
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APPENDIX F. Generic Data Call-in
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GENERIC DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient(s) identified in Attachment 1 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 product(s)
containing this active ingredient(s). Within 90 days after you receive this Notice you must
respond as set forth in Section III below. Your response must state:
1. how you will comply with the requirements set forth in this Notice and its Attachments 1
through 4; or,
2. why you believe you are exempt from the requirements listed in this Notice and in
Attachment 3, Requirements Status and Registrant's Response Form, (see section III-B);
or,
3. why you believe EPA should not require your submission of data in the manner specified
by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of your
product(s) subject to this Notice will be subject to suspension. We have provided a list of all of
your products subject to this Notice in Attachment 2, Data Call-in Response Form, as well as a
list of all registrants who were sent this Notice (Attachment 4).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and
Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
(expiration date 12-31-92).
This Notice is divided into six sections and five Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable
Adverse Effects
Section VI - Inquiries And Responses To This Notice
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The Attachments to this Notice are:
Attachment 1 - Data Call-in Chemical Status Sheet
Attachment 2 - Data Call-in Response Form
Attachment 3 - Requirements Status And Registrant's Response Form
Attachment 4 - List Of All Registrants Sent This Data Call-in Notice
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 ingredient(s).
SECTION II. DATA REQUIRED BY THIS NOTICE
A. DATA REQUIRED
The data required by this Notice are specified in Attachment 3, Requirements
Status and Registrant s Response Form. Depending on the results of the studies required
in this Notice, additional testing may be required.
B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements
specified in Attachment 3, Requirements Status and Registrant's Response Form, within
the time frames provided.
C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test
standards outlined in the Pesticide Assessment Guidelines for those studies for which
guidelines have been established.
These EPA Guidelines are available from the National Technical Information
Service (NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel:
703-487-4650).
Protocols approved by the Organization for Economic Cooperation and
Development (OECD) are also acceptable if the OECD-recommended test standards
conform to those specified in the Pesticide Data Requirements regulation (40 CFR §
158.70). When using the OECD protocols, they should be modified as appropriate so that
the data generated by the study will satisfy the requirements of 40 CFR § 15o. Normally,
the Agency will not extend deadlines for complying with data requirements when the
studies were not conducted in accordance with acceptable standards. The OECD protocols
are available from OECD, 1750 Pennsylvania Avenue N.W., Washington, D.C. 20006.
All new studies and proposed protocols submitted in response to this Data Call-In
Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a) (6)].
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D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-in does not in any way supersede or
change the requirements of any previous Data Call-in(s), or any other agreements entered
into with the Agency pertaining to such prior Notice. Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of Intent to Suspend their
affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice 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.
B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice are: 1) voluntary cancellation, 2) delete
use(s), (3) claim generic data exemption, (4) agree to satisfy the data requirements
imposed by this Notice or (5) request a data waiver(s).
A discussion of how to respond if you chose 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 data requirements of this
Notice is contained in Section III-C. A discussion of options relating to requests for data
waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your
response, one or both must be used in your response to the Agency. These forms are the
Data-Call-in Response Form (Attachment 2) and the Requirements Status and Registrant's
Response Form (Attachment 3). The Data Call-In Response Form must be submitted as
part of every response to this Noticed Flease 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 identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by
requesting voluntary cancellation of your product(s) containing the active
ingredient (s) that is the subject of this Notice. If you wish to voluntarily cancel
your product, you must submit a completed Data Call-In Response Form
indicating your election of this option. Voluntary cancellation is item number b
on the Data Call-In Response Form. If you choose this option, this is the only form
that you are required to complete.
If you 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.
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2. Use Deletion - You may avoid the requirements of this Notice by
eliminating the uses or 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, 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 on the Requirements
Status and Registrant's Response Form. 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 and
Emergency Response Branch, Registration Division, (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, must bear an amended label.
3. 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(s) if the active ingredient(s) in the
product is derived exclusively from purchased, registered pesticide products
containing the active ingredient(s). 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:
a. The active ingredient(s) in your registered product must be present
solely because of incorporation of another registered product which
contains the subject active ingredient(s) and is purchased from a source not
connected with you; and,
b. every registrant who is the ultimate source of the active
ingredient (s) in your product subject to this DCI must be in compliance
with the requirements of this Notice and must remain in compliance; and
c. you must have provided to EPA an accurate and current
"Confidential Statement of Formula" for each of your products to which
this Notice applies.
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 product specific data.
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 registrant^)
who have committed to generate and submit the required data fail to take
appropriate steps to meet the requirements or are no longer in compliance with this
Data Call-In Notice, the Agency will consider that both they and you are not in
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.
4. Satisfying the Data Requirements of this Notice - There are various options
available to satisfy the data requirements of this Notice. These options are
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discussed in Section III-C of this Notice and comprise options 1 through 6 on the
Requirements Status and Registrant's Response Form and option 6b and 7 on the
Data Caii-ln Response Form! it you choose option 6b or 7, you must submit both
forms as well as any other information/data pertaining to the option chosen to
address the data requirement.
5. Request for Data Waivers. Data waivers are discussed in Section III-D of
this Notice and are covered by options 8 and 9 on the Requirements Status and
Registrant's Response Form. If you choose one of these options, you must submit
both forms as well as any other information/data pertaining to the option chosen
to address the data requirement.
C. SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-in Response Form that you agree to satisfy
the data requirements (i.e. you select option 6b and/or '(), 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),
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 CFR Part 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
Registrant's Response Form and/or footnotes to the form. It 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
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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 or 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. A 90-day progress report must be
submitted for all studies. This 9T)-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 requirement(s), you must
submit a request to the Agency which includes: (1) a detailed description of the
expected difficulty and (2) a proposed schedule including alternative dates for
meeting such requirements on a step-by-step basis. You must explain any technical
or laboratory difficulties and provide documentation from the laboratory
performing the testing. While EPA is considering your request, the original
deadline remains. The Agency will respond to your request in writing. If EPA
does not grant your request, the original deadline remains. Normally, extensions
can be requested only in cases of extraordinary testing problems beyond the
expectation or control of the registrant. Extensions will not be given in submitting
the 90-day responses. Extensions will not be considered if the request for
extension is not made in a timely fashion; in no event shall an extension request be
considered if it is submitted at or after the lapse of the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data —
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.
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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 your offer. To qualify for this option,
you must submit documentation to the Agency proving that you have made an offer
to another registrant (who has an obligation to submit data) to share in the burden
of developing that data. You must also submit to the Agency a completed EPA
Form 8570-32, Certification of Offer to Cost Share in the Development of Data.
In addition, you must demonstrate that the other registrant to whom the offer was
made has not accepted your offer to enter into a cost sharing agreement by
including a copy of your offer and proof of the other registrant s receipt of that
offer (such as a certified mail receipt). Your offer must, in addition to anything
else, offer to share in the burden of producing the data upon terms to be agreed or
failing agreement to be bound by binding arbitration as provided by FIFRA section
3(c) (2) (B) (iii) and must not qualify this offer. The other registrant must also
inform EPA of its election of an option to develop and submit the data required by
this Notice by submitting a Data Call-In Response Form and a Requirements Status
and Registrant's Response Form committing to develop and submit the data
required by this Notice.
In order for you to avoid suspension under this option, you may not
withdraw your offer to share in the burdens of developing the data. In addition,
the other registrant must fulfill its commitment to develop and submit the data as
required by this Notice. If the other registrant fails to develop the data or for some
other reason is subject to suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension proceedings, unless
you commit to submit, and do submit the required data in the specified time frame.
In such cases, the Agency generally will not grant a time extension for submitting
the data.
Option 4, Submitting an Existing Study —
If you choose to submit an existing study in response to this Notice, you
must determine that the study satisfies the requirements imposed by this Notice.
You may only submit a study that has not been previously submitted to the Agency
or previously cited by anyone. Existing studies are studies which predate issuance
of this Notice. Do not use this option if you are submitting data to upgrade a
study. (See Option 5).
You should be aware that if the Agency determines that the study is not
acceptable, the Agency will require you to comply with this Notice, normally
without an extension of the required date 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:
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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(7) " raw
data means any laboratory worksheets, records, memoranda, notes, or
exact copies thereof, that are the result of original observations and
activities of a study and are necessary for the reconstruction and evaluation
of the report of that study. In the event that exact transcripts of raw data
have been prepared (e.g., tapes which have been transcribed verbatim,
dated, and verified accurate by signature), the exact copy or exact
transcript may be substituted for the original source as raw data. Raw data
may include photographs, microfilm or microfiche copies, computer
printouts, magnetic media, including dictated observations, and recorded
data from automated instruments." The term "specimens", according to 40
CFR 160.3(7), means "any material derived from a test system for
examination or analysis."
b. Health and safety studies completed after May 1984 must also
contain all GLP-required quality assurance and quality control information,
pursuant to the requirements of 40 CFR Part 160. Registrants must also
certify at the time of submitting the existing study that such GLP
information is available for post-May 1984 studies by including an
appropriate statement on or attached to the study signed by an authorized
official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for
the Guideline relevant to the study provided in the FIFRA Accelerated
Reregistration Phase 3 Technical Guidance and that the study has been
conducted according to the Pesticide Assessment Guidelines (PAG) or
meets the purpose of the PAG (both available from NTIS). A study not
conducted according to the PAG may be submitted to the Agency for
consideration if the registrant believes that the study clearly meets the
purpose of the PAG. The registrant is referred to 40 CFR 158.70 which
states the Agency's policy regarding acceptable protocols. If you wish to
submit the study, you must, in addition to certifying that the purposes of
the PAG are met by the study, clearly articulate the rationale why you
believe the study meets the purpose of the PAG, including copies of any
supporting information or data. It has been the Agency's experience that
studies completed prior to January 1970 rarely satisfied the purpose of the
PAG and that necessary raw data are usually not available for 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
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Agency of such a study. If such a 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.
This option should also be used to cite data that has been previously
submitted to upgrade a study, but has not yet been reviewed by the Agency. You
must provide the MRID number of the data submission as well as the MRID
number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4
above, apply to all data submissions intended to upgrade studies. Additionally
your submission of data intended to upgrade studies must be accompanied by a
certification that you comply with each of those criteria as well as a certification
regarding protocol compliance with Agency requirements.
Option 6, Citing Existing Studies —
If you choose to cite a study that has been previously submitted to 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.
D. REQUESTS FOR DATA WAIVERS
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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^) are inapplicable and do not apply to your product.
1. Low Volume/Minor Use Waiver — Option 8 on the Requirements Status
and Registrant's Response Eorm. Section 3(c)(2) (A) of FIFKA requires EPA to
consider the appropriateness of requiring data for low volume, minor use
pesticides. In implementing this provision EPA considers as low volume pesticides
only those active ingredient (s) 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 (s) 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(s) 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(s) 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 product(s), as part of your 90-day
response to this Notice:
a. Total company sales (pounds and dollars) of all registered
product(s) containing the active ingredient(s). If applicable to the active
ingredient(s), 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.
b. Provide an estimate of the sales (pounds and dollars) of the active
ingredient (s) for each major use site. Present the above information by
year for each of the past five years.
c. Total direct production cost of product (s) containing the active
ingredient (s) 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.
d. Total indirect production cost (e.g. plant overhead, amortized plant
and equipment) charged to product(s) containing the active ingredient(s) by
year for the past five years. Exclude all non-recurring costs that were
directly related to the active ingredient (s), such as costs of initial
registration and any data development.
e. 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 requirement and associated test) of conducting the
testing needed to fulfill each of these data requirements.
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f. 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.
g. For each of the next ten years, a year-by-year forecast of company
sales (pounds and dollars) of the active ingredient(s), direct production
costs of product(s) containing the active ingredient(s) (following the
parameters in item c above), indirect production costs of product(s)
containing the active ingredient(s) (following the parameters in item d
above), and costs of data development pertaining to the active ingredient (s).
h. A description of the importance and unique benefits of the active
ingredient (s) to users. Discuss the use patterns and the effectiveness of the
active ingredient(s) relative to registered alternative chemicals and
non-chemical control strategies. Focus on benefits unique to the active
ingredient(s), 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 (s) in terms
of its benefits, you should provide information on any of the following
factors, as applicable to your product(s):
(1) documentation of the usefulness of the active ingredient (s)
in Integrated Pest Management, (b) description of the beneficial impacts on
the environment of use of the active ingredient(s), as opposed to its
registered alternatives, (c) information on the breakdown of the active
ingredient(s) 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.
2. Request for Waiver of Data —Option 9 on the Requirements Status and
Registrant s Response FofrrT This option may be used if you believe that a
particular data requirement should not apply because the corresponding use is no
longer registered or the requirement is inappropriate. You must submit a rationale
explaining why you believe the data requirements should not apply. You must also
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.
You will be informed of the Agency's decision in writing. If the Agency
determines that the data requirements of this Notice do not apply to your
product (s), you will not be required to supply the data pursuant to section
3(c)(2)(B). If EPA determines that the data are required for your product(s), you
must choose a method of meeting the requirements of this Notice within the time
frame provided by 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.
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IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
A. NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice
due to failure by a registrant to comply with the requirements of this Data Call-In Notice,
pursuant to FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a
Notice of Intent to Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt
of this Notice.
2. Failure to submit on the required schedule an acceptable proposed or final
protocol when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on
a study as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by
this Notice.
5. Failure to take a required action or submit adequate information pertaining
to any option chosen to address the data requirements (e.g., any required
action or information pertaining to submission or citation of existing studies
or offers, arrangements, or arbitration on the sharing of costs or the
formation of Task Forces, failure to comply with the terms of an agreement
or arbitration concerning joint data development or failure to comply with
any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section III-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:
a. inform EPA of intent to develop and submit the data required by
this Notice on a Data Call-In Response Form and a Requirements Status
and Registrant's Response Form; of,
b. fulfill the commitment to develop and submit the data as required
by this Notice; or,
c. otherwise take appropriate steps to meet the requirements stated in
this Notice, unless you commit to submit and do submit the required data
in the specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at
any time following the issuance of this Notice.
B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
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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 or 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.
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 Federal Insecticide, Fungicide, and
Rodenticide Act.
The Agency has determined that such disposition by registrants of existing stocks
for a suspended registration when a section 3 (c) (2) (B) data request is outstanding would
generally not be consistent with the Act's purposes. Accordingly, the Agency anticipates
granting registrants permission to sell, distribute, or use existing stocks of suspended
produces) only in exceptional circumstances. If you believe such disposition of existing
stocks of your product(s) which may be suspended for failure to comply with this Notice
should be permitted, you have the burden of clearly demonstrating to EPA that granting
such permission would be consistent with the Act. You must also explain why an ' existing
stocks" provision is necessary, including a statement of the quantity of existing stocks and
your estimate of the time required for their sale, distribution, and use. Unless you meet
this burden the Agency will not consider any request pertaining to the continued sale,
distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this
Notice and your product is in 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(s) for which the Agency has particular risk concerns will be determined on
case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period
required by this Notice will not result in the Agency granting any additional time to sell,
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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 listed in Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-in Response Form (Attachment 2) and a
completed Requirements Status and Registrant's Response Form (Attachment 3) and any other
documents required by this Notice, ana should be submitted to the contact person identified in
Attachment 1. If the voluntary cancellation or generic data exemption option is chosen, only the
Data Call-In Response Form need be submitted.
The Office of Compliance (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,
Louis P. True, Jr., Acting Director
Special Review
and Reregistration Division
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Attachment 1. Chemical Status Sheet
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2355 DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s)
containing 2355.
This Generic Data Call-In Chemical Status Sheet, contains an overview of data required
by this notice, and point of contact for inquiries pertainingto the reregistration of 2355. 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 2), (4) a list of registrants receiving this DCI (Attachment 4), (5) the EPA
Acceptance Criteria (Attachment 5), and (6) the Cost Share and Data Compensation Forms in
replying to this 2355 Generic Data Callln (Attachment F). Instructions and guidance accompany
each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for 2355 are
contained in the Requirements Status and Registrant's Response, Attachment C. The Agency has
concluded that additional product chemistry data on 2355 are needed. These data are needed to
fully complete the reregistration of all eligible 2355 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 Shanaz Bacchus at (703) 308-8065.
All responses to this Notice for the generic data requirements should be submitted to:
Shanaz Bacchus, Chemical Review Manager
Accelerated Reregistration Branch
Special Review and Registration Division (H7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: 2355
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Attachment 2. Generic DCI Response Forms Inserts (Form
A) plus Instructions
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SPECIFIC INSTRUCTIONS FOR THE GENERIC DATA CALL-IN RESPONSE FORM
This Form is designed to be used to respond to call-ins for generic and product specific
data for the purpose of reregistering pesticides under the Federal Insecticide Fungicide and
Rodenticide Act. Fill out this form each time you are responding to a data call-in for which EPA
has sent you the form entitled "Requirements Status and Registrant's Response."
Items 1-4 will 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.
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 suggesting for reducing this burden, to Chief, Information Policy
Branch, PM-223, 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.
INSTRUCTIONS
Item 1. This item identifies your company name, number and address.
Item 2. This item identifies the ease number, ease name, EPA chemical number
and chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the EPA product registrations relevant to the data
call-in. Please note that you are also responsible for informing the Agency
of your response regarding any product that you believe may be covered
by this data call-in but that is not listed by the Agency in Item 4. You must
bring any such apparent omission to the Agency's attention within the
period required for submission of this response form.
Item 5. Cheek 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. You do not need to complete any item on the Requirements
Status and Registrant's Response Form for any product that is voluntarily
cancelled.
Item 6a. Check this item if this data call-in is for generic data as indicated in Item
3 and if 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
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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.
Item 6b. Check this Item if the data call-in is a generic data call-in 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.
Item 7a. Check this item if this call-in if a data call-in as indicated in Item 3 for a
manufacturing use product (MUP), and if your product is a manufacturing
use product for which you agree to supply product-specific data. Attach
the Requirements Status and Registrants Response Form that indicates how
you will satisfy those requirements.
Item 7b. Check this item if this call-in is a data call-in for an end use product (EUP)
as indicated in Item 3 and if your product is an end use product for which
you agree to supply product-specific data. Attach the Requirements Status
and Registrant s Response Form that indicates how you will satisfy those
requirements.
Item 8. 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.
Item 9. Enter the date of signature.
Item 10. Enter the name of the person EPA should contact with questions regarding
your response.
Item 11. Enter the phone number of your company contact.
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Attachment 3. Requirements Status and Registrants'
Response Forms Inserts (Form B) plus Instructions
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SPECIFIC INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANTS RESPONSE FORM
Generic Data
This form is designed to be used for registrants to respond to call-in- for generic and
product-specific data as part of EPA's reregistration program under the Federal Insecticide
Fungicide and Rodenticide Act. Although the form is the same for both product specific and
generic data, instructions for completing the forms differ slightly. Specifically, options for
satisfying product specific data requirements do not include (1) deletion or uses or (2) request for
a low volume/minor use waiver. These instructions are for completion of generic data
requirements.
EPA has developed this form individually for each data call-in addressed to each registrant, and
has preprinted this form with a number of items. DO NOT use this form for any other active
ingredient.
Items 1 through 8 (inclusive) will have been preprinted on the form. You must complete all other
items on this form by typing or printing legibly.
Public reporting burden for this collection of information is estimated to average 30 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 suggesting for reducing this burden, to Chief, Information Policy Branch, PM-223,
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.
INSTRUCTIONS
Item 1. This item identifies your company name, number, and address.
Item 2. This item identifies the case number, case name, EPA chemical number and
chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the guideline reference numbers of studies required to support
the product(s) being reregistered. These guidelines, in addition to requirements
specified in the Data Call-In Notice, govern the conduct of the required studies.
Item 5. 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
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Item 6.
submitted in connection with the study. As noted in Section III 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.
This item identifies the code associated with the use pattern of the pesticide. A
brief description of each code follows:
A.
B.
C.
D.
E.
F.
G.
H.
I.
J.
K.
L.
M.
N.
0.
Terrestrial food
Terrestrial feed
Terrestrial non-food
Aquatic food
Aquatic non-food outdoor
Aquatic non-food industrial
Aquatic non-food residential
Greenhouse food
Greenhouse non-food crop
Forestry
Residential
Indoor food
Indoor non-food
Indoor medical
Indoor residential
Item 7.
This item identifies the code assigned to the substance that must be used for
testing. A brief description of each code follows.
EP
MP
MP/TGAI
PAI
PAI/M
PAI/PAIRA
PAIRA
PAIRA/M
PAIRA/PM
TEP
TEP_*
TEP/MET
TEP/PAI/M
TGAI/PAIRA
TGAI
TGAI/TEP
TGAI/PAI
MET
IMP
End-Use Product
Manufacturing-Use Product
Manufacturing-Use Product and Technical Grade
Active Ingredient
Pure Active Ingredient
Pure Active Ingredient and Metabolites
Pure Active Ingredient or Pure Active Ingredient
Radiolabelled
Pure Active Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled and Metabolites
Pure Active Ingredient Radiolabelled and Plant
Metabolites
Typical End-Use Product
Typical End-Use Product, Percent Active Ingredient
Specified
Typical End-Use Product and Metabolites
Typical End-Use Product or Pure Active Ingredient
and Metabolites
Technical Grade Active Ingredient or Pure Active
Ingredient Radiolabelled
Technical Grade Active Ingredient
Technical Grade Active Ingredient or Typical
End-Use Product
Technical Grade Active Ingredient or Pure Active
Ingredient
Metabolites
Impurities
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DEGR Degradates
*See: guideline comment
Item 8. This item identifies the time frame allowed for submission of the study or protocol
identified in item 2. The time frame runs from the date of your receipt of the Data
Call-In Notice.
Item 9. 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.
1. (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 protocol and progress reports required in
item 5 above.
2. (Agreement to Cost Share) I have entered into an agreement with one or
more registrants to develop data jointly. By indicating that I have chosen
this option, I certify that I will comply with all the requirements pertaining
to sharing in the cost of developing data as outlined in the Data Call-In
Notice.
3. (Offer to Cost Share) I have made an offer to enter into an agreement with
one or more registrants to develop data Jointly. I am submitting a copy of
the form "Certification of Offer to Cost Share in the Development of Data"
that describes this offer/agreement. By indicating that I have chosen this
option, I certify that I will comply with all the requirements pertaining to
making an offer to share in the cost of developing data as outlined in the
Data Call-in Notice.
4. (Submitting Existing Data) I am submitting an existing study 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.
5. (Upgrading a Study) I am submitting or citing 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.
6. (Citing a Study) I am citing an existing study that has been previously
classified by EPA as acceptable, core, core minimum, or a study that has
not yet been reviewed by the Agency. I am providing the Agency's
classification of the study.
7. (Deleting Uses) I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
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8. (Low Volume/Minor Use Waiver Request) I have read the statements
concerning low volume-minor use data waivers in the Data Call-in Notice
and I request a low-volume minor use waiver of the data requirement. I
am attaching a detailed justification to support this waiver request
including, among other things, all information required to support the
request. I understand that, unless modified by the Agency in writing, the
data requirement as stated in the Notice governs.
9. (Request for Waiver of Data) I have read the statements concerning data
waivers other than low volume minor-use data waivers in the Data Call-in
Notice and I request a waiver of the data requirement. I am attaching an
identification of the basis for this waiver and a detailed justification to
support this waiver request. The justification includes, 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.
Item 10. This item must be signed by an authorized representative of your company. The
person signing must include his/her title, and must initial and date all other pages
of this form.
Item 11. Enter the date of signature.
Item 12. Enter the name of the person EPA should contact with questions regarding your
response.
Item 13. Enter the phone number of your company contact.
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Attachment 4. List of Registrant(s) sent this DCI (Insert)
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APPENDIX G. Product Specific Data Call-in
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DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet, to
submit certain product specific data as noted herein to the U.S. Environmental Protection
Agency (EPA, the Agency). These data are necessary to maintain the continued registration
ofyour product(s) containing this active ingredient. Within 90 days after you receive this
Notice you must respond as set forth in Section III below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments A through G; or
2. Why you believe you are exempt from the requirements listed in this Notice and
in Attachment 3, Requirements Status and Registrant's Response Form, (see
section III-B); or
3. Why you believe EPA should not require your submission of product specific
data in the manner specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list
of all of your products subject to this Notice in Attachment 2, Data Call-In Response Form, as
well as a list of all registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-
0107 (expiration date 12-31-92).
This Notice is divided into six sections and seven Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable
Adverse Effects
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Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-in Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Grouping or End-Use Products tor Meeting Acute Toxicology Data
Requirements tor Reregistration
EPA
5 - EPA Acceptance Criteria
6 - List or Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms, and Product Specific Data Report
Form
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the
data needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional
generic data requirements are being imposed. You have been sent this Notice because you
have product(s) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment 3,
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional testing may be required.
II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD
protocols, they should be modified as appropriate so that the data generated by the study will
satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for
complying with data requirements when the studies were not conducted in accordance with
acceptable standards. The OECD protocols are available from OECD, 1750 Pennsylvania
Avenue N.W., Washington, D.C. 20006.
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All new studies and proposed protocols submitted in response to this Data Call-in Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-in does not in any way supersede or change
the requirements of any previous Data Call-in(s), or any other agreements entered into with the
Agency pertaining to such prior Notice. Registrants must comply with the requirements of all
Notices to avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific data must
be submitted to the Agency within 90 days after your receipt of this Notice. Failure to
adequately respond to this Notice within 90 days of your receipt will be a basis for issuing a
Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for issuance of
NOIS due to failure to comply with this Notice are presented in Section IV-A and IV-B.
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or
(c) request a data waiver (s).
A discussion of how to respond if you chose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product specific
data requirements of this Notice is contained in Section III-C. A discussion of options relating to
requests for data waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used in your response to the Agency. These forms are the Data-Call-in
Response Form and the Requirements Status and Registrant's Response Form, Attachment 2 and
Attachment 3. The Data Call-in Response Form must be submitted as part of every response to
this Notice. In addition, one copy or the Requirements Status and Registrant's Response Form
must be submitted for each product listed on the Data Call-In Response Form unless the
voluntary cancellation option is selected or unless the product is identical to another (refer to the
instructions for completing the Data Call-In Response Form in Attachment 2). Please note that
the company's authorized representative is required to sign the 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.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must submit a completed Data Call-
In Response Form, indicating your election of this option. Voluntary cancellation is item number
b on the Data Calf-In Response Form. If you choose this option, this is the only form that you
are required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
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2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisly the product specific data requirements of this Notice. These options
are discussed in Section III-C of this Notice and comprise options 1 through 6 on the
Requirements Status and Registrant's Response Form and item numbers 7a and 7b on the Data
Call-In Response Form. Deletion of a use(s) and the low volume/minor use option are not valid
options lor fulfilling product specific data requirements.
3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section 111-D ol this Notice and are covered by option 7 on the Requirements Status
and Registrant's Response Form. If you choose one of these options, you must submit both
forms as well as any other information/data pertaining to the option chosen to address the data
requirement.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy the
product specific data requirements (i.e. you select item number 7a 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)
I have made offers to cost-share (Offers to Cost Share)
I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(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 CFR Part 160), be conducted according to the Pesticide Assessment
Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.
The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports. The noted
deadlines run from the date of the receipt of this Notice by the registrant. If the data are not
submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected 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
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laboratory performing the testing. While EPA is considering your request, the original deadline
remains. The Agency will respond to your request in writing. If EPA does not grant your
request, the original deadline remains. Normally, extensions can be requested only in cases of
extraordinary testing problems beyond the expectation or control of the registrant. Extensions
will not be given in submitting the 90-day responses. Extensions will not be considered if the
request for extension is not made in a timely fashion; in no event shall an extension request be
considered if it is submitted at or after the lapse of the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data — Registrants may only choose
this option for acute toxicity data and certain efficacy data and only if EPA has indicated in the
attached data tables that your product and at least one other product are similar for purposes of
depending on the same data. If this is the case, data may be generated for just one of the
products in the group. The registration number of the product for which data will be submitted
must be noted in the agreement to cost share by the registrant selecting this option. If you choose
to enter into an agreement to share in the cost of producing the required data but will not be
submitting the data yourself, you must provide the name of the registrant who will be submitting
the data. You must also provide EPA with documentary evidence that an agreement has been
formed. Such evidence may be your letter offering 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 — This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer
to pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration^), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general
policy, absent other relevant considerations, it will not suspend the registration of a product of a
registrant who has in good faith sought and continues to seek to enter into a joint data
development/cost sharing program, but the other registrant(s) developing the data has refused to
accept your offer. To qualify for this option, you must submit documentation to the Agency
proving that you have made an offer to another registrant (who has an obligation to submit data)
to share in the burden of developing that data. You must also submit to the Agency a completed
EPA Form 8570-32, Certification of Offer to Cost Share in the Development of Data,
Attachment 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 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 burdens of developing the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant
fails to develop the data or for some other reason is subject to suspension, your registration as
well as that of the other registrant will normally be subject 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(j) " 'raw data' means any laboratory worksheets,
records, memoranda, notes, or exact copies thereof, that are the result of original
observations and activities of a study and are necessary for the reconstruction and
evaluation of the report of that study. In the event that exact transcripts of raw
data have been prepared (e.g., tapes which have been transcribed verbatim, dated,
and verified accurate by signature), the exact copy or exact transcript may be
substituted for the original source as raw data. Raw data' may include
photographs, microfilm or microfiche copies, computer printouts, magnetic media,
including dictated observations, and recorded data from automated instruments."
The term "specimens", according to 40 CFR 160.3(k), means "any material
derived from a test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study
signed by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according to the PAG may be
submitted to the Agency for consideration if the registrant believes that the study
clearly meets the purpose of the PAG. The registrant is referred to 40 CFR
158.70 which states the Agency's policy regarding acceptable protocols. If you
wish to submit the study, you must, in addition to certifying that the purposes of
the PAG are met by the study, clearly articulate the rationale why you believe the
study meets the purpose of the PAG, including copies of any supporting
information or data. It has been the Agency's experience that studies completed
prior to January 1970 rarely satisfied the purpose of the PAG and that necessary
raw data are usually not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.
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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.
This option should also be used to cite data that has been previously submitted to upgrade
a study, but has not yet been reviewed by the Agency. You must provide the MRID number of
the data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to all
data submissions intended to upgrade studies. Additionally your submission of data intended to
upgrade studies must be accompanied by a certification that you comply with each of those
criteria as well as a certification regarding protocol compliance with Agency requirements.
Option 6, Citing Existing Studies — If you choose to cite a study that has been previously
submitted to EPA, that study must have been previously classified by EPA as acceptable or it
must be a study which has not yet been reviewed by the Agency. Acceptable toxicology studies
generally will have been classified as "core-guideline" or ' core minimum." For all other
disciplines the classification would be "acceptable." With respect to any studies for which you
wish to select this option you must provide the MRID number of the study you are citing and, if
the study has been reviewed by the Agency, you must provide the Agency's classification of the
study.
If you are citing a study of which you are not the original data submitter, you must submit
a completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-in Response Form and the
Requirements Status and Registrant's Response Form, as appropriate.
III-D REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete Justification for the request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies. (Note: any
supplemental data must be submitted in the format required by PR Notice 86-5). This will be the
only opportunity to state the reasons or provide information in support of your request. If the
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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 Requirements Status
and Registrant's Response Form. Product specific data requirements for product chemistry,
acute toxicity and efficacy (where appropriate) are required for all products and the Agency
would grant a waiver only under extraordinary circumstances. You should also be aware that
submitting a waiver request will not automatically extend the due date for the study in question.
Waiver requests submitted
without adequate supporting rationale will be denied and the original due date will remain in
force.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-in Notice, pursuant to
FIFRA section 3(c) (2) (B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this
Notice.
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 III-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:
a. inform EPA of intent to develop and submit the data required by this
Notice on a Data Call-In Response Form and a Requirements Status and
Registrant's Response Form;
b. fulfill the commitment to develop and submit the data as required by this
Notice; or
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c. otherwise take appropriate steps to meet the requirements stated in this
Notice, unless you commit to submit and do submit the required data in the
specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEP TABLE
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 would generally not
be consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may
be suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act.
You must also explain why an "existing stocks" provision is necessary, including a statement of
the quantity of existing stocks and your estimate of the time required for their sale, distribution,
and use. Unless you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in 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
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risk concerns will be determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you demonstrate
to the Agency that you are in full compliance with all Agency requirements, including the
requirements of this Notice. For example, if you decide to voluntarily cancel your registration
six months before a 3 year study is scheduled to be submitted, all progress reports and other
information necessary to establish that you have been conducting the study in an acceptable and
good faith manner must have been submitted to the Agency, before EPA will consider granting
an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6 (a) (2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information to
the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data CalHn Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for
product specific data) and any other documents required by this Notice, and should be submitted
to the contact person(s) identified in Attachment 1. If the voluntary cancellation or generic data
exemption option is chosen, only the Data Call-In Response Form need be submitted.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Louis P. True, Jr., Acting Director
Special Review and
Reregistration Division
Attachments
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-in Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
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5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Cost Share and Data Compensation fr'orms, and Product Specific Data Report
Form
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Attachment 1. Chemical Status Sheet
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2355 DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing 2355.
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 2355.
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), (5j the EPA Acceptance Criteria
(Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6) and (7) the Cost Share
and Data Compensation Forms in replying to this 2355 Product Specific Data Call-In
(Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for 2355 are contained
in the Requirements Status and Registrant's Response, Attachment 3. The Agency has concluded
that additional data on 2355 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 2355 products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of 2355, please contact Shanaz
Bacchus at (703) 308-80B5.
If you have any questions regarding the product specific data requirements and procedures
established by this Notice, please contact Franklin Gee at (703) 308-8008.
(703) 308-8184.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Frank Rubis
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: 2355
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Attachment 2. Product Specific Data Call-In Response
Forms (Form A inserts) Plus Instructions
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes." If you choose this
option, you will not have to provide the data required by the Data Call-In Notice and
you will not have to complete any other forms. Further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing
Stocks provision of the Data Call-In Notice (Section IV-C).
Item 6. Not applicable since this form calls in product specific data only. However, if your
product is identical to another product and you qualify for a data exemption, you
must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide the
EPA registration numbers of your source(s); you would not complete the
"Requirements Status and Registrant's Response" form. Examples of such products
include repackaged products and Special Local Needs (Section 24c) products which
are identical to federally registered products.
Item 7a. 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. If you are
requesting a data waiver, answer yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with Option
7 (Waiver Request) for each study for which you are requesting a waiver. See Item
6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier number assigned by EPA in Item
3. This number must be used in the transmittal document for any data
submissions in response to this Data Call-In Notice.
Item 4. The guideline reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the requirements
specified in the Notice, govern the conduct of the required studies. Note that series
61 and 62 in product chemistry are now listed under 40 CFR 158.155 through
158.180, SubpartC.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use pattern(s) of the pesticide associated with the product specific requirements
is (are) identified. For most product specific data requirements, all use patterns are
covered by the data requirements. In the case of efficacy data, the required studies
only pertain to products which have the use sites and/or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Document unless EPA
determines that a longer time period is necessary.
Item 9. Enter only one of the following response codes for each data requirement to show
how you intend to comply with the data requirements listed in this table. Fuller
descriptions of each option are contained in me Data Call-In Notice.
1. I will generate and submit data by the specified due date (Developing Data). By
indicating that I have chosen this option, I certify that I will comply with all the
requirements pertainingto the conditions for submittal of this study as outlined in the
Data Call-In Notice. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form (EPA
Form 8570-29) and (2) two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4).
2. I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing). I am submitting a copy of this agreement. I understand that this
option is available only for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this Notice that my product is similar enough to another
product to qualify for this option. I certify that another party in the agreement is
committing to submit or provide the required data; if the required study is not
submitted on time, my product may be subject to suspension. By the specified due
date, I will also submit: (1) a completed "Certification With Respect To Data
Compensation Requirements" form (EPA Form 8570-29) and (2) two completed
and signed copies of the Confidential Statement of Formula (EPA Form 8570-4).
3. I have made offers to share in the cost to develop data (Offers to Cost Share). I
understand that this option is available only for acute toxicity or certain efficacy data
and only if EPA indicates in an attachment to this Data Call-In Notice that my product
is similar enough to another product to qualify for this option. I am submitting
evidence that I have made an offer to another registrant (who has an obligation to
submit data) to share in the cost of that data. I am also submitting a completed
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"Certification of Offer to Cost Share in the Development Data" form. I am
including a copy of my offer and proof of the other registrant's receipt of that offer.
I am identifying the party which is committing to submit or provide the required data;
if the required study is not submitted on time, my product may be subject to
suspension. I understand that other terms under Option 3 in the Data Call-in Notice
(Section III-C.l.) apply as well. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
4. By the specified due date, I will submit an existing study that has not been submitted
previously to the Agency by anyone (Submitting an Existing Study). I certify that
this study will meet all the requirements for submittal of existing data outlined in
Option 4 in the Data Call-in Notice (Section III-C.l.) and will meet the attached
acceptance criteria (for acute toxicity and product chemistry data). I will attach the
needed supporting information along with this response. I also certify that I have
determined that this study will fill the data requirement for which I have indicated this
choice. By the specified due date, I will also submit a completed "Certification With
Respect To Data Compensation Requirements" form (EPA Form 8570-29) to
show what data compensation option I have chosen. By the specified due date, I will
also submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed copies
of the Confidential Statement of Formula (EPA Form 8570-4).
5. By the specified due date, I will submit or cite data to upgrade a study classified by
the Agency as partially acceptable and upgradable (Upgrading a Study). I will
submit evidence of the Agency's review indicating that the study may be upgraded
and what information is required to do so. I will provide the MRID or Accession
number of the study at the due date. I understand that the conditions for this option
outlined Option o in the Data Call-In Notice (Section III-C.l.) apply. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies of the Confidential Statement of Formula (EPA Form
8570-4).
6. By the specified due date, I will cite an existing study that the Agency has classified
as acceptable or an existing study that has been submitted but not reviewed by the
Agency (Citing an Existing Study). If I am citing another registrant's study, I
understand that this option is available only for acute toxicity or certain efficacy data
and only if the cited study was conducted on my product, an identical product or a
product which EPA has "grouped" with one or more other products for purposes of
depending on the same data. I may also choose this option if I am citing my own
data. In either case, I will provide the MRID or Accession number(s) for the cited
data on a "Product Specific Data Report" form or in a similar format. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies of the Confidential Statement of Formula (EPA Form
8570-4).
7. I request a waiver for this study because it is inappropriate for my product (Waiver
Request). I am attaching a complete justification for this request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies.
[Note: any supplemental data must be submitted in the format required by P.R. Notice
86-5]. I understand that this is my only opportunity to state the reasons or provide
information in support of my request. If the Agency approves my waiver request, I
will not be required to supply the data pursuant to Section 3(c)(2)(B) of FIFRA. If
the Agency denies my waiver request, I must choose a method of meeting the data
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requirements of this Notice by the due date stated by this Notice. In this case, I must,
within 30 days of my receipt of the Agency's written decision, submit a revised
"Requirements Status and Registrant's Response" Form indicating the option chosen.
I also understand that the deadline for submission of data as specified by the original
data call-in notice will not change. By the specified due date, I will also submit: (1)
a completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
Items 10-13. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
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Attachment 3. Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and
Instructions
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
Item 1-3. Completed by EPA. Note the unique identifier number assigned by EPA in item 3.
This number must be used in the transmittal document for any data submissions in
response to this Data Call-In Notice.
Item 4. The guidelines reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the requirements
specified in the Notice, govern the conduct of the required studies. Note that series
61 and 62 in product chemistry are now listed under 40 CFR 158.155 through
158.180, Subpartc.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use patters (s) of the pesticide associated with the product specific requirements
is (are) identified. For most product specific data requirements, all use patterns are
covered by the data requirements. In the case of efficacy data, the required studies
only pertain to products which have the use sites and/ or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Documents unless EPA
determines that a longer time period is necessary.
Item 9. Enter Only one of the following response codes for each data requirement to show
how you intend to comply with the data requirements listed in this table. Fuller
descriptions of each option are contained in the Data Call-In Notice.
1. I will generate and submit data by the specified due date (Developing Data).
By indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined in the
Data Call-In Notice.
2. I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing). I am submitting a copy of this agreement. I understand that
this option is available on for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this notice that my product is similar. Enough to another
product to qualify for this option. I certify that another party in the agreement is
committing to submit or provide the required data; if the required study is not
submitted on time, my product my be subject to suspension.
3. I have made offers to share in the cost to develop data (Offers to Cost Share).
I understand that this option is available only for acute toxicity or certain efficacy data
and only if EPA indicates in an attachment to this Data Call-In Notice that my product
is similar enough to another product to qualify for this option. I am submitting
evidence that I have made an offer to another registrant (who has an obligation to
submit data) to share in the cost of that data. I am also submitting a completed "
Certification of offer to Cost Share in the Development Data" form. I am including
a copy of my offer and proof of the other registrant's receipt of that offer. I am
identifying the party which is committing to submit or provide the require data; if the
required study is not submitted on time, my product may be subject to suspension.
I understand that other terms under Option 3 in the Data Call-in Notice (Section III-
C.l.) apply as well.
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4. By the specified due date, I will submit an existing study that has not been
submitted previously to the Agency by anyone (submitting an Existing Study). I
certify that this study will meet all the requirements for submittal of existing data
outlined in option 4 in the Data Call-in Notice (Section III-C.l.) and will meet the
attached acceptance criteria (for acute toxicity and product chemistry data). I will
attach the needed supporting information along with this response. I also certify that
I have determined that this study will fill the data requirement for which I have
indicated this choice.
5. By the specified due date, I will submit or cite data to upgrade a study
classified by the Agency as partially acceptable and upgrade (upgrading a study). I
will submit evidence of the Agency's review indicating that the study may be
upgraded and what information is required to do so. I will provide the MRID or
Accession number of the study at the due date. I understand that the conditions for
this Option outlined Option 5 in the Data Call-in Notice (Section III-C.l.) apply.
6. By the specified due date, I will cite an existing study that the Agency has
classified as acceptable or an existing study that has been submitted but not reviewed
by the Agency (Citing an Existing Study). If I am citing another registrant's study,
I understand that this option is available only for acute toxicity or certain efficacy data
and only if the cited study was conducted on my product, an identical product or a
product which EPA has "grouped" with one or more other products for purposes of
depending on the same data. I may also choose this option if I am citing my own
data. In either case, I will provide the MRID or Accession number (s) number (s) for
the cited data on a "Product Specific Data Report" form or in a similar format. If I
cite another registratrant's data, I will submit a completed "Certification With Respect
To Data Compensation Requirements" form.
7. I request a waiver for this study because it is inappropriate for my product
(Waiver Request). I am attaching a complete justification for this request, including
technical reasons, data and references to relevant EPA regulations, guidelines or
policies. [Note: any supplemental data must be submitted in the format required by
P.R. 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 require to supply the data pursuant to Section 3(c) (2) (B) of
FIFRA. If the Agency denies my waiver request, I must choose a method of meeting
the data requirements of this Notice by the due date stated by this Notice. In this
case, I must, within 30 days of my receipt of the Agency's written decision, submit
a revised "Requirements Status chosen. I also understand that the deadline for
submission of data as specified by the original data cal-in notice will not change.
Items 10-13. Self-explanatory.
NOTE:You may provide additional information that does not fit on this form in a signed letter
that accompanies this form. For example, you may wish to report that your product has already been
transferred to another company or that you have already voluntarily cancelled this product. For
these cases, please supply all relevant details so that EPA can ensure that its records are correct.
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Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
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THERE IS NO BATCHING FOR THIS CASE
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Attachment 5. EPA Acceptance Criteria
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SUBDIVISION D
Guideline Study Title
Series 61 Product Identity and Composition
Series 62 Analysis and Certification of Product Ingredients
Series 63 Physical and Chemical Characteristics
167
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61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Name of technical material tested (include product name and trade name, if appropriate).
2. Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each
intentionally-added inert ingredient.
3. Name and upper certified limit for each impurity or each group of impurities present at _>_ 0.1% by weight and
for certain lexicologically significant impurities (e.g., dioxins, nitrosamines) present "af < 0.1%.
4. Purpose of each active ingredient and each intentionally-added inert.
5. Chemical name from Chemical Abstracts index of Nomenclature and Chemical Abstracts Service (CAS)
Registry Number for each active ingredient and, if available, for each intentionally-added inert.
6. Molecular, structural, and empirical formulas, molecular weight or weight range, and any company assigned
experimental or internal code numbers for each active ingredient.
7. Description of each beginning material in the manufacturing process.
EPA Registration Number if registered;
for other beginning materials, the following:
Name and address of manufacturer or supplier.
Brand name, trade name or commercial designation.
Technical specifications or data sheets by which manufacturer or supplier describes composition,
properties or toxicity.
8. Description of manufacturing process.
Statement of whether batch or continuous process.
Relative amounts of beginning materials and order in which they are added.
Description of equipment.
Description of physical conditions (temperature, pressure, humidity) controlled in each step and the
parameters that are maintained.
Statement of whether process involves intended chemical reactions.
Flow chart with chemical equations for each intended chemical reaction.
Duration of each step of process.
Description of purification procedures.
Description of measures taken to assure quality of final product.
9. Discussion of formation of impurities based on established chemical theory addressing (1) each impurity which
may be present at _>_ 0.1% or was found at _>_ 0.1% by product analyses and (2) certain lexicologically
significant impurities~(see #3).
168
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62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered. Use a table to present the
information in items 6, Y, and 8.
Does your study meet the following acceptance criteria?
1. Five or more representative samples (batches in case of batch process) analyzed for each active ingredient and
all impurities present at > 0.1%.
2. Degree of accountability!)!" closure _>_ ca 98%.
3. Analyses conducted for certain trace toxiclmpurities at lower than 0.1% (examples, nitrosamines in the case of
products containing dinitroanilines or containing secondary or tertiary amines/alkanolamines plus nitrites;
polyhalogenated dibenzodioxins and dibenzofurans). [Note that in the case of nitrosamines both fresh and stored
samples must be analyzed.].
4. Complete and detailed description of each step in analytical method used to analyze above samples.
5. Statement of precision and accuracy of analytical method used to analyze above samples.
6. Identities and quantities (including mean and standard deviation) provided for each analyzed ingredient.
7. Upper and lower certified limits proposed for each active ingredient and intentionally added inert along with
explanation of how the limits were determined.
8. Upper certified limit proposed for each impurity present at > 0.1% and for certain lexicologically significant
impurities at < 0.1% along with explanation of how limit determined.
9. Analytical methods to verify certified limits of each active ingredient and impurities (latter not required if exempt
from requirement of tolerance or if generally recognized as safe by FDA) are fully described.
10. Analytical methods (as discussed in #9) to verify certified limits validated as to their precision and accuracy.
169
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63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered.
Does your study meet the following acceptance criteria?
63-2 Color
Verbal description of coloration (or lack of it)
Any intentional coloration also reported in terms of Munsell color system
63-3 Physical State
Verbal description of physical state provided using terms such as "solid, granular, volatile liquid"
Based on visual inspection at about 20-25° C
63-4 Odor
Verbal description of odor (or lack of it) using terms such as "garlic-like, characteristic of aromatic
compounds"
Observed at room temperature
63-5 Melting Point
Reported in ° C
Any observed decomposition reported
63-6 Boiling Point
Reported in ° C
Pressure under which B.P. measured reported
Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25° C
Density of technical grade active ingredient reported in g/ml or the specific gravity of liquids reported with
reference to water at 20° C. [Note: Bulk density of registered products may be reported in lbs/ft3 or
Ibs/gallon.]
63-8 Solubility
Determined in distilled water and representative polar and non-polar solvents, including those used in
formulations and analytical methods for the pesticide
Measured at about 20-25° C
Reported in g/100 ml (other units like ppm acceptable if sparingly soluble)
63-9 Vapor Pressure
Measured at 25° C (or calculated by extrapolation from measurements made at higher temperature if pressure
too low to measure at 25° C)
Experimental procedure described
Reported in mm Hg (torr) or other conventional units
63-10 Dissociation Constant
Experimental method described
Temperature of measurement specified (preferably about
20-25 °C)
63-11 Octanol/water Partition Coefficient
Measured at about 20-25° C
Experimentally determined and description of procedure provided (preferred method-45 Fed. Register 77350)
Data supporting reported value provided
63-12 pH
Measured at about 20-25° C
Measured following dilution or dispersion in distilled water
63-13 Stability
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined
170
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SUBDIVISION F
Guideline Study Tide
81-1 Acute Oral Toxicity in the Rat
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
81-3 Acute Inhalation Toxicity in the Rat
81-4 Primary Eye Irritation in the Rabbit
81-5 Primary Dermal Irritation Study
81-6 Dermal Sensitization in the Guinea Pig
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81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 young adult rats/sex/group.
3.r Dosing, single oral may be administered over 24 hrs.
4.*^ Vehicle control if other than water.
5. Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mg/kg).
6. Individual observations at least once a day.
7. Observation period to last at least 14 days, or until all test animals appear normal whichever is longer.
8. Individual daily observations.
9. Individual body weights.
10. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
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81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 animals/sex/group.
3.* Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
4. Dosing, single dermal.
5. Dosing duration at least 24 hours.
6.^ Vehicle control, only if toxicity of vehicle is unknown.
7.~ Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
8. Application site clipped or shaved at least 24 hours oefore dosing.
9. Application site at least 10% of body surface area.
10. Application site covered with a porous nonirritating cover to retain test material and to prevent
ingestion.
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
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81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use or
contains particles of inhalable size for man (aerodynamic diameter 15 pm or less).
3. At least 5 young adult rats/sex/group.
4. Dosing, at least 4 hours by inhalation.
5. Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
6. Chamber temperature, 22° C (+_2°), relative humidity 40-60%.
7. Monitor rate of air flow.
8. Monitor actual concentrations of test material in breathing zone.
9. Monitor aerodynamic particle size for aerosols.
10. Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of respirable
substance).
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
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81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive, causes severe
dermal irritation or has a pH of < 2 or > 11.5.
3. 6 adult rabbits.
4. Dosing, instillation into the conjunctival sac of one eye
per animal.
5. Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or particulate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24 hours.
8. Eyes examined and graded for irritation before dosing and
at 1, 24, 48 and 72 hr, then daily until eyes are normal
or 21 days (whichever is shorter).
9.^ Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
175
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81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a pH of < 2 or > 11.5.
3. 6 adult animals.
4. Dosing, single dermal.
5. Dosing duration 4 hours.
6. Application site shaved or clipped at least 24 hours prior to dosing.
7. Application site approximately 6 cm2.
8. Application site covered with a gauze patch held in place with nonirritating tape.
9. Material removed, washed with water, without trauma to application site.
10. Application site examined and graded for irritation at 1, 24, 48 and 72 hr, then daily until normal or 14 days
(whichever is shorter).
11 .^ Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
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81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a
pHof <2or >11.5.
3. One offhe following methods is utilized:
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehler test
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig.
4. Complete description of test.
5.^ Reference for test.
6.~ Test followed essentially as described in reference document.
7. Positive control included (may provide historical data conducted within the last 6 months).
Criteria marked with an * are supplemental and may not be required for every study.
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178
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Attachment 6. List of All Registrants Sent This Data Call-In (insert) Notice
179
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180
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Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions
181
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182
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184
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed copies of the form are
required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible party must be provided.
d. All applicable information which is on the product specific data submission must also be reported on the
CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and pounds per cubic feet
for solids.
f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently registered source products
must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all common names for
the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be reported under column 10
and must be exactly the same as on the source product's label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or grams. In no case will
volumes be accepted. Do not mix English and metric system units (i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must represent pure active form.
m. The upper and lower certified limits for ail active and inert ingredients must follow the 40 CFR 158.175
instructions. An explanation must be provided if the proposed limits are different than standard certified
limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs become obsolete for that
specific formulation.
185
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186
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r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
Approval Expires 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223. U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill In blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Name of Firm(s)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Dale
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete
187
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188
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United States Environmental Protection Agency ,-teo S7>>
Washington, DC 20460
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190
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APPENDIX H. FACT SHEET
191
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192
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-95-005
January 1995
R.E.D. FACTS
Fosamine ammonium
Pesticide
Reregistration
Use Profile
All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can be used
without posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered years ago be reregistered to ensure that they meet
today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
fact sheet summarizes the information in the RED document for
reregistration case 2355, fosamine ammonium.
Fosamine ammonium is an herbicide/plant growth regulator used to
control brush and herbaceous plants on noncropland. It is applied to
nonagricultural rights-of-way (e.g. highways, railroads, and utilities),
industrial sites, and fencerows.
Fosamine ammonium is formulated in end use products as a water
soluble liquid. It is applied once per year from Spring to early Fall, by
aircraft, backpack and handwands. After application, the brush control
effects of the pesticide are achieved by inhibiting bud growth the following
year.
Use practice limitations prohibit fosamine ammonium from being used
on croplands or in irrigation systems. It may not be applied directly to
water, or areas where surface water is present, including intertidal areas.
Soils treated with this herbicide cannot be converted to food/feed croplands
within one year of treatment.
Fosamine ammonium is not registered for use in California and
Arizona.
Regulatory
Fosamine ammonium was first registered as a pesticide in the U.S. in
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History
Human Health
Assessment
1975. It was registered for non-cropland (non-food use) areas such as
railroads, pipelines, utility and highway rights-of way, reforestation areas,
drainage ditch banks, storage areas, industrial plants, and other similar sites.
However, this product was voluntarily cancelled on June 22, 1994.
A second product was registered in 1980 with the same uses as the
original product except for reforestation uses. This product currently is
marketed under two trade names. The registrant requested to voluntarily
cancel direct applications to water, ditch banks, and to other sites which are
adjacent to and surrounding domestic water supply reservoirs, supply
streams, lakes and ponds. The Agency is processing this request, which
involves publishing a Notice of Intent to delete these uses in the Federal
Register. Because there are no other current registrants and there are
outstanding environmental data requirements to support continued
registration of these uses, the Agency expects that these sites will be deleted
from the label by early 1995.
Toxicity
Fosamine ammonium is classified as Toxicity Category II for acute
dermal studies in mammalian species. This classification represents the
second most severe level of acute toxicity for studies using laboratory
animals (Toxicity Category I is the highest). Fosamine ammonium is very
mildly toxic for acute oral and acute inhalation (Toxicity Category IV), and
is not a dermal sensitizer.
In one subchronic oral study, the laboratory animals given the highest
dose of fosamine ammonium exhibited some statistically significant effects,
including effects to the kidneys, bladder and decreases in body weight.
There were no subchronic neurotoxic effects of fosamine ammonium at any
dose level.
Fosamine ammonium displayed some mutagenic potential in one in
vitro test for chromosome aberrations, while four other tests were negative
for mutagenic potential.
Dietary Exposure
Since there are no registered food uses for fosamine ammonium, no
dietary exposure is expected.
Occupational and Residential Exposure
Based on current use patterns, workers may be exposed to fosamine
ammonium during and after application of the pesticide. Worker exposure
estimates are based on the assumption that workers wear long pants, long
sleeved shirt, shoes, and no gloves, except for workers using backpacks
(who are assumed to wear chemical resistant gloves). The primary route of
exposure to fosamine ammonium is expected to be dermal. Another
potential route of exposure is through inhalation. However, based on the
exposure assumptions, the potential for inhalation exposure is negligible.
Human Risk Assessment
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Environmental
Assessment
Since no food uses are registered, fosamine ammonium poses no
human dietary risks. Regarding acute toxicity, fosamine ammonium falls in
Toxicity Category II for acute dermal exposure. However, the mild skin
effects observed with this chemical do not trigger any significant
toxicological concerns. The herbicide/plant growth regulator is of low
toxicity by the oral and inhalation routes. Based on the mixed results of
studies suggesting mutagenetic potential, the Agency is requiring additional
testing with germ cells as a confirmatory study.
Based on the current use pattern of fosamine ammonium, the
estimated exposure to workers, which is likely to reflect a worse-case
scenario, does not pose a serious threat to workers. However, there are no
known significant acute or chronic toxicological endpoints that warrant the
establishment of risk mitigation measures or minimum personal protective
equipment (PPE) requirements to protect handlers of the pesticide. Clothing
as described in the exposure assessment will provide adequate protection to
handlers. In addition, EPA is requiring application restrictions and user
safety recommendations on end-use product labeling.
Environmental Fate
Fosamine ammonium is not very persistent under aerobic or anaerobic
conditions and degrades rapidly in most soils. Dissipation of fosamine
ammonium is dependent on rapid, microbial mediated degradation. Thus,
in field studies fosamine ammonium was found to be highly soluble in water
and is mobile in various soils. However, in the sterile conditions of the
laboratory, fosamine ammonium is stable to hydrolysis. Although fosamine
ammonium is a mobile compound, there is little evidence that leaching is a
major route of dissipation. Data on the residues of fosamine ammonium
indicate they are also relatively mobile.
Fosamine ammonium may be found in surface waters with low
microbiological activities or long hydrological residence times.
Exposure of fosamine ammonium to non-target aquatic plants can
result from spray drift from treated areas, surface runoff, or wind blown
soil particles. However, no acute risk quotients exceed the level of concern,
so no acute effects to aquatic plants are expected from the normal use of
fosamine ammonium.
The risk to terrestrial non-target plants cannot be determined until
Tier I and Tier II data requirements have been fulfilled. Results of the most
sensitive terrestrial plant species tested are needed in order to conduct an
acute risk assessment.
Any movement of fosamine ammonium from the treatment site via
spray drift, surface runoff, or wind blown soil particles can adversely affect
non-target and endangered/threatened plants. Direct application of rights-
of-way are a special concern, because large numbers of endangered plants
grow in rights-of-way areas. Thus applications of fosamine ammonium at
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the registered rates may pose a significant risk to endangered plant species
inhabiting treated rights-of-way.
EPA has been working with the U.S. Fish and Wildlife Service and
other federal and state agencies to develop a program to avoid jeopardizing
endangered species. The Endangered Species Program is expected to be
final soon. Further limitations on the use of fosamine ammonium may be
imposed at that time.
Further droplet size spectrum and field drift studies are due to the
Agency at the end of June 1995 as part of the spray drift data requirements
to be submitted by the Spray Drift Task Force. If the new data suggest
substantially different drift potential, the Agency will reassess its impact on
the associated environmental risks at that time.
Ecological Effects
Exposure to non-target aquatic organisms can result from spray drift
and runoff from treated areas. However, acute effects to freshwater fish
and aquatic invertebrates are not expected from the normal use of fosamine
ammonium. Fosamine ammonium is practically nontoxic to coldwater and
warmwater fish, and does not appear to bioaccumulate in fish. However, a
nine percent fish mortality was observed in the accumulation in fish study.
Fosamine ammonium is practically nontoxic to freshwater invertebrates and
to estuarine species.
Fosamine ammonium is practically nontoxic to honey bees, which are
used to assess the effects on non-target insects.
Fosamine ammonium is practically nontoxic to avian species on an
acute oral and a subacute dietary basis. Mixed results were found in the
avian reproductive studies. In one mallard duck study, there was some
indication of chronic reproductive effects. However, in another avian
reproductive study, using the bob white quail as the test organism, there
were no reproductive effects at any dose level.
Fosamine ammonium is practically nontoxic to small mammalian
species. Acute oral and subacute dietary risks to non-endangered and
endangered non-target mammals are not expected to result from current
label uses.
Ecological Effects Risk Assessment
Based on the data, fosamine ammonium dissipation is predominantly
dependent on rapid microbial-mediated degradation. It is also mobile in
mineral soils. However, fosamine ammonium should not pose a threat to
groundwater or surface waters because it rapidly degrades in aerobic and
anaerobic environments. There are no Maximum Concentration Levels
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Additional Data
Required
Product Labeling
Changes Required
(MCLs) or drinking water health advisories for fosamine ammonium or its
degradates.
The health and environmental data on fosamine ammonium indicate a
low level of toxicity of this pesticide. However, the inconclusive results in
the avian reproductive studies have led the Agency to require a new mallard
duck reproduction study on a confirmatory basis. In addition, risk
mitigation measures are required to reduce the potential for avian
reproductive effects.
EPA is requiring the following additional generic data for fosamine
ammonium to confirm its regulatory assessments and conclusions:
Certification of limits (62-2), Avian reproduction, mallards (71-4b), In-vivo
cytogenetics (84-2a), Droplet size spectrum and field drift data (201-1, 202-
1), Method validation for worker exposure (231, 232), Terrestrial plant
(122-1, 123-1), and Aerobic aquatic (164-2, 162-4) if aquatic sites are not
deleted.
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 fosamine ammonium end-use products must comply with EPA's
current pesticide product labeling requirements, and with the following:
a) Within the Environmental Hazards section of the Precautionary Statement
of the label:
"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 washwaters or
rinsate."
b) To reduce environmental loading and potential exposure to non-target
species, the product label must include language to limit use as outlined
below:
i) the end-use product can be applied only once annually during the
period after spring growth has hardened to the development of fall
coloration in deciduous species, and
ii) the maximum application rate for low shrubs/brush is 16 Ib a.i./A,
and for tall dense woody species with very heavy foliage can be 24 Ib
a.i./A.
c) The end-use product labels cannot include directions for applications to
aquatic sites. The current, sole registrant has submitted an application for
amended registration to delete these uses from its product registration.
Future submissions of appropriate data to support registration for these uses
will be considered by the Agency.
d) The Agency is requiring the following labelling statements to be located
on all end-use products containing fosamine ammonium:
Application Restrictions:
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Regulatory
Conclusion
For More
Information
"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 applications."
Entry Restrictions
The Agency is establishing the following entry restrictions for
the occupational uses of fosamine ammonium end-use products:
For liquid applications:
"Do not enter or allow others to enter the treated area until
sprays have dried."
Other Labelling Requirements:
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 clothing immediately after handling this
product. If gloves are worn, wash the outside of gloves before
removing. As soon as possible, wash thoroughly and change
into clean clothing."
These statements must be included on the labels, as they are
appropriate, after product-specific PPE requirements are set by the Agency.
Although it is not required under the current labeling, it is assumed that the
workers wear long pants, long sleeved shirts, shoes, and socks.
The use of currently registered products containing fosamine
ammonium in accordance with approved labeling, except use in aquatic
sites, will not pose unreasonable risks or adverse effects to humans or the
environment. The registrant has voluntarily requested cancellation of the
aquatic uses. The Agency is not including the aquatic uses in its eligibility
decision, because of the inadequate environmental data and the impending
deletion of those uses from all current registrations. Therefore, all uses of
fosamine ammonium products, other than application to aquatic sites, are
considered eligible for re registration.
Fosamine ammonium products will be reregistered once the required,
product-specific data, revised Confidential Statements of Formula, and
revised labeling are received and accepted by EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for fosamine ammonium 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
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Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregistration Information System at
703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA. GOV, or using ftp on FTP.EPA.GOV, or using
WWW (World Wide Web) on WWW.EPA.GOV.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fax 513-489-8695.
Following the comment period, the fosamine ammonium 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 fosamine ammonium RED, or reregistration of individual products
containing fosamine ammonium, please contact the Special Review and
Reregistration Division (7508W), OPP, US EPA, Washington, DC 20460,
telephone 703-308-8000.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
free 1-800-858-7378, between 8:00 am and 6:00 pm Central Time, Monday
through Friday.
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