United States Office of Prevention. Pesticides EPA 738-S-93-001
Environmental Protection and Toxic Substances February 1993
Agency (H-7508W) '
&EPA Reregistration
Eligibility Document
(RED)
Iron Salts
Recycled/Recyclable
Printed on paper that contains
at least 50% recycled fiber
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United States
Environmental Protection
Agency
Office of Prevention, Pesticides
And Toxic Substances
(H-7508W)
EPA-738-F-93-002
February 1993
R.E.D. FACTS
Iron Salts
Pesticide All pesticides sold or used in the United States must be registered by
Reregistration 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 registration, 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 undue hazards to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this
and explains why in a Reregistration Eligibility Document, or RED. This
fact sheet summarizes the information in the RED for iron salts.
Use Profile The iron salts consist of three pesticide active ingredients that are
eligible for reregistration: Iron (HI) sulfate, Iron (n) sulfate monohydrate,
and Iron (II) sulfate heptahydrate.
Iron salts are registered for use as herbicides to control moss on
lawns, turf, ornamental herbaceous plants, woody shrubs and vines.
Registered products are formulated as soluble concentrates and granulars.
They are applied by sprinkler can, hose-end sprayer, spreader, or by hand.
The major use of iron salts in the United States is non-pesticidal, as a
fertilizer micronutrient. Iron salts also are used as an electrolyte in dry
cell batteries, as an animal feed additive, as a galvanizer and as an
emulsion-breaker. They have further uses in water purification and sewage
treatment, and in textile dying and calico printing.
Regulatory Iron salts first were registered as pesticides in 1962. In addition to
History *e current outdoor moss control uses, iron salts were registered previously
for use inside households, and in and around commercial, institutional and
industrial premises.
At present, a total of 13 products are registered containing iron salts
as sole or one of several active ingredients; one product contains Iron (ffl)
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sulfate, nine contain Iron (n) sulfate monohydrate, and three contain Iron
(n) sulfate heptahydrate.
A fourth active ingredient, Iron n ammonium sulfate, is not being
supported for reregistration and so is not covered in this RED.
Human Health Toxicity
Assessment
Iron salts are present normally in the environment. Iron is the fourth
most abundant element and the second most abundant metal in the earth's
crystal rocks. Iron occurs in a wide variety of minerals, and is present in
foods naturally and through added ingredients.
The iron salts are of low acute toxicity through oral, dermal and
inhalation routes of exposure. They have been placed in Toxicity Category
m for these effects. Although a mutagenicity study using microorganisms
showed positive results, it is unlikely that such effects would result in
humans or other mammals at the levels of exposure expected from the use
of iron salts as pesticides. Other toxicity studies normally required for
reregistration were not necessary to evaluate the risks of the iron salts.
Dietary Exposure
Dietary exposure is not expected to result from use of the iron salts
as pesticides. No food or feed-related uses are registered, and no
tolerances (maximum residue limits) or exemptions from the requirement
of a tolerance are established. Further, the iron salts are generally
recognized as safe (GRAS) by the Food and Drug Administration for use
as a flavoring agent and nutrient supplement in foods (please see 40 CFR
180.2(a)).
Occupational and Residential Exposure
The potential for mixer, loader and applicator exposure exists when
liquid or granular iron salts products are applied to lawns, turf and other
outdoor sites using spreaders, sprinkler cans or by hand. However, these
inorganic salts are of little concern from a toxicity perspective. Any
exposure of mixers, loaders or applicators is considered inconsequential.
Human Risk Assessment
The risks to people from dietary, occupational and residential
exposure to iron salts pesticides are considered negligible. It is general
knowledge that these compounds are of low toxicity. They are
intentionally added to foods as flavoring agents and nutrient supplements,
and they have an inherent function in the metabolic systems of humans and
domestic animals.
Environmental Environmental Fate
Assessment The environmental fate and transport of iron salts is dominated by
three processes: the conversion of Iron (II) to Iron (IE), the formation of
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insoluble oxides and hydroxides that also are well known components of
soils, and the distinct surface chemistry of the iron salts that causes their
adsorption with other soil components, forming larger soil particles.
Use of the iron salts produces iron oxides and hydroxides that are no
different from those normally found in soils, and which give them their
brown and red colors. Although certain bacteria can reduce Iron (ffl) to
the more mobile Iron (II), this is rapidly immobilized.
Therefore, the use of iron salts as herbicides to control moss is not
expected to contribute significantly to the chemistry and fate of the
compounds existing naturally in the environment. No unreasonable effects
are expected from the use of these pesticide products as directed.
Ecological Effects
In dietary acute toxicity studies, iron salts are practically nontoxic to
bird species and are nontoxic or slightly toxic to rats. Iron (II) sulfate
heptahydrate, the most toxic form of the iron salts compounds, is
moderately toxic to aquatic invertebrates and slightly toxic to fish.
No adverse effects to avian, mammalian or aquatic populations are
anticipated from the use of iron salts. Iron is one of the earth's most
abundant elements, and it is immobilized at the pH range of 5-9. Runoff
to aquatic systems is unlikely since the parent compounds convert very
rapidly to less soluble forms in the environment. Furthermore, the
oxidized iron compounds bind tightly to soil under turf.
No adverse effects to endangered species are anticipated from the use
of iron salts.
Additional Data EPA is requiring additional physical chemistry studies as
Required confirmatory data and to complete the generic data base for iron salts.
Product-specific product chemistry studies and revised labeling also are
required for reregistration. These additional studies are being required
through Data Call-Ins issued in conjunction with the iron salts RED.
Product Labeling The labels of all registered iron salts products must comply with
Changes Required EPA's current pesticide labeling requirements. In addition, to protect
surface waters, end-use product labels must bear the following
Environmental Hazards statement:
"Do not apply directly to water, or to areas where surface water is
present or to intertidal areas below the mean high water mark. Do
not contaminate water when disposing of equipment washwater or
rinsate."
Regulatory • The three pesticide active ingredients discussed in the iron salts
Conclusion RED wil1 not result ^ unreasonable adverse effects to human health or the
environment, and all registered products containing these active ingredients
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are eligible for reregistration. These products will be reregistered once the
required generic and product-specific data and revised labeling are received
and accepted by EPA.
• Registered products containing iron salts as well as other active
ingredients will be reregistered once the other active ingredients also are
determined to be eligible for reregistration.
For More EPA is requesting public comments on the Reregistration Eligibility
Information Document (RED) for iron salts 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 or to submit written comments, please contact the
Pesticide Docket, Public Response and Program Resources Branch, Field
Operations Division (H-7506C), Office of Pesticide Programs (OPP), US
EPA, Washington, DC 20460, telephone 703-305-5805.
Following the comment period, the iron salts RED 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 iron salts or about EPA's pesticide
reregistration program, please contact the Special Review and
Reregistration Division (H-7508W), OPP, US EPA, Washington, DC
20460, telephone 703-308-8000. For information about reregistration of
individual iron salts products, please contact Joanne Miller, Product
Manager, Registration Division (H-7505C), OPP, US EPA, Washington,
DC 20460, telephone 703-305-7830.
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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REREGISTRATION ELIGIBILITY DOCUMENT
IRON SALTS
LISTD
CASE 4058
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
WASHINGTON, D.C.
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IRON SALTS REREGISTRATION ELIGIBILITY TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Jim Saulmon Biological Analysis Branch
Ed Brandt Economic Analysis Branch
Steve Jaiboe Biological Analysis Branch
Environmental Fate and Effects Division
Conception Rodriguez Ecological Effects Branch
Sylvia Termes Environmental Fate and Groundwater Branch
Mary Frankenberry Science Analysis and Coordination Staff
Health Effects Division
Jane Smith Chemical Coordination Branch
Pat McLaughlin Toxicology Branch II
Judy Smith Occupational and Residential Exposure Branch
Registration Division
Shyem Mathur Registration Support Branch
Ian Blackwell Registration Support Branch
Jesse Mayes Fungicide-Herbicide Branch
Special Review and Reregistration Division
Barbara Briscoe Accelerated Reregistration Branch
Yvonne Brown Accelerated Reregistration Branch
Policy and Special Projects Staff
Jean Frane Food Safety & Regulator Tracking Section
Office of General Counsel
Alan Carpien
Office of Compliance Monitoring
Phyllis Flaherty FIFRA Policy & Analysis Branch Policy and Grants
Division
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TABLE OF CONTENTS
I. EXECUTIVE SUMMARY 1
H. INTRODUCTION 2
m. CASE OVERVIEW 3
A. Chemical Overview 3
B. Use Profile 4
C. Regulatory History 6
IV. SCIENCE ASSESSMENT OF IRON SALTS 6
A. Physical Chemistry Assessment 6
B. Human Health Assessment 7
C. Environmental Assessment 9
V. RISK MANAGEMENT AND REREGISTRATION DECISION FOR IRON
SALTS 14
A. Determination of Eligibility 14
VI. ELIGIBILITY DECISION 14
A. Eligible and Ineligible Uses 15
VH. ACTIONS REQUIRED BY REGISTRANTS 15
A. Additional Generic Data Requirements 15
B. Product specific data requirements 15
C. Labeling Requirements for Manufacturing-Use and End-Use Products ... 15
VIII. APPENDICES
APPENDIX A - Use Patterns Subject to Reregistration
APPENDIX B - Table of the Generic Data Requirements and Studies Used to Make the
Reregistration Decision
APPENDIX C - Citations Considered to be Part of the Data Base Supporting the
Reregistration of Iron Salts
APPENDIX D - List of Available Related Documents
APPENDIX E - Pesticide Reregistration Handbook
APPENDIX F - Generic Data Call-In
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Attachment A - Chemical Status Sheet
Attachment B - Generic DCI Response Forms (Form A) plus Instructions
Attachment C - Requirements Status and Registrants' Response Forms (Form
B) plus Instructions
Attachment D - List of all Registrant(s) sent this DCI
Attachment E - Cost Share/Data Compensation Forms
APPENDIX G - Product Specific Data Call-In
Attachment A - Chemical Status Sheet
Attachment B - Product Specific DCI Response Forms (Form A) plus Instructions
Attachment C - Requirements Status and Registrants' Response Forms (Form
B) plus Instructions
Attachment D - EPA Grouping of End Use Products for meeting Acute
Toxicology Data Requirements.
Attachment E - EPA Acceptance Criteria
Attachment F - List of all Registrant(s) sent this DCI
Attachment G - Cost Share/Data Compensation Forms
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GLOSSARY OF TERMS AND ABBREVIATIONS
a.i. Active Ingredient
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
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
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
HDT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a substance
that can be expected to cause death in 50% of test animals. It is usually
expressed as the weight of substance per weight or volume of water or feed, e.g.,
mg/1 or ppm.
LD50 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.
Ld,o Lethal Dose-low. Lowest Dose at which lethality occurs
LEL Lowest Effect Level
MP Manufacturing-Use Product
MRID Master Record Identification (number). EPA's system of recording and tracking
studies submitted.
N/A Not Applicable
NPDES National Pollutant Discharge Elimination System
111
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GLOSSARY OF TERMS AND ABBREVIATIONS (cont.)
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
ppm Parts Per Million
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TC Toxic Concentration. The dose at which a substance produces a toxic effect.
IV
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I. EXECUTIVE SUMMARY
The active ingredients covered in this document include iron (III) sulfate, iron (II)
sulfate monohydrate and iron (II) sulfate heptahydrate in the chemical case iron salts.
Products containing these active ingredients are used as herbicides for the control of moss on
ornamental herbaceous plants, lawns, turf, wood shrubs and vines. This Reregistration
Eligibility Document (RED) addresses the eligibility for reregistration of products containing
these active ingredients for the above mentioned use sites only.
The U.S. EPA (hereafter referred to as "the Agency") has determined that the uses of
these three active ingredients, as they are currently registered, will not cause unreasonable
risk to humans or the environment. Therefore, products containing the iron salts are eligible
for reregistration. The Agency is requiring additional studies on physical chemistry as
confirmatory data and for purposes of labeling to complete the generic data base.
Before reregistering the products containing these iron salts, the Agency is requiring
that product specific data and revised labeling be submitted within eight months of the
issuance of this document. These data include product chemistry and acute toxicity testing.
After reviewing these data and any revised labels and finding them acceptable, the Agency
will reregister a product based on whether or not that product meets the requirements in
Section 3(c)(5) of FIFRA.
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H. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregistration of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregistration process to
be completed in nine years. There are five phases to the reregistration process. The first
four phases of the process focus on identification of data requirements to support the
reregistration of an active ingredient and the generation and submission of data to fulfill the
requirements. The fifth phase is a review by the U.S. Environmental Protection Agency
(referred to as "the Agency") of all data submitted to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for registration" before
calling in data on products and either reregistering products or taking "other appropriate
regulatory action." Thus, reregistration involves a thorough review of the scientific data
base underlying a pesticide's registration. The purpose of the Agency's review is to reassess
the potential hazards arising from the currently registered uses of the pesticide; to determine
the need for additional data on health and environmental effects; and to determine whether
the pesticide meets the "no unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility
of the registered uses of iron (III) sulfate, iron (II) sulfate monohydrate, and iron (II) sulfate
heptahydrate. The document consists of six sections. Section I is the introduction. Section
II describes these iron salts, their uses, data requirements and regulatory history. Section in
discusses the human health and environmental assessment based on the data available to the
Agency. Section IV presents the reregistration decision for iron salts. Section V discusses
the reregistration requirements for iron salts. Finally, Section VI is the Appendices which
support this Reregistration Eligibility Document. Additional details concerning the Agency's
review of applicable data are available on request.1
1 EPA's reviews of data on the set of registered uses considered for EPA's analysis may be
requested from the Public Response and Program Resources Branch, Field Operations Division
(H7506C), Office of Pesticide Programs, EPA, Washington, DC 20460.
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CASE OVERVIEW
A. Chemical Overview
The following active ingredients are covered by this Reregistration Eligibility
Document:
1. Chemical Name: Iron (III) sulfate
o CAS Registry Number: 10028-22-5
o Office of Pesticide Programs Chemical Code: 34902
o Empirical Formula:
2. Chemical Name: Iron (II) sulfate monohydrate
o CAS Registry Number: 17375-41-6
o Office of Pesticide Programs Chemical Code: 50507
o Empirical Formula: FeSO4H2O
3. Chemical Name: Iron (II) sulfate heptahydrate
o CAS Registry Number: 7782-63-0
o Office of Pesticide Programs Chemical Code: 50502
o Empirical Formula: FeSO4-7H2O
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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 iron (HI)
sulfate, iron (II) sulfate monohydrate and iron (n) sulfate heptahydrate is in Appendix
A.
1. For Iron (HI) sulfate:
Type of Pesticide: Herbicide
Use Sites: Ornamental lawns and turf—terrestrial non-food, outdoor
residential
Target Pest: Mosses
Formulation Types Registered:
Soluble concentrate/liquid
Method and Rates
of Application: Equipment - Sprinkler can and hose-end sprayer.
Method and Rate - Soluble concentrate/liquid (1 qt./500
sq.ft.)
'iming - When needed.
2. For Iron (II) sulfate monohydrate:
Type of Pesticide: Herbicide
Use Sites: Ornamental herbaceous plants, ornamental lawns and
turf, ornamental woody shrubs and vines-terrestrial non-
food, outdoor residential.
Target Pests: Mosses
Formulation Types Registered:
Granular
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Method and Rates of Application:
Equipment - By hand and spreader
Method and Rate - Ground; broadcast; sprinkle; spot
treatment
Ornamental Hervaceous Plants
35 Ib iron/A.
Ornamental Lawns
35 Ib kon/A.
Ornamental Woody Srubs and Vines
35 Ib iron/A.
Timing - When needed; Fall; Winter; Spring; Early
Spring.
3. For Iron (D) sulfate heptahydrate:
Type of Pesticide: Herbicide
Use Sites: Ornamental lawns and turf—terrestrial non-food, Outdoor
Residential
Target Pests: Mosses
Formulation Types Registered:
Soluble concentrate/liquid, Soluble concentrate/solid,
Granular
Method and Rates of Application:
Equipment
Spreader; sprinkler can; by hand; sprayer
Method and Rate Spray
Ornamental lawns and turf
57 Ib iron/A.
Timing
When needed.
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C. Regulatory History
Pesticidal products containing iron salts were first registered in the United States
in 1962. In addition to active products which are currently approved for use on
ornamental herbaceous plants, ornamental perennial, ornamental lawns, ornamental
woody shrubs and ornamental turfs, iron salts were previously registered for
household or domestic dwellings (indoor) and commercial institutional and industrial
areas/premises. The current uses include moss control in areas where moss growth is
profuse due to high precipitation rates, primarily in the Northwest. Currently there
are 14 registered products with these ingredients; 1 with iron (III) sulfate, 9 with iron
(II) sulfate monohydrate, and 3 with iron (II) sulfate heptahydrate.
The major use of iron salts in the United States is non-pesticidal, as a fertilizer
micronutrient. Other uses include as an electrolyte in dry cell batteries, as an animal
feed additive, as a galvanizer, as an emulsion-breaker, as a coagulant, in water
purification and sewage treatment, and as mordant in textile dyeing and calico
printing.
Iron II ammonium sulfate is currently not being supported and is not covered
in this Reregistration Eligibility Document.
IV. SCIENCE ASSESSMENT OF IRON SALTS
The Agency has conducted a thorough review of the scientific data base for iron salts
for the purposes of determining the reregistration eligibility of these pesticides. These
findings are summarized below. The complete references cited in the text are in the
Bibliography (Appendix C).
A. Physical Chemistry Assessment
Iron (III) sulfate is a grayish-white powder, or rhombic or rhombohedral
crystals. The commercial product usually contains about 20% water and is yellowish
in color. It is slowly soluble in water, rapidly soluble in the presence of a trace of
iron (III) sulfate, sparingly soluble in alcohol, practically insoluble in acetone and
ethyl acetate.
Iron (II) sulfate monohydrate is white to a yellow crystal powder. It is soluble
in water and forms a monohydrate at 65°C.
Iron (II) sulfate heptahydrate may appear as blue green crystals or granules
and is usually odorless. It is efflorescent in dry air and oxidizes in moist air forming
a brown coating of basic iron (III) sulfate. The tetrahydrate is formed at 56.6°C.
iron (II) sulfate heptahydrate is soluble in water and practically insoluble in alcohol.
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B. Human Health Assessment
1. Toxicology Assessment
The toxicological data base on iron (III) sulfate, iron (n) sulfate
monohydrate, and iron (II) sulfate heptahydrate is adequate and will support
reregistration eligibility.
a. Acute and Subchronic Toxicity
ACUTE TQXICITY VALUES
TEST
Iron III Sulfate
Oral LD50~rat
Inhalation LC50--rat
Dermal LD50~rabbit
Eye Irritation
Dermal Irritation
Dermal Sensitization
RESULT
1487 - 2102 mg/kg
>1.10mg/L
> 2000 mg/kg
corrosive
corrosive
negative
TOXICITY
CATEGORY
m
III
HI
I
IV
-
Iron (III) sulfate, in an acute oral study in rats, had an LD50 of
1487 mg/kg in females and 2102 mg/kg in males. An acute dermal
toxicity test in rabbits with Iron (III) sulfate found an LD50 greater than
2000 mg/kg. An acute inhalation toxicity study in rats using iron (III)
sulfate determined the LC50 to be greater than 1.10 mg/L.
Iron (II) sulfate heptahydrate, in an acute oral study in rats,
showed an LD,0 of 1389 mg/kg and an acute oral study in rabbits
showed an LDto of 2778 mg/kg(4). The LDso determined for this
compound in mice was 1520 mg/kg(4). A sensitization study using
guinea pigs with iron (II) sulfate monohydrate and iron (III) sulfate
found no indication of contact sensitization by this compound.
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b. Mutagenicity
A mutation study in E.. coli reported positive results at 30
umol/L(4). With due regard for the continuing exposure that human
beings have had to the iron and sulfate components of these chemicals
over many generations, it is considered unlikely that this reported result
in microorganisms has any bearing on probable effects in humans or
other mammals at the levels expected from use of these compounds as
pesticides.
c. Metabolism
Iron sulfates are normal constituents of the diet and are
metabolized and utilized by the body.
d. Other Toxicological Consideration
The lexicological data on iron sulfates within the Agency and in
the literature are adequate for assessing risk to humans. Not all of the
toxicity data usually required for pesticide registration or reregistration
are necessary for the present uses of iron sulfates. There are some
unusual factors in this case which indicate that specific studies to fulfill
the usual data requirements are not necessary to regulate these
substances as pesticides. Iron sulfates are normally present in the
environment. They may be present in foods naturally and as added
ingredients. There is no reason to expect that pesticide usage in
accordance with the product label or labeling accompanying the product
will constitute any hazard beyond that from ordinary exposure.
2. Exposure Assessment
a. Dietary
Dietary exposure to iron (III) sulfate, iron (II) sulfate
heptahydrate, and iron (II) sulfate monohydrate is not expected to occur
from pesticidal use. There are no active products involving pesticidal
uses on food or animal feed. Therefore, there are no tolerances or
exemptions from the requirements of tolerances established for iron
salts. Since there are no lexicological endpoints of concern and no
food uses, no risk assessment was performed for dietary exposure.
Iron (II) sulfate is generally recognized as safe as noted in 40 CFR
180.2(a). The Food and Drug Administration has affirmed that iron
(III) sulfate and iron (II) sulfate (hepta and monohydrate) are generally
recognized as safe (GRAS) for use in food as flavoring agents and
nutrient supplements, respectively, with no limitations other than
8
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current good manufacturing practice.
b. Occupational and Residential
As stated in Appendix A, iron (III) sulfate and iron (n) sulfate
hepta- and monohydrate are applied to turf and ornamental lawns using
drop and broadcast spreaders, sprinkler cans, and by hand. These
inorganic salts are formulated as a granular and soluble concentrate
(liquid and solid). They are used as a herbicide to control moss on
residential lawns and ornamental turf. The potential for
mixer/loader/applicator exposure exists; however, these inorganic salts
are of little concern from a toxicity perspective. Any
mixer/loader/applicator exposure to these inorganic salts is considered
inconsequential and no additional exposure data are required for
reregistration eligibility.
3. Risk Assessment
The human risks from both dietary and occupational exposures are
considered to be negligible. The general knowledge of iron (III) sulfate and
iron (II) sulfate hepta- and monohydrate indicate low toxicities associated with
these compounds. They are used by humans as food flavoring agents and food
nutrient supplements, and have inherent function in the metabolic pathways of
humans and domestic animals. No additional hazard or exposure data are
required for reregistration eligibility.
C. Environmental Assessment
1. Environmental Fate
The Agency is relying on data available in the scientific literature to
assess the environmental fate and transport of iron salts as used in pesticidal
compounds. No environmental fate data were submitted by registrants.
a. Environmental Chemistry and Fate
Iron is the fourth most abundant element and the second most
abundant metal in the Earth's crystal rocks. Iron occurs in a wide
variety of minerals among them the oxides hematite (a-Fe^) and
magnetite (F%O4), the "hydrated oxide oxide limonite"
(~"2Fe2(V3H2C)"), the oxyhydroxide geothite and its polymorph
lepidocrocite (a-FeOOH and 7-FeOOH, respectively), ferrihydrite
("5Fe2O3'9H2O"), in carbonates such as siderite (FeCO3), in sulfides
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(pyrite and marcasite, FeS2; chalcopyrite, CuFeS2, etc.), phosphates
(for example vivianite) and incomplex silicates. (1,2) Weathering (that
is, "the group of processes such as the chemical action of air,
rainwater, plants and bacterial, and the mechanical action of changes of
temperature whereby rocks on exposure to weather change in character,
decay and finally crumble into soil")(3) has considerably influenced the
distribution of iron in the earth. The oxides and hydroxide minerals of
iron are strong pigments and are responsible, for the most part, for the
brown and red colors of soils. The presence of hematite and goethite
in soils (usually associated with gibsite and kaolinite) is indicative of an
advanced stage of weathering.(4)
The oxidation of ferrous iron to ferric iron (from here on
referred to as Fe(II) and Fe(III), respectively) is a very important
aspect of the chemistry of iron salts in the environment. The
oxidation is dependent on the pH and the redox potential of the medium
(water; soil) and the nature of the ligands that may be complexed to
Fe(II). But in general, Fe(II) is more prevalent only in very acid media
of very low oxygen content, rather than in more basic media of normal-
to-high oxygen content, the latter being the most commonly
encountered condition. The speciation and subsequent fate and
transport of Fe(II) and Fe(III) in the environment is, therefore,
determined by the pH and redox potential of the media and by the
nature of the ligands to which they complex. (1,2,5,6)
Under normal environmental conditions (pH 5 to 9; aerobic
environments), the highly soluble Fe(II) salts will be rapidly oxidized to
Fe(III), but this oxidation is accompanied by the formation of less
soluble oxide and hydroxide. (7) The precipitation of Fe(III)
oxides/oxyhydroxides from oxidation of Fe(II) salts or from Fe(III)
salts occurs in a stepwise manner, which involves (a) formation of low-
molecular weight species of poor crystalline ordering; (b) formation of
red cationic polymers; (c) aging of the polymers, with eventual
conversion to better defined oxide phases; (d) precipitation of
oxide/oxyhydroxide phases of well defined crystallographic
characteristics. (5) The rate of formation and the onset of the polymeric
species are known to be strongly influenced by the nature of the
counter anion of the salts. (5) In the case of salts of the divalent sulfate
counter anion, precipitation occurs at lower pHs than with salts of
monovalent counter anions (for example, nitrate, chloride). Like in
laboratory experiments, the use of Fe(II) and Fe(II) sulfates in a
terrestrial environment leads to the formation of insoluble
oxide/oxyhydroxide species.(7)
The oxide/oxyhydroxide species that form from the use of Fe
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(II) or Fe(III) sulfates are the same oxide/oxyhydroxide species
(principally ferrihydrite, goethite, lepidocrocite, and hematite) that are
present in soils as a result of weathering.(4,7) Thermodynamic and
kinetic factors influence the predominance of certain species over
other. (7) Soil temperature, soil moisture and soil pH are significant
environmental factors that control the distribution of these species.(8)
For example, it has been observed that goethite is commonly the sole
iron oxide in cool and temperate zones, but in the majority of tropical
or subtropical regions hematite is the predominant oxide, although it is
rarely free of goethite. (8) The lepidocrocite-goethite association in
soils is less understood. The predominance of lepidocrocite in a soil
has been attributed to the prevalence of conditions favoring reduction of
Fe(III) to Fe(II) followed by movement of Fe(H) to better aerated sites,
where oxidation to Fe(III) and precipitation of lepidocrocite occurs. (9)
Ferrihydrite may be considered as a young iron oxide of low order of
crystallinity. Subsequent transformation of ferrihydrite into other
oxides of iron is dominated by the environmental conditions.(lO)
One of the most important properties of iron oxides/
oxydroxides (naturally occurring or formed by precipitation from iron
salts) is their very active surface chemistry.(11) The surfaces of iron
oxides and hydroxides acquire a pH-dependent charge, which controls
the adsorption of a wide range of chemical species. Anions (such as
molybdate, sulfate, arsenate, silicate, phosphate, and organic anions) as
well as metal cations are known to chemisorb onto iron oxides and
oxyhydroxide surfaces.(6,11,12,13) In the environment, iron
oxides/oxyhydroxides are known to serve as a sink for metals such as
copper, lead, zinc, cadmium, cobalt, nickel and manganese.(11)
Adsorption of phosphate by iron oxides/ oxyhydroxides is an important
process in soils; together with aluminum, calcium, magnesium,
potassium, and manganese (II), they control the solubility of phosphates
in soils.(14) Soils rich in iron oxide/oxyhydroxides (for example,
oxisols) are known to fix large amounts of phosphate fertilizers.(15)
Humic substances and other organic materials are known to adsorb onto
oxide/ oxyhydroxide particulates. The surface properties of oxides/
oxyhydroxides determine the degree of aggregation/cementation of soil
and mineral particulates, where the iron oxides/hydroxides are believed
to behave as binding agents for the particulates.(16,17)
Some microorganisms (mainly anaerobic bacteria) are known to
reduce Fe(III) oxide/oxyhydroxides to Fe(II),(18) with the subsequent
re-mobilization of iron as more soluble Fe(II) species. This occurs
predominantly in oxygen deficient soils, such as poorly drained soils.
However, Fe(II) can be immobilized again by precipitation (for
example, as siderite, vivianite or a sulfide) or by re-oxidation.
11
-------
Although acid mine drainage could potentially stabilize Fe(II) species,
the effect of bacterially mediated oxidation by organisms such as
Thiobacillus ferrooxidans results in formation of insoluble Fe(III)
oxides/oxyhydroxides.(19) Free, mobile Fe(II) or Fe(III) cations are
not expected to persist under normal environmental conditions when the
Fe(II) and (III) sulfates are used as herbicides to control moss in
outdoor residential sites or as foliar spray fertilizers to correct iron
chlorosis. The chemical species that are produced from the reactions of
Fe(II) and Fe(III) sulfates under environmental conditions are not
expected to differ from those iron minerals commonly encountered in
soils. No unreasonable environmental effects are expected from the use
of these salts as directed.
b. Environmental Fate Assessment
In summary, the fate and transport of Fe(II) and Fe(III) salts in
the environment is dominated by three major processes: (1) the pH-
redox potential dependent oxidation of Fe(II) to Fe(III); (2) the
formation of insoluble oxides and hydroxides that are also well known
components of soils; and (3) the distinct surface chemistry of the oxides
and hydroxides of iron that control the adsorption of anions, cations
and organic material or the adsorption of iron species onto the surfaces
of mineral and organic components of soils, contributing to the
aggregation of soil particles into larger units.
In terrestrial environments, the use of Fe(II) and Fe(HI) sulfates
is expected to produce iron oxides and hydroxides that are no different
from the iron oxides and hydroxides found in soils and which are
responsible for their brown and red colors. Although certain bacteria
can reduce Fe(III) to the more mobile Fe(II), reoxidation and re-
precipitation to Fe(III) oxides and hydroxides will rapidly immobilize
any free Fe(II) that may form.
Therefore, the use of iron salts as herbicides to control moss in
residential outdoor ornamentals (herbaceous and woody plants; lawns
and turf) or as fertilizers to correct chlorosis in plants is not expected to
contribute significantly to the chemistry and fate of the compounds
existing naturally in the environment.
2. Ecological Effects
Ecological effects data presented here are derived from the six basic
tests typically required by the Agency for assessing ecological hazard.
12
-------
a. Ecological Effects Data
(1) Non-Target Terrestrial
Iron (II) sulfate heptahydrate and iron (n) sulfate
monohydrate are classified as practically non-toxic to the
bobwhite quail on an acute oral basis. The LDJO was 2250
mg/kg for iron (II) sulfate heptahydrate and for sulfate
monohydrate the LD50 is >2150 mg/kg. On a dietary basis,
both active ingredients are classified as practically non-toxic for
the bobwhite quail and the mallard duck. The LCX for iron (II)
sulfate heptahydrate was >5620 ppm for both the bobwhite
quail and the mallard duck. For iron (n) sulfate monohydrate,
the LC50 was >5000 ppm for both the bobwhite quail and the
mallard duck.
Iron (II) sulfate heptahydrate was classified as practically
non-toxic to rats on an acute oral basis. The LD50 was >5
g/kg. Iron (III) sulfate was classified as non-toxic to male rats
on an acute oral basis. The LDJO was 2,102 mg/kg. The LD50
for female rats was 1,487 mg/kg which classifies iron (III)
sulfate as slightly toxic on an acute oral basis.
(2) Non-Target Aquatic
Iron (II) sulfate heptahydrate is the most toxic form of
the iron salts compounds. The EC50 of 7.1 ppm for Daphnia
pulex and LC50 of 20.8 ppm for rainbow trout classify iron salts
as moderately toxic to aquatic invertebrates and slightly toxic to
fish.
b. Ecological Effects Risk Assessment
(1) Non-Endangered Species
No adverse effects to avian, mammalian or aquatic
populations are anticipated from the use of iron salts. Iron is
one of the most abundant elements and will be immobilized at
the environmentally important pH range of 5-9. There is very
little likelihood for runoff to aquatic systems since the parent
compounds convert very rapidly to less soluble forms in the
environment. Furthermore these oxidized iron compounds bind
tightly to soil under turf.
13
-------
(2) Endangered Species
No adverse effects to terrestrial or aquatic endangered
species are anticipated from the use of iron salts.
V. RISK MANAGEMENT AND REREGISTRATION DECISION FOR IRON SALTS
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after
submission of relevant data concerning an active ingredient, whether products
containing the active ingredient are eligible for reregistration. The Agency has
completed its review of data from the open literature and generic data submitted by
registrants, and has determined that the data are sufficient to support reregistration of
products containing iron salts. Appendix B identifies the generic data that the Agency
reviewed as part of its determination of reregistration eligibility of iron salts, and lists
the submitted studies that the Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to
assess registered uses of iron salts and to determine that these uses can be used
without resulting in unreasonable adverse effects to humans and the environment.
The Agency therefore finds that products containing iron salts as an active ingredient
are eligible for reregistration. The reregistration of particular products is addressed in
Section VI of this document.
The Agency made its reregistration eligibility determination based upon the
target data base required for reregistration, the current guidelines for conducting
acceptable studies to generate such data and the data identified in Appendix B.
Although the Agency has found that current products containing iron salts are eligible
for reregistration, it should be understood that the Agency may take appropriate
regulatory action, and/or require the submission of additional data to support the
registration of products containing iron salts, if new information comes to the
Agency's attention or if the data requirements for reregistration (or the guidelines for
generating such data) change.
The following is a summary of the regulatory positions and rationales for iron
salts. Where labeling revisions are imposed, specific language is set forth in Section
V of this document.
VI. ELIGIBILITY DECISION
The Agency has sufficient information on the human health effects of iron salts and
on its potential for causing effects in fish and wildlife and the environment when used to
control moss growth in outdoor residential areas. The Agency concludes that products
14
-------
containing iron salts for these uses are eligible for reregistration. Only certain generic
physical chemistry data studies on iron salts are needed as confirmatory information. The
Agency has determined that iron salt containing products, labeled and used as specified in
this Reregistration Eligibility Document, will not pose unreasonable risks or adverse effects
to humans or the environment.
A. Eligible and Ineligible Uses
The Agency has determined that all currently registered uses are eligible for
reregistration at this time.
VH. ACTIONS REQUIRED BY REGISTRANTS
A. Additional Generic Data Requirements
The generic data base supporting the reregistration of iron salt-containing
products has been reviewed and determined to be substantially complete. Although
some of the generic product chemistry data requirements are acceptable, additional
data are required as confirmatory. The required confirmatory data is based on the
fact that not all companies complied with all product chemistry guideline
requirements. These are part of the generic Data Call-In requirements in Appendix
F.
B. Product specific data requirements
1. Additional Product-Specific Data Requirements
Based on the reviews of the generic data for iron salts, the products
containing iron salts are eligible for reregistration. 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 G; Attachment E) and if not,
commit to conduct new studies. If the 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.
C. Labeling Requirements for Manufacturing-Use and End-Use Products
All labels or labeling of end-use products and Manufacturing-Use
Products must contain the following label statements:
15
-------
1. Manufacturing-Use Products
In addition to the above requirements under 40 CFR §156.10 and the
Pesticide Registration Handbook, for end-use products, labels and labeling of
all manufacturing-use products must contain the following Environmental
Hazards statement:
"Do not discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans or public waters unless this product is specifically
identified and addressed in an NPDES permit. Do not discharge this product
into sewer systems without previously notifying the sewage treatment plant
authority. For guidance, contact your State Water Board or Regional Office of
U.S. EPA."
2. 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. Labels must
consistently reflect any potential eye and skin hazard. Please follow the
instructions in the Pesticide Reregistration Handbook with respect to labels and
labeling.
16
-------
IV. APPENDICES
-------
APPENDIX A - Case 4058, (Iron Salts] Chemical 034902 [Ferric sulfate]
Mil ApptcMlon Typ.. Application Timing. App»o«lon EqdplMiil
Fom
USES ELIGIBLE FOR REREGISTRATION
Miravnufn AppNocoon
R.I.
MiWmum
ApptcMlon DM*
M.K.*
App.
M.nf
App..*
M».n>i«
B0tww^vi App<> ^
M».n«.
(O^rt
^ . > * j
nMnnovvo
Entry
hmvri
I0^»
0~g>.pNo
UirAMkm
Mto>Md
O-ID.^J
UMUmHMkm
NONFOOD/NONFEED USES
Ornamantal Lawns and Turf Use Groups: Terrestrial Non-Food Crop and Outdoor Residential
Spray, When needed. Hose-end Sprayer
Spray, When needed. Sprinkler can
sen.
SC/L
na
na
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
As needed
As needed
not spec
not spec
Abbreviations used
Header:max=maximum; min=minimum; apps= applications; not spec = not specified; na=not applicable
Form : SC/L=soluble concentrate/liquid
-------
APPENDIX A- Case 4058, [Iron Salts] Chemical 050502 [Ferrous sulfate heptahydratej
SITE A«*orton Typ.. Aw4c.Ho, Tiling. A***** EqdfxnM
Fetm
USES ELIGIBLE FOR REREGISTRATION
MMnum AmfieBtlM
R.I.
Mninuii
AtVfeMkm Brt.
M.n/
AW-.
M«.«
A«».«
ftkuhu
Wn. hMvri
Itotw-nAw.. •
Mntbu
(dry.)
fexifaurf
6*v
* - -•
•wvvw
<0«y)
OngntNo
UnkMkm
Alo~d
B-loxcl
UMUnAMicra
NONFOOD/NONFEED USES
Ornamental Lawns and Turf Use Groups: Terrestrial Non-Food Crop and Outdoor Residential
Sprinkle, When needed. Sprinkle can
Spray, When needed, Sprayer
Broadcast, When needed. Spreader
Broadcast, When needed, Spreader
Sprinkle, When needed, Sprinkler can
Broadcast, When needed. By hand
SC/S
SC/S
G
SC/S
SC/L
SC/S
na
na
na
na
na
na
52.272 Ib
Iron per acre
52.272 Ib
Iron per acre
1 3.9392 Ib
Iron per acre
41 .81 76 Ib
Iron per acre
Dose cannot
be calculated
41. 8176 Ib
Iron per acre
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
Abbreviations used
Header: max=maximum; min- minimum; apps«= applications; not spec=not specified; na = not applicable
Form : G= granular; SC/L=soluble concentrate/liquid; SC/S = soluble concentrate/solid
-------
APPENDIX A- Case 4058, [Iron Salts] Chemical 050507 [Ferrous sulfate monohydratel
Form
USES ELIGIBLE FOR REREGISTRATION
R.I.
Modnuin
Af|««tion RM>
Mm*
*«-
M.». •
A*-.*
Mra.R>u
Min.huml
BMw«n AM.. •
MU.D.I.
|iHe
IMmfam
A»»w«d
DMhnMd
ItolMMton.
NONFOOD/NONFEED USES
Ornamental Herbaceous Plants Use Groups: Terrestrial Non-Food Crop and Outdoor Residential
Broadcast, Fall, Spreader
Broadcast, Fall, By hand
Sprinkle, When needed. Not on Label
G
G
G
na
na
na
34.848 Ib
Iron per acre
34.848 Ib
Iron
per acre
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
not spec
not spec
not spec
not spec
not spec
Ornamental Lawns and Turf Use Groups: Terrestrial Non-Food Crop and Outdoor Residential
Broadcast, Early Spring, Not on Label
Broadcast, Early Spring, Spreader
Spot treatment, Fall, Not on Label
Broadcast, Spring, Spreader
Broadcast, When needed. Spreader
Broadcast, Winter, Spreader
Spot treatment, Early Spring, Not on Label
Broadcast, Fall, By hand
Broadcast, Fall, Not on Label
G
G
G
G
G
G
G
G
G
na
na
na
na
na
na
na
na
na
Dose cannot
be calculated
27.8784 Ib
Iron per acre
Dose cannot
be calculated
19.193616
Iron per acre
36.3 Ib Iron
per acre
10.0052 Ib
Iron per acre
Dose cannot
be calculated
34.848 Ib
Iron
per acre
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
-------
APPENDIX A- Case 4058, [Iron Salts] Chemical 050507 [Ferrous sulfate monohydrate]
Broadcast, Fall, Spreader
Form
G
DM*
na
•Minim
Afl*crtonB«.
34.848 Ib
Iron
per acre
Mm./
*«-.
not
spec
Mn.*
*»•.•
Mutate
not
spec
AMI. ntfflfvv
BMomnAiv*.*
M.«.nm
(0-V«)
not spec
*fc - • •
FMJWGVW
&MV
hMvri
ID»*»
not spec
OaftfH,
IMmtom
Mwmd
Dl»«[imd
UnlMMlfam
Ornamental Woody Shrubs and Vines Use Groups: Terrestrial Non-Food Crop and Outdoor Residential
Broadcast, Fall, Spreader
Broadcast, Fall, By hand
Sprinkle, When needed, Not on Label
G
G
G
na
na
na
34.848 Ib
Iron per acre
34.848 Ib
Iron
per acre
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
not spec
not spec
not spec
not spec
not spec
Abbreviations used
Header: max = maximum; min=minimum; apps=applications; not spec = not specified; na=not applicable
Form : G= granular
-------
APPENDIX B
Table of The Generic Data Requirements and
Studies Used to Make the Reregistration Decision
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for the
iron salts covered by this Reregistration Eligibility document. It contains generic data
requirements that apply to iron salts in all products, including data requirements for which a
"typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in which
they appear in 40 CFR Part 158. the reference numbers accompanying each test refer to the test
protocols set in the Pesticide assessment Guidelines, which are available from the National
Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical.
O Indoor residential
3. Bibliographic citation (Column 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.
-------
IRON III SULFATE
GUIDELINE GUIDELINE NAME
§158.120 Product Chemistry
USE BIBLIOGRAPHIC
SITES CITATION
61-1
61-2(a)
61-2(b)
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-10
63-12
63-13
Chemical Identity
Beginning Materials and Manufacturing Process
Formulation of Impurities
Preliminary Analysis
Certification of Limits
Analytical Methods
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Dissociation Constant
pH
Storage Stability
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
41764501, 41764502
41764501, 41764502
41764501, 41764502
41764501, 41764502
41764501, 41764502
41764501, 41764502
DATA GAP
DATA GAP
DATA GAP
DATA GAP
DATA GAP
DATA GAP
DATA GAP
DATA GAP
DATA GAP
DATA GAP
-------
IRON III SULFATE
GUIDELINE GUIDELINE NAME
§158.130 Environmental Fate
USE BIBLIOGRAPHIC
SITES CITATION
All environmental fate data requirements have been waived.
§158.135 Toxicology
81-1
81-2
81-3
81-4
81-5
81-6
§158.145
71-l(a)
71-2(a)
71-2(b)
72-l(a)
72-l(c)
72-2(a)
Acute oral tox. rat
Acute dermal tox. rabbit
Acute inhal. tox rat
Primary eye irritation-rabbit
Primary dermal irritation
Dermal sensitization/guinea pig
Ecological Effects
Acute Avian Oral Toxicity -Quail/Duck
Avian Dietary Toxicity -Quail/Duck
Acute avian diet, duck
Freshwater Fish Toxicity -Bluegill
Fish toxicity rainbow trout
Freshwater Invertebrate Toxicity
All
All
All
All
All
All
All
All
All
All
All
All
42170701
42171702
42171703
41758701
41758702
41758703
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
-------
IRON II SULFATE MONOHYDRATE
GUIDELINE GUIDELINE NAME
§158.120 Product Chemistry
USE BIBLIOGRAPHIC
SITES CITATION
61-1
61-2(a)
61-2(b)
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-10
63-12
63-13
Chemical Identity
Beginning Materials and Manufacturing Process
Formulation of Impurities
Preliminary Analysis
Certification of Limits
Analytical Methods
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Dissociation Constant
pH
Storage Stability
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
142309
142309
142309
142309
142309
142309
142309
142309
142309
142309
142309
142309
142309
142309
142309
142309
-------
IRON II SULFATE MONOHYDRATE
GUIDELINE GUIDELINE NAME
§158.130 Environmental Fate
USE BIBLIOGRAPHIC
SITES CITATION
All environmental fate data requirements have been waived.
§158.135
81-1
81-2
81-3
81-4
81-5
81-6
§158.145
71-l(a)
71-2(a)
71-2(b)
72-l(a)
72-l(c)
72-2(a)
Toxicology
Acute oral tox. rat
Acute dermal tox. rabbit
Acute inhal. tox rat
Primary eye irratibn-rabbit
Primary dermal irritation
Dermal sensitization/Guinea pigs
Ecological Effects
Acute Avian Oral Toxicity -Quail/Duck
Avian Dietary Toxicity -Quail/Duck
Acute avian diet, duck
Freshwater Fish Toxicity -Bluegill
Fish toxicity rainbow trout
Freshwater Invertebrate Toxicity
All
All
All
All
All
All
All
All
All
All
All
All
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
41763701
40091902
40091903
40091904
40091905
40091906
40091907
-------
IRON II HEPTAHYDRATE
GUIDELINE GUIDELINE NAME USE BIBLIOGRAPHIC
SITES CITATION
§158.120 Product Chemistry
61-1
61-2(a)
61-2(b)
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-10
63-12
63-13
Chemical Identity
Beginning Materials and Manufacturing Process
Formulation of Impurities
Preliminary Analysis
Certification of Limits
Analytical Methods
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Dissociation Constant
pH
Storage Stability
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
i
i
i
i
i
i
i
i
i
i
i
i
i
i
i
i
1 Public literature and information was provided to the Agency as part of the reregistration process. The public literature is
identified the bibliography.
-------
IRON II HEPTAHYDRATE
GUIDELINE GUIDELINE NAME
§158.130 Environmental Fate
USE BIBLIOGRAPHIC
SITES CITATION
All environmental fate data requirements have been waived.
§158.135
81-1
81-2
81-3
81-4
81-5
81-6
§158.145
71-l(a)
71-2(a)
71-2(b)
72-l(a)
72-l(c)
72-2(a)
Toxicology
Acute oral tox. rat
Acute dermal tox. rabbit
Acute Inhalation-Rat
Primary eye irration-rabbit
Primary dermal irritation
Dermal sensitization/Guinea pigs
Ecological Effects
Acute avian oral quail/duck
Acute avian diet, quail
Acute avian diet, duck
Fish toxicity bluegill
Fish toxicity rainbow trout
Invertebrate toxicity
All
All
All
All
All
All
All
All
All
All
All
All
WAIVED
WAIVED
137725
137726
137726
WAIVED
40142201
40142202
40142203
40142204
40142205
40142206
-------
APPENDIX C
IRON SALTS BIBLIOGRAPHY
Citations Considered to be Part of the Data Base
Supporting the Reregistration of Iron Salts
-------
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 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.
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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.
-------
REFERENCES
1. Cotton, F.A. and Wilkinson, G. Advanced Inorganic Chemistry. Fifth Edition.
John Wiley and Sons, New York, 1988.
2. Greenwood, N.N. and Earnshaw, A. Chemistry of the Elements. Pergaman
Press, Oxford, UK, 1984.
3. A Dictionary of Mining. Mineral, and Related Terms, US Department of the
Interior, Bureau of Mines, 1968.
4. Schulze, D.G. "An Introduction to Soil Mineralogy" in Minerals in Soil
Environments. Second Edition edited by J.B. Dixon and S.B. Weed. Soil Science
Society of America, Madison, WI, 1989, p.5.
5. Flynn, C.M., Jr. "Hydrolysis of Inorganic Iron (HI) Salts", Chemical Reviews.
vol. 84, 1984, pp. 31-41.
6. Stumm, W. and Morgan, J.J. Aquatic Chemistry- An Introduction Emphasizing
Chemical Equilibria in Natural Waters. Second Edition, John Wiley and Sons,
New York, 1981.
7. Schwertmann, U and Taylor, R.M. "Iron Oxides" in Minerals in Soil
Environments. Second Edition edited by J.B. Dixon and S.B. Weed. Soil Science
Society of America, Madison, WI, 1989. pp 379-438.
8. Reference 7, p. 398.
9. Reference 7, p. 403.
10. Reference 7, p. 405.
11. Reference 7, p. 407-418.
12. Smith, R.S. and Akhtar. "Cationic Flotation of Oxides and Silicates" in Flotation.
A.M. Gaudin Memorial Volume. M.C. Fuerstenau, Editor. Volume I, 1976.
Published by the Society of Mining Engineering, AIME, New York, pp 87-179.
13. Fuerstenau, M.C. and Palmer, B.R. "Anionic Flotation of Oxides and Silicates"
in Flotation. A.M. Gaudin Memorial Volume. M.C. Fuerstenau, Editor, Volume
I, 1976, pp. 146-196. Published by the Society of Mining Engineering, AIME,
New York.
14. Lindsay, W.L. Chemical Equilibria in Soils. John Wiley and Sons, New York,
pp. 177-180.
-------
15. Reference 7. p. 415.
16. Reference 7. p. 416-418.
17. Healey, T.W. "Principles of Dispersion and Aggregation of Mineral Fines", in
Beneficiation of Mineral Fines, edited by P. Scnmasnndaran and N. Arbiter,
Society of Mining Engineering, AIME, 1979, pp 12-161 to 12-178.
18. Reference 7, p. 419.
19. Karasthannasis, A.D., Evangelou, V.P. and Thompson, Y.L. "Aluminum and
Iron Equilibria in Soil Solutions and Surface Waters of Acid Mine Watersheds",
J. Environ. Oual.. Vol. 17, 1988, pp. 534-543.
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IRON SALTS BIBLIOGRAPHY
MRID CITATION
Faith, W. L., Keyes, D. B. and R. L. Clark, 1965 Industrial Chemical's. John
Wiley & Sons, Inc., N. Y., N. Y., Pages 386-9.
Windholz, H. (Ed.) 1983. The Merck Index. 10th Edition, Merck & Co. Inc.,
Rathway, N. J, Page 3982.
Weast, R. C. (Ed.) 1986. CRC Handbook of Chemistry and Physics. CRC Press,
Inc., Boca Raton, FL, Pages 13-98.
Lindsay, W. L., 1979, Chemical Equilibria in Soils John Wiley & Sons, N. Y.,
Page 131.
Thorpe's Dictionary of Applied Chemistry Vol. vn, 1937 Longmans, Green and
Co, New York N.Y., Pages 57-58.
Material Data Safety Sheet, Ferrous Sulfate Heptahydrate, 1987, Crown
Technology, Inc., Indianapolis, IN.
Product Data Sheet; Ferrous Sulfate Heptahydrate, Crown Technology, Inc.,
Indianapolis, IN.
Material Safety Data Sheet Ferrous Sulfate Monohydrate, Q. C. Corporation
Baltimore, MD 21200.
Material Safety Data Sheet Ferrous Sulfate Heptahydrate Synergy Production
Group, Inc. Detroit, MI 48234.
Sax, N. L, and Lewis, R. J. SR, 1989. Dangerous Properties of Industrial
Materials. 7th Ed. Van Nostrand Reinhold, New York. N.Y.
00142309 Klettke, M., Product Chemistry of Ferrous Sulfate Monohydrate., Charles H.
Lilly Company, 1990.
00137725 Klettke, M. Primary Eye Irritation Study, Ferrous Sulfate, Project T. 1008, Harris
Laboratories, Inc. 1990.
00137726 Klettke, M., Primary Skin Irritation Study, Project T. 1009, Harris Laboratories,
Inc. 1990.
40091902 Fletcher, D. (1986) Acute Oral Toxicity Study with Ferrous Sulfate Monohydrate
in Bobwhite Quail: Laboratory Project ID: BLAL No. 85 QD 61. Unpublished
study prepared by Bio-Life Associates, Ltd. 27 p.
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MRTO
40091903
40091904
40091905
40091906
40091907
40142201
40142202
40142203
40142204
40142205
CITATION
Fletcher, D. (1986) 8-Day Dietary LC50 Study with Ferrous Sulfate Monohydrate
in Mallard Ducklings: Laboratory Project ID: BLAL No. 85 DC 63. Unpublished
study prepared by Bio-Life Associates, Ltd. 28 p.
Fletcher, D. (1986) 8-Day Dietary LC^ Study with Ferrous Sulfate Monohydrate
in Bobwhite Quail: Laboratory Project ID: BLAL No. 85 QC 61. Unpublished
study prepared by Bio-Life Associates, Ltd. 28 p.
Surprenant, D. (1986) Acute Toxicity of Ferrous Sulfate Monohydrate to
Rainbow Trout: Laboratory Project ID: BW-86-11-2227: Study
#11501.0886.6100.103. Unpublished study prepared by Springborn Bionomics,
Inc. 19 p.
Surprenant, D. (1986) Acute Toxicity of Ferrous Sulphate Monohydrate to
Bluegill: Laboratory Project ID: BW-86-11-2228: Study #11501.0886.6100,100.
Unpublished study prepared by Springborn Bionomics, Inc. 19 p.
Surprenant, D. (1986) Acute Toxicity of Ferrous Sulfate Monohydrate to
Daphnids (Daphnia magna): Laboratory Project ID: BW-86-112229: Study
#11501.0886.6100.110. Unpublished study prepared by Springborn Bionomics,
Inc. 18 p.
Grimes, L; Jaber, M. (1986) Ferrous Sulfate Heptahydrate: An Acute Oral
Toxicity Study with the Bobwhite: Laboratory Project ID: 223-103. Unpublished
study prepared by Wildlife International Ltd. 18 p.
Grimes, J.; Jaber, M. (1986) Ferrous Sulfate Heptahydrate: A Dietary LC50
Study with the Bobwhite: Laboratory Project ID: 223101. Unpublished study
prepared by Wildlife International Ltd. 17 p.
Grimes, J.; Jaber, M. (1986) Ferrous Sulfate Heptahydrate: A Dietary LC50
Study with the Mallard: Laboratory Project ID: 223102. Unpublished study
prepared by Wildlife International Ltd.
Surprenant, D. (1986) Acute Toxicity of Ferrous Sulfate Heptahydrate ...to
Bluegill (Lepomis macrochirus): Bionomics Report #BW-86-12-2262: Bionomics
Study #1297.0786.6101.100. Unpublished study prepared by Springborn
Bionomics, Inc. 6 p.
Surprenant, D. (1986) Acute Toxicity of Ferrous Sulfate Heptahydrate...to
Rainbow Trout (Salmogairdneri): Bionomics Report #BW-87-3-2317: Bionomics
Study #1297.0786.6101.103. Unpublished study prepared by Springborn
Bionomics, Inc. 7 p.
-------
MRP) CITATION
40142206 Surprenant, D. (1986) Acute Toxicity of Ferrous Sulfate Heptahydrate...to
Daphnids (Daphnia pulex): Bionomics Report #BW-87-32318: Bionomics Study
#1297.0786.6101.110. Unpublished study prepared by Springborn Bionomics,
Inc. 6 p.
41758701 Robbins, G., Pimary Eye Irritatancy Study in Rabbits, Ferric Sulfate, Fern Floe:
Lab Project No. D3082. Unpublished Study prepared by Cosmopolitan Safety
Evaluation, 1990.
41758702 Robbins, G., Pimary Eye Irritatancy Study in Rabbits, Ferric Sulfate, Fern Floe:
Lab Project No. E3082. Unpublished Study prepared by Cosmopolitan Safety
Evaluation, 1990.
41758703 Robbins, G., Guinea Pig Sensitization, Ferric Sulfate, Ferri Floe: Lab Project
No. F3082. Unpublished Study prepared by Cosmopolitan Safety Evaluation,
1991.
41763701 Robbins, G. (1990) Guinea Pig Sensitization (Buhler): WGM-30 Brand: Lab
Project Number: F3081. Unpublished study prepared by Cosmopolitan Safety
Evaluation, Inc. 19 p.
41764501 Gohlke, A., Product Identity and Disclosure of Ingredients, Tennessee Chemical
Company's Ferri-Floc, Ferric Sulfate Lab Project No 1991-1. Unpublished Study
prepared by Tennessee Chemical Co., 1991.
41764501 Gohlke, A., Analysis and Certification of Ingredinents in Tennessee Chemical
company's Ferri-Floc, Tennessee Chemical Company's Ferri-Floc, Ferric Sulfate
Lab Project No 1991-2. Unpublished Study prepared by Tennessee Chemical Co.,
1991.
42171701 Robbins, G. (1992) Acute Oral Toxicity in Rats: Ferric Sulfate, Ferri Floe: Lab
Project Number: A3251. Unpublished study prepared by Cosmopolitan Safety
Evaluation, Inc. 28 p.
42171702 Robbins, G. (1991) Acute Dermal Absorption in Rabbits: Ferric Sulfate, Ferri
Floe: Lab Project Number: B3251. Unpublished study prepared by Cosmopolitan
Safety Evaluation, Inc. 24 p.
42171703 Robbins, G. (1991) Acute Inhalation Study in Rats: Ferric Sulfate, Ferri Floe:
Lab Project Number: C3251. Unpublished study prepared by Cosmopolitan Safety
Evaluation, Inc. 34 p.
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APPENDIX D
List of Available Related Documents
The following is a list of available documents related to iron salts. Its purpose is to
provide a path to more detailed information if it is needed. These accompanying documents are
part of the Administrative Record for iron salts 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. Iron salts RED Fact Sheet
4. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
-------
Appendix E, F, & G are separate
docucments
-------
APPENDIX E
Pesticide Reregistration Handbook
and PR Notice 91-2
-------
PR Notice 91-2
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.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 Program's policy 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(i). 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
of 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 good 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
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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)(l)(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
product composition because the nominal concentration would be
the amount of active ingredient typically found in the product.
It is important for registrants to note that certified
limits for active ingredients are not considered to be trade
secret information under FIFRA section 10(b). In this respect the
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,*1 all
currently registered products as well as all applications for new
registration must comply with this Notice by specifying the
nominal concentration expressed as a percentage by weight as the
label claim in the ingredient(s) statement and equivalence
statements if applicable (e.g., elemental arsenic, metallic zinc,
salt of an acid). In addition, the requirement for performing
sample analyses of five or more representative samples must be
fulfilled. Copies of 'the raw analytical data must be submitted
with the nominal ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR
158.170. All products are required to provide certified limits
for each active, inert ingredient, impurities of toxicological
significance(i.e., upper limit(s) only) and on a case by case
basis as specified by EPA. These limits are to be set 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.
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IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lower then the minimum
level to achieve efficacy. This is extremely important for
products which are intended to control pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 153.640.
In those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make
the registration process more uniform and more manageable for
both the agency and the regulated community. It is the Agency's
intention to implement the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority programs, i.e., reregistration, new chemical, or
fast track (FIFRA section 3(c)(3)(B). Therefore,
applicants/registrants are expected to comply with the
requirements of this Notice as follows:
(1) Beginning July 1, 1991, all new product registrations
submitted to the Agency are to comply with the
requirements of this Notice.
(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) above 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) 557-5024
Ann* S. Lindsay, Director
Registration Division (H-7505
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APPENDIX F
Generic Data Call-In
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Attachment A
Chemical Status Sheet
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IRON SALTS: DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have produces)
containing Iron Salts.
This Generic Data Call-In Chemical Status Sheetr contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
icon salts. 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 B), (3) the Requirements
Status and Registrant's Form (Attachment C), (4) a list of registrants receiving this DCI
(Attachment D), (5) the EPA Acceptance Criteria (Attachment E), and (6) the Cost Share and
Data Compensation Forms in replying to this Iron Salts Generic Data Call-In (Attachment F).
Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for iron
salts are contained in the Requirements Status and Registrant's Response. Attachment C.
The Agency has concluded that additional product chemistry data on iron salts are needed.
These data are needed to fully complete the reregistration of all eligible zinc salts 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 Yvonne Brown at (703) 308-8073.
All responses to this Notice for the generic data requirements should be submitted to:
Yvonne Brown, 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: IRON SALTS
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Attachment B
Generic DCI Response Forms (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 th
purpose of reregistering pesticides under the Federal Insecticide Fungicide and Rodenticide Act. F
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 o
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 chemic
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. Pleas
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
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 y
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 registratio
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 th
and-any other outstanding Data Call-In Notice), and incorporate that product into al
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 produc
(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. Attac
the Requirements Status and Registrant's Response Form that Indicates how you wil
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 Requireme
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 C
Requirements Status and Registrants' Response Forms
(Form B) plus Instructions
-------
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 eall-in- for generic and
produet-speeifie 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 reguirements do not include (1) deletion of uses or (2) request for a
low volume/minor use waiver. These instructions are for completion of generic data reguirements
EPA has developed this form individually for each data call-in addressed to each registrant, and ha
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
Nanagement and Budget, Paperwork Reduction Project 2070-0107, Washington, D.C. 20503.
INSTRICIONS
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 chemic
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 reguired to support t
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 an
whether protocols and 1, 2, or 3-year progress reports are reguired to be submitted in
connection with the study. As noted in Section ffl of the Data Call-In Notice, 90-d
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 Reguirements Status and Registrant's Response
Form.
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Item 6. This item identifies the code associated with the use pattern of the pesticide. A brief
description of each code follows:
A. Terrestrial food
B. Terrestrial feed
C. Terrestrial non-food
D. Aquatic food
E. Aquatic non-food outdoor
F. Aguatic non-food industrial
G. Aquatic non-food residential
H. Greenhouse food
I. Greenhouse non-food crop
J. Forestry
K. Residential
L. Indoor food
M. Indoor non-food
N. Indoor medical
O. Indoor residential
Item 7. This item identifies the code assigned to the substance that must be used for testing.
A brief description of each code follows.
EP End-Use Product
MP Manufacturing-Use Product
MP/TGAI Manufacturing-Use Product and Technical Grade Active
Ingredient
PAI Pure Active Ingredient
PAI/M Pure Active Ingredient and Metabolites
PAI/PAIRA Pure Active Ingredient or Pure Active Ingredient Radiolabelled
PAIRA Pure Active Ingredient Radiolabelled
PAIRA/M Pure Active Ingredient Radiolabelled and Metabolites
PAIRA/PM Pure Active Ingredient Radiolabelled and Plant Metabolites
TEP Typical End-Use Product
TEP _ * Typical End-Use Product, Percent Active Ingredient Specified
TEP/MET Typical End-Use Product and Metabolites
TEP/PAI/M Typical End-Use Product or Pure Active Ingredient and
Metabolites
TGAI/PAIRA Technical Grade Active Ingredient or Pure Active Ingredient
Radiolabelled
TGAI Technical Grade Active Ingredient
TCAI/TEP Technical Grade Active Ingredient or Typical End-Use Produc
TGAI/PAI Technical Grade Active Ingredient or Pure Active Ingredient
MET Metabolites
IMP Impurities
DEGR Degradates
*See: guideline comment
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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 reguirement. Brief descriptions of each code follow. The Data Call-I
Notice contains a fuller description of oach 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 reguirements pertaining to the
conditions for submittal of this study as outlined in the Data Call-In Notice a
that I will provide the protocol and progress reports reguired in item 5 above
2. (Agreement to Cost Share) I have entered into an agreement with one or mo
registrants to develop data jointly. By indicating that I have chosen this optio
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 o
or more registrants to develop data jointly. I am submitting a copy of the for
"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 dat
to upgrade a study described in the Data Call-In Notice. I am indicating on
attached correspondence the Master Record Identification Number (MRID) th
EPA has assigned to the data that I am citing as well as the MRID of the stu
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 no
yet been reviewed by the Agency. I am providing the Agency's classfication of
the study.
7. (Deleting Uses) I am attaching an application for amendment to my
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registration deleting the uses for which the data are required.
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 an
I request a low-volume minor use waiver of the data reguirement. I am
attaching a detailed justification to support this waiver request including,
among other things, all information reguired to support the request. I
understand that, unless modified by the Agency in writing, the data
reguirement as stated in the Notice governs.
9. (Reguest for Waiver of Data) I have read the statements concerning data
waivers other than lowvolume minor-use data waivers in the Data Call-In
Notice and I request a waiver of the data requirement. I am attaching an
identification of the basis for this waiver and a detailed justification to suppo
this waiver request. The justification includes, among other things, all
information required to support the reguest. I understand that, unless modifie
by the Agency in writing, the data reguirement as stated in the Notice gover
Item 10. This item must be signed by an authorized representative of your company. The
percon signing must include his/her title, and must initial and date all other pages o
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 D
List of Registrants) sent this DCI
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APPENDIX G
Product Specific Data Call-In
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ATTACHMENT A
Chemical Status Sheet
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IRON SALTS: DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have produces)
containing iron salts.
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 iron
salts. 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 B), (3) the Requirement
Status and Registrant's Form (Attachment C), (4) EPA's Grouping of End-Use Products for Meeti
Acute Toxicology Data Requirement (Attachment D), (5) the EPA Acceptance Criteria (Attachmen
E), (6) a list of registrants receiving this DCI (Attachment F) and (7) the Cost Share and Data
Compensation Forms in replying to this iron salts Product Specific Data Call-in (Attachment G).
Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for iron salts are containe
in the Requirements Status and Registrant's Response. Attachment C. The Agency has concluded
that additional data on iron salts are needed for specific products. These data are required to be
submitted to the Agency within the timeframe listed. These data are needed to fully complete the
reregistration of all eligible iron salts products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of iron salts, please contact Yvon
Brown at (703) 308-8073.
If you have any questions regarding the product specific data requirements and procedures
established by this Notice, please contact Joanne Miller (703) 305-7830.
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All responses to this Notice for the Product Specific data requirements should be submitted
to:
Joanne Miller, Product Manager Team 23
Herbicide/Fungicide Branch
Registration Division (H7505C)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: IRON SALTS
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ATTACHMENT B
PRODUCT SPECIFIC DATA CALL-IN RESPONSE FORMS (Form A) 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 an
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 Existi
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 whic
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 requesti
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 (Waive
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 repo
that your product has already been transferred to another company or that yo
have already voluntarily cancelled this product. For these cases, please suppl
all relevant details so that EPA can ensure that its records are correct.
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ATTACHMENT C
PRODUCT SPECIFIC REQUIREMENT STATUS AND
REGISTRANT'S RESPONSE
FORMS (Form B) PLUS 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 guideline reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the requiremen
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
Subpart C.
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 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 th
Data Call-In Notice.
2. I have entered into an agreement with one or more registrants to develop data jointl
(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 anothe
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.
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 dat
and only if EPA indicates in an attachment to this Data Call-In Notice that my
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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
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 m-C.l.) apply as well.
4. By the specified due date, I will submit an existing study that has not been submitte
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 m-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 t
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 upgradable (upgrading a Study). I will
submit evidence of the Agency's review indicating that the study may be upgraded
and what information is required to do so. I will provide the MRID or Accession
number of the study at the due date. I understand that the conditions for this option
outlined Option 5 in the Data Call-In Notice (Section m-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
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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. If I cite anoth
registrant'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 mis 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 meetin
the data requirements of this Notice by the due date stated by this Notice. In this
case, I must, within 30 days of my receipt of the Agency's written decision, submit a
revised "Requirements Status and Registrant's Response" Form indicating the option
chosen. I also understand that the deadline for submission of data as specified by th
original data call-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 D
EPA GROUPING OF END-USE PRODUCTS FOR MEETING
DATA REQUREMENTS FOR REREGISTRATION
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EPA'S DECISION NOT TO BATCH END-USE PRODUCTS CONTAINING IRON SALTS
FOR PURPOSES OF MEETING ACUTE TOXICITY DATA REQUIREMENTS FOR
REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregistration of end-use products containing the active ingredient
iron salts, the Agency considered batching end-use products. This process involves grouping simi
products for purposes of acute toxicity. Factors considered in the sorting process include each
product's active and inert ingredients (identity, percent composition and biological activity), type o
formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and labeling
(e.g., signal word, use classification, precautionary labeling, etc.).
Batching has been attempted using the readily available
information described above, and frequently acute toxicity data on individual end-use products has
been found to be incomplete. Notwithstanding the batching process, the Agency reserves the right
to require, at any time, acute toxicity data for an individual end-use product should the need arise.
After consideration of the available information described above, batching of end-use
products containing iron salts was not possible. The accompanying table lists all the end-use
products containing iron salts. These products were either considered not to be similar for purpos
of acute toxicity or the Agency lacked sufficient information for decision making purposes.
Registrants of these products are responsible for meeting the acute toxicity data requirements for
each product. Registrants must generate all the required acute lexicological studies for each of
their products. If a registrant chooses to rely upon previously submitted acute toxicity data, he/sh
may do so provided that the data base is complete and valid by today's standards (see acceptance
criteria attached), the formulation tested is considered by the Agency to be similar for acute toxici
and the formulation has not been significantly altered since submission and acceptance of the acute
toxicity data. Regardless of whether new data is generated or existing data is referenced, registran
must clearly identify the test material by it's EPA Registration Number.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI
Notice contains two response forms which are to be completed and submitted to the Agency within
90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant will mee
the data requirements for each product. The second form, "Requirements Status and Registrant's
Response," lists the product specific data required for each product, including the standard six acu
toxicity tests. A registrant must select one of the following options: Developing Data (Option 1),
Submitting an Existing Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an
Existing Study (Option 6). Since the end-use products containing iron salts could not be batched,
registrants cannot choose from the remaining options: Cost sharing (Option 2) or Offers to Cost
Share (Option 3).
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End-Use Products Containing Irons Salts (none were batched).
EPA R«g. No.
538-223
557-1838
802-504
802-509
802-543
802-558
3234-44
7001-290
7404-03
7404-04
7404-10
34704-713
64864-13
64864-14
% Active Ingredient
15.2% ferrous sulfate monohydrate
40.0% ferrous sulfate heptahydrate
4.78% ferrous sulfate heptahydrate
8.80% ferrous sulfate monohydrate
35.0% ferric sulfate
32.0% ferric sulfate monohydrate
95.4% ferrous sulfate monohydrate
32.5% ferrous sulfate monohydrate
15.0% ferrous sulfate monohydrate
25.38% ferrous sulfate monohydrate
17.05% ferrous sulfate monohydrate
39.85% ferrous sulfate monohydrate
65.0% ferrous sulfate heptahydrate
17.0% ferrous sulfate monohydrate
6.6% ferrous sulfate heptahydrate
Formulation Type
granular
granular
granular
soluble cone.
granular
granular
granular
granular
granular
granular
granular
soluble cone.
granular
soluble cone.
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ATTACHMENT E
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
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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 e
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 at <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) Regi
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 assig
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, proper
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 wh
may be present at >. 0.1 % or was found at >_ 0.1 % by product analyses and (2) certain lexicologically signific
impurities (see #3).
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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, 7, 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 or closure ^ ca 98%.
3. Analyses conducted for certain trace toxic impurities at lower than 0.1 % (examples, nitrosamines in the case of
products containing dinitroanilines or containing secondary or tertiary amines/alkanolamines plus nitri
polyhalogenated dibenzodioxins and dibenzofurans). [Note that in the case of nitrosamines both fresh and sto
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 w
explanation of how the limits were determined.
8. Upper certified limit proposed for each impurity present at J>. 0.1 % and for certain lexicologically signific
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 exe
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.
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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 compoun
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 w
reference to water at 20° C. [Note: Bulk density of registered products may be reported in lbs/ft3 or Ibs/gallo
63-8 Solubility
Determined in distilled water and representative polar and non-polar solvents, including those used in fonnulat
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 press
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 7735
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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
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SUBDIVISION F
Guideline Study Title
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. 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.
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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 gin, 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 before 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 prev
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 inhaiable size for man (aerodynamic diameter 15 urn 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.
g. 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 respira
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 conjunctiva! 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.
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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 cm*.
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 d
(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 of the following methods is utilized:
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehlertest
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig.
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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ATTACHMENT F
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
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ATTACHMENT G
COST SHARE AND DATA COMPENSATION FORMS
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r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFEft TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
Approval Expire* 12-31-92
Public reporting burden for this collection of information is estimated to average 15 minutes per response includina
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
Company Number
Chemical Name
EPA Chemical Number
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:
Dale
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
t4 form and a £*£*** therein are true, accurate, and ^^^^^Z 9y "
misleading statement may be punishable by fine or imprisonment or both under apphcable law.
Signature of Company's Authorized Representative
Name and Title (Please Type or Print)
EPA Form 8570-32
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&EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH
DATA COMPENSATION
RESPECT TO
REQUIREMENTS
Form Approved
OMB No. 2070-0106
Approval Expires 12-31-9
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
Chemical Name
Company Number
EPA Chemical Number
I Certify that:
1. For each study cited in support of registration or re registration under the Federal Insecticide, Fungicide and
RodentickJe Act (FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the
written permission of the original data submitter to cite that study.
2. That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use
study. I am the original data submitter, or I have obtained the written permission of the original data submitter, or I
have notified in writing the company(ies) that submitted data I have cited and have offered to: (a) Pay
compensation for those data in accordance with sections 3(c)(1)(D) and 3(c)(2)(D) of FIFRA; and (b) Commence
negotiation to determine which data are subject to the compensation requirement of FIFRA and the amount of
compensation due, if any. The companies I have notified are: (check one)
[ ] All companies on the data submitters' list for the active ingredient listed on this form (Cite-All
Method or Cite-All Option under the Selective Method). (Also sign the General Offer to Pay
below.)
[ ] The companies who have submitted the studies listed on the back of this form or attached
sheets, or indicated on the attached "Requirements Status and Registrants' Response Form,"
3. That I have previously complied with section 3(c)(1 )(D) of FIFRA for the studies I have cited in support of
registration or reregistration under FIFRA.
Signature
Date
Name and Title (Please Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the
registration or reregistration of my products, to the extent required by FIFRA sections 3(c)(1)(D) and 3(c)(2)(D).
Signature
Date
Name and Title (Please Type or Print)
EPA Form 8570-31 (4-90)
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xv EPA
United States Environmental Protection Agency
Washington. DC 20460
Formulator's Exemption Statement
(40 CFR 152.85)
Form Approved
OMD No. 2070-0060
Approval expires 9-30-90
Applicant's Name and Address
EPA File Symbol/Registration Number
Product Name
Date of Confidential Statement of Formula (EPA Form 8S70-4J
As an authorized representative of the applicant for registration of the product
identified above, I hereby certify that:
(1) This product contains the following active ingredients):
(2) Of these, each active ingredient listed in paragraph (4) is present solely as the
result of the incorporation into the product (duringformulation or packaging) oi
another product which contains that active ingredient, which is registered under
FIFRA Section 3, and which is purchased by us from another producer.
(3) Indicate by checking (A) or (B) below which paragraph applies:
D (A) An accurate Confidential Statement of Formula (EPA Form 8570-4) for
the above identified product is attached to this statement. That formula
statement indicates, by company name, registration number, and product
name, the source of the active ingredient(s) listed in paragraph (1).
OR
D (B) The Confidential Statement of Formula (CSF) (EPA Form 8570-4) refer-
enced above and on file with the EPA is complete, current, and accurate and
contains the information required on the current CSF.
(4) The following active ingredients in this product qualify for the formulator's
exemption.
Active Ingredient
Source
Product Wanna
Registration Number
Signature
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