Iii 

United States 

Environmental Protection 

Agency 

Office of Prevention, Pesticides EPA 738-S 

and Toxic Substances 

(H-750BW) February • 

&EPA Reregistration 

Eligibility Document 

(RED) 

Iron Salts 

United States 

Environmental Protection 

Agency 

Office of Prevention, Pesticides EPA-738-F-93-002 

And Toxic Substances February 1993 

IH-7508WJ 

&EPA 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 ~registered to ensure that they meet 

today's more stringent standards. 

In evaluating pesticides for reregistration, EPA obtains and reviews a 

complete set of studies from pesticide producers, describing the human 

health and environmental effects of each pesticide. The Agency imposes 

any regulatory controls that are needed to effectively manage each 

pesticide's risks. EPA then reregisters pesticides that can be used without 

posing 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 

fuct sheet summarizes the information in the RED for iron salts. 

Use Profile The iron salts consist of three pesticide active ingredients that are 

Regulatory 

History 

eligible for reregistration: Iron (III) sulfate, Iron (II) 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. 

Iron salts first were registered as pesticides in 1962. In addition to 

the 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 (III) 
I 

sulfate, nine conlain Iron (II) sulfate monohydrate, and three conlain Iron 

(II) sulfate heptahydrate. 

A fourth active ingredient, Iron II ammonium sulfate, is not being 

supported for reregistration and so is not covered in this RED. 

Human Health Toxicity 

Assessment Iron salts are present nonnally 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, dennal and 

inhalation routes of exposure. They have been placed in lbxicity Category 

ill 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 melabolic systems of humans and 

domestic animals. 

Environmental Environmental Fate 

Assessment The environmental fu.te and transport of iron salts is dominated by 

three processes: the conversion of Iron (II) to Iron (Ill), the formation of 

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Additional Data 

Required 

Product Labeling 

Changes Required 

Regulatory 

Conclusion 

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 (Ill) to 

the more mobile Iron (ll), this is rapidly immobiliz.ed. 

Therefore, the use of iron salts as herbicides to control moss is not 

expected to contribute significantly to the chemistry and fute of the 

compounds existing naturally in the environment. No unreasonable effec~ 

are expected from the use of these pesticide products as directed. 

Ecological Effects 

In dietary acute toxicity studies, iron salts are practically nontoxic tc 

bird species and are nontoxic or slightly toxic to rats. Iron (ll) sulfute 

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 JX>pulations 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 U! 

of iron salts. 

EPA is requiring additional physical chemistry studies as 

confirmatory data and to complete the generic data base fur 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. 

The labels of all registered iron salts products must comply with 

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." 

• The three pesticide active ingredients discussed in the iron salts 

RED will not result in unreasonable adverse effects to human health or t1 

environment, and all registered products containing these active ingredien 

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For More 

Information 

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. 

EPA is requesting public comments on the Reregistration Eligibility 

Document (RED) for iron salts during a 60-day time period, as announced 

in a Notice of Availability published in the Federal Re~ister. Th 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 8:00am and 6:00pm 

Central Time, Monday through Friday. 

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REREGISTRATION ELIGffiiLITY DOCUMENT 

IRON SALTS 

LISTD 

CASE 4058 

ENVIRONMENTAL PROTECTION AGENCY 

OFFICE OF PESTICIDE PROGRAMS 

SPECIAL REVIEW AND REREGISTRATION DIVISION 

WASHINGTON, D.C. 

Iii 

IRON SALTS REREGISTRATION ELIGIBILITY TEAM 

Office of Pesticide Programs: 

Bioloeical and Economic Analysis Division 

Jim Saulmon Biological Analysis Branch 

Ed Brandt Economic Analysis Branch 

Steve Jarboe Biological Analysis Branch 

Environmental Fate and Effects Division 

Concepcion Rodriguez Ecological Effects Branch 

Sylvia Termes Environmental Fate and Groundwater Branch 

Mary Frankenberry Science Analysis and Coordination Staff 

Health Effects Division 

Jane Smith 

Pat McLaughlin 

Judy Smith 

Registration Division 

Shyem Mathur 

Ian Blackwell 

Jesse Mayes 

Chemical Coordination Branch 

Toxicology Branch II 

Occupational and Residential Exposure Branch 

Registration Support Branch 

Registration Support Branch 

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 
I 
I 

TABLE OF CONTENTS 

I. EXECUTIVE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I 

II. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 

ill. CASE OVERVIEW ...................................... 3 

A. Chemical Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 

B. Use Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 

C. Regulatory History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 

IV. SCIENCE ASSESSMENT OF ffiON SALTS . . . . . . . . . . . . . . . . . . . . . 6 

A. Physical Chemistry Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 

B. Human Health Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 

C. Environmental Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 

V. RISK MANAGEMENT AND REREGISTRATION DECISION FOR ffiON 

SALTS .............................................. 14 

A. Determination of Eligibility ............................. 14 

VI. ELIGIBILITY DECISION ................................. 14 

A. Eligible and Ineligible Uses ............................. 15 

VII. ACTIONS REQUffiED 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 
I 

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 DC! 

Attachment E - Cost Share/Data Compensation Forms 

APPENDIX G - Product Specific Data Call-In 

Attachment A - Chemical Status Sheet 

Attachment B - Product Specific DC! 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 DC! 

Attachment G - Cost Share/Data Compensation Forms 

II 
a.i. 

CAS 

CSF 

EEC 

EP 

EPA 

F!FRA 

FFDCA 

HDT 

LC,. 

LEL 

MP 

MRID 

N/A 

NPDES 

GWSSARY OF TERMS AND ABBREVIATIONS 

Active Ingredient 

Chemical Abstracts Service 

Confidential Statement of Formula 

Estimated Environmental Concentration. The estimated pesticide concentration 

in an environment, such as a terrestrial ecosystem. 

End-Use Product 

U.S. Environmental Protection Agency 

Federal Insecticide, Fungicide, and Rodenticide Act 

Federal Food, Drug, and Cosmetic Act 

Highest Dose Tested 

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. 

Median Lethal Dose. A statistically derived single dose that can be expected to 

cause death in 50% of the test animals when administered by the route indicated 

(oral, dermal, inhalation). It is expressed as a weight of substance per unit 

weight of animal, e.g., mg/kg. 

Lethal Dose-low. Lowest Dose at which lethality occurs 

Lowest Effect Level 

Manufacturing-Use Product 

Master Record Identification (number). EPA's system of recording and tracking 

studies submitted. 

Not Applicable 

National Pollutant Discharge Elimination System 

Ill 
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GWSSARY OF TERMS AND ABBREVIATIONS (cont.) 

NOEL 

OPP 

ppm 

TD 

TC 

No Observed Effect Level 

Office of Pesticide Programs 

Parts Per Million 

Toxic Dose. The dose at which a substance produces a toxic effect. 

Toxic Concentration. The dose at which a substance produces a toxic effect. 

IV 
I 

I. EXECUTIVE SUMMARY 

The active ingredients covered in this document include iron (Ill) sulfate, iron {TI) 

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 FlFRA. 
II. 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 Adntinistrator shall deterntine 

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 effCcts; 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 (Ill) 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 ill 

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. 

2 
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ill. 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: F~(S0 h 

2. Chemical Name: Iron (II) sulfate monohydrate 

o CAS Registry Number: 17375-41-6 

o Office of Pesticide Programs Chemical Code: 50507 

3. Chemical Name: Iron (11) sulfate heptahydrate 

o CAS Registry Number: 7782-63-0 

o Office of Pesticide Programs Chemical Code: 50502 

o Empirical Fonnula: FeS04-7H20 

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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 (III) 

sulfate, iron (II) sulfate monohydrate and iron (II) sulfate heptahydrate is in Appendix 

A. 

1. For Iron (Ill) sulfate: 

Type of Pesticide: Herbicide 

Use Sites: 

Target Pest: 

Ornamental lawns and turf--terrestrial non-food, outdoor 

residential 

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.) 

Timing - When needed. 

2. For Iron (IU sulfate monohydrate: 

Type or Pesticide: Herbicide 

Use Sites: Ornamental herbaceous plants, ornamental lawns and 

turf, ornamental woody shrubs and vines--terrestrial nonfood, 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 lb iron/ A. 

Ornamental Lawns 

35 lb iron/ A. 

Ornamental Woody Srubs and Vines 

35 lb iron/ A. 

Timin~ - When needed; Fall; Winter; Spring; Early 

Spring. 

3. For Iron (ll) sulfate heptabydrate: 

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 lb iron/A. 

Timine: 

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 (Ill) 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 (D) sulfate 

monohydrate, and iron (II) sulfate heptahydrate is adequate and will support 

reregistration eligibility. 

a. Acute and Subchronic Toxicity 

ACUTE TOXICITY VALVES 

TEST RESULT TOXICITY 

Iron III Sulfate CATEGORY 

Oral LD50--rat 1487 - 2102 mg/kg III 

Inhalation LC50--rat > 1.10 mg/L m 

Dermal LD50--rabbit >2000 mg/kg Ill 

Eye Irritation corrosive I 

Dermal Irritation corrosive N 

Dermal Sensitization negative -

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 (ill) 

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,, of 1389 mg/kg and an acute oral study in rabbits 

showed an LD, of 2778 mg/kg(4). The LD50 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. 

7 
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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 toxicological 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 (Ill) 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 :1.0 toxicological 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 

(Ill) sulfate and iron (11) 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 (II) 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-Fez03) and 

magnetite (F~0 ), the "hydrated oxide oxide limonite" 

(- "2Fe,O, · 3H,O"), the oxyhydroxide geothite and its polymorph 

lepidocrocite (a-FeOOH and -y-FeOOH, respectively), ferrihydrite 

("5Fe;,03 • 9H20"), in carbonates such as siderite (FeC03), in sulfides 

9 
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(pyrite and marcasite, FeS

2; chalcopyrite, CuFeS

2, etc.), phosphates 

(for example vivianite) and incomplex silicate,.(l,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(!!) 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 normalto-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. (I ,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(lll), but this oxidation is accompanied by the formation of less 

soluble oxide and hydroxide.(?) The precipitation of Fe(Ill) 

oxides/oxyhydroxides from oxidation of Fe(II) salts or from Fe(III) 

salts occurs in a stepwise manner, which involves (a) formation of lowmolecular 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.(?) 

The oxide/oxyhydroxide species that form from the use of Fe 

10 
(II) or Fe(Ill) 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.(?) 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(Ill) to Fe(Il) followed by movement of Fe(Il) 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.(l4) Soils rich in iron oxide/oxyhydroxides (for example, 

oxisols) are known to fix large amounts of phosphate fertilizers.(l5) 

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.(l6,17) 

Some microorganisms (mainly anaerobic bacteria) are known to 

recuce Fe(Ill) oxide/oxyhydroxides to Fe(II),(l8) 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(ll) can be immobilized again by precipitation (for 

example, as siderite, vivianite or a sulfide) or by re-oxidation. 

II 
I 

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 

FeOI) 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(IID salts in 

the environment is dominated by three major processes: {1) the pHredox 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(III) 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 reprecipitation 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 
I 

a. Ecological Effects Data 

(I) Non-Target Terrestrial 

Iron (II) sulfate heptahydrate and iron (II) sulfate 

monohydrate are classified as practically non-toxic to the 

bobwhite quail on an acute oral basis. The LDso was 2250 

mg/kg for iron (II) sulfate heptahydrate and for sulfate 

monohydrate the LDso 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 LC,. for iron (II) 

sulfate heptahydrate was > 5620 ppm for both the bobwhite 

quail and the mallard duck. For iron (II) sulfate monohydrate, 

the LC,. 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 LD50 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 .I 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 

(!) 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 pafent 

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. 

W. RISK MANAGEMENT AND REREGISTRATION DECISION FOR IRON SALTS 

A. Detennination 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. EL!Gffi!LITY 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 
I 

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. 

j Vll. 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 
li 

1. Manufacturing-Use Products 

In addition to the above requirements under 40 CFR § 156.10 and the 

Pesticide Reregistration 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 
I 
APPENDIX A- Case 4058, [Iron Salts] Chemical 050502 (Ferrous sulfate heptahyd

= -T .... -....... -- .......... ••• ... ••• _ ..... -

.......... --· 

USES ELIGIBLE FOR REREGISTRATION 

NONFOOD/NONFEED USES 

Ornamental Lawns and Turf Use Groups; Terrestrial Non-Food Crop and Outdoor Residential 

Sprinkle, Whan needed, Sprinkle can sets "' 52.2721b Iron pet acra spec "" spec ""' 

Spray, When nel'lded, Sprayer SC/S "' 52.272 lb per acre spec "" spac "" 

Bro11dcast, When needed, Spreader G "' 13.9392 lb Iron per acre spec "" spec "" 

Broadcast, When needed, Spra!!der SC/S "' 41.8178 lb oo< Iron per IIICte spec spec "" 

Sprinkle, When needed, Sprinkler can SC/L "' Dose cannot ""' oo< be spec spec 

Brosdc11st, When needed, By hand SC/S "' 41.8176 lb Iron per acre spec "" lpec ""' 

Abbreviations used 

He110"'. Form : 

max .. maximum; min"' minimum; apps .. applications; not spec= not specified; na .. not epplicabh1 

G = grenular; SC/l .. solubh1 concentrete/liquid; SC/S =soluble concentrete/solid 

--·· 

-·- -· 

... .. ,., .. 

,..,., 

-

..... 

not spec not spec 

not spec not spec 

llOt spec not spec 

not spec not tpec not SPIIC not tpec not spec not apec 
APPENDIX A- Case 4058, [Iron Salts] Chemical 034902 [Ferric sulfate] 

811"1' .......... ......,..._ ... ,;_ .. 

- -- - ..... e..---· -·- -...., 

·-

..... ..... 

USES RIGIBLE FOR REREGISTRATION 

NONFOOD/NONFEEO USES 

Ornamental Lawns and Turf Uee Groups: Terrestrial Non-Food Crop and Outdoor Residential 

Sprey, When n11aded, Hose-end Sprayer SC/l "" Dose cannot oo< oo< Aa needed not apao be calculated spec spec Spray, When needltd, Sprinkler can SC/l "" Dose c11nnot "" oo< As needed not spec be calculated spec spec 

Abbreviations used 

Heeder;max •maximum; min =minimum; epps .. applications; not spec .. not specified; ne• not applicable 

Form : SC!L =soluble concantrataJ1iquid 
APPENDIX B 

Table of The Generic Data Requirements and 

Studies Used to Make the Reregistration Decision 

Iii 

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: 

I. 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 

D 

Terrestrial non-food 

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 

0 

Indoor medical. 

Indoor residential 

3. Biblio~raphic citation (Column 3). If the Agency has acceptable data in its ftles, this 

column lists the identifying number of each study. This normally is the Master Rerord 

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 US

SIT

§158.120 Product Chemistry 

61·1 Chemical Identity All 

6l-2(a) Beginning Materials and Manufacturing Process All 

6l-2(b) Formulation of Impurities All 

62-l Preliminary Analysis All 

62-2 Certification of Limits All 

62-3 Analytical Methods All 

63-2 Color All 

63-3 Physical State All 

63-4 Odor All 

63-5 Melting Point All 

63-6 Boiling Point All 

63-7 Density All 

63-8 Solubility All 

63-lO Dissociation Constant All 

63-12 pH All 

63-!3 Storage Stability All 
IRON III SULFATE 

GUIDELINE GUIDELINE NAME US

SIT

§158.130 Environmental Fate 

All environmental fate data requirements have been waived. 

§158.135 Toxicology 

81-1 Acute oral tox. rat All 

81-2 Acute dennal tox. rabbit All 

81-3 Acute inhal. tox rat All 

81-4 Primary eye irritation-rabbit All 

81-5 Primary dermal irritation All 

81-6 Dermal sensitization/guinea pig All 

§158.145 Ecological Effects 

71-l(a) Acute Avian Oral Toxicity -QualUDuck All 

71-2(a) Avian Dietary Toxicity -Quail/Duck All 

71-2(b) Acute avian diet. duck All 

72-1 (a) Freshwater Fish Toxicity -Bluegill All 

72-l(c) Fish toxicity rainbow trout All 

72-2(a) Freshwater Invertebrate Toxicity All 
IRON II SULFATE MONOHYDRATE 

GUIDELINE GUIDELINE NAME USE 

SITE

§158.120 Product Chemistry 

61-1 Chemical Identity All 

61-2(a) Beginning Materials and Manufacturing Process All 

61-2(b) Formulation of Impurities All 

62-1 Preliminary Analysis All 

62-2 Certification of Limits All 

62-3 Analytical Methods All 

63-2 Color All 

63-3 Physical State All 

63-4 Odor All 

63-5 Melting Point All 

63-6 Boiling Point All 

63-7 Density All 

63-8 Solubility All 

63-10 Dissociation Constant All 

63-12 pH All 

63-13 Storage Stability All 
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IRON II SULFATE MONOHYDRATE 

GUIDELINE GUIDELINE NAME USE 

SIT

§158.120 Product Chemistry 

61-1 Chemical Identity All 

61-2(a) Beginning Materials and Manufacturing Process All 

61-2(b) Formulation of Impurities All 62-1 Preliminary Analysis All 62-2 Certification of Limits All 62-3 Analytical Methods All 63-2 Color All 63-3 Physical State All 

63-4 Odor All 63-5 Melting Point All 63-6 Boiling Point All 

63-7 Density All 63-8 Solubility All 

63-10 Dissociation Constant All 

63-12 pH All 63-13 Storage Stability All 
IRON II SULFATE MONOHYDRATE 

GUIDELINE GUIDELINE NAME USE 

SIT

§158.130 Environmental Fate 

All environmental fate data requirements have been waived. 

§158.135 Toxicology 

81-1 Acute oral tox. rat All 

81-2 Acute dermal tox. rabbit All 

81-3 Acute inhal. tox rat All 

81-4 Primary eye irratiOn-rabbit All 

81-5 Primary dermal irritation All 

81-6 Dermal sensitization/Guinea pigs All 

§158.145 Ecological Effects 

71-1(a) Acute Avian Oral Toxicity -Quail/Duck All 

71-2(a) A vi an Dietary Toxicity -Quail/Duck All 

71-2(b) Acute avian diet. duck All 

72-1(a) Freshwater Fish Toxicity -Bluegill All 

72-1(c) Fish toxicity rainbow trout All 

72-2(a) Freshwater Invertebrate Toxicity All 
IRON II HEPTAHYDRATE 

GUIDELINE GUIDELINE NAME US

SIT

§I58.120 Product Chemistry 

6I·I Chemical Identity All 

6I·2(a) Beginning Materials and Manufacturing Process All 

6I-2(b) Formulation oflmpurities All 

62-1 Preliminary Analysis All 

62-2 Certification of Limits All 

62-3 Analytical Methods All 

63-2 Color All 

63-3 Physical State All 

63-4 Odor All 

63-5 Melting Point All 

63-6 Boiling Point All 

63-7 Density All 

63-8 Solubility All 

63-10 Dissociation Constant All 

63-12 pH All 

63-13 Storage Stability All 

Public literature and information was provided to the Agency as part of the reregistration process

identified the bibliography. 
IRON II HEPTAHYDRATE 

GUIDELINE GUIDELINE NAME USE 

SIT

§!58 .130 Environmental Fate 

All environmental fate data requirements have been waived. 

§158.135 Toxicology 

81-1 Acute oral tox. rat All 

81-2 Acute dermal tox. rabbit All 

81-3 Acute Inhalation-Rat All 

81-4 Primary eye irration-rabbit All 

81-5 Primary dermal irritation All 

81-6 Dermal sensitization/Guinea pigs All 

§158.145 Ecological Effects 

71-l(a) Acute avian oral quaiUduck All 

71-2(a) Acute avian diet. quail All 

71-2(b) Acute avian diet. duck All 

72-l(a) Fish toxicity bluegill All 

72-l(c) Fish toxicity rainbow trout All 

7?-'U~) JnvPrlPhMtP tnYir-ihr ... 
li 
Iii 

APPENDIX C 

ffiON SALTS BIBLIOGRAPHY 

Citations Considered to be Part of the Data Base 

Supporting the Reregistration of Iron Salts 
li 

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: 

(I) 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 tum followed by an 

alphabetic suffix which shows the relative position of the study within the 

volume. 
I 

I. 

2. 

REFERENCES 

Cotton, F.A. and Wilkinson, G. Advanced Inor~anic Chemistr,y, Fifth Edition. 

John Wiley and Sons, New York, 1988. 

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. • Ao Introduction to Soil Mineralogy• in Minerals in S2i! 

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 (III) Salts", Chemical Reviews, 

vol. 84, 1984, pp. 31-41. 

6. Stumm, W. and Morgan, J.J. Aguatic Chemistry- An Introduction Emphasizin~ 

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. 

II. Reference?, 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. 
Iii 

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 Mjneral 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", 

1, Environ. QIW., Vol. 17, 1988, pp. 534-543. 
MRID 

00142309 

00137725 

00137726 

40091902 

ffiON SALTS BffiLIOGRAPHY 

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, lOth Edition, Merck & Co. Inc., 

Rathway, N. J, Page 3982. 

Weast, R. C. (Ed.) 1986. CRC Handbook of Chemist[)' 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 Dictiomuy of Applied Chemistry Vol. VJJ, 1937 Longmans, Green and 

Co, New York N.Y., Pages 57-58. 

Material Data Safety Sheet, Ferrous Sulfate Heptahydrate, 1987, Crown 

Technology, Inc., Indianapolis, JN. 

Product Data Sheet; Ferrous Sulfate Heptahydrate, Crown Technology, Inc., 

Indianapolis, JN. 

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. I., and Lewis, R. J. SR, 1989. Dan~erous PrOJlerties of Industrial 

Materials, 7th Ed. Van Nostrand Reinhold, New York. N.Y. 

Klettke, M., Product Chemistry of Ferrous Sulfate Monohydrate., Charles H. 

Lilly Company, 1990. 

Klettke, M. Primary Eye Irritation Study, Ferrous Sulfate, Project T.l008, Harris 

Laboratories, Inc. 1990. 

Klettke, M., Primary Skin Irritation Study, Project T.1009, Harris Laboratories, 

Inc. 1990. 

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. 
Iii 

MRID 

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 Quall: 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, J.; 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 (Salmo gairdneri): Bionomics Report #BW -87-3-2317: Bionomics 

Study #1297.0786.6101.103. Unpublished study prepared by Springborn 

Bionomics, Inc. 7 p. 
MRID 

40142206 

41758701 

41758702 

41758703 

41763701 

41764501 

41764501 

42171701 

42171702 

42171703 

CITATION 

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. 

Robbins, G., Pimary Eye lrritatancy Study in Rabbits, Ferric Sulfate, Ferri Floc: 

Lab Project No. D3082. Unpublished Study prepared by Cosmopolitan Safety 

Evaluation, 1990. 

Robbins, G., Pimary Eye lrritatancy Study in Rabbits, Ferric Sulfate, Ferri Floc: 

Lab Project No. E3082. Unpublished Study prepared by Cosmopolitan Safety 

Evaluation, 1990. 

Robbins, G., Guinea Pig Sensitization, Ferric Sulfate, Ferri Floc: Lab Project 

No. F3082. Unpublished Study prepared by Cosmopolitan Safety Evaluation, 

1991. 

Robbins, G. (1990) Guinea Pig Sensitization (Buhler): WGM-30 Brand: Lab 

Project Number: F3081. Unpublished study prepared by Cosmopolitan Safety 

Evaluation, Inc. 19 p. 

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. 

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. 

Robbins, G. (1992) Acute Oral Toxicity in Rats: Ferric Sulfate, Ferri Floc: Lab 

Project Number: A3251. Unpublished study prepared by Cosmopolitan Safety 

Evaluation, Inc. 28 p. 

Robbins, G. (1991) Acute Dermal Absorption in Rabbits: Ferric Sulfate, Ferri 

Floc: Lab Project Number: B3251. Unpublished study prepared by Cosmopolitan 

Safety Evaluation, Inc. 24 p. 

Robbins, G. (1991) Acute Inhalation Study in Rats: Ferric Sulfate, Ferri Floc: 

Lab Project Number: C3251. Unpublished study prepared by Cosmopolitan Safety 

Evaluation, Inc. 34 p. 
I 

APPENDIXD 

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 infonnation 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 
Iii 

Appendix E, F, & G are separate 

docucments 

I 

APPENDIXE 

Pesticide Reregistration Handbook 

and PR Notice 91-2 
PR Notice 91-2 
I 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

PR NOTICE U-2 

OFFICE OF 

PREVENTION, PESTICIDES 

ANO TOXIC SUBSTANCES 

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(1). Accordingly, the Agency has 

established the nominal concentration as the only acceptable 

label claim for the amount of active ingredient in the product. 

I I. 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 
I 

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 lO(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 SCREDOLE, 11 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. 
I 

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 Track11 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 

Anne 

~~-d~~ 8. Lindaay, Dir~etar Cl- Regi;tration Civision (H-7505 
li 
li 

APPENDIXF 

<;t,neric Data Call-In 
Iii 
Iii 

Attachment A 

Chemical Status Sheet 

IRON SALTS: DATA CALL-IN CHEMICAL STATUS SHEET 

INTRODUCTION 

You have been sent this Generic Data Call-In Notice because you have product(s) 

containing Iron Salts. 

This Generic Data Call-In Chemical Status Sheet, contains an overview of data 

required by this notice, and point of contact for inquiries pertaining to the reregistration of 

ieon salts. This attachment is to be used in conjunction with (I) 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 DC! 

(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 Re~istrant'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 
I 
I 

Attachment B 

Generic DCI Response Fonns (Fonn A) plus Instructions 
Iii 
I 

SPECIFlC INSTRUCTIONS FOR 1HE GENERIC DATA CALL-IN RESPONSE FORM 

This Fonn 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 fonn each time you are responding to a data call-in for which EPA has sent you the fonn 

entitled "Requirements Status and Registrant's Response. • 

Items 1-4 will have been preprinted on the fonn Items 5 through 7 must be completed by the 

registrant as appropriate Items 8 through II must be completed by the registrant before submitting a 

response to the Agency. 

Public I'ejX>rting burden for this collection of information is estimated to average 15 minutes per 

l'e.SJX)Ose, 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, Jnfonnation Policy Branch, PM-223, U S 

Environmental Protection Agency, 401 M St , S W , Washington, DC 20460; and to the Office o 

Management and Budget, Paperwork Reduction Project 2070-0107, Washington, D C 20503 

INSTRUCTIONS 

Item I 

Item 2 

Item 3 

Item 4 

Item 5 

Item 6a 

This item identifies your company name, number and address. 

This item identifies the ease number, ease name, EPA chemical number and chemic 

name. 

This item identifies the date and type of data call-in. 

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. 

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. 

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. 
li 

Item 6b 

Item 7a 

Item 7b 

Item 8 

Item 9 

Item 10 

Item II 

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 a! 

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. 

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 Reeistrant's Reswnse Form that Indicates how you wil 

satisfy those requirements. 

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 Re~istrants' Response Form that indicates how you will satisfy those 

requirements. 

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 Re~istrant's 

Resoonse Form that indicates how you will satisfy those requirements. 

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 

Enter the date of signature. 

Enter the name of the person EPA should contact with questions regarding your 

response. 

Enter the phone number of your company contact. 
I 

Attachment C 

Requirements Status and Registrants' Response Fonns 

(Form B) plus Instructions 
IIi 
Iii 

SPECIFIC INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND 

REGISTRANTS RESPONSE FORM 

Generle 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 

Fungieide and Rodenticide Act. Although the form is the same for both produet speeifie and 

generic data, instructions for eompleting the forms differ slightly. Specifieally, options for 

satisfying produet specific data reguirements do not inelude (I) deletion of uses or (2) request for a 

low volume/minor use waiver. These instructions are for completion of ~eneric 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 I. 

Item 2. 

Item 3. 

Item 4. 

Item 5. 

This item identifies your company name, number, and address. 

This Item identifies the case number, case name, EPA chemical number and chemic 

name. 

This item identifies the date and type of data call-in. 

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. 

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 ill 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. 
Item 6. This item identifies the code associated with the use pattern of the pesticide. A brief 

description of each code follows: 

Item 7. 

A. 

B. 

c. 

D. 

E. 

F. 

G. 

H. 

I. 

J. 

K. 

L. 

M. 

N. 

0. 

Terrestrial food 

Terrestrial feed 

Terrestrial non-food 

Aquatic food 

Aquatic non-food outdoor 

Aguatic non-food industrial 

Aquatic non-food residential 

Greenhouse food 

Greenhouse non-food crop 

Forestry 

Residential 

Indoor food 

Indoor non-food 

Indoor medical 

Indoor residential 

This item identifies the code assigned to the substance that must be used for testing. 

A brief description of each code follows. 

EP 

MP 

MP/TGAI 

PAl 

PAVM 

PAVPAIRA 

PAIRA 

PAIRAIM 

PAIRA/PM 

TEP 

TEP • 

TEP/MET 

TEP/PAVM 

TGAVPAIRA 

TGAI 

TCAVTEP 

TGAVPAI 

MET 

IMP 

DEGR 

*See: guideline comment 

End-Use Product 

Manufacturing-Use Product 

Hanufacturing-Use Product and Technical Grade Active 

Ingredient 

Pure Active Ingredient 

Pure Active Ingredient and Metabolites 

Pure Active Ingredient or Pure Active Ingredient Radiolabelled 

Pure Active Ingredient Radiolabelled 

Pure Active Ingredient Radiolabelled and Metabolites 

Pure Active Ingredient Radiolabelled and Plant Metabolites 

Typical End-Use Product 

Typical End-Use Product, Percent Active Ingredient Specified 

Typical End-Use Product and Metabolites 

Typical End-Use Product or Pure Active Ingredient and 

Metabolites 

Technical Grade Active Ingredient or Pure Active Ingredient 

Radiolabelled 

Technical Grade Active Ingredient 

Technical Grade Active Ingredient or Typical End-Use Produc 

Technical Grade Active Ingredient or Pure Active Ingredient 

Metabolites 

Impurities 

Degradates 
Item 8. 

Item 9. 

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. 

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 optic 

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. 1 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 1 have chosen this option, 1 

certify that 1 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) 1 am submitting an existing study that has never 

before been submitted to EPA. By indicating that I have chosen this option, 1 

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 infonnation 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, 1 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 
li 

Item 10. 

Item 11. 

Item 12. 

Item 13. 

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 concerrting 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 

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. 

Enter the date of signature. 

Enter the name of the person EPA should contact with questions regarding your 

response. 

Enter the phone number of your company contact. 
I 

APPENDIX G 

Product Specific Data Call-In 
I 
I 

ATTACHMENT A 

Chemical Status Sheet 

I 

IRON SALTS: DATA CALL-IN CHEMICAL STATUS SHEET 

INTRODUCTION 

You have been sent this Product Specific Data Call-In Notice because you have product(s) 

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 Fonn (Attachment B), (3) the Requirement 

Status and Registrant's Fonn (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 DC! (Attachment F) and (7) the Cost Share and Data 

Compensation Fonns 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 Reguirements Status and Reeistrant'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 timefrarne 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. 
I 

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 
li 

ATTACHMENT B 

PRODUCT SPECIFIC DATA CALL-IN RESPONSE FORMS (Fonn A) PLUS 

INSTRUCTIONS 
I 
li 

INSTRUCTIONS FOR COMPLETING THE "DATA CALL-IN RESPONSE" FORM 

FOR PRODUCT SPECIF1C 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 N-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 fonn 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. 

I 

APPENDIX C 

IRON SALTS BffiLIOGRAPHY 

Citations Considered to be Part of the Data Base 

Supporting the Reregistration of Iron Salts 
I 

' ' 
Iii 

GYIDE TO APPENDIX C 

I. CONTENTS OF BlliLIOGRAPHY. 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 subntitted 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 sotted 

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 

subntitted 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. 
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: 

(I) 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 pennit 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. 
Iii 

ATIACHMENT C 

PRODUCT SPECIFlC REQUIREMENT STATUS AND 

REGISTRANT'S RESPONSE 

FORMS (Form B) PLUS INSTRUCTIONS 

INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND 

REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFlC 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. 

Item 5. 

Item 6. 

Item 7. 

Item 8. 

Item 9. 

I. 

2. 

3. 

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. 

The study title associated with the guideline reference number is identified. 

The use pattem(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. 

The substance to be tested is identified by EPA. For product specific data, the 

product as formulated for sa1e and distribution is the test substance, except in rare 

cases. 

The due date for submission of each study is identified. lt is normally based on 8 

months after issuance of the Reregistration Eligibility Document unless EPA 

determines that a longer time period is necessary. 

Enter only one of the following response Codes for each data reguirement to 

show how you intend to comply with the data requirements listed in this table. 

Fuller descriptions of each option are contained in the Data Call-In Notice. 

I will generate and submit data by the specified due date (Developing Data). By 

indicating that I have chosen this option, I certify that I will comply with all the 

requirements pertaining to the conditions for submittal of this study as outlined in th 

Data Call-In Notice. 

I have entered into an agreement with one or more registrants to develop data joint! 

(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. 

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 
Iii 

product is similar enough to another product to qualify for this option. I am 

submitting evidence that I have made an offer to anoth~r 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 tenns under Option 3 in the Data 

Call-In Notice (Section Ill-C.!.) 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 Ill-C.!.) and will meet the attached 

acceptance criteria (for acute toxicity and product chemistry data). I will attach the 

needed supporting infonnation 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 III-C.!.) 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 
I 

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 prcxluct (waiver 

Request). I am attaching a complete justification for this request, including technical 

reasons, data and references to relevant EPA regulations, guidelines or policies. 

[Note: any supplemental data must be submitted in the format required by P.R. 

Notice 86-5]. I understand that this is my only opportunity to state the reasons or 

provide information in support of my request. If the Agency approves my waiver 

request, I will not be required to supply the data pursuant to Section 3(c)(2)(B) of 

FIFRA. If the Agency denies my waiver request, I must choose a method of 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" Fonn 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.;,xplanatory. 

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. 
li 
I 

AITACHMENT D 

EPA GROUPING OF END-USE PRODUCTS FOR MEETING 

DATA REQUREMENTS FOR REREGISTRATION 
Iii 
Iii 

EPA'S DECISION NOT TO BATCH END-USE PRODUCTS CONTAINING ffiON 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 hatching 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 

fonnulation (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 

infonnation described above, and frequently acute toxicity data on individual end-use products has 

been found to be incomplete. Notwithstanding the hatching 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, hatching 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 toxicological 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 fonn, "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 hatched, 

registrants cannot choose from the remaining options: Cost sharing (Option 2) or Offers to Cost 

Share (Option 3). 
End-Use Products Containing Irons Salts (none were hatched) • 

EPA Reg. No. ~ Active lngr&dient . Formulation T}"Pe 

538·223 15.2% ferrow flllfate monohydrate granular 

557-1838 40.0% ferrous INlfate beptahydrate granular 

802-504 4.78% ferrous sulfate heptahydrate granular 

8.80% ferrous sulfate monohydrate 

802-509 35.0% ferric sulfate soluble cone. 

802-543 32.0% ferric sulfate monohydrate granular 

802-558 95.4% ferrous ~rulfate monohydrate granular 

3234-44 32.5% ferrous sulfate monohydrate granular 

7001-290 15.0% ferrous sulfate monohydrate granular 

7404..()3 25.38% ferrous sulfate monohydrate granular 

740441 17.05% ferrous sulfate monohydrate granular 

7404-10 39.85% ferrous sulfate monohydrate granular 

34704-713 65.0% ferrous rnllfate heptahydrate 10luble cone. 

64864-13 17.0% ferrous sulfate monohydrate granular 

64864-14 6.6% ferrous sulfate heptahydrate soluble cone. 
ATIACHMENT E 

EPA ACCEPTANCE CRITERIA 
Iii 
I 

Guideline 

Series 61 

Series 62 

Series 63 

SUBDIVISION D 

Study Title 

Product Identity and Composition 

Analysis and Certification of Product Ingredients 

Physical and Chemical Characteristics 
I 

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 tl3de 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 2:!. 0.1% by weight and 

for certain toxicologically significant impurities (e.g., dioxins, nitrosa.mines) 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 (tempelllture, pressure, humidity) controlled in each step and the 

parameters that are maintained. 

Statement of whether process involves intended chemical reactions. 

Flow chart with chemica] 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 L 0.1% or was found at L 0.1% by product analyses and (2) certain toxicologically signific 

impurities (see #3). 
Iii 

6l 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._ 

2._ 

3._ 

4. 

s._ 

6. 

7. 

8. 

9._ 

10. 

Five or more representative samples (batches in case of batch process) analyzed for each active ingredient and all 

impurities present at ..2:. 0.1%. 

Degree of accountability or closure ..2:. £! 98%. 

Analyses conducted for certain tnlCe 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 nitrosa.mines both fresh and sto 

samples must be analyzed.]. 

Complete and detailed description of each step in analytical method used to analyze above samples. 

Statement of precision and accuracy of analytical method used to analyze above samples. 

Identities and quantities (including mean and standard deviation) provided for each analyzed ingredient. 

Upper and lower certified limits proposed for each active ingredient and intentionally added inert along w 

explanation of how the limits were determined. 

Upper certified limit proposed for each impurity present at ~ 0.1% and for certain toxicologically signific 

impurities at < 0. 1% along with explanation of bow limit determined. 

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. 

Analytical methods (as discussed in #9) to verify certified limits validated as to their precision and accuracy. 
63 Pbysical and Chemical Characteristics 

ACCEPTANCE CRITilRIA 

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 o 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 o 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 Q! the specific gravity of liquids reported w 

reference to water at 20° C. [Note: Bulk density of registered products may be reported in lbs/ft' or lbs/gallo 

63-8 Solubility 

Determined in distilled water and representative polar and non-polar solvents, including those used in formulat 

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 o C) 

Experimental procedure described 

Reported in mm Hg (torr) or other conventionaJ 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 
I 

Data supporting reported vaJue 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 delermined 

Stability at normal and elevated temperatures 

Sensitivity to sunlight determined 
Iii 

Guideline 

81-1 

81-2 

81-3 

81-4 

81-5 

81-<; 

SUBDIVISION F 

Study DUe 

Acute Oral Toxicity in the Rat 

Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig 

Acute Inhalation Toxicity in the Rat 

Primary Eye Irritation in the Rabbit 

Primary Dermal Irritation Study 

Dermal Sensitization in the Guinea Pig 
Iii 81~1 Acute Oral Toxicity in the Rat 

ACCEPTANCE CRITERIA 

Docs 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. 

S. __ Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mglkg). 

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 anima1s. 
I 

81-l Acute Dermal toxicity in the Rat. Rabbit or Guinea Pig 

ACCEPTANCE CRITERIA 

Does your study meet the following acceptance criteria? 

1. __ Identify material tested (technical, end-use product, etc). 

2. __ At least 5 animals/sex/group. 

3.!__ Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 3So-4SO 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. 

II. __ 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 supplementa1 and may not be required for every study. 
I 

81-3 Acute Inhalation Toxicity in the Rat 

ACCEPTANCE CRITERIA 

Does your study meet the foUowing acceptance criteria? 

!. __ Identify material tested (technical, end-use product, etc). 

2. Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use or 

-- contains particles of inhalable size for man (aerodyna.mic diameter 15 p.m or less). 

3. __ At least S young adult rats/sex/group. 

4. __ Dosing, at least 4 hours by inhalation. 

5. __ Chamber air flow dynamic, at least 10 air changeslbour, at least 19% oxygen content. 

6. __ Chamber temperature, 22° C (±2"), relative humidity 40-60%. 

7. __ Monitor rate of air flow. 

8. __ Monitor actual concentrations of test material in breathing woe. 

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._ 

12. 

13. 

14. 

Individual observations at least once a day. 

Observation period to last at least 14 days. 

Individual body weights. 

Gross necropsy on all animaJs. 
814 Primary Eye Irritation in the Rabbit 

ACCEPTANCE CRITERIA 

Does your study meet the following acceptance criteria? 

1. __ Identify material tested (technical, end-use product, etc). 

2. __ Study not required if material is corrosive, causes severe 

dermal irritation or has a pH of <2 or ~11.5. 

3. 6 adult rabbits. 

4. __ Dosing, instillation into the conjunctival sac of one eye 

pe>' 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 I, 24, 48 and 72 hr, then daily until eyes are normal 

or 21 days (whichever is shorter). 

9.!......,.. Individua1 daily observations. 

Criteria marked with an* are supplemental and may not be required for every study. 
I 

81-S Primary Dennallrritation Study 

ACCEPTANCE CRITERIA 

Does your study meet the following acceptance criteria? 

l. __ Identify material tested (technical, eod-use product, etc). 

2. __ Study not required if material is corrosive or bas a pH of ~2 or 211.5. 

3. __ 6 adult animals. 

4. __ Dosing, sinj:le dermal. 

5. __ Dosing duration 4 hours. 

6. __ Application site shaved or clipped at least 24 hours prior to dosing. 

7 . __ Application site approximately 6 em'. 

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.!__ lndividuaJ daily observations. 

Criteria marked with an • are supplemental and may not be required for every study. 
I 

81-6 Dennal Sensitization in the Guinea Pig 

ACCEPTANCE CRITERIA 

Does your study meet the following acceptance criteria'? 

1._ Identify material tested (technical, cod-use product, etc). 

2._ Study not required if material is conosive or has a 

pH of .5_2 or 2Jl.S. 

3._ One of the following methods is utilized: 

__ Freund's complete adjuvant test 

__ Guinea pig maximization test 

__ Split adjuvant technique 

Buehler test 

__ OpeD epicutaneous test 

__ Mauer optimization test 

__ Footpad technique in guinea pig. 

4._ Complete description of test. 

S. !_ 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. 
I 

AITACHMENT F 

LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE 

li 

ATIACHMENT G 

COST SHARE AND DATA COMPENSATION FORMS 
li 
United States Environmental Protection Agency Form Approved 

ft EPA Washington, DC 20460 

~ CERTIFICATION WITH RESPECT TO OMB No. 2070-0106 

'i'7 DATA COMPENSATION REQUIREMENTS Approval Explr .. 12-31-i2 

Public reporting burden for this collection of infonnation 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 Polley 

Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office 

of Management and Budget, PapeiWork Reduction Project (2070-01 06), Washington, DC 20503. 

Please fill In blanks below. 

Company Name Company Number 

Chemical Name EPA Chemlc::el Number 

I Certify that: 

1. For each study cited in support of registration or reregistration under the Federal Insecticide, Fungicide and 

Rodenticide Act (FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the 

written permission of the original data 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 1 have cited and have offered to: (a) Pay 

compensation for those data in accordance with sections 3(c)(1 )(D) and 3{c){2)(0) 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) 

I I 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.) 

I I The companies who have submitted the studies listed on the back of this form or attached 

sheets, or indicated on the anached NRequirements Status and Registrants' Response Form,N 

3. That 1 have previously complied with section 3(c)(1)(D) of FIFRA for the studies I have cited in support of 

registration or reregistration under FJFRA. 

Signature Date 

Name and Title (Please Type or Print) 

GENERAL OFFER TO PAY: 1 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 F:orm 8570-31 (4-90) 
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United States Environmental Protection Agency Form Approved n EPA Washington, DC 20460 

~, CERTIFICATION OF OFFER TO COST OMB No. 2070-0106 

SHARE IN THE DEVELOPMENT OF DATA Approval Explrea 12·31·92 

Public reporting burden for this collection of infonnation 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, 40, 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 Chemle~~l 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 

dale(s): 

Name ol Firm{s) Date of Offer 

Certification: 

I certify that t am duly authorized to represent the company named above, and that the statements that I have made on 

this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or 

misleading statement may be punishable by fine or imprisonment or both under applicable law. 

Signature ol Company's Authorized Representative Dale 

Name and Tille (Please Type or Print) 

EPA Form 8570·32 
&EPA 

UnniiCI Stites Environmentll Protecuon A;ency Wl&hin;ton, DC 20460 

Formulator's Exemption Statement 

(40 CFR 152.85! 

Fonn Approved 

OMD No. 2070-0060 

Approval expires 9-30-90 

EPA File Symboi/Ae;ilttltion Number 

O.te of Confldentill Stlltement of Formula (EPA Form 1570~) 

As an authorized representative of the applicant for registration of the product 

identified above, I hereby certify that: 

(I) This product contains the following active ingredient(s): 

(2) or these, each active ingredient listed in paragraph (4) is present solely as the 

result of the incorporation into the product (duringformulotion or packaging) of 

another product which contains that active ingredient, which is registered under 

FlFRA Section 3, and which is purchased by us from another producer. 

(3) Indicate by checking (A) or (B) below which paragraph applies: 

0 (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 (l ). 

OR 

0 (B) The Confidential Statement of Formula (CSF) (EPA Form 8570-4) referenced 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. 

Source 

Active ln;red1ent Product Neme Registret•on Number 

S•;nature Neme 1nd T•tle 011e 

t:PA Form 8670-27(10-86) 
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