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United States Environmental Protection Agency Office of Prevention, Pesticides EPA738-S andToxic Substances (H-750BW) February • 

# &EPA Reregistration Eligibility Document (RED)

Iron SaltsUnited 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 Allpesticides 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 ofeach 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 ofiron 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 orone ofseveral active ingredients; oneproduct contains Iron 

### (III)

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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 ofminerals, and is present in foods naturally and through added ingredients. The iron salts are oflow acute toxicity through oral, dennal and inhalation routes ofexposure. They 

### have been placed in lbxicity Category ill for these effects. Although a mutagenicity study using microorganisms showed positiveresults, it is unlikely that such effects would result in humans or other mammals at thelevels ofexposure expected from the use ofiron salts as pesticides. Other toxicity studies normally required for reregistration were not necessary 

### to evaluate the risks ofthe iron salts. Dietary Exposure Dietary exposure is not expected to result from use ofthe iron salts as pesticides. No 

### food or feed-related uses areregistered, and no tolerances (maximum residue limits) or exemptions from the requirement ofa tolerance are established. Further, the iron salts are generally recognized as safe (GRAS) by theFood 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 Thepotential for mixer, loader and applicator exposure exists when liquid orgranular iron salts products are applied to lawns, turfand other outdoor sites using spreaders, sprinkler cans orby hand. However, these inorganic salts are oflittle concern from a toxicity perspective. Any exposure ofmixers, 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. Itis general knowledge that these compounds are oflow toxicity. They are intentionally added to foods as flavoring agents and nutrient supplements, and they have an inherent function in the melabolic systems ofhumans and domestic animals. 

### Environmental Environmental Fate 

### Assessment The environmental fu.te and transport ofiron salts is dominated by three processes: the conversion ofIron (II) to Iron (Ill), the formation of

2

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Additional Data Required

Product Labeling Changes Required

Regulatory Conclusion insoluble oxides and hydroxides that also arewell known 

### components of soils, and the distinct surface chemistry ofthe 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 ofiron 

### salts as herbicides to 

### control moss is not expected to contribute significantly to the chemistry and fute ofthe 

### compounds existing naturally in 

### the environment. No unreasonable

**effec~** 

### areexpected from the use ofthese pesticideproducts 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 ofthe 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 ofiron salts. 

### Iron is one ofthe earth's most abundant elements, and 

### it is immobilized at the pH range of5-9. Runoff to 

### aquatic systems is unlikely since the parentcompounds 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! 

### ofiron 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 ofall 

### 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 ofequipment 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 bereregistered 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 oncethe 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 timeperiod, as announced in a Notice ofAvailability published in theFederal

**Re~ister.** Th obtain a 

### copy ofthe RED or to 

### submit written comments, please contact the Pesticide Docket, PublicResponse and Program Resources Branch, Field Operations Division (H-7506C), Office 

### ofPesticide Programs (OPP), US EPA, washington, DC 20460, telephone 703-305-5805. Following the commentperiod, the iron salts RED 

### will beavailable 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. Forinformation 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 ofpesticides, 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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REREGISTRATIONELIGffiiLITY DOCUMENT IRON SALTS LISTD CASE 4058

ENVIRONMENTAL PROTECTION AGENCY OFFICE OF PESTICIDE PROGRAMS SPECIAL REVIEW AND REREGISTRATION DIVISION WASHINGTON, D.C.

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IRON SALTS REREGISTRATION ELIGIBILITY TEAM 

### Office ofPesticide Programs: Bioloeical and Economic Analysis Division Jim Saulmon Biological Analysis Branch Ed Brandt Economic Analysis Branch SteveJarboe Biological Analysis Branch Environmental Fate and Effects Division Concepcion Rodriguez Ecological Effects Branch SylviaTermes 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 ofGeneral Counsel Alan Carpien 

### Office ofCompliance Monitoring Phyllis Flaherty FIFRA Policy & Analysis Branch Policy and Grants Division

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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 ofEligibility ............................. 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 ofthe 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 ofIron Salts APPENDIX D

- List ofAvailable Related Documents APPENDIX E

- Pesticide Reregistration Handbook APPENDIX F

- Generic Data Call-In

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Attachment A - Chemical Status Sheet Attachment B

- Generic DCI Response Forms (Form A) plus Instructions Attachment C - Requirements Status and Registrants' Response Forms (Form 

### B) plus Instructions Attachment D - List ofall Registrant(s) sent this DC! Attachment E - Cost Share/Data Compensation Forms APPENDIX G - Product Specific Data Call-In Attachment A - Chemical Status Sheet AttachmentB

- ProductSpecificDC!ResponseForms (FormA) plusInstructions 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 ofall 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 OFTERMS AND ABBREVIATIONS Active Ingredient Chemical Abstracts Service Confidential Statement ofFormula 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 DoseTested Median Lethal Concentration. A statisticallyderived concentration ofa substance that can be expected to cause death in 50% of test animals. It is usually expressed as theweight ofsubstance perweight orvolumeofwaterorfeed, e.g., mg/1 or ppm. Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50% ofthe test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as a weight of substance per unit weight ofanimal, 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 ofrecording 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 ofPesticide 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

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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 ofmoss on ornamental herbaceous plants, lawns, turf, wood shrubs andvines. This Reregistration Eligibility Document (RED) addresses the eligibility for reregistration ofproducts containing these active ingredients for the above mentioned use sites only. TheU.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 oflabeling to complete the generic database. Before reregistering the products containing these iron salts, the Agency is requiring that product specific data and revised labeling be submitted within eight months ofthe issuance ofthis document. These data includeproduct 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) ofFlFRA.II. INTRODUCTION In 

### 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was 

### amended to accelerate the reregistration ofproducts 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 ofthe process focus on identification ofdata requirements to support the reregistration ofan active ingredient and the generation and submission ofdata to fulfill the requirements. The fifth phase is a review by the U.S. Environmental Protection Agency (referred to as "the Agency") ofall 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 ofthe scientific data base underlying a pesticide's registration. The purpose ofthe Agency's review is to reassess the potential hazards arising from the currently registered uses ofthe 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 ofFIFRA. This document presents the Agency's decision regarding the reregistration eligibility ofthe registered uses ofiron (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 ofapplicable data are available on request. 1

1EPA's reviews ofdata on the set ofregistered uses considered for EPA'sanalysis may be requested from the Public Response and Program Resources Branch, Field Operations Division (H7506C), Office ofPesticide 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 ofPesticide 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 ofPesticide Programs Chemical Code: 50507

3. Chemical Name: Iron (11) sulfate heptahydrate


### o CAS Registry Number: 7782-63-0
o Office ofPesticide Programs Chemical Code: 50502
o Empirical Fonnula: FeS04-7H2 0



### 3

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B. Use Profile The following is information on the current registered uses with an overview ofuse sites and application methods. A detailed table ofthese uses ofiron (III) sulfate, iron (II) sulfate monohydrate and iron (II) sulfate heptahydrate is 

### in Appendix 

## A. 1. For Iron (Ill) sulfate: 

### Type ofPesticide: 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 orPesticide: 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

4

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Methodand Rates ofApplication: 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) 

### sulfateheptabydrate: Type 

### ofPesticide: 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 ofApplication: EQuipment Spreader; sprinkler can; by hand; sprayer 

### Method and Rate Spray Ornamental lawns and turf 

### 57 lb iron/A. Timine: 

### When needed.



### 5

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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. Thecurrent 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 ofiron 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 ofthe scientific data base for iron salts for the purposes ofdetermining the reregistration eligibility ofthese 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 ofa 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.



### 6

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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, of2778 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 ofcontact 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 ofthese 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 ofthese compounds 

### as pesticides.


### c. Metabolism Iron sulfates are normal constituents ofthe 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 ofthe toxicity data usually required for pesticide registration or reregistration 

### are necessary for the present uses ofiron 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 oftolerances established for iron salts. Since there are :1.0 

### toxicological endpoints ofconcern 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 turfand 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. Thepotential for mixer/loader/applicator exposure exists; however, these inorganic salts are oflittle 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 ofiron (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 orexposure 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 ofiron 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 ofminerals 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, FeS2; chalcopyrite, CuFeS2, etc.), phosphates (for example vivianite) and incomplex silicate,.(l,2) Weathering (that is, "the group ofprocesses such as the chemical action ofair, rainwater, plants and bacterial, and the mechanical action ofchanges of temperature whereby rocks on exposure to weather change in character, decay and finally crumble into soil")(3) has considerably influenced the distribution ofiron 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 ofsoils. Thepresence ofhematite and goethite in soils (usually associated with gibsite and kaolinite) is indicative ofan advanced stage ofweathering.(4) The oxidation offerrous iron to ferric iron (from here on referred to as Fe(!!) and Fe(III), respectively) is a very important aspect ofthe chemistry ofiron salts in the environment. The oxidation is dependent on the pH and the redox potential ofthe medium (water; soil) and the nature ofthe 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 ofnormalto-high oxygen content, the latter being the most commonly encountered condition. The speciation and subsequent fate and transport ofFe(II) and Fe(III) in the environment is, therefore, determined by the pH and redox potential ofthe media and by the nature ofthe 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 ofless soluble oxide and hydroxide.(?) The precipitation ofFe(Ill) oxides/oxyhydroxides from oxidation of Fe(II) salts or from Fe(III) salts occurs in a stepwise manner, which involves (a) formation oflowmolecular weight species ofpoor crystalline

**ordering~** (b) formation of red cationic polymers; (c) aging ofthe polymers, with eventual conversion to better defined oxide phases; (d) precipitation of oxide/oxyhydroxide phases ofwell defined crystallographic characteristics.(5) The rate of formation and the onset ofthe polymeric species are known to be strongly influenced by the nature ofthe counter anion ofthe salts.(5) In the case ofsalts ofthe 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 ofFe(II) and Fe(II) sulfates in a terrestrial environment leads to the formation ofinsoluble oxide/oxyhydroxide species.(?) The oxide/oxyhydroxide species that form from the use ofFe 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 ofweathering.(4,7) Thermodynamic and 

### kinetic factors influence the predominance ofcertain species over other.(?) Soil temperature, soil moisture and soil pH are significant environmental factors that control the distribution ofthese 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 oftropical or subtropical regions hematite is the predominantoxide, although it is rarely free ofgoethite.(8) The lepidocrocite-goethite association 

### in soils is less understood. Thepredominance oflepidocrocite 

### in a soil has been attributed to the prevalence ofconditions favoring reduction of Fe(Ill) to Fe(Il) followed by movement ofFe(Il) to betteraerated sites, where oxidation to Fe(III) and precipitation oflepidocrocite occurs.(9) Ferrihydrite may be considered as a young iron oxide oflow order of crystallinity. Subsequent transformation offerrihydrite into other oxides ofiron is dominated by the environmental conditions.(lO) One ofthe most important properties ofiron oxides/ oxydroxides (naturally occurring or formed by precipitation from iron salts) is their very active surface chemistry.(11) The surfaces ofiron oxides and hydroxides acquire a pH-dependentcharge, which controls the adsorption ofa wide range ofchemical 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 ofphosphate by iron oxides/ oxyhydroxides is an important process in soils; together with aluminum, calcium, magnesium, potassium, and manganese (II), they control the solubility ofphosphates in soils.(l4) Soils rich in iron oxide/oxyhydroxides (for example, oxisols) are known to fix large amounts ofphosphate fertilizers.(l5) Humic substances and other organic materials are known to adsorb onto oxide/ oxyhydroxide particulates. The surface properties ofoxides/ oxyhydroxides determine the degree ofaggregation/cementation ofsoil 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 ofiron 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 ofbacterially mediated oxidation 

### by organisms such as Thiobacillus ferrooxidans results in formation ofinsoluble 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 ofthese salts as directed.
b. Environmental Fate Assessment In summary, the fate and transport ofFe(II) and Fe(IID salts in the environment is dominated by three major processes: {1) the pHredox potential dependent oxidation ofFe(II) to Fe(III); (2) the formation ofinsoluble oxides and hydroxides that are also well known components of soils; and (3) the distinct surface chemistry ofthe oxides and hydroxides ofiron that control the adsorption ofanions, cations and organic material or the adsorption ofiron species onto the surfaces of mineral and organic components ofsoils, contributing to the aggregation of soil particles into larger units. In terrestrial environments, the use ofFe(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 ofiron 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 ofthe 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 

## >5620ppm 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 

### of7.I ppm for Daphnia pulex and LC50 

### of20.8 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 oraquatic populations are anticipated from the use ofiron salts. Iron is one of the most abundant elements and will be immobilized at the environmentally important pH range of5-9. There is very little likelihood for runoffto 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 oraquatic endangered species are anticipated from the use ofiron 

### salts. 

## W. RISK MANAGEMENT AND REREGISTRATION DECISION FOR IRON SALTS 

### A. Detennination ofEligibility Section 4(g)(2)(A) ofFIFRA calls for the Agency to determine, after submission ofrelevant data concerning an active ingredient, whether products containing the active ingredient are eligible for reregistration. The Agency has completed its review ofdata 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 ofits determination ofreregistration eligibility ofiron 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 ofiron 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 ofparticular products is addressed in Section VI ofthis 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 ofadditional data to support the registration ofproducts containing iron salts, ifnew information comes to the Agency's attention or ifthe data requirements for reregistration (or the guidelines for generating such data) change. The following is a summary ofthe regulatory positions and rationales for iron salts. Where labeling revisions are imposed, specific language is set forth in Section V ofthis document. 

### VI. EL!Gffi!LITY DECISION The Agency has sufficient information on the human health effects ofiron 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 EligibilityDocument, will not pose unreasonable risks or adverse effects to humans or the environment. 

### A. Eligible and IneligibleUses 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 DataRequirements The generic data base supporting the reregistration ofiron salt-containing products has been reviewed and determined to be substantially complete. Although some ofthe 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 ofthe generic Data Call-In requirements in Appendix 

### F. B. Product specific data requirements 1. 

### Additional Product-Specific Data

### Requirements Based on the reviews ofthe generic data for iron salts, theproducts 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 ofeligibility 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 ifnot, commit to conduct new studies. Ifthe 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 ofend-use products and Manufacturing-Use Products must contain the following label statements: 

### 15

# li

1. 

### Manufacturing-UseProducts 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 ofall 

### 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

# IAPPENDIXA-Case4058,[IronSalts]Chemical050502(Ferroussulfateheptahydrate]=-T....-.......--..........•••...•••_.....---·..........USESELIGIBLEFORREREGISTRATIONNONFOOD/NONFEEDUSESOrnamentalLawnsandTurfUseGroups;TerrestrialNon-FoodCropandOutdoorResidentialSprinkle,Whanneeded,Sprinklecansets"'52.2721b""""'IronpetacraspecspecSpray,Whennel'lded,SprayerSC/S"'52.272lb""""peracrespecspacBro11dcast,Whenneeded,SpreaderG"'13.9392lb""""IronperacrespecspecBroadcast,Whenneeded,Spra!!derSC/S"'41.8178lboo<""IronperIIICtespecspecSprinkle,Whenneeded,SprinklercanSC/L"'Dosecannot""'oo<bespec specBrosdc11st,Whenneeded,ByhandSC/S"'41.8176lb""""'IronperacrespeclpecAbbreviationsusedHe110"'.Form:max..maximum;min"'minimum;apps..applications;notspec=notspecified;na..notepplicabh1G=grenular;SC/l..solubh1concentrete/liquid;SC/S=solubleconcentrete/solid-·--·---··"-.....,.,..-,..,.,.....-InotspecnotspecnotspecnotspecllOtspecnotspecnotspecnottpecnotSPIICnottpecnotspecnotapecIE-.,APPENDIXA-Case4058,[IronSalts]Chemical034902[Ferricsulfate]811"1'................,..._...,;_..-·--------.....e..---·....,-·-..........-USESRIGIBLEFORREREGISTRATIONNONFOOD/NONFEEOUSESOrnamentalLawnsandTurfUeeGroups:TerrestrialNon-FoodCropandOutdoorResidentialSprey,Whenn11aded,Hose-endSprayerSC/l""Dosecannotoo<oo<AaneedednotapaobecalculatedspecspecSpray,Whenneedltd,SprinklercanSC/l""Dosec11nnot""oo<AsneedednotspecbecalculatedspecspecAbbreviationsusedHeeder;max•maximum;min=minimum;epps..applications;notspec..notspecified;ne•notapplicableForm:SC!L=solubleconcantrataJ1iquid

# APPENDIX B TableofThe Generic Data Requirements and Studies Used to Makethe ReregistrationDecision

# Iii
GUIDE TO APPENDIX B Appendix B contains listings ofdata 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 appearin 40CFRPart 158. thereference numbersaccompanying each test refer to 

### thetest protocols set in the Pesticide assessment Guidelines, which are available from the National 

### Technical Information Service, 5285 PortRoyal 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). Ifthe 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 acomplete citation ofthe study.•

IRON III SULFATE
GUIDELINE GUIDELINE NAME USE BIBLIOGRAPHIC SITES CITATION

§158.120 Product Chemistry

61·1 Chemical Identity All 41764501, 41764502

6l-2(a) Beginning Materials and Manufacturing Process All 41764501, 41764502

6l-2(b) Formulation of Impurities All 41764501, 41764502

62-l Preliminary Analysis All 41764501, 41764502

62-2 Certification of Limits All 41764501, 41764502

62-3 Analytical Methods All 41764501, 41764502

63-2 Color All DATA GAP

63-3 Physical State All DATA GAP

63-4 Odor All DATA GAP

63-5 Melting Point All DATA GAP

63-6 Boiling Point All DATA GAP

63-7 Density All DATA GAP

63-8 Solubility All DATA GAP

63-lO Dissociation Constant All DATA GAP

63-12 pH All DATA GAP

63-!3 Storage Stability All DATA GAP111

IRON III SULFATE GUIDELINE GUIDELINE NAME USE BIBLIOGRAPHIC SITES CITATION

§158.130 Environmental Fate

All environmental fate data requirements have been waived.
§158.135 Toxicology 81-1 Acute oral tox. rat All 42170701

81-2 Acute dennal tox. rabbit All 42171702

81-3 Acute inhal. tox rat All 42171703

81-4 Primary eye irritation-rabbit All 41758701

81-5 Primary dermal irritation All 41758702

81-6 Dermal sensitization/guinea pig All 41758703

§158.145 Ecological Effects 71-l(a) Acute Avian Oral Toxicity -QualUDuck All WANED

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

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

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

72-l(c) Fish toxicity rainbow trout All WANED

72-2(a) Freshwater Invertebrate Toxicity All WAIVEDIll

IRON II SULFATE MONOHYDRATE

GUIDELINE GUIDELINE NAME USE BIBLIOGRAPHIC SITES CITATION

§158.120 Product Chemistry

61-1 Chemical Identity All 142309

61-2(a) Beginning Materials and Manufacturing Process All 142309

61-2(b) Formulation of Impurities All 142309

62-1 Preliminary Analysis All 142309

62-2 Certification of Limits All 142309

62-3 Analytical Methods All 142309

63-2 Color All 142309

63-3 Physical State All 142309

63-4 Odor All 142309

63-5 Melting Point All 142309

63-6 Boiling Point All 142309

63-7 Density All 142309

63-8 Solubility All 142309

63-10 Dissociation Constant All 142309

63-12 pH All 142309

63-13 Storage Stability All 142309

# I l

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# ].,IRONIISULFATEMONOHYDRATEGUIDELINEGUIDELINENAMEUSEBIBLIOGRAPHICSITESCITATION§158.120ProductChemistry61-1ChemicalIdentityAll14230961-2(a)BeginningMaterialsandManufacturingProcessAll14230961-2(b)FormulationofImpuritiesAll14230962-1PreliminaryAnalysisAll14230962-2CertificationofLimitsAll14230962-3AnalyticalMethodsAll14230963-2ColorAll14230963-3PhysicalStateAll14230963-4OdorAll14230963-5MeltingPointAll14230963-6BoilingPointAll14230963-7DensityAll14230963-8SolubilityAll14230963-10DissociationConstantAll14230963-12pHAll14230963-13StorageStabilityAll142309Ill

IRON II SULFATE MONOHYDRATE

GUIDELINE GUIDELINE NAME

USE BIBLIOGRAPHIC SITES CITATION

§158.130 Environmental Fate

All environmental fate data requirements have been waived.
§158.135 Toxicology 81-1 Acute oral tox. rat All WAIVED

81-2 Acute dermal tox. rabbit

All WAIVED

81-3 Acute inhal. tox rat

All WAiVED

81-4 Primary eye irratiOn-rabbit

All WANED

81-5 Primary dermal irritation

All WAIVED

81-6 Dermal sensitization/Guinea pigs

All 41763701

§158.145 Ecological Effects 71-1(a) Acute Avian Oral Toxicity -Quail/Duck All 40091902

71-2(a) A vi an Dietary Toxicity -Quail/Duck All 40091903

71-2(b) Acute avian diet. duck

All 40091904

72-1(a) Freshwater Fish Toxicity -Bluegill All 40091905

72-1(c) Fish toxicity rainbow trout All 40091906

72-2(a) Freshwater Invertebrate Toxicity All 40091907IRON II HEPTAHYDRATE
GUIDELINE GUIDELINE NAME USE BIBLIOGRAPHIC SITES CITATION

§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. The public literature is

identified

the bibliography. •.,

IRON II HEPTAHYDRATE GUIDELINE GUIDELINE NAME USE BIBLIOGRAPHIC SITES CITATION

§!58 .130 Environmental Fate

All environmental fate data requirements have been waived.
§158.135 Toxicology 81-1 Acute oral tox. rat All WAIVED

81-2 Acute dermal tox. rabbit All WAIVED

81-3 Acute Inhalation-Rat All 137725

81-4 Primary eye irration-rabbit All 137726

81-5 Primary dermal irritation All 137726

81-6 Dermal sensitization/Guinea pigs All WAIVED

§158.145 Ecological Effects 71-l(a) Acute avian oral quaiUduck

All 40142201

71-2(a) Acute avian diet. quail

All 40142202

71-2(b) Acute avian diet. duck All 40142203

72-l(a) Fish toxicity bluegill All 40142204

72-l(c) Fish toxicity rainbow trout All 40142205

**7?-'U~)** JnvPrlPhMtP tnYir-ihr ... **·~·** ·----

# li

# Iii

APPENDIX 

# C ffiON SALTS BIBLIOGRAPHY Citations Considered to be Part ofthe Data Base Supporting the ReregistrationofIron Salts

# li

d. Trailingparentheses. Forstudies submitted tothe Agency in thepast, 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 theregistration number, experimental usepermitnumber, 

### 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 trailingparentheses identifies the EPA accession number ofthe volume in 

### which 

### the original submission of the study appears. The six-digit accession numberfollows 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 ofthe 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 ofMines, 1968. 

### 4. Schulze, D.G. •Ao 

### Introduction to 

### Soil Mineralogy• in Minerals in 

### S2i! Environments, Second Edition 

### edited 

### byJ.B. Dixon and S.B. Weed. Soil Science 

### Society ofAmerica, Madison, WI, 1989, p.5. 5. Flynn, C.M., Jr. "Hydrolysis ofInorganic 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 byJ.B. Dixon and S.B. Weed. Soil Science Society ofAmerica, 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. "CationicFlotation ofOxides and Silicates• in Flotation. A.M. Gaudin Memorial Volume, M.C. Fuerstenau, Editor. Volume I, 1976. 

### Published by the Society ofMining Engineering, AIME, New York. pp 87-179. 13. Fuerstenau, M.C. and Palmer, B.R. "Anionic Flotation ofOxides and Silicates" in 

### Flotation. A.M. Gaudin Memorial Volume, M.C. Fuerstenau, Editor, Volume 

### I, 1976, pp. 146-196. Published by the Society ofMining 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 ofDispersion and Aggregation ofMineral Fines", in Beneficiation of Mjneral Fines, 

### edited 

### by P. Scnmasnndaran and N. Arbiter, 

### Society ofMining 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 ofAcid MineWatersheds", 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 HandbookofChemist[)'and Physics. CRCPress, Inc., 

### Boca Raton, FL, Pages 13-98. Lindsay, W. 

### L., 1979, Chemical EQuilibria in Soils John Wiley & 

### Sons, N. Y., Page 131. Thorpe'sDictiomuy ofApplied ChemistryVol. 

### VJJ, 1937Longmans, 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 ofFerrous Sulfate Monohydrate., Charles H. Lilly Company, 1990. Klettke, M. PrimaryEyeIrritation Study,FerrousSulfate, ProjectT.l008, Harris Laboratories, Inc. 1990. Klettke, M., Primary Skin Irritation Study, ProjectT.1009, Harris Laboratories, Inc. 1990. Fletcher, D. (1986) Acute Oral Toxicity Studywith Ferrous SulfateMonohydrate 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-DayDietaryLC50StudywithFerrousSulfateMonohydrate in

### Mallard Ducklings: Laboratory ProjectID: BLALNo. 85 DC 63. Unpublished study prepared by Bio-Life Associates, Ltd. 28 p. Fletcher, D. (1986) 8-DayDietaryLC,Studywith Ferrous SulfateMonohydrate 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 (Lepomismacrochirus): BionomicsReport #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 RainbowTrout (Salmogairdneri): 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 Eyelrritatancy Study in Rabbits, Ferric Sulfate, FerriFloc: Lab Project No. D3082. Unpublished Study prepared by Cosmopolitan Safety Evaluation, 1990. Robbins, G.,PimaryEyelrritatancy Studyin Rabbits, Ferric Sulfate, FerriFloc: 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 ofIngredients, Tennessee Chemical Company'sFerri-Floc, Ferric SulfateLab Project No 1991-1. Unpublished Study prepared by Tennessee Chemical Co., 1991. Gohlke, A., Analysis and Certification of Ingredinents in Tennessee Chemical 

### company'sFerri-Floc, Tennessee Chemical Company'sFerri-Floc, FerricSulfate LabProjectNo 1991-2. Unpublished Studyprepared byTennessee ChemicalCo., 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: LabProject Number: B3251. Unpublished studyprepared by Cosmopolitan Safety Evaluation, Inc. 24 p. Robbins, G. (1991) Acute Inhalation Study in Rats: Ferric Sulfate, Ferri Floc: Lab

### ProjectNumber: C3251. Unpublished studypreparedbyCosmopolitanSafety Evaluation, Inc. 34 p.

# I

APPENDIXD List of

## AvailableRelated Documents The following is a list ofavailable documents related to iron salts. Its purpose is to providea path to moredetailed infonnation if

### it is needed. Theseaccompanying documents are 

### partoftheAdministrativeRecord foriron saltsand areincluded in theEPA'sOfficeofPesticide 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

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Appendix E, F, & 

# G are separate docucments

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APPENDIXE PesticideReregistrationHandbook andPRNotice91-2

## PRNotice 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

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amounts of an ingredient that may legally be present 40 CFR 158.175. The lower certified limit is used as the enforceable 

### lower limit for the product composition according to FIFRA section 12(a) (l)(C), while the nominal concentration appearing on the label would be the routinely achieved concentration used for calculation of dosages and dilutions. The nominal concentration would in fact state the greatest degree of accuracy that is warranted with respect to actual product composition because the nominal concentration would be the amount of active ingredient typically found in the product. It is important for registrants to note that certified limits for active ingredients are not considered to be trade secret information under FIFRA section 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.

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IV. PRODUCTS THAT REQUIRE EFFICACY DATA All pesticides are required to be efficacious. Therefore, the certified lower limits may not be lower then the minimum level to achieve efficacy. This is extremely important for products which are intended to control pests which threaten the 

### public health, e.g., certain antimicrobial and rodenticide products. Refer to 40 CFR 153.640. 

### In those cases where efficacy limits have been established, the Agency will not accept certified lower limits which are below that level for the shelf life of the product. V. COMPLIANCE SCHEDULE As described earlier, the purpose of this Notice is to make the registration process more uniform and more manageable for both the agency and the regulated community. It is the Agency's intention to implement the requirements of this notice as smoothly as possible so as not to disrupt or delay the Agency's high priority programs, i.e., reregistration, new chemical, or fast track (FIFRA section 3(c) (3) (B). Therefore, applicants/registrants are expected to comply with the requirements of this Notice as follows: (1) Beginning July 1, 1991, all new product registrations submitted to the Agency are to comply with the requirements of this Notice. (2) Registrants having products subject to reregistration under FIFRA section 4(a) are to comply with the requirements of this Notice when specific products are called in by the Agency under Phase V of the Reregistration Program. (3) All other products/applications that are not subject to (1) and (2) above will have until July 1, 1997, to comply with this Notice. such applications should note "Conversion to Nominal Concentrations on the application form. These types Or amendments will not be handled as "Fast Track 11 

### 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



# ~~-d~~ Anne 8. 

### Lindaay,

**Dir~etar** 

### Cl- 

### Regi;tration Civision (H-7505

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APPENDIXF <;t,nericData Call-In

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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 ofcontact 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 ofregistrants 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 (AttachmentF). 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 ofall 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 ofPesticide Programs U.S. Environmental Protection Agency Washington, D.C. 20460 RE: IRON SALTS

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Attachment B Generic 

### DCI Response Fonns (Fonn A) plus Instructions

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# I
SPECIFlC INSTRUCTIONS FOR 1HEGENERIC 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 ofreregistering 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 mustbecompleted 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 ofinformation 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 ofinformation. Send comments regarding the burden estimate or any other

### aspect ofthis collection ofinformation, 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 ofdata 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 ofyour 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 ofthis response form. Cheekthis item for each product registration you wish to cancel voluntarily. If

### a 

### registration number is listed for aproduct for which you previously requested voluntary cancellation, indicate in Item 5 the date ofthat 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 ifthis data call-in is for generic data as indicated in Item 3and ify are eligible for aGeneric 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 ofa Generic Data Exemption as explained in the Data Call-In Notice.

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Item 6b

Item 7a

Item 7b

Item 8

Item 9 Item 10
Item II Ifyou are eligible for orclaim a Generic Data Exemption, enter the EPA registratio Number ofeach registered source ofthat active ingredient that you use in your 

### product. Typically, 

### ifyou 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, oruse any unregistered produc (regardless ofthe fact that some ofyour sources are registered), you may not claim a Generic Data Exemption and you may not select this item. 

### Check this Item ifthe 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 ofthis data call-in. Attac the Requirements Status and Reeistrant's Reswnse Form that Indicates how you 

### wil satisfy those requirements. 

### Check this item ifthis call-in ifa 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 ifthis call-in is a data call-in for an end use product (EUP) as indicated in 

### Item 3 and ifyour 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 ofyour company and the person signing must include his/her title. Additional pages used in your response must beinitialled and dated in the space provided for the certification Enter the date ofsignature. Enter the name ofthe person EPA should contact with questions regarding your response. Enter the phone number ofyour company contact.

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Attachment C Requirements Status and Registrants' Response Fonns (Form B) plus Instructions

# IIi

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SPECIFIC INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND REGISTRANTS RESPONSEFORM Generle Data This form is designed to 

### be used for registrants to respond to eall-in- for generic and produet-speeifie data as partofEPA'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 ofuses or (2) request for a low volume/minor use waiver. These instructions are for completion of

**~eneric** datareguirements EPA has developed this form individually for each data call-in addressed to each registrant, and ha preprinted this form with a number ofitems. 

### DO NOT use this form for any otheractive ingredient. Items 1 through 8 (inclusive) will have been preprinted on the form. You must completeall other items on this form by typing orprinting legibly. Public reporting burden for this collection ofinformation 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 ofinformation. Send comments regarding the burden estimate or any other aspect ofthis collection ofinformation, 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 ofdata call-in. This item identifies the guideline reference numbers ofstudies reguired to support t product(s) being reregistered. These guidelines, in addition to requirements specified in the Data Call-In Notice, govern the conduct ofthe required studies. This item identifies the study title associated with the guideline reference number 

### an whetherprotocols and 

### 1, 2, or 3-yearprogress reports are reguired to be submitted 

### in connection with the study. As noted in Section illofthe Data Call-In Notice, 90-d progress reports are required for all studies. 

### Ifan 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 ofthe pesticide. A brief description ofeach 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 briefdescription 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 orTypical End-Use Produc 

### Technical Grade Active Ingredient or Pure Active Ingredient Metabolites 

### Impurities DegradatesItem 8.

Item 9. This item Identifies the time frame allowed for submission ofthe study orprotocol identified in item 2. The time frame runs from the date ofyour receipt ofthe Data Call-In Notice. Enter the appropriate Response Code or Codes to show how you intend to comply with each data reguirement. Briefdescriptions ofeach code follow. The Data Call-I Notice contains a fuller description ofoach ofthese 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 ofthis 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 datajointly. By indicating that I have chosen this optic I certify that I will comply with all the requirements pertaining to sharing in the cost ofdeveloping 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 datajointly. 1am submitting a copy ofthe for "Certification ofOffer to Cost Share in the Development ofData" that describes this offer/agreement. By indicating that 1have chosen this option, 1 certify that 1will comply with all the requirements pertaining to making an offer to share in the cost ofdeveloping data as outlined in the Data Call-In Notice. 4. (Submitting Existing Data) 1am 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 ofexisting 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, 1certify 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 ofthe stu I am attempting to upgrade. 6. (Citing a Study) I am citing an existing study that has been previously classified by EPA as acceptable, core, core minimum, or a study that has no yet been reviewed by the Agency. I am providing the Agency's classfication of the study. 7. (Deleting Uses) I am attaching an application for amendment to my

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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-minoruse data 

### waivers in 

### the Data Call-In Notice an I request a low-volume minor use waiver ofthe data reguirement. I am attaching a detailedjustification 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 ofData) I have read the statements concerrting data 

### waivers otherthan lowvolume minor-use data 

### waivers in 

### the Data Call-In Notice and I request a waiver ofthe data requirement. I am attaching an identification ofthebasis for this waiver and a detailedjustification to suppo this waiver request. Thejustification includes, among otherthings, 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 ofyour company. The percon signing must include his/her title, and must initial and date all otherpages o 

### this form. Enter the date ofsignature. Enter the name ofthe person EPA should contact with questions regarding your response. Enter the phone number ofyour 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 ofdata 

### required 

### by this notice, and 

### point ofcontact for inquiries pertaining to 

### the reregistration ofiron 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 ofEnd-Use Products for Meeti Acute Toxicology Data Requirement (Attachment D), (5) the EPA Acceptance Criteria (Attachmen E), (6) a list ofregistrants 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 ofall 

### eligible iron salts 

### products. INQUIRIES AND RESPONSES TOTHIS NOTICE If

### you have any questions regarding the generic database ofiron salts, please contact Yvon Brown at (703) 308-8073. 

### Ifyou 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 ofPesticide Programs 

### U.S. Environmental 

### Protection Agency Washington, D.C. 20460 RE: IRON SALTS

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ATTACHMENTB PRODUCT SPECIFIC DATA CALL-IN RESPONSE FORMS (Fonn 

### A) PLUS INSTRUCTIONS

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INSTRUCTIONS FOR COMPLETING THE "DATA CALL-IN RESPONSE" FORM FOR PRODUCT SPECIF1C DATA Item 1-4. Already completed by EPA. Item 

### 5. Ifyou wish to 

### voluntarilycancel yourproduct, answer "yes." Ifyou choose this option, you 

### will not have to

### provide the 

### datarequired by 

### the Data Call-In Notice an you will 

### not have to 

### complete any other forms. Further sale and distribution ofyour product afterthe effective date ofcancellation must 

### be in accordance with the Existi Stocks provision ofthe Data Call-In Notice (Section N-C). 

### Item 6. Not applicable since this form calls in product specific data only. However, ifyour product is identical to anotherproduct 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 ofyoursource(s); you would notcomplete the "Requirements Status and Registrant's Response" form. Examples ofsuch products include repackagedproducts and Special Local Needs (Section 24c) products whic are identical 

### to federally registered products. 

### Item 7a. For each manufacturinguse 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. Forthese cases, please suppl all 

### relevant details so that EPA can ensure that its records are correct.

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APPENDIX C IRONSALTS BffiLIOGRAPHY Citations Considered to 

## be Partofthe Data Base Supporting the Reregistration ofIron Salts

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' 

## '

# Iii

GYIDE TO APPENDIX C I. CONTENTS OF BlliLIOGRAPHY. This bibliography contains citations ofall studies considered relevant by EPA inarriving atthe positions and conclusions stated elsewhere in the Reregistration Eligibility Document. Primary sources for studies 

### in this bibliography have

### been thebody ofdata 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 OFENTRY. The unit ofentry 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. Theresulting "studies" generallyhavea distinct title (or at least a single subject), can stand alone for purposes ofreview and can be described with a conventional bibliographiccitation. TheAgency 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 tothe 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 tothe bibliography late in thereview 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. Whenevertheauthor could confidentlybeidentified, the Agency has chosen to show a personal author. When no individual was identified, the Agency has shown an identifiablelaboratory ortesting facility as theauthor. When no authororlaboratory 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. Whenthe dateis followed by a question mark, the bibliographerhas deduced the date from the evidence contained in the document. When the date appears as (19??), theAgency was unabletodetermineorestimatethedateofthedocument.

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. Trailingparentheses. Forstudies submitted to

### theAgency in thepast, 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" istheregistrationnumber, experimentalusepennitnumber, 

### 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 identifiestheEPA accession numberofthevolume in which 

### the original submission of the study appears. The six-digit accession numberfollows 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 ofthe 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 identifiernumber assigned by EPA in Item 3 This number must be used 

### in thetransmittal 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 ofstudies required to 

### support the product's continued registration are identified. These guidelines, in addition to the requiremen specified in 

### the Notice, govern the conduct ofthe 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) ofthe 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 ofefficacy 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 thetest substance, except in rare cases. The due date for submission ofeach study is identified. ltis normally based on 8 months after issuance ofthe Reregistration Eligibility Document unless EPA determines that a longer time period is necessary. Enter only one ofthe following response Codes for each data reguirement to 

### show how you intend to comply with the data requirements listed in this table. Fuller descriptions ofeach 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 ofthis study as outlined in th 

### Data Call-In Notice. I have entered into an agreement with oneor more registrants to develop datajoint! 

### (Cost Sharing). I am submitting a Copy ofthis agreement. I understand that this option is available only for acute toxicity or certain efficacy data and only ifEPA 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: ifthe 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 {Offersto Cost Share). I understand that this option is available only for acute toxicity or certain efficacy dat 

### and only ifEPA 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. Iam submitting evidence that I have made an offerto**anoth~r** 

### registrant (who has an 

### obligation to submit data) to 

### share in the cost ofthat data. I am also submitting a completed "CertificationofOfferto Cost Share 

### in theDevelopment Data" form I am including a copy ofmy offer and proofofthe other registrant's receipt ofthat 

### 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 notbeen submitte previously to 

### the Agency by anyone (Submitting an Existing Study). I certify that 

### this study will meet all the requirements for submittal ofexisting 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 Ihave 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 (upgradinga Study). I will 

### submit evidence ofthe 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 ofthe study at the due date. Iunderstand 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). IfI am citing another registrant's study, I 

### understand that this option is available only for acute toxicity or certain efficacy

# I

data and onlyifthe cited study was conducted on my product, an identical product or a product which EPA has "grouped" 

### with oneor more otherproducts for purposes of depending on the same data. I may also choose this option ifI am citing my own data. In eithercase, I 

### will provide theMRID or Accession Number(s) for the cited data on a "Product Specific Data Report" form or in a similar format. IfI cite anoth registrant's data, 

### I will submit a completed "Certification with Respect To Data 

### CompensationRequirements" form. 7. I request a waiver for this study because itis inappropriate for my prcxluct (waiver Request). I am attaching a completejustification for this request, including technical reasons, data and references torelevant EPA regulations, guidelines orpolicies. [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 thereasons or provide information in support ofmy request. Ifthe Agency approves my waiver request, I will not be required to supply the datapursuant to Section 3(c)(2)(B) of FIFRA. Ifthe Agency denies my waiver request, I must choose a method ofmeetin the data requirements ofthis Notice by the due date stated by this Notice. In this case, I must, within 30 days ofmy receipt ofthe 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 ofdata 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 OFEND-USE PRODUCTS FOR MEETING DATA REQUREMENTS FOR REREGISTRATION

# Iii

# Iii
EPA'S DECISION NOT TO BATCH END-USE PRODUCTS CONTAINING ffiON SALTS FORPURPOSES OFMEETING ACUTE TOXICITY DATA REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number ofanimals needed to fulfill the acute toxicity data requirements for reregistration ofend-useproducts containing the active ingredient 

### iron salts, 

### the Agency considered hatching end-use products. This process involves grouping simi products for purposes ofacute 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, atany time, acute toxicity data for an individual end-use product should the need arise. Afterconsideration ofthe available information described above, hatching ofend-use products containing iron salts was not possible. The accompanying table lists all the end-use products containing iron salts. These products were eitherconsidered not to be similar for purpos ofacute toxicity or the Agency lacked sufficient information for decision making purposes. Registrants ofthese 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. Ifa 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 ofthe acute toxicity data. Regardless ofwhether 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 DataCall-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 ofreceipt. 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 ofthe 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 notbe hatched, registrants cannot choose from the remaining options: Cost sharing (Option 2) or Offers to Cost 

### Share (Option 3).

## End-Use ProductsContaining IronsSalts (none were hatched)•

EPA Reg. No.**~** Active lngr&dient . FormulationT}"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 ofProduct Ingredients Physical and Chemical Characteristics

# I

61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria? 1. Name oftechnical material tested (includeproductname and tl3de name, ifappropriate). 2.__ Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and e intentionally-added inert ingredient. 3. Name and upper certifiedlimit for each impurity oreach group ofimpurities present at 2:!. 0.1% by weightand for certain toxicologically significant impurities (e.g., dioxins, nitrosa.mines) present at <0.1%. 4. Purpose ofeach active ingredient and each intentionally-addedinert. 5. Chemical name from Chemical AbstractsindexofNomenclatureand Chemical AbstractsService (CAS) Regi Number for each active ingredient and, ifavailable, 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 ofeach beginning material in the manufacturing process. EPA Registration Number ifregistered; for other beginning materials, the following: Name and address ofmanufacturer or supplier. Brand name, trade name orcommercial designation. Technicalspecificationsordatasheetsbywhichmanufacturerorsupplierdescribes composition,proper ortoxicity. 8.
__ Description ofmanufacturing process. Statement ofwhether batch orcontinuousprocess. Relativeamounts ofbeginning materials and order in which they are added. Description ofequipment. Description of physical conditions (tempelllture, pressure, humidity) controlled in each step and the parameters that are maintained. Statement ofwhether process involves intended chemical reactions. Flow chart with chemica] equations for each intended chemical reaction. Duration ofeach step ofprocess. Description ofpurification procedures. Description ofmeasures taken to assure quality offinal product. 9. Discussion offormation ofimpurities based onestablished chemical theory addressing (1) each impurity wh may bepresentat L 0.1% orwasfound at L 0.1%by productanalyses and (2) certain toxicologicallysignific impurities (see #3).

# Iii

6l Analysis and Certification ofProduct Ingredients
ACCEPTANCE CRITERIA The following criteria apply to the technical grade ofthe active ingredient being reregistered. Use a table to presentthe information initems 6, 7, and 8. Doesyour study meet the following acceptance criteria?

1._ 2._ 3._

4. 

## s._ 6. 7. 8. 9._ 10. Fiveor more representative samples (batches in caseofbatch process) analyzed for each active ingredientand all impuritiespresent at ..2:. 0.1%. Degree ofaccountabilityorclosure ..2:. £!98%. Analyses conducted for certain tnlCe toxic impurities at lower than 0.1% (examples, nitrosamines inthe case of products containing dinitroanilines or containing secondary or tertiary amines/alkanolamines plus nitri polyhalogenateddibenzodioxinsand dibenzofurans). [Note that in the case ofnitrosa.mines both fresh and sto samples must be analyzed.]. Complete and detailed description ofeach step in analytical method used to analyze above samples. Statement ofprecision and accuracy ofanalytical 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 ofhow 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 ofbow limit determined. Analytical methods toverify certified limitsofeach activeingredientand impurities(latternot required ifexe from requirement oftolerance or ifgenerally 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 ChemicalCharacteristics ACCEPTANCE CRITilRIA
The following criteria apply to the technical grade ofthe active ingredient being reregistered. Does your study meet the following acceptance criteria? 63-2 ColorVerbal description ofcoloration (or lack ofit) 

# = Any intentional colorationalso reported in terms ofMunsell color system 63-3 Physical State Verbal description ofphysical state provided using terms such as •solid, granular, volatileliquid"

__ Based on visual inspectionat about 20-25o C 63-4 Odor Verbal descriptionofodor(or lack ofit)using terms suchas "garlic-like, characteristic ofaromatic compoun Observed at room temperature 63-5 Melting Point Reported in oC

__ 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 oftechnical grade active ingredient reported in g/ml Q! the specific gravity of liquids reported w reference towaterat20° C. [Note: Bulkdensityofregistered productsmay be reported inlbs/ft'orlbs/gallo 63-8 Solubility Determinedindistilledwaterand representative polarandnon-polarsolvents, includingthoseused informulat and analytical methods for the pesticide Measured at about 20-25° C Reported in g/100 ml (other units likeppm acceptable ifsparingly soluble) 63-9 Vapor Pressure Measured at 25° C (or calculated by extrapolation from measurements made at higher temperature ifpress too low tomeasure at 25o C) Experimental procedure described Reported in mm Hg (torr) or other conventionaJ units 63-10 Dissociation Constant Experimental method described Temperature ofmeasurement specified (preferably about 20-25"C) 63-11 Octanol/water Partition Coefficient Measured at about 20-25° C

__ Experimentally determined and description ofprocedure provided (preferred method-45 Fed. Register 7735

# I

Data supportingreported vaJue provided 63-12 pH Measured atabout 20-25° C Measured following dilutionordispersion in distilledwater 63-13 Stability Sensitivityto metal ionsand metal delermined Stability at normal and elevated temperatures Sensitivity to sunlightdetermined

# Iii

Guideline 81-1 81-2 81-3 81-4 81-5 81-<; SUBDIVISION F Study DUe Acute Oral Toxicity in the Rat AcuteDermal Toxicity inthe Rat, Rabbit or Guinea Pig Acute InhalationToxicity in the Rat Primary Eye Irritation in the Rabbit Primary Dermal Irritation Study Dermal Sensitization intheGuinea 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 ifother 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, oruntil 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 theRat. Rabbit orGuinea Pig
ACCEPTANCE CRITERIA

Does your study meet the following acceptance criteria?

1.
__Identifymaterial tested (technical, end-use product, etc). 2.
__At least5 animals/sex/group. 3.!__Rats 200-300 gm, rabbits 2.0-3.0kg or guinea pigs 3So-4SO gm. 4.
__Dosing, singledermal. 5.
__Dosing duration at least 24 hours. 6.!...__Vehicle control, only iftoxicity ofvehicle is unknown. 7•

__Doses tested, sufficient to determine a toxicity category or a limitdose (2000 mg/kg). 8.
__Applicationsite clipped or shaved at least 24 hours before dosing. 9.
__Applicationsite at least 10% ofbody 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 14days. 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 InhalationToxicity in theRat

ACCEPTANCE CRITERIA
Does your study meet the foUowing acceptance criteria?

!.
__ Identify material tested (technical, end-useproduct, etc). 2. Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use or

-- contains particles ofinhalable size for man (aerodyna.mic diameter 15 p.m orless). 3.
__ Atleast S young adult rats/sex/group. 4.
__ Dosing, at least 4 hours by inhalation. 5.
__ Chamber air flow dynamic, at least 10air changeslbour, at least 19% oxygen content. 6.
__ Chamber temperature, 22° C (±2"), relative humidity40-60%. 7.
__ Monitor rate ofair flow. 8.
__ Monitoractual concentrations oftest material in breathing woe. 9. Monitor aerodynamic particle size for aerosols. 10.-- Doses tested, sufficient todetermine a toxicity category or a limitdose (5 mg!Lactual concentration ofrespira 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 notrequired ifmaterial is corrosive, causes severe dermal irritationorhas a pH of <2 or

**~11.5.** 3. 6 adultrabbits. 4.
__ Dosing, instillationinto the conjunctival sac ofone eye pe>' animal. 5.
__ Dose, 0.1 ml ifa liquid; 0.1 ml or not more than 100mg ifa solid, paste orparticulate 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 irritationbefore 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.
__ Identifymaterial tested (technical, eod-use product, etc). 2.
__ Study notrequired ifmaterial is corrosive orbas a pH of

**~2** or211.5. 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 inplace 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 notbe 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 ifmaterial is conosive orhas a pH of.5_2 or2Jl.S. 3._ One ofthe following methods is utilized:

__Freund's complete adjuvant test

__Guinea pig maximization test

__Splitadjuvant technique Buehler test

__OpeD epicutaneous test

__Mauer optimization test

__Footpad technique inguinea pig. 4._ Complete description oftest. 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 OFALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE

# li

ATIACHMENT G COST SHARE AND DATA COMPENSATION FORMS

# liUnited 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 regardingthe burden estimate orany other aspect ofthis 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; andtothe Office of Management and Budget, PapeiWork Reduction Project (2070-0106), Washington, DC 20503. Please fill In blanks below. Company Name Company Number
Chemical Name EPA Chemlc::el Number

ICertifythat: 1. For each study cited in supportof registration or reregistration underthe Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) that is an exclusive use study, I amthe originaldata submitter, or I have obtainedthe written permission of the original datasubmitterto cite that study. 2. Thatfor each studycited in supportof registration orreregistration under FIFRAthat is NOTan exclusive use study, I am the originaldatasubmitter, orI have obtained the written permissionof the original data submitter, or I have notified in writing the company(ies) that submitted data 1have cited and haveofferedto: (a) Pay compensationforthose datain accordancewith sections3(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 FIFRAandthe amountof compensationdue, if any. The companies I have notified are: (checkone) 

### I I All companies on the data submitters' listfor the active ingredient listedonthisform (Cite-All Method orCite-All Option underthe Selective Method). (Also sign the General Offerto Pay below.) 

### I I The companies who have submitted the studies listed onthe backof this form orattached sheets, or indicated on the anached NRequirements Status and Registrants' Response Form,N 3. That 1have previouslycompliedwith section 3(c)(1)(D) of FIFRAfor 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: 1herebyoffer and agree to paycompensationto otherpersons. 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)

# Iii
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 forthis collectionof infonnation is estimated to average 15 minutes per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining thedata needed, and completing and reviewing the collection of information. Sendcomments regardingthe burden estimate oranyother aspect of this collection of information, including suggestionsfor reducing this burden,to Chief, Information Policy Branch, PM-223, U.S. Environmental Protection Agency, 40, M St., S.W., Washington, DC 20460; and tothe 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: Icertifythat tam duly authorizedto represent the company named above, and that the statementsthat I have made on this form and all attachments therein are true, accurate, and complete. Iacknowledge that any knowingly false or misleading statement may be punishable byfine orimprisonment 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 StitesEnvironmentll ProtecuonA;ency Wl&hin;ton, DC 20460 

## Formulator's Exemption Statement (40 CFR 152.85! FonnApproved OMDNo.2070-0060 Approvalexpires9-30-90 EPAFile Symboi/Ae;ilttltionNumber

O.teofConfldentill StlltementofFormula(EPA Form**1570~)** 

### As an authorized representative ofthe applicant for registration ofthe product identified above, I hereby certifythat: (I)

### Thisproductcontainsthe following active ingredient(s):

(2) 

## orthese,eachactiveingredientlisted inparagraph(4) 

### is presentsolelyas the resultoftheincorporationintotheproduct(duringformulotionor packaging)

### of anotherproductwhich containsthatactiveingredient,whichisregistered under FlFRA Section 3, and which is purchased by

### us from anotherproducer. (3) Indicateby checking (A) or(B) below which paragraph applies: 

## 0 (A)An accurate ConfidentialStatementofFormula(EPA Form8570-4)for 

### the above identified product is attached to this statement. That formula statement indicates, by company name, registration number, and product name. the source ofthe active ingredient(s) listed inparagraph (l). OR 

## 0 (B)The Confidential StatementofFormula(CSF)(EPA Form 8570-4)

### referenced above and onfile withthe EPAis complete,current,and accurate and contains the informationrequired 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 1ndT•tle 011e

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

# Iii