APPENDIX F

Generic Data Call-In


containing iron salts for these uses are eligible for reregistration. Only certain generic
physical chemistry data studies on iron salts are needed as confirmatory information. The
Agency has determined that iron salt containing products, labeled and used as specified in
this Reregistration Eligibility Document, will not pose unreasonable risks or adverse effects
to humans or the environment.

4 Vu.

A. Eligible and Ineligible Uses

The Agency has determined that all currently registered uses are eligible for
reregistration at this time.

ACTIONS REQUIRED BY REGISTRANTS
A. Additional Generic Data Requirements

The generic data base supporting the reregistration of iron salt-containing
products has been reviewed and determined to be substantially complete. Although
some of the generic product chemistry data requirements are acceptable, additional
data are required as confirmatory. The required confirmatory data is based on the
fact that not all companies complied with all product chemistry guideline
requirements. These are part of the generic Data Call-In requirements in Appendix
F,

B. Product specific data requirements
1. Additional Product-Specific Data Requirements

Based on the reviews of the generic data for iron salts, the products
containing iron salts are eligible for reregistration. Section 4(g)(2)(B) of
FIFRA calls for the Agency to obtain any needed product-specific data
regarding the pesticide after a determination of eligibility has been made. The
product specific data requirements are listed in Appendix G, the Product
Specific Data Call-In Notice.

Registrants must review previous data submissions to ensure that they
meet current EPA acceptance criteria (Appendix G; Attachment E) and if not,
commit to conduct new studies. If the registrant believes that previously
submitted data meet current testing standards, then study MRID numbers
should be cited according to the instructions in the Requirement Status and
Registrants Response Form provided for each product.

Cc. Labeling Requirements for Manufacturing-Use and End-Use Products

All labels or labeling of end-use products and Manufacturing-Use
Products must contain the following label! statements:

15




‘United States Environmental Protection Agency
Washington, DC 20460 Form Approved

nn
. OMB No. 2070-0060
EPA  Formulator’s Exemption Statement | Approvalapires 9-30-00
(40 CFR 152.85)
Appiicant’s Name and Address EPA Fite Symbo!/Registration Number

Product Name

Oste of Confidentiat Statement of Formuls (EPA Form 8570-4)

As an authorized representative of the applicant for registration of the product
identified above, I hereby certify that:

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

(2) Of these, each active ingredient listed in paragraph (4) is present solely as the
result of the incorporation into the product (during formulation or packaging) of
another product which contains that active ingredient, which is registered under
FIFRA Section 3, and which is purchased by us from another producer.

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

C2 (A) An accurate Confidential Statement of Formula (EPA Form 8570-4){or
the above identified product is attached to this statement. That formula
statement indicates, by company name, registration number, and product
name, the source of the active ingredient(s) listed in paragraph (1).

OR

CD (B) The Confidential Statement of Formula (CSF) (EPA Form 8570-4) refer-
enced above and on file with the EPA is complete, current, and accurate and
contains the information required on the current CSF.

(4) The following active ingredients in this product qualify for the formulator’s
exemption.

Source
Active Ingredient Product Name Registration Number

Signature Name and Title Date

EPR Form 6670-27 (10-86)


Item 6b

Item 7a

Item 7b

Item 8

Item 9

Ttem 10

Item 11

If you are eligible for or claim a Generic Data Exemption, enter the EPA registratio
Number of each registered source of that active ingredient that you use in your
product,

Typically, if you purchase an EPA-registered product from one or more other
producers (who, with respect to the incorporated product, are in compliance with th
and-any other outstanding Data Call-In Notice), and incorporate that product into al
your products, you may complete this item for all products listed on this form If,
however, you produce the active ingredient yourself, or use any unregistered produc
(regardless of the fact that some of your sources are registered), you may not claim a
Generic Data Exemption and you may not select this item.

Check this Item if the data call-in is a generic data call-in as indicated in Item 3 and if
you are agreeing to satisfy the generic data requirements of this data call-in. Attac
the Requirements Status and Registrant’s Response Form that Indicates how you wil

satisfy those requirements.

Check this item if this call-in if a data call-in as indicated in Item 3 for a
manufacturing use product (MUP), and if your product is a manufacturing use
product for which you agree to supply product-specific data. Attach the Requireme
Status and Registrants’ Response Form that indicates how you will satisfy those

requirements.

Check this item if this call-in is a data call-in for an end use product (EUP) as
indicated in Item 3 and if your product is an end use product for which you agree to
supply product-specific data, Attach the Requirements Status and Registrant’s
Response Form that indicates how you will satisfy those requirements.

This certification statement must be signed by an authorized representative of your
company and the person signing must include his/her title. Additional pages used in
your response must be initialled and dated in the space provided for the certification
Enter the date of signature.

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

Enter the phone number of your company contact.


TRON SALTS: DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

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

This Product Specific Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of iron
salts. This attachment is to be used in conjunction with (1) the Product Specific Data Call-In
Notice, (2) the Product Specific Data Call-In Response Form (Attachment B), (3) the Requirement
Status and Registrant’s Form (Attachment C), (4) EPA’s Grouping of End-Use Products for Meeti
Acute Toxicology Data Requirement (Attachment D), (5) the EPA Acceptance Criteria (Attachmen
E), (6) a list of registrants receiving this DCI (Attachment F) and (7) the Cost Share and Data
Compensation Forms in replying to this iron salts Product Specific Data Call-In (Attachment G).
Instructions and guidance accompany each form.

DATA RE! D THIS NOTICE

The additional data requirements needed to complete the database for iron salts are containe

in the Requirements Status and Registrant’s Response, Attachment C. The Agency has concluded
that additional data on iron salts are needed for specific products. These data are required to be

submitted to the Agency within the timeframe listed. These data are needed to fully complete the
reregistration of all eligible iron salts products.

INQUL AND RESPONSES TO THIS NOTICE

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

If you have any questions regarding the product specific data requirements and procedures
established by this Notice, please contact Joanne Miller (703) 305-7830.


Method and Rates of Application:

Equipment - By hand and spreader

Method and Rate - Ground; broadcast; sprinkle; spot
treatment

Omamental Hervaceous Plants
35 Ib iron/A.

Ornamental Lawns
35 Ib iron/A.

Ornamental Woody Srubs and Vines
35 Ib iron/A.

Timing - When needed; Fall; Winter; Spring; Early
Spring.

3. For Iron (I) sulfate heptahydrate:

Type of Pesticide:

Use Sites:

Target Pests:

Herbicide

Omamental lawns and turf--terrestrial non-food, Outdoor
Residential

Mosses

Formulation Types Registered:

Soluble concentrate/liquid, Soluble concentrate/solid,
Granular

Method and Rates of Application:

Equipment

Spreader; sprinkler can; by hand; sprayer

Method and Rate Spray
Omamental lawns and turf
57 Ib iron/A.
Timing
When needed.


Ttem 10.

Ttem 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
conceming low volume-minor use data waivers in the Data Call-In Notice an
I request a low-volume minor use waiver of the data reguirement. I am
attaching a detailed justification to support this waiver request including,
among other things, all information reguired to support the request. I
understand that, unless modified by the Agency in writing, the data
Teguirement as stated in the Notice governs.

9. (Reguest for Waiver of Data) I have read the statements concerning data
waivers other than lowvolume minor-use data waivers in the Data Call-In
Notice and I request a waiver of the data requirement. I am attaching an
identification of the basis for this waiver and a detailed justification to suppo
this waiver request. The justification includes, among other things, all
information required to support the reguest. I understand that, unless modifte
by the Agency in writing, the data reguirement as stated in the Notice gover

This item must be signed by an authorized representative of your company. The
percon signing must include his/her title, and must initial and date all other pages o
this form.

Enter the date of signature.

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

Enter the phone number of your company contact.




62 Analysis and Certification of Product Ingredients

ACCEPTANCE CRITERIA

‘The following criteria apply to the technical grade of the active ingredient being reregistered. Use a table to present the
information in items 6, 7, and 8.

Does your study meet the following acceptance criteria?

1.

2.

we

~

ae

|

|

10.

Five or more representative samples (batches in case of batch process) analyzed for each active ingredient and all
impurities present at > 0.1%.

Degree of accountability or closure > ca 98%.

Analyses conducted for certain trace toxic impurities at lower than 0.1% (examples, nitrosamines in the case of
products containing dinitroanilines or containing secondary or tertiary amines/alkanolamines plus nitri
polybalogenated dibenzodioxins and dibenzofurans). [Note that in the case of nitrosamines both fresh and sto
samples must be analyzed.].

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

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

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

Upper and lower certified limits proposed for each active ingredient and intentionally added inert along w
explanation of how the limits were determined.

Upper certified limit proposed for each impurity present at > 0.1% and for certain toxicologically signific
impurities at <0.1% along with explanation of how limit determined.

Analytical methods to verify certified limits of each active ingredient and impurities (latter not required if exe
from requirement of tolerance or if generally recognized as safe by FDA) are fully described.

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


L061 600% lIv AWWIXO], ayesqauaauy Jayemysory — (2)Z-ZL
9061 600b tv non Moqures ANOIxO} Ysty (9) T-ZL
S061600P Iv InSonyg- ANOXOL ysty syeMYsary — (®)T-ZL
061600 lv 3Onp “Ip uerawanoy —(Q)Z-TL
€061600 lv yong rend- Aro Areyiq ueay — (®)z-12
7061600? liv WONG /EN}- AWOKE, TIO uRAY ANY (B)I-TZ
Spa [va}sojorgy Spr-gs1§
IOLE9LI¥ liv said eauinn juoneznisues peuod 9-18
CaAIVK Iv voneL feuap ArewLig $-18
CaAIVA Iv ugges-uoneut eke Arewud v8
CaAIVK Iv ye XO} “TeYUT anoy €-18
CaAIVA uv yiqqes “Xo} [euuap aynoy ZR
CaAIVA Iv yeI *XO) PeJO aNoy I-18
AB0[0HKOL SETSTS
“peaTem usaq oaky syvawasmber wep oye} [eyUSUIUOIIAUD [VY
ayey [EWaUIUOMAUT OCT"SsT§

NOLLV.LIO SALLIS
OIHdvaoorala = sn @WVN SNITAGINGS = ANITACIND

ALVUGAHONOW @LVATINS I NOU




CaAIVA qv AYOIXOL, ayerQayaauy] Joyemysory — (8) Z-ZL.
daAIVA Iv mon moqurer Ay191K0}) Ys — (9) [-7,
qa AIVA. Iv [t8enyg- Ayoixoy, yst.y yeMysary —-(®) | -7
CHAIVA. uv Yonp “yorp uRIAR andy (Q)Z-TL.
GaAIVM Iv yonay[rend- Ajioixoy, Areyiq ueay —(e)Z-1L
CaAIVA qv yongysirend- Ayorxoy pug uelAy annoy (®) I-12
SHOT 11 F0]OIT SpTgs1s
COLBSLIP HV Sid vouinduoneznisuss Teuad O18
ZOLBSLIP Iv voneuN euuep Aewug ¢-18
TOL8SLI¢ Ilv Vqqes-uonepwt aAo Arewiug rig
COLILI@P tv yes XO} “eyUT anoy €-18
COLILIZ Iv yiqqes *xo} TeuLap anoy T-IR
IOLOLIZP nv yeI *XO} TRIO BNIy I-18
ABOlOIXOL, SEL SSTS
“POATEA Useq SARI] sJUaWaLINbas EVEp ayef EJUSWIUOITAUD ITV
a7Bq [BMIUTTOIAUA OLT'SST§

NOILV.LIO SALIS
OFHdVeOOr Tala asn AWVYN FUNITHCINS ANITACIND

ALVATAS OT NOU


SPECIFIC INSTRUCTIONS FOR THE GENERIC DATA CALL-IN RESPONSE FORM

This Form is designed to be used to respond to call-ins for generic and product specific data for th
purpose of reregistering pesticides under the Federal Insecticide Fungicide and Rodenticide Act. F
out this form each time you are responding to a data call-in for which EPA has sent you the form
entitled "Requirements Status and Registrant’s Response.”

Items 1-4 will have been preprinted on the form Items 5 through 7 must be completed by the
registrant as appropriate Items 8 through 11 must be completed by the registrant before submitting a
Tesponse to the Agency.

Public reporting burden for this collection of information is estimated to average 15 minutes per
response, including time for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the collection of information. Send
comments regarding the burden estimate or any other aspect of this collection of information,
including suggesting for reducing this burden, to Chief, Information Policy Branch, PM-223, U §
Environmental Protection Agency, 401 M St, S W , Washington, D C 20460; and to the Office o
Management and Budget, Paperwork Reduction Project 2070-0107, Washington, D C 20503

INSTRUCTIONS

Ttem 1

Ttem 2

Item 3

Ttem 4

Ttem 5

Item 6a

This item identifies your company name, number and address.

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

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

This item identifies the EPA product registrations relevant to the data call-in. Pleas
note that you are also responsible for informing the Agency of your response
regarding any product that you believe may be covered by this data call-in but that
not listed by the Agency in Item 4. You must bring any such apparent omission to
the Agency’s attention within the period required for submission of this response
form.

Cheek this item for each product registration you wish to cancel voluntarily. Ifa
registration number is listed for a product for which you previously requested
voluntary cancellation, indicate in Item 5 the date of that Tequest. You do not need to
complete any item on the Requirements Status and Registrant’s Response Form for
any product that is voluntarily cancelled.

Check this item if this data call-in is for generic data as indicated in Item 3 and if y
are eligible for a Generic Data Exemption for the chemical listed in Item 2 and used
in the subject product. By electing this exemption, you agree to the terms and
conditions of a Generic Data Exemption as explained in the Data Call-In Notice.


63 Physical and Chemical Characteristics

ACCEPTANCE CRITERIA

The following criteria apply to the technical grade of the active ingredient being reregistered.
Does your study meet the following acceptance criteria?

63-2 Color
Verbal description of coloration (or lack of it}
Any intentional coloration also reported in terms of Munsell color system

63-3 Physical State
Verbal description of physical state provided using terms such as “solid, granular, volatile liquid”
Based on visual inspection at about 20-25° C

63-4 Odor
Verbal description of odor (or lack of it) using terms such as “garlic-like, characteristic of aromatic compoun

Observed at room temperature

63-5 Melting Point
Reported in °C
____ Any observed decomposition reported
63-6 Boiling Point
Reported in °C
Pressure under which B.P. measured reported
Any observed decomposition reported

63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25° C
Density of technica] grade active ingredient reported in g/ml or the specific gravity of liquids reported w
reference to water at 20° C. [Note: Bulk density of registered products may be reported in Ibs/ft? or Ibs/gatlo

63-8 Solubility

Determined in distilled water and representative polar and non-polar solvents, including those used in formulat
and analytical methods for the pesticide

Measured at about 20-25° C

Reported in g/100 ml (other units like ppm acceptable if sparingly soluble)

63-9 Vapor Pressure
Measured at 25° C (or calculated by extrapolation from measurements made at higher temperature if press
too low to measure at 25° C)
Experimental procedure described
Reported in mm Hg (torr) or other conventional units

63-10 Dissociation Constant

Experimental method described

Temperature of measurement specified (preferably about
20-25°C)

63-11 Octanol/water Partition Coefficient
Measured at about 20-25° C
Experimentally determined and description of procedure provided (preferred method-45 Fed. Register 7735


10.

i.

12.

13.

14.

REFERENCES

Cotton, F.A. and Wilkinson, G. Advanced Inorganic Chemistry, Fifth Edition.
John Wiley and Sons, New York, 1988.

Greenwood, N.N. and Earnshaw, A. Chemistry of the Elements. Pergaman
Press, Oxford, UK, 1984.

f Mining. Min id_ Relat , US Department of the
Interior, Bureau of Mines, 1968.

Schulze, D.G. “An Introduction to Soil Mineralogy” in Minerals _in Soil
Environments, Second Edition edited by J.B. Dixon and S.B. Weed. Soil Science
Society of America, Madison, WI, 1989, p.5.

Flynn, C.M., Jr. “Hydrolysis of Inorganic Iron (HI) Salts", Chemical Reviews,
vol, 84, 1984, pp. 31-41.

Stumm, W. and Morgan, J.J}. A ig Chemistry- An Introduction Emphasizin

Chemical Equilibria in Natural Waters, Second Edition, John Wiley and Sons,
New York, 1981.

Schwertmann, U and Taylor, R.M. “Iron Oxides” in Minerals in Soil
Environments, Second Edition edited by J.B. Dixon and S.B. Weed. Soil Science
Society of America, Madison, WI, 1989. pp 379-438.

Reference 7, p. 398.

Reference 7, p. 403.

Reference 7, p. 405.

Reference 7, p. 407-418.

Smith, R.S. and Akhtar. “Cationic Flotation of Oxides and Silicates” in Flotation
A.M, Gaudin Memorial Volume, M.C. Fuerstenau, Editor. Volume 1, 1976,
Published by the Society of Mining Engineering, AIME, New York. pp 87-179.
Fuerstenau, M.C. and Palmer, B.R. “Anionic Flotation of Oxides and Silicates"
in Flotation, A.M, Gaudin Memorial Volume, M.C. Fuerstenau, Editor, Volume

I, 1976, pp. 146-196. Published by the Society of Mining Engineering, AIME,
New York.

Lindsay, W.L. Chemical Equilibria in Soils. John Wiley and Sons, New York,
pp. 177-180.


E TO APP.

CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere
in the Reregistration Eligibility Document. Primary sources for studies in this
bibliography have been the body of data submitted to EPA and its predecessor agencies
in support of past regulatory decisions. Selections from other sources including the
published literature, in those instances where they have been considered, are included.

UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a distinct
title (or at least a single subject), can stand alone for purposes of review and can be
described with a conventional bibliographic citation. The Agency has also attempted to
unite basic documents and commentaries upon them, treating them as a single study.

IDENTIFICATION OF ENTRIES, The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number", This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit “Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4(d)(4) below for further explanation). In a few cases,
entries added to the bibliography late in the review may be preceded by a nine character
temporary identifier. These entries are listed after all MRID entries. This temporary
identifying number is also to be used whenever specific reference is needed.

FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.

a. Author. Whenever the author could confidently be identified, the Agency has chosen
to show a personal author. When no individual was identified, the Agency has shown
an identifiable laboratory or testing facility as the author. When no author or laboratory
could be identified, the Agency has shown the first submitter as the author.

b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced the
date from the evidence contained in the document. When the date appears as
(1922), the Agency was unable to determine or estimate the date of the document.

c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.


Attachment A - Chemical Status Sheet

Attachment B - Generic DCI Response Forms (Form A) plus Instructions

Attachment C - Requirements Status and Registrants’ Response Forms (Form
B) plus Instructions

Attachment D - List of all Registrant(s) sent this DCI

Attachment E - Cost Share/Data Compensation Forms

APPENDIX G - Product Specific Data Call-In

Attachment A - Chemical Status Sheet

Attachment B - Product Specific DCI Response Forms (Form A) plus Instructions

Attachment C - Requirements Status and Registrants’ Response Forms (Form
B) plus Instructions

Attachment D - EPA Grouping of End Use Products for meeting Acute
Toxicology Data Requirements.

Attachment E - EPA Acceptance Criteria

Attachment F - List of ali Registrant(s) sent this DCI

Attachment G - Cost Share/Data Compensation Forms

ii


Additional Data
Required

Product Labeling
Changes Required

Regulatory
Conclusion

insoluble oxides and hydroxides that also are well known components of
soils, and the distinct surface chemistry of the iron salts that causes their
adsorption with other soil components, forming larger soil particles.

Use of the iron salts produces iron oxides and hydroxides that are nc
different from those normally found in soils, and which give them their
brown and red colors. Although certain bacteria can reduce Iron (II) to
the more mobile Iron (ID, this is rapidly immobilized.

Therefore, the use of iron salts as herbicides to control moss is not
expected to contribute significantly to the chemistry and fate of the
compounds existing naturally in the environment. No unreasonable effect:
are expected from the use of these pesticide products as directed.
Ecological Effects

In dietary acute toxicity studies, iron salts are practically nontoxic tc
bird species and are nontoxic or slightly toxic to rats. Iron (I) sulfate
heptahydrate, the most toxic form of the iron salts compounds, is
moderately toxic to aquatic invertebrates and slightly toxic to fish.

No adverse effects to avian, mammalian or aquatic populations are
anticipated from the use of iron salts. Iron is one of the earth’s most
abundant elements, and it is immobilized at the pH range of 5-9. Runoff
to aquatic systems is unlikely since the parent compounds convert very
rapidly to less soluble forms in the environment. Furthermore, the
oxidized iron compounds bind tightly to soil under turf.

No adverse effects to endangered species are anticipated from the u:
of iron salts.

EPA is requiring additional physical chemistry studies as
confirmatory data and to complete the generic data base for iron salts.
Product-specific product chemistry studies and revised labeling also are
required for reregistration. These additional studies are being required
through Data Call-Ins issued in conjunction with the iron salts RED.

The labels of all registered iron salts products must comply with
EPA's current pesticide labeling requirements. In addition, to protect
surface waters, end-use product labels must bear the following
Environmental Hazards statement:

"Do not apply directly to water, or to areas where surface water is

present or to intertidal areas below the mean high water mark. Do

not contaminate water when disposing of equipment washwater or

Tinsate."

© The three pesticide active ingredients discussed in the iron salts
RED will not result in unreasonable adverse effects to human health or 1
environment, and all registered products containing these active ingredier

3




Item 8.

Ttem 9.

This item Identifies the time frame allowed for submission of the study or protocol
identified in item 2. The time frame runs from the date of your receipt of the Data
Call-In Notice.

Enter the appropriate Response Code or Codes to show how you intend to comply
with each data reguirement. Brief descriptions of each code follow. The Data Call-I
Notice contains a fuller description of oach of these options.

1,

@eveloping Data) I will conduct a new study and submit it within the time
frames specifled in item 8 above. By indicating that I have chosen this option
I certify that I will comply with all the reguirements pertaining to the
conditions for submittal of this study as outlined in the Data Call-In Notice a
that I will provide the protocol and progress reports reguired in item 5 above

(Agreement to Cost Share) I have entered into an agreement with one or mo
registrants to develop data jointly. By indicating that I have chosen this optio
I certify that I will comply with all the requirements pertaining to sharing in
the cost of developing data as outlined in the Data Call-In Notice.

(Offer to Cost Share) I have made an offer to enter into an agreement with o
or more registrants to develop data jointly. I am submitting a copy of the for
“Certification of Offer to Cost Share in the Development of Data” that
describes this offer/agreement. By indicating that I have chosen this option, I
certify that I will comply with all the requirements pertaining to making an
offer to share in the cost of developing data as outlined in the Data Call-In
Notice.

(Submitting Existing Data) I am submitting an existing study that has never
before been submitted to EPA. By indicating that I have chosen this option, I
certify that this study meets all the requirements pertaining to the conditions
for submittal of existing data outlined in the Data Call-In Notice and I have
attached the needed supporting information along with this response.

(Upgrading a Study) I am submitting or citing data to upgrade a study that
EPA has classified as partially acceptable and potentially upgradeable. By
indicating that I have chosen this option, I certify that I have met all the
Tequirements pertaining to the conditions for submitting or citing existing dat
to upgrade a study described in the Data Call-In Notice. I am indicating on
attached correspondence the Master Record Identification Number (MRID) th
EPA has assigned to the data that I am citing as well as the MRID of the stu
I am attempting to upgrade.

(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 revicwed by the Agency. I am providing the Agency's classfication of
the study.

(Deleting Uses) I am attaching an application for amendment to my




United States Office of Prevention, Pesticides EPA 738-S
Environmental Protection and Toxic Substances
Agen

jency (H-7508W) February *

SEPA Reregistration

Eligibility Document
(RED)

Iron Salts


81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig

ACCEPTANCE CRITERIA

Does your study meet the following acceptance criteria?

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

2. At least 5 animals/sex/group.

3.* Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.

4. Dosing, single dermal.

5. Dosing duration at least 24 hours.

6. Vehicle control, only if toxicity of vehicle is unknown.

7. Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).

8. Application site clipped or shaved at least 24 hours before dosing.

9. Application site at least 10% of body surface area.

10. Application site covered with 2 porous nonirritating cover to retain test material and to prev
ingestion.

1h. Individual observations at least once a day.

12. Observation period to last at least 14 days.

13. Individual body weights.

14, Gross necropsy on all animals.

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


Human Health
Assessment

Environmental
Assessment

sulfate, nine contain Iron (II) sulfate monohydrate, and three contain Iron
i) sulfate heptahydrate.

A fourth active ingredient, Iron I ammonium sulfate, is not being
supported for reregistration and so is not covered in this RED.

Toxicity

Iron salts are present normally in the environment. Iron is the fourth
most abundant element and the second most abundant metal in the earth’s
crystal rocks, Iron occurs in a wide variety of minerals, and is present in
foods naturally and through added ingredients.

The iron salts are of low acute toxicity through oral, dermal and
inhalation routes of exposure. They have been placed in Toxicity Category
III for these effects. Although a mutagenicity study using microorganisms
showed positive results, it is unlikely that such effects would result in
humans or other mammals at the levels of exposure expected from the use
of iron salts as pesticides, Other toxicity studies normally required for
reregistration were not necessary to evaluate the risks of the iron salts.
Dietary Exposure

Dietary exposure is not expected to result from use of the iron salts
as pesticides. No food or feed-related uses are registered, and no
tolerances (maximum residue limits) or exemptions from the requirement
of a tolerance are established. Further, the iron salts are generally
recognized as safe (GRAS) by the Food and Drug Administration for use
as a flavoring agent and nutrient supplement in foods (please see 40 CFR
180.2(a)).

Occupational and Residential Exposure

The potential for mixer, loader and applicator exposure exists when
liquid or granular iron salts products are applied to lawns, turf and other
outdoor sites using spreaders, sprinkler cans or by hand. However, these
inorganic salts are of little concern from a toxicity perspective. Any
exposure of mixers, loaders or applicators is considered inconsequential.
Human Risk Assessment

The risks to people from dietary, occupational and residential
exposure to iron salts pesticides are considered negligible. It is general
knowledge that these compounds are of low toxicity. They are
intentionally added to foods as flavoring agents and nutrient supplements,
and they have an inherent function in the metabolic systems of humans and
domestic animals.

Environmental Fate

The environmental fate and transport of iron salts is dominated by
three processes: the conversion of Iron (II) to Iron (IM), the formation of


81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA

Does your study meet the following acceptance criteria?

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

2.____ Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use or
contains particles of inhalable size for man (aerodynamic diameter 15 ym or less).

At least 5 young adult rats/sex/group.

Dosing, at least 4 hours by inhalation.

Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.

Chamber temperature, 22° C (+2), relative humidity 40-60%.

Monitor rate of air flow.

Monitor actual concentrations of test material in breathing zone.

Monitor aerodynamic particle size for aerosols.

Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of respira
substance).

1h. Individual observations at least once a day.

Observation period to last at least 14 days,

Individual body weights.

14.____ Gross necropsy on al! animals.

MLL LT

Serr anay


PINbiyeyp.jueoU0D ejqnjos= 7/95 1 uRo04
xqeoydde 30U~ eu !peytoeds you= 2ede 10u ‘suopsoydde = sdde ‘NWR Uj ‘Une = xeWpeOH

Boer suoneRerqay

peyengjeo eq
upo sopquuds ‘pepeeu vey ‘Avsds

oeda | aods
youuve esoq eu os

peda jou | pepeousy | you | 10u

pareinojes oq
youuss 980g eu vos JeAeidg pus-es0}{ ‘popes UeYAA ‘ABadS

doid poog-UON (pinse10] :edNo/g oef) pi, puB sume jejUCWEUIO

‘eds | code
cede you | pepoousy | you | ou

(AUSpisey Jooping pue
$3SN Q334NON/O004NON

NOLLYULSIOauaY HO4 31819113 $3SN

teat oe)
en on om xe

fan, Bwwy urna | gay | say my sopmoginy ma

ome Coenen ee) run onsoudy wripan sag anucinbg uoqaoydiy “Bupa, uoneaytdy “wdAL omeowity AUS

[aresjns 21394) ZOBPEO eswWaYD [sues UO] ‘EGO aseD - ¥ XIaNaud¥



ATTACHMENT C

PRODUCT SPECIFIC REQUIREMENT STATUS AND
REGISTRANT’S RESPONSE
FORMS (Form B) PLUS INSTRUCTIONS




I. INTRODUCTION

In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregistration of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregistration process to
be completed in nine years. There are five phases to the reregistration process. The first
four phases of the process focus on identification of data requirements to support the
reregistration of an active ingredient and the generation and submission of data to fulfill the
requirements. The fifth phase is a review by the U.S. Environmental Protection Agency
(referred to as “the Agency") of all data submitted to support reregistration.

FIFRA Section 4(g)(2){A) states that in Phase 5 “the Administrator shall determine
whether pesticides containing such active ingredient are eligible for registration" before
calling in data on products and either reregistering products or taking “other appropriate
regulatory action.” Thus, reregistration involves a thorough review of the scientific data
base underlying a pesticide’s registration. The purpose of the Agency’s review is to reassess
the potential hazards arising from the currently registered uses of the pesticide; to determine
the need for additional data on health and environmental effects; and to determine whether
the pesticide meets the "no unreasonable adverse effects" criterion of FIFRA.

This document presents the Agency’s decision regarding the reregistration eligibility
of the registered uses of iron (111) sulfate, iron (I) sulfate monohydrate, and iron (Il) 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 III
discusses the human health and environmental assessment based on the data available to the
Agency. Section IV presents the reregistration decision for iron salts. Section V discusses
the reregistration requirements for iron salts. Finally, Section VI is the Appendices which
support this Reregistration Eligibility Document. Additional details concerning the Agency’s
review of applicable data are available on request.!

' EPA’s reviews of data on the set of registered uses considered for EPA’s analysis may be
requested from the Public Response and Program Resources Branch, Field Operations Division
(H7506C), Office of Pesticide Programs, EPA, Washington, DC 20460.

2


PR Notice 91-2




APPENDIX G

Product Specific Data Call-In


60E7PrI Iv Arges ades01g £I-€9
euxaal tv Hd Z1-€9
60ETPI Iv WURISUOD UOHPIOSSIC OI-t9
6OEZHI Iv Anmqnjos 8-€9
6OEZHT Iv Aysuaq L£9
OOEZPI Iv qiog 3uylog = 9-€9
6OECHI Iv qiog 3unpeW S-€9
GOLF Tv 10PO £9
GOETI Iv ares feorsAyd €-€9
60C7PrI uw 40}05 £9
60ETFI Tv spopay peondjeuy €-79
OOETI Tv SW] Jo uoTRayTED réarés)
GOETH nv siskpeuy Areuiuil[aig 1-279
60EZPI Iv sayundwy jo uoneinuoy —(q)Z-19
6OE7FI lv ssadoig SuuMpoRsNURW] pue speuaeW Suuuseg —-(®) 7-19
6OE7I tv Aynuap] eormayD 1-19

Ansmmays ynpold OZ1'SS1§

NOLLV.LIO SALIS

OIHd VaOOT Tala aso AWVN SNITAGIND §=ANITICIND

ALVUGAHONOW HLVAINS H NOU


MRID

40091903

40091904

40091905

4009 1906

40091907

40142201

40142202

40142203

40142204

40142205

CITATION

Fletcher, D. (1986) 8-Day Dietary LC50 Study with Ferrous Sulfate Monohydrate
in Mallard Ducklings: Laboratory Project ID: BLAL No. 85 DC 63. Unpublished
study prepared by Bio-Life Associates, Ltd. 28 p.

Fletcher, D. (1986) 8-Day Dietary LCs, Study with Ferrous Sulfate Monohydrate
in Bobwhite Quail: Laboratory Project ID: BLAL No. 85 QC 61. Unpublished
study prepared by Bio-Life Associates, Ltd. 28 p.

Surprenant, D. (1986) Acute Toxicity of Ferrous Sulfate Monohydrate to
Rainbow Trout: Laboratory Project ID: BW-86-11-2227: Study
#11501.0886.6100.103. Unpublished study prepared by Springborn Bionomics,
Inc. 19 p.

Surprenant, D. (1986) Acute Toxicity of Ferrous Sulphate Monohydrate to
Bluegill: Laboratory Project ID: BW-86-11-2228: Study #11501.0886.6100.100,
Unpublished study prepared by Springborn Bionomics, Inc. 19 p.

Surprenant, D. (1986) Acute Toxicity of Ferrous Sulfate Monohydrate to
Daphnids (Daphnia magna): Laboratory Project ID: BW-86-112229: Study
#11501.0886.6100.110. Unpublished study prepared by Springborn Bionomics,
Inc. 18 p.

Grimes, J.; Jaber, M. (1986) Ferrous Sulfate Heptahydrate: An Acute Oral
Toxicity Study with the Bobwhite: Laboratory Project ID: 223-103. Unpublished
study prepared by Wildlife International Ltd. 18 p.

Grimes, J.; Jaber, M. (1986) Ferrous Sulfate Heptahydrate: A Dietary LC50
Study with the Bobwhite: Laboratory Project ID: 223101. Unpublished study
Prepared by Wildlife International Ltd. 17 p.

Grimes, J.; Jaber, M. (1986) Ferrous Sulfate Heptahydrate: A Dietary LC50
Study with the Mallard: Laboratory Project ID: 223102. Unpublished study
prepared by Wildlife International Ltd.

Surprenant, D. (1986) Acute Toxicity of Ferrous Sulfate Heptahydrate ...to
Bluegill (Lepomis macrochirus): Bionomics Report #BW-86-12-2262: Bionomics
Study #1297.0786.6101.100. Unpublished study prepared by Springborn
Bionomics, Inc. 6 p.

Surprenant, D. (1986) Acute Toxicity of Ferrous Sulfate Heptahydrate...to
Rainbow Trout (Salmo gairdneri): Bionomics Report #BW-87-3-2317: Bionomics
Study #1297.0786.6101.103. Unpublished study prepared by Springborn
Bionomics, Inc, 7 p.


United States Environmental Protection Agency | Form Approved

rr Washington, DC 20460
7 CERTIFICATION WITH RESPECT To | MP Ne 2070-0106
DATA COMPENSATION REQUIREMENTS] Approval Expires 12-31-92

Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.

Please fill In blanks below.

Company Name Company Number
Chemical Name EPA Chemical Number
| Certify that:

4, For each study cited in support of registration or reregistration under the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) that is an exclusive use study, | am the original data submitter, or 1 have obtained the
written permission of the original data submitter to cite that study.

2. That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use
study, | am the orginal data submitter, or | have obtained the written permission of the original data submitter, or |
have notified in writing the company(ies) that submitted data | have cited and have offered to: (a) Pay
compensation for those data in accordance with sections 3(c)(1)(D) and 3(¢)(2){D} of FIFRA; and (b) Commence
negotiation to determine which data are subject to the compensation requirement of FIFRA and the amount of
compensation due, if any. The companies have notified are: (check one)

L] All companies on the data submitters’ list for the active ingredient listed on this form (Cite-All
Method or Cite-All Option under the Selective Method). (Also sign the General Offer to Pay

below.)

{] The companies who have submitted the studies listed on the back of this form or attached
sheets, or indicated on the attached "Requirements Status and Registrants’ Response Form,”

3. That | have previously complied with section 3(c)(1)(D) of FIFRA for the studies | have cited in support of
registration or reregistration under FIFRA.

Signature Date

Name and Title (Please Type or Print)

GENERAL OFFER TO PAY: | hereby offer and agree to pay compensation to other persons, with regard to the
registration or reregistration of my products, to the extent required by FIFRA sections 3(¢)(1)(D) and 3(¢}2)(D).

Signature Date

Name and Title (Pleese Type or Print)

EPA Form 8570-31 (4-90)



APPENDIX E

Pesticide Reregistration Handbook
and PR Notice 91-2


MRID

40142206

41758701

41758702

41758703

41763701

41764501

41764501

42171701

42171702

42171703

TTATI

Surprenant, D. (1986) Acute Toxicity of Ferrous Sulfate Heptahydrate...to
Daphnids (Daphnia pulex): Bionomics Report #BW-87-32318: Bionomics Study
#1297.0786.6101.110. Unpublished study prepared by Springborn Bionomics,
Inc. 6 p.

Robbins, G., Pimary Eye Irritatancy Study in Rabbits, Ferric Sulfate, Ferri Floc:
Lab Project No. D3082. Unpublished Study prepared by Cosmopolitan Safety
Evaluation, 1990,

Robbins, G., Pimary Eye Lrritatancy Study in Rabbits, Ferric Sulfate, Ferri Floc:
Lab Project No. E3082. Unpublished Study prepared by Cosmopolitan Safety
Evaluation, 1990.

Robbins, G., Guinea Pig Sensitization, Ferric Sulfate, Ferri Floc: Lab Project
No. F3082. Unpublished Study prepared by Cosmopolitan Safety Evaluation,
1991.

Robbins, G. (1990) Guinea Pig Sensitization (Buhler): WGM-30 Brand: Lab
Project Number: F3081. Unpublished study prepared by Cosmopolitan Safety
Evaluation, Inc. 19 p.

Gohlke, A., Product Identity and Disclosure of Ingredients, Tennessee Chemical
Company’s Ferri-Floc, Ferric Sulfate Lab Project No 1991-1. Unpublished Study
prepared by Tennessee Chemical Co., 1991.

Gohtke, A., Analysis and Certification of Ingredinents in Tennessee Chemical
company’s Ferri-Floc, Tennessee Chemical Company’s Ferri-Floc, Ferric Sulfate
Lab Project No 1991-2, Unpublished Study prepared by Tennessee Chemical Co.,
1991.

Robbins, G. (1992) Acute Oral Toxicity in Rats: Ferric Sulfate, Ferri Floc: Lab
Project Number: A3251. Unpublished study prepared by Cosmopolitan Safety
Evaluation, Inc. 28 p.

Robbins, G. (1991) Acute Dermal Absorption in Rabbits: Ferric Sulfate, Ferri
Floc: Lab Project Number: B3251. Unpublished study prepared by Cosmopolitan
Safety Evaluation, Inc. 24 p.

Robbins, G. (1991) Acute Inhalation Study in Rats: Ferric Sulfate, Ferri Floc:
Lab Project Number: C3251. Unpublished study prepared by Cosmopolitan Safety
Evaluation, Inc. 34 p.




Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following
elements describing the earliest known submission:

ay

Q)

QB)

(4)

Submission date. The date of the earliest known submission appears
immediately following the word "received."

Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit number,
petition number, or other administrative number associated with the
earliest known submission.

Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.

Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume in
which the original submission of the study appears. The six-digit
accession number follows the symbol “CDL,” which stands for "Company
Data Library." This accession number is in tum followed by an
alphabetic suffix which shows the relative position of the study within the
volume,


APPENDIX C
IRON SALTS BIBLIOGRAPHY

Citations Considered to be Part of the Data Base
Supporting the Reregistration of Iron Salts


ATTACHMENT F

LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE


SEPA

Pesticide
Reregistration

Use Profile

Regulatory
History

United States Office of Prevention, Pesticides EPA-738-F-93-002
Environmentai Protection And Toxic Substances February 1993
Agency (H-7508W}

R.E.D. FACTS

Iron Salts

All pesticides sold or used in the United States must be registered by
EPA, based on scientific studies showing that they can be used without
posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered years ago be reregistered to ensure that they meet
today’s more stringent standards.

In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide’s risks. EPA then reregisters pesticides that can be used without
posing undue hazards to human health or the environment.

When a pesticide is eligible for reregistration, EPA announces this
and explains why in a Reregistration Eligibility Document, or RED. This
fact sheet summarizes the information in the RED for iron salts.

The iron salts consist of three pesticide active ingredients that are
eligible for reregistration: Iron (III) sulfate, Iron (11) sulfate monohydrate,
and Iron (II) sulfate heptahydrate.

Iron salts are registered for use as herbicides to control moss on
lawns, turf, ornamental herbaceous plants, woody shrubs and vines.
Registered products are formulated as soluble concentrates and granulars.
They are applied by sprinkler can, hose-end sprayer, spreader, or by hand.

The major use of iron salts in the United States is non-pesticidal, as a
fertilizer micronutrient. Iron salts also are used as an electrolyte in dry
cell batteries, as an animal feed additive, as a galvanizer and as an
emulsion-breaker. They have further uses in water purification and sewage
treatment, and in textile dying and calico printing.

Iron salts first were registered as pesticides in 1962. In addition to
the current outdoor moss control uses, iron salts were registered previously
for use inside households, and in and around commercial, institutional and
industrial premises.

At present, a total of 13 products are registered containing iron salts
as sole or one of several active ingredients; one product contains Iron (III)


uideli

81-1
81-2
81-3
81-4
81-5
81-6

SUBDIVISION F

Study Title

Acute Oral Toxicity in the Rat

Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
Acute Inhalation Toxicity in the Rat

Primary Eye Irritation in the Rabbit

Primary Dermal Irritation Study

Dermal Sensitization in the Guinea Pig






Guideline

Series 61
Series 62
Series 63

SUBDIVISION D

Study Title

Product Identity and Composition
Analysis and Certification of Product Ingredients
Physical and Chemical Characteristics


1. Manufacturing-Use Products

In addition to the above requirements under 40 CFR §156.10 and the
Pesticide Reregistration Handbook, for end-use products, labels and labeling of
all manufacturing-use products must contain the following Environmental
Hazards statement:

“Do not discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans or public waters unless this product is specifically
identified and addressed in an NPDES permit. Do not discharge this product
into sewer systems without previously notifying the sewage treatment plant
authority. For guidance, contact your State Water Board or Regional Office of
U.S, EPA.”

2. End-Use Products

The labels and labeling of all products must comply with EPA’s current
regulations and requirements as specified in 40 CFR §156.10. Labels must
consistently reflect any potential eye and skin hazard. Please follow the
instructions in the Pesticide Reregistration Handbook with respect to labels and
labeling.

16


2.

Although acid mine drainage could potentially stabilize Fe(II) species,
the effect of bacterially mediated oxidation by organisms such as
Thiobacillus ferrooxidans results in formation of insoluble Fe(II)
oxides/oxyhydroxides.(19) Free, mobile Fe(II) or Fe(II) cations are
not expected to persist under normal environmental conditions when the
Fe(II) and (II) sulfates are used as herbicides to control moss in
outdoor residential sites or as foliar spray fertilizers to correct iron
chlorosis. The chemical species that are produced from the reactions of
Fe(II) and Fe(III) sulfates under environmental conditions are not
expected to differ from those iron minerals commonly encountered in
soils. No unreasonable environmental effects are expected from the use
of these salts as directed.

b. Environmental Fate Assessment

In summary, the fate and transport of Fe(II) and Fe(IID) salts in
the environment is dominated by three major processes: (1) the pH-
redox potential dependent oxidation of Fe(II) to Fe(III); (2) the
formation of insoluble oxides and hydroxides that are also well known
components of soils; and (3) the distinct surface chemistry of the oxides
and hydroxides of iron that control the adsorption of anions, cations
and organic material or the adsorption of iron species onto the surfaces
of mineral and organic components of soils, contributing to the
aggregation of soil particles into larger units.

In terrestrial environments, the use of Fe(II) and Fe(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(II) to the more mobile Fe(II), reoxidation and re-
precipitation to Fe(III) oxides and hydroxides will rapidly immobilize
any free Fe(II) that may form.

Therefore, the use of iron salts as herbicides to control moss in
residential outdoor ornamentals (herbaceous and woody plants; lawns
and turf) or as fertilizers to correct chlorosis in plants is not expected to
contribute significantly to the chemistry and fate of the compounds
existing naturally in the environment.

Ecological Effects

Ecological effects data presented here are derived from the six basic

tests typically required by the Agency for assessing ecological hazard,

12


Data supporting reported value provided

63-12 pH
Measured at about 20-25° C

Measured following dilution or dispersion in distilled water

63-13 Stability

Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined


dv9 vivd lv Ayyiqeis 82101. ET -€9
dv9 VLVd Iv Hd ZI-€9
dvV9 VLVd lv quRysuoD uoneossiq  —OT-£9
dv9 VIVaG lv ATiqnjos 8-£9
dv) Viva Iv Aysuoq £9
dv9 VLvd Iv qulog Surplog 9-€9
dv9 Viva lv qulog Bun[aw S-£9
dv) viva Iv 100 reo
dv9 Viva lv ayers jearsAyd €-€9
dv) Viva Iv Jojo 7-9
ZOSPOLTY IOSPOLIP = TTV spoylaypy feondjeuy €-29
ZOSPOLTP ‘LOSPOLIP Iv SW] JO uoNROyNIaD Féarés)
ZOSPOLIP ‘IOSPOLTIP = IIV sisyeuy Areurunard 1-79
ZOSPOLTY ‘1OSPOLIY =I sonundwy Jo uoneinuoy —(9)Z-19
ZOSPOLT ‘TOSPOLIP Iv ssaoo1g Suunjovjnuew pue spevaiey suruutseg = (8)7-19
ZOSPILT ‘LOSPOLIF Iv Aynuspy peorwsyD 1-19

Axspurayy PNpoIg OZI'SST§

NOLLV.LIO SALIS

OIHdVuDOr did = gsn @WVN ANITAGIND = aNITACIND

ALVATAS WI NOU!


ATTACHMENT G

COST SHARE AND DATA COMPENSATION FORMS




81-6 Dermal Sensitization in the Guinea Pig

ACCEPTANCE CRITERIA

Does your study meet the following acceptance criteria?

1.___ Identify material tested (technical, end-use product, etc).
2.___ Study not required if material is corrosive or has a
pH of <2 or > 11.5.
3.____ One of the following methods is utilized:
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehler test
Open epicutancous test
Mauer optimization test
Footpad technique in guinea pig.
4.___ Complete description of test.
5.2% __ 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.








ai.
CAS
CSF

EEC

EPA
FIFRA
FFDCA
HDT

LCs

LDso

LEL
MP

MRID

N/A

NPDES

GLOSSARY OF TERMS AND ABBREVIATIONS
Active Ingredient
Chemical Abstracts Service
Confidential Statement of Formula

Estimated Environmental Concentration. The estimated pesticide concentration
in an environment, such as a terrestrial ecosystem.

End-Use Product

U.S. Environmental Protection Agency

Federal Insecticide, Fungicide, and Rodenticide Act

Federal Food, Drug, and Cosmetic Act

Highest Dose Tested

Median Lethal Concentration. A statistically derived concentration of a substance
that can be expected to cause death in 50% of test animals. It is usually
expressed as the weight of substance per weight or volume of water or feed, e.g.,
meg/I or ppm.

Median Lethal Dose. A statistically derived single dose that can be expected to
cause death in 50% of the test animals when administered by the route indicated
(oral, dermal, inhalation). It is expressed as a weight of substance per unit
weight of animal, e.g., mg/kg.

Lethal Dose-low. Lowest Dose at which lethality occurs

Lowest Effect Level

Manufacturing-Use Product

Master Record Identification (number). EPA’s system of recording and tracking
studies submitted.

Not Applicable

National Pollutant Discharge Elimination System

iii


ATTACHMENT A
Chemical Status Sheet


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

Item 1-4,

Item 5.

Ttem 6.

Item 7a.

Item 7b.

Items 8-11.

NOTE:

FOR PRODUCT SPECIFIC DATA
Already completed by EPA.

If you wish to voluntarily cancel your product, answer “yes.” If you choose this
option, you will not have to provide the data required by the Data Call-In Notice an
you will not have to complete any other forms. Further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existi
Stocks provision of the Data Call-In Notice (Section IV-C).

Not applicable since this form calls in product specific data only. However, if your
product is identical to another product and you qualify for a data exemption, you
must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide the
EPA registration numbers of your source(s); you would not complete the
"Requirements Status and Registrant’s Response" form. Examples of such products
include repackaged products and Special Local Needs (Section 24c) products whic
are identical to federally registered products.

For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding “yes.”

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.

Self-explanatory.

You may provide additional information that does not fit on this form in a
signed letter that accompanies this form. For example, you may wish to repo
that your product has already been transferred to another company or that yo
have already voluntarily cancelled this product. For these cases, please suppl
all relevant details so that EPA can ensure that its records are correct.


IRON SALTS REREGISTRATION ELIGIBILITY TEAM

Office of Pesticide Programs:

Biological and Economic Analysis Division

Jim Saulmon Biological Analysis Branch

Ed Brandt Economic Analysis Branch

Steve Jarboe Biological Analysis Branch

Environmental Fate and Effects Division

Concepcion Rodriguez Ecological Effects Branch

Sylvia Termes Environmental Fate and Groundwater Branch
Mary Frankenberry Science Analysis and Coordination Staff
Health Effects Division

Jane Smith Chemical Coordination Branch

Pat McLaughlin Toxicology Branch I

Judy Smith Occupational and Residential Exposure Branch
Registration Division

Shyem Mathur Registration Support Branch

Tan Blackwell Registration Support Branch

Jesse Mayes Fungicide-Herbicide Branch

Special Review and Reregistration Division
Barbara Briscoe Accelerated Reregistration Branch
Yvonne Brown Accelerated Reregistration Branch

Policy and Special Projects Staff
Jean Frane Food Safety & Regulator Tracking Section

Office of General Counsel
Alan Carpien

Office of Compliance Monitoring
Phyllis Flaherty FIFRA Policy & Analysis Branch Policy and Grants
Division


81-5 Primary Dermal Irritation Study

ACCEPTANCE CRITERIA

Does your study meet the following acceptance criteria?

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

Study not required if material is corrosive or has a pH of <2 or >I1.5.

6 adult animals.

Dosing, single dermal.

Dosing duration 4 hours.

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

_____ Application site approximately 6 cn’.

____ Application site covered with a gauze patch held in place with nonirnitating tape.
Material removed, washed with water, without trauma to application site.
Application site examined and graded for irritation at 1, 24, 48 and 72 hr, then daily until normal or 14 d
(whichever is shorter).

11.*___ Individual daily observations.

lL.
2.
3.
4.
5.
6.
7.
8.
a

10

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


ATTACHMENT B

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


81-1 Acute Oral Toxicity in the Rat

ACCEPTANCE CRITERIA

Does your study meet the following acceptance criteria?

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

-___ At least 5 young adult rats/sex/group.

Dosing, single oral may be administered over 24 hrs.

Vehicle control if other than water.

Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mg/kg).

Individual observations at least once a day.

Observation period to last at least 14 days, or until all test animals appear normal whichever is longer.
Individual daily observations.

Individual body weights.

Gross necropsy on ali animals.

Sewmsynneune

ETE Lt


product is similar enough to another product to qualify for this option. I am
submitting evidence that I have made an offer to another registrant (who has an
obligation to submit data) to share in the cost of that data. I am also submitting a
completed "Certification of Offer to Cost Share in the Development Data" form I
am including a copy of my offer and proof of the other registrant’s receipt of that
offer. I am identifying the party which is committing to submit or provide the
required data: if the required study is not submitted on time, my product may be
subject to suspension. I understand that other terms under Option 3 in the Data
Call-In Notice (Section ITI-C.i.) apply as well.

By the specified due date, 1 will submit an existing study that has not been submitte
previously to the Agency by anyone (Submitting an Existing Study). I certify that
this study will meet all the requirements for submittal of existing data outlined in
Option 4 in the Data Call-In Notice (Section TI-C.1.) and will meet the attached
acceptance criteria (for acute toxicity and product chemistry data). I will attach the
needed supporting information along with this response. J also certify that I have
determined that this study will fill the data requirement for which I have indicated t
choice.

By the specified due date, I will submit or cite data to upgrade a study classified by
the Agency as partially acceptable and upgradable (upgrading a Study). I will
submit evidence of the Agency’s review indicating that the study may be upgraded
and what information is required to do so. J will provide the MRID or Accession
number of the study at the due date. I understand that the conditions for this option
outlined Option 5 in the Data Call-In Notice (Section III-C.1.) apply.

By the specified due date, 1 will cite an existing study that the Agency has classified
as acceptable or an existing study that has been submitted but not reviewed by the
Agency (Citing an Existing Study). If I am citing another registrant’s study, I
understand that this option is available only for acute toxicity or certain efficacy




amounts of an ingredient that may legally be present 40 CFR
158.175. The lower certified limit is used as the enforceable
lower limit for the product composition according to FIFRA
section 12(a)(1)(C), while the nominal concentration appearing on
the label would be the routinely achieved concentration used for
calculation of dosages and dilutions.

The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual
product composition because the nominal concentration would be
the amount of active ingredient typically found in the product.

It is important for registrants to note that certified
limits for active ingredients are not considered to be trade
secret information under FIFRA section 10(b). In this respect the
certified limits will be routinely provided by EPA to States for
enforcement purposes, since the nominal concentration appearing
on the label may not represent the enforceable composition for
purposes of section 12(a)(1)(C).

III. REQUIREMENTS

As described below under Unit V. " COMPLIANCE SCHEDULE," 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.


b. Mutagenicity

A mutation study in EB. coli reported positive results at 30
umol/L(4). With due regard for the continuing exposure that human
beings have had to the iron and sulfate components of these chemicals
over many generations, it is considered unlikely that this reported result
in microorganisms has any bearing on probable effects in humans or
other mammals at the levels expected from use of these compounds as
pesticides.

c Metabolism

Iron sulfates are normal constituents of the diet and are
metabolized and utilized by the body.

d. Other Toxicological Consideration

The toxicological data on iron sulfates within the Agency and in
the literature are adequate for assessing risk to humans. Not all of the
toxicity data usually required for pesticide registration or reregistration
are necessary for the present uses of iron sulfates. There are some
unusual factors in this case which indicate that specific studies to fulfill
the usual data requirements are not necessary to regulate these
substances as pesticides. Iron sulfates are normally present in the
environment. They may be present in foods naturally and as added
ingredients. There is no reason to expect that pesticide usage in
accordance with the product label or labeling accompanying the product
will constitute any hazard beyond that from ordinary exposure.

Exposure Assessment
a. Dietary

Dietary exposure to iron (III) sulfate, iron (II) sulfate
heptahydrate, and iron (II) sulfate monohydrate is not expected to occur
from pesticidal use. There are no active products involving pesticidal
uses on food or animal feed. Therefore, there are no tolerances or
exemptions from the requirements of tolerances established for iron
salts. Since there are no toxicological endpoints of concern and no
food uses, no risk assessment was performed for dietary exposure.
Iron (II) sulfate is generally recognized as safe as noted in 40 CFR
180.2(a). The Food and Drug Administration has affirmed that iron
(IIE) sulfate and iron (II) sulfate (hepta and monohydrate) are generally
recognized as safe (GRAS) for use in food as flavoring agents and
nutrient supplements, respectively, with no limitations other than


00142309

00137725

00137726

40091902

IRON SALTS BIBLIOGRAPHY
ITATION

Faith, W. L., Keyes, D. B. and R. L. Clark, 1965 Industrial Chemical’s, John
Wiley & Sons, Inc., N. Y., N. Y., Pages 386-9.

Windholz, H. (Ed.) 1983. The Merck Index, 10th Edition, Merck & Co. Inc.,
Rathway, N. J, Page 3982.

Weast, R. C. (Ed.) 1986. CRC Handbook of Chemistry and Physics, CRC Press,
Inc., Boca Raton, FL, Pages 13-98.

Lindsay, W. L., 1979, Chemica! Equilibria in Soils John Wiley & Sons, N. Y.,

Page 131.

”s Diction: f Li hemi. Vol. VI, 1937 Longmans, Green and
Co, New York N.Y., Pages 57-58.

Material Data Safety Sheet, Ferrous Sulfate Heptahydrate, 1987, Crown
Technology, Inc., Indianapolis, IN.

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

Material Safety Data Sheet Ferrous Sulfate Monohydrate, Q. C. Corporation
Baltimore, MD 21200.

Material Safety Data Sheet Ferrous Sulfate Heptahydrate Synergy Production
Group, Inc. Detroit, MI 48234.

Sax, N. [I., and Lewis, R. J. SR, 1989. Dangerous Properties of Industria
Materials, 7th Ed. Van Nostrand Reinhold, New York. N.Y.

Klettke, M., Product Chemistry of Ferrous Sulfate Monohydrate., Charles H.
Lilly Company, 1990.

Klettke, M. Primary Eye Irritation Study, Ferrous Sulfate, Project T.1008, Harris
Laboratories, Inc. 1990.

Klettke, M., Primary Skin Irritation Study, Project T.1009, Harris Laboratories,
Inc. 1990.

Fletcher, D. (1986) Acute Oral Toxicity Study with Ferrous Sulfate Monohydrate
in Bobwhite Quail: Laboratory Project ID: BLAL No..85 QD 61. Unpublished
study prepared by Bio-Life Associates, Ltd. 27 p.


Appendix E, F, & G are separate
docucments


All responses to this Notice for the Product Specific data requirements should be submitted
to:

Joanne Miller, Product Manager Team 23
Herbicide/Fungicide Branch

Registration Division (H7505C)

Office of Pesticide Programs

U.S. Environmental Protection Agency
Washington, D.C. 20460

RE: IRON SALTS


CASE OVERVIEW

A. Chemical Overview

The following active ingredients are covered by this Reregistration Eligibility
Document:

1 Chemical Name: Iron (III) sulfate
° CAS Registry Number: 10028-22-5
° Office of Pesticide Programs Chemical Code: 34902

0 Empirical Formula: Fe,(SO,)3

2. Chemical Name: Iron (II) sulfate monohydrate
0 CAS Registry Number: 17375-41-6
° Office of Pesticide Programs Chemical Code: 50507

o Empirical Formula: FeSO,H,O

3. Chemical Name: Iron (11) sulfate heptahydrate
° CAS Registry Number: 7782-63-0
° Office of Pesticide Programs Chemical Code: 50502

° Empirical Formula: FeSO,7H,O


o &h 3
isa! UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
Vay norte WASHINGTON, D.C. 20460

OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES

PR NOTICE 91-2

NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDES

ATTENTION: Persons Responsible for Federal Registration of
Pesticide Products.

SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement

I. PURPOSE:

The purpose of this notice is to clarify the Office of
Pesticide Program's policy with respect to the statement of
percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient (s)
specified in the ingredient statement on the label must be stated
as the nominal concentration of such ingredient(s), as that term
is defined in 40 CPR 158.153(i). Accordingly, the Agency has
established the nominal concentration as the only acceptable
label claim for the amount of active ingredient in the product.

II. BACKGROUND

For some time the Agency has accepted two different methods
of identifying on the label what percentage is claimed for the
ingredient(s) contained in a pesticide. Some applicants claimed a
percentage which represented a level between the upper and the
lower certified limits. This was referred to as the nominal
concentration. Other applicants claimed the lower limit as the
percentage of the ingredient(s) that would be expected to be
present in their product at the end of the product's shelf-life.
Unfortunately, this led to a great deal of confusion among the
regulated industry, the regulators, and the consumers as to
exactly how much of a given ingredient was in a given product.
The Agency has established the nominal concentration as the only
acceptable label claim for the amount of active ingredient in the
product.

Current regulations require that the percentage listed in
the active ingredient statement be as precise as possible
reflecting good manufacturing practices 40 CFR 156.10(g) (5). The
certified limits required for each active ingredient are intended
to encompass any such "good manufacturing practice" variations 40
CFR 158.175(c) (3).

The upper and lower certified limits, which must be proposed
in connection with a product's registration, represent the


For More
Information

are eligible for reregistration. These products will be reregistered once the
required generic and product-specific data and revised labeling are received
and accepted by EPA.

© Registered products containing iron salts as well as other active
ingredients will be reregistered once the other active ingredients also are
determined to be eligible for reregistration.

EPA is requesting public comments on the Reregistration Eligibility
Document (RED) for iron salts during a 60-day time period, as announced
in a Notice of Availability published in the Federal Register. To obtain a
copy of the RED or to submit written comments, please contact the
Pesticide Docket, Public Response and Program Resources Branch, Field
Operations Division (H-7506C), Office of Pesticide Programs (OPP), US
EPA, Washington, DC 20460, telephone 703-305-5805.

Following the comment period, the iron salts RED will be available
from the National Technical Information Service (NTIS), 5285 Port Royal
Road, Springfield, VA 22161, telephone 703-487-4650.

For more information about iron salts or about EPA’s pesticide
reregistration program, please contact the Special Review and
Reregistration Division (H-7508W), OPP, US EPA, Washington, pc
20460, telephone 703-308-8000. For information about reregistration of
individual iron salts products, please contact Joanne Miller, Product
Manager, Registration Division (H-7505C), OPP, US EPA, Washington,
DC 20460, telephone 703-305-7830.

For information about the health effects of pesticides, or for
assistance in recognizing and managing pesticide poisoning symptoms,
please contact the National Pesticides Telecommunications Network
(NPTN). Call toll-free 1-800-858-7378, between 8:00 am and 6:00 pm
Central Time, Monday through Friday.


Item 6.

Item 7.

This item identifies the code associated with the use pattern of the pesticide. A brief
description of each code follows:

OZ EP AMM ROMO OD >

Terrestrial food

Terrestrial feed

Terrestrial non-food
Aquatic food

Aquatic non-food outdoor
Aguatic non-food industrial
Aquatic non-food residential
Greenhouse food
Greenhouse non-food crop
Forestry

Residential

Indoor food

Indoor non-food

Indoor medical

Indoor residential

This item identifies the code assigned to the substance that must be used for testing.
A brief description of each code follows.

EP
MP
MP/TGAI

PAI
PAM
PAI/PAIRA
PAIRA
PAIRA/M
PAIRA/PM
TEP

TEP _*
TEP/MET
TEP/PAI/M

TGAI/PAIRA

TGAI
TCAL/TEP
TGAI/PAI
MET

IMP
DEGR

*See: guideline comment

End-Use Product

Manufacturing-Use Product

Hanufacturing-Use Product and Technical Grade Active
Ingredient

Pure Active Ingredient

Pure Active Ingredient and Metabolites

Pure Active Ingredient or Pure Active Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled

Pure Active Ingredient Radiolabelled and Metabolites

Pure Active Ingredient Radiolabelled and Plant Metabolites
Typical End-Use Product

Typical End-Use Product, Percent Active Ingredient Specified
Typical End-Use Product and Metabolites

Typical End-Use Product or Pure Active Ingredient and
Metabolites

Technical Grade Active Ingredient or Pure Active Ingredient
Radiolabelled

Technical Grade Active Ingredient

Technical Grade Active Ingredient or Typical End-Use Produc
Technical Grade Active Ingredient or Pure Active Ingredient
Metabolites

Impurities

Degradates


IV. APPENDICES




IRON SALTS: DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

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

This Generic Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
jeon salts. This attachment is to be used in conjunction with (1) the Generic Data Call-In
Notice, (2) the Generic Data Call-In Response Form (Attachment B), (3) the Requirements
Status and Registrant's Form (Attachment C), (4) a list of registrants receiving this DCI
(Attachment D), (5) the EPA Acceptance Criteria (Attachment E), and (6) the Cost Share and
Data Compensation Forms in replying to this Iron Salts Generic Data Cail-In (Attachment F).
Instructions and guidance accompany each form,

ATA RE D BY NOTICE

The additional data requirements needed to complete the generic database for iron

salts are contained in the Requirements Status and Registrant's Response, Attachment C.
The Agency has concluded that additional product chemistry data on iron salts are needed.
These data are needed to fully complete the reregistration of all eligible zinc salts products.

AND. PON TO THIS NOTICE

If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Yvonne Brown at (703) 308-8073.

All responses to this Notice for the generic data requirements should be submitted to:

Yvonne Brown, Chemical Review Manager
Accelerated Reregistration Branch

Special Review and Registration Division (H7508W)
Office of Pesticide Programs

U.S. Environmental Protection Agency

Washington, D.C. 20460

RE: IRON SALTS


(pyrite and marcasite, FeS,; chalcopyrite, CuFeS,, etc.), phosphates
(for example vivianite) and incomplex silicates.(1,2) Weathering (that
is, “the group of processes such as the chemical action of air,
rainwater, plants and bacterial, and the mechanical action of changes of
temperature whereby rocks on exposure to weather change in character,
decay and finally crumble into soil")(3) has considerably influenced the
distribution of iron in the earth. The oxides and hydroxide minerals of
iron are strong pigments and are responsible, for the most part, for the
brown and red colors of soils. The presence of hematite and goethite
in soils (usually associated with gibsite and kaolinite) is indicative of an
advanced stage of weathering.(4)

The oxidation of ferrous iron to ferric iron (from here on
referred to as Fe(II) and Fe(iil), respectively) is a very important
aspect of the chemistry of iron salts in the environment. The
oxidation is dependent on the pH and the redox potential of the medium
(water; soil) and the nature of the ligands that may be compiexed to
Fe(II). But in general, Fe(II) is more prevalent only in very acid media
of very low oxygen content, rather than in more basic media of normal-
to-high oxygen content, the latter being the most commonly
encountered condition. The speciation and subsequent fate and
transport of Fe(II) and Fe(III) in the environment is, therefore,
determined by the pH and redox potential of the media and by the
nature of the ligands to which they complex. (1,2,5,6)

Under normal environmental conditions (pH 5 to 9; aerobic
environments), the highly soluble Fe(II) salts will be rapidly oxidized to
Fe(HI), but this oxidation is accompanied by the formation of less
soluble oxide and hydroxide.(7) The precipitation of Fe(III)
oxides/oxyhydroxides from oxidation of Fe(II) salts or from Fe(II)
salts occurs in a stepwise manner, which involves (a) formation of low-
molecular weight species of poor crystalline ordering; (b) formation of
ted cationic polymers; (c) aging of the polymers, with eventual
conversion to better defined oxide phases; (d) precipitation of
oxide/oxyhydroxide phases of well defined crystallographic
characteristics.(5) The rate of formation and the onset of the polymeric
species are known to be strongly influenced by the nature of the
counter anion of the salts.(5) In the case of salts of the divalent sulfate
counter anion, precipitation occurs at lower pHs than with salts of
monovalent counter anions (for example, nitrate, chloride). Like in
laboratory experiments, the use of Fe(II} and Fe(IH) sulfates in a
terrestrial environment leads to the formation of insolubie
oxide/oxyhydroxide species.(7)

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

10


| oeds | 90ds || poreinojeo oq

oeds you} sede 0u you | rou |] rouues osog pu 9 (@qay Uo ION ‘Wey Yseopealg
e108 40d
osds | oods u0y
cede you eds jou 10u jou ql avert eu 5 puay Ag ‘84 ‘Iseopeoig

ede | 90ds || porejnowwo oq
sedsjou| oodsiou | you | rou |! rouse osog eu 9 feqe"] uo ION “Buds Aue3 “juoUNeeL odg

eds | seds || o1om sed vos)

edz jou | oeds jou you you QI ZS00'01 eu 9 sopesidg “10}UIAA “IsBOpROIg
oeds | oeds 91908 19d
sede jou} sodsiou f iou | jou voll gi e°9e pu 5 aepecids ‘popeou usyp ‘seopeodg

deds | code I siom sed voy
seds jou} sedsiou | you | acu fl qigcei-eL ou 5 sepeeids ‘Buuds yseopeoig

veds | a0de || poywinoyeo oq
sedsiou} oodeiou | sou | rou | yours osog ov 9 10qe7 Uo JON “Wey WUOUNGON Jods

sede | sede || ose 10d aow
sede you} sodarou | sou | rou || apezezz eu 9 topeaidg ‘Buudg Ape3 “eeopeoig

eds | sede || pereinojeo oq
veds zou} osedsiou | you | you |! rouues esoq eu 9 18997 uo 20K ‘Buds Aueq “Iseopaosg

Iehuepiaey s00ping pue do1g poo7-u0K jeujeeue] :ednoID esp) pn] pus GUAGE, IUELIEWI

pods | sede || parsinojeo oq

goede ou] ods ou you | you |] iouur osoq Bu 9 Jsqey UO ION ‘popeou uoYsA ‘opunds
e108 20d
eds uolt
veda you} ads you you al Brave vu By puey Ag ‘1184 “eeopeoig

eds ff 0100 t0d us
you WU aps pe eu 9 Jepeoids ‘}1}e4 eeopeosg

geds jou | eds 100

JPRUEPIEeYy ZOOpING pus do1g poos-LON JeUIseHe] -edNID eB) EIUB|g snowseqon jeNoUIEUIQ

$3SN G334NON/GOO4NON
NOLLVULSIDISHSY YOd JTBIOITS S3SN

{ajespAyouow ayeyins snoiia4] ZOGOGO [esWaYD (ses UO] ‘BGO ase% - ¥ xIaNada¥



IV. PRODUCTS THAT REQUIRE EFFICACY DATA

All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lower then the minimum
level to achieve efficacy. This is extremely important for
products which are intended to control pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 153.640.

In those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.

V. COMPLIANCE SCHEDULE

As described earlier, the purpose of this Notice is to make
the registration process more uniform and more Manageable for
both the agency and the regulated community. It is the Agency's
intention to implement the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority programs, i.e., reregistration, new chemical, or
fast track (FIFRA section 3(c) (3) (B). Therefore,
applicants/registrants are expected to comply with the
requirements of this Notice as follows:

(1) Beginning July 1, 1991, all new product registrations
submitted to the Agency are to comply with the
requirements of this Notice.

(2) Registrants having products subject to reregistration
under FIFRA section 4(a) are to comply with the
requirements of this Notice when specific products are
called in by the Agency under Phase V of the
Reregistration Program.

(3) All other products/applications that are not subject to
(1) and (2) above will have until July 1, 1997, to
comply with this Notice. Such applications should note
"Conversion to Nominal Concentrations on the
application form. These types Or amendments will not be
handled as "Fast Track" applications but will be
handled as routine requests.

VI. FOR FURTHER INFORMATION

Contact Tyrone Aiken for information or questions concerning

this notice on (703) 557-5024
Gow EL
han peerenias a

Anne 8. Lindsay, Director
Registration Olvision (H-7505


Ecological Effects Data
(qd) Non-Target Terrestrial

Iron (11) sulfate heptahydrate and iron (II) sulfate
monohydrate are classified as practically non-toxic to the
bobwhite quail on an acute oral basis. The LD,, was 2250
me/kg for iron (11) sulfate heptahydrate and for sulfate
monohydrate the LD, 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 LCs) for iron (II)
sulfate heptahydrate was > 5620 ppm for both the bobwhite
quail and the mallard duck. For iron (II) sulfate monohydrate,
the LC, was >5000 ppm for both the bobwhite quail and the
mallard duck.

Iron (II) sulfate heptahydrate was classified as practically
non-toxic to rats on an acute oral basis. The LD, was >5
g/kg. Iron (III) sulfate was classified as non-toxic to male rats
on an acute oral basis. The LDsy was 2,102 mg/kg. The LDso
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 ECs, of 7.1 ppm for Daphnia
pulex and LC.) of 20.8 ppm for rainbow trout classify iron salts
as moderately toxic to aquatic invertebrates and slightly toxic to
fish.

Ecological Effects Risk Assessment
(1) | Non-Endangered Species

No adverse effects to avian, mammalian or aquatic
populations are anticipated from the use of iron salts. Iron is
one of the most abundant elements and will be immobilized at
the environmentally important pH range of 5-9. There is very
little likelihood for runoff to aquatic systems since the parent
compounds convert very rapidly to less soluble forms in the
environment, Furthermore these oxidized iron compounds bind
tightly to soil under turf.

13




Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following
elements describing the earliest known submission:

ay

Q)

(3)

4)

Submission date. The date of the earliest known submission appears
immediately following the word “received.”

Administrative number. The next element immediately following the
word “under” is the registration number, experimental use permit number,
petition number, or other administrative number associated with the
earliest known submission.

Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.

Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume in
which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for "Company
Data Library." This accession number is in turn followed by an
alphabetic suffix which shows the relative position of the study within the
volume.


APPENDIX C
IRON SALTS BIBLIOGRAPHY

Citations Considered to be Part of the Data Base
Supporting the Reregistration of Iron Salts






APPENDIX B

Table of The Generic Data Requirements and
Studies Used to Make the Reregistration Decision


TABLE OF CONTENTS

1 EXECUTIVE SUMMARY ....... 0.0.00 cee eee eee eee eee 1
i. INTRODUCTION .. 10.0.0. ee tee eee 2
IM. CASE OVERVIEW .......0 00.2 ce eee ee ene 3
A. Chemical Overview 2.00. eee eee 3
B. Use Profile 2... ce eee te eens 4
Cc. Regulatory History 2... cee eee ee ene 6
IV. SCIENCE ASSESSMENT OF IRON SALTS ..........--0 2002 eee 6
A. Physical Chemistry Assessment . 2... 01 - eee eee eee 6
B. Human Health Assessment... 20 ee ee eee 7
Cc. Environmental Assessment 2... 6 ee ee 9

Vv. RISK MANAGEMENT AND REREGISTRATION DECISION FOR IRON

SALTS 006. nee eee 14
A. Determination of Eligibility... 2.6.6 0. eee ee ee eee 14
VIL. ELIGIBILITY DECISION .. 0.2.26 eee 14
A. Eligible and Ineligible Uses . 2... 2. ee ee eee 15
VI. ACTIONS REQUIRED BY REGISTRANTS .........0000-00 2225 eee 15
A. Additional Generic Data Requirements ...... 0.20 2 ee eee eee 15
B. Product specific data requirements .. 6... . eee eee ee eee 15

Cc. Labeling Requirements for Manufacturing-Use and End-Use Products ... 15

Vili, APPENDICES
APPENDIX A - Use Pattems Subject to Reregistration

APPENDIX B - Table of the Generic Data Requirements and Studies Used to Make the
Reregistration Decision

APPENDIX C - Citations Considered to be Part of the Data Base Supporting the
Reregistration of Iron Salts

APPENDIX D - List of Available Related Documents
APPENDIX E - Pesticide Reregistration Handbook

APPENDIX F - Generic Data Call-In


15.

16.

17.

18.

19.

Reference 7. p. 415.

Reference 7. p. 416-418.

Healey, T.W. "Principles of Dispersion and Aggregation of Mineral Fines”, in
Beneficiation of Mineral Fines, edited by P. Scnmasnndaran and N. Arbiter,
Society of Mining Engineering, AIME, 1979, pp 12-161 to 12-178.

Reference 7, p. 419.

Karasthannasis, A.D., Evangelou, V.P. and Thompson, Y.L. “Aluminum and
Iron Equilibria in Soil Solutions and Surface Waters of Acid Mine Watersheds”,

L_Environ. Qual., Vol. 17, 1988, pp. 534-543.




‘AydexBorigig ayy peynuapt
ST sunyerayy oqnd ayy, “ssaooid uonensigesar ay) jo wed se Aouasy ayy 0} papraosd sem uoneUOJUT pue ame] oNgNd =;

1 qv Amnqeig a8eing = 1-€9
1 lv Hd Z1-£9
\ Hv que\suoD uoTeIoossiIq’ = QT-€9
1 Nv Aupiqnjos 8-£9
1 lv Aysuad L-£9
i lv qulog Zurpog 9-€9
1 Iv qlog Sun; ¢-€9
' Iv JopO £9
1 Iv ayes Teoiskyd €-€9
1 Iv Jojop 7-€9
1 Iv spomeW [eondjeuy €-%9
1 Iv SHWYT Jo UoNROy TAD e209
1 lIv siskfeuy Areurwyaig 1-79
1 liv sonundwy Jo vonefnunoy — (q)Z-19
1 lv ssaooig SuuMoejnuey pue syeuayeyy guruiseg —(8)Z-19
1 lv Ayquepy jeorweyo 1-19

Ausquraq) JNpPOAd OZL"SS1§
NOLLV.LIO SALLIS
OIHd VUeOOr Tala asa @WYN SNITACINS = YNITACIND

aLVAGAHV.IddH II NOU!




current good manufacturing practice.
b. Occupational and Residential

As stated in Appendix A, iron (III) sulfate and iron (II) sulfate
hepta- and monohydrate are applied to turf and ornamental lawns using
drop and broadcast spreaders, sprinkler cans, and by hand. These
inorganic salts are formulated as a granular and soluble concentrate
(liquid and solid). They are used as a herbicide to control moss on
residential lawns and ornamental turf. The potential for
mixer/loader/applicator exposure exists; however, these inorganic salts
are of little concern from a toxicity perspective. Any
mixer/loader/applicator exposure to these inorganic salts is considered
inconsequential and no additional exposure data are required for
reregistration eligibility.

“3. Risk Assessment

The human risks from both dietary and occupational exposures are
considered to be negligible. The general knowledge of iron (III) sulfate and
iron (II) sulfate hepta- and monohydrate indicate low toxicities associated with
these compounds. They are used by humans as food flavoring agents and food
nutrient supplements, and have inherent function in the metabolic pathways of
humans and domestic animals. No additional hazard or exposure data are
required for reregistration eligibility.

Environmenta! Assessment
1, Environmental Fate

The Agency is relying on data available in the scientific literature to
assess the environmental fate and transport of iron salts as used in pesticidal
compounds. No environmental fate data were submitted by registrants.

a. Environmental Chemistry and Fate

Tron is the fourth most abundant element and the second most
abundant metal in the Earth’s crystal rocks. Iron occurs in a wide
variety of minerals among them the oxides hematite (a-Fe,O,) and
magnetite (Fe,O,), the "hydrated oxide oxide limonite"
(~"2Fe,0,-+3H,0"), the oxyhydroxide geothite and its polymorph
lepidocrocite (a-FeOOH and y-FeOOH, respectively), ferrihydrite
("5Fe,0,+9H,0"), in carbonates such as siderite (FeCO,), in sulfides


B. Use Profile

The following is information on the current registered uses with an overview
of use sites and application methods. A detailed table of these uses of iron (I)
sulfate, iron (II) sulfate monohydrate and iron (II) sulfate heptahydrate is in Appendix
A.

1. For Iron (0) sulfate:

Type of Pesticide: Herbicide

Use Sites: Omamental lawns and turf--terrestrial non-food, outdoor
residential
Target Pest: Mosses

Formulation Types Registered:
Soluble concentrate/liquid

Method and Rates

of Application: Equipment - Sprinkler can and hose-end sprayer.
Method and Rate - Soluble concentrate/liquid (1 qt./500
sq.ft.)

Timing - When needed.

2. For Iron (ID sulfate monohydrate:

Type of Pesticide: Herbicide

Use Sites: Ornamental herbaceous plants, ormamental lawns and
turf, omamental woody shrubs and vines--terrestrial non-
food, outdoor residential.

Target Pests: Mosses

Formulation Types Registered:
Granular


REREGISTRATION ELIGIBILITY DOCUMENT

IRON SALTS
LIST D

CASE 4058

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


81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA

Does your study meet the following acceptance criteria?

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

2.____ Study not required if material is corrosive, causes severe
dermal irritation or has a pH of <2 or >11.5.

3.____ 6 adult rabbits.

4.___ Dosing, instillation into the conjunctival sac of one eye
per animal.

5._____ Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if & solid, paste or particulate substance.

6.____ Solid or granular test material ground to a fine dust.

7.____ Eyes not washed for at least 24 hours.

8.____ Eyes examined and graded for irritation before dosing and
at 1, 24, 48 and 72 hr, then daily unti! eyes are normal
or 21 days (whichever is shorter).

9% Individual daily observations.

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


Attachment C

Requirements Status and Registrants’ Response Forms
(Form B) plus Instructions


4

VI.

(2) Endangered Species

No adverse effects to terrestrial or aquatic endangered
species are anticipated from the use of iron salts.

RISK MANAGEMENT AND REREGISTRATION DECISION FOR IRON SALTS
A. Determination of Eligibility

Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after
submission of relevant data concerning an active ingredient, whether products
containing the active ingredient are eligible for reregistration. The Agency has
completed its review of data from the open literature and generic data submitted by
registrants, and has determined that the data are sufficient to support reregistration of
products containing iron salts. Appendix B identifies the generic data that the Agency
reviewed as part of its determination of reregistration eligibility of iron salts, and lists
the submitted studies that the Agency found acceptable.

The data identified in Appendix B were sufficient to allow the Agency to
assess registered uses of iron salts and to determine that these uses can be used
without resulting in unreasonable adverse effects to humans and the environment.

The Agency therefore finds that products containing iron salts as an active ingredient
are eligible for reregistration. The reregistration of particular products is addressed in
Section VI of this document.

The Agency made its reregistration eligibility determination based upon the
target data base required for reregistration, the current guidelines for conducting
acceptable studies to generate such data and the data identified in Appendix B.
Although the Agency has found that current products containing iron salts are eligible
for reregistration, it should be understood that the Agency may take appropriate
regulatory action, and/or require the submission of additional data to support the
Tegistration of products containing iron salts, if new information comes to the
Agency's attention or if the data requirements for reregistration (or the guidelines for
generating such data) change.

The following is a summary of the regulatory positions and rationales for iron
salts. Where labeling revisions are imposed, specific language is set forth in Section
V of this document.

ELIGIBILITY DECISION

The Agency has sufficient information on the human health effects of iron salts and

on its potential for causing effects in fish and wildlife and the environment when used to
control moss growth in outdoor residential areas. The Agency concludes that products

14


GLOSSARY OF TERMS AND ABBREVIATIONS (cont.)

NOEL No Observed Effect Level

OPP Office of Pesticide Programs

ppm Parts Per Million

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

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


Pllos/e1B.jUE9UNd oIqGN|O8 = g/9g ‘pINbIVelEjUESLOD eQnjos = V/Og !e[NUEIB= 5 : wto4

e1jjgeds you = aeds jou :suopeordde = edde ‘un URW fWinuIeu = xeUd uopeoH

siqeordde jouw

a a ee

pads | oeds || cior sed vos
vedarou| oodsyou | sou | rou |] aocia ie eu s/0$ pusy Ag ‘pepoou uoym “iseopsoig

sede | oeds || pereinojeo oq
geds 1ou | sede you you | rou |} iouues esog Bu Vos usa sopuudg ‘pepeou uous, ‘opuUds

veda | sede || e100 sed vox
sede rou| oedsjou | rou | rou # gigzia iy eu ids Jopeoidg ‘pepoou uoy “Iseopeosg

2eds | oeds || e100 16d vox
aedesou| oodsyou | sou | sou |i aizece‘et eu 9 sepeerds ‘popeou usy “IseopRorg

oads } oeds e108 16d Uda

eds iou| oedsiou | you | jou azzzs eu s/aS Joheids ‘pepeou wey ‘Asidg
pads | oeds || olop 10d wos
eds jou} oedsiou | rou } rou UZLe7S eu s/os uva epuuds ‘popesu uoyy ‘epiuuds

Tenueprsey 100ping pus dos poog-UON [auIsen0] ‘sdn0sD 967) sn] pus sums IURLIELIO

S4SNM G3adNON/GOO4NON

NOILVULSIDaH3Y YOd 378/917 Sash

masts vogromity “Thrin, Lopoycy "wiky vowaoeity — a4NS

(alespAyeyday ajeyjns snouey} ZOGOGO [eatuaYD [Ses UOL|] ‘gGOY ase - v XtaNadav



End-Use Products Containing Irons Salts (none were batched).

EPA Reg. No: % Active Ingredient:

! 538-223 15.2% ferrous sulfate monohydrate granular

557-1838 40.0% ferrous sulfate heptahydrate granular
802-504 4.78% ferrous sulfate heptahydrate granular

: 8.80% ferrous sulfate monohydrate

802-509 35.0% ferric sulfate soluble conc,

| 802-543 32.0% ferric sulfate monohydrate granular

802-558 95.4% ferrous sulfate monohydrate granular
3234-44 32.5% ferrous sulfate monohydrate granular
7001-290 15.0% ferrous sulfate monohydrate granular
740403 25.38% ferrous sulfate monohydrate granular

t 7404-04 17.05% ferrous sulfate monohydrate granular

| 7404-10 39.85% ferrous sulfate monohydrate granular

| 34704-713 65.0% ferrous sulfate heptabydrate soluble conc.

| 64864-13 17.0% ferrous sulfate monohydrate granular

| 64864-14 6.6% ferrous sulfate heptahydrate soluble conc.



INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT’S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA

Item 1-3 Completed by EPA. Note the unique identifier number assigned by EPA in Item 3
This number must be used in the transmittal document for any data submissions
in response to this Data Call-In Notice.

Item 4. The guideline reference numbers of studies required to support the product’s
continued registration are identified. These guidelines, in addition to the requiremen
specified in the Notice, govern the conduct of the required studies. Note that series 61
and 62 in product chemistry are now listed under 40 CFR 158.155 through 158.180

Subpart C.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use pattern(s) of the pesticide associated with the product specific requirements is

(are) identified. For most product specific data requirements, all use patterns are
covered by the data requirements. In the case of efficacy data, the required studies
only pertain to products which have the use sites and/or pests indicated.

Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases.

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

months after issuance of the Reregistration Eligibility Document unless EPA
determines that a longer time period is necessary.

Ttem 9, Enter only one of the following response Codes for each data requirement to
show how you intend to comply with the data requirements listed in this table.
Fuller descriptions of each option are contained in the Data Call-In Notice.

1, I will generate and submit data by the specified due date (Developing Data). By
indicating that f have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined in th
Data Call-In Notice.

2. I have entered into an agreement with one or more registrants to develop data joint!
(Cost Sharing). I am submitting a Copy of this agreement. I understand that this
option is available only for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this Notice that my product is similar enough to anothe
product to qualify for this option. I certify that another party in the agreement is
committing to submit or provide the required data: if the required study is not
submitted on time, my product may be subject to suspension.

3, I have made offers to share in the cost to develop data (Offers to Cost Share). I
understand that this option is available only for acute toxicity or certain efficacy dat
and only if EPA indicates in an attachment to this Data Call-In Notice that my


L EXECUTIVE SUMMARY

The active ingredients covered in this document include iron (IID sulfate, iron (i)
sulfate monohydrate and iron (II) sulfate heptahydrate in the chemical case iron salts.
Products containing these active ingredients are used as herbicides for the control of moss on
ornamental herbaceous plants, lawns, turf, wood shrubs and vines. This Reregistration
Eligibility Document (RED) addresses the eligibility for reregistration of products containing
these active ingredients for the above mentioned use sites only.

The U.S. EPA (hereafter referred to as “the Agency”) has determined that the uses of
these three active ingredients, as they are currently registered, will not cause unreasonable
risk to humans or the environment. Therefore, products containing the iron salts are eligible
for reregistration. The Agency is requiring additional studies on physical chemistry as
confirmatory data and for purposes of labeling to complete the generic data base.

Before reregistering the products containing these iron salts, the Agency is requiring
that product specific data and revised labeling be submitted within eight months of the
issuance of this document. These data include product chemistry and acute toxicity testing.
After reviewing these data and any revised labels and finding them acceptable, the Agency
will reregister a product based on whether or not that product meets the requirements in
Section 3(c)(5) of FIFRA.


EPA’S DECISION NOT TO BATCH END-USE PRODUCTS CONTAINING IRON SALTS
FOR PURPOSES OF MEETING ACUTE TOXICITY DATA REQUIREMENTS FOR
REREGISTRATION

In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregistration of end-use products containing the active ingredient
iron salts, the Agency considered batching end-use products. This process involves grouping simi
products for purposes of acute toxicity. Factors considered in the sorting process include each
product’s active and inert ingredients (identity, percent composition and biological activity), type o
formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and labeling
(e.g., signal word, use classification, precautionary labeling, etc.).

Batching has been attempted using the readily available
information described above, and frequently acute toxicity data on individual end-use products has
been found to be incomplete. Notwithstanding the batching process, the Agency reserves the right
to require, at any time, acute toxicity data for an individual end-use product should the need arise.

After consideration of the available information described above, batching of end-use
products containing iron salts was not possible. The accompanying table lists all the end-use
products containing iron salts. These products were either considered not to be similar for purpos
of acute toxicity or the Agency lacked sufficient information for decision making purposes.
Registrants of these products are responsible for meeting the acute toxicity data requirements for
each product. Registrants must generate all the required acute toxicological studies for each of
their products. If a registrant chooses to rely upon previously submitted acute toxicity data, he/sh
may do so provided that the data base is complete and valid by today’s standards (see acceptance
criteria attached), the formulation tested is considered by the Agency to be similar for acute toxici
and the formulation has not been significantly altered since submission and acceptance of the acute
toxicity data. Regardless of whether new data is generated or existing data is referenced, registran
must clearly identify the test material by it's EPA Registration Number.

In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCi
Notice contains two response forms which are to be completed and submitted to the Agency within
90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant will mee
the data requirements for each product. The second form, “Requirements Status and Registrant's
Response," lists the product specific data required for each product, including the standard six acu
toxicity tests. A registrant must select one of the following options: Developing Data (Option 1),
Submitting an Existing Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an
Existing Study (Option 6). Since the end-use products containing iron salts could not be batched,
registrants cannot choose from the remaining options: Cost sharing (Option 2) or Offers to Cost
Share (Option 3).


61 Product Identity and Composition
ACCEPTANCE CRITERIA

Does your study meet the following acceptance criteria?

1. Name of technical material tested (include product name and trade name, if appropriate).

2. Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and e
intentionally-added inert ingredient.

3. Name and upper certified limit for each impurity or each group of impurities present at > 0.1% by weight and
for certain toxicologically significant impurities (e.g., dioxins, nitrosamines) present at <0.1%.

4. Purpose of each active ingredient and each intentionally-added inert.

5. Chemical name from Chemical Abstracts index of Nomenclature and Chemical Abstracts Service (CAS) Regi

Number for each active ingredient and, if available, for each intentionally-added inert.

6. Molecular, structural, and empirical formulas, molecular weight or weight range, and any company assig
experimental or internal code numbers for each active ingredient.

7. Description of each beginning material in the manufacturing process.

EPA Registration Number if registered; for other beginning materials, the following:
Name and address of manufacturer or supplier.

Brand name, trade name or commercial designation.

Technical specifications or data sheets by which manufacturer or supplier describes composition, proper
or toxicity.

|

8,____ Description of manufacturing process.

Statement of whether batch or continuous process.

Relative amounts of beginning materials and order in which they are added.
Description of equipment.

Description of physical conditions (temperature, pressure, bumidity) controlled in each step and the
parameters that are maintained.

Statement of whether process involves intended chemical reactions.

Flow chart with chemical equations for each intended chemical reaction.
Duration of each step of process.

Description of purification procedures.

Description of measures taken to assure quality of final product.

[Tt |

IIT

9. Discussion of formation of impurities based on established chemical theory addressing (1) each impurity wh
may be present at > 0.1% or was found at > 0.1% by product analyses and (2) certain toxicologically signific
impurities (see #3).


United States Environmental Protection Agenc:
rn Washington, DC 20460 % | Ferm Approved
7 CERTIFICATION OF OFFER TO COST | OMB No. 2070-0106
SHARE IN THE DEVELOPMENT OF DATA} Approval Explres 12-31

Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.

92

Please fill in blanks below.

Company Name Company Number

Chemical Name EPA Chemica! Number

1 Certify that:

My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.

My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3{c)(2){B)(iii} of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):

Name of Firm(s) Date of Offer

ification:

| certify that | am duly authorized to represent the company named above, and that the statements that! have made on
this form and all attachments therein are true, accurate, and complete. | acknowledge that any knowingly false or
Misleading statement may be punishable by fine or imprisonment or both under applicable law.

Signature of Company's Authorized Representative Date

Name and Title (Please Type or Print)

EPA Form 8570-32


Attachment B

Generic DCI Response Forms (Form A) plus Instructions


SPECIFIC INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANTS RESPON8E FORM

nerl

This form is designed to be used for registrants to respond to eall-in- for generie and
produet-speeifie data as part of EPA’s reregistration program under the Federal Insectieide
Fungieide and Rodenticide Act. Although the form is the same for both Produet speeifie and
generie data, instructions for eompleting the forms differ slightly. Specifieally, options for
satisfying produet specific data reguirements do not inelude (1) deletion of uses or (2) request for a
low volume/minor use waivcr, These instructions are for completion of generic data reguirements

EPA has developed this form individually for each data call-in addressed to each registrant, and ha
preprinted this form with a number of items. DQ NOT use this form for any other active
ingredient.

Items 1 through 8 (inclusive) will have been preprinted on the form. You must complete ail other
items on this form by typing or printing legibly.

Public reporting burden for this collection of information is estimated to average 30 minutes per
response, including time for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the collection of information. Send
comments regarding the burden estimate or any other aspect of this collection of information,
including suggesting for reducing this burden, to Chief, Information Policy 8ranch, PM-223, U.S.
Environmental Protection Agency, 401 M St., S.W., Washington, D.C. 20460; and to the Office of
Nanagement and Budget, Paperwork Reduction Project 2070-0107, Washington, D.C. 20503.

INSTRICIONS

Item 1. This item identifies your company name, number, and address.

Item 2. This Item identifies the case number, case name, EPA chemical number and chemic
name.

Item 3. This item identifies the date and type of data call-in,

Ttem 4. This item identifies the guideline reference numbers of studies reguired to support t

product(s) being reregistered. These guidelines, in addition to requirements specified
in the Data Call-In Notice, govern the conduct of the required studies.

Item 5. This item identifies the study title associated with the guideline reference number an
whether protocols and 1, 2, or 3-year progress reports are reguired to be submitted in
connection with the study. As noted in Section III of the Data Call-In Notice, 90-d
Progress reports are required for all studies.

If an asterisk appears in Item 5, EPA has attached information relevant to this
guideline reference number to the Reguirements Status and Registrant’s Response
Form,


Vv.

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, omamental lawns, ornamental
woody shrubs and ornamental turfs, iron salts were previously registered for
household or domestic dwellings (indoor) and commercial institutional and industrial
areas/premises. The current uses include moss control in areas where moss growth is
profuse due to high precipitation rates, primarily in the Northwest. Currently there
are 14 registered products with these ingredients; 1 with iron (Il) sulfate, 9 with iron
I) sulfate monohydrate, and 3 with iron (II) sulfate heptahydrate.

The major use of iron salts in the United States is non-pesticidal, as a fertilizer
micronutrient. Other uses include as an electrolyte in dry cell batteries, as an animal
feed additive, as a galvanizer, as an emulsion-breaker, as a coagulant, in water
purification and sewage treatment, and as mordant in textile dyeing and calico
printing.

Iron If ammonium sulfate is currently not being supported and is not covered
in this Reregistration Eligibility Document.

SCIENCE ASSESSMENT OF IRON SALTS

The Agency has conducted a thorough review of the scientific data base for iron salts

for the purposes of determining the reregistration eligibility of these pesticides. These
findings are summarized below. The complete references cited in the text are in the
Bibliography (Appendix C).

A. Physical Chemistry Assessment

Iron (III) sulfate is a grayish-white powder, or rhombic or rhombohedral
crystals. The commercial product usually contains about 20% water and is yellowish
in color. It is slowly soluble in water, rapidly soluble in the presence of a trace of
iron (11I) 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.

Tron (If) 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.


ATTACHMENT E

EPA ACCEPTANCE CRITERIA


{I) or Fe(II) sulfates are the same oxide/oxyhydroxide species
(principally ferrihydrite, goethite, lepidocrocite, and hematite) that are
present in soils as a result of weathering.(4,7) Thermodynamic and
Kinetic factors influence the predominance of certain species over
other.(7) Soil temperature, soil moisture and soil PH are significant
environmental factors that control the distribution of these species.(8)
For example, it has been observed that goethite is commonly the sole
iron oxide in cool and temperate zones, but in the majority of tropical
or subtropical regions hematite is the predominant oxide, although it is
rarely free of goethite.(8) The lepidocrocite-goethite association in
soils is less understood. The predominance of lepidocrocite in a soil
has been attributed to the prevalence of conditions favoring reduction of
Fe(III) to FeCl) followed by movement of Fe(II) to better aerated sites,
where oxidation to Fe(II) and precipitation of lepidocrocite occurs. (9)
Ferrihydrite may be considered as a young iron oxide of low order of
crystallinity. Subsequent transformation of ferrihydrite into other
oxides of iron is dominated by the environmental conditions.(10)

One of the most important properties of iron oxides/
oxydroxides (naturally occurring or formed by precipitation from iron
salts) is their very active surface chemistry.(11) The surfaces of iron
oxides and hydroxides acquire a pH-dependent charge, which controls
the adsorption of a wide range of chemical species. Anions (such as
molybdate, sulfate, arsenate, silicate, phosphate, and organic anions) as
well as metal cations are known to chemisorb onto iron oxides and
oxyhydroxide surfaces. (6, 11,12,13) In the environment, iron
oxides/oxyhydroxides are known to serve as a sink for metals such as
copper, lead, zinc, cadmium, cobalt, nickel and manganese. (11)
Adsorption of phosphate by iron oxides/ oxyhydroxides is an important
process in soils; together with aluminum, calcium, magnesium,
potassium, and manganese (II), they control the solubility of phosphates
in soils.(14) Soils rich in iron oxide/oxyhydroxides (for example,
oxisols) are known to fix large amounts of phosphate fertilizers.(15)
Humic substances and other organic materials are known to adsorb onto
oxide/ oxyhydroxide particulates. The surface properties of oxides/
oxyhydroxides determine the degree of aggregation/cementation of soil
and mineral particulates, where the iron oxides/hydroxides are believed
to behave as binding agents for the particulates.(16,17)

Some microorganisms (mainly anaerobic bacteria) are known to
reduce Fe(III) oxide/oxyhydroxides to Fe(II),(18) with the subsequent
re-mobilization of iron as more soluble Fe(II) species. This occurs
predominantly in oxygen deficient soils, such as poorly drained soils.
However, Fe(II) can be immobilized again by precipitation (for
example, as siderite, vivianite or a sulfide) or by re-oxidation.

11


APPENDIX D
List of Available Related Documents

The following is a list of available documents related to iron salts. Its purpose is to
provide a path to more detailed information if it is needed. These accompanying documents are
part of the Administrative Record for iron salts and are included in the EPA’s Office of Pesticide
Programs Public Docket.

1.

2.

Health and Environmental Effects Science Chapters
Detailed Label Usage Information System (LUIS) Report
Tron salts RED Fact Sheet

PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement


ATTACHMENT D

EPA GROUPING OF END-USE PRODUCTS FOR MEETING
DATA REQUREMENTS FOR REREGISTRATION


E TO APPENDIX B

Appendix B contains listings of data requirements which support the reregistration for the
iron salts covered by this Reregistration Eligibility document. It contains generic data
Tequirements that apply to iron salts in all products, including data Tequirements for which a
“typical formulation” is the test substance.

The data table is organized in the following format:

1. Data Requirement (Column 1). The data requirements are listed in the order in which
they appear in 40 CFR Part 158. the reference numbers accompanying each test refer to the test
protocols set in the Pesticide assessment Guidelines, which are available from the National
Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.

2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:

OZZC KA MoOMmMyAw>

Terrestrial food

Terrestrial feed

Terrestrial non-food
Aquatic food

Aquatic non-food outdoor
Aquatic non-food industrial
Aquatic non-food residential
Greenhouse food
Greenhouse non-food
Forestry

Residential

Indoor food

Indoor non-food

Indoor medical.

Indoor residential

3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this

column lists the

identifying number of each study. This normally is the Master Record

Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the Study.


B. Human Health Assessment

L Toxicology Assessment

The toxicological data base on iron (IID) sulfate, iron (I) sulfate
monohydrate, and iron (II) sulfate heptahydrate is adequate and will support
reregistration eligibility.

a. Acute and Subchronic Toxicity

CUTE TOXICITY VAL

r TEST RESULT TOXICITY
Tron III Sulfate CATEGORY

Oral LDg.--rat 1487 - 2102 mg/kg
Inhalation LC.o--rat > 1.10 mg/L i
Dermal LD,o--rabbit >2000 mg/kg sia
Eye Irritation corrosive I
Dermal Irritation corrosive IV

1

L Dermal Sensitization negative | - |

Tron (III) sulfate, in an acute oral study in rats, had an LD yo 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 LDgy greater than
2000 mg/kg. An acute inhalation toxicity study in rats using iron (III)
sulfate determined the LCs, to be greater than 1.10 mg/L,

Iron (II) sulfate heptahydrate, in an acute oral Study in rats,
showed an LD,, of 1389 mg/kg and an acute oral study in rabbits
showed an LD,, of 2778 mg/kg(4). The LD. determined for this
compound in mice was 1520 mg/kg(4). A sensitization study using
guinea pigs with iron (II) sulfate monohydrate and iron (II) sulfate
found no indication of contact sensitization by this compound.


Attachment A

Chemical Status Sheet








Items 10-13

NOTE:

data and only if the cited study was conducted on my product, an identical product or
a product which EPA has "grouped" with one or more other products for purposes of
depending on the same data. I may also choose this option if I am citing my own
data. In either case, I will provide the MRID or Accession Number(s) for the cited
data on a "Product Specific Data Report” form or in a similar format. If I cite anoth
registrant's data, I will submit a completed "Certification with Respect To Data
Compensation Requirements" form.

I request a waiver for this study because it is inappropriate for my product (waiver
Request). I am attaching a complete justification for this request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies.
{Note: any supplemental data must be submitted in the format required by P.R.
Notice 86-5]. I understand that this is my only opportunity to state the reasons or
provide information in support of my request. If the Agency approves my waiver
request, I will not be required to supply the data pursuant to Section 3(c)(2)(B) of
FIFRA, If the Agency denies my waiver request, I must choose a method of meetin
the data requirements of this Notice by the due date stated by this Notice. In this
case, I must, within 30 days of my receipt of the Agency’s written decision, submit a
revised “Requirements Status and Registrant’s Response” Form indicating the option
chosen. I also understand that the deadline for submission of data as specified by th
original data call-in notice will not change.

Self-explanatory.

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.


OOEZPT Iv Aiqns ees = ET -£9
GOETH tv Hd Z1-€9
60€ZPI Iv queysuoD uoNeDossiIq =» OT-£9
GOETH lv Amqnjos 8-£9
6OEZPT Iv Aysueq L-€9
GOETH Iv qWiod Surpog 9-€9
6OETPI lv qwlog 8unpoW S-€9
6OEZPI Iv JOpo £9
6OEZHI Iv areig jeorskyd €-€9
GOEZPI Iv JojoD z-€9
60EZHI Iv spoyey reondjeuy £-279
GOETH Iv smmury Jo uoRROYTIED Z-%
6OETPT nv sisfyeuy Areupujard 1-79
6OETPT uv sanundwy jo uonemuoy — (q)7-19
6OEZHI Nv ssacolg ZULINjORsNURP] puE sjeLoe ZuluuIseg = (8) 7-19
6OEZPI Iv Aynuapy yeowsyD 1-19

Anspway. npord OZ1'8S1§

NOLLV.LIO SALIS

OIHdVUOOTIsIad = SN. WYN SNITSCINO §=SNITICIND

ALVUGAHONONM ALVATINS I NOU




EE ND Set LE

IO OL

SO@ZPIOr Tv ynoy Moqures Aqiorxo} ystq (9) [-ZL.
w2Zr1Or Iv WSanjq Ayorxoy ysiy (RB) L-ZL
€O7ZPIOP nv YONP “Ip ueBLAR aINoy — (Q)Z-1L
CWOC7FIOP lv Trenb "jarp uerae aynoy (8) z-1L
10@Zrl0r nv yonpysjienb pero vere aynoy = (R)T- 1,
SPOT [IFO]OIT SpT“gsy§
CaAIVA Tv s8id vauinguonezyisuas [ewueq 9-18
SCLLET Iv uoneiL feulep Arewig S18
QTLLEI tv yqqes-uoneut of Arewtig v-18
S@LLET Iv TeY-vONeeYyLT any £18
CHAIVM qv WQQRI *XO} Feuap annoy ZI
CaAIVA TIlv yel *XO} TRIO anoy I-18
ABOPOIXOL, SET*SSTS
“Peale Us9q BABY SJUOUWTINbe! eyep a32J [EJUAUIUOITAUA [TV
ayy [SUAMITMOMAUA OCT SST§

NOLLV.LID SALIS
OIHd VaDOr ala asn QWVYN ANITACINO § SNITACIND

ALVAGAHV.LdaH Il NOU