2 

### Table of Contents

Contents

I. Introduction

................................ ................................ ................................ ............................. 3

II. Scientific Assessments

................................ ................................ ................................ ............ 5

A. Human Health Assessment

................................ ................................ ................................ .... 5

Hazard Characterization

................................ ................................ ................................ .......... 5

Dietary Exposure Assessment

................................ ................................ ................................ . 5

Residential and Occupational Exposure

................................ ................................ ................. 5

Aggregate Risks

................................ ................................ ................................ ...................... 5

Human Incidents

................................ ................................ ................................ ..................... 5

Food Tolerances

................................ ................................ ................................ ...................... 6

B. Environmental Assessment

................................ ................................ ................................ ... 6

Ecological Risk Characterization

................................ ................................ ............................ 6

Endangered Species Assessment

................................ ................................ ............................ 7

Endocrine Disruptor Screening Program

................................ ................................ ................ 7

III. Proposed Interim Registration Review Decision

................................ ................................ . 7

IV. Next Steps and Timeline

................................ ................................ ................................ ...... 83



### I. Introduction

This document is the Environmental Protection Agency’s (EPA or the Agency) Proposed Interim Registration Review Decision for iron salts and is being issued pursuant to 40 CFR sections

155.56 and 155.58

. A registration review decision is the Agency's determ ination whether a pesticide meets, or does not meet, the standard for registration in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Agency may issue, when it determines it to be appropriate, a proposed interim registration review dec ision before completing a registration review. Among other things, the proposed interim registration review decision may require new risk mitigation measures, impose interim risk mitigation measures, identify data or information required to complete the re view, and include schedules for submitting the required data, conducting the new risk assessment and completing the registration review. For further

information on iron salts , additional documents can be found in EPA’s public docket ( EPA

- HQ

OPP

- 2008

- 0626 ) at www.regulations.gov

.

FIFRA, as amended by the Food Quality Protection Act (FQPA) of 1996, mandated the continuous review of existing pesticides. All pesticides distributed or sold in the United States general ly must be registered by the EPA based on scientific data showing that they will not cause unreasonable risks to human health or to the environment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability to assess and reduce risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects. Changes in science, public policy, and pesticide use practices will o ccur over time. Through the registration review program, the Agency periodically reevaluates pesticides to make sure that as these changes occur, products in the marketplace can continue to be used safely. Information on this program is provided as www.epa.gov/oppsrrd1/registration_review/

.

In 2006, the Agency implemented the registration review program pursuant to FIFRA section 3(g) and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration.

The iron salts registration review case includes two active chemicals, ferric sulfate and ferrous sulfate monohydrate. The other chemicals in this case, including ferrous sul fate heptahydrate and ferrous ammonium sulfate, are not found in any active US pesticide registrations. Therefore, only ferric sulfate and ferrous sulfate monohydrate are included in this proposed interim

decision. Iron is the fourth most abundant elemen t and the second most abundant metal in the earth’s crystal rocks. Iron occurs in a wide variety of minerals, and it is present in foods naturally and through added ingredients.

Iron salts are herbicides registered for use on outdoor lawns and ornamental s to control mosses

in a variety of residential an d commercial areas

. There are no registered agricultural uses of these products. There are 16 registered products containing ferrous sulfate and ferric sulfate monohydrate . For ferrous sulfate the end us e products are formulated as a granular and applied by hand or spreader. For ferric sulfate monohydrate , the end use products are formulated as soluble concentrate/liquid and applied by sprinkler can and hose

- end

- sprayer. The Reregistration Eligibility Dec ision document (RED) for iron salts was completed in 1996

.4

Pursuant to 40 CFR section 155.50, EPA formally initiated registration review for iron salts (case

4058 )

. The following highlights significant events that have occurred during the registration

review of iron salts :

 D ecember

, 2008

– Publication of Iron Salts Summary Document for a 60

- day public comment period . The Summary Document included the P reliminary W or k P lan (PWP) and was accompanied by the scoping document and problem formulation.

 May

, 2009

- Final Work Plan (FWP) for Iron Salts was issued

– One public comment

w as received from the FIFRA Endangered Species Task Force regarding data compensation during the 60

- day comment period for the Iron Salts PWP . No other

comments were received ; thus

, the FWP did not modify the PWP.

 July

, 2010

– Generic Data Call

- In Notice (GDCI) for iron salts was issued . The DCI

requ ired submission of p lant toxicity, honey bee, and product chemistry data , which have

been satisfied by the registrants.

Additional information on iron salts, including this Proposed Interim Registration Review Decision and the following supporting documents

, can be found in EPA’s public docket

EPA

- HQ

- OPP

- 2008

- 0626, accessed at www.regulations.gov

.

 Registration Review Preliminary Risk Assessment for Ferric and Ferrous Sulfates. E.

Oden kirchen, S. Sankula. D421836. August 19, 2014.

 HED Risk Assessment from the Reregistration Eligibility Decision. Smith, Jane. November 11, 1992.

 EFED Risk Assessment from the Reregistration Eligibility Decision . Abramovich, Akiva D. November 27, 1992.5



### II. Scientific Assessmen ts

A. Human Health Assessment

A summary of the Agency’s human health risk assessment is presented below. The Agency relied upon the previous iron salts human health risk assessment

, HED Risk Assessment from the Reregistration Eligibility Decision (RED) (November, 1992)

, to support the registration review of iron salts since no significant changes have been made to impact the risk conclusions for this

case.

Hazard Characterization

Ferric sulfate and ferrous sulfate monohydrate are generally recogniz ed as safe by the Food and Drug Administration for use in food as a flavoring agent (21 CFR 184.1307) and a nutrient supplement (21 CFR 184.1315), respectively

, with no limitation other than adherence to current requirements for good manufacturing practice s. After consideration, the Agency found that,

g iven the low toxicity of iron salts, the limited pesticidal use of these compounds, their wide spread presence in the environment, as well as their intrinsic function in human metabolic pathways, no new risk assessment was needed to support the registration review for iron salts

.

Dietary Exposure Assessment

There are no registered agricultural uses of iron salts; therefore dietary exposure from the registered pesticidal uses of these compounds is not expec ted and a dietary risk assessment is not required.

Residential and Occupational Exposure

Given the low toxicity of iron salts , the Agency concludes that any residential exposures, as well as mixer/loader/applicator and post application occupational risks to these compounds as a result of the existing uses are considered inconsequential and are not of concern

.

Aggregate Risks

EPA has no concern for aggregate risk resulting from the existing uses of iron salts given the

pre valence of the compounds in the environment.

Human Incidents

The OPP Incident Database System (IDS) was searched for human incidents in the United States from 2002 to 2008 involving iron salts. IDS includes reports of incidents from various sources,

inc luding mandatory Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 6 (a) (2) reports from registrants, other federal and state health and environmental agencies and individual consumers. There was one incident reported for ferric sulfate a nd four incidents were reported for ferrous sulfate monohydrate. Incidents included coughing, sweating, lethargy, rash, shortness of breath, salvation and throat irritation. For more details, please refer to Updated6

Review of Ferric Sulfate Incident Report s and Updated Review of Ferrous Sulfate Monohydrate Incident Reports in the iron salts docket.

Food Tolerances

Iron salts are not registered for use on food and there are no US tolerances established for iron

salts.

B. Environmental Assessment

A summary of the Agency’s environmental risk assessment for iron salts is presented below. For detailed discussions of all aspects of the environmental risk assessment, see the Registration

Review Preliminary Risk Assessment for Ferric and Ferrous Sulfates

, ( August 19 , 2014 )

available in the public docket EPA

- HQ

- OPP

- 2008

- 0626

, which can be accessed on http://www.regulations.gov/

.

Ecological Risk Charact erization

The 1992 risk assessment in support of the iron salts RED evaluated the current lawn and turf uses of these two compounds for the control of moss. These uses include granules and hose

- end or watering can applications. The RED indicated no risk concerns for the labeled uses of ferrous and ferric sulfates to terrestrial vertebrates or animals, and aquatic plants. A review of the Problem Formulation documents’ listings of uses for the two chemicals and the summarized toxicological and environment al fate data indicate s nothing has fundamentally changed since the completion of the RED risk assessment. Therefore, the Agency concludes that the finding of no concerns for direct effects to terrestrial vertebrates or aquatic plants and animals found

summarized in the RED still remains accurate.

The RED did not assess the risk to terrestrial plants for ferrous and ferric sulfate s
, and plant studies were identified as data gaps in the Problem Formulation for both chemicals

. Terrestrial plant toxicity studies were included for vegetative vigor and seedling emergence in the Data Call In for Registration Review. A current understand ing of the use patterns for the two chemicals shows that uses are confined to watered in (watering can or hose end sprayer) and granular applications to lawns and turf. These application scenarios are not over the top spray applications so spray drift lo ading to adjacent areas to the use site is not expected. Moreover, the Agency does not expect that runoff loadings will be significant to any degree because the compounds are expected to ionize and any resultant iron runoff is expected to be exceedingly

l ow and largely ma sked by natural iron background. Consequently no complete exposure pathway, drift or runoff, of the applied ferric sulfate or ferrous sulfate is expected to off

- site plants. In light of this understanding of the exposure pathways for non

- t arget plants, EPA concludes that there are no concerns for direct effects to terrestrial plants.

The RED did not assess the risk to terrestrial arthropods and pollinators for ferrous and ferric sulfates and honeybee effects studies (the surrogate species for pollinator and arthropods risk assessment) were identified as data gaps in the Problem Formulation for both chemicals. A honey bee acute contact toxicity study was included in the Data Call In for Registration Review.

Concerns for ferric sulfate effec ts on individual honey bees contacting sprayed areas are weakly7

supported by the available data. Multiple lines of evidence would suggest that both compounds may lethally affect bees in treated areas. Consideration of the uncertain effects thresholds, th e low attraction of target mossy areas for bees, and the expected low geographic extent for any given application of the compounds applied to the intended use areas would suggest that any putative bee effects would not rise to a level where hives would be impacted.

Endangered Species Assessment

T here is no reasonable expectation for any registered use of iron salts to cause direct or indirect adverse effects to threatened and endangered terrestrial vertebrates , terrestrial plants , terrestrial

invertebr ates, and aquatic organisms

. This is because the treated area is very small relative to the range of species, most of the product use is expected to occur outside of are as inhabited by listed species, and the viscosity and very low solubility of iron salts makes it unlikely to runoff or leach from the target application site into non

- target areas. Furthermore, since iron salts are an effective physical repellent, listed animals are generally expected to avoid treated application

sites. EPA has made a “no ef fect” determination under the Endangered Species Act (ESA) to Federally lis ted terrestrial vertebrates, terrestrial invertebrates, plants and aquatic organisms and designated critical habitat for such species and has therefore concluded that consultation w ith the

Fish and Wildlife Service and the National Marine Fisheries Service under ESA s ection 7(a)(2) is not required for these species

.

Endocrine Disruptor Screening Program

EPA has developed the Endocrine Disruptor Screening Program to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen , or other such endocrine effects as the Administrator may designate.” Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and November 2010, EPA issued test

orders/data call

- ins for the first group of 67 chem icals and published a second list of chemicals proposed for order issuance in the future. Iron salts is not among the group of 58 pesticide active ingredients on the initial list nor are they proposed on the second list of chemicals to be screened

under t he EDSP. Accordingly, as part of registration review, EPA will issue future EDSP

orders/data call

- ins for registration review chemicals, including iron salts . For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future chemical lists proposed for screening, the test guidelines and the Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/.

In the interim, EPA is making no human health or environmental safety findings associated w ith the EDSP screening of iron salts . Before completing this Registration Review, the Agency will make an EDSP FFDCA section 408(p) determination.



### III

. Proposed Interim Registration Review Decision

In accordance with 40 CFR Sections 155.56 and 155.58, the Agency is issuing this P roposed

I nterim R egistration R eview D ecision. EPA’s proposed Interim Registration Review Decision

for iron salts is that (1) no additional data are required at this time; and (2) no changes to the8

affected registrations or their labeling are needed at this time

. The EPA does not expect registered uses of iron salts to result in adverse effects to human health, pending determination

under the EDSP. In addition, EPA does not ex pect iron salts to have direct or indirect adverse

effects to non

- listed and listed terrestrial vertebrates , terrestrial plants , terrestrial invertebrates, and aquatic organisms or to adversely modify any designated critical habitat for such species and

ha s made a “no effect” determination under the Endangered Species Act (ESA) for those species and designated critical habitat for such species. This P roposed I nterim Registration Review

D ecision does not cover the EDSP component of the iron salts registration review case. The Agency is issuing a P roposed I nterim R egistration Review Decision pending t he completion of EDSP work for this case under FFDCA Section 408(p).



### I V. Next Steps and Timeline

A. Interim Registration Review Decision

A Federal Register N otice will announce the availability of this P roposed I nterim R egistration

R eview D ecision for iron salts and allow a 60

- day comment period. If there are no significant comments or additional information submitted to the docket during the comment period that leads the Agency to change its decision, EPA may issue an I nterim R egistration R eview

D ecision for iron salts (case 4058 ). However, a final decision for iron salts may be issued without having previously issued an interim decision

. A final decision on the iron salts registration review case will occur after an EDSP FFDCA section 408(p) determination has been

made

.