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. Interim Registration Review Decision ................................................................................. 8

IV. Next Steps and Timeline ...................................................................................................... 83 

### I. Introduction

This document is the Environmental Prot ection Agency’s (EPA or the Agency) Interim Registration Review Decision for iron salts and is being is sued pursuant to 40 CFR sections 155.56 and 155.58. A registration review decision is the Agency's determination whether a pesticide meets, or does not meet, the standard for registration in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Agen cy may issue, when it determines it to be appropriate, an interim registration review deci sion before completing a registration review. Among other things, the interim registration revi ew decision may require new risk mitigation measures or impose interim risk mitigation m easures. Additional supporting documents can be found in EPA’s public docket for the registrati on review of iron salts (docket number EPA-HQOPP-2008-0626) at www.regulations.gov

.

FIFRA, as amended by the Food Quality Pr otection Act (FQPA) of 1996, mandates the continuous review of existing pest icides. All pesticides distributed or sold in the United States generally must be registered by the EPA based on sc ientific 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 polic ies and practices change, all regi stered pesticides continue to meet the statutory standard of no unreasonable a dverse effects. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the Agency periodically reevaluates pes ticides 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 registratio n review program pursuant to FIFRA section 3(g) and will review each regist ered 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 sulfate heptahydrate and ferrous ammonium sulfate, are not found in any ac tive US pesticide registrations. Therefore, only

ferric sulfate and ferrous sulfat e monohydrate are included in this interim decision. Iron is the

fourth most abundant element and the second most abundant metal in the earth’s crustal rocks. Iron occurs in a wide variety of minerals, and it is present in foods natu rally and through added ingredients.

Iron salts are herbicides registered for use on outdoor lawns and ornamentals to control mosses in a variety of residential and co mmercial areas. There are no registered agricultural uses of these products. There are 16 registered products co ntaining ferrous sulfate and ferric sulfate monohydrate. For ferrous sulfate, the end use produc ts are formulated as a granular and applied by hand or spreader. For ferric sulfate monohydrat e, the end use products are formulated as soluble concentrate/liquid and a pplied by sprinkler can and hose-end-sprayer. The Reregistration Eligibility Decision document (RED) fo r iron salts was completed in 1996.4 Pursuant to 40 CFR section 155.50, EPA formally init iated registration review for iron salts (case 4058). The following highlights sign ificant events that have oc curred during the registration

review of iron salts:

 December, 2008 – Publication of the iron salts Summary Document for a 60-day public comment period. The Summary Document incl uded the Preliminary Work Plan (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 was received from the FIFRA Endangered Species Task Force regarding data compensation during the 60-day comment pe riod 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 required submission of plant toxicity, honey b ee, and product chemistry data, which have been satisfied by the registrants.

 September, 2014 – Proposed Interim Regist ration Review Decision for iron salts was issued – One public comment was received from the Center for Biological Diversity (the Center); in their comment, the Center “conc urs with the EPA that there is no reasonable expectation for iron salts to cau se direct or indirect advers e effects to threatened and endangered species, and will not adversely modify or destroy any listed species’ critical habitat. Accordingly, the Center agrees th at consultations unde r Section 7 are not required for these pesticides.” No othe r comments were received; thus, the Interim Registration Review Decision did not change from the Proposed Interim Registration

Review Decision

.

 March, 2015 – The Agency is now publishing the iron salts Interim Registration Review

Decision , dated February 11, 2015, in docket EPA-HQ-OPP-2008-0626.

Additional information, including this Interim Registration Review Decision , the following EFED risk assessment, and other supporti ng documents, can be found in EPA’s public docket for the registration review of ir on salts (docket number EPA-HQ-OPP-2008-0626),

which can be accessed at www.regulations.gov

.

 EFED Registration Review Preliminary Risk Assessment for Ferric and Ferrous Sulfates. E. Odenkirchen, S. Sankula. D421836. August 19, 2014.

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

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

### II. Scientific Assessments

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 ch anges have been made to impact the risk conclusions for this

case.

Hazard Characterization

Ferric sulfate and ferrous sulf ate monohydrate are generally rec ognized as safe by the Food and Drug Administration for use in food as a fla voring 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 practices. Af ter consideration, the Agency found that, given the low toxicity of ir on salts, the limited pesticidal use of these compounds, their widespread 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 diet ary exposure from the registered pesticidal uses of these compounds is not expected and a dietary risk assessment is not required.

Residential and Occupational Exposure

Given the low toxicity of iron salts, the Agency concludes that any reside ntial exposures, as well as mixer/loader/applicator and post application occupational risk s to these compounds as a result of the existing uses are considered in consequential and are not of concern.

Aggregate Risks

EPA has no concern for aggregate risk resulting from the existing uses of iron salts, given the prevalence of the compounds in the environment.

Human Incidents

As part of the risk assessment process, EPA s earched available human incident databases (the OPP Incident Database System (IDS) and NI OSH SENSOR-Pesticides) in January, 2015 for reported human incidents in the United St ates involving iron salts (PC codes 034902 and 050507) from 2010 to 2015. IDS includes reports of incidents from various sources, including mandatory Federal Insecticide, Fungicide and Ro denticide Act (FIFRA) Section 6 (a) (2) reports from registrants, other federal and state hea lth and environmental agencies and individual consumers. During the 2010 – 2015 timeframe, there were three reported in cidents of moderate severity (Main IDS) and eighteen reported incidents of minor se verity (Aggregate IDS). Overall6 there are few incidents involving iron salts reported to IDS. Sy mptoms reported include loss of appetite, chills, irregular heartb eat, erythema, and skin irritation.

A review of SENSOR-Pesticides from 1998-2011 identi fies a total of 33 singl e active ingredient (ai) cases involving iron salts (PC c odes 034902 and 050507), stemming from 33 separate events. Thirty one of these cases were reported from Washington State. Most cases involved the applicator (mainly homeowner applicators) applying MossOUT (EPA Reg. No. 802-509) to their lawn and having ocular exposure from spray, spill, or splash.

For more details on human incidents, please refer to the Iron Salts: Tier 1 Review of Human Incidents for Preliminary Ri sk Assessment (01/28/15) , available in public docket number EPAHQ-OPP-2008-0626, which can be accessed at http://www.regulations.gov/

.

Food Tolerances

Iron salts are not registered as pesticides 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 th e environmental risk assessment, see the Registration Review Preliminary Risk Assessmen t for Ferric and Ferrous Sulfates dated August 19, 2014, available in public docket number EPA- HQ-OPP-2008-0626, which can be accessed at http://www.regulations.gov/

.

Ecological Risk Characterization

The 1992 risk assessment in support of the iron sa lts 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 fo r 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 us es for the two chemicals and the summarized toxicological and enviro nmental fate data indicates 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 ve rtebrates or aquatic pl ants and animals found

summarized in the RED still remains accurate.

The RED did not assess the risk to terrestrial plants for ferrous and ferric sulfates, and plant studies were identified as data gaps in the Pr oblem Formulation for both chemicals. Terrestrial plant toxicity studies were incl uded for vegetative vigor and seedli ng emergence in the Data Call In for Registration Review. A current understandi ng of the use patterns for the two chemicals shows that uses are confined to watered in (w atering 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 loading 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 low and largely7 masked by natural iron background. Consequently no complete exposure pathway, drift or runoff, of the applied ferric sulfate or ferrous sulfat e is expected to off-site plants. In light of this understanding of the exposure pathways for non-ta rget plants, EPA concl udes that there are no

concerns for direct effect s to terrestrial plants.

The RED did not assess the risk to terrestrial arthropods and pollinators for ferrous and ferric sulfates and honeybee effects stud ies (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 st udy was included in the Data Ca ll In for Registration Review.

Concerns for ferric sulfate effect s on individual honey bees cont acting sprayed areas are weakly supported by the available data. Multiple lines of evidence would sugge st that both compounds may lethally affect bees in treated areas. Cons ideration of the uncertain effects thresholds, the 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 le vel where hives would be impacted.

Endangered Species Assessment

There is no reasonable expectation fo r any registered use of iron salt s to cause direct or indirect adverse effects to threatened and endangered terrest rial vertebrates, terrestrial plants, terrestrial invertebrates, and aquatic organisms. This is beca use the treated area is very small relative to the range of species, most of the product use is expe cted to occur outside of areas inhabited by listed species, and the viscosity and very low solubility of iron salts ma kes it unlikely to runoff or leach from the target application site into non-target areas. Furthermor e, since iron salts are effective physical repellents, listed animals are generally e xpected to avoid treated application sites. EPA

has made a “no effect” determination under th e Endangered Species Act (ESA) to Federally listed terrestrial vertebrates, terrestrial inverteb rates, plants and aquatic organisms and designated critical habitat for such species and has therefor e concluded that consulta tion with the Fish and

Wildlife Service and the National Marine Fisher ies Service under ESA section 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 ac tive and other ingredients) may have an effect in humans or wildlife similar to an effect pr oduced 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 Oc tober 2009 and November 2010, EPA issued test

orders/data call-ins for the firs t group of 67 chemicals and publis hed a second list of chemicals proposed for order issuance in the future. Iron sa lts is not among the group of 58 pesticide active ingredients on the in itial list nor are they proposed on the se cond list of chemicals to be screened under the EDSP. Accordingly, as part of regi stration 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 polic ies and procedures, the list of 67 chemicals, future chemical lists proposed for screening, the test guidelines and the Ti er 1 screening battery, please visit our website: http://www.epa.gov/endo/.8 In the interim, EPA is making no human health or environmental safety findings associated with the EDSP screening of iron salts. Before completing this Registration Review, the Agency will

make an EDSP FFDCA secti on 408(p) determination.



### III. Interim Registration Review Decision

In accordance with 40 CFR Sections 155.56 and 155.58, the Agency is issuing this Interim Registration Review Decision. EPA’s Interim Regist ration Review Decision fo r iron salts is that (1) no additional data are required at this time; an d (2) no changes to the a ffected registrations or their labeling are need ed at this time. In addition, EPA does not expect iron salts to have direct or

indirect adverse effects to non-liste d and listed terrestrial vertebrates, terrestria l plants, terrestrial invertebrates, and aquatic organisms or to adve rsely modify any designate d critical habitat for such species and has made a “no effect” determ ination under the Endangered Species Act (ESA) for those species and designated critical habita t for such species. This Interim Registration

Review Decision does not cover th e EDSP component of the iron sa lts registration review case. The Agency is issuing an Interim Registra tion Review Decision pending the completion of

EDSP work for this case under FFDCA Section 408(p).



### IV. Next Steps and Timeline

A. Registration Review Decision

A Federal Register Notice will announce the availa bility of this Interim Registration Review

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