Sulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176 Proposed Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

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### Table of Contents

I. Introduction .............................................................................................................. ................ 3

II. Scientific Assessments ................................................................................................... ......... 6

A. Environmental Assessment ................................................................................................ 6

B. Human Health Assessment ............................................................................................... 11 C. Endocrine Disruptor Screening Program ....................................................................... 11 D. Incident Report ........................................................................................................... ...... 12

E. Public Comments............................................................................................................ ... 13

F. Environmental Justice ..................................................................................................... .. 14

G. Characterization of Econ omic Benefits of Sulfur.............................................14 III. Proposed Interim Registra tion Review Decision ............................................................... 15 A. Ecological Risk ........................................................................................................... ....... 15 B. Endangered Species Risk Mitigation Measures ............................................................. 16 C. Voluntary Adoption of Risk Mitigation Measuares....................................................... 17 IV. Next Steps and Timeline ................................................................................................... ... 19 A. Proposed Interim Regist ration Review Decision ............................................................ 19

B. Bulletins Live! Comment Period ...................................................................................... 19 C. Implementation of Mitigation Measures......................................................................... 19

D. Consultation with the U.S. Fish and Wildlife Service .................................................... 19 Appendix A ................................................................................................................... .............. 21 Appendix B...................................................................................................29

Label Table ................................................................................................................... ............... 31Sulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176 Proposed Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

3 I. INTRODUCTION

This document is the Environmental Prot ection Agency’s (EPA or the Agency) Proposed

Interim Registrati on Review Decision for Sulfur and is being issued pursuant to 40 CFR sections 155.56 and 155.58. A registration revi ew 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 (F IFRA). The Agency may issue, when it determines it to be appropriate, an interim registra tion review decision before co mpleting a registration review. Among other things, the interim registration review decision may (1) require new risk mitigation measures; (2) impose interim risk mitigation measures; (3) identify data or information required to complete the review; and (4) include schedules for submitting the required data, conducting the new risk assessment and completing the registration review.

FIFRA, as amended by the Food Quality Pr otection Act (FQPA) of 1996, mandated the continuous review of existing pes ticides. 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 pr ogram is intended to make sure th at, as the abilit y to assess and reduce risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreas onable adverse effects. Change s in science, public policy, and pesticide use practices will occur over time. Thr ough 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 safel y. Information on this program is provided as www.epa.gov/oppsrrd1/registration_review /.

In 2006, the Agency implemented the regist ration 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 st andard for registration.

Pursuant to 40 CFR §155.50, the Agency formally initiated registration review for sulfur (Case 0031). The Agency’s registra tion review of sulfur (Case 0031) includes all pesticidal uses of sulfur which include agricultural as well as gas cartridge uses. Gas cartridge products that contain sulfur may also contain carbon and sodium or potassium nitrate. Sodium and potassium nitrate (Case 4052) and carbon a nd carbon dioxide (Case 4019) ar e also undergoing registration review. Consequently, there are several common support documents and regulatory conclusions shared among these cases. Furtherm ore, the registration review proposed and proposed interim decisions for all compounds with gas cartridge us es are being made available for public comment simultaneously.

Sulfur has been used as a pesticide in th e United States since th e 1920s. A Reregistration Eligibility Decision (RED ) was signed in 1991. Sulfur is currently registered for use as an insecticide, acaricide and fungici de on a wide range of field a nd greenhouse-grown food and feed crops, livestock (and livestock quart ers; ex. horse, dairy cattle, goats, poultry, and sheep spray),

and indoor and outdoor residential s ites (ex. dog spray). Use sites incl ude tree fruit, nuts, berries, vegetables, root crops, field crops, pets (dogs), or namentals, and turf (including residential lawns and golf courses). Formulations include dust, water dispersible granul es or dry flowable,Sulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176 Proposed Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

4 emulsifiable concentrate, flowable concentrate, liquid, liquid ready-to-u se, wettable powder, and wettable powder/dust and may be applied by ch emigation, soil band treatment (ground sprayer, aircraft), soil treatment (soil incorporation tr eatment), low volume spray concentrate (low volume ground concentrate), high volume spray or dilute (high volume ground sprayer), or dust (ground or aircraft). Products containing el emental sulfur are registered for use on crops at relatively high rates up to 122.5 lb a.i./A per application, but can also be used as a soil amendment (non-pesticidal use) to increase fertility and/or reduce the pH of highly alkaline soils at much higher rates (up to approximately 3,300 lb a.i./A for highly alkaline cl ay soils that need ex tensive acid ification,

Mullen et al. 2007 1 ).

In addition to the uses listed above, sulfur is also registered for use in gas cartridge products. Gas cartridges are registered to contro l burrowing mammals and are available in small and large sizes, where the large pr oducts are registered and labe led for use to control mammals such as coyotes, red foxes, and skunks. Gas ca rtridges are registered fo r outdoor use only. To use the products, the user lights the fuse, places th e cartridge in the burrow or den and seals the

entrance. Animals within the burrow or den are asphyxiated by the release of carbon dioxide and other toxic gases. The following timeline highlights significant even ts that have occurred during the registration review of sulfur and can be found in the public docket (EPA-HQ-OPP-2008-0176):

 March 26, 2008 – The Agency published the Sulfur Registration Review Summary

Document , dated March 19, 2008 in docket number EPA-HQ-OPP-2008-0176 for a 90- day public comment period. The Summary Document included the Agency’s Preliminary Work Plan for Sulfur , a Sulfur Fact Sheet, the Problem Formulation for Ecological Risk Assessment for Sulfur, dated February 7, 2008, the Problem Formulation for Ecological Risk Assessment, for Carbon Dioxide and Ga s Fumigant Producing Cartridges: Carbon, Sawdust, Sodium Nitrate, Potassium Nitrate, and Sulfur , dated March 17, 2008 and the Sulfur Human Health Risk Scoping Docu ment in Support of Registration Review , dated January 17, 2008. The Agency received one comment concerning the Sulfur Summary

Document. The comment did not change the work plan for the registration review of sulfur.

 September 4, 2008 – The Agency published the Sulfur Final Work Plan , dated August 15, 2008 which stated that the Agency would conduct a comprehensive ecological risk assessment that included an endangered speci es risk assessment, and that EPA would conduct new occupational and residential ex posure risk assessments for registration

review. The Sulfur Final Work Plan also stated that the Agency then anticipated requiring a subchronic inhalation study for use in quant itatively assessing risk to handlers.

 February 18, 2009 – The Agency published Sulfur. Human Health Risk Scoping Document in Support of Registrati on Review – Addendum , dated January 29, 2009. This addendum explained why the subchronic inhalation study for sulfur w ould no longer be required.

 April 8, 2010 – The Agency initiated inform al consultation under the Endangered Species Act (ESA) section 7(a)(2) with the U.S. Fi sh and Wildlife Service (FWS) for the gas cartridge uses of sulfur, carbon and inorganic nitrate.

1 Mullen, R., Lentz, E. and M. Watson. 2007. The Ohio St ate University Extension Fact Sheet (Soil Acidification: How to lower the soil pH, by R. Mullen, E. Lentz, and M. Watson, AGF-507-07, dated 2007)Sulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176 Proposed Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

5  May 26, 2010 – The Agency published the draft Registration Review Ecological Risk Assessment and Effects Determinations, Carbon, Carbon Dioxide, Sawdust, Sodium

Nitrate, Potassium Nitrat e and Sulfur Gas Cartridges , dated March 30, 2010 for a 60-day public comment period. During that time, one comment was received from USFWS Region 4. EPA made a “May Affect and Likely to Adversely Affect (LAA)” determination for federally listed terrestrial mammals, terrestr ial birds, and terrestrial invertebrates and designated critical habitats. EP A also concluded “No Effect” for aquatic species given the expected lack of exposure to non-ta rget taxa (75 FRN 29534 FRL–8826–6).

 December 17, 2010 – The Agency published the EFED Response to Comments for Registration Review for Carbon, Ni trates, and Sulfur Gas Cartridges , dated October 20,

2010 and Input for Mitigation Options for Endange red and Threatened Species Identified in EFED’s Carbon, Nitrates, and Sulfur Gas Ca rtridges Registration Review Ecological Risk Assessment and Effects Determination , dated November 16, 2010. This document responded to comments received concerning the draft ecological risk assessment.

 July 16, 2012 – The Agency provided an Addendum to the environmental fate and ecological risk assessment for carbon dioxid e and for carbon, sawdust, sodium nitrate, potassium nitrate and sulf ur containing cartridges . This document updated the EPA’s list of threatened and endangered species with “L AA” determinations as a result of direct effects from gas cartridge use. The document also outlined potential mitigation that, if adopted by the registrants, would result in ch anging the determination to “No Effect” for certain species.

 June 26, 2013 – The Agency published draft human health and ecological risk assessments for uses of sulfur other than gas cartridges: Sulfur. Summary of Human Health Risk Assessments to Support Registration Review , dated May 1, 2013, and Sulfur Environmental Fate and Ecological Prelim inary Risk Assessment , dated May 29, 2013. During the 60 day comment period for these draft risk assessments, one comment was received. The comment did not challenge or impact the conclu sions of the draft risk assessments.

 June 28, 2013 – The Agency finalized the Revision to the environmental fate and ecological risk assessment for carbon dioxide and for ca rbon, sawdust, sodium nitrate, potassium nitrate and sulfur co ntaining cartridges . This document provides an updated list of potentially affected species and additional mitigation options.

 June 2014 – The Agency is now publishing the Sulfur Proposed Interim Registration

Review Decision , dated May 28, 2014 in docket number EPA-HQ-OPP-2008-0176 for a 60-day public comment period.

Because the Agency’s endangered species risk assessment of sulfur found the potential for

direct and indirect adverse effect s to federally listed terrestrial organisms from exposure to some

uses of sulfur, and because sulfur has not been evaluated under the Endocrine Disruptor Screening Program (EDSP), the Agency’s issuance of a Fina l Registration Review Decision for sulfur is dependent upon the result of Sec tion 7 Endangered Species consulta tion with the U.S. Fish andSulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176 Proposed Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

6 Wildlife Service and a conclusi on under the EDSP. Pending the outcome of these actions, EPA intends to issue an Interim Regist ration Review Decision for sulfur.

For further information on Sulfur , additional documents can be found in EPA’s public docket (EPA-HQ-OPP-2008-0176) at www.regulations.gov

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II. SCIENTIFIC ASSESSMENTS

A. Environmental Assessment

A summary of the Agency’s environmental risk assessment is presented below. A qualitative risk assessment was conducted for terrestrial organisms and a quantitative risk assessment was conducted for aquatic organisms. Fo r detailed discussions of all aspects of the

environmental risk assessment, see the Environmental Fate and Ecol ogical Effects Preliminary Risk Assessment for the Re gistration Review of Sulfur , dated May 29, 2013; the Inorganic Nitrate – Nitrite, Carbon and Carbon Dioxide, and Sulfur Registration Review Draft Ecological Risk Assessment and Endangered Species Effects Determination , dated March 30, 2010; and, subsequent Addendum documents, dated July 16, 2012 and June 28, 2013, in the public docket EPA-HQ-OPP-2008-0176) which can be accessed on http://www.regulations.gov . The latter risk assessment evaluated the active ingredients from th ree different registration review cases that are co-formulated into fumigant gas cartridges containing sulfur, carbon and carbon dioxide, and potassium and sodium nitrate. The findings of th e gas cartridge assessment are applicable to all three registration review cases. Therefore, the produc ts that were the subject of the assessment are referred to hereafter as “gas cartridges.” The subs equent sections of this document will distinguish sulfur uses by conventional ( i.e.

, non-gas cartridge) uses and gas cartridge us es, respectively, with appropriate headers.

Exposure Assessment

Conventional uses Potential transport mechanisms include runof f, spray drift, wind erosion, and direct deposition. For aquatic organisms (i .e., plants and animals), primar y routes of e xposure include spray drift and runoff. However, the Agency beli eves aquatic exposure to be negligible because sulfur is practically insoluble in water. For birds, mammals, reptiles and terrestrial-phase amphibians, primary routes of exposure to sulfur include consumption of contaminated feed items and surface water. Due to the high application rates of sulfur, terrestrial exposure values estimated through modeling would exceed the highest dose tested in toxicity studies for these taxa. However,

as described below in the Risk Characterization section, the Agency considers the potential for risk to these taxa to be very low for a number of reasons. Exposure to terrestrial plants may occur mostly through direct contact, sin ce root uptake is unlikel y, due to the low solubi lity or insolubility of sulfur. Furthermore, exposure to terrestrial invertebrates ma y occur via direct contact and consumption of contaminated feed items.Sulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176 Proposed Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

7 Gas cartridge uses Given that exposure from gas car tridge uses is limited to sealed burrows, estimated environmental concentrations (EECs) based on aqua tic and terrestrial exposures were not derived. The primary route of exposure is transport of cartridge by-products (i.e., gases produced through ignition of the cartridges) via diffusion, which w ill occur entirely with in a sealed burrow if products are used as directed. As a result, neither r unoff nor spray drift is expected to be a potential transport mechanism to aquatic or terrestrial habitats.

Effects Characterization

Terrestrial Organism Toxicology

Acute studies indicate that su lfur is practically nontoxic on an acute ba sis to terrestrial animals including birds, and by extension, terrest rial-phase amphibians a nd reptiles, mammals, and honeybees. In the bird and mammal studies, no definitive toxicity endpoints were reached because the necessary effects were not observed up to and including the highest test concentrations. Toxicity data on terrestrial plants are not available.

Conventional uses Because sulfur is registered for use as an inse cticide, it is conceivabl e that adverse effects are possible for some invertebrates, even though honeybee toxicity data suggest that sulfur is practically nontoxic on an acute co ntact exposure basis to honeybees.

Adverse effects may be possible to some plant species due to well established documentation on sulfur use that suggest or require th at certain crops should or must be avoided. The use of inorganic fungicides, such as sulf ur and copper, has been well documented in the literature (Elis and Bradley, 1992 2 ). Beckerman (2008 3 ) stated, “Sulfur is the oldest recorded fungicide and has been used for more than 2,000 years, early in agriculture history, the Greeks recognized its efficacy against rust on wheat. Sulfur can be used as a preventative fungicide against powdery mildew, rusts and other diseases. Sulfur prevents fungal spores from germinating, so it should be applied before the disease develops”. Beckerman (2008) and others recommend against using sulfur when temperatur es are expected to exceed 80 o F to reduce the risk of phytotoxicity. It

is also documented that certain varieties of gooseberries, curra nts, apricots, raspberries, and cucurbits are susceptible to sulfur phytotoxicity.

Gas cartridge uses The primary effect expected from exposur e to the gases produced by the ignition of cartridge use is acute mortality to the organisms within the trea ted area. Findings of various efficacy studies show high levels of mortality for most of the organisms tested. No direct exposure to listed and non-listed terrestrial plants or terrestrial inverteb rates is anticipated.

2 Ellis, B.W and Bradley, F.M. 1992. The orga nic Gardner’s Handbook of Natural Inset and Disease Control, Rodale Press. Emmaus, PA. 534pp.

3 Beckerman, J. 2008. Using Organic Fungicides. Disease Management Strategies. Purdue

Extension BP-69-W.Sulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176 Proposed Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

8 Aquatic Organism Toxicology Acute studies indicate that sulfur is pract ically nontoxic on an acute basis to aquatic animals including freshwater fish, and by exte nsion aquatic-phase amphibians, freshwater

invertebrate, and estuarine/marine invertebrate s. The available aquatic studies indicated no mortality at the solubility limit in water (4.87 ppb). Furthermore, av ailable toxicity data from the open literature also indicate sulfur is practically non-toxic to freshwater fish, freshwater aquatic invertebrates and aquatic-phase am phibians on an acute basis.

Risk Characterization

Terrestrial Organisms

Conventional uses Due to the ubiquitous nature of elemental sulf ur, its rapid incorporation into the sulfur cycle, and its low toxicity, the Agency concludes th at risk to terrestrial animals is low. However, the potential for risk to certain t ypes of terrestrial plants and te rrestrial invertebrates exists.

Given the insecticidal uses of sulfur, it stands to reason th at some non-target terrestrial arthropods may be adversely affected when exposed. The data available on the honey bee, however, indicates low toxicity ba sed on acute contact and oral e xposure. A subset of arthropods located within the target area ma y be adversely affected from su lfur applications, for example, flying or leaf-dwelling insects.

For terrestrial plants, two lines of evidence suggest that some plant species may be adversely affected by conventional sulfur applicati ons. First, all five of the available ecological incident reports for sulfur involve terrestria l plants. Second, current label requirements and agricultural extension guidance indicate that certain crops are not to be treat ed with sulfur due to their increased sensitivity. Th ese include, but may not be lim ited to, certain varieties of gooseberries, currants, apricots, raspberries, and cucu rbits. However, the number and spatial extent of these potentially susceptible species is not presently known.

Gas cartridge uses The labeled use for the gas cartri dges containing sulfur is to k ill target pests living in the

treated burrows and dens. Theref ore, the risk assessment assu mes that non-listed and listed

terrestrial vertebrate and invertebrate animals li ving in treated burrows or dens will be killed. However, adverse effects from the application of th e cartridges are localized to the application site

based on the label instructions to seal the burro w or den following the appl ication. As a result, exposure to terrestrial animals is expected to impa ct only the small number of individuals that may be found in the burrow or dens of target pests. For terrestrial non-listed a nd listed species that do

not inhabit burrows or dens, no si gnificant exposure to the cartr idge’s by-products is expected based on the labeled use pattern.

Although there is no fate or toxicity data available for modeling and no reported major incidents, the Agency has made a “May Affect , LAA” determination for listed burrowing speciesSulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176 Proposed Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

9 including birds (and by extension reptiles and am phibians), and mammals due to mortality as an acute direct effect based on asphyxiation from the combustion products. However, given the life history of listed invertebrate sp ecies, EPA has determined that th e cartridges will have no direct effect on listed invertebrates (see the June 28, 2013 Revision to the environmental fate and ecological risk assessment for carbon dioxide and for carbon, sawdust, sodi um nitrate, potassium nitrate and sulfur co ntaining cartridges ). Specifically, the burro ws of burrowing listed invertebrates are not large enough to allow for gas cartridge insertion and use. In addition, listed cave dwelling spiders are unlikely to be either exposed to or aff ected by gas cartridges because the cave entrance(s) is too large and/or not feasible to seal as required by th e gas cartridge labels. Furthermore, it is expected that a cave would be too large for the gas cartridge to effectively remove all of the oxygen, which is required for the product to be used appropr iately, regardless of

the entrance size.

Aquatic Organisms

Conventional uses Sulfur is a natural and ubiquitous component of U.S. waters and the addition of elemental sulfur from pesticidal uses is not likely to be a concern. Based on low toxicity of sulfur to aquatic organisms, the lack of ecological incidents for th ese taxa, and the rapid incorporation of elemental sulfur into the natural sulfur cycle once release d, the Agency has determined that there are no potential risks to listed a nd non-listed aquatic organisms.

Gas cartridge uses Aquatic exposure to gas cartridges is not e xpected given the method of application. Based on the lack of exposure and low toxi city potential of sulf ur to aquatic organisms, the Agency has determined that there is no potential risk to listed and non-listed aquatic organisms.

Endangered Species Assessment

Conventional uses The Agency is making a No Effect determination for all listed a quatic species, and a No Effect determination for direct effects to listed terrestrial vertebrates that do not rely on insects as a primary food source. Given the po ssibility of risk to some listed terrestrial invertebrates and terrestrial plants, the Agency is not able to make an endangered species determination on terrestrial invertebrates, terrestrial plants, i ndirect effects to terrestrial vert ebrates with insects as a primary

food source or indirect effects fo r listed taxa that are dependent on terrestrial plants. Sulfur is registered as an insecticide, ev en though the Agency classifies su lfur as practically non-toxic to honeybees. Regarding risk to plants, users are re quired by product labels to avoid sulfur use on certain plants. Users also receive information from agricultural extension agents regarding use

considerations. To address these uncertainties, furt her evaluation of listed species life history is

needed to determine whether terre strial invertebrates co-occur wi th sulfur use sites, whether obligate relationships exist with listed terrestrial vertebrates, and whether listed terrestrial plants

co-occur with sulfur use sites.Sulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176 Proposed Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

10 Gas cartridge uses EPA’s endangered species assessment for the gas cartridges, completed on March 30, 2010, found the potential for direct effects to 64 listed speci es from gas cartridge use. Since then, the risk assessment has undergone several levels of refinement as a result of public comment, internal deliberation, and an ongoing informal consulta tion with the FWS. Based on its most recent

assessment, EPA has concluded that 55 listed species may be dir ectly affected by gas cartridge

use. Please see the Revision to the environmental fate and ecological risk assessment for carbon dioxide and for carbon, sawdus t, sodium nitrate, potassiu m nitrate and sulfur containing cartridges , dated June 28, 2013 for additional information. This document is available in the public docket (EPA-HQ-OPP-2008-0176). At the time of this assessment, the Island night lizard was among 56 species with a direct e ffect finding. In April 2014, the U. S. Fish and Wildlife Service removed the night lizard from the Federal List of Threatened and Endangered Wildlife [79 FR 18190 (April 1, 2014)].

The March 30, 2010, list of species with potentia l for direct effects was revised based on the following:

 Comments received from FW S Region 4 were considered in refining the “direct effects” list for species whose range is solely within the boundary of FWS Region

4.

 The life history traits of each species on the list were re-evaluated to ensure all such species inhabit dens or burrows at some point in their life-cy cle and confirm that

the burrow or den would accommodate either of the two sizes of gas cartridge. Species were added or removed from the direct effects list de pending on den type use and the potential for exposure to gas cartridges.

EPA has made “LAA” determinations for 55 listed terrestrial vertebrate species (birds, mammals, reptiles and amphibians) that burrow or use small dens at some point in their life-cycle

based on acute direct effects fr om asphyxiation from the gas cartr idge product at the application site. Supporting evidence for sele ction of listed species with “LAA” determinations is based on habitat and life history information for taxa representing listed species.

EPA has also concluded that a number of species may be indirectly affected by gas cartridge use from direct effects to target species. For instance, th e burrow of a listed species, such as a snake, may not receive a direct gas cartri dge application, but if nearby burrows are treated which shelter potential prey for the snake, the snake is indirectly affected in that its available food supply has been reduced. Gas cartridges may also i ndirectly affect plant sp ecies through effects on pollinators and animals involved in seed dispersal.

EPA has made a “No Effect” determination fo r all listed aquatic or ganisms based on both the lack of exposure and the low toxicity potential of sodium a nd potassium nitrate to aquatic organisms.Sulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176 Proposed Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

11 Water Quality

Sulfur is not identified as a cause of impair ment for any water bodies listed as impaired under section 303(d) of the Clean Water Act. 4 In addition, no Total Maximum Daily Loads (TMDL) have been developed for sulfur. 5 More information on impaired water bodies and TMDLs can be found at the Agency’s website. 6

B. Human Health Assessment

The Agency considered the sulfur human health scoping document, its supporting documents, and the most updated Agency science policies and risk asse ssment methodologies to prepare a qualitative risk assessment in support of the regist ration review of sulfur. The human health conclusions apply to conventional and gas cartridge uses. Because of the low toxicity of sulfur, the Agency determined that a quantitativ e human health risk assessment was not required under registration review. In this Proposed Inte rim Registration Review Decision, EPA is making no human health or environmental safety findings associated with the EDSP screening of sulfur. Before completing this Registration Review, the Agency will make an EDSP FFDCA section 408(p) determination.

For detailed discussions of a ll aspects of the human health risk assessment, see the Sulfur. Summary of Human Health Risk Asse ssments to Support Registration Review , dated May 1, 2013. A summary of the Agency’s human health risk assessment is presented below.

Exposure to sulfur from conventional uses is possible via the di et, as well as from residential and occupational use. However, th e Agency believes that worker and bystander exposures are not likely to occur fr om gas cartridge uses. Acute toxici ty of sulfur is low, although it is recognized as an eye and skin irritant. Available data do not indicate any systemic toxicity and no endpoints of toxicological concer n have been identifie d. Therefore, the Agency does not believe that any quantitative dietary, residential, aggregat e or occupational risk assessments are needed for conventional or gas cartri dge uses of sulfur.

Qualitatively, dietary risk is low because of sulfur’s low toxicity to mammals. Sulfur is exempt from tolerances on commodities due to it s low toxicity. Resident ial and occupation risks are low due to protective requirements on produc t labels for preventing eye and skin irritation.

Furthermore, sulfur is a natura lly occurring, ubiquitous element in the environment that is also essential to the human body and needed at relati vely high levels. Therefor e, there are no dietary, residential, occupational, or a ggregate (dietary + dr inking water) risks of concern for sulfur.

C. Endocrine Disruptor Screening Program

4 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885

5 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl _pollutant_detail?p_pollutant_group_id=885&p_pollutant_ group_name=PESTICIDES

6 http://www.epa.gov/owow/tmdl/Sulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176 Proposed Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

12 EPA has developed the Endocri ne Disruptor Screening Progr am to determine whether certain substances (including pes ticide 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 desi gnate.” 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 ch emicals and published a s econd list of chemicals proposed for order issuance in the future. Sulfur was not among th e group of 58 pesticide active ingredients on the initial lis t nor is it proposed on the second list of chemic als to be screened under the EDSP. Accordingly, as part of registrati on review, EPA may issue future EDSP orders/data call-ins for registration review ch emicals, including sulfur. For fu rther information on the status of the EDSP, the policies and proc edures, the list of 67 chemicals, future chemical lists proposed for screening, the test guidelin es and the Tier 1 screeni ng battery, please visit our

website: http://www.epa.gov/endo/

.

In the interim, EPA is not making an EDSP determination for sulfur. Before completing this Registration Review, the Agency will make an EDSP FFDCA section 408(p) determination.

D. Incident Reports

Human Incidents

The U.S.EPA 2008 human health scoping document ( see EPA-HQ-OPP-2008-0176-0003 in sulfur docket) cites an occupational risk assessment that concluded that additional precautionary language and personal protective equipment (PPE) should be requi red for pesticide handlers ( i.e., those mixing/loading and applying the products) in addition to a longer Rest ricted Entry Interval (REI) to prevent skin and eye irritation inci dents among field workers re -entering treated fields. The PPE requirements, along with a 24-hour REIs have been incorporated into sulfur product labels in response to incident reports.

The most current incident report, complete d in 2013 is consistent with the analyses conducted previously, in 2009. In the 2009 review , there were 10 single chemical incidents identified in Incident Data System (IDS) from 2000 to 2008; there were 958 incidents identified

in Poison Control Center Data from 1993 to 2005; there were 63 incidents identified in CA PISP

data from 2002-2006; and 189 inci dents were reported to Cent ers for Disease Control and Prevention/National Institute for Occupational Sa fety and Health (CDC/N IOSH) Sentinel Event Notification System for Occupa tional Risk-Pesticides (SENSO R) data from 1998 to 2005.

The 2013 incident report includes analyses of inci dents reported to the Main and Aggregate IDSfrom January 1, 2009, to January 24, 2013 and from incidents reported to NIOSH SENSORPesticides database from 2006-200 9. One incident of moderate se verity was reporte d to the Main IDS; 43 incidents of minor severity to the Aggr egate IDS; and, 50 incidents involving the single active ingredient sulfur. Of the 50 single AI cases , 33 were low in severit y, 16 were moderate in severity and 1 case was high in severity.Sulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176 Proposed Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

13 Across the databases and incidents reviewed in 2009 and 2013 7,8 , the relative number of reported incidents is low, the severity of reported health effects is low, and for most databases the dermal, ocular and respiratory symptoms/h ealth effects were reflective of the known irri tating properties of sulfur. The incident information supports the risk conclusions in the RED and the EPA poisoning manual, which state that sulfur has irritating properties but it is a relatively low mammalian toxicity pesticide.

Ecological Incidents

A review of the Ecological Incide nt Information System EIIS ( see EPA-HQ-OPP-2008-

0176-0051, i.e. 2013 EFED Risk Assessment), which is maintained by the Agency’s Office of Pesticide Programs, indicates that a total of five incidents between 1999 and 2001 have been reported to the Agency that include d sulfur. It was determined that sulfur exposure was “probable” for only one incident, while the nature or sulfur exposure in the remaining four incidents was not as clear. It is not known if the reported in cidents were the result of product misuse. A review of the Aggregate Incide nt Reports (v. 1.0) database c ontained in the Incident Data System (IDS), and the Avian Monitoring Informa tion System (AIMS) for ecological incidents involving sulfur was completed on March 12, 2013. AIMS did not repo rt any incident s in relation to avian species. IDS reported one minor fish and wildlife incident.

For the incidents review conducted as part of the 2010 Registration Review Ecological Risk Assessment and Effects Determinations, Carbon, Carbon Dioxide, Sa wdust, Sodium Nitrate, Potassium Nitrate and Sulfur Gas Cartridges, no gas cartridge incidents we re reported to the EIIS.

E. Public Comments

On May 26, 2010, the Agency formally issued the Inorganic Nitrate – Nitrite, Carbon and Carbon Dioxide, and Sulfur Registration Revi ew; Draft Ecological Risk Assessment and Endangered Species Effects Determination ; Notice of Availability in the Federal Register and initiated a 60-day public comment period. During that time, one comment was received from FWS Region 4. FWS Region 4 suggested the removal of three species including the Key Largo cotton mouse ( Peromyscus gossypinus ), lower keys marsh rabbit ( Sylvilagus palustris hefneri ), and the red hills salamander ( Phaeognathus hubrichti ), and provided additional information about the Anastasia Island beach mouse ( Peromyscus polionotus phasma ), Choctawhatchee beach mouse ( Peromyscus polionotus allophrys ), and southeastern beach mouse ( Peromyscus polionotus

niveiventris ).

EPA removed three species (red hills salamander, lower keys marsh rabbit, and Key Largo cotton mouse) as a result of the comments from FWS Region 4 stating th at these species would not likely be exposed to gas cartridge uses. EPA in itially removed the three species of beach mice from the direct effects list. However, these specie s were returned to the direct effects list due to the potential for the habitat of th e house mouse, which is a pest species not specifically excluded by the gas cartridge labels, to overlap in some areas with the habitat of the three beach mice,

7 U.S.EPA 2013. Sulfur: Updated Review of Human Incidents. Office of Chemical Safety and Pollution Prevention. Office of Pesticide Programs. DP 410259. March 21, 2013.

8 The 2013 HED incident review will be posted to the do cket with this Proposed Interim Decision for Sulfur.Sulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176 Proposed Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

14 although they inhabit separate burrows. Accordi ng to the information from FWS Region 4, gas cartridges may potentially be used to control the house mouse and therefore mistakenly used in

beach mice burrows.

On June 26, 2013, the Agency issued draft hum an health and ecologi cal risk assessments

for uses of sulfur othe r than gas cartridges: Sulfur. Summary of Human Health Risk Assessments to Support Registration Review , dated May 1, 2013, and Sulfur Environmental Fate and Ecological Preliminary Risk Assessment , dated May 29, 2013. During the 60 day comment period for these

draft risk assessments, one comment was received from Landis Int. on behalf of Georgia Gulf Sulfur. The comment did not challenge or impact th e conclusions of the draft risk assessments as

it concurred with statements made in the HED and EFED Risk Assessments.

F. Environmental Justice

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all people, regardless of race, color, nati onal origin, or income, in the development, implementation, and enforcement of environmenta l laws, regulations, and policies. To help address potential enviro nmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their loca tion, cultural practices, or other factors, may have atypical, unusually high exposure to su lfur, compared to the general population. The Agency did not receive any comments concerning a ny environmental justice issues. At this time,

EPA does not believe that use of the registered pesticide produc ts containing sulfur will cause harm to or a disproportionate impact on at-risk communities.

For additional information regarding enviro nmental justice issues, please visit EPA’s

website at: www.epa.gov/compliance/environmentaljustice/index.html

.

G. Characterization of Economic Benefits of Sulfur

Sulfur is an inorganic pestic ide that is reported to play an important role in plant disease/pest management on many major and minor crops and in pest resistance management because no pest has been reported to be resistan t to sulfur. Sulfur is important for the organic growers because of a limited number of compounds available for controlling pests. Of the high sulfur use crops (from 2004-2012) including grapes, tomatoes, peaches, oranges, apples, cherries, carrots, grapefruit, pist achios, and strawberries, the aver age cost of sulfur per acre ( i.e. , over 1998- 2012) is lower than the average cost per acre for the available and crop respective alternative pesticides ( An Overview of the Benefits of Sulfur Use on Agricultural Crops ). Therefore, available information suggests that sulfur is a relatively inexpe nsive fungicide compar ed to most of its

alternatives.Sulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176 Proposed Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

15 III. PROPOSED INTERIM REGI STRATION REVIEW DECISION

Per the Sulfur Preliminary Work Plan, EP A has completed human health and ecological risk assessments, including an endangered species risk assessment, for sulfur as part of registration review. The Agency is, therefore, issuing a Proposed Interim Registra tion Review Decision pursuant to 40 CFR sections 155.56 and 155.58. The registration revi ew timeline in the Sulfur Final Work Plan projected that the Agency w ould issue the preliminary risk assessments in December 2012 and issue the proposed registrati on review decision in June 2013. However, due to comments received, mitigation discussions with the registrants, and info rmal consultation with the FWS concerning geospatial information for the listed species of concern, the anticipated timeframes needed to be revised. The Agency now anticipates issuing an Interim Registration

Review Decision in late 2014.

Conventional uses Based on the screening-level risk assessments, th ere are potential risks of direct effects to

listed terrestrial invertebrates and terrestrial plants (monocots and di cots) from the use of sulfur on some of its registered use sites. Listed species of birds, mammals, reptil es and terrestrial-phase amphibians may also be affected th rough indirect effects b ecause of the potentia l direct effects on

listed and non-listed terrestrial invertebrate and terr estrial plant species. Potential direct effects on listed terrestrial invertebrates and terrestrial plants from the use of sulfur may be associated with modification of primary constituent elements of designated critical habitats, where such designations have been made. However, at this cu rrent stage of the Registration Review process, it is premature to make effects determinations for listed species until further refinements are

conducted.

Gas cartridge uses According to the Agency’s endangered species risk assessment of sulfur, potential for

adverse effects to a number of listed species exists from us e in gas cartridge products.

Proposed Interim Registration Review Decision In this Proposed Interim Re gistration Review Decision, EP A is making no human health or environmental safety findings associated with the EDSP screening of sulfur. That is, EPA proposes that sulfur be eligible for continued registration, provide d that mitigation measures are incorporated onto product labels. In addition, before completing this Registration Review, the Agency will make an EDSP FFDCA section 408( p) determination. Therefore, issuance of the Agency’s final registration revi ew decision is dependent upon (1 ) the completion of Section 7 Endangered Species consultation with the U.S. Fi sh and Wildlife Service and (2) a conclusion under the EDSP FFDCA section 408(p). Pending the outcome of these actions, the Agency intends to issue this Interim Registrati on Review Decision for sulfur.

A. Ecological Risk

Conventional uses EPA has determined that there is potential for adverse effects to some non-target terrestrial invertebrate and terrestrial plant species. For example, the potent ial for terrestrial plant exposure exists from off-site transport via the various application forms and high applica tion rates of sulfur.Sulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176 Proposed Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

16 However, given the long use histor y, the lack of incide nts since 2001 –and that the three of five

incidents taken from 1999-2001 incl ude other pesticides while the two remaining incidents are not associated with a high degree of ce rtainty for sulfur – as well as the fact that sulfur is quickly incorporated into the sulfur cycle upon contact with water or soil, the Agency considers these risks to be low and does not anticipate further data need s for terrestrial plants. The Agency will conduct a more thorough evaluation prior to the issuance of a fina l Registration Review Decision for sulfur.

Gas cartridge uses

EPA has determined that there is potential for adverse eff ects to non-targe t, non-listed

terrestrial animals that inhabit burrows or dens. Ho wever, adverse effects to non-listed terrestrial animals from the application of the gas cartridges are localized to the app lication site. In addition, all gas cartridge product labels in clude the statement, “Check all burrows for signs of non-target species. If present, do not treat burrows”, wh ich would limit the potential for exposure. The combination of the localization of adverse impact s as well as the protect ive label language for nontarget species leads EPA to conclude that exposur e to non-target, non-listed terrestrial animals is expected to impact only a small number of non-tar get organisms, if any. For the ecological risk assessment, the Agency reviewed available ecological incident data and found that there were no reported ecological incidents attri buted to gas cartridge use.

EPA has determined that the use of gas car tridge products containing potassium and

sodium nitrate, carbon and carbon dioxide, and sulfur is likely to adversely affect (LAA) 55 listed species. Although an individual from a listed species may not be more likely than an individual from a non-listed species to be adversely affected by a gas cartridge, under the ESA, an action is “ likely to adversely affect” a listed species if even a single member of that species is likely to be adversely affected. Please see Appendix A for a summary of individual li sted species which may be directly affected by gas cartridges. The Agency has also concluded that a number of non-listed species may be indirectly a ffected by gas cartridge use.

B. Endangered Species Risk Mitigation Measures

In developing this Proposed Interim Registra tion Review Decision, th e Agency considered a number of mitigation measures that would reduce risk to many listed species from gas cartridge

use. Possible measures include:

 Limiting the potential target species for ga s cartridge applications to only those listed explicitly on product labels.

 Prohibiting gas cartridge use in areas wh ere certain listed sp ecies are known to

occur.

 Permitting gas cartridge use in areas where certain listed species are known to occur only at times of year when the species is not likely to inhabit po tential cartridge use

sites.

 National level adoption of application para meters for United States Department of Agriculture (USDA) Animal and Plant H ealth Inspection Service (APHIS) WildlifeSulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176 Proposed Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

17 Service’s (WS) personnel that resulted from USDA/APHIS WS’ consultations with

FWS.

 National level adoption of protective measures the California Department of Pesticide Regulation (CDPR) introduced to protect affected endangered and threatened species in California. CDPR received concurrence on the effectiveness of these measures through consultation w ith FWS. The EPA intends to revisit the

CDPR consultation with the FWS to ensure adequate protections remain in place for federally listed species that are likely to be affected by gas cartridge use.

For additional information on these mitigation measures and which listed species they apply to, please refer to the June 28, 2013, Revision to the Environmental Fate and Ecological Risk Assessment for Carbon Dioxide and for Car bon, Sawdust, Sodium Nitrate, Potassium Nitrate and Sulfur Containing Cartridges , available in the public doc ket (EPA-HQ-OPP-2008-0176) at www.regulations.gov

.

C. Voluntary Adoption of Risk Mitigation Measures

In discussions with the Agency, the gas cartridge registrants have all agreed to adopt some but not all of the above mitigation measures. Pe nding the result of Section 7 Endangered Species

consultation with the U.S. Fish and Wildlife Servi ce, the Agency does not intend to require all of the risk mitigation measures identified above to be adopted at this time. The following list represents the mitigation measures that the gas cartridge registrants have voluntarily agreed to incorporate into their gas cartridge registrations . These changes will serve to mitigate risk to 18 listed species of concern from use of the gas cartridges:

1) A label amendment incorporating a reference to the Bulletins Live! internet application, ( Bulletins Live! ), which will identify county or sub- county level restrictions for 5 of the listed species found to be directly affected by gas cartr idge use. The geographically specific areas where gas cartri dge use would be prohibited ar e based on available listed species’ range information obtained from FW S field offices. The Agency received this information as part of informal Section 7 Endangered Species consultation with FWS. Based on the information provided by FWS, the Agency has developed maps that depict the proposed geographic areas of prohi bited gas cartridge us e. With this label change, the LAA determination can be cha nged to a “No Effect” determination for 5 listed species: Hualapai Mexican vole, Mo rro Bay kangaroo rat, Utah prairie dog, Coachella Valley fringe-toed lizard, and gopher tortoise.

2) Prohibiting gas cartridge use within spec ific federally-managed areas for 6 listed species through the Bulletins Live! internet application. The Agen cy verified with managers/representatives of these federal lands that gas cartridges are not used in these areas, so this limitation would not impact any current use. With this label change, the LAA determination would be changed to a “N o Effect” determination for the following species due to their range inhabiting only federal lands: Mount Graham red squirrel (Coronado National Forest), Ca rolina northern flying squirrel ( Cherokee National

Forest, Jefferson National Forest, Nantahala National Forest, Pisgah National Forest,Sulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176 Proposed Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

18 Middle Prong Wilderness, Great Smoky Mountains Nationa l Park, and Blue Ridge Parkway), Desert slender salamander ( Santa Rosa Wilderness), Santa Rosa Island fox ( Channel Island National Park)

, San Miguel Island fox (Cha nnel Island National Park)

, and Santa Cruz Island fox ( Channel Island National Park).

3) Creation of sub-labels for USDA’s gas cartr idge registrations, EPA Reg. Nos. 56228-

2 and 56228-21. One sub-label would be in tended for use only by USDA APHIS WS’ personnel and one sub-label would be intended for broad consumer use, including

homeowners. The creation of th e sub-labels would serve tw o purposes. First, the USDA APHIS WS’ use sub-label would adopt the application parameters for USDA APHIS WS’ personnel resulting fr om USDA APHIS WS’ consultations with FWS, which allows EPA to change the effects determina tion for certain species from LAA to “not likely to adversely affect” (NLAA). The cons umer use sub-label w ould, like all other gas cartridge labels, restrict use of the produc t to only target species, which allows EPA

to make a “no effect” determination on 7 additional listed species, but only for the consumer use products. Since the WS’ use pr oduct will not have target species only

restriction, EPA will make an NLAA determ ination for those 7 species and seek

concurrence on that finding from FWS.

To implement these mitigation measures, gas cartridge product registrations and labels will

be amended to include a reference to the Bulletins Live! internet application. The labels will require gas cartridge users to refer to Bulletins Live! to view applicable Endangered Species Protection Bulletins before using the product to ensure that they do not use the product in a prohibited area. The bulletins will be available through the EPA Bulletins Live! website (http://www.epa.gov/oppfead1/endange r/bulletins). A teleph one number that users can call for Bulletin information if they do not have internet access will also be provided.

The gas cartridge registrants have agreed to prohibit use in the areas where 11 of the listed species with potential for dir ect effects from the gas cartridge use are known to occur. The proposed Bulletins Live! label language required to implemen t these prohibitions can be found in

the label table section of this Proposed Interim Registra tion Review Decision. Appendix B provides a list of the counties, by state, that will have geographic restrictions. The draft Bulletins, organized by state, are ava ilable for viewing in the doc ket (EPA-HQ-OPP-2008-0176).

The Agency believes that implementation of mitig ation measures to address the risk to the directly affected listed species will also prov ide protection for many listed species which may be indirectly effected by the us e of the gas cartridges.

Although these mitigation measures would result in “No Effect” determinations for 18 (11 No Effect determinations based on geographic use prohibitions and 7 No Effect determinations for target species only restriction, for consumer use pr oducts) of the listed specie s identified in the risk assessment, 44 listed species remain for which th e EPA would make either a “LAA” or “NLAA” determination from direct effects of gas cartridge use (37 with no mitigatio n and 7 with mitigation only on consumer use products; USDA APHIS WS’ us e would remain “NLAA”). There are also

LAA determinations for listed terrestrial mammals, birds, invertebrates, and plants for indirect effects from the use of the cartridges. The Agency will continue through informal consultationSulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176 Proposed Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

19 with FWS to further refine this list of directly affected species and explore other mitigation options. However, with regards to the Agency’s finding of “LAA” for a number of listed species, the Agency is required to initiate formal Endangere d Species Act (ESA) Sec tion 7 consultation with

the FWS.

Therefore, due to the remaining work EPA w ill undertake with the FWS, and also due to EDSP- related considerations, the Agency is issuing a proposed interi m registration review decision at this time, which will be finalized upon completion of the formal ESA consultation with

FWS and the EDSP determination.

IV. NEXT STEPS AND TIMELINE

A. Proposed Interim Registration Review Decision

In accordance with 40 CFR 155.56 and 155.58, the Agency is issuing this Sulfur Proposed Interim Registration Review Decisi on and placing it in th e sulfur registration review docket (EPAHQ-OPP-2008-0176). A Federal Regist er Notice will announce its avai lability and allow a 60-day public comment period. If there are no significant comments or additional information submitted to the docket during that comment period that woul d lead the Agency to change its decision, EPA will issue an Interim Registration Review Decision for sulfur (Case 0031). The Agency anticipates the Sulfur Interim Registration Review Decision w ill be issued in late 2014. The Agency expects to issue a final decision on the sulfur registra tion review case after bot h (1) conclusion of ESA Section 7 consultation with the FWS and (2) an EDSP FFDCA section 408(p) determination has

been made.

B. Bulletins Live! Comment Period

The Agency will make the individual draft Bulletins, which illustrate the geographic prohibitions protecting the listed species for the gas cartridges, available for stakeholder comment concurrent with this Proposed Interim Registra tion Review Decision. A ppendix B provides a list of the counties, by state, that wi ll have geographic restrictions. The draft Bulletins, organized by state, are available for viewing in the docket (EPA-HQ-OPP-2008-0176).

C. Implementation of Mitigation Measures

Once the Interim Registration Review Decision is issued in final, registrants will be required to submit proposed amendments and regi stered and amended labels that include the agreed-upon endangered species risk mitigation to the Agency for approval within 60 days of issuance of the Interim Regi stration Review Decision.

D. Consultation with the U.S. Fish and Wildlife Service

Under Section 7 of the ESA, EPA is required to consult with the rele vant federal agency when it determines that the registered uses may affect listed species (or any designated critical habitat for those species). As discussed above, the latest revi sion to the gas cartridge risk assessment ( Revision to the Environmental Fate and Ecological Risk Asse ssment for CarbonSulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176 Proposed Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

20 Dioxide and for Carbon, Sawdust, Sodium Nitrat e, Potassium Nitrate and Sulfur Containing Cartridges

, dated June 28, 2013) describes the listed sp ecies found that may be affected from the use of gas cartridges and the pr oposed risk mitigation solutions for many of those species. For those species where a mitigation solution has b een implemented on the product labels that eliminates risk to such species, the Agency will change its endangered species risk finding from “LAA” to “no effect,” eliminating the requirement for the Agency to consult on these species. In the case of the USDA sub-label speci fically for WS applicators, as well as the spec ies covered by California DPR’s consultation with FWS, the Ag ency may change its endangered species risk finding from “likely to adversely affect” to “not likely to adversely affect” where an acceptable mitigation solution based on previous consultations has been implemented allowing use in the range of a listed species of concern. For these sp ecies with a “not likely to adversely affect” determination, the Agency intends to seek concur rence from the FWS through the current informal Section 7 Endangered Species consultation. Additi onally, EPA will continue informal consultation

with FWS to further refine th e list of gas cartridge “LAA” species. Communication with FWS species experts may provide certai n insight on the life history of lis ted species that may lead to further changes in EPA’s effects determinations. For those species where an acceptable mitigation solution has not been implemented on the product labels that allows EPA to make either a “no effect” or “not likely to advers ely affect” determination, the Agen cy intends to initiate formal Section 7 Endangered Species consultation with the FWS following issuance of the Interim Registration Review Decision.Sulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176Proposed Interim Registration Review Decisionwww.regulations.govPesticide Re-evaluation Division21Appendix AListed Non-Target Species Subject to an LAA Determination Based on Direct EffectsNo.Species CommonNameScientific NameNo. ofCountiesCounty (State)a1 Alabama BeachMousePeromyscuspolionotusammobates1 Baldwin (AL)2 Alameda WhipsnakeMasticophislateraliseuryxanthus4 Alameda, Contra Costa, San Joaquin, Santa Clara (CA)3 Amargosa VoleMicrotuscalifornicusscirpensis1 Inyo (CA)4 Anastasia IslandBeach MousePeromyscuspolionotus phasma1 St. John’s (FL)5 Arroyo SouthwesternToadBufo californicus(=microscaphus)8 Los Angeles, Monterey, Orange, Riverside, San Bernardino, San Diego, SantaBarbara, Ventura (CA)6 Black-footed Ferret,EndangeredMustela nigripes141 Apache, Coconino, Navajo, Yavapai (AZ)County-level range not defined (CO)Logan (KS)Big Horn, Blaine, Carbon, Carter, Chouteau, Custer, Fergus,Garfield, GoldenValley, Hill, Jefferson, Lewis and Clark, Liberty, McCone, Musselshell,Petroleum, Phillips, Powder River, Prairie, Rosebud, Stillwater, Sweet Grass,Toole, Treasure, Valley, Wheatland, Yellowstone (MT)Adams, Antelope, Arthur, Banner, Blaine, Boone, Box Butte, Boyd, Brown,Buffalo, Chase, Cherry, Cheyenne, Clay,Colfax, Custer, Dawes, Deuel, Dundy,Filmore, Franklin, Frontier, Furnas, Garden, Garfield, Gosper, Grant, Greeley,Hall, Hamilton, Harlan, Hayes, Hitchcock, Holt, Hooker, Howard, Jefferson,Kearney, Keith, Keya Paha, Kimball, Knox, Lincoln, Logan, Loup, Madison,McPherson, Merrick, Morrill, Nance, Nuckrolls, Perkins, Phelps, Pierce, Platte,Sulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176Proposed Interim Registration Review Decisionwww.regulations.govPesticide Re-evaluation Division22No.Species CommonNameScientific NameNo. ofCountiesCounty (State)aPolk, Red Willow, Rock, Saline, Scotts Bluff, Seward, Sheridan, Sherman,Sioux, Thayer, Thomas, Valley,Webster, Wheeler, York (NE)Colfax (NM)Adams, Billings, Bowman, Dunn, Golden Valley, Grant, Hettinger, McKenzie,Mercer, Morton, Oliver, Sioux, Slope, Stark (ND)Corson, Custer, Dewey, Gregory, Jackson, Lyman, Mellette, Pennington,Shannon, Todd, Tripp, Ziebach (SD)County-level range not defined (UT)Big Horn, Carbon, Fremont, Hot Springs, Lincoln, Natrona, Park, Sublette,Sweetwater, Uinta, Washakie (WY)Counties in addition to the above which contain only experimental populations:Adams, Alamosa, Arapahoe, Archuleta, Baca, Broomfield, Conejos, Costilla,Delta, Douglas, Kiowa, Kit Carson, La Plata, Larimer, Las Animas, Moffat,Montezuma, Montrose, Morgan, Otero, Prowers, Pueblo, Rio Blanco,Saguache, San Miguel, Washington, Weld (CO)County-level range not defined (SD)Uintah (UT)Albany (WY)7 Blunt-nosed LeopardLizardGambelia silus5 Monterey, San Benito, San Luis Obispo, Santa Barbara, Ventura (CA)8 Bog TurtleClemmysmuhlenbergii49 Fairfield, Litchfield (CT)New Castle (DE)Baltimore, Carroll, Cecil, Harford (MD)Burlington, Gloucester, Hunterdon, Mercer, Monmouth, Morris, Ocean, Salem,Somerset, Sussex, Union, Warren (NJ)Sulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176Proposed Interim Registration Review Decisionwww.regulations.govPesticide Re-evaluation Division23No.Species CommonNameScientific NameNo. ofCountiesCounty (State)aCayuga, Columbia, Dutchess, Genesee, Onondaga, Orange, Oswego, Putnam,Rensselaer, Rockland, Seneca, Sullivan, Ulster, Wayne, Westchester (NY)Adams, Berks, Bucks, Carbon, Chester, Cumberland, Delaware, Lancaster,Lebanon, Lehigh, Monroe, Montgomery, Northampton, Schuylkill, York (PA)9 Buena Vista LakeOrnate ShrewSorex ornatusrelictus2 Kern, San Luis Obispo, Additional portions of the range within CA still need tobe refined (CA)10 California Redlegged FrogRana draytonii30 Alameda, Butte, Contra Costa, El Dorado, Fresno, Kern, Los Angeles, Marin,Mariposa, Mendocino, Merced, Monterey, Napa, San Benito, San Bernardino,San Diego, San Joaquin, San Luis Obispo, San Mateo, Santa Barbara, SantaClara, Santa Cruz, Siskiyou, Solano,Sonoma, Stanislaus, Tehama, Trinity,Tuolumne, Ventura (CA)11 California TigerSalamander (SantaBarbara DPS)Ambystomacaliforniense1 Santa Barbara (CA)12 California TigerSalamander (CentralValley DPS)Ambystomacaliforniense5 Monterey, San Benito, San Luis Obispo, Santa Cruz, Sonoma (CA)13 California TigerSalamander (SonomaDPS)Ambystomacaliforniense31 Alameda, Amador, Butte, Calaveras, Colusa, Contra Costa, El Dorado, Fresno,Glenn, Kern, Kings, Madera, Marin, Mariposa, Merced, Napa, Placer,Sacramento, San Joaquin, San Luis Obispo, San Mateo, Santa Clara, SantaCruz, Solano, Sonoma, Stanislaus, Sutter, Tulare, Tuolumne, Yolo, Yuba,Additional portions of the range within this state still need to be refined (CA)14 Carolina NorthernFlying SquirrelbGlaucomyssabrinus coloratus20 Ashe, Avery, Buncombe, Caldwell, Graham, Haywood, Henderson, Jackson,McDowell, Mitchell, Swain, Transylvania, Watauga, Yancey (NC)Carter, Monroe, Sevier, Unicoi (TN)Grayson, Smyth (VA)15 ChoctawhatcheeBeach MousePeromyscuspolionotusallophrys3 Bay, Okaloosa, Walton (FL)16 Coachella ValleyFringe-toed LizardbUma inornata2 Riverside, San Bernardino (CA)Sulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176Proposed Interim Registration Review Decisionwww.regulations.govPesticide Re-evaluation Division24No.Species CommonNameScientific NameNo. ofCountiesCounty (State)a17 Copperbelly WaterSnakeNerodiaerythrogasterneglecta12 Kosciusko, St. Joseph, Steuben (IN)Branch, Calhoun, Cass, Eaton, Hillsdale, St. Joseph (MI)Defiance, Hardin, Williams (OH)18 Desert SlenderSalamanderbBatrachosepsaridus1 Riverside (CA)19 Desert TortoiseGopherus agassizii13 Mohave (AZ)Imperial, Inyo, Kern, Los Angeles, Riverside, San Bernardino, San Diego (CA)Clark, Esmeralda, Lincoln, Nye (NV)Washington (UT)20 Eastern Indigo SnakeDrymarchon coraiscouperi98 Appling, Atkinson, Bacon, Berrien, Bryan, Bulloch, Camden, Charlton, Clinch,Coffee, Echols, Emanuel, Evans, Irwin, Jeff Davis, Lanier, Liberty, Long,Lowndes, McIntosh, Randolph, Tattnall, Telfair, Wayne, Wheeler (GA)Alachua, Bay, Brevard, Broward, Calhoun, Charlotte, Citrus, Clay, Collier,Columbia, DeSoto, Dixie, Duval, Escambia, Franklin, Gadsden, Gilchrist,Glades, Gulf, Hamilton, Hardee, Hendry, Hernando, Highlands, Hillsborough,Holmes, Indian River, Jackson, Jefferson, Lafayette, Lake, Lee, Leon, Levy,Liberty, Madison, Manatee, Marion, Martin, Miami-Dade, Monroe, Nassau,Okaloosa, Okeechobee, Orange, Osceola,Palm Beach, Pasco, Pinellas, Polk,Putnam, Santa Rosa, Sarasota, Seminole, St. Johns, St. Lucie, Sumter,Suwannee, Taylor, Union, Volusia,Wakulla, Walton, Washington (FL)Baldwin, Coffee, Covington, Dale, Escambia, Geneva, Houston, Mobile,Washington (AL)21 Fresno Kangaroo RatDipodomysnitratoides exilis1 Fresno (CA)22 Giant Garter SnakeThamnophis gigas31 Alameda, Amador, Butte, Calaveras, Colusa, Contra Costa, El Dorado, Fresno,Glenn, Kern, Kings, Lake, Madera, Mariposa, Merced, Napa, Nevada, Placer,Sacramento, San Joaquin, San Luis Obispo, Santa Clara, Santa Cruz, Solano,Stanislaus, Sutter, Tehama, Tulare, Tuolumne, Yolo, Yuba, Additional portionsof the range within this state still need to be refined (CA)23 Giant Kangaroo RatDipodomys ingens4 Monterey, San Benito, San Luis Obispo, Ventura (CA)24 Gopher TortoisebGopheruspolyphemus25 Choctaw, Mobile, Washington (AL)St. Tammany, Tangipahoa, Washington (LA)Clarke, Covington, Forrest, George, Greene, Hancock, Harrison, Jackson,Sulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176Proposed Interim Registration Review Decisionwww.regulations.govPesticide Re-evaluation Division25No.Species CommonNameScientific NameNo. ofCountiesCounty (State)aJasper, Jefferson Davis, Jones, Lamar, Marion, Pearl River, Perry, Smith, Stone,Walthall, Wayne (MS)25 Gray WolfCanis lupus221 County level range not defined (CO)Alger, Baraga, Cheboygan, Chippewa, Delta, Dickinson, Emmet, Gogebic,Houghton, Iron, Keweenaw, Luce,Mackinac, Marquette, Menominee,Ontonagon, Presque Isle, Schoolcraft (MI)Adams, Antelope, Arthur, Banner, Blaine, Boone, Box Butte, Boyd, Brown,Buffalo, Burt, Butler, Cass, Cedar, Chase, Cherry, Cheyenne, Clay, Colfax,Cuming, Custer, Dakota, Dawes, Dawson, Deuel, Dixon, Dodge, Douglas,Dundy, Fillmore, Franklin, Frontier, Furnas, Gage, Garden, Garfield, Gosper,Grant, Greeley, Hall, Hamilton, Harlan, Hayes, Hitchcock, Holt, Hooker,Howard, Jefferson, Johnson, Kearney, Keith, Keya Paha, Kimball, Knox,Lancaster, Lincoln, Logan, Loup, Madison, McPherson, Merrick, Morrill,Nance, Nemaha, Nuckolls, Otoe, Pawnee, Perkins, Phelps, Pierce, Platte, Polk,Red Willow, Richardson, Rock, Saline, Sarpy, Saunders, Scotts Bluff, Seward,Sheridan, Sherman, Sioux, Stanton,Thayer, Thomas, Thurston, Valley,Washington, Wayne, Webster, Wheeler, York (NE)Elko (NV)Catron, Grant, Hidalgo, Sierra (NM)Adams, Barnes, Benson, Billings, Bottineau, Bowman, Burke, Burleigh, Cass,Cavalier, Dickey, Divide, Dunn, Eddy, Emmons, Foster, Golden Valley, GrandForks, Grant, Griggs, Hettinger, Kidder, LaMoure, Logan, McHenry, McIntosh,McKenzie, McLean, Mercer, Morton, Mountrail, Nelson, Oliver, Pembina,Pierce, Ramsey, Ransom, Renville, Richland, Rolette, Sargent, Sheridan, Sioux,Slope, Stark, Steele, Stutsman, Towner, Traill, Walsh, Ward, Wells, Williams(ND)County-level range not defined (OR)County-level range not defined (SD)County-level range not defined (UT)Sulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176Proposed Interim Registration Review Decisionwww.regulations.govPesticide Re-evaluation Division26No.Species CommonNameScientific NameNo. ofCountiesCounty (State)aChelan, Kittitas, Klickitat, Okanogan,Snohomish, Whatcom, Yakima (WA)Adams, Ashland, Barron, Bayfield, Burnett, Chippewa, Clark, Douglas, EauClaire, Florence, Forest, Iron, Jackson, Juneau, Langlade, Lincoln, Marathon,Marinette, Marquette, Menominee, Monroe, Oconto, Oneida, Polk, Portage,Price, Rusk, Sawyer, Shawano, Taylor, Vilas, Washburn,Waupaca, Wood (WI)Counties in addition to the above which contain only experimental populations:Big Horn, Fremont, Hot Springs, Lincoln, Park, Sublette, Teton (WY)Apache, Gila, Greenlee, Navajo (AZ)County-level range not defined (NM)County-level range not defined (TX)26 Houston ToadBufo houstonensis9 Austin, Bastrop, Burleson, Colorado,Lavaca, Lee, Leon, Milam, Robertson(TX)27 Hualapai MexicanVolebMicrotus mexicanushualpaiensis1 Mohave (AZ)28 Key Largo WoodratNeotoma floridanasmalli1 Monroe (FL)29 Mississippi GopherFrogRana capito sevosa2 Harrison, Jackson (MS)30 Morro Bay KangarooRatbDipodomysheermannimorroensis1 San Luis Obispo (CA)31 Mount Graham RedSquirrelbTamiasciurushudsonicusgrahamensis1 Graham (AZ)32 Northern IdahoGround SquirrelSpermophilusbrunneus brunneus3 Adams, Valley, Washington (ID)33 Pacific Pocket MousePerognathuslongimembrispacificus3 Los Angeles, Orange, San Diego (CA)34 Perdido Key BeachMousePeromyscuspolionotustrissyllepsis2 Baldwin (AL)Escambia (FL)Sulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176Proposed Interim Registration Review Decisionwww.regulations.govPesticide Re-evaluation Division27No.Species CommonNameScientific NameNo. ofCountiesCounty (State)a35 Petrel, Hawaiiandark-rumpedPterodromaphaeopygiasandwichensis3 Hawaii, Kauai, Maui36 Point ArenaMountain BeaverAplodontia rufanigra1 Mendocino (CA)37 Pygmy RabbitBrachylagusidahoensis3 Benton, Douglas, Grant, Additional portions of the range within WA still needto be refined (WA)38 Red WolfEndangeredCanus rufus4 County-level range not defined - FL, NC, SCCounties in addition to the above which contain only experimental populations:Beaufort, Dare, Hyde, Tyrrell (NC)County-level range not defined (TN)39 San BernardinoMerriams KangarooRatDipodomysmerriami4 Los Angeles, Orange, Riverside, San Bernardino (CA)40 San Francisco GarterSnakeThamnophis sirtalistetrataenia1 Santa Cruz (CA)41 San Joaquin Kit FoxVulpes macrotismutica21 Alameda, Calaveras, Contra Costa, Fresno, Kern, Kings, Madera, Mariposa,Merced, Monterey, Sacramento, San Benito, San Joaquin, San Luis Obispo,Santa Barbara, Santa Clara, Santa Cruz, Solano, Stanislaus, Tulare, Tuolumne(CA)42 San Miguel IslandFoxbUrocyon littoralislittoralis1 Santa Barbara (CA)43 Santa Catalina IslandFoxUrocyon littoraliscatalinae1 Los Angeles (CA)44 Santa Cruz IslandFoxbUrocyon littoralissantacruzae1 Santa Barbara (CA)45 Santa Cruz Long-toedSalamanderAmbystomamacrodactylumcroceum2 Monterey, Santa Cruz (CA)46 Santa Rosa IslandFoxbUrocyon littoralissantarosae1 Santa Barbara (CA)47 Shearwater, Newell'sTownsend'sPuffinus auricularisnewelli4 Hawaii, Honolulu, Kauai (HI)Manu’a (American Samoa)Sulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176Proposed Interim Registration Review Decisionwww.regulations.govPesticide Re-evaluation Division28No.Species CommonNameScientific NameNo. ofCountiesCounty (State)a48 Sonora TigerSalamanderAmbystomatigrinum stebbinsi2 Cochise, Santa Cruz (AZ)49 Southeastern BeachMousePeromyscuspolionotusniveiventris7 Brevard, Broward, Indian River, Martin, Palm Beach, St. Lucie, Volusia (FL)50 St. Andrew BeachMouseMicrotuspennsylvanicusdukecampbelli2 Bay, Gulf (FL)51 Stephens KangarooRatDipodomysstephensi4 Orange, Riverside, San Bernardino, San Diego (CA)52 Tipton Kangaroo RatDipodomysnitratoidesnitratoides5 Fresno, Kern, Kings, San Luis Obispo, Tulare, Additional portions of the rangewithin CA still need to be refined (CA)53 Utah Prairie DogbCynomys parvidens7 Beaver, Garfield, Iron, Kane, Piute, Sevier, Wayne (UT)54 Vole, Florida SaltMarshMicrotuspennsylvanicusdukecampbelli1 Levy (FL)55 Wyoming ToadBufo baxteri(=hemiophrys)1 Albany (WY)aList of counties obtained from the U.S. Fish and Wildlife Service endangered species website:http://www.fws.gov/endangered/species/usspecies.html. The counties include populations that are threatened, endangered, and experimental. When the counties only contain experimentalpopulations, these counties are listed separately.bThe registrants have voluntarily agreed to mitigate riskto this species resulting in a No Effect determination.Sulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176Proposed Interim Registration Review Decisionwww.regulations.govPesticide Re-evaluation Division29Appendix BIndexCounties with Proposed Gas Cartridge Endangered Species Protection BulletinsAlabama Counties:Baldwin, Choctaw, Clarke, Marengo, Mobile, Sumter, WashingtonArizona Counties:Graham, MohaveCalifornia Counties:Los Angeles, Riverside, San Bernardino,San Luis Obispo, Santa Barbara, VenturaLouisiana:Livingston, St. Helena, St.John the Baptist, St. Tammany, Tangipahoa, WashingtonMississippi:Amite, Clarke, Covington, Forrest, George, Greene, Hancock, Harrison, Jackson, Jasper, Jefferson Davis, Jones, Lamar, Lauderdale,Lawrence, Marion, Newton, Pearl River,Perry, Pike, Rankin, Scott, Simpson, Smith, Stone, Walthall, WayneNorth Carolina:Ashe, Avery, Buncombe, Burke, Caldwell, Cherokee, Clay,Graham, Haywood, Henderson, Jackson, Macon, Madison, McDowell,Mitchell, Swain, Transylvania, Watauga, YanceySulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176Proposed Interim Registration Review Decisionwww.regulations.govPesticide Re-evaluation Division30Tennessee:Blount, Carter, Cocke, Greene, Johnson, Monroe, Sevier, Sullivan, UnicoiUtah:Beaver, Garfield, Iron, Kane,Millard, Piute, Sanpete,Sevier, Washington, WayneVirginia:Grayson, Russell, Smyth, Washington, WytheSulfur Case 0031 Docket Number EPA-HQ-OPP-2008-0176Proposed Interim Registration Review Decisionwww.regulations.govPesticide Re-evaluation Division31Gas Cartridge Label Table(For gas cartridge products containing the active ingredient sulfur)Summary of Labeling Changes for Gas Cartridge UsesDescriptionAmended Labeling Language for Gas Cartridge Use ProductsPlacement on LabelEnd Use ProductsLanguage to restrict useto target species only“Only use for sites, pests, and application methods specified on this labeling.”Directions for UseAfter statementabout reading entirelabeling and insert.Language to restrict useto target species only“This product may only be used to control[insert pests and sites]...”Directions for UseUnder “UseRestrictions”Endangered Speciesconsiderations“Endangered Species:It is a Federal offense to use any pesticide in a manner that results in the death of anendangered species. Use of this product may pose a hazardto endangered or threatened species. When using thisproduct, you must follow the measures contained in the Endangered Species Protection Bulletin for the county inwhich you are applying the product. To obtain Bulletins, no more than six months before using this product, consulthttp://www.epa.gov/espp/ or call 1-800-447-3813. You must use the Bulletin valid for the month in which you willapply the product.”Directions for UseUnder “UseRestrictions”Endangered speciesconsiderations“It is a Federal offense to use any pesticide in a manner that results in the death of an endangered species. See theEndangered Speciessection in the Directions for Use section of this labeling.”EnvironmentalHazards section