Inorganic nitrates Case 4052 Doc ket Number EPA

- HQ

- OPP

- 2007

- 1118 Interim Registration Review Decision www.regulations.gov Pesticide Re

- evaluation Division

2 

### Table of Contents

I. INTRODUCTION

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

I. RESPONSE TO COMMENTS

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

III. SCIENTIFIC ASSESSMENT

................................ ................................ .......................... 9

II. INTERIM REGISTRATION REVIEW DECISION

................................ .................... 9

Appendix A: Listed Non

- Target Species Subject to Section 7 Consultation with Fish and

Wildlife Service

................................ ................................ ................................ ........................... 14

Appendix B: Listed Non

- Target Species with Changes to EPA Effect Determinations from the June 28, 2013 Revi sed Gas Cartridge Ecological Risk Assessment

................................ . 16

Appendix C: Gas Cartridge Label Table for All Gas Cartridge Products

........................... 18

Appendix D: Geographic Range s Maps for Species with Planned Bulletin s

........................ 19Inorganic nitrates Case 4052 Doc ket Number EPA

- HQ

- OPP

- 2007

- 1118 Interim Registration Review Decision www.regulations.gov Pesticide Re

- evaluation Division

3 I. INTRODUCTION

This document is the Environmental Protection Agency’s (EPA or the Agency) Interim Registration Review Decision for Inorganic Nitrate/Nitrite and is being issued 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 Agency may issue, when it determines it to be appropriate, an interim registration review decision before com pleting 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 s and completing the registration review. For

further information on Inorganic Nitrate /Nitrite , additional documents can be found in EPA’s public docket (EPA

- HQ

- OPP

- 2007

- 1118 ) at www.regulations.gov

.

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

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

Pursuant to 40 CFR §155.50, the Agency formally initiated registration review for Inorganic Nitrates ( c ase 4052 ). Of the inorganic nitrates and nitrites reregist ration case, only the active ingredients sodium nitrate and potassium nitrate now have existing pesticide registrations. Therefore, the Agency’s risk assessments and registration review decision pertain only to sodium and potassium nitrate. These active ingredients are mixed with sodium and potassium nitrate and in some cases, sulfur, to create fumigant gas cartridges which release toxic fumes after ignition. These gas producing cartridges are placed in animal burrows to control small mammals

. Gas cartridge products that contain sodium and potassium nitrate may also contain sulfur and sodium or potassium nitrate. C arbon and carbon dioxide ( c ase 4019) and sulfur ( c ase 0031 ) are also undergoing registration review. Consequently, there are severa l common support docu ments and regulatory conclusions shared among these cases. Furthermore, the registration review interim decisions for all compounds with gas cartridge uses are being made available simultaneously.

S odium and potassium nitrate have bee n used as pesticide s in the United States since the 1940s. A Reregistration Eligibility Decision (RED) was signed for sodium and potassium nitrateInorganic nitrates Case 4052 Doc ket Number EPA

- HQ

- OPP

- 2007

- 1118 Interim Registration Review Decision www.regulations.gov Pesticide Re

- evaluation Division

4 in September 1991. The Agency’s registration review of sodium and potassium nitrate (case

40 52 ), and of carbo n and carbon dioxide (case 40 19 ) are centered solely on their use in gas cartridge products. Consequently, there are several common support documents between these cases, and the regulatory elements of these cases are also the same. Since sulfur (case 0031 ) has uses other than as a gas cartridge, the registration review of case 0031 includes regulatory

elements common to case 40 52 and case 4019

. Since the assessment and proposed regulatory

decision for sodium and potassium nitrate are ba sed on their use as gas cartridges, these active ingredients are r eferred to hereafter as both “sodium and potassium nitrate ” or as “gas cartridges.”

Gas cartridges are registered for outdoor use to control burrowing mammals (EPA Reg.

Nos. 4

- 463, 73342

- 8 , 9086

- 4, 10551

- 1, and 56228

- 2) and relatively large mammals in dens (EPA Reg. No. 56228

- 21). A list of existing gas cartridge products and their target pests is provided in the table below. To use the products, the user lights the fuse, places the cartrid ge in the burrow or den and seals all known exits/entrances. Animals within the burrow or den are asphyxiated by the release of carbon dioxide and other toxic gases.

EPA Registration Number Product Name Registrant Target Species

4

- 463 Smoke'em Bonide Products, Inc Woodchucks, gophers

73342

- 8 Amdro Gopher Gasser Ambrands Gophers, ground squirrels

9086

- 4 Revenge Rodent Smoke

Bomb Roxide International,

Inc. Gophers, woodchucks

10551

- 1 The Giant Destroyer Atlas Chemical Corporation Moles, gophers, woodchucks, Norway rats, ground squirrels,

skunks

56228

- 2 Gas Cartridge U.S. Department of Agriculture Woodchucks, yellow

bellied marmots, ground

squirrels, prairie dogs

56228

- 21 Large Gas Cartridge U.S. Department of Agriculture Coyotes, red foxes,

st riped skunks

The following timeline highlights significant actions during the registration review of sodium and potassium nitrate and can be found in the public docket ( EPA

- HQ

- OPP

- 2007

- 1118 )

.

• March 26, 2008

– The Agency published the Inorganic N itrate / N

itrite Summary

Document , dated March 19, 2008 in docket number EPA

- HQ

- OPP

- 2007

- 1118 for a 60

- day public comment period. The Summary Document included the Agency’s Preliminary Work Plan for Inorganic Nit rate/Nitrite , a n Inorganic N itrates Fact Sheet, the ProblemInorganic nitrates Case 4052 Doc ket Number EPA

- HQ

- OPP

- 2007

- 1118 Interim Registration Review Decision www.regulations.gov Pesticide Re

- evaluation Division

5 Formulation for Ecological Risk Assessment, for Carbon Dioxide and Gas Fumigant Producing Cartridges: Carbon, Sawdust, Sodium Nitrate, Potassium Nitrate, and Sulfur

, dated March 17, 2008 and the Sodium Nitrate (076104) and Potassium Nitrate (076103).

Human Health Assessment Problem Formulation Document in Support of Registration

Review

, dated March 6, 2008

. The Agency received no comments concerning the Inorganic Nitrate/Nitrite Summary Document

.

• August 2 1 , 2008

– The Agency published the Inorganic N itrate / N

itrite Final Work Plan

, dated August 19, 2008 which stated that the Agency would conduct a comprehensive ecological risk assessment that included an endangered species risk assessment, and that

EPA would not conduct a human health risk assessment for registration review

. The Inorganic N itrate /Nitrite Final Work Plan also concluded that the Agency would not require additional human health or environmental fate and effects data.

• April 8, 2010

– The Agency initiated informal consultation under the Endangered Species Act (ESA) section 7(a)(2) with the U .S. Fish and Wildlife Service (FWS) for the gas cartridge uses of sulfur, carbon and inorganic nitrate.

• May 26, 2010

– The Agency published the draft Registration Review Ecological Risk Assessment and Effects Determinations

, Carbon, Carbon Dioxide, Sawdust, Sodium Nitrate, Potassium Nitrate and Sulfur Gas Cartridges

, dated March 30, 2010 for a 60

- day public comment period. During that time, one comment was received from U.S. Fish and Wildlife Service ( FWS ) Region 4

. EPA made a “May Affect and Likely to Adversely

Affect (LAA) ” determination for federally listed terrestrial mammals, terrestrial birds,

and terrestrial invertebrates and a likely to modify determination for designated critical

habitats

. EPA also concluded “No Effect” for aquatic species given the expected lack of

exposure to non

- target taxa ( EPA

- HQ

- 2010

- 0434; FRL

– 8 826

– 6 )

.

• December 17 , 2010

– The Agency published the EFED Response to Comments for Registration Review for Carbon, Nitrates, an d Sulfur Gas Cartridges , dated October 20,

2010 and Input for Mitigation Options for Endangered and Threatened Species Identified in EFED’s Carbon, Nitrates, and Sulfur Gas Cartridges Registration Review Ecological Risk Assessment and Effects Determination , dated November 16 , 2010

. This document responded to comments received c on cerning the draft ecological risk assessment.

• July 16, 2012

– The Agency provided an Addendum to the e nvironmental f ate and Ecological Risk Assessment for Carbon Dioxide and for Carbon, Sawdust, Sodium
Nitrate, Potassium Nitrate and Sulfur Containing Cartridges

. This document updated

EPA’s list of threatened and endangered species with “ LAA ” determinations as a result of direct effects from gas cartridge use. The document also ou tlined potential mitigation

that , if adopted by the registrants

, would result in changing the determination to “ No

Effect ” for certain species.

• June 28 , 2013

– The Agency finalized the Revision to the Environmental Fate and Ecological Risk Assessment for Carbon Dioxide and for Carbon, Sawdust, SodiumInorganic nitrates Case 4052 Doc ket Number EPA

- HQ

- OPP

- 2007

- 1118 Interim Registration Review Decision www.regulations.gov Pesticide Re

- evaluation Division

6 Nitrate, Potassium Nitrate and Sulfur Containing Cartridges

. This document provides an updated list of potentially affected species and additional mitigation options.

• June 4

, 2014

– The Agency published the Inorganic Nitrate/Nitrite Proposed Interim Registration Review Decision , dated May 30

, 2014 in docket number EPA

- HQ

- OPP

2007

- 1118 for a 60

- day public comment period. Comments were received from the Center for Biological Diversity, Defenders of Wildlife, the California Department of Pesticide Regulation, the USDA Animal and Plant Health Inspection Service (APHIS), and the Agricultura l Commissioner of San Luis Obispo County, California.

• September 2015

– The Agency is publishing the Inorganic Nitrate/Nitrite Interim Registration Review Decision and the Response to Public Comments on the Registration Review Proposed Interim Decisions fo r Gas Cartridge s

For further information on s odium and potassium nitrate

, additional documents can be

found in EPA ’s public docket (EPA

- HQ

- OPP

- 2007

- 1118 ) at www.regulations.gov

.

I. RESPONSE TO COMMENTS

Below is a summary of the primary comments and Agency responses on the Proposed

Interim Registration Review Decision for Sodium and P otassium N itrate

. A more detailed summary of comments on the Proposed Interim Registration Review Decision for sodium and potassium n itrate and the Agency’s response can be found in the Response to Public Comments on the Registration Review Proposed Interim Decisions for Gas Cartridge in EPA’s public

docket for EPA’s public docket for sodium and potassium nitrate (EPA

- HQ

- OPP

- 2007

- 1118) at www.regulations.gov

.

In the Proposed Interim Registration Review Decision for Sodium and Potassium Nitrate

, the Agency proposed the use of the Bulletin s Live! 1 internet application for endangered species risk mitigation for gas cartridges, which would have resulted in the Agency making a “No Effect” determination on 11 listed species by prohibiting the use of all gas cartridges within the geographic range of the followin g species:

1. Carolina northern flying squirrel

2. Coachella Valley fringe

- toed lizard

3. Desert slender salamander

4. Gopher tortoise

5. Hualapai Mexican vole

6. Morro Bay kangaroo rat

7. Mount Graham red squirrel

8. San Miguel Island fox

9. Santa Cruz Island fox

10. Santa Rosa Island fox

11. Utah prairie dog

1 When the Proposed Interim Registration Review Decision for potassium and sodium nitrates was issued, the first

version of Bulletins Live! was available. However, an updated version, Bulletins Live! Two, is now available at http://www.epa.gov/espp/bulletins.htm

.Inorganic nitrates Case 4052 Doc ket Number EPA

- HQ

- OPP

- 2007

- 1118 Interim Registration Review Decision www.regulations.gov Pesticide Re

- evaluation Division

7 The Agency had also proposed to work with USDA/APHIS to split their gas cartridge registrations into separate sub

- labels. One sub

- label would be for USDA/APHIS Wildlife Services use only, and would not restrict use to target species o nly. The other sub

- label would be for consumer use and would restrict use to target species only.

The comments received by the Center for Biological Diversity and Defenders of Wildlife did not result in any changes to the proposed mitigation. However, the comments received by the California Department of Pesticide Regulation (CDPR), the Agricultural Commissioner of San Luis Obispo County, California, and the USDA Animal and Plant Health Inspection Service (APHIS) did result in changes to the proposed mitig ation. Based on the public comments which are described in further detail below, EPA has decided to issue Bulletin s on 4 of the 11 species that were proposed: the g opher tortoise, Hualapai Mexican vole, Mount Graham red squirrel, and Utah prairie dog. With the exception of the Utah prairie dog, the Bulletin s will prohibit use of all gas cartridge products within the geographic range of the species. For the Utah prairie dog, the

Bulletin s will prohibit use of certain gas cartridge products within the geograp hic range of the species. There will not be a Bulletin prohibiting use of the USDA/APHIS Large Gas Cartridge product ( EPA Reg No. 56228

- 21) in the geographic range of the Utah prairie dog. Additionally, the Agency will work with USDA/APHIS to pursue separa te registrations for gas cartridge products that may be used in areas prohibited by Bulletin s if certain conditions are met. Below is a summary and brief discussion of the primary comments and Agency responses.

CDPR and the San Luis Obispo County Agricu ltural Commissioner commented that for many of the listed species identified in the assessment to be at risk in California, protective measures are currently in place. Similar to Bulletin s Live!, California noted that it has employed a publicly accessible web

- based tool ( PRESCRIBE ) to provide pesticide specific use limitations intended to protect listed species. It is important to note, however, that in general, the pesticide use limitations p rovided in PRESCRIBE are voluntary measures. Also, the mitigation

recommended in PRESCRIBE differs from what the Agency had proposed in that it recommends that “qualified individuals” who have been trained to distinguish dens and burrows of target species from those of nontarget species make the cartridge applications in listed species’ range. The Agency, on the other hand, had proposed that cartridge use be prohibited within the geographic range of the six listed species provided below. By prohibiting use in those ranges, the Agency would have been able to make a No Effect determination for these six listed species.

1. Morro Bay kangaroo rat

2. Coachella Valley fringe

- toed lizard

3. Desert slender salamander

4. Santa Rosa Island fox

5. San Miguel Island fox

6. Santa Cruz Is land fox

The Agency reviewed the existing protection measures in PRESCRIBE and considered incorporating these measures into the Agency’s Bulletin s Live! approach. Based on discussions with CDPR, the PRECRIBE measures for gas cartridges were based on an existing 1996

consultation where FWS concurred with CDPR’s “Not Likely to Adversely Affect (NLAA)”Inorganic nitrates Case 4052 Doc ket Number EPA

- HQ

- OPP

- 2007

- 1118 Interim Registration Review Decision www.regulations.gov Pesticide Re

- evaluation Division

8 determination. However, the U.S. Fish and Wildlife Serv ice (FWS) informed EPA and CDPR

that consultation would need to be re

- initiated to determine whether the existing PRESCRIBE

measures based on the 1996 c onsultation are still protective of the listed species of concern. In addition, FWS indicated that a number of species have been listed since the 1996 concurrence, and that these species would also need to be considered as part of the consultation re

- initiation. Therefore, EPA will not issue endangered species protection Bulletin s for listed species in California prior to formal Section 7 Endangered Species consultation with FWS.

USDA/APHIS also submitted a number of substantive comments to the Agency. Based upon several discussions with USDA/APHIS in August and September 2015, the Agency will work with USDA/APHIS to pursue separate registrations for gas cartridge products that may be used in areas prohibit ed by Bulletin s if:

• The products are only used by USDA/APHIS personnel, and

• USDA/APHIS has completed Section 7 consultations with the FWS on the use of these products within the specified area and follows all FWS specifications for use

.

On a September 1, 2 015 conference call, USDA/APHIS indicated that they do not believe their large gas cartridge product (Reg No. 56228

- 21) poses a risk to the Utah prairie dog because the dens or burrows of the target pes ts for that product would not likely provide habitat f or the prairie dog. Therefore, they did not agree to a Bulletin prohibiting use of the large gas cartridge in the range of the Utah prairie dog. However, EPA concluded in its 2013 revised risk assessment that exposure to the small and large gas cartridges is likely to adversely affect (LAA) the Utah prairie dog. Therefore, the Agency has decided to issue Bulletin s for the Utah prairie dog only for the small gas cartridge products (Reg. No. 9086

- 4, 73342

- 8, 4

- 463, 10551

- 1, and

56228

- 2) and to formally consul t with FWS on the risk of the large gas cartridge to the Utah prairie dog.

USDA/APHIS also commented on the use prohibitions in the geographic range of the Carolina northern flying squirrel and other species that the Agency had, at the time of the Propose d Interim Registration Review Decision for sodium and potassium nitrate , determined to be entirely within the boundaries of federal lands. USDA/APHIS declined to agree to those use prohibitions because the resolution of the geographic range maps provided b y the Agency did not allow USDA/APHIS to determine whether or not the habitat delineations were in agreement with boundaries of Federal lands. Upon further Agency review of the range for the Carolina northern flying squirrel, only 79% of the species range occurs within Federal land boundaries. As a result, the Agency is no longer proposing Bulletin s for this species prior to formal consultation.

USDA/APHIS had also requested further detail on the sub

- labeling approach that was proposed for their gas cartri dge registrations. However, after the Proposed Interim Registration Review Decision was published, the Agency discussed the feasibility of the sub

- label approach with State Lead Agencies that handle pesticide registration and enforcement, and it was

determ ined that the sub

- label approach would be difficult for the states to enforce. Instead, USDA has agreed to split the APHIS and consumer uses into their own separate registrations. Details on this approach are outlined below in the Endangered Species Risk M itigation

Measures.Inorganic nitrates Case 4052 Doc ket Number EPA

- HQ

- OPP

- 2007

- 1118 Interim Registration Review Decision www.regulations.gov Pesticide Re

- evaluation Division

9 As a result of the comments from USDA/APHIS, the Agency will not issue endangered species protection Bulletin s for the following listed species prior to formal Section 7 Endangered Species consultation with the FWS:

1. Carolina northern fl ying squirrel

2. Utah prairie dog, for USDA/APHIS large gas cartridge, EPA Reg. No. 56228

- 21

In summary, as a result of public comments received on the Proposed Interim Registration Review Decision, the Agency can no longer make a “No Effect” determination, f or all gas cartridge sizes, on the 8 species listed above (6 species as a result of comments from California and 2 species as a result of comments from USDA/APHIS) and will proceed with formal Section 7 Endangered Species consultation with the FWS for thes e and all the other listed species determined to have a potential direct or indirect risk from gas cartridge use. See Appendix A for the full list of direct effect species that will require consultation.

The Agency is making a “No Effect” determination, a nd will issue endangered species protection Bulletin s for the: g opher tortois e, Hualapai Mexican vole, Mount Graham red squirrel,

and the Utah prairie dog (all gas cartridge products except for USDA/APHIS large gas cartridge, EPA Reg. No. 56228

- 21). The Ag ency will proceed with formal Section 7 consultation with the FWS on the Utah prairie dog for the USDA/APHIS’ large gas cartridge, as described above.

I I I. SCIENTIFIC ASSESSMENT

For a full description of the Agency’s ecological assessment and human health risk

assessments , please refer to the Proposed Interim Registration Review Decision for sodium and potassium nitrate , which can be found in EPA ’s public docket (EPA

- HQ

- OPP

- 2007

- 1118 ) at www.regulations.gov

.

II. INTERIM REGISTRATION REVIEW DECISION

In accordance with 40 CFR Sections 155.56 and 155.58, the Agency is issuing this Interim Registration Review Decision. Except for the EDSP and ESA components of this case,

the Agency has made the following i nterim r egistration review d ecision: (1) no additional data are required at this time; and (2) changes to the affected registrations and their labeling are

needed at this time.

In this interim Registration Review D ecision, EPA is making no human health or

environ mental safety findings associated with the EDSP screening of sodium and potassium

nitrate , nor is it making a complete endangered species finding. The Agency’s final registration

review decision for sodium and potassium nitrate will depend upon both the re sult of the completion of an ESA Section 7 consultation with FWS , and an EDSP FFDCA section 408(p)

determination.Inorganic nitrates Case 4052 Doc ket Number EPA

- HQ

- OPP

- 2007

- 1118 Interim Registration Review Decision www.regulations.gov Pesticide Re

- evaluation Division

10 A. Human Health Risk

Based on the most recent human health risk assessments for sodium and potassium

nitrate , the Agency determined that t here are no human health risks of concern for the currently registered uses of sodium and potassium nitrate

.

B. Ecological Risk

Gas cartridge uses

EPA has determined that there is potential for adverse effects to non

- target, non

- listed

terrestrial animals that inhabit burrows or dens. However, adverse effects to non

- listed terrestrial

animals from the application of the gas cartridges are localized to the application site . In addition, all gas cartridge product labels include the statement, “Check all burrows for signs of

non

- target species. If present, do not treat burrows.” This statement limits the potential for

exposure. The combination of the lo calization of adverse impacts as well as the protective label language for non

- target species leads EPA to conclude that exposure to non

- target, non

- listed terrestrial animals is expected to impact only a small number of non

- target organisms , if any

. For

t he ecological risk assessment, the Agency reviewed available ecological incident data and found that there were no reported ecological incidents attributed to gas cartridge use.

In the Proposed Interim Registration Review Decision for S odium and Po tassiu m N itrate

, it was explained that EPA had determined that the use of gas cartridge products containing potassium and sodium nitrate , carbon and carbon dioxide, and in some gas cartridge products,

sulfur

, is LAA 56 listed species. 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.

Through the risk mitigation measures described below, the Agency will be able to change

the LAA determination to “No Effect” for a number of species.

Given the high benefit s of gas cartridge use, as summarized in the Proposed Interim

Decision for S odium and P otassium N itrate , and low risks, the Agency concludes that the gas cartridge uses of sodium and potassium nitrate will not pose unreasonable risk to non

- target
terrestrial invertebrate species and terrestrial plant species . No mitigation measures are required

to address risk to non

- target non

- listed species. However, to address risk to threatened and endangered species, the gas cartridge registrants have agreed to the mitigation measures

described below.

Endangered Species Risk Mitigation Measures

In developing the Proposed Interim Registration Review Decision, the Agency considered a number of mitigation measures that would re duce risk to many listed species from gas cartridge use. For additional information on the proposed mitigation measures, please refer to the June 28, 2013, Revision to the Environmental Fate and Ecological Risk Assessment for Carbon Dioxide and for Carbon, Sawdust, Sodium Nitrate, Potassium Nitrate and SulfurInorganic nitrates Case 4052 Doc ket Number EPA

- HQ

- OPP

- 2007

- 1118 Interim Registration Review Decision www.regulations.gov Pesticide Re

- evaluation Division

11 Containing Cartridges , available in the public docket ( EPA

- HQ

- OPP

- 2007

- 1118 ) at www.regulations.gov

.

In this Interim Registration Review Decision, the Agency is outlining the approach it is taking in regards to endangered species risk. This approach is a result of both the public comment period on the Proposed Interim Registration Review Decision as well as subsequent

discussions with CDPR, FWS, and USDA/APHIS personnel on the feasibility of proposed EPA mitigations measures.

Bulletin s Live!

Most of the mitigation measures outlined in the P roposed I nterim Registration Review

D ecision relied on the use of the Bulletin s Live! Two as a means to geographically represent certain areas where gas cartridge use would be prohibited. Prohibition of gas cartridge use in the range of listed burrowing species for which an LAA determination was initially concluded allows EPA to change this determination to “No Effect” det ermination for those listed species

. The registrants agreed to include language on their gas cartridge product labels that would require users to check the Bulletin s Live! website before making an application. The Agency initially proposed to issue Bulleti n s in Bulletin s Live! for the following 11 listed species:

1. Carolina northern flying squirrel (NC, TN, VA)

2. Coachella Valley fringe

- toed lizard (CA)

3. Desert slender salamander (CA)

4. Gopher tortoise (AL, LA, MS)

5. Hualapai Mexican vole (AZ)

6. Morro Bay kangaroo rat (CA)

7. Mount Graham red squirrel (AZ)

8. San Miguel Island fox (CA)

9. Santa Cruz Island fox (CA)

10. Santa Rosa Island fox (CA)

11. Utah prairie dog (UT)

As described above in the Response to Comments section, several comments resulted in changes to the Agency’s p roposed plan

. The Agency will use Bulletin s Live! Two to issue geographic restrictions for gas cartridge use via a requirement on the product label check the

website prior to application. Based on the comments on the P roposed Interim Decision and subsequen t dialogue with FWS and registrants including USDA/ APHIS, EPA will issue final

Bulletin s for the following listed species:

1. Gopher tortoise (AL, LA, MS)

2. Hualapai Mexican vole (AZ)

3. Mount Graham red squirrel (AZ)

4. Utah prairie dog (UT) ( Bulletin s on Reg. Nos. 9086

- 4

, 73342

- 8

, 4

- 463

, 10551

- 1

, and 56228

- 2 only)Inorganic nitrates Case 4052 Doc ket Number EPA

- HQ

- OPP

- 2007

- 1118 Interim Registration Review Decision www.regulations.gov Pesticide Re

- evaluation Division

12 At this time, the Agency no longer plans to issue Bulletin s for the following species at
this time and will instead consult with FWS :

• Coachella Valley fringe

- toed lizard, Desert slender salamander, Morro Bay kangaroo rat, San Miguel Island fox, Santa Cruz Island fox, and the Santa Rosa

Island fox

, due to comments from CDPR and the San Luis Obispo County Agricultural Commissioner

• Carolina northern flying squirrel, due to comments from USDA /APHIS

• Utah prairie dog Bulletin s for USDA’s Large Gas Cartridge product (Reg. No.

56228

- 21 ), due to comments from USDA /APHIS

The Bulletin for each gas cartridge product, except for the gas cartridge products registered by USDA for USDA/APHIS Wildlife Service us e only, will contain the following language:

• “ Use of gas cartridges (containing some or all of the following active ingredients: carbon dioxide, carbon, sodium nitrate, potassium nitrate, and sulfur) is prohibited

in this area. ”

For the USDA gas cartridge products registered by USDA for USDA/APHIS Wildlife Service use only, the Bulletin will contain the following language:

• “ Use of the gas cartridge products by USDA/APHIS personnel is prohibited in this area, unless USDA/APHIS has consulted with the U.S. FW S on the use

of these products within the specified area and follows all U.S. FWS specifications for use. ”

Separation of Uses of the USDA/ APHIS Gas Cartridge Products

In the Proposed Interim Registration Review Decision , the Agency proposed the creatio n of sub

- labels for USDA’s gas cartridge registrations, EPA Reg. Nos. 56228

- 2 (“Gas Cartridge”)

and 56228

- 21 (“Large Gas Cartridge”). One sub

- label would b e intended for use only by

USDA/ APHIS Wildlife Services’ personnel and one sub

- label would be i ntended for consumer use, including homeowners . The USDA/ APHIS Wildlife Services’ product label would not be restricted to target species only. The consumer use sub

- label would restrict use of the product to only target species, which allows EPA to make a “no effect” determination on 7 listed species, but only for the consumer use products. The other gas cartridge product labels already include this restriction. Since the Wildlife Services’ use product will not have a target species only restriction, EPA wi ll make an NLAA determination for those 7 species and seek concurrence on that finding from FWS. See Appendix B below for a list of species for which EPA found a

NLAA

.

After the Proposed Interim Registration Review Decision was published, the Agency

disc ussed the feasibility of the sub

- label approach with State Lead Agencies that handle pesticide registration and enforcement, and it was determined that the sub

- label approach would be difficult for the states to enforce. Instead, USDA has agreed to split t he APHIS and consumer uses into their own separate registrations. This will result in a total of four APHIS gas cartridge registrations:Inorganic nitrates Case 4052 Doc ket Number EPA

- HQ

- OPP

- 2007

- 1118 Interim Registration Review Decision www.regulations.gov Pesticide Re

- evaluation Division

13 1) “Large Gas Cartridge” for APHIS use 2) “Large Gas Cartridge” for consumer use 3) “G as Cartridge” for APHIS use 4) “G as Cartridge” for consumer use

APHIS has agreed to amend their existing registrations, 56228

- 2 (“Gas Cartridge”) and

56228

- 21 (“Large Gas Cartridge”), to make them for APHIS use only. They will submit applications for new registration numbers for their c onsumer use products.

C. Final Registration Review Decision

The Agency expects to issue a final decision on the sodium and potassium nitrates registration review case after both (1) conclusion of ESA Section 7 consultation with the FWS and (2) an EDSP FFDCA section 408(p) determination has been made.

D. Implementation of Mitigation Measures

Once this Interim Registration Review Decision is issued, USDA/ APHIS has agreed to amend existing registrations for USDA/APHIS Wildlife Service use and submit new ap plications for consumer use. All of the registrants will add the link to Bulletin s Live! Two and accompanying label language to their product labels. Additionally, registrants will amend their

labels to require use on target species only (except for the USDA/ APHIS use only products). The registrants will submit proposed amendments to their existing product labels and appl ications for new products (USDA/ APHIS) to the Agency for approval within 60 days of issuance of the Interim Registration Review Dec ision.

E. ESA Section 7 Consultation with the U.S. Fish and Wildlife Service

Under Section 7 of the ESA, EPA is required to consult with the relevant federal agency when it determines that the registered uses may affect listed species (or any designated c ritical habitat for those species). The latest revision to the gas cartridge risk assessment ( Revision to the Environmental Fate and Ecological Risk Assessment for Carbon Dioxide and for Carbon, Sawdust, Sodium Nitrate, Potassium Nitrate and Sulfur Contain ing Cartridges

, dated June 28,

2013 ) provides a list of the threatened and endangered species that may be affected by the use of gas cartridges. Through the risk mitigation measures described above, the Agency was able to change the effects determination o f a few species (see above, Section IV, Endangered Species Risk Mitigation Measures ). For those species specified in Section IV above where the effects determination was changed to No Effect , this will result in the Agency no longer having to seek

formal S ection 7 consultation with FWS. See Appendix B for a list of those species where an acceptable mitigation solution has been /will be implemented on the product labels that allows

EPA to make either a “no effect” or NLAA determination. The species with an NL AA determination, as well as the list of species in Appendix A, will require consultation with FWS.

The Agency intends to initiate formal Section 7 Endangered Species consultation with the FWS following issuance of this Interim Registration Review Decision

.14 Appendix A: Listed Non

- Target Species Subject to Section 7 Consultation with Fish and

Wildlife Service

No. Species Common Name Scientific Name

1 Alabama Beach Mouse Peromyscus polionotus ammobates

2 Alameda Whipsnake Masticophis lateralis euryxanthus

3 Amargosa Vole Microtus californicus scirpensis

4 Anastasia Island Beach Mouse Peromyscus polionotus phasma

5 Arroyo Southwestern Toad Bufo californicus (=microscaphus)

6 Black

- footed Ferret, Endangered Mustela nigripes

7 Blunt

- nosed Leopard Lizard Gambelia silus

8 Bog Turtle Clemmys muhlenbergii

9 Buena Vista Lake Ornate Shrew Sorex ornatus relictus

10 California Red

- legged Frog Rana draytonii

11 California Tiger Salamander (Santa Barbara DPS) Ambystoma californiense

12 California Tiger Salamander ( Central Valley DPS) Ambystoma californiense

13 California Tiger Salamander (Sonoma DPS) Ambystoma californiense

14 Carolina Northern Flying Squirrel Glaucomys sabrinus coloratus

15 Choctawhatchee Beach Mouse Peromyscus polionotus allophrys

16 Coachella Valley Fringe

- toed Lizard Uma inornata

17 Copperbelly Water Snake Nerodia erythrogaster neglecta

18 Desert Slender Salamander Batrachoseps aridus

19 Desert Tortoise Gopherus agassizii

20 Eastern Indigo Snake Drymarchon corais couperi

21 Fresno Kangaroo Rat Dipodomys nitratoides exilis

22 Giant Garter Snake Thamnophis gigas

23 Giant Kangaroo Rat Dipodomys ingens

24 Gray Wolf Canis lupus

25 Houston Toad Bufo houstonensis

26 Key Largo Woodrat Neotoma floridana smalli

27 Mississippi Gopher Frog Rana capito sevosa

28 Morro Bay Kangaroo Rat Dipodomys heermanni morroensis

29 Northern Idaho Ground Squirrel Spermophilus brunneus brunneus

30 Pacific Pocket Mouse Perognathus longimembris pacificus

31 Perdido Key Beach Mouse Peromyscus polionotus trissyllepsis

32 Petrel, Hawaiian dark

- rumped Pterodroma phaeopygia sandwichensis

33 Point Arena Mountain Beaver Aplodontia rufa nigra

34 Pygmy Rabbit Brachylagus idahoensis

35 Red Wolf

- Endangered Canus rufus

36 San Bernardino Merriams Kangaroo

Rat Dipodomys merriami

37 San Francisco Garter Snake Thamnophis sirtalis tetrataenia

38 San Joaquin Kit Fox Vulpes macrotis mutica

39 San Miguel Island Fox Urocyon littoralis

40 Santa Catalina Island Fox Urocyon littoralis catalinae

41 Santa Cruz Island Fox Urocyon littoralis santacruzae

42 Santa Cruz Long

- toed Salamander Ambystoma macrodactylum croceum

43 Santa Rosa Island Fox Urocyon littoralis santarosae15 No. Species Common Name Scientific Name

44 Shearwater, Newell's Townsend's Puffinus auricularis newelli

45 Sonora Tiger Salamander Ambystoma tigrinum stebbinsi

46 Southeastern Beach Mouse Peromyscus polionotus niveiventris

47 St. Andrew Beach Mouse Microtus pennsylvanicus dukecampbelli

48 Stephens Kangaroo Rat Dipodomys stephensi

49 Tipton Kangaroo Rat Dipodomys nitratoides

50 Utah Prairie Dog Cynomys parvidens

51 Vole, Florida Salt Marsh Microtus pennsylvanicus dukecampbelli

52 Wyoming Toad Bufo baxteri ( hemiophrys)16 Appendix B: Listed Non

- Target Species with Changes to EPA Effect Determinations from the June 28, 2013 Revised Gas Cartridge Ecological Risk Assessment

No. Species

Common Name Scientific Name Current EPA

Effects

Determination Reason for Change

1 Alabama Beach

Mouse Peromyscus polionotus

ammobates No Effect (consumer use

products)

NLAA (APHIS use only products) See USDA/APHIS section in page 1 2 above

2 Anastasia Island

Beach Mouse Peromyscus polionotus

phasma No Effect (consumer use

products)

NLAA (APHIS use only products) See USDA/APHIS section in page 12 above

3 Bog Turtle Clemmys muhlenbergii No Effect (consumer use

products)

NLAA (APHIS use only products) See USDA/APHIS section in page 12 above

4 Choctawhatchee

Beach Mouse Peromyscus polionotus allophrys No Effect (consumer use

products)

NLAA (APHIS use only products) See USDA/APHIS section in page 12 above

5 Gopher Tortoise Gopherus polyphemus No Effect Changed from LAA to No Effect due to risk mitigation measures.

6 Hualapai

Mexican Vole Microtus

mexicanus hualpaiensis No Effect Changed from LAA to No Effect due to risk mitigation measures.

7 Island Night

Lizard Xantusia

riversiana N/A Effects determination no longer needed. Species was delisted from the Federal List of Endangered and Threatend Animals on April 1, 2014 due to recovery

. 8 Mount Graham Red Squirrel Tamiasciurus

hudsonicus grahamensis No Effect Changed from LAA to No Effect due to risk mitigation measures.

9 Perdido Key

Beach Mouse Peromyscus polionotus trissyllepsis No Effect (consumer use

products)

NLAA (APHIS use only products) See USDA/APHIS section in page 12 above17 10 Southeastern

Beach Mouse Peromyscus polionotus

niveiventris No Effect (consumer use

products)

NLAA (APHIS use only products) See USDA/APHIS section in page 12 above

11 St. Andrew

Beach Mouse Microtus pennsylvanicus dukecampbelli No Effect (consumer use

products)

NLAA (APHIS use only products) See USDA/APHIS section in page 12 above

12 Utah Prairie Dog Cynomys parvidens No Effect (small gas cartridges) Changed from LAA to No Effect due to risk mitigation measures on small gas cartridge products. Effects determination of USDA’s Large Gas Cartridge product remains LAA for

the Utah Prairie Dog

.18 Appendix C: Gas Cartridge Label Table for All Gas Cartridge Products

Description Amended Labeling Language for Gas Cartridge Use Products Placement on Label

Language to restrict use to target species only “Only use for sites, pests, and application methods specified on this labeling.”

[ Exception: For the USDA /APHIS gas cartridge p roduct s for USDA/APHIS Wildlife Services use only, this language is not required.] Directions for Use

After statement about reading entire labeling and insert.

Language to restrict use to target species only “This product may only be used to

control [insert pests and sites ]...”

[ Exception: For the USDA /APHIS gas cartridge p roduct s for USDA/APHIS Wildlife Services use only, this language is not required.] Directions for Use

Under “Use Restrictions”

Endangered Species

considerations “ Endangered Species: It is a Federal offense to use any pesticide in a

manner that results i n the death of an endangered species. Use of this product may pose a hazard to endangered or threatened species. When using this product, you must

follow the measures contained in the Endangered Species Protection

Bulletin for the area in which you are

app lying the product. To obtain

Bulletin s, no more than six months before using this product, consult http://www.epa.gov/espp/ or call 1

- 800

- 447

- 3813. You must use the

Bulletin valid for the month in which you will apply the product.” Directions for Use

Under “Use Restrictions”

Endangered species

considerations “It is a Federal offense to use any pesticide in a manner that results in the death of an endangered species. See

the Endangered Species section in the

Directions for Use section of this labeling.” Environmental Hazards section

Endangered species

considerations Remove references to the Gopher Tortoise, Hualapai Mexican Vole, and

the Utah Prarie Dog

.

[ Exception: For the USDA Large Gas Cartridge product (Reg No. 56228

- 21),

do not remove the referen ce to the Utah Prarie Dog.] Endangered Species

Considerations Section19 Appendix D: Geographic Range s Maps for Species with Planned Bulletin s

Figure 1 . Geographic Range of Bulletin s for the Mt. Graham red squirrel20 Figure 2 . Geographic Range of the Bulletin s for the Utah prairie dog21 Figure 3

. Geographic Range of Bulletin s for the Hualapai Mexican vole22 Figure 4

. Geographic Range of Bulletin s for the gopher tortoise