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3 Sodium F luoride Registration Review Team

Human Health
Jonathan Leshin Timothy Dole
Julie VanAlstine

Environmental Fate and Effects
William Erickson
S iroos Mostaghimi Najm Shamim

Risk Management
SanYvette Williams Stacey Grigsby
Julie Chao Rose Kyprianou

Office of General Counsel Philip RossDocket Number EPA

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### Table of Contents

Introduction

................................ ................................ ................................ ........................... 5 Anticipated Data Needs

................................ ................................ ................................ ........ 5 Statutory and Regulatory Authority

................................ ................................ ...................... 5
Sodium Fluoride Chemical Facts

................................ ................................ .......................... 6 Use/Usage Information

................................ ................................ ................................ ......... 6
Recent Actions

................................ ................................ ................................ ...................... 7
Scientific Assessments

................................ ................................ ................................ .......... 7
7.1 Human Health Assessment

................................ ................................ ............................. 7
7.1.1 Hazard Characterization and Risk

................................ ................................ .......... 7
7.1.2 Dietary Exposure Assessment

................................ ................................ ................. 7
7.1.3 Food Tolerances

................................ ................................ ................................ ...... 7
7.1.4 Residential and Occupational Exposure Assessment

................................ ............. 7
7.1.5 Human Health Incidents

................................ ................................ ......................... 8
7.2 Environmental Risk Assessment

................................ ................................ .................... 8
7.2.1 Environmental Fate and Exposure

................................ ................................ .......... 8
7.2.2 Ecological Risk Characterization

................................ ................................ ............ 8
7.2.3 Threatened and Endangered Species

................................ ................................ ...... 9
7.2.4 Ecological Incidents

................................ ................................ ................................ 9
7.3 Endocrine Disruptor Screening Program (EDSP)

................................ .......................... 9 Combined Preliminary Work Plan and Proposed Interim Registration Review Decision

. 10 Next Steps and Timeline

................................ ................................ ................................ ..... 10

Appendix A T oxicology Profile

................................ ................................ ............................. 12

List of Tables
Table 1

– Chemical Facts for Sodium fluoride

................................ ................................ ............. 6
Table 2

– Anticipated Combined Preliminary Work Plan and Proposed Interim Registration
Review Schedule for Sodium fluoride

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## Introduction

This document is the Environmental Protection Agency’s (EPA or “ the a gency ” ) combined Preliminary Work Plan (PWP) and Proposed Interim Registration Review Decision for s odium fluoride (NaF) and is being issued pursuant to 40 CFR Sections 155.50, 155.5 6 and 155.58. This document explains what EPA’s Office of Pesticide Programs know s about sodium fluoride, noting that no additional data nor further assessments are required, and provides an anticipated timeline for completing sodium fluoride’s review. It also includes the agency’s Proposed Interim Registration Review Decision for sodium fluoride.

A registration review decision is the a gency '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, a proposed interim registration review decision before completing a registration review. Among other things, the proposed interim registration review decision may require new risk mitigation measures, impose interim risk mitigation measures, identify data or information req uired to complete the review, and include schedules for submitting the required data, conducting the new risk assessment and completing the registration review.

Sodium fluoride is registered for use as a wood preservative to protect the groundline portio n of existing wooden utility poles. It is formulated as an impregnated pole wrap material. The first product containing sodium fluoride as an active ingredient was registered in 1964, and it has been used chiefly as a wood preservative. There is currentl y one end use product with sodium fluoride as an active ingredient and all other previously registered sodium fluoride products have
been cancelled

. The Reregistration Eligibility Decision document (RED) for sodium fluoride

was issued in 2007

. 1 D ocuments associated with this registration review can be found in docket
EPA

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- 0655 at www.regulations.gov.



## A nticipated D ata N eeds

There are no anticipated data needs to support the registration review for sodium fluoride.



## S tatutory and Regulator y Authority

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 wi ll not cause unreasonable risks to human health or to the environment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability to assess and reduce risk evolves and as policies and practices c hange, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects to human health or the environment. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration re view program, the agency periodically reevaluates pesticides to make sure that as these changes occur,

1 Located at http://www.epa.gov/oppsrrd1 / reregistration/sodium

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6 products in the marketplace can continue to be used safely. Information on this program is provided a t www 2 .epa.gov/pesticide

- reevaluation

.

The agency is implementing the registration review program pursuant to FIFRA section 3(g) and will review each registered pesticide every 15 years to determine whether it continues to meet
the FIFRA standard for registration. The regulations governing registration review begin at 40 CFR 155.40. The agency will consider benefits information and data as required by FIFRA. The public phase of registration review begins when the initial docket is opened for each ca se. The docket is the Agency’s opportunity to state what it knows about the pesticide and what additional risk analyses and data or information it believes are needed to make a registration
review decision

.


## Sodium F l u oride Chemical Facts

Sodium fluoride chemical facts are shown in Table 1 below.

Table 1

– Chemical Facts for Sodium F luoride

Chemical Name Sodium fluoride Pesticide type Wood preservative

Case 3132

Chemical Classification Inorganic, ionic

PC Code 075202

CAS Number 7681

- 49

- 4 Year first registered 1964 Reregistration Eligibility Decision (RED) 2007

Dual use Antimicrobial use only

40 CFR Citation There are no registered food/feed uses and no established tolerances
for NaF
Antimicrobials Division, Chemical Review Manager SanYvette Williams, williams.sanyvette@epa.gov , (703)305

- 7702

Antimicrobials Division, Product Manager Julie Chao (acting), chao.julie@epa.gov

, (703)305

- 6411



## Use/Usage Information

Sodium fluoride is registered for use as a wood preservative to protect the groundline portion of existing wooden utility poles. There is one end use product (EPA Reg. No. 75341

- 4)

, and it contains 70.6 percent sodium fluoride. This product is formulated as an impregnated pole wrap
material. T he pole wrap is placed around a 20 inch deep excavated section of the pole and stapled or tacked to the pole, and the earth is replaced to two inches above the original groundline

. Also, there is no usage information available in the Kline Biocides Report based on a search conducted on November 24, 2014.Docket Number EPA

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## Recent Actions

There are no pending regulatory actions for sodium fluoride.



## Scientific Assessments

The agency’s human health and environmental fate and ecological risk assessments for sodium
fluoride which were conducted for the 2007 RED can be found in the public docket EPA

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OPP

- 20 07

- 0 833 at www.regulations .gov.



## 7.1 Human Health Assessment

7.1.1 Hazard Characterization and Risk

The toxicological database is considered adequate for character izing hazard and assessing risk
fro m this use of NaF (see Appendix A for more information) . No additional studies are anticipated to b e needed for registration review.



### 7.1.2 Dietary Exposure Assessment

The only FIFRA

- registered use of sodium fluoride is as a wood preservative (utility pole wrap).
Th is use is not expected to result in direct or indirect dietary (food) or drinking water exposu re. Although sodium fluoride has been cleared by FDA as an indirect food additive for use as a bonding agent for aluminum foil, stabilizer, or preservative , a dietary assessment is not required since this use pattern does not have a registration under FIF RA. A drinking water assessment is not required at this time.

7.1.3 

### Food Tolerances

There are no U

. S

. tolerances or exemptions from tolerances for sodium fluoride because there are no currently registered uses under FIFRA for this active ingredient associated with food or feed.



### 7.1.4 Residential and Occupational Exposure Assessment

There are no toxicological e ndpoints for repeat dose dermal exposure to sodium flouride;
therefore

, repeat dose dermal exposures do not need to be assessed. Although there is a hazard from acute dermal exposure due to the corrosive nature of sodium flouride, this hazard is
minimized by the formulation as a wrap and the label

- required PPE. Because sodium flouride is of low volatility, inhalation exposures to sodium fl u oride gas or vapor are anticipated to be
minimal and do not need to be assessed. In addition

, the formulation as a wr ap minimizes the potential for exposure to aerosols of sodium fluoride . Therefore, occupational and residential assessments are not required at this time.Docket Number EPA

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### 7.1.5 Human Health Incidents

There are a total of two incidents listed in the OPP Incident Data System for the period 12/2007

, when the RED was completed, to the present (search conducted on 8/28/2014). Both of these
incidents are rated a s minor. The two incidents are described below:

 In 201 0

, a worker experienced quarter sized burns on his forearms after app lying the product . This product also contained creosote and sodium dichromate and was ca ncelled
in 2004

.

 In 2012, a worker experienced respiratory symptoms after installing a pole wrap product. No other information was given

, and it was not clear how whether t hese symptoms were associated with the product given the low volatility of sodium flouride and the low potential for aerosol release from the pole wrap.



## 7.2 Environmental Risk Asse ss ment

The agency has not previously conducted a risk assessment that supports a complete end angered species determination for sodium fluoride.



### 7.2.1 Environmental Fate and Exposure

Sodium fluoride is an in organic substance which does not undergo hydrolysis but is water
soluble an d dissociates in water to Na and F ions (EPA RED 2007). Sodium fluoride does not adversely affect soil biomass, microflora and macro invertebrates, and is not expected to be bio

accumulative. A field monitoring study of sodium fluoride treated poles found that sodium and
fluoride ions occasionally ex ceed backgroun d levels but do not appear to migrate outward from treated poles more than 10 cm or more than 50 cm deep. Sodium flouride levels returned to background levels by the end of the 18 month study. Therefore, s odium fluoride is not expected to pose a hazard to groundwater or surface waters.



### 7.2.2 Ecological Risk Characterization

Considering the lack of any acute toxic ity to fish and aquatic invertebrates (EPA RED 2007) , any potential exposure to sodium fluoride through direct contact or ingestion is expected to hav e negligible toxicological ef fects. Sodium fluoride is not expected to move from the base of treated poles into surface waters, because the product is a wrap applied undergroun d and the base of the pole is covered with soil after application. Monitoring h as shown that any sodium fluoride leached from poles remains in the soil near the pole and rapidly dissociates into Na and F ions.

T he amount of dissolved residues in aquatic environments is expected to be negligible, far below levels that might be toxic to aquatic organisms . Therefore, exposure of aquatic plants and chronic exposure of fish and aquatic invertebrates is not expected.

The use of sodium fluoride as an underground pole wrap is not expected to result in any significant risk to terrestrial wil dlife . Sodium fluoride is practically nontoxic to birds on a dietary basis (EPA RED 2007). Although moderately toxic to small mammals on an acute

- oral basis, minimal exposure is expected based on the nature and location of the product use site. Exposure of honey bees also is unlikely . Bioaccumulation is not expected.Docket Number EPA

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### 7.2.3 Threatened and Endangered Species

Although a risk assessment has not been previously conducted to support a complete endangered species determination, t here is n o expectation for the registered use of the sodium fluoride wood

preservative wrap to cause direct or indirect adverse effects to threatened and endangered species . Also, n o adverse modification of any designated critical habitat for such species is

exp ected from the use of sodium fluoride as a utility pole wrap

. Exposure of terrestrial species is unlikely, because the product is a wrap applied underground to the base of poles that are covered by soi l after application. Aquatic species are also unlikely to be exposed, because sodium fluoride remains near the base of poles, rapidly dissociates into F and Na ions, and is unlikely to runoff or leach from the target application site into non

- target areas

.

Furthermore, sodium fluoride is practically nontoxic to fish and aquatic invertebrates, is practically nontoxic to birds when administered in their diet, and is not expected to
bioaccumulate

.

Based on both the lack of potential exposure and sodium fluo ride ’s practically nontoxic effects to fish, aquatic invertebrates and birds, the agency has made a “no effect ” (NE) determination for federally listed species and designated critical habitats and has concluded that consultation with
the U.S. Fish and Wild life Services (USFWS) and NOAA’s National Marine Fisheries Service (NMFS) is not required under the E ndangered S pecies A ct (ESA) section 7(a) 2. EPA anticipates conducting no further analysis of potential risks to endangered or threatened species

.



### 7.2.4 Ecolo gical Incidents

There are no fish or wildlife poisoning incidents in OPP’s Incident Data System (IDS) involving NaF as of September 2014.



## 7.3 Endocrine Disruptor Screening Program (EDSP)

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxici ty, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturati on, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups. As part of its 2007 reregistration decision for sodium fluoride , EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database . However, as required by FFDCA section 408(p), sodium fluoride is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two

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10 determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to
interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine

- related effects caused by the substance, and
establish a dose

- response relationship between the dose and the E, A, or T effect.

U nder FFDCA section 408(p), the a gency must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/d ata call

- ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and nine inert ingredients. A second list of chemicals identified for EDSP screening was published on June 14, 2013

2 2 and includes some pesticides schedule d for registration review and chemicals found in water

. Neither of these lists should be construed as a list of known or likely endocrine disruptors.

For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our
website. 3

3 

## Combined Preliminary Work Plan and Pr oposed Interim Registration Review Decision

In accordance with 40 CFR Sections 1550.50, 155.5 6 and 155.58, the a gency is issuing this

c ombined Preliminary Work Plan and Proposed Interim Registration Review Decision
document. Except for the EDSP component of the sodium fluoride registration review case, t he

a gency has made the following proposed decision that n o addi tional data and no further risk

assessments are required

. In addition, EPA does not expect sodium fluoride to have direct or
indirect adverse effects to non

- listed and listed species or to adversely modify any designated critical habitat for such species and has made a “no effect” determination under the E SA for all listed species and designated cri tical habitat for such species.


## Next Steps and Timeline

A Federal Register N otice will announce the availability of this combine d Preliminary Work
Plan and Proposed Interim R egistration R eview D ecision for sodium fluoride and allow a 60

- day comment period

. If there are no significant comments or additional information submitted to the docket during the comment period that leads the a gency to change its decisi on, EPA may issue

an interim decision. The final decision on the r egistration r eview for sodium fluoride (case 3132) will occur after an EDSP FFDCA section 408(p) determination is made

. See the estimated timeline for the completion of sodium fluoride registr ation review in Table 2

.

2 See http://www.regulations.gov/#!documentDetail;D=EPA

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- 2009

- 0477

- 0074 for the final second list of
chemicals.

3 http://www.epa.gov/endo/Docket Number EPA

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11 Table 2

– Anticipated Combined Preliminary Work Plan and Proposed Interim Registrat ion Review Schedule for Sodium F luoride

Anticipated Activity Target Date* Completion Date Combined Preliminary Work Plan and Interim Registration Review Decision and Implementation Open 60

- Day Public Comment Period for Combined Preliminary
Work Plan and Proposed Interim Decision 12

- 2014

Close Public Comment Period 02

- 2015

Issue Interim Decision 06

- 2015 Begin Post Decision Follow up 2 015 Total (years) 1

* The anticipated schedule will be revised as necessary ( e.g ., need arising under the Endocrine Disruptor Screening Program with respect to the active ingredients in this case).Docket Number EPA

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# Appendix A T oxicology Profile

Acute Toxicity for Product Labeling

The acute toxicity database for sodium fluoride is considered complete. Sodium fluoride has a high order of toxicity via the oral route of exposure (Toxicity Category II) and a moderate order of toxicity via the dermal and inhalation routes of exposure (To xicity Category III). Primary eye irritation studies classify sodium fluoride as severely irritating (Toxicity Category I I ) whereas dermal irritation studies classify sodium fluoride as a mild or slight irritant (Toxicity Category IV). Sodium fluoride is n ot a dermal sensitizer.

Table A1

– Acute Toxicity Studies for Sodium Fluoride

Guideline No./ Study Type MRID No. Results Toxicity Category

870.1100/ Acute oral toxicity 43778501 LD 50 (combined) = 105 (93

- 119 CL)

Male LD 50 = 120 mg/kg

Female LD 50 = 89 mg/kg I I

870.1200/ Acute dermal toxicity 43778502 LD 50 > 2000 mg/kg III

870.1300/ Acute inhalation toxicity 43778503 LC 50 = 1.00 mg/L III

870.2400/ Acute eye irritation 43778504 Severely irritating to unwashed eyes I I

870.2500/
Acute dermal irritation 43778505 Slightly Irritating I V

870.2600/
Skin sensitization 43778506
40866801 Buehler: Not a skin sensitizer

Not a dermal sensitizer No

No subchronic or chronic toxicological endpoints have been selected for the use of sodium fluoride as an impregnated pole wrap due to the determination of no exposure.Docket Number EPA

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13 Acute Tox icity References

40866801 Siglin, J. (1988). Delayed Contact Hypersensitivity Study in Guinea Pigs

with Patox

- Lite: Final Report: SLS Study No. 3191.8. Unpublished study prepared by Springborn Life Sciences, Inc. 24 p.

43778501 Wnorowski G. (1995). Acute Oral Toxicity Defined LD50 (in Rats):

Composite NaF: Lab Project Number: 3719:P320. Unpublished study prepared by Product Safety Labs. 28 p.

43778502 Wno rowski G. (1995). Acute Dermal Toxicity Limit test (in Rats):

Composite NaF: Lab Project Number: 3722:P322. Unpublished study prepared by Product Safety Labs. 15 p.

43778503 Wnorowski, G. (1995). Acute Inhalation Toxicity Defined LC50 (in Rats):

Composite NaF: Lab project Number: 3724:P330. Unpublished study prepared by Product Safety Labs. 42p.

43778504 Wnorowski, G. (1995). Primary Eye Irritation (in Rabbits): Composite

NaF: Lab project Number: 3720:P324. Unpublished study prepared by product Safety Labs . 26 p.

43778505 Wnorowski, G. (1995). Primary Skin Irritation (in Rabbits): Composite

NaF: Lab Project Number: 3721: P326. Unpublished study prepared by Product Safety Labs. 16 p.

43778506 Wnorowski, G. (1995). Dermal Sensitization Test

- Buehler Method (in

Guinea Pigs): Composite NaF: Lab Project Number: 3723: P328. Unpublished study prepared by Product Safety Labs. 24 p.