Docket Number EPA

- HQ

- OPP

- 2014

- 0655 www.regulations.gov

2Docket Number EPA

- HQ

- OPP

- 2014

- 0655 www.regulations.gov

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 Jacqueline Hardy Rose Kyprianou

Office of General Counsel Philip RossDocket Number EPA

- HQ

- OPP

- 2014

- 0655 www.regulations.gov

4 

### 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 Interim Registration Review Decision

................................ ................................ ................ 10 Next Steps and Timeline

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

Appendix A T oxicology Profile

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

List of Tables Table 1

– Chemical Fact s for Sodium Fluoride

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

– Registration Review Schedule for Sodium Fluoride

................................ .................. 11Docket Number EPA

- HQ

- OPP

- 2014

- 0655 www.regulations.gov

5 

## Introduction

This document is the Environmental Protection Agency’s (EPA or “ the a gency ” ) Interim Registration Review Decision for s odium fluoride (NaF)

. It is being issued pursuant to 40 CFR Sections 155.56 and 155.58. 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 n interim registration review decision before completing a registration review. Among other things, the interim registration review decision may require new risk mitigation measures, impose risk mitigation measures, identify data or information required to complete the review, and include schedules for submitting the required data, conducting the new risk assessment and completing the registration review.

The Proposed Interim Registration Review Decision for sodium fluoride was issued for public comment on December 24, 2014 and closed on February 23, 2015. During the 60

- day public comment period, no comments were received concerning registration review of NaF

. As a result, no change s were made to the document.

Sodium fluoride is registered for use as a wood preservative to protect the groundline portion of existing wooden utility poles. It is formulated into an impregnated pole wrap material. The first product containing sodium fluoride a s an active ingredient was registered in 1964, and it has been used chiefly as a wood preservative. There is currently one technical and one end use product with sodium fluoride as an active ingredient and all other previously registered sodium fluoride pr oducts 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

- HQ

- OPP

- 20 14

- 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 Regulatory 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 will not cause unreasonable risks to human health or to the environment when used as directed on product labeling. The re gistration review program is intended to make sure that, as the ability to assess and reduce risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects to human he alth or the environment. 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 changes occur,

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

- fluorideDocket Number EPA

- HQ

- OPP

- 2014

- 0655 www.regulations.gov

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 benef its information and data as required by FIFRA. The public phase of registration review begins when the initial docket is opened for each case. The docket is the Agency’s opportunity to state what it knows about the pesticide and what additional risk anal yses 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 J acqueline Hardy

, hardy.jacqueline @epa.gov , (703) 308

- 6416



## Use/Usage Information

S odium f luoride is registered for use as a wood preservative to protect the groundline por tion of existing wooden utility poles. There is one technical (EPA Reg. No. 75341

- 19) and one end use product (EPA Reg. No. 75341

- 4)

, and they contain 97.5 and 70.6 percent sodium fluoride

, respectively . Th e product is formulated into 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.Docket Number EPA

- HQ

- OPP

- 2014

- 0655 www.regulations.gov

7 

## Recent Actions

There are no recent ac tions 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

- HQ

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 the use of NaF (see Appendix A for more information) . No additional studies are anticipated to be 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 exposure. 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 FIFRA. 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 endpoints for repeat dose dermal exposure to sodium flouride; therefore

, repeat dose dermal exposures do not need to be as sessed. 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

. The label required PPE includes elongated chemical resistant sleeves and chemical resistant gloves.

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 wrap minimizes the po tential for exposure to aerosols of sodium fluoride . Therefore, occupational and residential assessments are not required at this time.Docket Number EPA

- HQ

- OPP

- 2014

- 0655 www.regulations.gov

8 

### 7.1.5 Human Health Incidents

There are a total of two incidents listed in the OPP Incident Data System for the period from 12 /2007 , when the RED was completed, to the present (search conducted on 4/ 28/201 5 ). 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 applying the prod uct . 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 respiratory s ymptoms 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 compl ete endangered 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 backg round 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. Sodium and fluoride are present in the environmental medi a. Even if they exceed the background level from a certain use, it is a localized phenomenon as these ions do not move downward or laterally on the soil surface. As time passes, the background level is retained. 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 ingestio n is expected to have 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 applic ation. Monitoring has 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 wildlife . Sodium fluoride is practically nontoxic to birds on a dietary basis (EPA RED 2007). Although moderately toxic to small mammals on an acute

- oralDocket Number EPA

- HQ

- OPP

- 2014

- 0655 www.regulations.gov

9 basis, minimal exposure is expected based on the nature and location of the prod uct use site. Exposure of honey bees also is unlikely. Bioaccumulation is not expected.



### 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 ex pectation 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 soil 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 f ish 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 fluoride ’s practically nontoxic effects to fish, aquatic inverteb rates 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 Wildlife Services (USFWS) and NOAA’s National Marine Fisheries Se rvice (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 Ecological Incidents
There are no fish or wildlife poisoning incidents in OPP’s Incident Data System (IDS) involving NaF as of April 201 5

.



## 7.3 Endocrine Disruptor Screening Program (EDSP)

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse

ou tcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include en dpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecolog ical 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 s elected 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 Pr ogram (EDSP).

EPA has developed the EDSP to determine whether certain substances (including pesticideDocket Number EPA

- HQ

- OPP

- 2014

- 0655 www.regulations.gov

10 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 e ndocrine effects as the Administrator may designate.” The EDSP employs a two

- tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a
chemical substance to intera ct 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 t he 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/data call

- ins for the first group of 67 chemicals, which contains 58 pesticide active ingred ients 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 scheduled 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 screen ing battery, please visit our website. 3

3 

## Interim Registration Review Decision

In accordance with 40 CFR Sections 1 55.5 6 and 155.58, the a gency is issuing this 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 interim decision that n o additional data and no further risk assessments are required at this time

. In addition, EPA does not expect sodium fluoride to have direct or indirect adv erse 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 Ste ps and Timeline

A Federal Register N otice will announce the availability of this Interim Registration Review
Decision for sodium fluoride

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

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

.

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

- HQ

- OPPT

- 2009

- 0477

- 0074 for the final second list of chemicals.

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

- HQ

- OPP

- 2014

- 0655 www.regulations.gov

11 Table 2

– Registrat ion Review Schedule for Sodium F luori de

Anticipated Activity Target Date Completion Date

Interim Registration Review Decision and Implementation Open 60

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

- 2014 12

- 2014

Close Public Comment Period 02

- 2015 02

- 2015

Issue Interim Decision and Begin Post Decision Follow up* 06

- 2015 06

- 2015 Total (years) 1

* A final decision on the sodium fluoride registration review case, in accordance with 40 CFR Section 155.58, will occur after an EDSP FFDCA section 408(p) determination has been made.Docket Number EPA

- HQ

- OPP

- 2014

- 0655 www.regulations.gov

12 

# 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 exposur e (Toxicity Category II) and a moderate order of toxicity via the dermal and inhalation routes of exposure (Toxicity Category III). Primary eye irritation studies classify sodium fluoride as severely irritating (Toxicity Category I I ) whereas dermal irritat ion studies classify sodium fluoride as a mild or slight irritant (Toxicity Category IV). Sodium fluoride is not 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

- HQ

- OPP

- 2014

- 0655 www.regulations.gov

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

43778502 Wnorowski 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.