Page 2 of 14

additives (21 C.F.R. § 172.665) and both are approved by the EPA as inert ingredients for food use (40 C.F.R. § 180.950 (e)) and non

- food use. Diutan, gellan and xanthan gums have similar saccharide components, differing in the specific arrangement of the polysaccharide components and saccharide units. Therefore, d ata available on polysaccharide, gellan and xanthan gums were used to fill data gaps for diutan gum.

D

- glucurono

- 6

- de oxy

- L

- manno

- D

- glucan, acetate, calcium magnesium potassium sodium salt exhibits low levels of acute toxicity. The oral LD 50 of Sprague

- Dawley rats is greater than 5 g/kg (5000 mg/kg) . The inhalation LC 50 in the rat is > 0.316 mg/L ( ~81.9 mg/kg ). It is mi nimally irritating to the rabbit eye. It is not an irritant to the rabbit skin and it was not a skin sensitizer in Dunkin

- Hartley guinea pigs.

In a 28

- day repeat dose oral toxicity (OECD Test Guideline 407) study there were no treatment

related adverse toxicological effects at doses up to 1000 mg/kg/day . The NOAEL is 1000 mg/kg/day

.

The reverse gene mutation assay with Salmonella typhimurium and Escherichia coli and a chromosome aberration test with human lymphocytes show that diutan gum is neither mutagenic nor clastogenic, respectively.

In a metabolism study in male and female rats the compound was absorbed, metabolized and excreted rapidly. The major route of excretion was the feces. There was no bioaccumulation.

No toxicological point of depa rture (toxicological endpoint) was identified due to the low levels of toxicity exhibited and due to the very large molecular weight and lack of systemic absorption of diutan gum . Quantitative assessments of exposure and risk are not necessary and have no t been conducted. The requested end

- use formulation concentration is 1.5% w/w. Exposures to humans (dermal, inhalation, oral) are expected to be low , based upon the low level of requested use and toxicological concerns are low based on the low levels of toxicity exhibited in the available toxicological studies.

Based upon the toxicity testing to fish, algae and daphnid s and based upon physical/chemical properties, the compound is not expected to present concerns for adverse environmental fate and effects

.

In view of the information summarized above and discussed in detail below, the Agency approves of the establishment of an exemption from the requirements of a tolerance for residues of D

glucurono

- 6

- deoxy

- L

- manno

- D

- glucan, acetate, calcium magnesium pot assium sodium salt (CAS Reg. No. 595585

- 15

- 2) when used as an inert ingredient in pesticides formulations under 40 CFR §180.910 (pre

- and post

- harvest application to crops) and §180.940 ( use in antimicrobial pesticide formulations ) for residues of and for the approval of non

- food use in agricultural and residential settings.Page 3 of 14

II. BACKGROUND

On 27 March 2015 the U.S. Environmental Protection Agency received a petition (IN

- 10815 from Keller and Heckman LLP (1001 G Street, N.W., Suite 500 West, Washin gton, DC 20001) on behalf of CP Kelco U.S. , Inc. (3100 Cumberland Blvd., Suite 600, Atlanta, GA 30339) to establish an exemption from the requirement of a tolerance under 40 CFR §180.910 (pre

- and post

- harvest application to crops) and §180.940 (a) (contact food surface areas) for residues of D

- glucurono

- 6

- deoxy

- L

- manno

- D

- glucan, acetate, calcium magnesium potassium sodium salt (diutan gum) (CAS Reg. No. 595585

- 15

- 2) when used as an inert ingredient (stabilizer/suspension agent) D

glucurono

- 6

- deoxy

- L

- manno

- D

- glucan, aceta te, calcium magnesium potassium sodium salt may be referred hereinafter as diutan gum. Much of the remaining discussion is taken from the various volumes (cited) of information/data submitted in support of this petition.

Diutan gum is a p olysaccharide similar to gellan gum (CAS Reg. No. 71010

- 52

- 1) and xanthan gum (CAS Reg. No. 11138

- 66

- 2). Gellan and xanthan gums are approved by the U.S. Food and Drug Administration (FDA) for use as food additives (21 C.F.R. § 172.665) and both are appro ved by the EPA as inert ingredients for food use (40 C.F.R. § 180.950 (e)) and non

- food use. Diutan, gellan and xanthan gums have similar saccharide components, differing in the specific arrangement of the polysaccharide components and saccharide units.

Diutan gum is used commercially in cementitious packaged products, oilfield spacer fluid and oilfield drilling fluids, oil drilling cement application, fire

- fighting foam application, concrete application, tire sealant products, cleaner products and coat ing products.

III. PHYSICAL/CHEMICAL PROPERTIES

Table 1.0 Physical/Chemical Properties Diutan Gum Color White to tan Physical state Powder Odor Slight odor pH Approximately neutral (1% solution) Density 1

. 4 3 kg/m 3 at 20.5 ± 0.05 ° C Partition coeff

icient Log K OW - 2.76 Water solubility Soluble, forms viscous solutions. 6.3 g/L @ pH 1 @ 20° C Vapor pressure ~0.1kPa @ 25° C Molecular formula (C 40 H 61 O 30 K) n Average Molecular Weight 5.18 Million DaltonsPage 4 of 14

Repeating Chemical Structure of Diutan Gum

IV. HAZARD CHARACTERIZATION

Limited studies are available on diuta n gum. However, diutan gum is a polysaccharide similar to gellan gum (CAS Reg. No. 71010

- 52

- 1) and xanthan gum (CAS Reg. No. 11138

- 66

- 2). Gellan and xanthan gums are ap proved by the U.S. Food and Drug Administration (FDA) for use as food additives (21 C.F.R. § 172.665) and both are approved by the EPA as inert ingredients for food use (40 C.F.R. § 180.950 (e)) and non

- food use. Diutan, gellan and xanthan gums have simil ar saccharide components, differing in the specific arrangement of the polysaccharide components and saccharide units. Therefore, data available on polysaccharide, gellan and xanthan gums were used fill data gaps for diutan gum.

Acute Oral Toxicity The o ral LD 50 in Sprague

- Dawley rats treated with “ polysaccharide gum ” (purity not specified) is greater than 5 g/kg (Baker, 1983 ; MRID 49601405 ). Six male and six female rats were treated with a single oral dose by gavage with 5000 mg/kg. All animals appeare d normal after intubation and during the two week observation period. There was no gross pathology in any animals at
necropsy.

Acute Inhalation ToxicityPage 5 of 14

Diutan gum was tested for a four

- hour acute inhalation toxicity in Sprague

- Dawley rats (5/sex) based on OECD Test Guideline 403 ( OCSPP Harmonized Test Guideline 870.1300). The concentration in air achieved 0.316 mg/L was below the nominal concentration of 4.9 mg/L. Test animals appeared normal throughout the four

- hour exposure period except for intermit tent nose rubbing which would indicate possible nasal irritation. One animal in the test group, two in the air

- exposed control group, and one in the unexposed control group exhibited a net weight loss. In the test group two animals exhibited mottled l u ng s; one animal exhibited mottled lungs w ith areas of consolidation and one anim al exhibited a mottled left kidney. All other organs and tissues appeared normal. In the ex p osed control g rou p, all organ and tissues appeared normal. In the unexposed control group, two animals exhibited mottle d lungs. All other organs and tissues appeared normal. Histopathological examination of the lungs of each group revealed some adverse effects

– focal tracheitis, small areas of interstitial pneumonia and small areas o f lymphoid interstitial infiltrates. The effects occurred in all groups however one animal in the test group also showed an area of consolidation , with lymphocytic, histiocytic and neutrophilic infiltrates and many bronchiole filled with suppurative exuda te. There were no deaths in the study. Some rats had trac h eitis and focal pneumonitis or peribronchitis. The incidence and severity of lesions does not seem to be significantly different among the test groups, the controls on arrival, those only exposed to air and unexposed controls. As a result it was concluded that the lesions were evidence of inter

- current infection not due to exposure to the test substance. The LC 50 was determined to be > 0.316 mg/L (Marrapese et al. 2015 ; Administrative volume no M RID number )

. Eye Irritation “Polysaccharide gum” (purity not specified) was used to test the potential for eye irritation in albino rabbits (Baker, 1983 ; MRID 49601405 ). One hundred mg of test material was instilled under the lower eyelid in one eye, e ach of six rabbits. The eye was allowed to close for one second, then rinsed and evaluated using the Draize method of scoring. None of the animals showed a positive reaction. The mean Draize score at 24 hours was 4.3 which indicates “minimally irritatin g” to the rabbit eye.

Skin Irritation Moreno (1984 ; MRID 49601406 ) conducted a skin irritation test on albino rabbits (strain not specified) exposed to the test substance (diutan gum purity not specified) . 7.5 g of the test article was mixed with Mazola Oil to a total volume of 15 ml (50%). The back and sides of each animal were clipped free of hair. The left side of each animal was abraded the right side remained intact. The test article was covered with 2.5 cm square gauze patches and secured with ad hesive tape. The torso was then wrapped with plastic which was secured with adhesive tape. The sites were occluded for 24 hours at which time the patches were removed. Animals were observed for skin reactions at 24 and 72 hours. Erythema and edema were scored according to the numerical Draize technique. Erythema was slight at 24 and 72 hours

. Edema was slight to moderate at 24 hours and slight at 72 hours. Mean scores for erythema and edema decreased during the study. The primary irritation index is 3.38 therefore the test article in considered a non

- irritant as defined in 40 CFR 1500.(3)(4).

Skin Sensitization Dunkin

- Hartley guinea pigs were exposed 50, 25, 10 and 5 % w/w in dried arachis oil BP respectively of test substance to two guinea pigs. E xposures were applied to the clipped flanksPage 6 of 14

under occlusive dressings for a period of 24 hr. The degree of erythema and edema was evaluated 1, 24 and 48 hours after dressing removal. The highest non

- irritant concentration of the test material and one con centration lower were selected for the main study. In the main study, 10 guinea pigs were tested and 5 served as controls. A row of three injections (0.1 ml each) was made on each side of the mid

- line into a 20 x 40 mm area. The injections were: Freund ’s Complete Adjuvant plus distilled water in the ratio of 1:1, a 5 % w/w formulation of the test material in dried arachis oil BP and a 5 % w/w formulation of the test material in a 1:1 preparation of Freund’s Complete Adjuvant plus dried arachis oil BP. The test results were that the test material produced a 0 % (0/10) sensitization rate and therefore is classified as a non

- sensitizer to the guinea pig under the conditions of this study.

Repeat Dose Toxicity A 28

- day repeated dose oral toxicity (OECD Test Guideline 407) study was conducted by Blagden, Mullee and Brooks (2001 ; MRID 49601409 ). The test material purity not specified

, maintained in sponsor files ) was administered by gavage to three groups each of five male and five female Sprague

- Dawl e y C rl:CD ® (SD) IGS BR rats for twenty eight consecutive days at dose levels of 150, 500 or 1000 mg/kg/day . A control group of five males and five females was dosed with vehicle alone (Arachis oil BP). Two recovery groups, each of five males and five females were treated with the high dose (1000 mg/kg/day ) or the vehicle alone for twenty eight consecutive days and then maintained without treatment for a further fourteen days.

Clinical signs, functional observations, bodyweight development and food and wate r consumption were monitored throughout the study. Hematology, blood chemistry and urinalysis were evaluated for all non

- recovery group animals at the end of the treatment period and for all recovery group animals at the end of the treatment free period. All animals were subjected to gross necropsy and histopathological evaluation of selected tissues.

There were no deaths during the study. There were no toxicologically significant abnormal clinical observations. There were no treatment related effect s for behavioral assessments, functional performance tests, sensory reactivity assessments, body weight development , no effect on body weight development, food or water consumption, no treatment related effects on hematology or blood chemistry, there were no treatment related effects seen in urinalysis. No treatment related effects in organ weights. No treatment related macroscopic effects seen at necropsy. No treatment related histopathological effects.

Repeated oral doses of the test material up to 10 00 mg/kg/day did not result in an y toxicologically significant changes in any of the parameters measured. The No Observed Effect Level (NOEL) was considered to be 1000 mg/kg/day

. Genetic Reverse Mutation Assay A reverse mutation assay was conducted ac cording to OECD Test Guid eline No. 471 (Thompson, 2001; MRID 49601410 ). Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 were used along with Escherichia coli strain WP2uvrA and treated with suspensions of the test material (purity not st ated) using the Ames incorporation method at five dose levels, in triplicate, both with and without metabolic activation with rat liver homogenate metabolizing system (10% liver S9 in standard co

- factors). From data in a preliminary assay, the doses chos en were 50 toPage 7 of 1 4

5000 μ g/plate. The vehicle (sterile distilled water) control plates gave counts of revertant colonies with in the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant co lonies, both with and without metabolic activation.

The test material caused no visible reduction in the growth of the bacterial background lawn at any dose level. The test material was tested up to the maximum recommended level of 5000 μ g/plate. An o paque sheen to the background lawns was observed at 5000 μ g/plate. When viewed under an inverted microscope, a very light globularity/oily appearance was noted. This did not prevent the scoring of revertant colonies.

No significant increases in the freq uency of revertant colonies were recorded for any of the bacterial strains with any dose of the test material either with or without metabolic activation. Under the conditions of this study the test material is considered to be non

- mutagenic.

Chromosome Aberration Test Wright and Jenkinson (2001 ; MRID 49601411 ) conducted a chromosome aberration test in human lymphocytes in vitro . The protocol followed the OECD Test Guideline 473. Duplicate cultures of human lymphocytes, treated with the test material w ere evaluated for chromosome aberrations at three dose levels 1250 μ g/ml, 2500 μ g/ml and 5000 μ g/ml as well as with vehicle and positive controls. Four treatment conditions were used in the study. Experiment 1, 4 hours in the presence of an induce rat l iver homogenate metabolizing system (S9 ) at a 1 % final concentration with cell harvest after a 20

- hour expression period. Experiment 1, 4

- hour expo sure in the absence of metabolic activation (S9) with a 20

- hour expression period. Experiment 2, the 4

- hou r exposure with addition of S9 was repeated (using a 2% final S9 concentration) Experiment 2, exposure time in the absence of metabolic activation was increased to 24 hours.

All vehicle (culture medium) controls gave frequencies of cells with aberration s within the range expected for normal human lymphocytes. All the positive control treatments gave statistically significant increases in the frequency of cells with aberrations indicating sati s factory performance of the test and activity of the metaboliz ing system. The test material did not induce any statistically significant increases in the frequency of cells with aberrations in either of two separate experiments, using a dose range that included a maximum concentration which was either the maximum sc orab le level of exposure or the maximum recommended dose level. The test material was shown to be non

- clastogenic to human lymphocytes in vitro

.

Metabolism A study ( OCSPP Harmonized Guideline 870.7485) was conducted to determine the absorption, tissue distribution and excretion of gellan gum (Selim, 1984 ; MRID 49601412 ). One adult male and female Sprague

- Dawley rats were orally dosed (gavage) with a single dose of 14 C and 3 H labeled gellan gum (950 or 980 mg/kg test substance purity not stated) and pl aced in Roth metabolism cages to determine respiratory levels of 14 CO 2 . An average of 0.5 % of dosed radioactivity was excreted as 14 CO 2

.Page 8 of 14

Four male rats and 4 female rats were dosed as described above and placed in metabolism cages. Urine and feces were collected for 7 days. All rats excreted almost all of the dosed radioactivity in the feces. Females excreted 86.79 % and 1.8 % of the dose 14 C in their feces and urine respectively. Males excreted 85.16 and 3.26 % of the dosed 14 C in their feces and ur ine respectively. Females excreted 4.06 % of the 3 H in their urine and 100.86 % in their feces, the males excreted 3.57 of the dosed 3 H radioactivity in their urine and 99.62 in their feces. Tissue and carcass radioactivity for 14 C averaged 3.77 % of the dose for males and 2.96 % of the dose for female rats.

Four additional male and female rats were orally dosed with ~ 1 g/kg (1000 mg/kg) of the radiolabelled gellan gum and blood samples were collected from the tail vein at different intervals. Averag e peak level of radioactivity for male and female rats was 5.5 hours and 5.25 hours respectively. The test data show most of the dosed radioactivity is excreted in the feces and that tissue levels of radioactivity at sacrifice is very low. Blood level of radioactivity is very low. Absorption via the GI tract is also low.

Neurotoxicity/Immunotoxicity

There were no neurotoxicity or immunotoxicity study data per se’. However

, the possibility for neurotoxic and immunotoxic effects w as considered. Based on the findings in the 28

- day repeat dose study and the metabolism study, there are no concerns for neurotoxicity or immunotoxicity. In the 28

- day repeat dose study t here were no toxicologically significant clinical observations

, behavioral assessments, functional performance tests or sensory reactivity assessments. There
were no treatment

- related effects regarding body weight development or food or water consumption.

Carcinogenicity

Based on the findings in the 28

- day repeat

- dose oral toxicity study a nd upon the findings in the metabolism study as well as the findings in the mutagenicity studies, the Agency believes there are no indications that indicate d

- glucurono

- 6

- deoxy

- L

- manno

- D

- glucan, acetate, calcium magnesium potassium sodium salt is a potenti al carcinogen.

V. Toxicity Endpoint Selection

There were no toxicologically adverse effects noted in the 28

- day oral feeding study (OECD Guideline 407) at doses up to and including 1000 mg/kg/day

. Diutan gum is a high molecular weight compound ( MW= 5.18 m illion dalton ) which indicates it is unlikely to be absorbed via any route of exposure (dermal, oral, inhalation) which is supported by the lack of toxicity noted in the OECD study and the metabolism study. In the metabolism study, approximately 85% of the compound was eliminated via the feces. Therefore no toxicological endpoints have been identified for risk assessment for any route of exposure.Page 9 of 14

VI. EXPOSURE

Human exposure may occur via dietary exposure from residues on crops or food handling and processing areas. Exposure could occur from use by residential pesticide handlers (applicators) and exposure could occur to persons occupationally involved in pesticide handling (mixing, loading, applying) this compound. Since no toxicological endpoi nt of concern has been identified, based on the lack of toxicological effects noted in the available studies, quantitative exposure and risk assessments are not necessary for dietary, dermal or inhalation exposure.

VII. AGGREGATE RISK

As there are no tox icological effects of concern and no toxicological endpoints have been identified for purposes of risk assessment, a quantitative aggregate risk assessment is not necessary and had not been conducted.

VIII. CUMULATIVE EXPOSURE

Cumulative effects from su bstances with a common mechanism of toxicity . Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particula r pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found D

- glucurono

- 6

- deoxy

- L

- manno

- D

- glucan, acetate, calcium magnesium potassium sodium salt to share a common mechanism of toxicity with any other substa nces, and benzyl acetate does do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that D

- glucurono

- 6

- deoxy

- L

manno

- D

- glucan, acetate, calcium magnesium potassium so dium salt does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's websi te at http://www.epa.gov/pesticides/cumulative

.

IX. ENVIRONMENTAL FATE & EFFECTS

Ready Biodegradability A study was performed to assess the ready biodegradability of the test substance (purity not stated) in an aerobic aqueous medium (Mead, 2001 ; MRID 49601413 ). The protocol followed the OECD Test Guideline No. 301B. At a concentration of 10 mg C/L (carbon/litre) was exposed to activated sewage sludge micro

- organisms with culture medium in sealed culture vessels in the dark at 21 ° C for 28 days. The degradation of the test material was assessed by the determination of the carbon dioxide produced. Control solutions with inoculum and the standard material, sodium benzoate were used for validation p urposes. The study data show 95 % degradation after 28 days and satisfied the 10

- day treatment window validation criterion whereby 60 % degradation must be attained within 10 days of the degradation rate exceeding 10 %. The test material can be considere d to be biodegradable under the terms and conditions of OECD Guideline No. 301B. The viscosity of the 25 g/L stock dispersion used to prepare the test vessels was determined in order to confirm complete hydration of the test material. The results of the viscosity analysis showed aPage 10 of 14

measure stock dispersion concentration of 101 % of the nominal value, thereby confirming complete hydration of the test material in the medium (deionized reverse osmosis water).

Toxicity to Rainbow Trout A fish acute toxicity test was conducted by Wetton and Mullee (2001 ; MRID 49601414 ) using rainbow trout ( Oncorhynchus mykiss ) using the OECD Test Guideline 203 (1992). Two groups of 10 fish were exposed in an aqueous dispersion of the test material at a single concentration o f 100 mg/L for 96 hours under semi

- static conditions. The number of mortalities and any sub

- lethal effects of exposure were determined at 3 and 6 hours after the start of exposure then daily for the duration until 96 hours. The 96

- hour LC 50 based on nomi nal test concentrations was greater than 100 mg/L thus the No Observed Effect Concentration was 100 mg/L. It was considered unrealistic to test at concentrations higher than 100 mg/L.

Algal Inhibition Test An algal inhibition test was conducted by Mead and Mullee (2001 ; MRID 49601418 ) on the alga Scenedesmus subspicatus exposed to the test substance (purity not stated). Following a range

finding test the alga was exposed to a test material concentration of 100 mg/L (six replicate flasks) for 72 hours, under constant illumination and shaking at a temperature of 24 ± 1 ° C. Samples of algal populations were removed daily and cell concentrations determined for the test group and control group using a hemocytometer and light microscope. The test data show the EC 50 values of > 100 mg/L thus the No Observed Effect Level was correspondingly determined to be 100 mg/L. It was considered unrealistic to expect concentrations in excess of 100 mg/L.

Marine Algal Inhibition Test Mead and Mullee (2002 ; MRID 49601417 ) conducted a marine algal inhibition test (purity not specified) to assess the effects on growth of Skeletonema costatum and Phaeodaclytum tricornutum according to ISO Test Guideline 10523. After a range

- finding test S. costatum was exposed to an aqueous dispersion of the test material at a concentration of 1000 mg/L (triplicate flasks) for 72 hours under constant illumination and s h aking at a temperature of 21 ± 1 ° C. Observations were conducted as described above. The EC 50 values for the test substanc e under the conditions of the study is > 1000 mg/L and the NOEC is > 1000 mg/L.

Acute Toxicity/

Daphnia A Daphnia sp. acute immobilization test was conducted by Mead and Mullee (2001 49601418 ) according to OECD Test Guideline 202. Following a range

- findi ng test, 40 daphnids (4 replicates of 10 animals) were exposed to an aqueous dispersion of the test material (EX 8343 purity not specified) at a concentration of 100 mg/L for 48 hours under static conditions. Immobilization and any adverse reactions to ex posure were recorded after 24 and 48 hours. The 48 hour EC 50 for the test material to Daphnia magna , based on nominal concentrations was greater than 100 mg/L thus the NOEC was considered to be 100 mg/L. Higher concentrations were considered unrealistic and therefore not assayed.

Acute Toxicity/Marine Copepod A study was performed according to the recommendation of the United Kingdom Proposal TC147/SC5/WG2 to assess acute toxicity to the marine copepod Acartia tonsa . After a rangePage 11 of 14

finding study, 4 r eplicates of 5 animals were exposed to an aqueous dispersion of the test material at concentrations of 10, 18, 32, 56, 100, 180, 320, 560, and 1000 mg/L for 48 hours under static conditions. The number of mortalities were recorded after 24 and 48 hours. The 48 hour LC 50 for the test material to Acartia tonsa based on nominal concentrations was 250 mg/L with 95% confidence limits of 210

- 300 mg/L. The No Observed Effect Concentration was 100 mg/L.

X. DETERMINATION OF SAFETY

Aggregate exposures to D

- glucu rono

- 6

- deoxy

- L

- manno

- D

- glucan, acetate, calcium magnesium potassium sodium salt would result from exposures to residues on food and water, exposure from handling (applying) and from exposure to post

- application residues. Exposures to the general U.S.
popu lation and to population subgroups via the dietary route have been considered. Based on the lack of toxicological concerns, aggregate exposure assessments have not been conducted and are not necessary. The proposed use of D

- glucurono

- 6

- deoxy

- L

- manno

- D

- gl ucan, acetate, calcium magnesium potassium sodium salt does not exceed the Agency’s level of risk concern.

XI. ENVIRONMENTAL JUSTICE

Potential areas of environmental justice concerns, to the extent possible, were considered in this human health risk as sessment, in accordance with U.S. Executive Order 12898, "Federal Actions to Address Environmental Justice in Minority Populations and Low

- Income Populations," http://www.eh.doe.gov/oep a/guidance/justice/eo12898.pdf ).

As a part of every pesticide risk assessment, OPP considers a large variety of consumer subgroups according to well

- established procedures. In line with OPP policy, HED estimates risks to population subgroups from pestic ide exposures that are based on patterns of that subgroup’s food and water consumption, and activities in and around the home that involve pesticide use in a residential setting. Extensive data on food consumption patterns are compiled by the USDA under
t he Continuing Survey of Food Intake by Individuals (CSFII) and are used in pesticide risk assessments for all registered food uses of a pesticide. These data are analyzed and categorized by subgroups based on age, season of the year, ethnic group, and reg ion of the country. Additionally, OPP is able to assess dietary exposure to smaller, specialized subgroups and exposure assessments are performed when conditions or circumstances warrant. Whenever appropriate, non

- dietary exposures based on home use of p esticide products and associated risks for adult applicators and for toddlers, youths, and adults entering or playing on treated areas post

- application are evaluated. Further considerations are currently in development as OPP has committed resources and e xpertise to the development of specialized software and models that consider exposure to bystanders and farm workers as well as lifestyle and traditional dietary patterns among specific subgroups.

XII. HUMAN STUDIES

This assessment does not rely on an y studies in which human subjects were intentionally exposed to a pesticide.Page 12 of 14

XIII INTERNATIONAL LIMITS:

There is no listing of this compound in the Codex Alimentarius and there is no known international limit set by any country.

XIV. RISK CHARACTERIZA TION

The Agency has considered the request for exemption from the requirement of a tolerance under 40 CFR §180.910 (pre

- and post

- harvest application to crops) and §180.940 (contact food surface areas) for the compound D

- glucurono

- 6

- deoxy

- L

- manno

- D

- glucan , acetate, calcium magnesium potassium sodium salt (CAS Reg. No. 595585

- 15

- 2) as an inert ingredient used in pesticide formulations intended for food

- use and non

- food use in agricultural and residential settings. The compound exhibits low levels of toxici ty from acute and subchronic exposures . It is not considered potentially mutagenic, immunotoxic or carcinogenic. Based upon the toxicological database, the Agency did not identify a toxicological point of departure (endpoint) and thus did not conduct qua ntitative assessments of exposure and risk. They are not necessary. The Agency believes the general population, the most highly exposed subpopulations (children) and workers

are not placed at unacceptable risks from expected low exposures to D

- glucurono

- 6

- deoxy

- L

manno

- D

- glucan, acetate, calcium magnesium potassium sodium salt (diutan gum)

. Therefore, the Agency approves of the requested use of D

- glucurono

- 6

- deoxy

- L

- manno

- D

- glucan, acetate, calcium magnesium potassium sodium salt (diutan gum) (CAS Reg. No. 595585

- 15

- 2) as an inert ingredient (stabilizer/suspension agent) used in pesticide formulations intended for food

use and non

- food use in agricultural and residential settings.Page 13 of 14 REFERENCES

Baker, J.K., 1983. Toxicity Test Results for S

- 657. Performing Lab. Applied Biological Science Labs. Glendale, CA. Unpublished report. MRID 49601405

Blagden, S.M., D. Mullee and P.N. Brooks. 2001. Twenty

- Eight Day Repeated Dose Oral (Gavage) Study in the Rat Test Article: EX 8343. Performing Lab. SafePharm Lab’s. Ltd. Derby, U.K. Unpublished study. MRID 49601409.

Hamburger, R.N. 1989. Report Of The Data From The Advanced Allergy Management Clinical Laboratory Study of PRIST and RAST and Gellan Gum Test Article EX 4967, 43013 and 43033. Perf orming Lab. Advanced Allergy Management. La Jolla, CA. Unpublished report. MRID 49601408.

Marrapese, M.E., Q.K. Ke and D.G. Graham. 2015. Petition Proposing an Exemption from the Requirement of a Tolerance for Diutan Gum Under 40 C.F.R. §180.910 and C.F.R §180.940.

Mead, C. 2001. Assessment of Ready Biodegradability; CO 2 Evolution Test. Test Article EX 8343. Performing Lab. SafePharm Lab’s. Ltd. Derby U.K. Unpublished study. MRID 49601413.

Mead, C. and D.M. Mullee. 2001. Algal Inhibitio n Test. Test Article EX 8343. Performing Lab. SafePharm Lab’s., Ltd. Derby, U.K., Unpublished study. MRID 49601418.

Mead, C. and D.M. Mullee. 2002. Marine Algal Inhibition Test. Test Article: EX 8343. Performing Lab. SafePharm Lab’s., Ltd. Der by U.K. Unpublished study. MRID 49601417.

Moreno, O. 1984. Primary Dermal Irritation in Albino Rabbits. Test Article EX

- 4967. Performing Lab. M B Research Laboratories, Inc. Spinnerstown, PA. Unpublished report. MRID 49601406

O’Connor, B.J. and D.M. Mullee. 2001. Determination of General Physico

- Chemical Properties and Spectra Test Article: EX 8343. Performing Lab. SafePharm Lab’s Ltd., Derby, U.K. Unpublished report. MRID 49601403.

Sanders, A. 2001. Skin Sensitization in the Guinea Pi g

– Magnusson and Kligman Maximization Method Test Article EX 8343. Performing Lab. Safepharm Laboratories Ltd. Derby, U.K. Unpublished study. MRID 49601407.

Selim, S. 1984. Rat Balance Study, Tissue Distribution and Blood Level of 14 C and 3 H Label ed Gellan Gum. Test Article 14 C and 3 H Labeled Gellan Gum . Performing Lab. Primate Research Institute N. M. State Univ., Holloman AFB, New Mexico. Unpublished study. MRID 49601412.Page 14 of 14

Sewell, I.G. and D.M. Mullee. 2002. Water Quality, Determination of Acute Lethal Toxicity to Marine Copepods ( Copepoda, Crustacea ). Acute Toxicity to Acartia tonsa Test Article: EX8343. Performing Lab. SafePharm Lab’s., Ltd. Derby, U.K. Unpublished study. MRID 49601416.

Thompson, P.W. 2001. Reverse Mutation Assa y “Ames Test” Using Salmonella typhimurium and Escherichia coli . Performing Lab. SafePharm Lab’s. Ltd. Derby, U.K. Unpublished study. MRID 49601410.

Tremain, S.P. 2001. Determination of Hazardous Physico

- Chemical Properties Test Article: EX 8343. Performing Lab. SafePharm Lab’s., Inc. Derby U.K. Unpublished report. MRID 49610404.

Wetton, P.M. and D.M. Mullee. 2001 a . Acute Toxicity to Rainbow Trout ( Oncorhynchus mykiss ) Test Article: EX 8343. Performing Lab. SafePharm Lab’s., Inc. Derby U.K. Unpublished study. MRID 49601414.

Wetton, P.M. and D.M. Mullee. 2001b. Acute Toxicity to Daphnia magna Test Article: EX 8343. Performing Lab. SafePharm Lab’s., Ltd. Derby, U.K. Unpublished study. MRID 49601415.

Wright, N.P. and P.C. Jenkins on. 2001. Chromosome Aberration Test in Human Lymphocytes In Vitro Test Article EX 8343. Performing Lab. SafePharm Lab’s. Derby, U.K. Unpublished study. MRID 49601411.