Triflusulfuron - methyl Dietary Exposure Assessment DP Barcode: D 37 6268

PC Code: 129002

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UNITED STA

TES ENVIRONMENTA L PROTECTION A GENCY WASHINGTON, D.C. 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION MEM ORANDUM DATE: February

17 , 2011 SUBJECT: Triflusulfuron - methyl : Chronic Aggregate Dietary Exposure (Food and Drinking Water) and Risk Assessment for the Section 3 Registration on Garden Beet PC Code: 129002 DP Barcodes: D 37 6268 Decision No.: 425459 Registration No. : 352 - 569 Petition No.: 9E7669 Regulatory Action: Section 3 Registration Risk Assessment Type: Single Chemical Aggregate, Dietary Case No.: NA T XR No.: NA CAS No.: 126535 - 15 - 7 MRID No.: NA 40 CFR: § 180.492 REVI EWER: Elizabeth Holman, Chemist

R isk Assessment Branch II (RAB2) Health Effects Division ( HED; 7509 P ) THROUGH: Debra Rate , Ph.D., Biologist

David Soderberg, Chemist Dietary Exposure Science Advisory Council Health Effects Division ( HED; 7509P ) and Richard L oranger, Ph. D., Branch Senior Scientist Risk Assessment Branch I I (RAB2) Health Effects Division ( HED; 7509P ) TO: Laura Nollen, Risk Manager Reviewer

Barbara Madden, Review Manager #5 Daniel (Dan) Rosenblatt , Chief Risk I ntegration, Minor Us e, and Emergency Response Branch Registration Division (7505P)Triflusulfuron - methyl Dietary Exposure Assessment DP Barcode: D 37 6268

PC Code: 129002

Page 2 of 10 Executive Summary A chronic aggregate dietary risk assessment (food and drinking water) w as conducted using the Dietary Exposure Evaluation Model (DEEM - FCI D TM , Version 2.03), which uses food consumption data from the U.S. Department of Agriculture ( USDA’s ) Continuing Survey s of Food I ntakes by

I ndividuals (CSFI I) from 1994 - 1996 and 1998. The analy s i s w as performed to support a Section 3 registration for use o f triflusulfuron - methyl [ methyl 2 - [[[[[4 - (dimethylamino) - 6 - (2,2,2 - trifluoroethoxy ) - 1,3,5 - triazin - 2 - yl ]amino]carbonyl]amino]sulfonyl] - 3 - methylbenzoate ] on garden beets . Triflusulfuron - methyl is currently registered for use on sugar beets and chicory . Ac ute Dietary

Exposure (Food and Drinking Water) Results and Characterization No appropriate endpoint attributable to a single dose was identified. As no acute dietary endpoint was identified, an acute exposure analy sis was not performed. Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization T he chronic analy sis is based on tolerance level residues and 100% crop treated a ssumption s . The HE D - recommended tolerance level for each raw agricultural commodity ( RAC ) w as entered as list ed below:

Beet, garden, roots ................................ ...................... 0.01 ppm Beet, garden, tops ................................ ........................ 0.0 2 ppm Additionally , the existing tolerances for sugar beet (roots and tops) and chicory were also entered (a value of 0.05 ppm for each commodity ). The general U.S. population and all population subgroups have risk estimates that are well below HED’s level of concern (i.e., 100% of the chronic population adjusted dose (cPAD ) ) . Estimated exposures are less than 1% of the cPAD for the U.S. population and all population subgroups, including tho se of infants and children. Cancer Dietary (Food and Drinking Water) Exposure Results and Characterization Triflusulfuron - methyl is a Group C (1986 Cancer Guidelines - possible human carcinogen) chemical , based on increased incidence of testicular cell a denomas in rats. The chronic RfD is considered adequately

protective of these effects and a quantitative cancer risk assessment using a cancer potency

factor is not required. I. Introduction Dietary risk assessment incorporates both exposure and toxic ity of a given pesticide. For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable doseTriflusulfuron - methyl Dietary Exposure Assessment DP Barcode: D 37 6268

PC Code: 129002

Page 3 of 10 (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects). This dose is referred to as th e population adjusted dose (PAD). The PAD is equivalent to the point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty

or safety factors. For acute and non - cancer chronic exposures, HED is concerned when estimated dietary risk ex ceeds 100% of the PAD. HED is generally concerned when estimated cancer risk exceeds one in one million. References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site: “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 6/21/2000, web link: http://www.epa.gov/fedrgstr/EPA - PEST/2000/July /Day - 12/6061.pdf ; or see SOP 99.6 (8/20/99). A dietary risk assessment for triflusulfuron - methyl on sugar beet was completed in 2000 (D260469, M.Doherty , 8/28/2000) . This assessment is for the new proposed use on garden beet, which also incorporates the existing uses on sugar beet and chicory . Chicory was not included in the 200 0 dietary

assessment. II. Residue Information Tr iflusulfuron - methyl is a sulfonylurea herbicide that inhibits the biosy nthesis of branched - chain amino acids in plants (via inhibition of the plant enzy me acetolactate sy

nthase). The herbicide is currently registered for food uses on sugar beet and chicor y . The petitioner has proposed a new Section 3 use on garden beets . See Table 1 below for a summary of the HED - recommended tolerances. Table 1. Summary of HED - Recommended Tolerances for Proposed New Use . Com mo dity Recom me nded Tolerance (ppm ) Beet, garden, roots 0.01 Beet, garden, tops 0.02 For both the existing and proposed uses, triflusulfuron - methyl parent serves as an adequate measure of misuse based on its percentage of the total radioactive residues ( TRR ) in the metabolism stud ies and the r esidues seen in crop field trials. HED is making the conservative assumption of 100% crop treated. In a previously

submitted processing study for sugar beet, even at exaggerated rates (8X) for the field trial used to generate the processing study sampl es, no triflusulfuron - methyl was found in the sugar beet roots or processed commodities (MRI D 42496869; see 6/7/93 G. J. Herndon review, D184250). Therefore, processed commodities of sugar beet were conservativelyTriflusulfuron - methyl Dietary Exposure Assessment DP Barcode: D 37 6268

PC Code: 129002

Page 4 of 10 estimated to have tolerance - level residue s of the raw agricultural commodity of sugar beet. III. Drinking Water Data The drinking water residues used in the dietary risk assessment were provided by the Environmental Fate and Effects Division (EFED) in the following memorandum: “ Estimated Dri nking Waters Concentrations (EDWCs) of Triflusulfuron - methyl for the Use in the Human Health Risk Assessment : New Use (I R - 4) of the Chemical on Garden Beets ” ( D373494 , J. Meléndez , 7 / 22 / 2010 ) and incorporated directly into this dietary

assessment. Water r esidues were incorporated in the DEEM - FCI D TM into the food categories “water, direct, all sources” and “water, indirect, all sources.” The EDWCs are based on the maximum application rates specified in the product label for the existing use on sugar beet . The registrant is proposing the new use of the chemical on garden beets . Based on an inspection of the new use of triflusulfuron - methyl , it was found that sugar beet still represents the scenario with the highest exposure. The previously modeled use covers the new use. T herefore, the drinkin g water assessment results do not change from the previous ones . For electronic copy of the previous drinking water assessment refer to DP Barcode D260078 . Surface water estimates were calculated using the Tier I I Pesticide Root Zone Model ( PRZM, v3.1 2.2, 5/12/2005) and the Exposure Analy sis Modeling Sy stem (EXAMS, v2.98.4.6, 4/25/2005). These simulation models are coupled to generate daily exposures and 1 - in - 10 y ear estimated drinking water concentrations of triflusulfuron - methyl residues that may oc cur in surface water bodies adjacent to application sites receiving triflusulfuron - methyl through runoff and spray drift. Groundwater estimates were calculated using the Screening Concentration in Ground Water (S CI - GROW v2.3, Jul. 29, 2003) regression mod el . These models and their descriptions are available at the EPA internet site: http://www.epa.gov/oppefed1/models/water/ . The EDWCs for the human health risk assessment are presented in Table 2 . RAB2 has selected the most conservative estimate in order to be sufficiently protective of human health. The maximum estimate of 0.50 ppb comes from the groundwater (SCI - GROW) estimate and was used in the chronic dietary analy sis . Table 2 . Estimat ed Drinking Water Concentrations (EDWCs) for H uman H ealth R isk A ssessment for A erial A pplication of T rif lusulfuron - M ethyl on Sugar Beets . Chemical Chronic Surface Water

PRZM/EXAMS (ppb) Acute and Chronic Ground Water SCI - GROW (ppb) * Triflusulfuron methyl 0.005 0.50Triflusulfuron - methyl Dietary Exposure Assessment DP Barcode: D 37 6268

PC Code: 129002

Page 5 of 10 IV. DEEM - FCID  Program and Consumption Information A triflusulfuron - methyl chronic dietary exposure assessment w as conducted using the DEEM FCI D  , Version 2.03 , which incorporates consumption data from USDA’s CSFI I , 1994 - 1996 and 1998. The 1994 - 96, 98 data are based on the reported consumption of more than 20,000 individuals over two non - consecutive survey day s. Foods “as consumed” (e.g., apple pie) are linked to EPA - defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly

by USDA/ARS and EPA. For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events. Based on analy sis of the 1994 - 96, 98 CSFI I consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is m ost appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 y ear old), children 1 - 2, children 3 - 5, children 6 - 12, y outh 13 - 19, adults 20 - 49, females 13 - 49, and adults 50+ y ears old. For chronic dietary

exposure assessment, an estimate of the residue level in each food or food form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily

consumption estimate for that food/food form to produce a residue intake estimate . The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure. Exposure is expressed in mg /kg body weight/day

and as a percent of the cPAD. This procedure is performed for each population subgroup. V. Toxicological Information The Health Effects Division (HED) has evaluated the toxicology database for triflusulfuron methyl . The RAB2 risk as sessment team reviewed the toxicology data for triflusulfuron - methyl with regard to the acute and chronic reference doses and the toxicological endpoint selection. Table 3 below provides a summary of the doses and endpoints recommended for use in the diet ary exposure assessments. Triflusulfuron - methyl is a Group C (1986 Cancer Guidelines - possible human carcinogen) chemical , based on increased incidence of testicular cell adenomas in rats. The chronic RfD is considered adequately p rotective of these effects and a quantitative cancer risk assessment using a cancer potency factor is not required. The FQPA safety factor was reduced to 1x for all exposure scenarios.Triflusulfuron - methyl Dietary Exposure Assessment DP Barcode: D 37 6268

PC Code: 129002

Page 6 of 10 Table 3. Summary of Toxicological Doses and Endpoints for Tri flusulfuron - Methyl for Use in Dietary and Non - Occupational Human Health Risk Assessments . Exposure/ Scenario Point of

Departure Uncertainty/FQPA

Safety Factors RfD, PAD, Level of Concern for Risk Assessment Study and Toxicological Effects Acute Dietary, General Population ( including Infants and Children and Females age 13 to 49) Not required. A n appropriate endpoint for this risk assessment w as not identified.

Chronic Dietary (All Populations) NOAEL=

2 . 44 mg/kg/day UF A = 10x

UF H = 10x FQPA SF= 1x Chro nic RfD =

0. 0244 mg/kg/day cPAD = 0.0 244 mg/kg/day Chronic oral toxicity/carcinogenicity in

the rat LOAEL = 30.6 mg/kg/day, based on decreased body w eight/weight gain, hematological changes (primarily males) and increased interstitial cell hyperplasia (m ales). Cancer (oral, dermal, inhalation) Classification: Group C (1986 Cancer Guidelines), based on increased incidence of testicular

interstitial cell adenomas in rats . The chronic RfD is considered adequately protective of these effects and a quantit ative assessment of cancer risk using a cancer potency factor is not required. Point of Departure (POD) = A data point or an estimated point that is derived from observed dose - response data and used to mark the beginning of extrapolation to determine risk associated w ith lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human po pulation (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. VI. Results /Discussion As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD. The DEEM - FCI D  analy s i s estimate s the dietary exposure of the U.S. population and various population subgroups. The results repor ted in Table 5 are for the general U.S. Population, all infants (<1 y ear old), children 1 - 2, children 3 - 5, children 6 - 12, y outh 13 - 19, females 13 - 49, adults 20 - 49, and adults 50+ y ears. Results of Acute Dietary (Food and Drinking Water) Exposure Analy sis No appropriate endpoint attributable to a single dose was identified. As no acute dietary endpoint was identified, an acute exposure analy sis was not performed .Triflusulfuron - methyl Dietary Exposure Assessment DP Barcode: D 37 6268

PC Code: 129002

Page 7 of 10 Results of Chronic Dietary (Food and Drinking Water) Exposure Analy sis The summary

table b elow lists t he results of the chronic dietary exposure analy sis . Estimated chronic dietary

risk estimates are less than 1% of the cPAD for the U.S. population and all population subgroups, including those of infants and children. Thus, a ll population exp osures are well below HED’s level of concern. Table 4 . Summary of Dietary Exposure and Risk for Triflusulfuron - Methyl.

Population Subgroup* Acute Dietary Chronic Dietary Cancer Dietary Exposure (mg/kg/day) % aPAD Dietary Exposure (mg/kg/d ay) % cPAD Dietary Exposure (mg/kg/day) Risk General U.S. Population N/A No acute dietary endpoint wa s identified N/A 0.000025 <1% N/A N/A All Infants (< 1 year old) 0.000050 <1% Children 1 - 2 years old 0.000052 <1% Children 3 - 5 years ol d 0.000056 <1% Children 6 - 12 years old 0.000041 <1% Youth 13 - 19 years old 0.000023 <1% Adults 20 - 49 years old 0.000020 <1% Adults 50+ years old 0.000019 <1% Females 13 - 49 years old 0.00002 1 <1% VII. Characterization of Input s/Outputs As the exposure estimates to all population subgroups were so low, it was not necessary to make refinements to the chronic dietary analy sis. I f it had been necessary to refine the analy sis, average field trial values could have been used in pla ce of tolerance level residues. In addition, estimates of percent crop treated could have been used. VIII. Conclusions Based on very

conservative assumptions, the chronic dietary risk estimates are well below HED’s level of concern for the general U.S. population and all population subgroups, including those comprised of infants and children. Inaddition, cancer risk from dietary exposure to triflusulfuron - methyl is not of concern to HED (the cRfD is protective of cancer effects). Based on the conserva tive nature of the chronic dietary endpoint and the drinking water assessment, exposure and risk to triflusulfuron - methyl are not expected to be underestimated.Triflusulfuron - methyl Dietary Exposure Assessment DP Barcode: D 37 6268

PC Code: 129002

Page 8 of 10 I X. List of Attachments Attachment 1: Residue Input File for Chronic Analy s i s Attachment 2: Results of Chronic Dietary Exposure Analy sisTriflusulfuron - methyl Dietary Exposure Assessment DP Barcode: D 37 6268

PC Code: 129002

Page 9 of 10 Attachment 1: Triflusulfuron - methyl Residue Input File Filename: F: \ Triflusulfuron \ Dietary \ Triflusulfuron - methyl Chronic final.R98 Chemical: Triflusulfuron - methyl RfD(Chronic): .0244 mg/kg bw/day NOEL(Chron ic): 2.44 mg/kg bw/day RfD(Acute): 0 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Date created/last modified: 02 - 17 - 2011/09:08:08/8 Program ver. 2.03

-------------------------------------------------------------------------------- EPA Crop Def Res Adj.Factors Comment Code Grp Commodity Name (ppm) #1 #2

-------- ---- ------------------------------- ---------- ------ ------ ------- 86010000 O Water, direct, all sour ces 0.000500 1.000 1.000 86020000 O Water, indirect, all sources 0.000500 1.000 1.000 01010500 1AB Beet, garden, roots 0.010000 1.000 1.000 01010501 1AB Beet, garden, roots - babyfood 0.010000 1.000 1 .000 01010520 1A Beet, sugar 0.050000 1.000 1.000 01010521 1A Beet, sugar - babyfood 0.050000 1.000 1.000 01010530 1A Beet, sugar, molasses 0.050000 1.000 1.000 01010531 1A Beet, suga r, molasses - babyfood 0.050000 1.000 1.000 01011000 1AB Chicory, roots 0.050000 1.000 1.000 02000510 2 Beet, garden, tops 0.020000 1.000 1.000 02001010 2 Chicory, tops 0.0500 00 1.000 1.000Triflusulfuron - methyl Dietary Exposure Assessment DP Barcode: D 37 6268

PC Code: 129002

Page 10 of 10 Attachment 2: Results of Triflusulfuron - methyl Chronic Dietary Exposure Analysis U.S. Environmental Protection Agency Ver. 2.00 DEEM - FCID Chronic analysis for TRIFLUSULFURON - METHYL (1994 - 98 data) Residue file name: F: \ Triflusulfuron \ Dietary \ Triflusulfuron - methyl Chronic final.R98 Adjustment factor #2 used. Analysis Date 02 - 17 - 2011/09:16:12 Residue file dated: 02 - 17 - 2011/09:08:08/8 Re ference dose (RfD, Chronic) = .0244 mg/kg bw/day

=============================================================================== Total exposure by population subgroup

--------------------------------------------------------------------- ---------- Total Exposure

----------------------------------- Population mg/kg Percent of Subgroup body wt/day Rfd

-------------------------------------- ------------- --------------- U.S. Population (total) 0.000025 0.1% U.S. Population (spring season) 0.0000 26 0.1% U.S. Population (summer season) 0.000026 0.1% U.S. Population (autumn season) 0.000025 0.1% U.S. Population (winter season) 0.000025 0.1% Northeast region 0.000024 0.1% Midwest region 0.000027 0.1% Southern region 0.000024 0.1% Western region 0.000026 0.1% Hispanics 0.000026 0.1% Non - hispanic whites 0.000025 0.1% Non - hispanic blacks 0.000025 0.1% No n - hisp/non - white/non - black 0.000025 0.1% All infants (< 1 year) 0.000050 0.2% Nursing infants 0.000019 0.1% Non - nursing infants 0.000061 0.3% Children 1 - 6 yrs 0.000054 0.2% Children 7 - 12 yrs 0.000039 0.2% Females 13 - 19 (not preg or nursing) 0.000022 0.1% Females 20+ (not preg or nursing) 0.000020 0.1% Females 13 - 50 yrs 0.000022 0.1% Females 13+ (preg/not nursing) 0.000025 0.1% Females 13+ (nursing) 0.000027 0.1% Males 13 - 19 yrs 0.000024 0.1% Males 20+ yrs 0.000019 0.1% Seniors 55+ 0.000019 0.1% Children 1 - 2 yrs 0.000052 0.2% Children 3 - 5 yrs 0.000056 0.2% Children 6 - 12 yrs 0.000041 0.2% Youth 13 - 19 yrs 0.000023 0.1% Adults 20 - 49 yrs 0.000020 0.1% Adults 50+ yrs 0.000019 0.1% Females 13 - 49 yrs 0.000021 0.1%

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