United States Forest Southern Fisheries Research Unit Department of Service Research 1650 Ramble Road Agriculture Station Blacksburg, VA 24060 _____________________________________________________________________ _________

June 22, 2004 Denise M. Keehner USEPA Headquarters, Office of Water Standards and Health Protection Division ( 4305T) 1200 Pennsylvania Avenue, NW Washington, DC 20460 Dear Ms. Keehner:

I am writing to formally retract my prior peer review of EPA's draft " Aquatic Life Water Quality Criteria for Selenium   2002", as transmitted to you via my letter dated April 23, 2002. Since that time, several issues have been brought to my attention which raise serious questions as to the scientific credibility of the draft document. Chief among the concerns are: ( 1) the full utility of the experimental design of my 1993 winter stress study, which was the controlling experiment used by EPA's contractor ( Great Lakes Environmental Center) to derive the 7.9 µ g/ g dw chronic criterion, went unrecognized, ( 2) the crucial linear regression equation relating selenium concentrations in fish ovaries to concentrations on a whole body basis was erroneously reported, and ( 3) assessments of risk to aquatic dependent wildlife were based on out of date information. I have re examined my own study as well as original data and reports of other research cited in the draft document. In the course of this analysis it became clear that the 3 concerns listed above are indeed legitimate and, I believe, constitute fatal flaws in the calculations and reasoning used by GLEC to prepare the draft; ergo, the chronic criterion should be substantially lower than 7.9. A detailed discussion of these concerns has been provided to the EPA ( Charlie Delos) on June 16, 2004 in the form of a draft manuscript written by several colleagues and myself. Because of the serious flaws I cannot ethically continue to let my previous endorsement of the 7.9 criterion stand. Please take notice that I no longer support the criterion as proposed in the draft document. I will be glad to discuss this matter further if you wish ( 540 231 6663; dlemly@ fs. fed. us).

Sincerely,

A. Dennis Lemly, Ph. D. Senior Scientist in Aquatic Toxicology cc: Dr. John Besser, Dr. Gregory Moller, Mr. Steve Canton, Mr. Robin Reash, Mr. Greg Masson


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: Shaunta Hill<PHONE_NUMBER>

Syngenta Crop Protection LLC. PP#

	EPA has received a pesticide petition PP#  2F8121 from Syngenta Crop Protection LLC., P.O. Box 18300, Greensboro, NC 27419-8300 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.

   	1. by establishing a tolerance for residues of Benzovindiflupyr in or on the raw agricultural commodity [Apple, wet pomace]insert] at [0.6] parts per million (ppm), [barley, grain] at [1.5] ppm, [barley, hay] at [15] ppm, [barley, straw] at [15] ppm, [corn, field, grain] at [0.02] ppm, [corn, field, forage] at [3] ppm, [corn, field, stover] at [15] ppm  [corn, pop, grain] at [0.02] ppm, [corn, pop, stover] at [15] ppm, [corn, sweet, ear] at [0.01] ppm, [corn, sweet, forage] at [4] ppm, [corn, sweet, stover] at [5] ppm, [cottonseed, subgroup 20C] at [0.15] ppm, [cotton, grin byprouducts] at [3] ppm, [vegetables, cucurbit, crop group 9] at [0.2] ppm,. [fruits, pome, crop group 11-10] at [0.2] ppm, [fruits, small vines climbing, except fuzzy kiwi subgroup 13-07F] at [1] ppm, [grain, aspirated fractions] at [7] ppm, [oat, grain] at [1.5] ppm, [oat, hay] at [15] ppm, [oat, straw] at [15] ppm, [peas and bean, dried shelled, except soybean, subgroup 6C] at [0.2] ppm  [peas, hay] at [7] ppm, [peas, vine] at [1.5] ppm, [peanut, nutmeat] at [0.01] ppm, [peanut, hay] at [15] ppm, [potato, wet peel] at [0.1] ppm, [raisin] at [4] ppm, [rapeseed, subgroup 20A] at [0.15] ppm, [rye, grain] at [0.1] ppm, [rye, hay] at [15] ppm,.[rye, straw] at [10] ppm, [soybean, seed] at [0.07] ppm, [soybean , forage] at [15] ppm,. [soybean, hay] at [50] ppm, [vegetables, fruiting, crop group 8-10] at [0.8] ppm, [vegetables, tuberous and corm subgroup 1C] at [0.02] ppm, [wheat, grain] at [0.1] ppm, [wheat, forage] at [4] ppm, [wheat, hay] at [15] ppm,[wheat, straw] at [10] ppm; and in or on the following animal commodities [cattle, fat] at [0.01] ppm, [cattle, kidney] at [0.01] ppm,[cattle, liver] at [0.01] ppm, [cattle, meat] at [0.01] ppm, [cattle, byproducts] at [0.01] ppm; [egg] at [0.01] ppm; [goat, fat] at [0.01] ppm,[goat, kidney] at [0.01] ppm, [goat, liver] at [0.01] ppm, [goat, meat] at [0.01] ppm, [goat, meat byproducts] at [0.01] ppm; ; [hog, fat] at [0.01] ppm; [hog, liver] at [0.01] ppm,[hog, meat] at [0.01] ppm, [hog, meat byproducts] at [0.01] ppm, [horse, fat] at [0.01] ppm, [horse, kidney] at [0.01] ppm, [horse, liver] at [0.01] ppm, [horse, meat] at [0.01] ppm,[horse, meat byproducts] at [0.01] ppm; [milk] at [0.01] ppm, [milk, fat] at [0.01] ppm; [egg] at [0.01] ppm; [poultry, byproducts] at [0.01] ppm, [poultry, fat] at [0.01] ppm, [poultry, liver] at [0.01] ppm, [poultry, meat] at [0.01] ppm, [poultry, skin] at [0.01] ppm, [sheep, fat] at [0.01] ppm, [sheep, kidney] at [0.01] ppm, [sheep, liver] at [0.01], [sheep, meat] at [0.01] ppm, [sheep, meat byproduct] at [0.01] ppm.  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. [Plant Metabolism studies with benzovindiflupyr (SYN545192) were performed in wheat, soybean and tomatoes as representative crops in order to characterize the fate of benzovindiflypur in all crops.  Two radiocarbon labels were studied in each crops, with 14-C labels positioned in phenyl and pyrazole ring structures.  Benzovindiflupyr was the predominant component of residue in most crops.  The metabolism in all plants (soybean, wheat, tomatoes) was very similar.  In all crops, the main path was via oxidative metabolism of alicyclic system, N-demethylation of pyrazole ring, conjugation of hydroxylated  parent and cleavage between phenyl and pyrazole ring. There was, however, some variation on the extent and nature of conjugations between crops.]

	2. Analytical method. [The proposed definition of the residue for benzovindiflupyr (SYN545192) in commodities of plant origin is parent SYN545192 for both compliance monitoring and consumer risk assessments.  The corresponding definitions in commodities of animal origin are parent SYN545192 for monitoring and sum of SYN545192 and SYN546039 for risk assessment. Both Method GRM042.03A and GRM042.04A for plant products have been developed determine parent SYN545192 and its metabolite SYN546039 (and conjugates) with a limit of quantification (LOQ) of 0.01 mg/kg for both analytes.  GRM042.04A also determines metabolite SYN545720 with an LOQ of 0.01 mg/kg.  Method GRM042.08A has been developed for the determination of SYN545192 and its metabolites SYN546039 and SYN546206 in rotational crops, with an LOQ of 0.01 mg/kg for all three analytes.  Method GRM042.06A (also known as Charles River Method No. 1887 Version 2.0) for animal products has been validated for use in pre-registration development studies.  The method determines parent SYN545192 and its metabolites SYN546039 and SYN546422, with an LOQ of 0.01 mg/kg for each analyte.   Method GRM023.03A was used to analyse residues of SYN545720 in the storage stability study demonstrating the storage stability of SYN545720 residues in a range of commodities under frozen conditions.]

	3. Magnitude of residues. [Field trials were carried out to determine the magnitude of residue in/on pome fruit (crop group 11-10), small cereal grains (wheat, barley), corn, cotton, cucurbits (crop group 9), dried shelled peas and  bean except soybean (subgroup 6C), fruiting vegetables (crop group 8-10), grape (subgroup 13-07F), peanuts, canola (rapeseed) subgroup 20A, soybean, and tuberous and corm subgroup 1C. The number and locations of the field trials are in accordance with OPPTS 860.1500. Field trials were carried out using the maximum label rates, maximum number of applications, and the minimum pre-harvest interval (PHI) for all the crops.  Additional trials have been conducted in Canada as supporting data to get registration in Canada and propose harmonized tolerances between US and Canada. Detected residues of benzovindiflupy in all crops support the propsed tolerances based on parent only.]

B. Toxicological Profile

	1. Acute toxicity.  [The estimated acute medical lethal dose (MLD) for benzovindiflupyr (SYN545192) via the oral route was 55 mg/kg.  The median lethal concentration (MLC) following acute inhalation exposure was estimated to be greater than 0.56 mg/l.  The acute dermal MLD was shown to be greater 2000 mg/kg.  SYN545192 was only mildly irritating to the skin and moderately irritating to the eyes. The acute toxicity studies place technical benzovindiflupyr in toxicity category II for oral and category III for dermal and inhalation. Benzovindiflupyr is not a dermal sensitizer.]

	2. Genotoxicty. [Benzovindiflupyr (SYN545192) has been examined in a range of in vitro and in vivo genotoxicity assays, including endpoints of bacterial and mammalian gene mutation and chromosomal damage.  In vitro, SYN545192 was negative for gene mutation in bacterial (Ames test) and mammalian cells (L5178Y TK[+/-] mouse lymphoma).  The L5178Y TK[+/-] assay, which is also able to detect chromosomal damage by assessment of colony sizes (small and large colony sizes are associated with clastogenic or mutagenic effects respectively), was also negative for clastogenicity.  In the in vitro cytogenetic assay using primary human lymphocyte cultures, SYN545192 did not induce any treatment-related chromosomal aberrations.   In vivo, SYN545192 was found to be non-clastogenic in the rat bone marrow micronucleus assay and did not induce micronuclei in bone marrow cells.]

	3. Reproductive and developmental toxicity. [Benzovindiflupyr (SYN545192) was evaluated for potential to cause effects on reproductive and developmental toxicity in a multi-generation reproductive toxicity study in the rat and in pre-natal developmental toxicity studies in the rat and rabbit.   	     Reproductive toxicity: SYN545192 was evaluated in a two-generation reproduction study in the rat at dietary inclusion levels of 0, 25, 100, 250 ppm (females) or 600 ppm (males). The parental NOAEL was considered to be 100 ppm (equivalent to 6.8 mg/kg/day for P generation males during pre-pairing).  The NOEL for reproduction was 600 ppm in males (equivalent to 40.5 mg/kg/day for P generation males during pre-pairing) and 250 ppm in females (equivalent to 19.4 mg/kg/day for P generation females during pre-pairing). The offspring NOEL for general toxic effects was 100 ppm (equivalent to 7.8 mg/kg/day for F1 generation males during pre-pairing).

	    Developmental Toxicity: In a developmental study in the rat, SYN545192 was administered at dose levels of 0, 7.5, 15 and 30 mg/kg/day.  All female animals survived until the scheduled necropsy.  Marked clinical signs of toxicity (ataxia, hunched posture, prostrate, decreased activity and ruffled fur) were observed at 30 mg/kg/day. Mean food consumption, body weight and body weight gain were lower at 30 mg/kg/day.  Mean foetal body weight was lower at 30 mg/kg/day and there was a slight delay in ossification which was considered to be related to the treatment with the test item and secondary to maternal toxicity. The NOEL for maternal and developmental toxicity was 15 mg/kg/day.

In a rabbit dose-range finding study, a dose level of 100 mg/kg/day produced severe body weight loss and reduced food consumption that resulted in the early termination of all females at this dose level. Excessive body weight losses and reduced food consumption also led to abortion and moribundity in individual females at 50 mg/kg/day indicating that this dose level was unsuitably high for a full developmental toxicity study. On this basis, dose levels of 0, 10, 20, and 35 mg/kg/day were selected for the definitive prenatal development toxicity study the rabbit.

There were no treatment-related effects on the dams at any dose level.  Marginal effects on maternal body weight gain were seen at 20 and 35 mg/kg/day during gestation days 13-20.  There were no effects on development.  The NOEL for maternal and developmental toxicity was 35 mg/kg/day.]

	4. Subchronic toxicity. [The short term toxicity of benzovindiflupyr has been evaluated by the oral route of administration in rats, mice and dog.   In addition, dermal toxicity was evaluated in rates in a 28-day study.

Dietary administration of SYN545192 to rats for at least 90 days was associated with in-life effects (reduced body weights, food consumption and food utilisation) at 750 ppm and above. Covariant liver weights were statistically higher in male animals treated at 1500 ppm and in females at 750 ppm. Centrilobular hepatocyte hypertrophy of the liver was noted at doses of 750 ppm and above in males and at 1500 ppm in females. The NOEL was considered to be 100 ppm for both males and females equating to an average of 7.6 mg/kg/day in males and 8.2 mg/kg/day in females.   Dietary administration of SYN545192 to mice at doses, 0, 100, 300 or 300 ppm for a period of at least 91 days was associated with significant initial body weight losses resulting in termination of two animals in the toxicokinetic satellite group at 500 ppm. The NOEL for this study was considered to be 100 ppm for both sexes, equating to an average compound intake of 17.0 mg/kg/day in males and 20.9 mg/kg/day in females. The NOEL is based on the occurrence of mortality in two animals at 500 ppm, initial body weight loss, decrease in body weight gain, an increased incidence of soft faeces in males,    In a 28-day dermal toxicity in rats, no treatment-related effects were observed at any dose level up to the limit dose of 1000 mg/kg..]

	5. Chronic toxicity. [Benzovindiflupre (SYN545192) has been evaluated for chronic toxicity in the rat and for carcinogenic potential in the rat and the mouse.   In a 2 year combined chronic toxicity/carcinogenicity study in  rats, SYN545192 was tested at dietary inclusion levels conducted at dietary inclusion levels of  0, 25, 100 and 600 ppm (males) or 400 ppm (females).

Significantly lower body weight gain, food consumption and food utilisation were observed in both sexes at the top dose.  ALP, ALT and AST values were consistently lower than control values at the top dose.  In males at 600 ppm, liver weight adjusted for body weight was statistically significantly increased.  There were no other effects on organ weight.  The incidence of centrilobular hypertrophy in the liver was statistically significantly higher in top dose males and females at 52 and 104 weeks. In males at 600 ppm, the incidence of eosinophilic cell foci in the liver was statistically significantly higher after 104 weeks, and a higher incidence of hepatocyte vacuolation was seen after 104 weeks.

A higher incidence of pigmented hepatocytes was observed in females at 400 ppm after 52 and 104 weeks. In males at 600 ppm, there was a treatment-related increase in the incidence of thyroid follicular cell adenomas.  There were no other treatment-related neoplastic findings.  A NOAEL was established at 100 ppm (4.88 mg/kg/day in males and 6.66 mg/kg/day in females).

In a carcinogenicity study with SYN545192 (purity 97%), four groups of 50 CD-1 mice/sex/group were fed diets containing 0, 20, 60 or 200 ppm SYN545192 for at least 80 consecutive weeks. The animals well tolerated the administered doses up to 8-0 weeks.

The administration of SYN545192 at 200 ppm was associated with a higher incidence of simple mucosal hyperplasia in the large intestine (colon and caecum) of males and females. There were no effects in the large intestine at 20 or 60 ppm in either sex.  There were no treatment related increases in neoplastic findings.

Based on the findings in this study, a No Observed Effect Level (NOEL) is established at 60 ppm, which is equivalent to 7.55 mg/kg/day in males and 8.67 mg/kg/day in females.]

	6. Animal metabolism. [The rat, goat, and hen metabolism studies were conducted to determine the nature of the benzovindiflupy residues in animals. The rat metabolism study has established that benzovindiflupyr is rapidly absorbed by rats following oral administration by gavage.  In both poultry and goat, the majority of the dosed radioactivity was excreted (mainly in the feces) and radioactivity remaining in dietary tissues, milk and eggs was low.  In the goat study, milk residues reached plateau residue concentrations (0.035  -  0.046 mg/kg), after 3 - 4 days dosing.  Residues in eggs from the hen study reached plateau residue concentrations after approximately 8 days (0.17  -  0.18 mg/kg in egg yolk and 0.03  -  0.04 mg/kg in egg white).

In both species, the highest tissue residues were observed in liver (0.697  -  1.279 mg/kg in goat and 0.188  -  0.249 mg/kg in hen) and kidney (0.185  -  0.280 mg/kg in goat).  Residue levels in fat-rich tissues of hen and goat were much lower, 0.043 mg/kg-0.1 mg/kg.

There was very little transfer of residues into tissues, milk or eggs following the dosing of benzovindiflupyr to the hen or the goat.  Metabolic profiles observed in livestock commodities arise from just three principle biotransformation.The principle routes of metabolism are i) N-pyrazole demethylation of SYN545192 and ii) oxidation resulting in        oo monohydroxylation of the alicyclic ring,       oo alicyclic ring opening of alicyclic monohydroxylated metabolites resulting in a dihydroxylated metabolite.

Overall the biotransformation pathway of SYN545192 in ruminants and poultry is well understood and consistent with that observed in the rat.]

	7. Metabolite toxicology. [SYN546039 (formed via mono hydroxylation on the alicyclic ring has been assessed for acute and oral toxicity, in vitro genotoxicity (Bacterial reverse mutation).  SYN546039 was not acutely toxic by oral route and was not genotoxic in vitro.  These data indicate that SYN546039 is of lower toxicity than parent SYN545192 and is not considered to be toxicological relevance.

Metabolites NOA449410 and SYN545720 (formed via cleavage between the pyrazole and phenyl ring) were also assessed for toxicity.  Both metabolites were not acutely toxic by oral route, were negative in vitro genotoxicity studies and were toxicologically benign up to the limit dose of 1000 mg/kg/day in a 28-day and 90-day studies in rat.   In rabbit developmental toxicity studies, these metabolites were not teratogenic. Based on these data, metabolites NOA449410 and SYN545720 can be characterized as having minimal toxic potential.

	8. Endocrine disruption. [Benzovindiflupyr (SYN545192) does not belong to a class of chemicals known as suspected of having adverse effects on the endocrine system. There is no evidence in other relevant toxicity studies (e.g. sub-chronic and chronic toxicity, developmental toxicity and multi-generation reproductive studies) which would suggest that benzovindiflupyr has any endocrine disruptive potential.

	9. Immunotoxicity. [A study was conducted, as specified in US OPPTSGuideline 870.7800, to provide information on suppression of the immune system which might occur as a result of repeated exposure to a test chemical.  Treatment of female CD-1 mice with benzovindflupyr on a continuous basis in the diet for a minimum of 28 days resulted in no suppression of the humoral immune component of the immune system, based on evaluation of the spleen and thymus weights, spleen cell numbers, and the T-cell dependent antibody response of splenocytes (antibody forming cell assay).

The no observed-effect level (NOEL) for the AFC (humoral immune response) assay was 400 ppm (equivalent to 97.1 mg/kg of body weight/day), the highest dose level evaluated.

C. Aggregate Exposure

	1. Dietary exposure. Tier III acute, short-term, intermediate-term, and chronic aggregate exposure evaluations were completed for benzovindiflupyr (SYN545192) using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID, version 3.15).  DEEM-FCID software incorporates food consumption data from the National Health and Nutrition Examination Survey)/"What We Eat in America" (NHANES/WWEIA) dietary survey conducted in 2003-2008.  Assessments were conducted for all proposed uses on cereals (wheat, barley, oat, rye and triticale), corn, soybean, peanuts, cotton, pome fruits (Crop Group 11), grapes (Small Fruits Vine Climbing Sub-Group 13-07F except fuzzy kiwi fruit), pulses (dry beans and peas Crop Group 6C), potatoes (Tuberous and Corm Subgroup 1C), cucurbits ( crop Group 9), fruiting vegetables (Crop Group 8), canola (Crop Group 20A), and a proposed non-food use on blueberries.  Import tolerances were proposed for coffee and sugarcane.  The definition of the residue for tolerance enforcement and risk assessment purposes for crops is parent benzovindiflupyr (SYN545192).  The assessments utilized residue data from field trials in which benzovindiflupyr was applied at the maximum intended use rate and samples were harvested at the minimum pre-harvest interval (PHI) to obtain maximum residues.  Percent of crop treated values were estimated based upon economic, pest, and competitive pressures.  Secondary residues in animal commodities were estimated based on "maximum reasonably balanced diets" and transfer information from feeding studies.  Drinking water estimates were incorporated directly into the dietary exposure assessment using the higher of the estimated drinking water concentrations (EDWCs) for surface and ground water.

	i. Food. Acute Exposure.  The acute dietary risk assessments were performed for all population subgroups with an acute reference dose (aRfD) of 0.15 mg/kg-bw/day based on an acute no observed adverse effect level (NOAEL) of 15 mg/kg/day prenatal developmental toxicity study in rats and an uncertainly factor of 100X.  The 100X safety factor includes intra- and interspecies variations.  No additional FQPA safety factor was applied.  At the 99.9[th]%-ile of exposures, acute food exposure to the U.S. population resulted in an acute food MOE of 14,254 or 0.7% of the aRfD (Benchmark MOE =100; aRfD = 0.15 mg/kg-bw/day) of exposures.  Acute food exposure to the most sensitive subpopulation (children 1 to 2 years old) resulted in an acute food MOE of 5,342 or 1.9% of the aRfD (Benchmark MOE =100; 0.15 mg/kg-bw/day).  Since the Benchmark MOE for this assessment was 100 and since the EPA generally has no concern for exposures above the benchmark or below 100% of the aRfD, Syngenta believes that there is a reasonable certainty that no harm will result from acute dietary (food) exposure to residues arising from the proposed uses for benzovindiflupyr.

Chronic Exposure.  The benzovindiflupyr chronic dietary (food only) risk assessments were performed for all population subgroups with a chronic reference dose of 0.05 mg/kg-bw/day based on a combined chronic/carcinogenicity study on rats with no observed adverse effect level (NOAEL) of 4.9 mg/kg-bw/day and an uncertainty factor of 100X for intra- and inter-species variations.   No additional FQPA safety factor was applied.  For the purpose of the aggregate risk assessment, exposure values were expressed in terms of margins of exposure (MOE), which were calculated by dividing the NOAEL by the exposures for each population subgroup.  In addition, exposures were also expressed as percentages of the reference dose (%RfD).  Chronic (food only) exposure to the U.S. population resulted in a chronic food MOE of 143,136 (0.1% of the chronic RfD of 0.05 mg/kg-bw/day).  The most sensitive sub-population was children (1-2 years old) with a chronic food MOE of 58,902 (0.2% of the chronic RfD).  Since the benchmark MOE for this assessment was 100 and since the EPA has no concern for exposures resulting in an MOE above the Benchmark MOE or below 100% of the reference dose, Syngenta believes that there is a reasonable certainty that no harm will result from dietary (food only) exposure to residues arising from the proposed uses for benzovindiflupyr.

Cancer.  Benzovindiflupyr is considered "not likely to be a human carcinogen".  Therefore, no cancer risk assessment was performed for benzovindiflupyr.

	ii. Drinking water. To determine the Estimated Drinking Water Concentrations (EDWCs) for SYN545192 in surface water the Tier 1 model, FQPA Index Reservoir Screening Tool (FIRST v1.1.1), was used.  For groundwater the Tier 1 model, Screening Concentration in Ground Water (SCI-GROW v2.3), was used.  The maximum field application rate for multiple crops including corn, cucurbits, fruiting vegetables, and corm vegetables, and grapes is 75 g ai/ha/application (0.068 lb. a.i./A/application) x 4 applications/year. A minimum 7 day retreatment interval is specified, and after the second application a fungicide with a different mode of action must be used.  The modeling was conducted using environmental fate parameters, in accordance with EPA's guidance, to identify the highest benzovindiflupyr (SYN545192) EDWCs from all proposed uses.  The predicted EDWCs were corrected with a Percent Cropped Area (PCA) adjustment factor of 0.95.  FIRST calculated a surface water acute EDWC of 6.515 ug/L (ppb) and a chronic EDWC of 1.596 ug/L (ppb).  SCI-GROW calculated a groundwater EDWC (acute and chronic) of 0.00428 ug/L (ppb).  Since the surface water EDWCs exceed the ground water EDWC, the surface water values are considered to be protective for any ground water concentration concerns.

Acute Exposure from Drinking Water.  The acute surface water EDWC of 6.515 ppb was input directly into the DEEM-FCID(TM) software as "water, direct and indirect, all sources" to model the acute drinking water exposures.  Exposure contributions at the 99.9[th]%-ile of exposures were determined by taking the difference between the aggregate (food + drinking water) exposures and the food (alone) exposures for each population subgroup.  Acute drinking water exposure to the U.S. population resulted in an acute drinking water MOE of 38,265 (0.3% of the acute RfD of 0.15 mg/kg-bw/day).  The most exposed sub-population was infants (<1 year old) with an acute drinking water MOE of 20,107 (0.5% of the aRfD of 0.15 mg/kg/day).  Since the benchmark MOE for this assessment was 100 and since the EPA has no concern for exposures resulting in an MOE above the Benchmark MOE or below 100% of the reference dose, Syngenta believes that there is a reasonable certainty that no harm will result from drinking water exposure to residues arising from the proposed uses for benzovindiflupyr.

Chronic Exposure from Drinking Water.  The chronic surface water EDWC of 1.596 ppb was input directly into the DEEM-FCID(TM) software as "water, direct and indirect, all sources" to model the chronic drinking water exposures.  Chronic drinking water exposure to the U.S. population resulted in a chronic drinking water MOE of 146,624 (0.1% of the chronic RfD of 0.05 mg/kg-bw/day).  Chronic drinking water exposure to the most exposed sub-population (infants, <1 year old) resulted in a chronic drinking water MOE of 56,864 (0.2% of the chronic RfD of 0.05 mg/kg-bw/day).  Since the benchmark MOE for this assessment was 100 and since the EPA has no concern for exposures resulting in an MOE above the Benchmark MOE or below 100% of the reference dose, Syngenta believes that there is a reasonable certainty that no harm will result from drinking exposure to residues arising from the proposed uses for benzovindiflupyr.

	2. Non-dietary exposure. Non-dietary residential exposure risk assessments were performed for use of benzovindiflupyr formulated as an emulsifiable concentrate, soluble liquid or wettable granule for residential turf including sod farms, golf courses, and sports fields.  Residential exposure risk assessments were performed for use of benzovindiflupyr formulated as a wettable granule for ornamentals grown in greenhouses and outdoor nurseries and for vegetable transplants grown for resale to customers.  Benzovindiflupyr is labeled for professional use only; therefore no residential handler exposure assessments are required.  Assessments were performed using a short-term dermal and incidental oral endpoint of 15 mg/kg/day based on the NOAEL from a prenatal developmental toxicity study in rats and an intermediate-term endpoint of 7.6 mg/kg/day based on the NOAEL from a 90-day dietary toxicity study in rats.  Dermal absorption was assumed to be 1.27% based on the in vivo/in vitro relationship between the rat and human dermal absorption systems.  The maximum residential exposure to adults was due to gardening activities using greenhouse and nursery treated plants, resulting in short- and intermediate-term residential MOEs of 27,780 and 14,075, respectively.  The maximum residential exposure to youths age 6-11 years was due to gardening activities using greenhouse and nursery treated plants, resulting in short- and intermediate-term residential MOEs of 40,583 and 20,562, respectively.  The maximum residential exposure to youths age 11-16 years was due activities on treated golf courses, resulting in short- and intermediate-term residential MOEs of 496,163 and 251,389, respectively.  The maximum residential exposure to children 1-2 years was due to play activities on treated turf, resulting in short- and intermediate-term residential MOEs of 12,030 and 6,095, respectively.

D. Cumulative Effects

	Cumulative Exposure to Substances with a Common Mechanism of Toxicity.  Section 408(b)(2)(D)(v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider "available information" concerning the cumulative effects of a particular pesticide's residues and "other substances that have a common mechanism of toxicity".  The EPA does not have, at this time, available data to determine whether benzovindiflupyr has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment.  For the purposes of this tolerance action, the EPA has not assumed that benzovindiflupyr has a common mechanism of toxicity with other substances.

E. Safety Determination

	1. U.S. population. The acute aggregate exposure calculation for proposed uses of benzovindiflupyr provided an MOE of 10,390 or 1.0% of the aRfD (Benchmark MOE = 100; aRfD = 0.15 mg/kg-bw/day) for the U.S. population.  The chronic aggregate exposure calculation for proposed uses of benzovindiflupyr provided an MOE of 73,134 or 0.1% of the cRfD (Benchmark MOE = 100; cRfD = 0.05 mg/kg-bw/day) for the U.S. population.  Since the aggregate MOEs exceed the benchmark MOE of 100, Syngenta believes that there is a reasonable certainty that no harm will occur to the U.S. Population from acute, short-term, intermediate-term, or chronic aggregate exposures arising from the proposed uses for benzovindiflupyr.

	2. Infants and children. The acute aggregate exposure calculation for proposed uses of benzovindiflupyr provided an MOE of 4,869 or 2.1% of the aRfD (Benchmark MOE = 100; aRfD = 0.15 mg/kg-bw/day) for children 1-2 years old (the most sensitive subpopulation for the acute assessment).  The short-term aggregate assessment resulted in an MOE of 10,886 for the children (1-2 years old) population subgroup (Benchmark MOE = 100).  The intermediate-term aggregate assessment resulted in an MOE of 5,516 for the children (1-2 years old) population subgroup (Benchmark MOE = 100). The chronic aggregate exposure calculation for proposed uses of benzovindiflupyr provided an MOE of 37,292 or 0.3% of the cRfD (Benchmark MOE = 100; cRfD = 0.05 mg/kg-bw/day) for the children (1-2 years old) (the most sensitive subpopulation for the chronic assessment).  Since the worst-case aggregate MOE of 5,516 exceeds the benchmark MOE of 100, Syngenta believes that there is a reasonable certainty that no harm will occur to infants and children from acute, short-term, intermediate-term, or chronic aggregate exposures arising from the proposed uses for benzovindiflupyr

F. International Tolerances

	There are currently no Maximum Residue Limits (MRLs) set for Benzovindiflupyr for crops by the Codex Alimentarius Commission and international MRLs for the fungicide Benzovindiflupyr have not been established.


[Federal Register Volume 82, Number 34 (Wednesday, February 22, 2017)]
[Proposed Rules]
[Pages 11329-11332]
[FR Doc No: 2017-03405]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 110

[Docket Number USCG-2015-0729]
RIN 1625-AA01

Port of Miami Anchorage Area; Atlantic Ocean, Miami Beach, FL

AGENCY: Coast Guard, DHS.

ACTION: Supplemental notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: The Coast Guard proposes to amend the Miami Anchorage. The
Miami Anchorage would be divided into two separate anchorage areas.
This action is necessary to reduce potential damage to threatened coral
posed by anchoring vessels. We invite your comments on this
supplemental proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before March 24, 2017.

ADDRESSES: You may submit comments identified by docket number USCG-
2015-0729 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email MST2 Benjamin R. Colbert, Sector
Miami Waterways Management Division, U.S. Coast Guard; telephone 305-
535-4317, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
SNPRM Supplemental notice of proposed rule making
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    On December 1, 2015, the Coast Guard published a notice of study
(80 FR 75020) that indicated we were evaluating amending the Miami
Anchorage to divide the anchorage into two smaller anchorage areas. The
proposed amendment was designed in coordination with a variety of local
stakeholders, including the South East Florida Coral Reef Initiative
(SEFCRI). Comments provided by these stakeholders, academic research,
and environmental reports raised concerns with the Coast Guard about
the potential for damage to the Florida Reef in the Miami Anchorage.
Examples of the body of work that influenced the Coast Guard in
proposing the amendment may be found in the docket.
    In response to the notice of study, the Coast Guard received four
comments. These comments were addressed in an NPRM published on May 10,
2016 (81 FR 28788). In response to the NPRM, we received four
additional comments. Two of the comments, one by the local non-profit
Miami Waterkeeper and the other by a private citizen, supported our
planned modification of the Miami Anchorage. The third and fourth
comments were submitted by the Biscayne Bay Pilots Association.
    The Biscayne Bay Pilots Association (pilots) submitted a comment,
through the Port of Miami, on May 17, 2016. This comment requested the
Coast Guard to evaluate changes in the proposed anchorage, including
shifting the outer anchorage west and shifting the southern boundary of
the outer anchorage north. In response to these comments, the Coast
Guard met with the Pilots to discuss the requests and the basis at
which the Coast Guard arrived at the proposed anchorage configuration.
During the meeting, the Coast Guard agreed that shifting the western
boundary of the outer anchorage approximately 300 feet to the west
would provide more room for large anchoring vessels. This change would
not have any effect on coral or hardbottom as the sea floor in that
area is sand.
    On June 11, 2016, the Pilots submitted a follow up comment to the
public docket expressing concern that the outer anchorage would expose
vessels to increased current and waves and, they claim, could increase
the chance a vessel would drag anchor. To properly assess environmental
conditions and risk of an anchor drag, the Coast Guard consulted with
the National Weather Service and Maersk Training Center. The National
Weather Service conducted a study, analyzing the previous year's
current in the vicinity of the anchorage. The Weather Service found
that the average current in the area of the outer anchorage over the
previous year was approximately 1.2 knots with current ranging plus or
minus half a knot from the mean current 70 percent of the time. This
information was provided to the Maersk Training Center in Svendborg,
Denmark. Subject matter experts at the Training Center indicated that
the conditions posed no significant hazard and that Masters would have
the training and experience to set an anchor in the deeper waters of
the outer anchorage.
    In addition to consulting with experts, the Coast Guard has made
minor changes to the proposed anchorage regulations that would further
ensure the safety of all vessels anchoring in the outer anchorage.
Vessels using the Miami Anchorage would be prohibited from anchoring
with engines off or in a ``dead ship'' status and would be required to
maintain a bridge watch with an English speaking deck officer. Finally,
the Coast Guard will submit amendments to the local Coast Pilot to
provide improved guidance to vessels planning to anchor in the outer
anchorage.
    In addition to the discussions with the Biscayne Bay Pilots
Association and SEFCRI discussed above, the Coast Guard consulted with
a number of other stakeholders and subject matter experts in the
development of this Supplemental Notice of Proposed Rulemaking (SNPRM).
Several biologists from the University of Miami and Nova Southeastern
University supported the proposed changes to the Miami Anchorage. The
Florida State Historical Preservation Officer determined that there
were no known cultural resources

that would be impacted by the proposed changes and opined that the
proposed changes to the anchorage would have no effect on historic
properties listed, or eligible for listing, on the National Register
for Historic Places. The Habitat Conservation Division of the National
Marine Fisheries Service supports relocating the anchorage as a means
to reduce the continued degradation of coral reef and hardbottom in
this area from anchoring activities. The Florida Department of
Environmental Protection strongly supports this rulemaking and
relocating the anchorage as a means to reduce the continued degradation
of coral reef and hardbottom in this area from anchoring activities.
    The Coast Guard is committed to continued outreach, consultation,
and communication in order to ensure effective rulemaking and invites
your comments to the proposed rule in this SNPRM. All comments
referenced above, having been received directly and not submitted to
the www.regulations.gov portal, will be added to the docket for public
review.

III. Discussion of Proposed Rule

    In this SNPRM, the Coast Guard proposes to amend the Miami
Anchorage by dividing the anchorage into two smaller anchorage areas.
The amended coordinates would establish two anchorages with a combined
area of approximately 1.5 square miles and reduce the total anchorage
area by approximately 3 square miles. The amended anchorage areas would
be established with the following coordinates:

                      Small Inner Western Anchorage
                    [Approximate water depths: 45 ft]
------------------------------------------------------------------------
                                       Latitude            Longitude
------------------------------------------------------------------------
NW Corner......................  25[deg]47'57.687''   080[deg]05'37.225'
                                  N.                   ' W.
NE Corner......................  25[deg]47'57.341''   080[deg]05'26.466'
                                  N.                   ' W.
SE Corner......................  25[deg]46'31.443''   080[deg]05'27.069'
                                  N.                   ' W.
SW Corner......................  25[deg]46'31.557''   080[deg]05'37.868'
                                  N.                   ' W.
------------------------------------------------------------------------

                      Large Outer Eastern Anchorage
                   [Approximate water depths: 120 ft]
------------------------------------------------------------------------
                                       Latitude            Longitude
------------------------------------------------------------------------
NW Corner......................  25[deg]48'13.841''   080[deg]04'59.155'
                                  N.                   ' W.
NE Corner......................  25[deg]48'04.617''   080[deg]04'04.582'
                                  N.                   'W.
SE Corner......................  25[deg]46'32.712''   080[deg]04'28.387'
                                  N.                   ' W.
SW Corner......................  25[deg]46'43.770''   080[deg]05'02.360'
                                  N.                   ' W.
------------------------------------------------------------------------

    Additionally, in response to comments received from the Biscayne
Bay Pilots Association and others, the Coast Guard has proposed minor
changes to the anchorage regulations. Vessels anchored in the Miami
Anchorage will prohibited from anchoring with engines off or in a
``dead ship'' status and vessels will be required to seek permission of
the Captain of the Port Miami prior to anchoring for longer than 72
hours. In addition to the above changes, we have reordered and reworded
the proposed anchoring regulations.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive orders.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. This SNPRM has not been designated
a ``significant regulatory action,'' under Executive Order 12866.
Accordingly, the SNPRM has not been reviewed by the Office of
Management and Budget.
    This regulatory action determination is based on the relatively
minor changes being proposed to the regulation. The regulation would
ensure 1.5 square miles of anchorage areas continue to exist, vessels
will be prohibited from anchoring with engines off or in a ``dead
ship'' status, and vessels will be required to seek permission of the
Captain of the Port Miami prior to anchoring for longer than 72 hours.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to use the
anchorage may be small entities, for the reasons stated in section IV.A
above this proposed rule would not have a significant economic impact
on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section. The Coast Guard will not retaliate against small entities that

question or complain about this proposed rule or any policy or action
of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves reducing
an anchorage. Normally such actions are categorically excluded from
further review under paragraph 34(f) of Figure 2-1 of Commandant
Instruction M16475.lD. We seek any comments or information that may
lead to the discovery of a significant environmental impact from this
proposed rule.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    Documents mentioned in this SNPRM as being available in the docket,
and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that Web site's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

List of Subjects in 33 CFR Part 110

    Anchorage grounds.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 110 as follows:

PART 110--ANCHORAGES

0
1. The authority citation for part 110 continues to read as follows:

    Authority:  33 U.S.C. 471, 1221 through 1236, 2071; 33 CFR 1.05-
1; Department of Homeland Security Delegation No. 0170.1.

0
2. Revise Sec.  110.188 to read as follows:

Sec.  110.188  Atlantic Ocean off Miami and Miami Beach, Fla.

    (a) The anchorage grounds. (1) Anchorage A. All area of the
Atlantic Ocean, encompassed by a line connecting the points of the
following North America Datum 83 coordinates:

------------------------------------------------------------------------
              Latitude                            Longitude
------------------------------------------------------------------------
     25[deg]47'57.687'' N.               080[deg]05'37.225'' W.
     25[deg]47'57.341'' N.               080[deg]05'26.466'' W.
     25[deg]46'31.443'' N.               080[deg]05'27.069'' W.
     25[deg]46'31.557'' N.               080[deg]05'37.868'' W.
------------------------------------------------------------------------

    (2) Anchorage B. All area of the Atlantic Ocean, encompassed by a
line connecting the points of the following North America Datum 83
coordinates:

------------------------------------------------------------------------
              Latitude                            Longitude
------------------------------------------------------------------------
   25[deg] 48' 13.841'' N.             080[deg] 04' 59.155'' W.
   25[deg] 48' 04.617'' N.             080[deg] 04' 04.582'' W.
   25[deg] 46' 32.712'' N.             080[deg] 04' 28.387'' W.
   25[deg] 46' 43.770'' N.             080[deg] 05' 02.360'' W.
------------------------------------------------------------------------

    (b) The regulations. (1) Vessels in the Atlantic Ocean in the
vicinity of Port of Miami entrance channel must anchor only within the
anchorage area hereby defined and established, except in cases of
emergency.
    (2) Prior to entering the anchorage area, all vessels must notify
the Coast Guard Captain of the Port, via the Biscayne Bay Pilots, on
VHF-FM channel 12 or 16.
    (3) All vessels within the designated anchorage must maintain a 24-
hour bridge watch by a licensed or credentialed deck officer proficient
in English, monitoring VHF-FM channel 16. This individual must confirm
that the ship's crew performs frequent checks on the vessel's position
to ensure the vessel is not dragging anchor.
    (4) Vessels may anchor anywhere within the designated anchorage
area provided that: Such anchoring does not interfere with the
operations of any other vessels currently at anchorage; and all anchor
and chain or cable is positioned in such a manner to preclude dragging
over reefs.
    (5) No vessel may anchor in a ``dead ship'' status (that is,
propulsion or control unavailable for normal operations) without the
prior approval of the Captain of the Port. Vessels experiencing
casualties such as main propulsion, main steering or anchoring
equipment malfunction or which are planning to perform main propulsion
engine repairs or maintenance, must,

immediately notify the Coast Guard Captain of the Port via Coast Guard
Sector Miami on VHF-FM channel 16.
    (6) No vessel may anchor within the designated anchorage for more
than 72 hours without the prior approval of the Captain of the Port. To
obtain this approval, contact the Coast Guard Captain of the Port via
the Biscayne Bay Pilots, on VHF-FM channel 12 or 16.
    (7) The Coast Guard Captain of the Port may close the anchorage
area and direct vessels to depart the anchorage during periods of
adverse weather or at other times as deemed necessary in the interest
of port safety or security.
    (8) Commercial vessels anchoring under emergency circumstances
outside the anchorage area must shift to new positions within the
anchorage area immediately after the emergency ceases.
    (9) Whenever the maritime or commercial interests of the United
States so require, the Captain of the Port, U.S. Coast Guard, Miami,
Florida, may direct relocation of any vessel anchored within the
anchorage area. Once directed, such vessel must get underway at once or
signal for a tug, and must change position as directed.

    Dated: February 15, 2017.
S.A. Buschman,
Rear Admiral, U.S. Coast Guard, Commander, Seventh Coast Guard
District.
[FR Doc. 2017-03405 Filed 2-21-17; 8:45 am]
BILLING CODE 9110-04-P