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EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER
(April 15, 2014)
EPA Registration Division contact: Tony Kish,<PHONE_NUMBER>
 Syngenta Crop Protection, LLC PP# 4F8269
EPA has received a pesticide petition 4F8269 from Syngenta Crop Protection, LLC, PO 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 establish a tolerance for residues of fungicide acibenzolar-S-methyl / CGA-245704 (Benzo [1,2,3] thiadiazo1e-7-carbothioic acid-S-methyl ester in or on the raw agricultural commodities

Pome Crop Group 11-10 at 0.03 parts per million (ppm)
Citrus Crop Group 10-10 at 0.01 parts per million (ppm)

EPA has determined that the petition contains data or information regarding the elements set forth in section 180.561 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. Syngenta believes the metabolism of acibenzolar S-methyl has been well characterized.  Only 4.6% and 14.9% of the total radioactive residue (TRR) was non-extractable in lettuce at the recommended application rate and three times the recommended application rate, respectively.  Non-extractables were also low in a tomato metabolism study, 3.4% and 7.4% in tomatoes and foliage, respectively.  The metabolism in these crops proceeded via hydrolysis of benzo [1,2,3] thiadiazole-7-carbothioic acid S-methyl ester to benzo [1,2,3] thiadiazole-7-carboxylic acid (BTCA), followed by conjugation as ester, glycoside and/or other plant constituents.  The metabolism profile supports the use of an analytical enforcement method that accounts for acibenzolar S-methyl and metabolites containing the benzo [1,2,3] thiadiazole-7-carboxylic acid (BTCA) moiety.

   Analytical method.  Syngenta Analytical Method AG-671A is a practical and valid method for the determination and confirmation of acibenzolar S-methyl (CGA245704) in raw agricultural commodities (RAC) and processing substrates from the tobacco, leafy (including brassica) and fruiting vegetable crop groups at a limit of quantitation (LOQ) of 0.02 ppm.  Based on recoveries of dry bulb onion samples fortified at the lower limit of method validation, the limit of detection (LOD) and limit of quantitation (LOQ) were calculated as 0.013 and 0.040 ppm, respectively.  The method involves extraction, solid phase cleanup of samples with analysis by high performance liquid chromatography (HPLC) with ultraviolet (UV) detection or confirmatory LC/MS.  The validity is demonstrated by the acceptable accuracy and precision obtained on numerous procedural recovery samples (radiovalidation and field trial sample sets), and by the extractability and accountability obtained by the analysis of weathered radioactive substrates using Analytical Method AG-671A.

   Magnitude of residues.  A total of 15 GLP residue studies containing 23 field trials have been conducted in Europe, New Zealand, Brazil, and the United States (ongoing) in pome fruit (apples and pears) and citrus (oranges) to determine the residues of acibenzolar-S-methyl resulting from various foliar spray and soil application regimes of the 50% w/w wettable granule formulation.  Foliar treatment regimes consisted of three to eight foliar applications at rates ranging from 20 to 100 g ai/A (1.4  -  7 oz/A) with PHIs ranging from 0 to >100 days after the last application. Soil applied drench application studies are ongoing in the U.S., but samples from exaggerated rate plots (4 applications at 227 g ai/A [16 oz 50WP] with a 0-day PHI) have been analyzed.

  Citrus
  In the orange trials, residues resulting from foliar applications were >LOQ (limit of quantitation; 0.01 ppm) throughout the 0 to 10-day sampling period and ranged from 0.02 to 0.20 ppm.  At a 30 day PHI in foliar applied samples, all residues were below 0.02 ppm. In the US orange trials receiving a 5X rate, applied as a soil drench, residues ranged from <0.01 ppm to 0.02 ppm (0 day PHI). Processing data indicates that residues do not concentrate in orange juice

   Oranges in California and Florida were treated with four soil applications (drench) of 0.5 lb ai/A Actigard(R) (5X rate) at 30 day intervals ending at 0-day PHI.  Three samples per site were analyzed for acibenzolar-S-methyl and its degradate, CGA-210007.   There were no residues greater than the level of quantitation (< 0.01 ppm) in any of the California samples (5X).  In Florida, the residues were < 0.02 ppm.

   Pome
   In apples and pears, residues resulting from foliar applications were < LOQ (limit of quantitation; 0.01 ppm) except when fruit were collected within seven days following the last application. The maximum residues found in the foliar application pear trials ranged from <0.01 to 0.08 ppm and <0.01 to 0.08 ppm in the foliar application apple trials (Table D-1).  At a 30 day PHI, all foliar applied residues were less than 0.02 ppm.  In the U.S. apple trials receiving an exaggerated 5X rate, applied as a soil drench, residues were <0.01 ppm. Processing data from pear trials indicate that residues will not concentrate in processed fractions.

   Apples trees growing in Washington and Michigan were treated with four soil drench applications of 0.5 lb ai/A Actigard(R) 50 WG (5X rate) at 30-day intervals ending at 0-day PHI.  Three samples per site were analyzed for acibenzolar-S-methyl and its primary degradate, CGA-210007.   There were no residues greater than the level of quantitation (< 0.01 ppm) in any of the 5X treated samples at either site.

   B. Toxicological Profile

    Acute toxicity. Acibenzolar S-methyl (CGA245704) has favorable acute toxicity characteristics, resulting in toxicity categories III or IV for oral, dermal and inhalation exposure routes. The acute oral LD50 is greater than 5000 mg/kg and the acute dermal LD50 is greater than 2000 mg/kg.  The acute inhalation LC50 is greater than 5.022 mg/L.  Acibenzolar S-methyl is categorized as slightly irritating to skin and eyes and a potential skin sensitizer.

      Genotoxicty. With the exception of the chromosome aberration study in CHO cells in culture (MRID 44014245), CGA245704 was negative for genotoxicity.  In the chromosome aberration study, there was evidence of a clastogenic response in CHO cells in the absence of S9 activation at 30 and 60 μg/mL at the 18-hour cell harvest time.  Compound precipitation was seen at 60 μg/mL.  Following the prolonged 42-hour cell harvest time, the number of polyploidy cells was increased at 30 and 60 μg/mL (1.8 to 4.3 fold increases, respectively) both with and without S9 activation.  There is also evidence of cell arrest at G2 both with and without S9 activation.  These findings, however, can only be considered to be suggestive evidence of a possible aneuploidy effect since the mouse micronucleus assay up to 4000 mg/kg (MRID 44014244) was negative (US EPA, 1999).  Regarding the mouse micronucleus assay, it is noted that data from the metabolism and pharmacokinetic study (MRID 44014250) indicated that the radioactive parent was found in the blood at 15-30 minutes.  Thus, there is evidence that the test material reached the bone marrow tissue in the mouse micronucleus assay.  Thus, the overall weight of evidence indicates that CGA245704 technical is not mutagenic or clastogenic and does not provoke unscheduled DNA synthesis when tested thoroughly in a battery of standard in vivo and in vitro independent assays, using both eukaryotes and prokaryotes, and with or without metabolic activation.

      3. Reproductive and developmental toxicity. The developmental toxicity characteristics of CGA245704 have been investigated in one guideline rabbit and two rat developmental toxicity studies.  There were no developmental toxicity findings in the rabbit study, and the maternal NOAEL was 50 mg/kg.  In the rat developmental toxicity study (MRID 44014236), EPA determined the maternal toxicity NOAEL to be 200 mg/kg/day and the developmental LOAEL to be 10 mg/kg/day based on umbilical hernias, which was the lowest LOAEL in the developmental toxicity studies.  Therefore, the current acute and chronic Population Adjusted Dose for females 13-50 years of age was determined to be 0.0033 mg/kg/day, which takes into account the FQPA 10x (sensitivity to pups) and the 3x (use of LOAEL instead of NOAEL) factors (HIARC; 12/9/1999). However, Syngenta has submitted additional information as part of a previous tolerance petition, which supports the conclusion that the umbilical hernia found at 10 mg/kg is not treatment related and that the additional uncertainty factors may be unwarranted.  Additional evidence was previously provided from additional rat developmental toxicity study (MRID 45089701), mechanistic developmental toxicity tests (MRID Nos. 440014238 and 44014239) and a rat developmental neurotoxicity study (MRID 45713601).  EPA later reviewed the additional support and agreed that the data supports the removal of some of the FQPA uncertainty factors.
In a subsequent rat developmental study, the maternal NOAEL was 350 mg/kg, and the developmental NOAEL was considered to be 150 mg/kg based on increased incidence of lumbar rib.  The umbilical hernia finding was not reproduced (MRID 45089701).  Based on the weight of evidence, the maternal NOAEL should be considered to be 50 mg/kg/day based on reduced body weight development and hemorrhagic perineal discharge at 200 mg/kg/day.  With regards to the developmental findings, the umbilical hernia that was observed at 10 mg/kg in the rat developmental toxicity study (MRID 44014236) was not reproduced in the subsequent rat teratogenicity investigations.  Furthermore, this finding did not follow a dose-response correlation in the original study. Therefore, the developmental NOAEL of this study should be considered to be 50mg/kg based on skeletal variations found at 200 mg/kg. Syngenta has reviewed all of the related developmental, reproductive, and pharmacokinetic studies for acibenzolar-S-methyl, and is still of the opinion that, absent the consequences of severe maternal toxicity, acibenzolar-S-methyl is not teratogenic in rat.
 In the rat multigeneration study, Acibenzolar S-methyl technical had no effect on rat reproductive parameters including gonadal function, estrus cycles, mating behavior, conception, parturition, lactation, weaning, and sex organ histopathology.  This is demonstrated by the results of the following reproductive and developmental studies:
      i. Prenatal developmental toxicity rats- Maternal NOAEL = 50 mg/kg/day.  LOAEL = 200 mg/kg/day based on reduced body weight development and hemorrhagic perineal discharge.  Developmental NOAEL = 50 mg/kg/day. LOAEL = 200 mg/kg/day based on increased incidence of skeletal variations.  Endpoints different from US EPA assessment, refer to weight of evidence assessment for further discussion of this endpoint
      ii. Prenatal developmental toxicity rabbits - Maternal NOAEL = 50 mg/kg/day. LOAEL = 300 mg/kg/day based on mortality, clinical signs of toxicity, decreased maternal body weight and food consumption.  Developmental NOAEL = 300 mg/kg/day. LOAEL = 600 mg/kg/day based on marginal increase in vertebral anomalies.
      iii. Prenatal developmental toxicity rats - Maternal NOAEL = 350 mg/kg/day. LOAEL >350 mg/kg/day based on no effects.  Developmental NOAEL = 150 mg/kg/day. LOAEL = 350 mg/kg/day based on increased incidence of lumbar rib.
      iv. Reproduction and fertility effects rats - Parental/Systemic NOAEL = 200 ppm (11-31 mg/kg/day). LOAEL = 2000 ppm (105-288 mg/kg/day) based on increased weights and hemosiderosis of the spleen.  Reproductive NOAEL = 4000 ppm (223-604 mg/kg/day). LOAEL is greater than 4000 ppm (223-604 mg/kg/day) based on no effects.
Offspring NOAEL = 200 ppm (11-31 mg/kg/day).  LOAEL = 2000 ppm (105-288 mg/kg/day) based on reduced pup body weight gains and lower pup body weights during lactation.
      v. Developmental Neurotoxicity - Maternal NOAEL = 4000 ppm (326.2  -  607.8 mg/kg/day) based on no adverse effects.  LOAEL = not determined.
Offspring NOAEL = 4000 ppm (326.2  -  607.8 mg/kg/day) based on no adverse effects on developmental neurotoxicity.  LOAEL = not determined.
      vi.	Special Developmental toxicity rats - Maternal and developmental NOAELs and LOAELs could not be identified by this protocol testing at 300 mg/kg/day. The most pronounced maternal and developmental toxicity occurred when dams were treated on GD6-15.
      vii.	Special Developmental toxicity rats - Maternal and developmental NOAELs and LOAELs could not be identified by this protocol testing at 400 mg/kg/day. The most pronounced maternal and developmental toxicity occurred when dams were treated on GD6-7 or GD8-9.
      viii.	Dermal developmental toxicity rats - Maternal and developmental NOAEL > 500 mg/kg/day. LOAEL >500 mg/kg/day based on no effects.
      ix. Range finding 1-generation reproduction rats- Parental/Systemic NOAEL = 209 mg/kg/day.  LOAEL = 410 mg/kg/day based on decreased body weight gain and food consumption in females.   Reproductive NOAEL = 410 mg/kg/day.  LOAEL = 728 mg/kg/day based on total resorptions in all dams.  Offspring NOAEL = 209 mg/kg/day. LOAEL = 410 mg/kg/day based on reduced pup body weight gains and lower pup body weights during lactation.
      4. Subchronic toxicity. No signs of neurotoxicity were noted with CGA245704 in both acute and subchronic studies even at the highest dose levels of 800 mg/kg and 8,000 ppm, respectively. The evaluated parameters included functional observation battery, motor activity measurement and neurohistopathologic assessment.  This is demonstrated by the results of the following studies:
      i. 90-Day oral toxicity rats- NOAEL: Males = 126 mg/kg/day; Females = 131 mg/kg/day. LOAEL: Males = 516 mg/kg/day; Females = 554 mg/kg/day based on decreased mean body weights, decreased food consumption and efficiency, and increased liver and spleen weights with correlates of glycogen and hemosiderosis for the liver and spleen, respectively.
      ii. 90-Day feeding study dogs- NOAEL = 50 mg/kg/day. LOAEL = 250 mg/kg/day based on decreased body weight, decreased haemoglobin-related parameters, hepatic and splenic hemosiderosis.
      iii. 28-Day dermal toxicity rats- NOAEL = 1,000 mg/kg/day; LOAEL = not identified
      iv. Subchronic Neurotox- Systemic NOAEL = 400 ppm (Males: 24.4 mg/kg/day; Females: 26.0 mg/kg/day). LOAEL = 2000 ppm (Males: 126 mg/kg/day; Females: 143 mg/kg/day) based on decreased body weight gain and food consumption.
      Neurotoxicity NOAEL = 8000 ppm (Males: 575 mg/kg/day; Females: 628 mg/kg/day) based on no effects. LOAEL = not determined.
      v.  28-Day dietary rats, special study- NOAEL = 4000 ppm (Males: 403 mg/kg/day; Females: 376 mg/kg/day). LOAEL = 12,000 ppm (Males: 1070 mg/kg/day; Females: 1000 mg/kg/day) based on decreased mean body weights, decreased liver weights, altered hematology parameters accompanied by increased spleen weights.
      vi.	 28-Day oral gavage rats, special study- NOAEL = 100 mg/kg/day. LOAEL = 800 mg/kg/day based on decreased body weights, and decreased hemoglobin-related parameters accompanied by hemosiderosis of the spleen, increased liver and spleen weights, and decreased thymus weights.
      vii.	 28-Day oral capsule dogs, special study- NOAEL = 50 mg/kg/day. LOAEL = 250 mg/kg/day based on decreased body weight, decreased hemoglobin-related parameters, hepatic and splenic hemosiderosis.
      viii.	 90-Day dietary mice, special study- NOAEL = 200 ppm (Males: 30.6 mg/kg/day; Females: 47.4 mg/kg/day). LOAEL = 1000 ppm (Males: 152 mg/kg/day; Females: 220 mg/kg/day) based on decreased mean body weights and body weight gain in males, increased spleen weights and splenic histopathology in both sexes.
      5. Chronic toxicity. Based on the available toxicity data, Syngenta believes the Reference Dose (RfD) for acibenzolar-S-methyl is 0.11 mg/kg/day. Currently, the chronic cPAD for Females (13-50 years) is 0.0033 mg/kg/day (US EPA, 1999, 2005). No carcinogenic activity was detected in mice and rats at the Maximum Tolerated Dose (MTD). There was no evidence of carcinogenicity in an 18-month feeding study in mice and a 24-month feeding study in rats. Dosage levels in both the mouse and the rat studies were adequate for identifying a cancer risk. Acibenzolar-S-methyl has been classified as a "Not Likely" human carcinogen based on the lack of carcinogenicity in rats and mice (US EPA, 1999, 2005).  This is based on the following studies:
      i.	 Combined Chronic/Carcinogenicity rats- NOAEL = 2500 ppm (Males: 96.9 mg/kg/day; Females: 111 mg/kg/day). LOAEL = 7500 ppm (Males: 312 mg/kg/day; Females: 388 mg/kg/day) based on decreased body weight, body weight gain and food efficiency, mild hemolytic anemia, and increased incidence of alveolar foam cells (females only).
      ii.	Chronic toxicity dogs- NOAEL = 25 mg/kg/day. LOAEL = 200 mg/kg/day based on effects consistent with hemolytic anemia, including hematological effects, hemosiderosis of the liver and spleen, extramedullary hematopoiesis of the spleen, and increased liver weights.
      iii.	Carcinogenicity mice- NOAEL = 100 ppm (Males: 11.1 mg/kg/day; Females: 10.8 mg/kg/day). LOAEL = 2000 ppm (Males: 237 mg/kg/day; Females: 234 mg/kg/day) based on mild hemolytic anemia and hemosiderosis of the liver, spleen, and bone marrow, and extramedullary hematopoiesis of the spleen. No evidence of carcinogenicity.
      6. Animal metabolism. Metabolism proceeded primarily via hydrolysis to form the corresponding carboxylic acid BTCA (CGA210007) which was subsequently conjugated with several amino acids including glycine, lysine and ornithine. Elimination was rapid in all cases. Oxidation of the aromatic ring of the acid was a very minor pathway observed in goats. The metabolic fate of CGA245704 in plants paralleled that observed in animals. The major metabolite in all test systems was the same hydrolysis product BTCA (CGA210007). Thus, the metabolism profile supports the use of an analytical enforcement method that accounts principally for parent and BTCA.
      7. Metabolite toxicology. In short-term toxicity studies in rats, benzo [1,2,3] thiadiazole-7-carboxylic acid (CGA210007) was found to be of , at most, equal or less toxicity than the parent compound.  As with parent CGA245704, the subchronic NOAEL for CGA210007 was 100 mg/kg bwt.
      8. Endocrine disruption. Acibenzolar S-methyl does not belong to a class of chemicals known or suspected of having adverse effects on the endocrine system.  Developmental toxicity studies in rats and rabbits and a reproduction study in rats gave no indication that acibenzolar S-methyl might have any effects on endocrine function related to development and reproduction.  Acibenzolar S-methyl is not a teratogenic hazard except at, or close to, the maximum tolerated dose.  The chronic studies also showed no evidence of a term effect related to the endocrine system.
  C. Aggregate Exposure

1. Dietary exposure.   Acute, short-term and chronic dietary exposure evaluations were completed for acibenzolar-S-methyl using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID, version 3.16).  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.  In addition to all current uses of acibenzolar-S-methyl, this exposure assessment included proposed foliar and soil drench treatment uses on pome fruits (Crop Group 11) and stone fruits  (Crop Group 12).  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 (food only) risk assessments were performed for all population subgroups using an acute reference dose (aRfD) of 0.082 mg/kg-bw/day, based upon a developmental toxicity study in the rat with a no observed adverse effect level (NOAEL) of 8.2 mg/kg-bw/day, an uncertainty factor (UF) of 10X for intra-species variations, a 10X UF for inter-species variations and a 1X FQPA safety factor.  For the purpose of the aggregate risk assessments, the exposure value was expressed in terms of margin of exposure (MOE), which was calculated by dividing the NOAEL by the exposure.  In addition, exposure was expressed as percent acute reference dose (%aRfD).  Acute exposure to the U.S. population resulted in a MOE of 1,123 or 8.9% of the aRfD (Benchmark MOE = 100; aRfD =0.082 mg/kg-bw/day).  Acute food exposure to the most sensitive subpopulation (children 1 to 2 years old) resulted in a MOE of 501 or 20.0% of the aRfD (Benchmark MOE =100; 0.082 mg/kg-bw/day).  Since the Benchmark MOE for this assessment was 100 and since the EPA generally has no concern for exposures below 100% of the aRfD, Syngenta believes that there is a reasonable certainty that no harm will result from acute food exposure to residues arising from all current and proposed uses for acibenzolar-S-methyl.

Chronic exposure:     The chronic food risk assessment for the general U.S. population (except children and females 13 to 49 years old) was performed using a chronic reference dose (cRfD) of 0.25 mg/kg-bw/day, based upon a carcinogenicity study in mice with a no observed adverse effect level (NOAEL) of 25 mg/kg/day, an uncertainty factor (UF) of 10X for intra-species variations, a 10X UF for inter-species variations and a 1X FQPA safety factor.  The chronic dietary (food only) risk assessments for children and females 13 to 49 years old was performed using a cRfD of 0.082 mg/kg-bw/day, based upon a developmental toxicity study in the rat with a no observed adverse effect level (NOAEL) of 8.2 mg/kg-bw/day, an uncertainty factor (UF) of 10X for intra-species variations, a 10X UF for inter-species variations, and a 1X FQPA safety factor.  For the purpose of the chronic aggregate risk assessments, the exposure values were expressed in terms of margin of exposure (MOE), which was calculated by dividing the no observed adverse effect level (NOAEL) by the exposure for each population subgroup.  In addition, exposure was expressed as a percent of the chronic reference dose (% cRfD).  Chronic exposure to the U.S. population resulted in a MOE of 6,506 or 1.5% of the cRfD (Benchmark MOE = 100; cRfD = 0.25 mg/kg-bw/day).  Chronic exposure to the most exposed sub-population (children 1 to 2 years old) resulted in a MOE of 2,653 or 3.8% of the cRfD (Benchmark MOE = 100; cRfD = 0.082 mg/kg-bw/day).  Since the Benchmark MOE for this assessment was 100 and since the EPA generally has no concern for exposures below 100% of the cRfD, Syngenta believes that there is a reasonable certainty that no harm will result from chronic dietary (food) exposure to residues arising from all current and proposed uses for acibenzolar-S-methyl.

Cancer.  A chronic cancer exposure analysis was not performed, since acibenzolar-S-methyl has been classified as a "not likely" human carcinogen.

ii. Drinking water. .  The Estimated Drinking Water Concentrations (EDWCs) of acibenzolar-S-methyl, determined as total toxic residues of acibenzolar-S-methyl and its degradate CGA-210007, were determined for the currently registered and proposed Section 3 uses on citrus and pome fruit using Tier l SCI-GROW (version 2.3), which estimates pesticide concentrations in ground water and Tier II PRZM/EXAMS (PE version 5.0) which estimates pesticide concentrations in surface water.  For ground water, the currently registered and proposed uses on citrus and pome fruit provided the highest EDWC of 0.482 ppb (acute and chronic).   For surface water, the currently registered and proposed use on apples provided the highest EDWCs of 23.5 ppb for acute and 7.55 ppb for chronic. The surface water EDWCs for apples have been corrected for a 0.95 PCA factor.  Since the surface water EDWCs exceed the ground water EDWC, the surface water values will be used for risk assessment purposes.

Acute Exposure from Drinking Water:  The acute EDWC of 23.5 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] percentile of exposures were determined by taking the difference between the aggregate (food + drinking water) exposures and the food (alone) exposures for
for each population subgroup.  Acute drinking water exposure U.S. population resulted in a MOE of 9,051 (1.1% of the acute RfD of 0.082 mg/kg-bw/day).  The most exposed sub-population was children (< 1 year old) with an acute MOE of 4,955 or 2.0% of the aRfD.  Since the Benchmark MOE for this assessment was 100, and since the EPA generally has no concern for exposures below 100% of the aRfD, Syngenta believes that there is a reasonable certainty that no harm will result from acute drinking water exposure to residues arising from all current and proposed uses of acibenzolar-S-methyl.

Chronic Exposure from Drinking Water:  The chronic EDWC of 7.55 ppb was input directly into the DEEM-FCID(TM) software as "water, direct and indirect, all sources" directly into the DEEM-FCID(TM) software to model the chronic drinking water exposures.  Chronic drinking water exposure to the U.S. population resulted in a MOE of 158,137 (0.1% of the cRfD of 0.25 mg/kg-bw/day).  The most sensitive subpopulation was infants (<1 year old) with a MOE of 61,330 (0.2% of the cRfD of 0.25 mg/kg-bw/day).  Since the Benchmark MOE for this assessment was 100 and since the EPA generally has no concern for exposures below 100% of the RfD, Syngenta believes that there is a reasonable certainty that no harm will result from chronic drinking water exposure to residues arising from all current and proposed uses of acibenzolar-S-methyl.

Cancer.  A chronic cancer exposure analysis was not performed, since acibenzolar-S-methyl has been classified as a "not likely" human carcinogen.

2. Non-dietary exposure. Short-term exposure assessments were conducted to assess exposures resulting from non-dietary residential contributions of acibenzolar-S-methyl arising from uses on golf course, as well as for exposures due to off-site drift of agricultural products. Activity scenarios for adults (19+ years old) included high contact dermal events and golfer.  Activity scenarios for 11-16 year old youths included golfer.  Activity scenarios for 6-11 year old youths included golfer.  Activity scenarios for children 1-6 years included re-entry into areas potentially subject to off-site drift of agricultural products.  For adults 19+, the worst-case short-term MOE was 1,648 (adult residential drift).  For youths 11-16, the worst-case short-term MOE was 24,460 (youth golfer).  For youths 6-11, the worst-case short-term MOE was 20,835 (youth golfer).  For children 1-6, the worst-case short-term MOE was 922 (combined dermal + hand-to-mouth, via off-site drift of agricultural products).  Since the Benchmark MOE for this assessment was 100 and since the EPA generally has no concern for exposures above the benchmark, Syngenta believes that there is a reasonable certainty that no harm will result from short-term non-dietary exposures arising from all current and proposed uses for acibenzolar-S-methyl.
D. Cumulative Effects

Cumulative Exposure to Substances 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 particular pesticide's residues and "other substances that have a common mechanism of toxicity."  Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to acibenzolar-S-methyl and any other substances, and acibenzolar-S-methyl does not appear to produce a toxic metabolite produced by other substances.  For the purposes of this tolerance action, the EPA has not assumed that acibenzolar-S-methyl has a common mechanism of toxicity with other substances.

E. Safety Determination

1. US. Population. Using the conservative assumptions described above, and based on the completeness and reliability of the toxicity data, the acute aggregate exposure calculation for current and proposed uses of acibenzolar-S-methyl provided a MOE of 999 or 10.0% of the aRfD (Benchmark MOE = 100; aRfD = 0.082 mg/kg-bw/day) for the U.S. population.   The chronic aggregate exposure analysis showed that exposure from all current and proposed uses resulted in a MOE of 6,249 or 1.6% of the cRfD (Benchmark = 100; cRfD = 0.25 mg/kg-bw/day) for the U.S. population.  A cancer exposure analysis was not performed, since there is no evidence of human carcinogenic potential for acibenzolar-S-methyl.  Since the worst-case aggregate MOE of 999 exceeds 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 or chronic aggregate exposures arising from all current and uses of acibenzolar-S-methyl.

2. Infants and children Using the conservative assumptions described above, and based on the completeness and reliability of the toxicity data, the acute aggregate exposure calculation for current and proposed uses of acibenzolar-S-methyl provided a MOE of 478 or 20.9% of the aRfD (Benchmark MOE = 100; aRfD = 0.082 mg/kg-bw/day) for children 1-2 years old (the most sensitive population subgroup).  The chronic aggregate exposure analysis showed that exposure from all current and proposed uses resulted in a MOE of 2,590 or 3.9% cRfD (Benchmark MOE = 100; cRfD = 0.082 mg/kg-bw/day) for children 1-2 years old (the most sensitive population subgroup).  A short-term aggregate MOE of 463 (LOC = 100) was determined for children (1-6 years old).   Since the worst-case aggregate MOE of 463 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 or chronic aggregate exposures arising from the current and proposed uses for all current and proposed uses of acibenzolar-S-methyl.

F. International Tolerances
There are no Codex maximum residue levels established for acibenzolar-S-methyl.  Permanent, time-limited, or provisional MRLs for a variety of commodities have been established in countries including Canada, Japan, Poland, Italy, South Korea and France.


[Federal Register Volume 87, Number 71 (Wednesday, April 13, 2022)]
[Notices]
[Pages 21885-21886]
[FR Doc No: 2022-07943]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9718-01-OA]

Request for Nominations for the Science Advisory Board IRIS
Hexavalent Chromium (Cr(VI)) Review Panel

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) Science Advisory
Board (SAB) Staff Office requests public nominations of scientific
experts to form a Panel to review the draft EPA Integrated Risk
Information System (IRIS) Toxicological Review of Hexavalent Chromium
(Cr(VI)). EPA's draft assessment includes a hazard identification
analysis, which summarizes the chemical properties, toxicokinetics, and
health effects associated exposure, and dose-response analysis, which
characterizes the quantitative relationship between chemical exposure
and each credible health hazard. These quantitative relationships are
then used to derive cancer and non-cancer toxicity values (e.g.,
inhalation unit risk, oral slope factor, reference concentration,
reference dose). The SAB Hexavalent Chromium Review Panel will consider
whether the conclusions found in the EPA's draft assessment are clearly
presented and scientifically supported. The Panel will also be asked to
provide recommendations on how the assessment may be strengthened.

DATES: Nominations should be submitted by May 4, 2022 per the
instructions below.

FOR FURTHER INFORMATION CONTACT: Any member of the public wishing
further information regarding this Notice and Request for Nominations
may contact Dr. Suhair Shallal, Designated Federal Officer (DFO), EPA
Science Advisory Board via telephone/voice mail<PHONE_NUMBER>, or
email at [email protected]. General information concerning the EPA
SAB can be found at the EPA SAB website at https://sab.epa.gov.

SUPPLEMENTARY INFORMATION:
    Background: The SAB (42 U.S.C. 4365) is a chartered Federal
Advisory Committee that provides independent scientific and technical
peer review, advice, and recommendations to the EPA Administrator on
the technical basis for EPA actions. As a Federal Advisory Committee,
the SAB conducts business in accordance with the Federal Advisory
Committee Act (FACA) (5 U.S.C. app. 2) and related regulations. The SAB
Staff Office is forming an expert panel, the SAB Hexavalent Chromium
Review Panel, under the auspices of the Chartered SAB. The SAB
Hexavalent Chromium Review Panel will provide advice through the
chartered SAB. The SAB and the SAB Hexavalent Chromium Review Panel
will comply with the provisions of FACA and all appropriate SAB Staff
Office procedural policies.
    The SAB Hexavalent Chromium Review Panel will conduct a review of
the draft EPA IRIS Toxicological Review of Hexavalent Chromium. EPA's
draft assessment includes a hazard identification analysis, which
summarizes the chemical properties, toxicokinetics, and health effects
associated exposure, and dose-response analysis, which characterizes
the quantitative relationship between chemical exposure and each
credible health hazard. These quantitative relationships are then used
to derive cancer and non-cancer toxicity values (e.g., inhalation unit
risk, oral slope factor, reference concentration, reference dose). The
SAB Hexavalent Chromium Review Panel will consider whether the
conclusions found in the EPA's draft assessment are clearly presented
and scientifically supported. The Panel will also be asked to provide
recommendations on how the assessment may be strengthened.
    Request for Nominations: The SAB Staff Office is seeking
nominations of nationally and internationally recognized scientists
with demonstrated expertise in the following disciplines: Toxicology,
specifically inhalation toxicology/dosimetry, hepatic nephrological,
genetic toxicology; epidemiology; systematic review; physiologically-
based pharmacokinetic (PBPK) modeling; carcinogenesis,

including gastrointestinal; risk assessment; and dose response
analysis.
    Process and Deadline for Submitting Nominations: Any interested
person or organization may nominate qualified individuals in the areas
of expertise described above for possible service on the SAB Panel.
Individuals may self-nominate. Nominations should be submitted in
electronic format (preferred) using the online nomination form on the
SAB website at https://sab.epa.gov (see the ``Public Input on
Membership'' list under ``Committees, Panels, and Membership''). To be
considered, nominations should include the information requested below.
EPA values and welcomes diversity. All qualified candidates are
encouraged to apply regardless of sex, race, disability, or ethnicity.
Nominations should be submitted in time to arrive no later than May 4,
2022. The following information should be provided on the nomination
form: Contact information for the person making the nomination; contact
information for the nominee; and the disciplinary and specific areas of
expertise of the nominee. Nominees will be contacted by the SAB Staff
Office and will be asked to provide a recent curriculum vitae and a
narrative biographical summary that includes: Current position,
educational background; research activities; sources of research
funding for the last two years; and recent service on other national
advisory committees or national professional organizations. Persons
having questions about the nomination procedures, or who are unable to
submit nominations through the SAB website, should contact the DFO at
the contact information noted above. The names and biosketches of
qualified nominees identified by respondents to this Federal Register
notice, and additional experts identified by the SAB Staff Office, will
be posted in a List of Candidates for the Panel on the SAB website at
https://sab.epa.gov. Public comments on the List of Candidates will be
accepted for 21 days. The public will be requested to provide relevant
information or other documentation on nominees that the SAB Staff
Office should consider in evaluating candidates.
    For the EPA SAB Staff Office a balanced review panel includes
candidates who possess the necessary domains of knowledge, the relevant
scientific perspectives (which, among other factors, can be influenced
by work history and affiliation), and the collective breadth of
experience to adequately address the charge. In forming the expert
panel, the SAB Staff Office will consider public comments on the Lists
of Candidates, information provided by the candidates themselves, and
background information independently gathered by the SAB Staff Office.
Selection criteria to be used for panel membership include: (a)
Scientific and/or technical expertise, knowledge, and experience
(primary factors); (b) availability and willingness to serve; (c)
absence of financial conflicts of interest; (d) absence of an
appearance of a loss of impartiality; (e) skills working in committees,
subcommittees and advisory panels; and, (f) for the panel as a whole,
diversity of expertise and scientific points of view.
    The SAB Staff Office's evaluation of an absence of financial
conflicts of interest will include a review of the ``Confidential
Financial Disclosure Form for Environmental Protection Agency Special
Government Employees'' (EPA Form 3110-48). This confidential form is
required and allows government officials to determine whether there is
a statutory conflict between a person's public responsibilities (which
include membership on an EPA federal advisory committee) and private
interests and activities, or the appearance of a loss of impartiality,
as defined by federal regulation. The form may be viewed and downloaded
through the ``Ethics Requirements for Advisors'' link on the SAB
website at https://sab.epa.gov. This form should not be submitted as
part of a nomination.
    The approved policy under which the EPA SAB Office selects members
for subcommittees and review panels is described in the following
document: Overview of the Panel Formation Process at the Environmental
Protection Agency Science Advisory Board (EPA-SAB-EC-02-010), which is
posted on the SAB website at https://sab.epa.gov.

Thomas Brennan,
Director, Science Advisory Board Staff Office.
[FR Doc. 2022-07943 Filed 4-12-22; 8:45 am]
BILLING CODE 6560-50-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am contacting you as an individual consumer requesting an extension of the comment period for the Food and Drug Administration's Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On my own behalf, I am requesting that the comment period for the Proposed Rule be extended from its current 75-day period for an additional 105 days, to 180 days.  This additional time is crucial for me as a consumer.

The Proposed Rule raises many significant issues and questions that are extremely relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I very likely would want to provide comments for. However, my time to devote to researching and providing thoughtful comments on these important questions is limited.  I know that the FDA has taken years to come up with the Proposed Rule, so it is not at all unreasonable to allow the public a mere six months to comment on this important issue. This is our only opportunity as consumers, to provide our feedback.

I feel very strongly about the significance of the electronic cigarette as an alternative to combustible tobacco cigarettes.  I firmly believe that they helped save my health, if not my life. I wish to provide you with my personal story, as well as scientific and evidence-based responses to your questions so that you can take my comment into consideration.

I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority in the past. I would therefore ask that you do so here, so that all who have a stake in this issue can provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


[Federal Register Volume 80, Number 105 (Tuesday, June 2, 2015)]
[Notices]
[Pages 31388-31389]
[FR Doc No: 2015-13352]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0748]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Generic Drug User Fee Cover
Sheet; Form FDA 3794

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments concerning collection of
information using Form FDA 3794 entitled ``Generic Drug User Fee Cover
Sheet.''

DATES: Submit either electronic or written comments on the collection
of information by August 3, 2015.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA, (44 U.S.C. 3501-3520),
Federal Agencies must obtain approval from the Office of Management and
Budget (OMB) for each collection of information they conduct or
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3)
and 5 CFR 1320.3(c) and includes Agency requests or requirements that
members of the public submit reports, keep records, or provide
information to a third party. Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day
notice in the Federal Register concerning each proposed collection of
information, including each proposed extension of an existing
collection of information, before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Generic Drug User Fee Cover Sheet; Form FDA 3794

OMB Control Number 0910-0727--Extension

    On July 9, 2012, the Generic Drug User Fee Act (GDUFA) (Pub. L.
112-144, Title 111) was signed into law by the President. GDUFA,
designed to speed the delivery of safe and effective generic drugs to
the public and reduce costs to industry, requires that generic drug
manufacturers pay user fees to finance critical and measurable program
enhancements. The user fees required

by GDUFA are as follows: A one-time fee for original abbreviated new
drug applications (ANDAs) pending on October 1, 2012 (also known as
backlog applications); fees for type II active pharmaceutical
ingredient (API) and final dosage form (FDF) facilities; fees for new
ANDAs and prior approval supplements (PASs); and a one-time fee for
drug master files (DMFs).
    The purpose of this notice is to solicit feedback on the collection
of information in an electronic form used to calculate and pay generic
drug user fees. Proposed Form FDA 3794, the Generic Drug User Fee Cover
Sheet, requests the minimum necessary information to determine if a
person has satisfied all relevant user fee obligations. The proposed
form is modeled on other FDA user fee cover sheets, including Form FDA
3397, the Prescription Drug User Fee Act Cover Sheet. The information
collected would be used by FDA to initiate the administrative screening
of generic drug submissions and DMFs, support the inspection of generic
drug facilities, and otherwise support the generic drug program. A copy
of the proposed form will be available in the docket for this notice.
    Respondents to this proposed collection of information would be
potential or actual generic application holders and/or related
manufacturers (manufacturers of FDF and/or APIs). Companies with
multiple applications will submit a cover sheet for each application
and facility. Based on FDA's database of application holders and
related manufacturers, we estimate that approximately 460 companies
would submit a total of 3,544 cover sheets annually to pay for
application and facility user fees. FDA estimates that the 3,544 annual
cover sheet responses would break down as follows: 1,439 facilities
fees, 942 ANDAs, 502 PASs, and 661 Type II API DMFs. The estimated
hours per response are based on FDA's past experience with other
submissions and range from approximately 0.1 to 0.5 hours. The hours
per response are estimated at the upper end of the range to be
conservative.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                              FDA form                                  Number of      responses  per    Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA 3794...........................................................             460              7.7            3,544    0.5 (30 min.)            1,772
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: May 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13352 Filed 6-1-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: November 28, 2007 (Volume 72, Number 228)]
[Rules and Regulations]
[Page 67240-67242]
[DOCID:fr28no07-5]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-0193; Directorate Identifier 2007-NE-43-AD;
Amendment 39-15273; AD 2007-24-07]
RIN 2120-AA64

Airworthiness Directives; General Electric Company (GE) CF6-
80C2B1 Turbofan Engine

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for a
GE CF6-80C2B1 turbofan engine, serial number (SN) 690203, with fan
disk, part number (P/N) 1703M78P11, SN RPMDA662, installed. This AD
requires stripping of thermal spray coating, inspection of dovetail
slots, and reapplication of thermal spray coating on certain stage 1
fan disks. This AD results from a report that a repair shop did not
meet the process requirements when applying copper-nickel-indium (Cu-
Ni-In) thermal coating to certain stage 1 fan disks. We are issuing
this AD to prevent possible uncontained release of multiple fan blades,
resulting in damage to the airplane.

DATES: This AD becomes effective January 2, 2008. The Director of the
Federal Register approved the incorporation by reference of certain
publications listed in the regulations as of January 2, 2008.
    We must receive any comments on this AD by January 28, 2008.

ADDRESSES: Use one of the following addresses to comment on this AD:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: U.S. Docket Management Facility, Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Contact General Electric Company via Lockheed Martin Technology
Services, 10525 Chester Road, Suite C, Cincinnati, Ohio 45215,
telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, for the service
information identified in this AD.

FOR FURTHER INFORMATION CONTACT: James Lawrence, Aerospace Engineer,
Engine Certification Office, FAA, Engine and Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803-5299; telephone: (781)
238-7176, fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: GE reported that while recertifying a non-GE
repair shop, they found the shop's process for coating dovetail slots
with a Cu-Ni-In thermal coating did not meet the standard requirements
of GE Substantiation Requirements Repair Document No. RSS-012-S2.
Further investigation by GE identified twelve affected stage 1 fan
disks. We discussed the issue with GE and the repair shop, and we
agreed to allow the repair shop to strip, inspect, and recoat the 12
disks instead of issuing an AD to require the actions. The repair shop
has stripped, inspected, and recoated 11 of the 12 disks. They have not
been able to get the final stage 1 disk, P/N 1703M78P11, SN RPMDA662,
to strip, inspect, and recoat that disk and it remains in service. This
condition, if not corrected, could result in an uncontained release of
multiple fan blades, and possible damage to the airplane

Relevant Service Information

    We have reviewed and approved the technical contents of GE Service
Bulletin (SB) No. CF6-80C2 S/B 72-1121, dated January 23, 2004, that
references procedures for stripping, inspecting, and recoating the
affected stage 1 fan disks.

Differences Between This AD and the Service Information

    GE SB No. CF6-80C2 S/B 72-1121, dated January 23, 2004, recommends
performing the actions within 3,500 cycles-since-last Cu-Ni-In thermal
spray coating of the dovetail slots. This AD requires performing the
actions within 3,500 cycles-since-last Cu-Ni-In thermal spray coating
of the dovetail slots, but before March 31, 2008.

FAA's Determination and Requirements of This AD

    Although no airplanes that are registered in the United States use
these GE CF6-80-C2B1 turbofan engines, the possibility exists that the
engines could be used on airplanes that are registered in the United
States in the future. The unsafe condition described previously is
likely to exist or develop on other GE CF6-80C2B1 turbofan engines of
the same type design. We are issuing this AD to prevent possible
uncontained release of multiple fan blades, resulting in damage to the
airplane. You must use the service information described previously to
perform the actions required by this AD.

FAA's Determination of the Effective Date

    Since there are currently no domestic operators of this engine
model, notice and opportunity for public comment before issuing this AD
are unnecessary. A situation exists that allows the immediate adoption
of this regulation.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety and was not preceded by notice and an opportunity for public
comment. However, we invite you to send us any written relevant data,
views, or arguments regarding this AD. Send your comments to an address
listed under ADDRESSES. Include ``AD Docket No. FAA-2007-0193;
Directorate Identifier 2007-NE-43-AD'' in the subject line of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of the rule that might
suggest a need to modify it.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this AD. Using the search function of the
DMS Web site, anyone can find and read the comments in any of our
dockets, including the name of the individual who sent the comment (or
signed the comment on behalf of an association, business, labor union,
etc). You may review the DOT's complete Privacy Act Statement in the
Federal Register published on April 11, 2000 (65 FR 19477-78).

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is the same as
the Mail address provided in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We have determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have 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.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a summary of the costs to comply with this AD and
placed it in the AD Docket. You may get a copy of this summary at the
address listed under ADDRESSES.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

0
Under the authority delegated to me by the Administrator, the Federal
Aviation Administration amends part 39 of the Federal Aviation
Regulations (14 CFR part 39) as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2007-24-07 General Electric Company: Amendment 39-15273. Docket No.
FAA-2007-0193; Directorate Identifier 2007-NE-43-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective January
2, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to GE CF6-80C2B1 turbofan engine, serial
number 690203, with fan disk, part number (P/N) 1703M78P11, SN
RPMDA662, installed. This engine is installed on, but not limited
to, a Boeing 747-300 airplane.

Unsafe Condition

    (d) This AD results from a report that a repair shop did not
meet the process requirements when applying copper-nickel-indium
(Cu-Ni-In) thermal coating to certain stage 1 fan disks. We are
issuing this AD to prevent possible uncontained release of multiple
fan blades, resulting in damage to the airplane.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within 3,500 cycles-since-last Cu-Ni-In thermal spray
coating of the dovetail slots, but no later than March 31, 2008,
unless the actions have already been done.

Stripping, Inspecting and Recoating the Stage 1 Fan Disk

    (f) Strip the Cu-Ni-In thermal coating from the pressure faces
and slot bottoms of the stage 1 fan disk, and perform a
microstructure evaluation. Use 3.A.(2)(a) through 3.A.(2)(b) of GE
Service Bulletin (SB) No. CF6-80C2 S/B 72-1121, dated January 23,
2004, to strip the thermal coating and perform the microstructure
evaluation.
    (g) Ultrasonic inspect, fluorescent penetrant inspect, and eddy
current inspect stage 1 fan disk. Use 3.A.(2)(c) of GE SB No. CF6-
80C2 S/B 72-1121, dated January 23, 2004, to inspect the disk.
    (h) Apply Cu-Ni-In thermal coating to the pressure faces and
slot bottoms of the stage 1 fan disks, using 3.A.(2)(d) of GE SB No.
CF6-80C2 S/B 72-1121, dated January 23, 2004.

Alternative Methods of Compliance

    (i) The Manager, Engine Certification Office, has the authority
to approve alternative methods of compliance for this AD if
requested using the procedures found in 14 CFR 39.19.

Related Information

    (j) Contact James Lawrence, Aerospace Engineer, Engine
Certification Office, FAA, Engine and Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803-5299; telephone: (781)
238-7176, fax:<PHONE_NUMBER>, for more information about this AD.

Material Incorporated by Reference

    (k) You must use GE Service Bulletin No. CF6-80C2 S/B 72-1121,
dated January 23, 2004, to perform the actions required by this AD.
The Director of the Federal Register approved the incorporation by
reference of this service bulletin in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Contact General Electric Company via
Lockheed Martin Technology Services, 10525 Chester Road, Suite C,
Cincinnati, Ohio 45215, telephone<PHONE_NUMBER>, fax (513) 672-
8422, for a copy of this service information. You may review copies
at the FAA, New England Region, 12 New England Executive Park,
Burlington, MA; or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Burlington, Massachusetts, on November 15, 2007.
Peter A. White,
Assistant Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
 [FR Doc. E7-22922 Filed 11-27-07; 8:45 am]

BILLING CODE 4910-13-P


COBALT COBALT POUNDS TONS BEGINNING COBALT ENDING APPLIED TO TO BE COBALT COBALT CUMULATIVE MONTH INVENTORY PURCHASES COBALT FINISHED TAPE RECYCLED OR EMITTED EMITTED TONS INVENTORY DISPOSED April 2002 2,698 13,068 2,455 1,095 11,992 224 0.11 1.89 May 2002 2,455 14,256 3,359 1,151 12,001 200 0.10 1.75 June 2002 3,359 15,444 3,616 1,302 13,631 254 0.13 1.85 July 2002 3,616 15,444 3,296 1,399 14,104 261 0.13 1.82 August 2002 3,296 14,520 2,563 1,321 13,937 ( 5) 0.00 1.32 September 2002 2,563 15,433 2,691 1,315 13,658 332 0.17 1.45 October 2002 2,691 19,008 2,411 1,641 17,318 330 0.16 1.42 November 2002 2,411 19,008 2,247 1,645 17,127 400 0.20 1.66 December 2002 2,247 15,444 2,698 1,310 13,844 ( 161)  0.08 1.53 January 2003 2,698 16,632 2,790 1,475 14,573 493 0.25 1.67 February 2003 2,790 13,068 2,078 1,219 12,703 ( 143)  0.07 1.34 March 2003 2,078 15,455 2,042 1,391 14,273 ( 174)  0.09 1.01 April 2003 2,042 17,857 2,868 1,486 15,260 286 0.14 1.04 AME COBALT EMISSIONS SUMMARY REPORT


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*
*
*
148
,000
32
.
5
1
0
0
,000
4
2
.
5*
1
988
1
,631,000
5
5
.
5
*
*
*
*
*
*
225
,000
48
.
5
1
0
5
,000
4
3
.
7*
1
989
1
,586,000
5
3
.
1
*
*
*
*
*
*
112
,000
2
3
.
8
*
1
70
,000
6
9
.
3
1
990
1
,414,000
4
6
.
6
*
*
*
*
*
*
180
,000
37
.
6
1
2
7
,000
5
0
.
7*
1
991
1
,740,000
5
6
.
3
*
*
*
*
*
*
195
,000
40
.
1
83
,000
32
.
4
*
1
992
1
,787,000
5
6
.
8
*
*
*
*
*
*
249
,000
49
.
9
1
4
5
,000
5
5
.
3*
1
993
1
,967,000
6
1
.
4
*
*
*
*
*
*
315
,000
61
.
3
98
,000
36
.
7
*
1
994
1
,861,000
5
6
.
3
*
*
*
*
*
*
255
,000
49
.
7
1
1
1
,000
4
4
.
0*
1
995
2
,217,000
6
7
.
7
*
*
*
*
*
*
313
,000
60
.
0
1
7
8
,000
7
0
.
1*
1
996
2
,310,000
6
9
.
6
*
*
*
*
*
*
275
,000
5
0
.
7
*
1
09
,000
41
.
7
*
2
001
3
,053,514
8
8
.
2
32
3,209
109
.
7
96
0,289
116
.
9
1
,089,907
76
.
6
488
,195
74
.
8
1
9
1
,914
7
0.
9
2
002
3
,355,658
9
5
.
7
37
3,140
126
.
1
1
,030,164
125
.
5
1
,201,855
83
.
9
586
,386
85
.
8
1
6
4
,113
5
9.
6
2
003
3
,369,723
9
2
.
7
40
8,342
125
.
0
1
,180,065
138
.
9
122
,577
78
.
2
503
,141
68
.
2
1
5
5
,598
5
4.
5
2
004
3
,478,451
9
4
.
2
29
2,406
8
8
.
6
1
,222,293
143
.
2
1
,205,919
82
.
8
547
,399
71
.
5
2
1
0
,434
7
3.
0
SOURCE: NATIONAL CENTER FOR HEALTH STATISTICS, NATIONAL HEALTH INTERVIEW SURVEY, 1982-1996, 2001-2004
CALCULATIONS PERFORMED BY THE EPIDEMIOLOGY AND STATISTICS UNIT
NOTES:
*
Estimate for which the numerator has a relative standard error of more than 30%.
BLACK
(1) With the revision of the National Health Interview Survey in 1997, the question "During the past 12 months, did anyone in
the family have asthma?" was eliminated and was replaced with two questions: "Have you ever been told by a doctor or other
health professional that you had asthma?" (Table 6) and "During the past 12 months, have you had an episode of asthma or
asthma attack?" (Table 10). Realizing the information gap resulting with the revised questions, "Do you still have asthma?"