[Federal Register Volume 75, Number 242 (Friday, December 17, 2010)]
[Notices]
[Page 79070]
[FR Doc No: 2010-31713]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Notice of Applications for Certificates of Public Convenience and
Necessity and Foreign Air Carrier Permits Filed Under Subpart B
(Formerly Subpart Q) During the Week Ending November 20, 2010

    The following Applications for Certificates of Public Convenience
and Necessity and Foreign Air Carrier Permits were filed under Subpart
B (formerly Subpart Q) of the Department of Transportation's Procedural
Regulations (See 14 CFR 301.201 et seq.). The due date for Answers,
Conforming Applications, or Motions To Modify Scope are set forth below
for each application. Following the Answer period DOT may process the
application by expedited procedures. Such procedures may consist of the
adoption of a show-cause order, a tentative order, or in appropriate
cases a final order without further proceedings.
    Docket Number: DOT-OST-2008-0043 and DOT-OST-2010-0283.
    Date Filed: November 15, 2010.
    Due Date for Answers, Conforming Applications, or Motion To Modify
Scope: December 6, 2010.
    Description: Joint application of Iberia L[iacute]neas
A[eacute]reas de Espa[ntilde]a, S.A. (``Iberia'') and Iberia's wholly
owned subsidiary Iberia L[iacute]neas A[eacute]reas de Espa[ntilde]a
Sociedad An[oacute]nima Operadora (``Iberia Operadora'') requesting the
transfer of Iberia's foreign air carrier permit to Iberia Operadora
effective immediately upon completion of the Iberia-British Airways
consolidation; and transfer of related authorizations is also
requested.

Renee V. Wright,
Program Manager, Docket Operations, Federal Register Liaison.
[FR Doc. 2010-31713 Filed 12-16-10; 8:45 am]
BILLING CODE 4910-9X-P


Thidiazuron Dietary Exposure Assessment DP Number: D321826 PC Code: 120301 Page: 1 of 10 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM DATE: 9/ 26/ 2005 SUBJECT: Thidiazuron: Chronic Dietary Exposure Assessment for the Reregistration Eligibility Decision Revised.

PC Code: 120301 DP Number: D321826 FROM: Toiya Goodlow, Chemist Reregistration Branch1 Health Effects Division ( 7509C)

THROUGH: Whang Phang, Branch Senior Scientist Reregistration Branch1 Health Effects Divison ( 7509C)

TO: John Pates, Chemical Review Manager Special Review and Reregistration Division ( 7508C)

Executive Summary Chronic dietary risk assessments were conducted using the Dietary Exposure Evaluation Model ( DEEM FCID   ) , Version 2.0 and Lifeline   Model Version 3.0, which used food consumption data from the United States Department of Agriculture's ( USDA's) Continuing Surveys of Food Intakes by Individuals ( CSFII) from 1994 1996 and 1998. The analyses were performed to support the reregistration eligibility decision.

Chronic Dietary Exposure Results and Characterization A Tier I chronic dietary exposure assessment was performed for thidiazuron. The assumptions of these dietary exposure assessments were tolerance level residues and 100% crop treated, with the Thidiazuron Dietary Exposure Assessment DP Number: D321826 PC Code: 120301 Page: 2 of 10 exception of ruminant meat, meat byproducts, and fat tolerances. Existing meat, meat byproduct, and fat tolerance levels were not used in the assessment because the magnitude of the residue study for ruminant commodities suggests higher residue values than the current tolerance level. Therefore, proposed tolerances were used for these commodities. The dietary exposure analyses for thidiazuron result in dietary risk estimates for food and water that are below the Agency's level of concern for chronic dietary exposure. For the chronic analyses, the highest exposure and risk estimates were for children 1 to 2 years old. For DEEM FCID   , the chronic exposure for children 1 to 2 years old was 0.002867 mg/ kg/ day, which utilizes 7.3% of the chronic Population Adjusted Dose ( cPAD) for thidiazuron. For the Lifeline Model, the chronic exposure for children 1 to 2 years was old 0.00254 mg/ kg/ day, which also utilizes 6.5% of the cPAD for thidiazuron.

I. Introduction The dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose ( i. e., the dose which HED has concluded will result in no unreasonable adverse health effects). This dose is referred to as the population adjusted dose ( PAD). The PAD is equivalent to the reference dose ( RfD) divided by the special Food Quality Protection Act ( FQPA) Safety Factor.

For non cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. References which discuss the chronic risk assessments in more detail are available on the EPA/ pesticides web site: " Available Information on Assessing Exposure from Pesticides, A User's Guide," 6/ 21/ 2000, web link: http:// www. epa. gov/ fedrgstr/ EPA PEST/ 2000/ July/ Day 12/ 6061. pdf; or see SOP 99.6 ( 8/ 20/ 99).

This action represents a revised version of the dietary exposure assessment dated May 2, 2005 for thidiazuron.

II. Residue Information Thidiazuron Use:

Currently thidiazuron tolerances are established for the combined residues of thidiazuron and its aniline containing metabolites.

CFR Reference: 40 § 180.403 Commodity Tolerance ( ppm) Cotton, undelinted seed 0.4 Meat, meat byproducts, and fat 0.2 Thidiazuron Dietary Exposure Assessment DP Number: D321826 PC Code: 120301 Page: 3 of 10 Poultry meat, meat byproducts, and fat 0.2 Eggs 0.1 Milk 0.05

Residues of Concern Plant: Parent only, thidiazuron [ 1 phenyl 3( 1,2,3 thidiazol 5 yl) urea]

Livestock commodities: Parent, thidiazuron and metabolites, 4 hydroxy thidiazuron [ 1( 4 hydrophenyl) 3( 1,2,3 thidiazol 5 yl) urea] and phenylurea Water: Parent, thidiazuron and photoproducts, photothidiazuron [ 1 pheynl 3( 1,2,5 thidiazol 3 yl) urea] and 1 cyano 3 phenylurea The residues of concern for plant and livestock commodities were determined by the HED Metabolism Committee ( 9/ 29/ 95, F. Fort). The water residues of concern were calculated in the Thidiazuron Drinking Water Assessment provided by EFED ( D244574, 9/ 24/ 04, A. Clem). Since the HED Metabolism Assessment Review Committee ( MARC) did not determine the residues of concern for water, EFED provided three surface water exposure scenarios for thidiazuron. The most conservative of the three scenarios was chosen for the dietary exposure assessment.

Residue Data Used for Chronic Assessments:

Tolerance level residues and 100% crop treated were used for all commodities included in these assessments, with the exception of ruminant meat, meat byproducts, and fat tolerances. Adequate magnitude of residue data are not available for ruminant livestock commodities. It is tentatively concluded, pending a storage stability and raw data to validate the feeding study, that residues of thidiazuron and its metabolites of concern are not expected to exceed 0.05 ppm for milk and 0.4 ppm for meat, meat byproducts, and fat. HED used these estimates in the dietary assessment from the existing magnitude of residue study to obtain reasonable high end estimates of total thidiazuron residues in ruminant livestock commodities.

Poultry commodities were not included in the dietary assessment. Tolerances are no longer required for residues of thidiazuron in/ on poultry. The presently registered uses of thidiazuron are classified as Category 3 of 40 CFR § 180.6( a) with respect to the need for tolerances in poultry and eggs i. e., there is no reasonable expectation of finite residues. No processing factors were incorporated into these assessments.

Potential drinking water concentrations for the chronic assessments were estimated using two EFED Tier 1 screening level models: FIRST, Version 1.0 and SCI GROW, Version 2.3. Since the HED Metabolism Assessment Review Committee ( MARC) did not determine the residues of concern for water, EFED provided three estimates for possible drinking water concentrations. Thidiazuron Dietary Exposure Assessment DP Number: D321826 PC Code: 120301 Page: 4 of 10 The most conservative numbers were used for the chronic assessments, which included thidiazuron and both photoproducts, photothidiazuron and 1 cyano 3 phenylurea in its estimate. The water concentration values used was 0.001 ppm for the chronic assessments.

III Program and Consumption Information Several reasonable peer reviewed softwares have recently been emerging for modeling dietary exposure to pesticides. For a variety of technical, historical, and availability reasons, DEEMTM was the program generally used by EPA's Office of Pesticide Programs ( OPP) for conducting its dietary risk assessments. With the advent and current availability of a number of other exposure software programs, OPP, registrants, and other interested parties have available to them the option of selecting other peer reviewed exposure software in conducting risk assessments for pestices. LifelineTM is one such model and is the sofware being used in this HED review. Dietary exposure assessments may also be performed with other, similar programs, and if submitted, such results will be reviewed by EPA for acceptability and comparability to existing peer reviewed software being used by OPP.

III a. DEEM FCID   Program and Consumption Information A thidiazuron chronic dietary exposure assessment was conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database ( DEEM FCID   , Version 2.0), which incorporates consumption data from USDA's Continuing Surveys of Food Intakes by Individuals ( CSFII), 1994 1996 and 1998. The 1994 96, 98 data are based on the reported consumption of more than 20,000 individuals over two non consecutive survey days. Foods " as consumed" ( e. g., apple pie) are linked to EPA defined food commodities ( e. g. apples, peeled fruit  cooked; fresh or N/ S; baked; or wheat flour  cooked; fresh or N/ S, baked) using publicly available recipe translation files developed jointly by USDA/ ARS and EPA. For chronic exposure assessment, consumption data are averaged for the entire U. S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events. Based on analysis of the 1994 96, 98 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U. S. population, all infants (< 1 year old), children 1 2, children 3 5, children 6 12, youth 13 19, adults 20 49, females 13 49, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or foodform ( e. g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/ food form to produce a residue intake estimate. The resulting residue intake estimate for each food/ food form is summed with the residue intake estimates for all other food/ food forms on the commodity residue list to arrive at the total average estimated exposure. Exposure is expressed in mg/ kg body weight/ day and as a percent of the Thidiazuron Dietary Exposure Assessment DP Number: D321826 PC Code: 120301 Page: 5 of 10 cPAD. This procedure is performed for each population subgroup.

III b. Lifeline   Program and Consumption Information Chronic dietary exposure estimates were also conducted using the Lifeline   model ( Version 3.0). These Lifeline   assessments were also conducted using the same consumption data as the DEEM FCID   ( CSFII, 1994 1996 and 1998 consumption data with FCID). Lifeline   uses the recipe file to relate RACs to foods " as eaten." Lifeline   converts the RAC residues into food residues by randomly selecting a RAC residue value from the " user defined" residue distribution ( created from the residue, percent crop treated, and processing factors data), and calculating a net residue for that food based on the ingredients' mass contribution to that food item. For example, ` apple pie' will have a residue distribution based on the residues provided for apples ( adjusted by the appropriate processing factors and percent crop treated), as well as the residues for each of the other ingredients in the apple pie recipe for which there may be tolerances. Lifeline   calculates dietary exposure from ` apple pie' based on the amount eaten, and the residue drawn from the ` apple pie' residue distribution for that eating occasion.

Lifeline   models the individual's dietary exposures over a season by selecting a new CSFII diary each day from a set of similar individuals based on age and season attributes. Lifeline   groups CSFII diaries based on the respondents' age and the season during which the food diary was recorded. Further information regarding the Lifeline   model can be found at the following web site: www. theLifeline   group. org.

IV. Toxicological Information Table I. Summary of Toxicological Dose and Endpoints for Dietary Exposure Assessment of Thidiazuron Exposure Scenario Dose Used in Risk Assessment, UF Hazard and Exposure Based Special FQPA Safety Factor Study and Toxicological Effects Chronic Dietary ( All populations) NOAEL= 3.93 mg/ kg/ day UF = 100 Chronic RfD = 0.0393 mg/ kg/ day FQPA SF = 1X cPAD = chronicRfD FQPA SF = 0.0393 mg/ kg/ day Dog chronic toxicity study LOAEL = 11.1 mg/ kg/ day based on increased incidence of anemia, changes in hematological parameters and marked hemosiderosis in liver and spleen.

Cancer Both rat and mouse carcinogenicity studies did not show treatment related increase in tumor incidences. Thidiazuron Dietary Exposure Assessment DP Number: D321826 PC Code: 120301 Page: 6 of 10 V. Results/ Discussion As stated above, for chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD. The DEEM FCID   analysis estimates the dietary exposure of the U. S. population and various population subgroups. The results reported in Table II are for the general U. S. Population, all infants (< 1 year old), children 1 2, children 3 5, children 6 12, youth 13 19, females 13 49, adults 20 49, and adults 50+ years.

Chronic dietary risks were also estimated using the Lifeline   model ( version 3.0). The Lifeline   chronic dietary exposure estimate is based on an average daily exposure from a profile of 1000 individuals over a one year period. Results of the Lifeline   analysis are fully consistent with DEEM FCID   results. The Lifeline   model estimates can also be found in Table II.

Results of Chronic Dietary Exposure Analysis The chronic assessments estimate the dietary exposure of the general U. S. population, all infants (< 1 year old), children 1 2, children 3 5, children 6 12, youth 13 19, adults 20 49, females 13 49, and adults 50+ years old. The highest exposure and risk estimates were for children 1 to 2 years old. For DEEM FCID   , the chronic exposure for children 1 to 2 years old was 0.002867 mg/ kg/ day, which utilizes 7.3% of the cPAD for thidiazuron. For the Lifeline Model, the chronic exposure for children 1 to 2 years was old 0.00254 mg/ kg/ day, which also utilizes 6.5% of the cPAD for thidiazuron. The results of the chronic dietary analyses for both models are reported in Table II.

Table II. Chronic Dietary Exposure and Risk Estimates for Thidiazuron Food and Water Population Subgroup 1 PAD, mg/ kg/ da y DEEM FCID Lifeline Water Concentration Estimates ( ppb) Exposure, mg/ kg/ day % PAD 2 Exposure, mg/ kg/ day % PAD 2 Chronic Dietary Estimates U. S. Population 0.0393 0.000899 2.3 0.000832 2.1 1.0 All infants (< 1 yr) 0.0393 0.000928 2.4 0.000809 2.1 1.0 Children 1 2 yrs 0.0393 0.002867 7.3 0.00254 6.5 1.0 Thidiazuron Dietary Exposure Assessment DP Number: D321826 PC Code: 120301 Page: 7 of 10 Children 3 5 yrs 0.0393 0.002252 5.7 0.00219 5.6 1.0 Children 6 12 yrs 0.0393 0.001482 3.8 0.00139 3.5 1.0 Youth 13 19 yrs 0.0393 0.000869 2.2 0.000814 2.1 1.0 Adults 20 49 yrs 0.0393 0.000680 1.7 0.000725 1.9 1.0 Adults 50+ yrs 0.0393 0.000567 1.4 0.000701 1.8 1.0 Females 13 49 yrs 0.0393 0.000595 1.5 0.000830 2.1 1.0 Cancer Dietary Estimate U. S. Population Toxicological studies did not indicate any cancer risks for thidiazuron, thus a cancer assessment was not performed.

1 The values for the population with the highest risk for each type of risk assessment are bolded. 2 Reported to 1 significant figure.

VI. Conclusions A Tier I dietary exposure assessment was performed for thidiazuron. The assumptions of these dietary exposure assessments were tolerance level residues and 100% crop treated, with the exception of ruminant meat, meat byproducts and fat. The dietary exposure analyses in this assessment for thidiazon result in dietary risk for food and water estimates that are below the Agency's level of concern for chronic dietary exposure. The highest exposure and risk estimates were for children 1 to 2 years old. For DEEM FCID   , the chronic exposure for children 1 to 2 years old was 0.002867 mg/ kg/ day, which utilizes 7.3% of the cPAD for thidiazuron. For the Lifeline Model, the chronic exposure for children 1 to 2 years was old 0.00254 mg/ kg/ day, which also utilizes 6.5% of the cPAD for thidiazuron.

As stated above, for chronic dietary exposure assessments, HED is concerned when dietary risk exceeds 100% of the PAD. Both models show that the chronic exposure is < 8% of the cPAD for thidiazuron.

VII. References DP Barcode D244574. Alex Clem. September 24, 2004. Drinking Water Assessment Felecia A. Fort. September 29, 1995. HED Metabolism Committee Decision following the 9/ 18/ 95 meeting.

MRID 43781901. DP Barcode D220968. Stephen Funk. February 15, 1996. Thidiazuron: Thidiazuron Dietary Exposure Assessment DP Number: D321826 PC Code: 120301 Page: 8 of 10 Response to the Phase 4 Review Magnitude of the Residue in Ruminants.

DP Barcode D319302. Toiya Goodlow. August 31, 2005. Thidiazuron: Revised HED Chapter of the Reregistration Eligibility Decision Document ( RED), Phase 3 Public Comments.

VIII. List of Attachments Attachment 1: DEEM FCID   Chronic Food plus Water Residue Input file; Lifeline available electronically. Attachment 2: Chronic DEEM FCID   Results file; Lifeline available electronically.

cc: T. Goodlow/ HED/ RRB1.

Attachment 1: DEEM FCID   Chronic Food plus Water Residue Input file.

U. S. Environmental Protection Agency Ver. 2.00 DEEM FCID Chronic analysis for THIDIAZURON 1994 98 data Residue file: C:\ 2004DEEMFCID\ Thidiazuron\ thidiazuron_ phase3_ food& H2O. R98 Adjust. # 2 NOT used Analysis Date 09 21 2005 Residue file dated: 08 29 2005/ 08: 27: 31/ 8 Reference dose ( RfD) = 0.0393 ( NOEL) = 3.93 mg/ kg bw/ day  Food Crop Residue Adj. Factors Comment Thidiazuron Dietary Exposure Assessment DP Number: D321826 PC Code: 120301 Page: 9 of 10 EPA Code Grp Food Name ( ppm) # 1 # 2        21000440 M Beef, meat 0.400000 1.000 1.000 21000441 M Beef, meat babyfood 0.400000 1.000 1.000 21000450 M Beef, meat, dried 0.400000 1.000 1.000 21000460 M Beef, meat byproducts 0.400000 1.000 1.000 21000461 M Beef, meat byproducts babyfood 0.400000 1.000 1.000 21000470 M Beef, fat 0.400000 1.000 1.000 21000471 M Beef, fat babyfood 0.400000 1.000 1.000 21000480 M Beef, kidney 0.400000 1.000 1.000 21000490 M Beef, liver 0.400000 1.000 1.000 21000491 M Beef, liver babyfood 0.400000 1.000 1.000 95001280 O Cottonseed, oil 0.300000 1.000 1.000 95001281 O Cottonseed, oil babyfood 0.300000 1.000 1.000 23001690 M Goat, meat 0.400000 1.000 1.000 23001700 M Goat, meat byproducts 0.400000 1.000 1.000 23001710 M Goat, fat 0.400000 1.000 1.000 23001720 M Goat, kidney 0.400000 1.000 1.000 23001730 M Goat, liver 0.400000 1.000 1.000 24001890 M Horse, meat 0.400000 1.000 1.000 27002220 D Milk, fat 0.050000 1.000 1.000 27002221 D Milk, fat  baby food/ infant for 0.050000 1.000 1.000 27012230 D Milk, nonfat solids 0.050000 1.000 1.000 27012231 D Milk, nonfat solids baby food/ in 0.050000 1.000 1.000 27022240 D Milk, water 0.050000 1.000 1.000 27022241 D Milk, water babyfood/ infant form 0.050000 1.000 1.000 27032251 D Milk, sugar ( lactose) baby food/ 0.050000 1.000 1.000 25002900 M Pork, meat 0.400000 1.000 1.000 25002901 M Pork, meat babyfood 0.400000 1.000 1.000 25002910 M Pork, skin 0.400000 1.000 1.000 25002920 M Pork, meat byproducts 0.400000 1.000 1.000 25002921 M Pork, meat byproducts babyfood 0.400000 1.000 1.000 25002930 M Pork, fat 0.400000 1.000 1.000 25002931 M Pork, fat babyfood 0.400000 1.000 1.000 25002940 M Pork, kidney 0.400000 1.000 1.000 25002950 M Pork, liver 0.400000 1.000 1.000 26003390 M Sheep, meat 0.400000 1.000 1.000 26003391 M Sheep, meat babyfood 0.400000 1.000 1.000 26003400 M Sheep, meat byproducts 0.400000 1.000 1.000 26003410 M Sheep, fat 0.400000 1.000 1.000 26003411 M Sheep, fat babyfood 0.400000 1.000 1.000 26003420 M Sheep, kidney 0.400000 1.000 1.000 26003430 M Sheep, liver 0.400000 1.000 1.000 86010000 O Water, direct, all sources 0.001000 1.000 1.000 86020000 O Water, indirect, all sources 0.001000 1.000 1.000 Attachment 2: Chronic DEEM FCID   Results file.

U. S. Environmental Protection Agency Ver. 2.00 DEEM FCID Chronic analysis for THIDIAZURON ( 1994 98 data) Residue file name: C:\ 2004DEEMFCID\ Thidiazuron\ thidiazuron_ phase3_ food& H2O. R98 Adjustment factor # 2 NOT used. Analysis Date 09 21 2005/ 09: 10: 03 Residue file dated: 08 29 2005/ 08: 27: 31/ 8 Reference dose ( RfD, Chronic) = .0393 mg/ kg bw/ day NOEL ( Chronic) = 3.93 mg/ kg bw/ day Thidiazuron Dietary Exposure Assessment DP Number: D321826 PC Code: 120301 Page: 10 of 10 =============================================================================== Total exposure by population subgroup

Total Exposure  Population mg/ kg Margin of Percent Subgroup body wt/ day Exposure 1/ of RfD     U. S. Population ( total) 0.000899 4,370 2.3%

U. S. Population ( spring season) 0.000897 4,383 2.3% U. S. Population ( summer season) 0.000897 4,383 2.3% U. S. Population ( autumn season) 0.000919 4,278 2.3% U. S. Population ( winter season) 0.000883 4,450 2.2%

Northeast region 0.000870 4,515 2.2% Midwest region 0.000974 4,036 2.5% Southern region 0.000852 4,610 2.2% Western region 0.000920 4,274 2.3%

Hispanics 0.001050 3,743 2.7% Non hispanic whites 0.000856 4,593 2.2% Non hispanic blacks 0.000973 4,040 2.5% Non hisp/ non white/ non black 0.001043 3,770 2.7%

All infants (< 1 year) 0.000928 4,235 2.4% Nursing infants 0.000290 13,568 0.7% Non nursing infants 0.001170 3,358 3.0% Children 1 6 yrs 0.002405 1,634 6.1% Children 7 12 yrs 0.001400 2,807 3.6%

Females 13 19 ( not preg or nursing) 0.000705 5,573 1.8% Females 20+ ( not preg or nursing) 0.000541 7,270 1.4% Females 13 50 yrs 0.000670 5,866 1.7% Females 13+ ( preg/ not nursing) 0.000798 4,926 2.0% Females 13+ ( nursing) 0.000754 5,213 1.9%

Males 13 19 yrs 0.001025 3,835 2.6% Males 20+ yrs 0.000739 5,319 1.9% Seniors 55+ 0.000563 6,976 1.4%

Children 1 2 yrs 0.002867 1,371 7.3% Children 3 5 yrs 0.002252 1,745 5.7% Children 6 12 yrs 0.001482 2,651 3.8% Youth 13 19 yrs 0.000869 4,521 2.2% Adults 20 49 yrs 0.000680 5,781 1.7% Adults 50+ yrs 0.000567 6,928 1.4% Females 13 49 yrs 0.000595 6,602 1.5%