0.47 (529)

                                      98

                    <0.01, <0.01, <0.01 [<0.01]
                    <0.01, <0.01, <0.01 [<0.01]
                    <0.02, <0.02, <0.02 [<0.02]
                                      --
                                      --
                                      --

                                     Bran

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC

                                     Flour

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC

                                   Middlings

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC

                                    Shorts

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC

                                     Germ

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC
                        Hinton, OK; 2011 (TK0050924-20)
Wheat
                              Pre-processed Grain
                                     (RAC)
                                  0.71 (791)

                                      216

                    <0.01, <0.01, <0.01 [<0.01]
                    <0.01, <0.01, <0.01 [<0.01]
                    <0.02, <0.02, <0.02 [<0.02]
                                      --
                                      --
                                      --

                                     Bran

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC

                                     Flour

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC

                                   Middlings

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC

                                    Shorts

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC

                                     Germ

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC
                       Richland, IA; 2011 (TK0014192-21)
Soybean
                              Pre-processed Seed
                                     (RAC)
0.09 (100.9)

                                      126

                    <0.01, <0.01, <0.01 [<0.01]
                    <0.01, <0.01, <0.01 [<0.01]
                    <0.02, <0.02, <0.02 [<0.02]
                                      --
                                      --
                                      --

                                     Meal

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC

                                     Hulls

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC

                                  Refined oil

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC

                                     Flour

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC

                                   Soy milk

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC

                                     Tofu

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC

                                   Soy sauce

                              <0.01 [<0.01]
                              <0.01[<0.01]
                              <0.02 [<0.02]
                                      NC
                                      NC
                                      NC

                                     Miso

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC

                                    Pollard

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC

                                   Crude oil

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC
                      Marysville, OH; 2011 (TK0014192-22)
Soybean
                              Pre-processed Seed
                                     (RAC)
0.09 (100.9)

130

                    <0.01, <0.01, <0.01 [<0.01]
                    <0.01, <0.01, <0.01 [<0.01]
                    <0.02, <0.02, <0.02 [<0.02]
                                      --
                                      --
                                      --

                                     Meal

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC

                                     Hulls

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC

                                  Refined oil

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC

                                     Flour

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC

                                   Soy milk

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC

                                     Tofu

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC

                                   Soy sauce

                              <0.01 [<0.01]
                              <0.01[<0.01]
                              <0.02 [<0.02]
                                      NC
                                      NC
                                      NC

                                     Miso

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC

                                    Pollard

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC

                                   Crude oil

                         <0.01, <0.01 [<0.01]
                         <0.01, <0.01 [<0.01]
                         <0.02, <0.02 [<0.02]
                                      NC
                                      NC
                                      NC
[1] Application rates in lb ai/A were calculated by the study reviewer from the approximate seeding rate (seed/A) and the actual seed treatment rate (mg ai/seed).  NOTE: Application rates in lb ai/A reported by the petitioner appear to have been calculated using the nominal seed treatment rate in mg ai/seed (0.15 mg ai/seed) instead of the actual seed treatment rates in mg ai/seed (0.14 and 0.155 mg ai/seed).
2 DAP = Days After Planting.  Seeds were planted within 8-43 days of treatment.
3 The LOQ was 0.01 ppm for each analyte in all matrices; the combined LOQ was <0.02 ppm.  Per trial averages were calculated by the study reviewer using the LOQ for values reported as <LOQ.
[4] Processing Factor = [Measured residue for analyte in the processed fraction] / [Measured residue for analyte in the RAC]. Processing factors for this study were not calculated (NC) because residues were below the LOQ (<0.01 ppm for both analytes) in the RAC and processed fraction.
[5] Combined residues of thiabendazole and benzimidazole. Residues of benzimidazole were not converted to parent equivalents..

860.1650 Submittal of Analytical Reference Standards

Analytical standards are currently available for thiabendazole (expiration 3/31/2017) and 5-hydroxy-thiabendazole (expiration 2/28/2014) in the EPA National Pesticide Standards Repository (email from Theresa Cole, ACB, 2/25/2014); a standard is not available for benzimidazole.

For benzimidazole, a new standard must be submitted.  For 5-hydroxy-thiabendazole, the registrant must either recertify the lot in the repository and send in an updated certificate of analysis (COA), or submit new standards (different lot #) if the previous lots will not be recertified.  If a new COA is being submitted, it should be faxed to the repository at<PHONE_NUMBER>.  Reference standards should be sent to the Analytical Chemistry Lab, which is located at Fort Meade, to the attention of either Theresa Cole or Thuy Ngygen at the following address:

	USEPA
	National Pesticide Standards Repository/Analytical Chemistry Branch/OPP
	701 Mapes Road
	Fort George G. Meade, MD  20755-5350

(Note that the mail will be returned if the extended zip code is not used.)

860.1850 and 860.1900 Confined and Field Accumulation in Rotational Crops
Revised Residue Chemistry Chapter of the Thiabendazole RED DP# 267871, 9/7/00, T. Morton

The available confined rotational crop data, discussed in the RED, are adequate, pending submission of information on sample storage intervals and supporting storage stability data for the metabolites benzimidazole and 5-hydroxy-thiabendazole that were required in the RED.  Based on the available data, the residues of concern are the same in rotated crops as in primary crops.

A limited field rotational crop study was required in the RED, and was included in the submission of the current petition.

Syngenta Crop Protection, LLC has submitted the results of a limited field rotational crop study on a leafy vegetable (lettuce), root and tuber vegetable (radish), and cereal grain (wheat) from 13 trials conducted in the United States during the 2010 growing season.  The trials were conducted in the North American Free Trade Agreement (NAFTA) Growing Zones 1 (NY; 1 trial with lettuce and radish), 2 (GA; 1 trial with radish), 4 (LA; 2 trials, one each with lettuce and radish), 5 (IA, OH, ND; 5 trials with wheat), 6 (TX; 2 trials, one with lettuce and radish and one with lettuce), 10 (CA; 1 trial with lettuce), and 11 (OR; 1 trial with lettuce and radish).  Together the submitted data reflect three trials for each crop at representative plantback intervals (PBIs) of 30, 90, and 270 days.

At each test location, one control plot and one treated plot were established, with separate treated subplots as needed for each commodity and PBI.  At each treated plot, a single bare-ground incorporated application of a flowable concentrate (water-dispersible suspension) for seed treatment (FS) formulation (Mertect(R) 340-F) containing 4.1 lb ai/gal thiabendazole was applied to the soil at a target rate of 0.0275 lb ai/A; actual application rates were 0.0258-0.0291 lb ai/A.  Applications were made in spray volumes of ~15-30 gal/A using ground equipment.  No adjuvants were included in the spray mixtures.  Rotational crops of lettuce, radish, and/or wheat were planted at target PBIs of 30, 90, and 270 days after application; actual PBIs were 26-32, 58-90, and 242-295 days.

Samples of lettuce leaves, radish roots and tops, and wheat grain and straw were collected at normal crop maturity.  Samples intended to be representative of fall and spring wheat forage were collected ~60 days after planting for fall forage and at the 6- to 8-inch stem elongation stage (approximately 25% dry matter) for spring forage.  Wheat hay was collected at early flower (boot) to soft dough stage.  Hay was dried in the field to 10-20% moisture content; drying intervals were not reported.

Samples were analyzed for residues of thiabendazole and benzimidazole using a liquid chromatography method with tandem mass spectrometry detection (LC/MS/MS), Method GRM040.01A.  This method was previously reviewed by the Agency and was found to be acceptable for data collection (refer to 47705110.DER1, DP# 363974, 11/30/09, S. Hummel).  The limit of quantitation (LOQ; determined as the lowest level of method validation, LLMV) was 0.01 ppm for each analyte, for a combined LOQ of 0.02 ppm.  The method was adequate for data collection based on acceptable concurrent recovery data.  The fortification levels used in concurrent method recovery were adequate to bracket expected residue levels.  Concurrent recoveries were corrected for apparent residues in controls; residues in the treated samples were not corrected for apparent residues in controls.  The method does not provide for conversion of residues of benzimidazole to parent equivalents.

Samples were stored frozen from harvest to analysis for 70-167 days (2.3-5.5 months) for lettuce leaves, 30-211 days (1.0-6.9 months) for radish roots and tops, 71-348 days (2.3-11.4 months) for wheat forage, 71-104  days (2.3-3.4 months) for wheat hay, 102-137 days (3.4-4.5 months) for wheat straw, and 74-115  days (2.4-3.8 months) for wheat grain.  All samples were analyzed within 0-16 days of extraction.  Acceptable storage stability data have been submitted demonstrating that residues of thiabendazole and benzimidazole in/on representative raw agricultural commodities are stable during frozen storage for up to ~10 months (refer to 48996712.der, interim report).  In addition, storage stability data are available indicating that residues of both analytes are stable during frozen storage for up to 28 months in/on whole potato and wet peel, for up to 23 months in/on wheat grain and straw (refer to the Residue Chemistry Chapter of the Thiabendazole RED; DP# 267871, 9/7/00, T. Morton), and for up to 22 months in/on soybean forage, hay, and seed (DP# 280701, 12/9/10, T. Morton).  These data are adequate to support the sample storage conditions and durations for the submitted study.

Following a single bare-ground incorporated application of the 4.1 lb ai/gal FS formulation of thiabendazole to the soil at a rate of 0.0258-0.0291 lb ai/A, residues of thiabendazole and benzimidazole were each below the LOQ (<0.01 ppm) in/on all samples of rotational crop commodities of lettuce, radish, and wheat at PBIs of 26-32, 58-90, and 242-295 days; combined residues were <0.02 ppm.

TABLE 7.  Summary of Residue Data in Rotational Crops Following Primary Treatment with Thiabendazole.
Commodity
                                  Total Rate
                                   (lb ai/A)
                                     PBI
                                    (days)
                            Residue Levels (ppm)[1]

                                       n
                                  Sample Min.
                                  Sample Max.
                                    LAFT[2]
                                    HAFT[2]
                                    Median
                                     Mean
                                   Std. Dev.
                 Thiabendazole, Benzimizole, Combined Residues
Lettuce, leaves
                                 0.0258-0.0280
                                     27-28
                                       3
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                     0.01
                                     0.01
                                      N/A

                                 0.0271-0.0282
                                     87-89
                                       3
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                     0.01
                                     0.01
                                      N/A

                                 0.0270-0.0279
                                    242-295
                                       3
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                     0.01
                                     0.01
                                      N/A
Radish, root
                                 0.0275-0.0278
                                     28-30
                                       3
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                     0.01
                                     0.01
                                      N/A

                                 0.0273-0.0277
                                     88-90
                                       3
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                     0.01
                                     0.01
                                      N/A

                                 0.0270-0.0276
                                    242-295
                                       3
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                     0.01
                                     0.01
                                      N/A
Radish, tops
                                 0.0275-0.0278
                                     28-30
                                       3
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                     0.01
                                     0.01
                                      N/A

                                 0.0273-0.0277
                                     88-90
                                       3
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                     0.01
                                     0.01
                                      N/A

                                 0.0270-0.0276
                                    242-295
                                       3
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                     0.01
                                     0.01
                                      N/A
Wheat, forage
                                 0.0281-0.0291
                                     26-32
                                       3
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                     0.01
                                     0.01
                                      N/A

                                 0.0274-0.0280
                                     58-88
                                       3
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                     0.01
                                     0.01
                                      N/A

                                 0.0271-0.0281
                                    266-273
                                       3
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                     0.01
                                     0.01
                                      N/A
Wheat, hay
                                 0.0281-0.0291
                                     26-32
                                       3
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                     0.01
                                     0.01
                                      N/A

                                 0.0274-0.0280
                                     58-88
                                       3
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                     0.01
                                     0.01
                                      N/A

                                 0.0271-0.0281
                                    266-273
                                       3
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                     0.01
                                     0.01
                                      N/A
Wheat, grain
                                 0.0281-0.0291
                                     26-32
                                       3
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                     0.01
                                     0.01
                                      N/A

                                 0.0274-0.0280
                                     58-88
                                       3
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                     0.01
                                     0.01
                                      N/A

                                 0.0271-0.0281
                                    266-273
                                       3
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                     0.01
                                     0.01
                                      N/A
Wheat, straw
                                 0.0281-0.0291
                                     26-32
                                       3
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                     0.01
                                     0.01
                                      N/A

                                 0.0274-0.0280
                                     58-88
                                       3
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                     0.01
                                     0.01
                                      N/A

                                 0.0271-0.0281
                                    266-273
                                       3
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                     0.01
                                     0.01
                                      N/A

Conclusions.   The submitted rotational crop study is adequate.  Following a single bare-ground incorporated application of the 4.1 lb ai/gal FS formulation of thiabendazole to the soil at a rate of 0.0258-0.0291 lb ai/A, residues of thiabendazole and benzimidazole were each below the   LOQ (<0.01 ppm) in/on all samples of rotational crop commodities of lettuce, radish, and wheat at PBIs of 26-32, 58-90, and 242-295 days; combined residues were <0.02 ppm.

An acceptable method was used for the determination of thiabendazole and benzimidazole in rotational crop commodities, and the study is supported by acceptable storage stability data

860.1550 Proposed Tolerances

The current tolerance expression for thiabendazole is:

"(1) Tolerances are established for the combined residues of the fungicide thiabendazole (2-(4-thiazolyl)benzimidazole) and its metabolite benzimidazole (free and conjugated) in or on the following food commodities:"  for plant commodities.

And

"(2) Tolerances are established for the combined residues of thiabendazole (2-(4-thiazolyl)benzimidazole) and its metabolites 5-hydroxythiabendazole (free and conjugated) and benzimidazole in or on the following food commodities:" for livestock commodities.

The tolerance expressions need to be updated as follows to reflect our current guidance.   This will be accomplished during Registration Review.

Existing tolerance for residues of thiabendazole and metabolite on wheat grain and straw.  The currently established tolerance for wheat grain is 1.0 ppm based on the originally submitted data set, showing interferences in the analytical method.  Although the residues were all non-quantifiable, the tolerance was set at 1.0 ppm because of the interference.   In the RED, the tolerance for residues in wheat grain was proposed to be reduced to 0.2 ppm, and in wheat straw to 0.5 ppm; these tolerances were based on foliar applications of thiabendazole to wheat.   However, in connection with the current petition, a full new data set was submitted for all wheat commodities at the currently registered use pattern.  The residues of thiabendazole and benzimidazole on wheat grain were all <LOQ (<0.01 ppm each, or <0.02 ppm total residues).  Thus, we conclude that the current tolerance for residues of thiabendazole and benzimidazole on wheat grain may be reduced to 0.05 ppm.

International Harmonization.   There is no issue with International Harmonization. CODEX  has not established any established maximum residue limits (MRLs) for thiabendazole on the requested commodities.  Canada has not established maximum residue limits (MRLs) for thiabendazole on the requested commodities.  We note that the U.S. tolerance expression is not harmonized with Canada, nor CODEX.  An International Residue Limit Status Sheet is attached in Appendix I.

Table 8. 	Tolerance Summary for Thiabendazole.  § 180.242
Commodity
Current/Proposed Tolerance (ppm)
Recommended Tolerance (ppm)
Comments; Correct Commodity Definition
alfalfa, forage
                                     0.02
                                     0.02
Alfalfa, forage
alfalfa, hay
                                     0.02
                                     0.02
Alfalfa, hay
alfalfa, seed
                                     0.02
                                       -
Tolerances are not normally set for alfalfa seed
barley, grain
                                     0.05
                                     0.05
Barley, grain
barley, hay
                                     0.15
                                      0.3
Barley, hay
Revised level based on OECD tolerance calculation procedures, and to be consistent across all hays and straws.
barley, straw
                                     0.15
                                      0.3
 Barley, straw
Revised level based on OECD tolerance calculation procedures, and to be consistent across all hays and straws.
Brassica, Head and Stem, subgroup 5-A
                                     0.02
                                     0.02

oats, forage
                                      0.2
                                      0.3
Oats, forage
Revised level based on OECD tolerance calculation procedures, and to be consistent across all cereal grain forages.
oats, grain
                                     0.05
                                     0.05
Oats, grain
oats, hay
                                     0.09
                                      0.3
Oats, hay
Revised level based on OECD tolerance calculation procedures, and to be consistent across all hays and straws.
oats, straw
                                     0.09
                                      0.3
Oats, straw
Revised level based on OECD tolerance calculation procedures, and to be consistent across all hays and straws.
Onion, bulb, Subgroup 3-07A
                                     0.02
                                     0.02

radish, tops
                                     0.02
                                     0.02
Radish, tops
rye, forage
                                      0.2
                                      0.2
Rye, forage
rye, grain
                                     0.05
                                     0.05
Rye, grain
rye, straw
                                     0.15
                                      0.3
Rye, straw
Revised level based on OECD tolerance calculation procedures, and to be consistent across all hays and straws.
spinach
                                     0.02
                                     0.02
Spinach
triticale, forage
                                      0.2
                                     0.23
Triticale, forage
Revised level based on OECD tolerance calculation procedures, and to be consistent across all cereal grain forages.
triticale, grain
                                     0.05
                                     0.05
Triticale, grain
triticale, hay
                                     0.09
                                     0.15
Triticale, hay
Revised level based on OECD tolerance calculation procedures, and to be consistent across all hays and straws.
triticale, straw
                                     0.09
                                     0.15
Triticale, straw
Revised level based on OECD tolerance calculation procedures, and to be consistent across all hays and straws.
Vegetable, Cucurbit group 9
                                     0.02
                                     0.02
Vegetable, Cucurbit, group 9
Vegetable, root (except sugarbeet), subgroup 1B
                                     0.02
                                     0.02
Revised level based on OECD tolerance calculation procedures.
Wheat, grain
                                      1.0
                                     0.05
Current tolerance for wheat grain is 1.0 ppm, tolerance recommended in RED was 0.2 ppm.  Current recommendation is based on full new data set showing all non-quantifiable residues.
wheat, forage
                                      0.2
                                      0.3
Wheat, forage
Revised level based on OECD tolerance calculation procedures, and to be consistent across all cereal grain forages.
wheat, hay
                                     0.09
                                      0.3
Wheat, hay
Revised level based on OECD tolerance calculation procedures, and to be consistent across all hays and straws.
Wheat, straw
                                      1.0
                                      0.3
RED recommended lowering tolerance.  Current recommendation is to be consistent across all hays and straws.

References

DP#:	165718
Subject:	ID# 060101-618.  Thiabendazole Phase V Review.  Metabolism Studies: Wheat, Soybean and Sugar Beet.
From:	L. Cheng
To:	F. RubisDated:	3/11/92
MRIDs:	41872901, 41872902 and 41872903

DP#s:	207850, 218096, 245782, 245785, and 245787
Subject:	Thiabendazole Reregistration. 860.1500 and 860.1340-Response to Agency Reviews for Magnitude of the Residue in Apples, Citrus, and Wheat; Analytical Method in Wheat and ILV, Magnitude of the Residue in Citrus and Banana Following Post-harvest Dip Application.
From:	S. Mason
To:	W. Sproat
Dated:	1/8/99
MRIDs:	43328301-43328303, 43328306, 43328307 and 43721901-43721904

DP#:	None
Subject:	Classification of Seed Treatments as Food or Nonfood Uses.
From:	Chemistry Science Advisory Council
To:	HED Chemistry Interest Group
Dated:	10/28/99
MRID:	None

DP#:	267871
Subject:	Thiabendazole (060101) Reregistration Case No. 2760.  Revised Product and Residue Chemistry Chapters for the Thiabendazole Reregistration Eligibility Decision (RED).
From:	T. Morton
To:	B. Edwards/S. Lewis
Dated:	9/7/00
MRIDs:	None

DP#:	270154
Subject:	Thiabendazole (Chemical No. 060101).  Reregistration Case No. 2670.  Nature of the Residue in Soybeans Grown form Seeds Treated with Thiabendazole (GLN 860.1300) and Magnitude of the Residues of Thiabendazole in/on Soybeans Grown from Seed Treated with Thiabendazole (GLN 860.1500).
From:	T. Morton
To:	B. Edwards/S. Lewis
Dated:	2/22/01
MRID:	45200301

DP#:	343139
Subject:	Thiabendazole: Final Threshold of Regulation Decision to Support Proposed New Use as a Seed Treatment for Dry Pea.  Petition No: PP#6E6323.
From:	D. Davis
To:	S. Stanton and B. Madden
Dated:	8/29/07
MRID:	None

RDI:SHummel:01/14/2014
PP#: none
DP Barcode: D410807, D410833, D313507
PC Code: 060101

Template Version September 2005

Appendix I  - International Residue Status Sheet

International Residue Limits
           Thiabendazole (PC Code 060101; Date of Request 12/12/13)
Summary of US and International Tolerances and Maximum Residue Limits
Residue Definition:
US
Canada
Mexico[1]
Codex[2]
40 CFR 180.242
Plants:  2-(4-thiazolyl)benzimidazole) and its metabolite benzimidazole (free and conjugated)
2-(4-thiazolyl)benzimidazole

Plants: thiabendazole

Commodity
Tolerance (ppm) /Maximum Residue Limit (mg/kg)

US
Canada
Mexico[1]
Codex[2]
Vegetable, root (except sugar beet); subgroup1B
0.02

Onion, bulb, subgroup 3-07A
0.02

Brassica, head and stem, subgroup 5A
0.02

Vegetable, cucurbit group 9
0.02

Alfalfa
0.02

Spinach
0.02

Small grains (barley, oats, rye, and triticale)
0.02

Wheat grain
1.0

Completed:   M. Negussie;  12/12/2013
[1] Mexico adopts US tolerances and/or Codex MRLs for its export purposes.
[2] * = absent at the limit of quantitation; Po = postharvest treatment, such as treatment of stored grains.  PoP = processed postharvest treated commodity, such as processing of treated stored wheat. (fat) = to be measured on the fat portion of the sample. MRLs indicated as proposed have not been finalized by the CCPR and the CAC.

Appendix II  - OECD Calculator

Compound
                                 Thiabendazole
                                 Thiabendazole
                                 Thiabendazole
Crop
                                 Wheat Forage
                                   Wheat Hay
                                  Wheat Straw
Region / Country
                                      US
                                      US
                                      US
GAP
                                 0.11 lb ai/A
                                 0.11 lb ai/A
                                 0.11 lb ai/A

Total number of data (n)
                                      19
                                      19
                                      19

Percentage of censored data
                                      53%
                                      79%
                                      89%
Number of non-censored data
                                       9
                                       4
                                       2

Lowest residue
                                     0.020
                                     0.020
                                     0.020
Highest residue
                                     0.210
                                     0.072
                                     0.083
Median residue
                                     0.020
                                     0.020
                                     0.020

Mean
                                     0.035
                                     0.025
                                     0.024
Standard deviation (SD)
                                     0.044
                                     0.015
                                     0.015

Correction factor for censoring (CF)
                                     0.649
                                     0.474
                                     0.404

Proposed MRL estimate

- Highest residue
                                     0.210
                                     0.072
                                     0.083
- Mean + 4 SD
                                     0.211
                                     0.086
                                     0.082
- CF x 3 Mean
                                     0.068
                                     0.036
                                     0.029
Unrounded MRL
                                     0.211
                                     0.086
                                     0.083

Rounded MRL
                                      0.3
                                     0.09
                                     0.09

High uncertainty of MRL estimate due to high level of censoring.

Residues (mg/kg)
Residues (mg/kg)
Residues (mg/kg)

                                     0.020
                                       *
                                     0.020
                                       *
                                     0.020
                                       *

                                     0.023

                                     0.021

                                     0.020
                                       *

                                     0.020
                                       *
                                     0.021

                                     0.020
                                       *

                                     0.020
                                       *
                                     0.020
                                       *
                                     0.020
                                       *

                                     0.020
                                       *
                                     0.020
                                       *
                                     0.020
                                       *

                                     0.020
                                       *
                                     0.020
                                       *
                                     0.020
                                       *

                                     0.021

                                     0.020
                                       *
                                     0.020
                                       *

                                     0.029

                                     0.020
                                       *
                                     0.020
                                       *

                                     0.020
                                       *
                                     0.020
                                       *
                                     0.020
                                       *

                                     0.025

                                     0.020
                                       *
                                     0.020
                                       *

                                     0.020
                                       *
                                     0.020
                                       *
                                     0.020
                                       *

                                     0.020
                                       *
                                     0.020
                                       *
                                     0.020
                                       *

                                     0.037

                                     0.020
                                       *
                                     0.023
                                       *

                                     0.071

                                     0.020
                                       *
                                     0.020
                                       *

                                     0.020
                                       *
                                     0.020
                                       *
                                     0.020
                                       *

                                     0.210

                                     0.072

                                     0.032

                                     0.027

                                     0.065

                                     0.083

                                     0.020
                                       *
                                     0.020
                                       *
                                     0.020
                                       *

                                     0.024

                                     0.020
                                       *
                                     0.020
                                       *

Compound
                                 Thiabendazole

                                 Thiabendazole
Crop
                                  Barley Hay

                                 Barley Straw
Region / Country
                                      US

                                      US
GAP
                                 0.11 lb ai/A

                                 0.11 lb ai/A

Total number of data (n)
                                      12

                                      12

Percentage of censored data
                                      58%

                                      67%
Number of non-censored data
                                       5

                                       4

Lowest residue
                                     0.020

                                     0.020
Highest residue
                                     0.200

                                     0.092
Median residue
                                     0.022

                                     0.020

Mean
                                     0.048

                                     0.034
Standard deviation (SD)
                                     0.057

                                     0.024

Correction factor for censoring (CF)
                                     0.611

                                     0.556

Proposed MRL estimate

- Highest residue
                                     0.200

                                     0.092
- Mean + 4 SD
                                     0.277

                                     0.130
- CF x 3 Mean
                                     0.088

                                     0.056
Unrounded MRL
                                     0.277

                                     0.130

Rounded MRL
                                      0.3

                                     0.15

High uncertainty of MRL estimate due to high level of censoring.

High uncertainty of MRL estimate due to high level of censoring.

Residues (mg/kg)

Residues (mg/kg)

                                     0.020
                                       *

                                     0.020
                                       *

                                     0.028

                                     0.038

                                     0.020
                                       *

                                     0.020
                                       *

                                     0.020
                                       *

                                     0.020
                                       *

                                     0.020
                                       *

                                     0.020
                                       *

                                     0.020
                                       *

                                     0.020
                                       *

                                     0.020
                                       *

                                     0.020
                                       *

                                     0.130

                                     0.092

                                     0.052

                                     0.072

                                     0.023

                                     0.020
                                       *

                                     0.026

                                     0.040

                                     0.200
                                       *

                                     0.020
                                       *


[Federal Register Volume 77, Number 78 (Monday, April 23, 2012)]
[Notices]
[Page 24198]
[FR Doc No: 2012-9651]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP12-101-000]

Carolina Gas Transmission Corporation; Notice of Request Under
Blanket Authorization

    Take notice that on April 3, 2012 Carolina Gas Transmission
Corporation (Carolina Gas), 601 Old Taylor Road, Cayce, South Carolina,
29033, filed in the above Docket, a prior notice request pursuant to
sections 157.205, 157.208 and 157.210 of the Commission's regulations
under the Natural Gas Act (NGA), for authorization to replace
approximately 7.6 miles of Carolina Gas existing Line 1 within the
existing easement in Aiken Country, South Carolina, all as more fully
set forth in the application which is on file with the Commission and
open to public inspection. The filing may also be viewed on the web at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. For assistance, please contact FERC Online Support
at<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Carolina Gas proposes to replace two segments of the existing 16-
inch-diameter natural gas pipeline Line 1 for a total of 7.6 miles,
within the existing right of way. Carolina Gas states that the
estimated cost of the project is $15,005,105.
    Any questions concerning this application may be directed to Randy
D. Traylor, Jr., Manager-System Planning, Carolina Gas Transmission
Corporation, 601 Old Taylor Road, Cayce, South Carolina 29033 at (803)
217-2255, or by email at<EMAIL_ADDRESS>    Any person may, within 60 days after the issuance of the instant
notice by the Commission, file pursuant to Rule 214 of the Commission's
Procedural Rules (18 CFR 385.214) a motion to intervene or notice of
intervention. Any person filing to intervene or the Commission's staff
may, pursuant to section 157.205 of the Commission's Regulations under
the Natural Gas Act (NGA) (18 CFR 157.205) file a protest to the
request. If no protest is filed within the time allowed therefore, the
proposed activity shall be deemed to be authorized effective the day
after the time allowed for protest. If a protest is filed and not
withdrawn within 30 days after the time allowed for filing a protest,
the instant request shall be treated as an application for
authorization pursuant to section 7 of the NGA.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (www.ferc.gov) under the ``e-Filing'' link.

    Dated: April 13, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-9651 Filed 4-20-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 170 (Friday, September 2, 2022)]
[Notices]
[Page 54212]
[FR Doc No: 2022-19058]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 1858-023]

Beaver City Corporation; Notice of Waiver Period for Water
Quality Certification Application

    On August 24, 2022, Beaver City Corporation submitted to the
Federal Energy Regulatory Commission (Commission) a copy of the request
for a Clean Water Act section 401(a)(1) water quality certification
filed with the Utah Department of Environmental Quality, Division of
Water Quality (Utah DEQ), in conjunction with the above captioned
project. Pursuant to 40 CFR 121.6 and section 4.34(b)(5) of the
Commission's regulations,\1\ we hereby notify the Utah DEQ of the
following:
---------------------------------------------------------------------------

    \1\ 18 CFR 4.34(b)(5).
---------------------------------------------------------------------------

    Date of Receipt of the Certification Request: August 2, 2022.
    Reasonable Period of Time to Act on the Certification Request: One
year (August 2, 2023).
    If the Utah DEQ fails or refuses to act on the water quality
certification request on or before the above date, then the agency
certifying authority is deemed waived pursuant to section 401(a)(1) of
the Clean Water Act, 33 U.S.C. 1341(a)(1).

    Dated: August 29, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-19058 Filed 9-1-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 145 (Monday, July 31, 2023)]
[Notices]
[Pages 49460-49461]
[FR Doc No: 2023-16193]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2016-0027; FRL-11136-01-OAR]

Proposed Information Collection Request; Comment Request;
Information Collection Request (ICR) for On-Highway Motorcycle
Certification and Compliance Program; EPA

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit an information collection request (ICR), ``Information
Collection Request (ICR) for On-Highway Motorcycle Certification and
Compliance Program'' (EPA ICR Number 2535.03, OMB Control Number 2060-
0710) to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act. Before doing
so, EPA is soliciting public comments on specific aspects of the
proposed information collection as described below. This is a proposed
extension of the ICR, which is currently approved through October 31,
2023. An Agency may not conduct or sponsor and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number.

DATES: Comments must be submitted on or before September 29, 2023.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2016-0027, online using www.regulations.gov (our preferred method), by
email to [email protected] or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania
Ave. NW, Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Julian Davis, Environmental Protection
Agency, 2000 Traverwood, Ann Arbor, MI 48105; telephone number: (734)
214-4029; fax number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will

be collecting are available in the public docket for this ICR. The
docket can be viewed online at www.regulations.gov or in person at the
EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW,
Washington, DC. The telephone number for the Docket Center is 202-566-
1744. For additional information about EPA's public docket, visit
http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: Under the Clean Air Act (42 U.S.C. 7521 et seq.)
manufacturers and importers of on-highway motorcycles must have a
certificate of conformity issued by EPA covering any vehicle they
intend to offer for sale in the United States. A certificate of
conformity represents that the respective vehicle conforms to all
applicable emissions requirements. In issuing a certificate of
conformity, EPA reviews vehicle information and emissions test data to
determine if the required testing has been performed and the required
emissions levels have been demonstrated. After a certificate of
conformity has been issued, the Agency may request additional
information to verify that the product continues to meet its certified
emissions standards throughout its useful life.
    Form Numbers:

------------------------------------------------------------------------
                                                                Current
           Form title                   New or previous        form No.
------------------------------------------------------------------------
Highway Motorcycle HC+NOX         Previous..................    5900-339
 Average Exhaust Emissions Model
 Year Report.
Manufacturer Production Report    Previous..................     5900-90
 for Engine/Equipment
 Manufacturers--Heavy-Duty,
 Nonroad, and Highway
 Motorcycles.
List of Emissions Related         New.......................
 Components.
Catalyst Information............  Previous..................    5900-464
AECD Reporting Template.........  New.......................
------------------------------------------------------------------------

    Respondents/affected entities: Entities potentially affected by
this action are on-highway motorcycle manufacturers and importers.
    Respondent's obligation to respond: Mandatory (40 CFR part 86).
    Estimated number of respondents: 95 (total).
    Frequency of response: Annual, unless otherwise specified under 40
CFR part 86, subpart E.
    Total estimated burden: 5,832 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $1,124,869 (per year), includes $31,998
annualized capital and $342,565 operation & maintenance costs.
    Changes in estimates: There is an increase of 379 hours but a
decrease of $63,760 in the total estimated cost from the previous ICR.
This increase in hours but decrease in total estimated cost is
primarily due to the inclusion of electric motorcycle manufacturers who
must certify their engine families but are not subject to exhaust or
evaporative emissions testing requirements.

Byron J. Bunker,
Director, Compliance Division, Office of Transportation and Air
Quality.
[FR Doc. 2023-16193 Filed 7-28-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 127 (Wednesday, July 7, 2021)]
[Notices]
[Page 35865]
[FR Doc No: 2021-14384]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Youth Access to American Jobs in Aviation Task Force; Notice of
Public Meeting

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

ACTION: Notice of public meeting.

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

SUMMARY: This notice announces a meeting of the Youth Access to
American Jobs in Aviation Task Force (YIATF).

DATES: The meeting will be held on September 13, 2021, from 9:00 a.m.-
3:30 p.m. Eastern Daylight Time.
    Requests for accommodations to a disability must be received by
August 30, 2021.
    Requests to submit written materials to be reviewed during the
meeting must be received no later than August 30, 2021.

ADDRESSES: The meeting will be held virtually. Members of the public
who wish to observe the virtual meeting may access the event live on
the FAA's Twitter, Facebook and YouTube channels. For copies of meeting
minutes along with all other information, please visit the YIATF
internet website at https://www.faa.gov/regulations_policies/rulemaking/committees/documents/index.cfm/committee/browse/committeeID/797.

FOR FURTHER INFORMATION CONTACT: Ms. Aliah Duckett, Federal Aviation
Administration, by email at<EMAIL_ADDRESS>or phone at 202-
267-8361. Any committee-related request should be sent to the person
listed in this section.

SUPPLEMENTARY INFORMATION:

I. Background

    The FAA established the Task Force by charter on October 3, 2019,
under Public Law 115-254. The Task Force is required by statute to
develop and provide independent recommendations and strategies to the
FAA Administrator to: (1) Facilitate and encourage high school students
in the United States to enroll in and complete career and technical
education courses, including science, technology, engineering, and
mathematics (STEM), that will prepare them to pursue a course of study
related to an aviation career at an institution of higher education, a
community college, or trade school; (2) facilitate and encourage these
students to enroll in a course of study related to an aviation career,
including aviation manufacturing, engineering and maintenance, at an
institution of higher education, including a community college or trade
school; and (3) identify and develop pathways for students to secure
registered apprenticeships, workforce development programs, or careers
in the aviation industry of the United States.

II. Agenda

    At the meeting, the agenda will cover the following topics:

 Welcome/Opening Remarks
 Approval of Previous Meeting Minutes
 Subcommittee Presentations
 Review of Action Items
 Closing Remarks

    A detailed agenda will be posted on the YIATF internet website
address listed in the ADDRESSES section at least 15 days in advance of
the meeting. Copies of the meeting minutes will also be available on
the YIATF internet website.

III. Public Participation

    The meeting will be open to the public and livestreamed. Members of
the public who wish to observe the virtual meeting can access the
livestream on the FAA social media platforms listed in the ADDRESSES
section on the day of the event.
    The U.S. Department of Transportation is committed to providing
equal access to this meeting for all participants. If you need
alternative formats or services because of a disability, such as sign
language, interpretation, or other ancillary aids, please contact the
person listed in the FOR FURTHER INFORMATION CONTACT section.
    The FAA is not accepting oral presentations at this meeting due to
time constraints. However, the public may present written statements to
the Task Force by providing a copy to the Designated Federal Officer
via the email listed in the FOR FURTHER INFORMATION CONTACT section.

Angela O. Anderson,
Director, Regulatory Support Division, Office of Rulemaking, Federal
Aviation Administration.
[FR Doc. 2021-14384 Filed 7-6-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 234 (Tuesday, December 6, 2011)]
[Notices]
[Page 76204]
[FR Doc No: 2011-31457]

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

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Wednesday,
December 7, 2011 at 9:30 a.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(10) and 17 CFR 200.402(a)(10), permit consideration
of the scheduled matter at the Closed Meeting.
    Commissioner Walter, as duty officer, voted to consider the item
listed for the Closed Meeting in closed session, and determined that no
earlier notice thereof was possible.
    The subject matter of the Closed Meeting scheduled for Wednesday,
December 7, 2011 will be:

A matter relating to enforcement proceedings.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: December 2, 2011.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-31457 Filed 12-2-11; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register: September 30, 2008 (Volume 73, Number 190)]
[Notices]
[Page 56817-56819]
[DOCID:fr30se08-52]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2008-0696; FRL-8722-7]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Reporting and Recordkeeping Requirements for the
Enforcement Policy Regarding the Sale and Use of Aftermarket Catalytic
Converters; EPA ICR No.1292.08, OMB Control No. 2060-0135

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection
Request (ICR) to the Office of Management and Budget (OMB). This ICR is
scheduled to expire on December 31, 2008. Before submitting the ICR to
OMB for review and approval, EPA is soliciting comments on specific
aspects of the proposed information collection as described below.

DATES: Comments must be submitted on or before December 1, 2008.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OECA-2008-0696 by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>
     Mail: Enforcement and Compliance Docket and Information
Center (ECDIC), Environmental Protection Agency, Mailcode: 2822T, 1200
Pennsylvania Ave., NW., Washington, DC 20460. Hand Delivery: EPA Docket
Center Public Reading Room, EPA West Building Room 3334, 1301
Constitution Avenue, NW., Washington, DC 20004. Such deliveries are
only accepted during the Docket's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OECA-
2008-0696. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://
www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/
epahome/dockets.htm.

FOR FURTHER INFORMATION CONTACT: Ross Ruske, Air Enforcement Division,
(2242A), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0069; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

How Can I Access the Docket and/or Submit Comments?

    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OECA-2008-0696 which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Enforcement and
Compliance Docket in the EPA Docket Center (EPA/DC), EPA West, Room
3334, 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Reading
Room is<PHONE_NUMBER>, and the telephone number for the Enforcement and
Compliance Docket is<PHONE_NUMBER>.
    Use http://www.regulations.gov to obtain a copy of the draft
collection of information, submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the public docket that are available electronically. Once
in the system, select ``search,'' then key in the docket ID number
identified in this document.

What Information Is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically
solicits comments and information to enable it to:
    (i) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility;
    (ii) Evaluate the accuracy of the Agency's estimate of the burden
of the proposed collection of information, including the validity of
the methodology and assumptions used;
    (iii) Enhance the quality, utility, and clarity of the information
to be collected; and
    (iv) Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

What Should I Consider When I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Offer alternative ways to improve the collection activity.
    6. Make sure to submit your comments by the deadline identified
under DATES.
    7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

What Information Collection Activity or ICR Does This Apply to?

    Affected entities: Entities potentially affected by this action are
the manufacturers of new aftermarket motor vehicle catalytic converters
and reconditioners of used motor vehicle catalytic converters. The SIC
code is 346. The other respondents are automobile exhaust repair
facilities.
    Their SIC code is 7533.
    Title: Reporting and Recordkeeping Requirements for the Enforcement
Policy Regarding the Sale and Use of Aftermarket Catalytic Converters
    ICR numbers: EPA ICR No. 1292.08, OMB Control No. 2060-0135.
    ICR status: This ICR is currently scheduled to expire on December
31, 2008. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register when approved, are listed in 40 CFR part 9, are displayed
either by publication in the Federal Register or by other appropriate
means, such as on the related collection instrument or form, if
applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: Section 203(a)(3) of the Clean Air Act (Act) prohibits
removing or rendering inoperative automobile emission control devices
or elements of design. But for the adoption of the aftermarket
catalytic converter enforcement policy (51 FR 28114-28119, 28133 (Aug.
5, 1986); 52 FR 42144 (Nov. 3, 1987)), the manufacture, sale or
installation of aftermarket catalytic converters (catalysts) not
equivalent to new original equipment (OE) catalysts would constitute a
violation of the Act. However, because replacement OE catalysts are
expensive, many consumers had elected to not replace catalysts that
malfunctioned subsequent to the expiration of the emissions warranty on
their vehicles. The Agency believes that allowing the installation of
aftermarket catalysts on older vehicles can be environmentally
beneficial if the Agency can be assured that the aftermarket catalysts
meet certain standards and if installers are accountable to select the
proper aftermarket catalyst for each vehicle application. Manufacturers
of new aftermarket catalysts are required, on a one-time basis, for
each catalyst line manufactured, to identify the catalyst physical
specifications and summarize pre-production testing of the prototype.
    The original policy required that, once production had begun, the
manufacturer would submit to EPA on a semi-annual basis the number of
each type of aftermarket catalyst manufactured and a summary of
information contained on warranty cards or, at the option of the
respondent, copies of warranty cards for all converters sold. This
reporting regarding sales and warranty information was eliminated in
March 1999, with the stipulation that records must be maintained and
the information submitted to EPA upon request.
    On a one-time basis, companies that recondition used catalysts
(catalyst reconditioners) must report the identity of the company and a
description of the test bench used for testing used catalytic
converters and the intended vehicle application(s) for each converter
type. All used converters must be tested individually to ensure they
are still functional. Additionally, the original policy required
catalyst reconditioners to report on a semi-annual basis the names and
addresses of distributors along with the number of each type of
converter sold to each distributor. This reporting requirement was
eliminated in March 1999, with the stipulation that records must be
maintained and the information submitted to EPA upon request.
    Companies that install aftermarket catalysts have no reporting
requirements, but for 6 months must keep copies of installation
invoices and records that show the reason an aftermarket catalyst
installation was appropriate. Removed catalysts must be tagged with
identifying information and be kept for 15 days.
    EPA allows the use of pre-printed documents or computer-generated
documents. All the recordkeeping under the policy is authorized by
section 114 of the Act, 42 U.S.C. 7414 and section 208 of the Act, 42
U.S.C. 7542. Parties who comply with these policies are allowed to
install aftermarket catalysts instead of OE catalysts. Confidentiality
provisions are found at 40 CFR part 2. These requirements have been in
effect for over 10 years. Startup costs have been completed. The
proposed ICR utilizes assumptions that are the same as the previous
ICR. An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 7
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    The ICR provides a detailed explanation of the Agency's estimate,
which is only briefly summarized here:
    Estimated total number of potential respondents: 30,014.
    Frequency of response: Annual.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 212,101 hours.
    Estimated total annual costs: $676,000. This includes an estimated
burden cost of $390,000 and an estimated cost of $286,000 for capital
investment or maintenance and operational costs.

Are There Changes in the Estimates From the Last Approval?

    There is anticipated to be no change in the hours in the total
estimated respondent burden compared with that identified in the ICR
currently approved by OMB.

What Is the Next Step in the Process for This ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. At that time, EPA will
issue another Federal Register notice pursuant to 5 CFR
1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB. If you have any
questions about this ICR or the approval process, please contact the
technical person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: September 24, 2008.
Granta Y. Nakayama,
Assistant Administrator, Office of Enforcement and Compliance
Assurance.
[FR Doc. E8-22943 Filed 9-29-08; 8:45 am]

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[Federal Register Volume 77, Number 203 (Friday, October 19, 2012)]
[Notices]
[Page 64346]
[FR Doc No: 2012-25741]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Endocrinologic and Metabolic Drugs Advisory Committee; Amendment
of Notice

AGENCY:  Food and Drug Administration, HHS.

ACTION: Notice.

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

    The Food and Drug Administration (FDA) is announcing an amendment
to the notice of meeting of the Endocrinologic and Metabolic Drugs
Advisory Committee. This meeting was announced in the Federal Register
of October 10, 2012 (77 FR 61609). The amendment is being made to
reflect a change in the Location and Procedure portions of the
document. There are no other changes.

FOR FURTHER INFORMATION CONTACT: Paul Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; FAX:
301-847-8533, email<EMAIL_ADDRESS>or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area), and follow the prompts to the desired center or product area.
Please call the Information Line for up-to-date information on this
meeting.

SUPPLEMENTARY INFORMATION:  In the Federal Register of October 10,
2012, FDA announced that a meeting of the Endocrinologic and Metabolic
Drugs Advisory Committee would be held on November 8, 2012. On page
61609, in the second column, the Location portion of the document is
changed to read as follows:
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room, (Rm. 1503), Silver Spring, MD
20993-0002. Information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
    On page 61609, in the third column, the Procedure portion of the
document is changed to read as follows:
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
November 2, 2012. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before October 25, 2012. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by October 26, 2012.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: October 15, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-25741 Filed 10-18-12; 8:45 am]
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