Risk quotients for the surrogate vascular plant, duckweed ( Lemna minor), were lower than the Agency's LOC for endangered and non endangered plants for all agricultural uses assessed. The 30 Key missing details included whether the study conduct followed standard guidelines, whether chlorate concentrations were analytically confirmed, the test concentrations, dose response information from each concentration, and water quality parameters from individual cultures. 55 endangered species LOC was exceeded for sodium chlorate's non agricultural uses. The highest RQ was approximately 13. The most sensitive endpoint in this study was reduction in dry weight. At the highest EEC of 39 mg/ L, the magnitude of effect would be expected to be somewhat greater than 40% because a 41% reduction in dry weight was observed at 29 mg/ L in the submitted study. However, as previously discussed, EECs from the non agricultural uses are considered conservative.

No studies in the following plant species have been submitted, which are required for herbicides: Skeletonema costatum ( a marine diatom), Anabaena flos aquae ( a blue green bacterium), and a freshwater diatom.

4.1.4. Uncertainties in the Aquatic Organism Risk Assessment There are a number of areas of uncertainty in the aquatic organism risk assessment that merit discussion. These include the following:

Uncertainties that may have caused an under estimation of risk   The risk assessment only considers the most sensitive species tested. Aquatic acute and chronic risks are based on acceptable toxicity data for the most sensitive fish, invertebrate, and plant species tested. Responses to a toxicant can be expected to be variable across species. Sensitivity differences between species can be considerable ( several orders of magnitude) for some chemicals ( Mayer and Ellersieck 1986). It is uncertain if the tested laboratory species is representative of most species' sensitivities to chlorate toxicity.

Open literature toxicity data were located that suggest that some fish and algal species may be more sensitive to chlorate toxicity than the surrogate species used in this assessment. Therefore, submission of confirmatory studies in non guideline fish and algal species would reduce uncertainty in this assessment ( see Section 3 for additional discussion).

  The risk assessment only considered a subset of possible use scenarios. Although chlorate has a label for a limited number of crops and non agricultural uses, they encompass a large geographic area. Also, the non agricultural uses may presumably be used without geographic limits. Some uses that may pose higher risks include those occurring in sensitive locations ( close proximity to aquatic environments and high runoff potentials).

  The risk quotients assume that exposure only occurs to chlorate. In some environments, chlorate may be reduced to chlorite, which has been shown to be more toxic to aquatic organisms than chlorate. This is of particular concern for invertebrates because the chlorite EC50 for daphnids is 0.15 mg/ L, which is approximately 6000 fold lower than the EC50 for chlorate of 920 mg/ L. Therefore, formation of even small amounts of chlorite could result risk to endangered and non endangered aquatic invertebrates at levels of concern to the agency. 56   The effect of pH on chlorate toxicity is uncertain. The available toxicity studies used pH environments that are slightly alkaline. The toxicity of chlorate is expected to be dependent on pH as well as redox condition. Therefore, submission of data that characterizes the effect of pH and redox condition of the media on chlorate toxicity to invertebrates would be of considerable value to this assessment, provided that the chemical species in the test media are adequately characterized ( qualitatively and quantitatively). Submission of such chlorate in toxicity studies for aquatic invertebrates would reduce uncertainty in this assessment because pH conditions as low as 5.5 are not uncommon, particularly in the Northeastern United States.

  Many of the labels do not specify the maximum number of applications or annual load; however, some labels for cotton indicate that multiple applications may be necessary. The Agency has assumed that chlorate may be applied twice annually to cotton at all application rates with a 30 day application interval and is applied once annually for all other uses. This assumption may have resulted in an under estimation of risk if chlorate may be applied more than twice annually ( or at shorter application intervals) to cotton or more than once annually to other crops.

Uncertainties that may have resulted in an over estimation of risk   As previously discussed, there is considerable uncertainty in the rate of formation/ decline of redox products of chlorate ( i. e., the kinetics of formation/ decline). Redox kinetics of the chlorine system is complex, studies are very difficult, and most of the data available are not suitable for estimating speciation and predominance in terrestrial and aquatic environments. GENEEC 2 and PRZM EXAMS are not ideal simulation models for chemicals in which one of the elements that can exist in more than one oxidation state. Therefore, conservative assumptions were made that likely resulted in an over estimation of exposure to chlorate.

  GENEEC 2 assumes a contiguous drainage basin that flows into a pond that is10 times smaller than the treated area. The application scenarios for the non agricultural uses may not be consistent with the scenario assumed by GENEEC 2.

  GENEEC 2 assumes no foliar interception, which likely resulted in an over estimation of exposure. Foliar interception is likely to occur because chlorate absorbs into plants. Any chlorate that absorbs into the plant will not likely enter surface water.

Uncertainties that may have resulted in an under estimation or an over estimation of risk   Surrogate species were used to predict potential risks for species with no data ( i. e., reptiles and amphibians). It was assumed that use of surrogate species toxicity data are sufficiently conservative to apply the broad range of species within taxonomic groups. If other species are more or less sensitive to chlorate and its degradates than the surrogates, risks may be under or over estimated, respectively.

4.1 Risks to Birds, Acute and Chronic Exposures 57 4.2.1. Risk Estimation  Integration of Exposure and Effects Data Acute risk quotients were not calculated because no mortality or signs of toxicity were observed in the submitted subacute or acute toxicity studies at concentrations that are above the limit for these types of studies.

Table 4 6 below presents avian reproduction risk quotients. These RQs were based on a NOAEC of 271 ppm ( MRID 46729701). At the LOAEC of 964 ppm, effects on egg production and thickness, embryonic survival ( early, late, and at hatch), and hatchling body weight occurred. Rqs for all crops and all avian food items assessed except fruits, pods, seeds, and small insects exceeded the Agency's LOC of 1.0. The highest RQ was 11.

Table 4 6. Avian Reproduction Risk Quotients Based on a NOAEC of 271 ppm ( MRID 46729701) and Estimated Upper 90th Percentile Residue Levels Crops Application Rate ( No. Of Applications / Interval) Predicted 90th Percentile Residue Levels short grass tall grass broadleaf forage, small insects fruit, pods, seeds, small insects Chili peppers; white/ Irish potatoes 12.5 lbs a. i./ Acre Single application EEC: 3000 RQ: 11 EEC: 1400 RQ: 5.2 EEC: 1700 RQ: 6.3 EEC: 190 RQ: 0.7 Cotton 7.5 lbs a. i./ Acre ( 2/ 30) EEC: 2800 RQ: 10 EEC: 1300 RQ: 4.8 EEC: 1600 RQ: 5.9 EEC: 170 RQ: 0.63 Corn; flax, guar; southern peas; rice; safflower; sorghum; soybeans; sunflower 7.5 lbs a. i./ Acre Single application EEC: 1800 RQ: 6.6 EEC: 830 RQ: 3.1 EEC: 1000 RQ: 3.7 EEC: 110 RQ: 0.41 Agricultural fallow land; dried beans; corn; cucurbitsa, flax, gourds; guar; southern peas; white/ Irish potatoes; rice; safflower; sorghum; soybeans; sunflower 6 lbs a. i./ Acre Single application EEC: 1400 RQ: 5.2 EEC: 660 RQ: 2.4 EEC: 810 RQ: 3.0 EEC: 90 RQ: 0.33 a The application rate for cucurbits is 6.1875 lbs a. i./ Acre 4.2.2. Risk Description  Interpretation of Direct Effects No acute risk to birds was identified at levels of concern to the Agency from chlorate's agricultural uses based on its low acute toxicity to birds. However, EFED cannot preclude acute risk from the non agricultural uses. Chlorate is applied at rates of 52 to 520 lbs/ Acre for these uses. 31 The corresponding EECs are 12,500 and 125,000 ppm, respectively, which are 31 The application rate for pre paving is 650 lbs a. i./ Acre; however, this use pattern would not likely result in exposure to birds. 58 approximately 2.5 to 25 fold higher than the highest concentration tested in the subacute bird toxicity studies. Therefore, acute risk to birds from these high application rates cannot be precluded.

Chronic RQs exceeded the Agency's LOC of 1.0 for all agricultural uses assessed for short grass, tall grass, broadleaf forage, and small insects. EECs for a majority of the uses and classes of food items were higher than the LOAEC in bobwhite quail of 964 ppm. At the LOAEC, frank reproductive effects occurred including a 67% reduction in eggs laid and 64% reduction in number of hatchlings per egg laid ( other reproductive effects were observed as well). Therefore, the magnitude of potential effects could be greater than 67% if birds are exposed during the reproductive season. The duration of exposure needed to produce reproductive effects is an uncertainty.

Risk quotients were not presented for chlorate's non agricultural uses. However, risk quotients would be considerably higher for birds foraging where chlorate is applied at the rates assessed for the non agricultural uses. EECs ranged from 12,500 to 125,000, which would result in risk quotients of 46 to 460. The size of the treated areas for these uses is uncertain; therefore, the likelihood that a bird would consume 100% of its diet from a treated area is uncertain.

4.3 Risk to Mammals, Acute Exposures 4.3.1. Risk Estimation, Integration of Exposure and Effects Data Acute risk quotients were not calculated for mammals. The LD50 from a core acute oral toxicity study in rats was > 5000 mg/ kg bw ( MRID 418199 01). In this study, 10% ( 1/ 10) of the rats administered 5000 mg/ kg died. Mortality was not observed at any other dose. Therefore, the data were not sufficient to allow for characterization of the dose response relationship, and the proximity of the LD50 to 5000 mg/ kg bw is uncertain. For this reason, formal risk quotients were not calculated. However, Tables 4 6 and 4 7 below, respectively, present a comparison of the body weight adjusted LD50s to the agricultural and non agricultural EECs. These ratios can be used to estimate high end risk to exposed mammals. Risk quotients would be lower than the values in Tables 4 6 and 4 7. 59 Table 4 6. Proximity of the lowest observed acute toxic dose in mammals to the upper 90th percentile EEC ( mg/ kg bw) for small ( 15 gram), medium ( 35 gram), and large ( 1000 gram) mammals ( Range of Maximum Application Rate for all Agricultural Uses). Food Item Size of Mammal ( grams) Adjusted lowest observed toxic dose from MRID 41819901 ( mg/ kg bw) a Range of EECs ( mg/ kg bw) b Ratio of lowest observed toxic dose to the upper 90th percentile EEC ( unitless) Short grass 15 10,989 1400  2900 0.13  0.26 35 8891 950  2000 0.11  0.22 1000 3846 200  450 0.052  0.12 Tall grass 15 10,989 630  1300 0.057  0.12 35 8891 440  910 0.049  0.10 1000 3846 99  210 0.026  0.055 Broadleaf plants/ small insects 15 10,989 770  1600 0.070  0.15 35 8891 540  1100 0.061  0.12 1000 3846 120  250 0.031  0.065 Fruits, pods, large insects 15 10989 86  180 < 0.01  0.016 35 8891 59  120 < 0.01  0.013 1000 3846 14  28 < 0.01  < 0.01 a The acute oral toxic dose was adjusted for body weight based on the formula recommended by Mineau et al. 1996: Adj. LD50 = LD50 ( TW/ AW) 0.25 : TW= weight of test organism ( reference body weight of adult rat is .350 grams); AW = weight of assessed organism. b EECs were calculated by assuming that small, medium, and large mammals consume 95%, 66%, and 15% of their body weight daily. Only the highest and lowest EECs from chlorate's agricultural uses are used in this assessment. These values are based on EECs presented in Table 3 8. 60 Table 4 7. Proximity of the lowest observed acute toxic dose in mammals to the predicted EEC ( mg/ kg bw) for small ( 15 gram), medium ( 35 gram), and large ( 1000 gram) mammals ( Based on the Range of Maximum Application Rates for all Non Agricultural Uses). Food Item Size of Mammal ( weight, grams) Adjusted lowest observed toxic dose ( mg/ kg bw) a Range of EECs ( mg/ kg bw) b Ratio of lowest observed toxic dose to the upper 90th percentile EEC ( unitless) Short grass 15 10989 11,900  119,000 1.1  11 35 8891 8200  82,000 0.93  9.3 1000 3846 1900  19,000 0.49  4.9 Tall grass 15 10989 5400  54,000 0.49  4.9 35 8891 3800  38,000 0.43  4.3 1000 3846 860  8600 0.22  2.2 Broadleaf plants/ small insects 15 10989 6700  67,000 0.61  6.1 35 8891 4600  46,000 0.52  5.2 1000 3846 1100  11,000 0.27  2.7 Fruits, pods, large insects 15 10989 740  7400 0.07  0.7 35 8891 520  5200 0.06  0.6 1000 3846 120  1200 0.03  0.3 a The acute oral toxic dose was adjusted for body weight based on the formula recommended by Mineau et al. 1996 for adjusting LD50s: Adj. LD50 = LD50 ( TW/ AW) 0.25 : TW= weight of test organism ( reference body weight of adult rat is 350 grams); AW = weight of assessed organism. b EECs were calculated by assuming that small, medium, and large mammals consume 95%, 66%, and 15%, respectively, of their body weight daily, and were calculated using the highest and lowest labeled application rates ( 52 lbs a. i./ Acre and 520 lbs a. i./ Acre) that are most likely to result in exposure.

4.3.2. Risk Description  Interpretation of Direct Effects Agricultural Uses For chlorate's agricultural uses, the ratio of the lowest body weight adjusted observed toxic dose in mammals ( 5000 mg/ kg bw) to the upper 90th percentile EEC was as high as 0.26 for small mammals, 0.22 for medium sized mammals, and 0.12 for large mammals ( short grass food items). For other food items, the ratios were # 0.15. If the LD50 is in close proximity to 5000 mg/ kg day, there may be potential risk at levels of concern to the Agency to non endangered small and medium sized mammals that forage on short grass and potential risk to large ( 1000 61 grams) endangered mammals that feed on short grass and small and medium sized endangered mammals that forage on several other food items. However, proximity of the LD50 to 5000 mg/ kg day cannot be determined based on the submitted data. Additional uncertainties in this assessment are discussed in Section 4.7.

Non Agricultural Uses, Spray Applications The ratios presented in Table 4 7 above suggest that there could be considerable risk to mammals of all sizes that forage in the area where chlorate is used for the non agricultural applications. However, potential risk was likely over estimated for the following reasons:

An LD50 has not been established. The highest dose tested in the available toxicity studies ( 5000 mg/ kg bw) induced 10% mortality. The proximity of the LD50 to 5000 mg/ kg bw is uncertain.

Many of the non agricultural uses will likely result in small contiguously treated areas. Therefore, the likelihood that an animal will consume 100% of its diet from chlorate treated areas is low for some of these uses.

Nonetheless, the EECs were predicted to be up to 11 times higher than the toxic dose of 5000 mg/ kg bw for the non agricultural uses. Therefore, there appears to be risk to mammals at levels of concern to the Agency.

Also, based on the very high application rates associated with the non agricultural uses of chlorate, ingestion of contaminated soil could represent a significant exposure pathway. Therefore, incidental ingestion via contaminated soil was estimated. Based on a maximum application rate of 650 lbs a. i./ Acre and a soil density of 1.3 grams/ cm3 ( Campbell 1985), 32 chlorate concentrations in the first 3 centimeters of soil could be as high as 1500 mg/ kg soil ( ppm). 33 2.4E8 mg a. i./ Acre ÷ 1.6E5 kg soil/ Acre = 1500 mg a. i./ kg soil This application rate is only labeled for pre paving, which is not likely to result in exposure to non target terrestrial animals. Also, this calculation assumes no foliar interception ( direct application to soil). For these reasons, this calculation represents a high end estimate. Using daily food intake, as estimated by Nagy ( 1987) ( EQ 1), a 20 gram mammal is estimated to consume approximately 3.7 grams of food ( wet weight) daily:

32 Campbell G S. 1985. Soil Physics with BASIC. Developments in Soil Science 14. Elsevier publishers. New York NY, USA. This soil density is considered a representative, mid range value.

33 650 lbs a. i./ Acre × 0.37 kg/ lb = 240.5 kg a. i./ Acre × 1E6 mg/ kg = 2.4E8 mg a. i./ Acre 1.2E8 cm3/ Acre x 1.3 g soil/ cm3 = 1.6 E8 g soil/ Acre ( 1.6E5 kg soil/ Acre) 62 F BW W =   0 621 1 0 564 . *

( ) .

where F is the food intake in grams of fresh weight per day, BW is the body mass ( wet weight) of the organism in grams, and W is the mass fraction of water in the food ( assumed to be 0.1). Therefore, the estimated dose of chlorate from dietary consumption of 100% soil would be 5.6 mg/ day ( 3.7 g soil day 1 × 0.001 kg g 1 × 1500 mg a. i. kg 1). This intake level corresponds to a body weight adjusted internal dose of 370 mg/ kg day for a 15 gram mammal ( 5.6 mg/ day ÷ 0.015 kg = 370 mg/ kg day). Direct comparison of this maximum possible soil intake value to the body weight adjusted acute oral LD50 of > 10,989 mg/ kg bw34 and adjusted reproduction NOAEL of 1100 mg/ kg bw would not result in risk to mammals at levels of concern to the Agency.

In addition, Beyer et al. ( 1994) reported that high end mammals with respect to soil consumption ( e. g., armadillos) consume up to 17% soil in their diet, and small mammals ( mice and voles) consume less than 2.5% soil in their diet. Therefore, this analysis likely resulted in an overestimation of exposure and risk.

Non Agricultural Uses, Granular Applications Risk Estimation Formal risk quotients were not calculated for reasons previously discussed. However, Table 4 8 below presents a comparison of the body weight adjusted lowest observed toxic dose in rats of 5000 mg/ kg day from MRID 41819901 to the granular application EECs ( mg/ ft2). These ratios are used to qualitatively describe potential risk.

34 Extrapolations from one mammal species to another needs to consider differences in the scaling of toxicity for differences in body weight. Therefore, the acute oral LD50 was adjusted for body weight based on the formula recommended by Mineau et al. 1996: Adj. LD50 = LD50 ( TW/ AW) 0.25 : TW= weight of test organism ( reference body weight of adult rat is .350 grams); AW = weight of assessed organism. 63 Table 4 8. Range of Ratios of Chlorate's Body Weight Adjusted LD50 to Granular EECs ( mg/ ft2) for Sodium Chlorate's Non Agricultural Uses ( Granular Formulations) Use Body Weight ( g) Rat LD50Adj mg/ kg bwa EEC ( mg/ ft2) b Ratio of LD50adj to EECc Parking lots, under asphalt paving, fence lines, building perimeters, ditch banks, picnic areas, vacant lots, wood decks, bleachers, cemeteries, fuel tanks, runways, helo pads, etc. 520 lbs a. i./ Acre 15 10,989 5400 33 35 8891 5400 17 1000 3846 5400 1.4 Around buildings, storage areas, fences, pumps, machinery, fuel tanks, recreational areas, roadways, guard rails, airports, rights of ways. 160 lbs a. i./ Acre 15 10,989 1700 10 35 8891 1700 5.4 1000 3846 1700 0.43 a Adj. LD50 = LD50 ( TW/ AW) 0.25 : TW= weight of test organism ( reference body weight of adult rat is .350 grams); AW = weight of assessed organism. b EEC = Application rate ( lbs/ Acre) x 453,000 mg/ lb ÷ 43,600 sq ft/ Acre c Ratio = EEC ÷ ( LD50adj × bw in kg)

Risk Description Granular applications of chlorate appear to pose risk to small, medium, and large mammals at levels of concern to the Agency. It was estimated that granular applications would result in chlorate concentrations that are between 0.42 and 33 times the mass of chlorate in every ft2 of chlorate treated areas that has been shown to be toxic to mammals. Although the habitat and feeding area of mammals are substantially greater than a ft2, the mg/ ft2 index is used to evaluate whether there is sufficient mass of chlorate within a treated area to potentially cause adverse effects to exposed mammals. U. S. EPA 1992 and U. S. EPA 2004 can be referenced for additional discussion on the LD50/ ft2 index.

The LD50/ ft2 method is used to encompass exposure via all routes ( oral, dermal, inhalation). However, as an ionic salt, chlorate will not likely appreciably absorb through the skin, and its low Henry's law constant and volatility suggest that inhalation will likely be negligible. Therefore, exposure will likely be limited largely to the oral route ( drinking water, contaminated food items, direct consumption of granules, preening activity). Although chlorate is a strong oxidant, it is not a strong irritant; therefore, mammals are not expected to intentionally avoid chlorate. In fact, chlorate could be particularly attractive to salt thirsty animals resulting in higher chlorate body burdens in these animals ( Klingman, 1977 as cited by the Agricultural Marketing Service of USDA ( 2000); on line at http:// www. ams. usda. gov/ nop/ NationalList/ TAPReviews/ SodiumChlorate. pdf). 64 Other uncertainties in this assessment are presented in Section 4.7.

4.4. Potential Reproduction Risk to Mammals A free standing NOAEL of 500 mg/ kg day was observed in a 2 generation reproduction toxicity study in rats. Resulting risk quotients are in Table 4 9 below. Interpretation of these risk quotients is difficult given that the available 2 generation toxicity study did not observe reproduction effects at any dose tested. Therefore, the reproduction NOAEL could be considerably higher than 500 mg/ kg bw. However, LOCs were exceeded for all weight classes of mammals for at least one food item.

Table 4 9. Mammalian Reproduction Risk Quotients Use Food Item RQ 15 gram mammal NOAELAdj: 1100 mg/ kg bw RQ 35 gram mammal NOAELAdj: 890 mg/ kg bw RQ 1000 gram mammal NOAELAdj: 380 mg/ kgbw Single application of 12.5 lbs a. i./ Acre Chili peppers; white/ Irish potatoes Short Grass EEC: 2900 RQ: 2.6 EEC: 1980 RQ: 2.2 EEC: 460 RQ: 1.2 Tall Grass EEC: 1300 RQ: 1.2 EEC: 910 RQ: 1.0 EEC: 210 RQ: 0.55 Broadleaf plants/ sm insects EEC: 1600 RQ: 1.5 EEC: 1100 RQ: 1.3 EEC: 260 RQ: 0.67 Fruits/ pods/ lg insects EEC: 180 RQ: 0.16 EEC: 120 RQ: 0.14 EEC: 29 RQ: 0.07 7.5 lbs a. i./ Acre ( 2 applications, 30 day interval) Cotton Short Grass EEC: 2700 RQ: 2.4 EEC: 1800 RQ: 2.1 EEC: 430 RQ: 1.1 Tall Grass EEC: 1200 RQ: 1.1 EEC: 840 RQ: 0.95 EEC: 195 RQ: 0.51 Broadleaf plants/ sm insects EEC: 1500 RQ: 1.4 EEC: 1000 RQ: 1.2 EEC: 240 RQ: 0.62 Fruits/ pods/ lg insects EEC: 170 RQ: 0.15 EEC: 120 RQ: 0.13 EEC: 27 RQ: 0.07 7.5 lbs a. i./ Acre ( single application) a Short Grass EEC: 1700 RQ: 1.6 EEC: 1200 RQ: 1.3 EEC: 280 RQ: 0.72 Tall Grass EEC: 790 RQ: 0.72 EEC: 540 RQ: 0.61 EEC: 130 RQ: 0.33 Broadleaf plants/ sm insects EEC: 970 RQ: 0.88 EEC: 670 RQ: 0.75 EEC: 150 RQ: 0.40 Corn; flax, guar; southern peas; rice; safflower; sorghum; soybeans; sunflower Agricultural fallow land; dried beans; corn; cucurbitsa, flax, gourds; guar; southern peas; white/ Irish potatoes; rice; safflower; sorghum; soybeans; sunflower ( see Table note a) Fruits/ pods/ lg insects EEC: 110 RQ: 0.10 EEC: 74 RQ: 0.08 EEC: 17 RQ: 0.04 a EECs and Rqs are similar for the 6.0 and 7.5 single applications, and LOC exceedances are equivalent; therefore, only results from the single application of 7.5 lbs a. i./ Acre are presented. 65 In addition, the available subchronic data suggest that mammals may be at risk from repeated exposures to chlorate. Chlorate is presumably stable under some environmental conditions; therefore, repeated exposures to chlorate is possible. Subchronic toxicity studies ranging in duration from 21 to 90 days suggest that chlorate may induce effects that could affect the growth, survival, or reproduction in exposed mammals at doses of approximately 100 mg/ kg bw per day, which is a dose that is 50 times lower than the acute oral LD50 of > 5000 mg/ kg bw. Effects observed in the repeated dose toxicity studies included decreased body weight ( up to approximately 30% decrease compared with control ( unexposed) animals), blood toxicity, and pituitary and thyroid effects ( including changes in hormone levels).

Reproduction risk quotients were not calculated for chlorate's non agricultural uses. However, based on the high application rates and resulting high potential EECs, risks from chlorate's nonagricultural uses could be considerably higher than risks presented for agricultural uses.

4.5. Endocrine Disruption Potential Effects observed in repeated dose toxicity studies in mammals indicate that chlorate could affect the endocrine system. For example, thyroid hormone levels were affected in rats maintained on drinking water supplemented with chlorate for 90 days.

EPA is required under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act ( FQPA), to develop a screening program to determine whether certain substances ( including all pesticide active and other ingredients) " may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate." Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee ( EDSTAC), EPA determined that there was scientific bases for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use The Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program ( EDSP). When the appropriate screening and/ or testing protocols being considered under the Agency's EDSP have been developed, chlorate may be subjected to additional screening and/ or testing to better characterize effects related to endocrine disruption.

4.6. Potential Risk to Terrestrial Plants Based on chlorate's non selective mode of action and lack of adequate toxicity data, EFED presumes risk to non target plants at levels above the Agency's level of concern for all uses. However, such risks cannot be quantified based on the currently available data. 66 4.7. Uncertainties in the Terrestrial Organism Risk Assessment There are a number of areas of uncertainty in the terrestrial risk assessment that merit discussion, which were previously discussed in Sections 2 and 3. These are summarized below.

Exposure Many of the labels are not clear regarding the maximum allowable annual applications ( number of applications or total load). The Agency assumed a maximum of 2 annual applications ( 30 days apart) for cotton and 1 annual application for all other uses. Risk may be underestimated if these assumptions do not accurately reflect chlorate's applications.

Stability of chlorate in terrestrial and aquatic environments is uncertain, but it is expected to exhibit wide spatial and seasonal variability.

There is considerable uncertainty in the rate of formation/ decline of redox products of chlorate ( i. e., the kinetics of formation/ decline).

Many of the non agricultural uses will likely result in small contiguously treated areas, which would reduce the likelihood that an animal would consume 100% of its diet from chlorate treated areas.

Chlorate is a dessicant that kills parts of plants that are generally edible to herbivorous organisms. Because the herbicide is absorbed by plants relatively rapidly and kills most exposed plants within several days to several weeks after exposure, some contaminated food items may not be attractive to herbivores for an extended period of time after treatment.

The risk assessment assumes that 100% of the exposure organism's diet is relegated to single food types foraged only from treated fields. These assumptions are likely to be conservative for many species and will tend to overestimate potential risks. The assumption of 100% diet from a treated area may be realistic for acute exposures, but long term exposures modeled as single food types composed entirely of material from a treated field is uncertain.

Toxicity The toxicity database is limited. No chronic studies in mallard ducks are available. Therefore, the relative sensitivity of these two surrogate species has not been evaluated. Also, the 2 generation reproduction toxicity study did not observe any toxic effects at any dose tested ( up to 500 mg/ kg bw/ day). Therefore, the reproduction NOAEL could be higher than 500 mg/ kg bw/ day.

Adequate non target terrestrial plant data are not available for this assessment. In the absence of such data, and based on the non specific mode of action of chlorate, EFED presumes considerable risk to non target plants. 67 None of the submitted acute toxicity studies in rats, mysid shrimp, or fish produced toxicity at or above the LD50 or LC50 (< 50% of tested organisms were affected by exposure) resulting in an over estimation of risk. The available data from these studies do not allow for an approximation of the highest dose or concentration tested to the LD50 or LC50. Therefore, the magnitude of the over estimation of risk on the risk assessment from using these toxicity values is uncertain.

An LD50 of 1200 mg/ kg day in rats has been reported in secondary sources. 35 However, this study report has not been obtained and evaluated by the Agency. If these data are reliable, then risks characterized in this assessment may have been under estimated.

Scope of Assessment Surrogate organisms were used to predict potential risks for species with no data ( i. e., reptiles and amphibians).

The risk assessment only considers the most sensitive species tested. Terrestrial acute and chronic risks are based on toxicity data for the most sensitive bird, mammal, and plant species tested. Responses to a toxicant can be expected to be variable across species. The position of the tested species relative to the distribution of all species' sensitivities to chlorate is unknown.

Sodium Chlorate is formulated with other active ingredients and with flame retardants. Potential effects that these other chemicals may have on chlorate's fate or toxicity is not considered in this assessment. The effects of prolonged, year after year use of chlorate in the same field is not known, particularly in semiarid sites that require irrigation ( e. g., Arizona, California), where there is a potential for salt build up over time.

4.8. Potential Risk to Threatened and/ or Endangered Species 4.8.1. Aquatic Organisms There are no geographical limitations on the non agricultural chlorate uses; therefore, the Agency assumes that there is considerable potential for exposure to endangered aquatic species. No chronic toxicity data are available in freshwater or saltwater fish or invertebrates; therefore, chronic risk to these surrogate organisms cannot be precluded. Although levels of concern were not exceeded, potential risk to listed fish, aquatic invertebrates, or aquatic plants cannot be precluded for the following reasons:

Fish. The data located in the open literature suggest that brown trout could be considerably more sensitive than other fish species that have been tested. Woodiwiss et al. ( 1974) ( summarized in Appendix M) reported a 48 hour LC50 of 7.3 mg/ L in brown trout for chlorate. No other studies in brown trout were located, and sufficient information was not available in the 35 Hayes, Wayland J., Jr. Pesticides Studied in Man. Baltimore/ London: Williams and Wilkins, 1982.. 68 publication to allow for an evaluation of data quality. However, this LC50 would trigger endangered species concerns for all chlorate agricultural and non agricultural uses. Also, it appears that chlorate was tested in the presence of another unspecified flame retardant in this study. Therefore, it is uncertain if the toxicity observed in this study was caused by chlorate, the other unidentified chemical, or a combination of the two. Nonetheless, these data could suggest that there may be considerable variability in species sensitivity to chlorate toxicity. Alternatively, these data could suggest that formulated products are more toxic to fish because all chlorate formulations contain fire retardants.

Aquatic Invertebrates. Chlorite could form from the reduction of chlorate in the environment. Chlorite is 6000 fold more toxic than chlorate to daphnids. 36 However, chlorite is expected to be a transient environmental redox product, and the currently available data do not allow for a realistic estimation of the amount of chlorite that may form in the environment.

Aquatic Plants. The data located in the open literature suggest that brown algae are considerably more sensitive than green algae to chlorate. A 14 day EC50 of 0.012 mM (   1 mg/ L) was reported for brown algae ( van Wijk et al., 1997). The EECs for the non agricultural uses ranged from 3.1 to 39 mg/ L, which exceed the EC50 for brown algae of   1 mg/ L. Therefore, there may be risk to some algal species that exceeds the Agency's level of concern for aquatic plants. As previously discussed, however, additional data are needed to address the considerable uncertainty in the aquatic EECs before risk can be definitively characterized. Also, no studies in the following plant species have been submitted, which are required for herbicides: Lemna gibba ( duckweed), Skeletonema costatum ( a marine diatom), Anabaena flos aquae ( a blue green bacterium), and a freshwater diatom.

Uncertainties in this assessment are equivalent to those presented in Section 4.1.4. Listed species that reside in areas where chlorate may be used were not located because its uses have no geographical restrictions. For example, rights of ways and airport fields are located in virtually every county in the United States. Therefore, the Agency presumes that there is considerable potential for exposure to chlorate by listed species.

4.8.2. Terrestrial Organisms Potential Risk to Endangered Birds No effects were observed in subacute dietary studies in mallard ducks or bobwhite quail at up to 5620 mg/ kg diet. However, acute risk to endangered birds cannot be precluded for chlorate's non agricultural uses because the EECs were significantly higher ( up to 125,000 mg/ kg food item) than the highest concentration tested in subacute dietary toxicity studies.

The reproduction study in bobwhite quail suggests that clear reproduction effects occurred at 964 ppm. EECs in this assessment were generally considerably higher than 964 ppm for agricultural and non agricultural uses. Therefore, potential direct effects to listed bird species is above the Agency's concern level for all uses.

36 The 48 hour acute EC50 in daphnids is 0.15 mg/ L ( MRID 940680 09). 69 Potential Acute Risk to Endangered Mammals For chlorate's agricultural uses, the ratio of the lowest observed toxic dose to mammals ( 5000 mg/ kg bw) to the upper 90th percentile EEC was as high as 0.26 for small mammals, 0.22 for medium sized mammals, and 0.12 for large mammals ( short grass food items). For other food items, the ratios were   0.15. If the LD50 is in close proximity to 5000 mg/ kg day, there may be risk at levels of concern to the Agency to endangered small, medium, and large mammals that forage on short grass and risk to small and medium sized endangered mammals that forage on several other food items.

There appears to be considerable potential acute risk to endangered mammals of all sizes that forage in the area where chlorate is used for the non agricultural applications. The EECs were up to 11 times higher than the toxic dose of 5000 mg/ kg bw for the non agricultural uses. However, there is uncertainty regarding the high EECs resulting from the non agricultural uses. Therefore, there appears to be risk to mammals at levels of concern to the Agency.

A number of uncertainties were noted in this assessment, which have previously been described in detail and are summarized in Section 4.7.

Potential Chronic Risk to Endangered Mammals Even though no reproduction effects were observed at up to 500 mg/ kg bw/ day in the submitted 2 generation reproduction toxicity study in mammals ( the highest concentration tested), the Agency cannot preclude risk to mammals because potential exposure levels in some mammalian weight classes are higher than the highest dose tested for all agricultural and non agricultural uses.

Based on the potential use sites, EFED presumes that there is potential for exposure to a large number and large variety of endangered species because these uses would presumably encompass every county in the United States. Therefore, states or counties with endangered species that reside in areas that may be treated with chlorate were not identified as part of this screening level assessment.

Potential Risk to Endangered Terrestrial Plants Sufficient toxicity data have not been submitted to the Agency to allow for a characterization of potential risk to terrestrial plants. Based on chlorate's non selective toxicity to plants, the Agency presumes that there is risk to endangered plants at levels of concern to the Agency from the use of chlorate on agricultural and non agricultural areas. 70 Critical Habitat In the evaluation of pesticide effects on designated critical habitat, consideration is given to the physical and biological features ( constituent elements) of a critical habitat identified by the U. S Fish and Wildlife and National Marine Fisheries Services as essential to the conservation of a listed species and which may require special management considerations or protection. The evaluation of impacts for a screening level pesticide risk assessment focuses on the biological features that are constituent elements and is accomplished using the screening level taxonomic analysis ( risk quotients, RQs) and listed species levels of concern ( LOCs) that are used to evaluate direct and indirect effects to listed organisms.

The screening level risk assessment has identified potential concerns for indirect effects on listed species for those organisms dependant upon species at risk from chlorate exposure. Considerable uncertainty in the potential for direct effects to listed species from chlorate's use identified in this assessment precludes a meaningful analysis of the potential of indirect effects to listed species. In light of the potential for indirect effects, the next step for EPA and the Service( s) is to identify which listed species and critical habitat are potentially implicated. Analytically, the identification of such species and critical habitat can occur in either of two ways. First, the agencies could determine whether the action area overlaps critical habitat or the occupied range of any listed species. If so, EPA would examine whether the pesticide's potential impacts on non endangered species would affect the listed species indirectly or directly affect a constituent element of the critical habitat. Alternatively, the agencies could determine which listed species depend on biological resources, or have constituent elements that fall into, the taxa that may be directly or indirectly impacted by the pesticide. Then EPA would determine whether use of the pesticide overlaps the critical habitat or the occupied range of those listed species. At present, the information reviewed by EPA does not permit use of either analytical approach to make a definitive identification of species that are potentially impacted indirectly or critical habitats that is potentially impacted directly by the use of the pesticide. EPA and the Service( s) are working together to conduct the necessary analysis.

This screening level risk assessment for critical habitat provides a listing of potential biological features that, if they are constituent elements of one or more critical habitats, would be of potential concern. These correspond to the taxa identified above as being of potential concern for indirect effects. This list should serve as an initial step in problem formulation for further assessment of critical habitat impacts outlined above, should additional work be necessary. 71 5. References Fletcher, J. S., J. E. Nellsen, and T. G. Pfleeger. 1994. Literature review and evaluation of the EPA food chain ( Kenaga) nomogram, an instrument for estimating pesticide residues on plants. Env. Toxicol. Chem. 13: 1381 1391. Heywood R, Sortwell RJ, Kelly PJ, Street AE. Toxicity of sodium chlorate to the dog. Vet Rec. 1972. 90( 15): 416 8.

Hoerger, F. and E. E. Kenaga. 1972. Pesticide residues on plants: correlation of representative data as a basis for estimation of their magnitude in the environment. in: F. Coulston and F. Corte ( editors), Environmental Quality and Safety: Chemistry, Toxicology, and Technology. Vol I. Georg Thieme Publishers, Stuttgart, West Germany, pp. 9 28.

Kurokawa Y, et al. 1985. Lack of promoting effect of potassium chlorate and sodium chlorate in two stage rat renal carcinogenesis. Journal of the American College of Toxicology. 4( 6): 331 337.

McCauley P. T., Robinson M., Daniel F. B., Olson G. R. The effects of subchronic chlorate exposure in Sprague Dawley rats. Drug Chem Toxicol. 1995 18( 2 3): 185 99.

National Toxicology Program ( NTP). 1999. Toxicology and Carcinogenesis Studies of Sodium Chlorate ( CAS No. 7775 09 9) in F344/ N Rats and B6C3F1 Mice ( Drinking Water Studies). TR517. Abstract available on line at http:// ntp. niehs. nih. gov.

U. S. EPA. 1992. Comparative analysis of acute avian risk from granular pesticides. Office of Pesticide Programs. Washington DC. March, 1992.

U. S. EPA. 2000. Wildlife Exposure Factors Handbook. Office of Research and Development, Washington, D. C. EPA/ 600/ R 93/ 187. December 1993.

U. S. EPA. 2004. Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs, U. S. Environmental Protection Agency. Office of Prevention, Pesticides and Toxic Substances. Office of Pesticide Programs. Washington, D. C. January 23, 2004.

073301 D303884 REDRevised


[Federal Register: June 4, 2010 (Volume 75, Number 107)]
[Rules and Regulations]
[Page 31677-31678]
[DOCID:fr04jn10-5]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-0089; Airspace Docket No. 10-ASW-1]

Amendment of Class E Airspace; Corpus Christi, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E airspace for the Corpus Christi, TX
area. Additional controlled airspace is necessary to accommodate new
Standard Instrument Approach Procedures (SIAPs) at Aransas County
Airport, Rockport, TX. The FAA is taking this action to enhance the
safety and management of Instrument Flight Rule (IFR) operations at the
airport.

DATES: Effective date 0901 UTC, September 23, 2010. The Director of the

Federal Register approves this incorporation by reference action under
1 CFR Part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone (817) 321-
7716.

SUPPLEMENTARY INFORMATION:

History

    On March 22, 2010, the FAA published in the Federal Register a
notice of proposed rulemaking to amend Class E airspace for the Corpus
Christi, TX area, reconfiguring controlled airspace at Aransas County
Airport (75 FR 13453) Docket No. FAA-2010-0089. Interested parties were
invited to participate in this rulemaking effort by submitting written
comments on the proposal to the FAA. No comments were received. Class E
airspace designations are published in paragraph 6005 of FAA Order
7400.9T signed August 27, 2009, and effective September 15, 2009, which
is incorporated by reference in 14 CFR Part 71.1. The Class E airspace
designations listed in this document will be published subsequently in
the Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by amending Class E airspace for the Corpus Christi, TX area.
The addition of new SIAPs at Aransas County Airport, Rockford, TX has
made this action is necessary for the safety and management of IFR
operations at the airport.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends controlled airspace at Aransas County Airport, Rockport,
TX.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR Part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR Part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(g), 40103, 40113, 40120; E. O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR Part 71.1 of the Federal
Aviation Administration Order 7400.9T, Airspace Designations and
Reporting Points, signed August 27, 2009, and effective September 15,
2009 is amended as follows:
* * * * *

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface.

* * * * *

ASW TX E5 Corpus Christi, TX [Amended]

Corpus Christi International Airport, TX
    (Lat. 27[deg]46'13'' N., long. 97[deg]30'04'' W.)
Corpus Christi NAS/Truax Field, TX
    (Lat. 27[deg]41'34'' N., long. 97[deg]17'25'' W.)
Port Aransas, Mustang Beach Airport, TX
    (Lat. 27[deg]48'43'' N., long. 97[deg]05'20'' W.)
Rockport, San Jose Island Airport, TX
    (Lat. 27[deg]56'40'' N., long. 96[deg]59'06'' W.)
Rockport, Aransas County Airport, TX
    (Lat. 28[deg]05'12'' N., long. 97[deg]02'41'' W.)
Ingleside, T.P. McCampbell Airport, TX
    (Lat. 27[deg]54'47'' N., long. 97[deg]12'41'' W.)
Robstown, Nueces County Airport, TX
    (Lat. 27[deg]46'43'' N., long. 97[deg]41'26'' W.)
Corpus Christi VORTAC, TX
    (Lat. 27[deg]54'14'' N., long. 97[deg]26'42'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7.5 mile radius of Corpus Christi International Airport and
within 1.4 miles each side of the 200[deg] radial of the Corpus
Christi VORTAC extending from the 7.5 mile radius to 8.5 miles north
of the airport, and within 1.5 miles each side of the 316[deg]
bearing from the airport extending from the 7.5 mile radius to 10.1
miles northwest of the airport, and within an 8.8-mile radius of
Corpus Christi NAS/Truax Field, and within a 6.3-mile radius of
Mustang Beach Airport, and within a 6.4-mile radius of T.P.
McCampbell Airport, and within a 6.3-mile radius of Nueces County
Airport, and within a 7.6-mile radius of Aransas County Airport, and
within 2 miles each side of the 010[deg] bearing from the Aransas
County Airport extending from the 7.6 mile radius to 9.9 miles north
of the airport, and within a 6.5-mile radius of San Jose Island
Airport, and within 8 miles west and 4 miles east of the 327[deg]
bearing from the San Jose Island Airport extending from the airport
to 20 miles northwest of the airport, and within 8 miles east and 4
miles west of the 147[deg] bearing from the airport extending from
the airport to 16 miles southeast of the airport, excluding that
portion more than 12 miles from and parallel to the shoreline.

    Issued in Fort Worth, Texas, on May 21, 2010.
Roger M. Trevino,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2010-13262 Filed 6-3-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: January 11, 2011 (Volume 76, Number 7)]
[Notices]
[Page 1620-1621]
[DOCID:fr11ja11-64]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0637]

Trials to Verify and Describe Clinical Benefit of Midodrine
Hydrochloride; Establishment of Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
opening of a public docket to provide a forum to facilitate
communication regarding the conduct of clinical trials needed to verify
and describe the clinical benefit of midodrine hydrochloride (HCl) when
used to treat symptomatic orthostatic hypotension.

DATES: Submit either electronic or written comments by July 11, 2011.

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

FOR FURTHER INFORMATION CONTACT: Wei Lu, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6196, Silver Spring, MD 20993-0002, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA approved PROAMATINE (midodrine HCl) for
marketing under its accelerated approval regulations, 21 CFR part 314,
subpart H, on September 6, 1996, to treat patients with symptomatic
orthostatic hypotension. Since that time, FDA has approved five generic
versions of this product. Orthostatic hypotension is a condition in
which patients are unable to maintain blood pressure in the upright
position and become dizzy or faint upon standing. Subpart H allows
approval of drugs to treat serious or life-threatening illnesses based
on adequate and well-controlled clinical trials establishing that the
drug has an effect on a surrogate endpoint that is reasonably likely to
predict clinical benefit or based on a clinical endpoint other than
survival or irreversible morbidity. Approval of PROAMATINE was based on
trials demonstrating that PROAMATINE increased 1-minute standing
systolic blood pressure, a surrogate marker considered likely to
correspond to a clinical benefit, principally relief of symptoms of
orthostatic hypotension and improved ability to perform life
activities.
    The subpart H regulations specify that approvals based upon
surrogate endpoints are ``subject to the requirement that the applicant
study the drug further to verify and describe its clinical benefit'' in
postmarketing studies. The postmarketing study requirement for
midodrine HCl was described in the new drug application (NDA)
submission seeking its approval and referenced in the Agency's 1996
approval letter. In the time since PROAMATINE was approved, the NDA
holder has sponsored clinical trials and information regarding the
drug's efficacy has been published, but data submitted to the Agency
have not verified the drug's clinical benefit to FDA's satisfaction.
Accordingly, on August 16, 2010, FDA issued a notice of opportunity for
a hearing (NOOH) on a proposal to withdraw approval of the NDA for
midodrine HCl.
    Although the NOOH process is proceeding on a separate track, FDA
recognizes that existing and potential sponsors may wish to conduct the
clinical trials needed to support continued marketing authorization of
midodrine HCl. To assist sponsors in planning and designing such
trials, we are placing in the docket a brief description of a
recommended clinical trial design. We are also inviting interested
parties to submit information to the docket such as any existing
controlled studies that verify the clinical benefit of midodrine HCl
when used to treat orthostatic hypotension. Physicians who treat
orthostatic hypotension and patient organizations that would like to
work with any

sponsors of new clinical trials are invited to submit correspondence to
the docket identifying themselves. We anticipate that any sponsor
planning to conduct new clinical studies may contact interested
physicians and organizations to solicit information and suitable
volunteer test subjects.
    The public docket is available for public review in the Division of
Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday.

    Dated: January 6, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-355 Filed 1-10-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: September 16, 2008 (Volume 73, Number 180)]
[Notices]
[Page 53456]
[DOCID:fr16se08-86]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213

Extension:
    Rule 17a-5(c), OMB Control No. 3235-0199, SEC File No. 270-199

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in the following rule: Rule 17a-
5(c) (17 CFR 240.17a-5(c)) under the Securities Exchange Act of 1934
(15 U.S.C. 78a et seq.) (``Exchange Act''). The Commission plans to
submit this existing collection of information to the Office of
Management and Budget for extension and approval.
    Rule 17a-5(c) generally requires broker-dealers who carry customer
accounts to provide statements of the broker-dealer's financial
condition to their customers. Paragraph (5) of Rule 17a-5(c) provides a
conditional exemption from this requirement. A broker-dealer that
elects to take advantage of the exemption must publish its statements
on its Web site in a prescribed manner, and must maintain a toll-free
number that customers can call to request a copy of the statements.
    The purpose of the Rule is to ensure that customers of broker-
dealers are provided with information concerning the financial
condition of the firm that may be holding the customers' cash and
securities. The Commission, when adopting the Rule in 1972, stated that
the goal was to ``directly'' send a customer essential information so
that the customer could ``judge whether his broker or dealer is
financially sound.'' The Commission adopted the Rule in response to the
failure of several broker-dealers holding customer funds and securities
in the period between 1968 and 1971.
    The Commission estimates that approximately 275 broker-dealer
respondents carrying approximately 110 million public customer accounts
incur an average burden of 138,000 hours per year to comply with the
Rule.
    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 control number.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimate of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    Comments should be directed to: Lewis W. Walker, Acting Director/
Chief Information Officer, Securities and Exchange Commission, c/o
Shirley Martinson, 6432 General Green Way, Alexandria, VA 22312, or
send an e-mail to<EMAIL_ADDRESS>
    Dated: September 8, 2008.
Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-21530 Filed 9-15-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: February 24, 2009 (Volume 74, Number 35)]
[Rules and Regulations]
[Page 8150-8151]
[DOCID:fr24fe09-4]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0736; Directorate Identifier 2008-NM-102-AD;
Amendment 39-15804; AD 2009-03-03]
RIN 2120-AA64

Airworthiness Directives; McDonnell Douglas Model DC-9-14, DC-9-
15, and DC-9-15F Airplanes; and Model DC-9-20, DC-9-30, DC-9-40, and
DC-9-50 Series Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
McDonnell Douglas airplanes listed above. This AD requires installing a
dam assembly for the container of the fuel boost pump of the center
tank located in the right main tank, and doing the related
investigative actions, and corrective actions if necessary. This AD
results from fuel system reviews conducted by the manufacturer. We are
issuing this AD to prevent the center tank fuel boost pump from
operating in a fuel vapor zone and becoming a potential ignition source
in the right main tank, potentially resulting in a fuel tank explosion
and consequent loss of the airplane.

DATES: This AD is effective March 31, 2009.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of March 31,
2009.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
3855 Lakewood Boulevard, MC D800-0019, Long Beach, California 90846-
0001; telephone<PHONE_NUMBER>, extension 2; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (telephone<PHONE_NUMBER>) is the Document Management
Facility, U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: William S. Bond, Aerospace Engineer,
Propulsion Branch, ANM-140L, FAA, Los Angeles Aircraft Certification
Office, 3960 Paramount Boulevard, Lakewood, California 90712-4137;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an airworthiness directive (AD) that would apply to
certain McDonnell Douglas airplanes. That NPRM was published in the
Federal Register on August 1, 2008 (73 FR 44937). That NPRM proposed to
require installing a dam assembly for the container of the fuel boost
pump of the center tank located in the right main tank, and doing the
related investigative actions, and corrective actions if necessary.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comment received.

Request for Service Bulletin Validation

    Northwest Airlines (NWA) has concerns that Boeing Service Bulletin
DC9-28-216, dated March 18, 2008, has not been fully validated on an
airplane. NWA states that the referenced service bulletin specifies
that the identified change was completed on an airplane having fuselage
number 807, before the initial release of the service bulletin.
However, although accomplishment of the referenced service bulletin was
started on that airplane (for a NWA airplane), it was determined that
the fuel line hardware specified in the service bulletin is incorrect,
and the actions could not be accomplished. NWA has contacted Boeing
regarding the problem, and adds that, as written, the referenced
service bulletin cannot be accomplished. NWA recommends that the
service bulletin be validated prior to release of the AD.
    We acknowledge the commenter's concern but we do not agree that
Boeing Service Bulletin DC9-28-216, dated March 18, 2008, cannot be
accomplished. The manufacturer has informed us that the fuel line
hardware specified in Boeing Service Bulletin DC9-28-216, dated March
18, 2008, is correct. During validation of the service bulletin on the
airplane having fuselage number 807, the identified problem was

corrected prior to the release of Boeing Service Bulletin DC9-28-216,
dated March 18, 2008. Therefore, we have made no change to the AD in
this regard.

Conclusion

    We reviewed the relevant data, considered the comment received, and
determined that air safety and the public interest require adopting the
AD as proposed.

Costs of Compliance

    We estimate that this AD affects 413 airplanes of U.S. registry. We
also estimate that it will take 3 or 7 work-hours per product,
depending on airplane configuration, to comply with this AD. The
average labor rate is $80 per work-hour. Required parts will cost
$1,142 or $1,697 per product, depending on configuration of the
airplane. Based on these figures, we estimate the cost of this AD to
the U.S. operators to be $570,766 or $932,141, or $1,382 or $2,257 per
product, depending on configuration of the airplane.

Authority for This Rulemaking

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

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979), and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2009-03-03 McDonnell Douglas: Amendment 39-15804. Docket No. FAA-
2008-0736; Directorate Identifier 2008-NM-102-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective March 31,
2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to McDonnell Douglas Model DC-9-14, DC-9-15,
DC-9-15F, DC-9-21, DC-9-31, DC-9-32, DC-9-32 (VC-9C), DC-9-32F, DC-
9-33F, DC-9-34, DC-9-34F, DC-9-32F (C-9A, C-9B), DC-9-41, and DC-9-
51 airplanes, certificated in any category; as identified in Boeing
Service Bulletin DC9-28-216, dated March 18, 2008.

Unsafe Condition

    (d) This AD results from fuel system reviews conducted by the
manufacturer. We are issuing this AD to prevent the center tank fuel
boost pump from operating in a fuel vapor zone and becoming a
potential ignition source in the right main tank, potentially
resulting in a fuel tank explosion and consequent loss of the
airplane.

Compliance

    (e) Comply with this AD within the compliance times specified,
unless already done.

Install Dam Assembly

    (f) Within 60 months after the effective date of this AD,
install a dam assembly for the container of the fuel boost pump of
the center tank located in the right main tank, and do the related
investigative and applicable corrective actions, by accomplishing
all the actions specified in the Accomplishment Instructions of
Boeing Service Bulletin DC9-28-216, dated March 18, 2008. Do the
applicable corrective actions before further flight.

Alternative Methods of Compliance (AMOCs)

    (g)(1) The Manager, FAA, Los Angeles Aircraft Certification
Office, ATTN: William S. Bond, Aerospace Engineer, Propulsion
Branch, ANM-140L, FAA, Los Angeles Aircraft Certification Office,
3960 Paramount Boulevard, Lakewood, California 90712-4137; telephone
(562) 627-5253; fax<PHONE_NUMBER>; has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.

Material Incorporated by Reference

    (h) You must use Boeing Service Bulletin DC9-28-216, dated March
18, 2008, to do the actions required by this AD, unless the AD
specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
3855 Lakewood Boulevard, MC D800-0019, Long Beach, California 90846-
0001; telephone<PHONE_NUMBER>, extension 2; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet http://www.myboeingfleet.com.
    (3) You may review copies of the service information that is
incorporated by reference at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington. For
information on the availability of this material at the FAA, call
425-227-1221 or<PHONE_NUMBER>.
    (4) You may also review copies of the service information at the
National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>, or
go to: http://www.archives.gov/federal_register/code_of_federal_
regulations/ibr_locations.html.

    Issued in Renton, Washington, on January 21, 2009.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E9-3125 Filed 2-23-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 54 (Monday, March 21, 2011)]
[Notices]
[Page 15305]
[FR Doc No: 2011-6488]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IN11-2-000]

Moussa I. Kourouma d/b/a Quntum Energy LLC; Notice of Designation
of Commission Staff as Non-Decisional

March 14, 2011.
    With respect to an order issued by the Commission on February 14,
2011 in the above-captioned docket, staff of the Office of Enforcement
(OE), are designated as non-decisional in deliberations by the
Commission in this docket. Accordingly, pursuant to 18 CFR 385.2202
(2010), they will not serve as advisors to the Commission or take part
in the Commission's review of any offer of settlement. Likewise, as
non-decisional staff, pursuant to 18 CFR 385.2201 (2010), they are
prohibited from communicating with advisory staff concerning any
deliberations in this docket.

    Dated: March 14, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-6488 Filed 3-18-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: July 14, 2010 (Volume 75, Number 134)]
[Notices]
[Page 40863-40864]
[DOCID:fr14jy10-120]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2010-0193]

Pipeline Safety: Information Collection Activities

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, PHMSA
invites comments on an information collection under Office of
Management and Budget (OMB) Control No. 2137-0598, titled
``Incorporation by Reference of Industry Standard on Leak Detection.''
PHMSA is preparing to

request approval from OMB for a renewal of the current information
collection.

DATES: Interested persons are invited to submit comments on or before
September 13, 2010.

ADDRESSES: Comments may be submitted in the following ways:
    E-Gov Web Site: http://www.regulations.gov. This site allows the
public to enter comments on any Federal Register notice issued by any
agency.
    Fax: 1-202-493-2251.
    Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building, Room W12-
140, Washington, DC 20590-0001.
    Hand Delivery: Room W12-140 on the ground level of the West
Building, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal holidays.
    Instructions: Identify the docket number, PHMSA-2010-0193, at the
beginning of your comments. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. You should know that anyone is able to
search the electronic form of all comments received into any of our
dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.) Therefore, you may want to review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477) or visit http://www.regulations.gov before
submitting any such comments.
    Docket: For access to the docket or to read background documents or
comments, go to http://www.regulations.gov at any time or to Room W12-
140 on the ground level of the West Building, 1200 New Jersey Avenue,
SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. If you wish to receive confirmation of receipt
of your written comments, please include a self-addressed, stamped
postcard with the following statement: ``Comments on PHMSA-2010-0193.''
The Docket Clerk will date-stamp the postcard prior to returning it to
you via the U.S. mail. Please note that due to delays in the delivery
of U.S. mail to Federal offices in Washington, DC, we recommend that
persons consider an alternative method (Internet, fax, or professional
delivery service) of submitting comments to the docket and ensuring
their timely receipt at DOT.

FOR FURTHER INFORMATION CONTACT: Cameron Satterthwaite by telephone at
202-366-1319, by fax at<PHONE_NUMBER>, or by mail at U.S. Department of
Transportation, Pipeline and Hazardous Materials Safety Administration,
1200 New Jersey Avenue, SE., PHP-30, Washington, DC 20590-0001.

SUPPLEMENTARY INFORMATION: Section 1320.8(d), Title 5, Code of Federal
Regulations requires PHMSA to provide interested members of the public
and affected agencies an opportunity to comment on information
collection and recordkeeping requests. This notice identifies an
information collection request that PHMSA will be submitting to OMB for
renewal and extension. The information collection expires October 31,
2010, and is identified under Control No. 2137-0598, titled:
``Incorporation by Reference of Industry Standard on Leak Detection.''
This information collection is contained in 49 CFR Part 195. The
following information is provided for each information collection: (1)
Title of the information collection; (2) OMB control number; (3) Type
of request; (4) Abstract of the information collection activity; (5)
Description of affected public; (6) Estimate of total annual reporting
and recordkeeping burden; and (7) Frequency of collection. PHMSA will
request a three-year term of approval for this information collection
activity.
    PHMSA requests comments on the following information collection:
    Title: Incorporation by Reference of Industry Standard on Leak
Detection.
    OMB Control Number: 2137-0598.
    Type of Request: Renewal of a currently approved information
collection.
    Abstract: Section 195.444 of the Federal pipeline safety
regulations requires operators of single phase hazardous liquid
pipeline facilities that use computational pipeline monitoring (CPM)
leak detection systems to comply with the standards set out in American
Petroleum Institute (API) publication API 1130. API 1130 requires
operators to record and retain certain information in connection with
the operation and testing of CPM systems. Compliance with API 1130,
including its record keeping requirements, supports pipeline safety by
ensuring the proper functioning of CPM leak detection systems.
    Affected Public: Operators of hazardous liquid pipelines.
    Estimated Number of responses: 50.
    Estimated Annual Burden Hours: 100 hours.
    Frequency of collection: On occasion.
    Comments are invited on:
    (a) The need for the proposed collection of information for the
proper performance of the functions of the agency, including whether
the information will have practical utility;
    (b) 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;
    (c) Ways to enhance the quality, utility, and clarity of the
information to be collected; and
    (d) Ways to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques.

    Issued in Washington, DC, on July 8, 2010.
Linda Daugherty,
Deputy Associate Administrator for Policy and Programs.
[FR Doc. 2010-17078 Filed 7-13-10; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register: October 20, 2008 (Volume 73, Number 203)]
[Notices]
[Page 62301-62302]
[DOCID:fr20oc08-71]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

Compendium of Flood Map Changes

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice of availability.

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SUMMARY: The Federal Emergency Management Agency (FEMA) announces the
availability of the Compendium of Flood Map Changes, which provides a
listing of changes made to the National Flood Insurance Program (NFIP)
maps that went into effect from January 1, 2008, through June 30, 2008.
Future notices of NFIP map changes will be made available approximately
every 6 months.

DATES: The listings include changes to NFIP maps that went into effect
from January 1, 2008, through June 30, 2008.

ADDRESSES: The Compendium of Flood Map Changes is available on the
Internet at http://www.fema.gov/plan/prevent/fhm/dl_comp.shtm.

FOR FURTHER INFORMATION CONTACT: William R. Blanton, Jr., Chief,
Engineering Management Branch, Mitigation Directorate, Federal
Emergency Management Agency, 500 C Street, SW., Washington, DC 20472,
(202) 646-3151.

SUPPLEMENTARY INFORMATION: In accordance with section 1360(i) of the
National Flood Insurance Reform Act of 1994, 42 U.S.C. 4101(i), this
notice is provided to inform interested parties of the availability of
changes made by FEMA to NFIP maps. In the Compendium of Flood Map
Changes, the two listings show communities affected by map changes made
by letter and communities affected by physical map changes. For each
Letter of Map Change, the first listing provides the map panel(s)
affected, effective (determination) date of the change, case number,
and determination type. For each physical map change, the Map Revision
listing provides the map panel(s) affected and the effective date

of the change. The listing also identifies: (1) Those panels on which
the Special Flood Hazard Areas have not been changed or have been
changed only to incorporate the Letters of Map Change issued before the
effective date; and (2) those panels for which a Flood Insurance Rate
Map is produced for the first time, resulting only in changes to flood
insurance and floodplain management requirements in the affected
community. Future notices of changes to NFIP maps will be made
available approximately every 6 months.
    The Compendium of Flood Map Changes is available on the Internet at
http://www.fema.gov/plan/prevent/fhm/dl_comp.shtm. The compendia shall
be available, free of charge, to Federal entities for lending
regulation, Federal agency lenders, and States and communities
participating in the National Flood Insurance Program, and at a cost to
all other parties. For more information, contact the FEMA Map Service
Center at<PHONE_NUMBER> or go to http://www.msc.fema.gov.

    Authority: 42 U.S.C. 4101(i).

    Dated: September 17, 2008.
Michael K. Buckley,
Acting Assistant Administrator, Mitigation Directorate, Department of
Homeland Security, Federal Emergency Management Agency.
 [FR Doc. E8-24794 Filed 10-17-08; 8:45 am]

BILLING CODE 9110-12-P


[Federal Register Volume 88, Number 198 (Monday, October 16, 2023)]
[Notices]
[Page 71395]
[FR Doc No: 2023-22739]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2018-0033]

Petition for Waiver of Compliance

    Under part 211 of title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on July 25, 2023, the Michigan
State Trust for Railway Preservation, Inc. (MSTRP), doing business as
The Steam Railroading Institute, petitioned the Federal Railroad
Administration (FRA) for an extension of a waiver of compliance from
certain provisions of the Federal railroad safety regulations contained
at 49 CFR part 240 (Qualification and Certification of Locomotive
Engineers). The relevant Docket Number is FRA-2018-0033.
    Specifically, MSTRP requests to extend its relief from Sec.
240.201(d), which requires that only certified persons operate
locomotives and trains. The current relief allows noncertified persons
to operate a locomotive as part of a ``Hands on the Throttle'' program
on Great Lakes Central Railroad owned and operated tracks. In support
of its petition, MSTRP notes that the relief would only apply to
persons participating in the program, and that participants would have
a valid driver's license and be under the direct supervision of a
certified and qualified locomotive engineer. Further, all movements
would take place during daylight hours and at restricted speed. MSTRP
states that the program generates interest in steam locomotive
technology to preserve knowledge and heritage of railroading into the
future.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted at https://www.regulations.gov. Follow the online instructions for submitting
comments.
    Communications received by December 15, 2023 will be considered by
FRA before final action is taken. Comments received after that date
will be considered if practicable. Anyone can search the electronic
form of any written communications and comments received into any of
our dockets by the name of the individual submitting the comment (or
signing the document, if submitted on behalf of an association,
business, labor union, etc.). Under 5 U.S.C. 553(c), the U.S.
Department of Transportation (DOT) solicits comments from the public to
better inform its processes. DOT posts these comments, without edit,
including any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacy-notice for the
privacy notice of regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2023-22739 Filed 10-13-23; 8:45 am]
BILLING CODE 4910-06-P