OVERVIEW OF HEXAZINONE RISK ASSESSMENT Introduction This document summarizes EPA's human health findings and conclusions for the herbicide hexazinone, as presented fully in the documents: HED Chapter for the Hexazinone Tolerance Reassessment Eligibility Decision, dated June 5, 2002, and Tier I Estimated Environmental Concentrations of Hexazinone, dated April 16, 2002 and addenda. The purpose of this overview is to assist the reader in better understanding the conclusions reached in the tolerance reassessment decision by identifying the key features and findings of the risk assessment. This overview was developed in response to comments and requests from the public, which indicated that the risk assessments were difficult to understand, that they were too lengthy, and that it was not easy to compare the assessments for different chemicals due to the use of different formats.

The Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act (FQPA) of 1996, requires EPA to review all the tolerances for registered chemicals in effect on or before the date of the enactment of FQPA. In reviewing these tolerances, the Agency must consider, among other things, aggregate risks from non occupational sources of pesticide exposure, whether there is increased susceptibility to infants and children, and the cumulative effects of pesticides with a common mechanism of toxicity. The tolerances are considered reassessed once the safety finding has been made or a revocation occurs. A Reregistration Eligibility Decision (RED) for hexazinone was completed in September 1994, prior to FQPA enactment; therefore, it needed to be updated to consider the provisions of the Act.

FQPA stipulates that when determining the safety of a pesticide chemical, EPA shall base its assessment of the risk posed by the chemical on, among other things, available information concerning the cumulative effects to human health that may result from dietary, residential, or other nonoccupational exposure to other substances that have a common mechanism of toxicity. The reason for consideration of other substances is due to the possibility that low level exposures to multiple chemical substances that cause a common toxic effect by a common mechanism could lead to the same adverse health effect as would a higher level of exposure to any of the substances individually. A person exposed to a pesticide at a level that is considered safe may in fact experience harm if that person is also exposed to other substances that cause a common toxic effect by a mechanism common with that of the subject pesticide, even if the individual exposure levels to the other substances are also considered safe.

EPA did not perform a cumulative risk assessment as part of the Tolerance Reassessment Decision (TRED) for hexazinone because the Agency has not yet initiated a comprehensive review to determine if there are any other chemical substances that have a mechanism of toxicity common with that of hexazinone. For purposes of this risk assessment, EPA has assumed that hexazinone does not have a common mechanism of toxicity with other substances. 2 In the future, the registrant may be asked to submit, upon EPA's request and according to a schedule determined by the Agency, such information as the Agency directs to be submitted in order to evaluate issues related to whether hexazinone shares a common mechanism of toxicity with any other substance and, if so, whether any tolerances for hexazinone need to be modified or revoked. The Agency has developed a framework for conducting cumulative risk assessments on substances that have a common mechanism of toxicity. This guidance was issued on January 16, 2002 (67 FR 2210 2214) and is available from the OPP Website at: http:// www. epa. gov/ pesticides/ trac/ science/ cumulative_ guidance. pdf.

The risk assessment, and documents pertaining to the Agency's report on FQPA tolerance reassessment progress and risk management decision for hexazinone are available on the Internet at http:// www. epa. gov/ pesticides/ reregistration/ status. htm and in the public docket for viewing. The Agency's report on FQPA tolerance reassessment progress and risk management decision for hexazinone will be announced in the Federal Register.

Use Profile Herbicide: Hexazinone is a herbicide registered for use on alfalfa, blueberries, pasture and range grasses, pineapple, and sugarcane. It is also registered for use on ornamental plants, forest trees, and non crop areas. Hexazinone works through the inhibition of photosynthesis and is used to control a variety of woody plants and weed species including geratum, alder, and alexander grass. There are no registered residential uses of hexazinone products.

Formulations: Hexazinone is formulated as a dry flowable (DF), emulsifiable concentrate (EC), soluble concentrate (SC), and as a granular (G). The range of percentage of active ingredient in the product formulations is 10 90%.

Rates, Methods and Timing of Application: The application rates range from 0.5 5.0 lbs. active ingredient per acre. For agricultural uses, the number of applications per year (or season) are typically limited to one. For forestry uses, the number of applications are typically 1 2 applications over a 20 to 40 year period in the East and 1 2 applications over a 60 to 80 year period in the West. Hexazinone formulations may be applied pre or post emergence by layby, broadcast, directed spray, or basal soil treatments using ground or aerial equipment. Hexazinone is mainly an early season use, pre harvest intervals (PHIs) range from 180 234 days for most uses, but PHIs are 30 and 45 days for alfalfa and blueberry, respectively.

Use Summary: Approximately 975,000 pounds of hexazinone active ingredient are used in the U. S. annually.

Major Use Sites For Hexazinone: Alfalfa represents approximately 35% of the total hexazinone usage and forestry approximately 60% of the usage. None of the crops that comprise the remaining 5% of use represents more than 1% of the total usage. 3 Registrant: Dupont Human Health Risk Assessment Acute Dietary (Food) Risk (For a complete discussion, see section 4.2.2 of the Human Health Risk Assessment)

Because no effects attributed to a single exposure were identified for the general population, the acute dietary exposure and risk assessment includes females 13 50 only. Acute dietary risk from food is calculated considering what is eaten in one day (in this instance, the full range of consumption values as well as the range of residue values in food). A risk estimate that is less than 100% of the acute Population Adjusted Dose (aPAD) (the dose at which an individual could be exposed on any given day and no adverse health effects would be expected) does not exceed the Agency's level of concern. The aPAD is the reference dose (RfD) adjusted for the FQPA Safety Factor. Table 1 presents the results of the acute dietary (food) exposure and risk analysis for females (13 50 years of age).

Table 1. Acute Dietary (Food) Exposure and Risk Population Subgroup Exposure (mg/ kg/ day) % aPAD Females (13 50 years) 0.003611 <1.0 ° The acute dietary risk estimate does not exceed the aPAD. The acute dietary risk estimate for females 13 50 years old is <1.0% of the aPAD.

° Because the toxic endpoint for acute dietary exposure concerns in utero exposure, the risk assessment is done for females of childbearing age (13 50) only. For the female (13 50 years) population subgroup, the acute No Observed Adverse Effect Level (NOAEL) of 400 mg/ kg/ day was established, based on decreased fetal weight, malformed kidneys, & skeletal abnormalities in a rat developmental toxicity study. The LOAEL was 900 mg/ kg/ day.

° An uncertainty factor (UF) of 100 was applied to the doses selected for the risk assessment to account for interspecies extrapolation (10x) and intraspecies variability (10x).

° For acute dietary exposure, the FQPA safety factor was reduced to 1X since the toxicology database for hexazinone contains acceptable developmental and reproduction studies in the rat and rabbit, and there is no quantitative or qualitative evidence of increased susceptibility in the fetuses or offspring in these studies. The risk assessment will not underestimate the exposure and risks posed by hexazinone. 4 ° The acute RfD for females 13 50: 400 mg/ kg/ day (NOAEL) ÷ 100 (UF) = 4.0 mg/ kg/ day. The acute PAD for females 13 50: 4.0 mg/ kg/ day ÷ 1 (FQPA) = 4.0 mg/ kg/ day.

° The acute dietary exposure analysis is based on the Dietary Exposure Evaluation Model (DEEM ™ ). The DEEM ™ analysis evaluated individual food consumption as reported by respondents in the USDA 1989 92 Continuing Surveys for Food Intake by Individuals (CSFII). The data are based on the reported consumption of more than 10,000 individuals over three days. For the acute exposure assessment, individual one day food consumption data are used on an individual by individual basis.

° The acute dietary exposure assessment for hexazinone is a tier I analysis. This is the most conservative type of analysis done by the Agency and it assumes that residues on foods as consumed are equal to the tolerance levels and that 100% of each crop is treated.

° The dietary exposure assessment included residue estimates of hexazinone (parent) and metabolites B, C, C 1, C 2, and F for ruminant commodities and metabolites A, B, C, D, and E for plant commodities. The metabolites and parent hexazinone are assumed to have equal toxicity based upon similarity in chemical structure.

° Because existing data were inadequate to calculate residue estimates for pasture and rangeland grass and grass hay, EPA constructed the maximum theoretical dietary burden (MTDB) of hexazinone to livestock using protective assumptions for the contributions of other hexazinonetreated feed items. Thus, tolerances for meats and milk can be reassessed. Additional field trial data for grass forage and grass hay, as well as rotational crop studies for corn and wheat are required. Because of the relatively low volume of use on pasture and rangeland, data from these confirmatory studies are not expected to significantly change current dietary risk estimates.

Chronic Dietary (Food) Risk (For a complete discussion, see section 4.2.3 of the Human Health Risk Assessment)

Chronic dietary risk from food is calculated by using the average consumption values for food and average residue values for those foods over a 70 year lifetime. A risk estimate that is less than 100% of the chronic PAD (cPAD) (the daily dose at which an individual could be exposed over the course of a lifetime and no adverse health effects would be expected) does not exceed the Agency's level of concern. Table 2 presents the results of the chronic dietary (food) exposure and risk analysis.

Table 2. Chronic Dietary (Food) Exposure and Risk Population Subgroup Exposure (mg/ kg/ day) % cPAD General U. S. 0.002167 4.3 Population Subgroup Exposure (mg/ kg/ day) % cPAD 5 All infants (< 1 year) 0.003752 7.5 Children (1 6 years) 0.0077449 15.5 Children (7 12 years) 0.003964 7.9 Females (13 50 years) 0.001308 2.6 ° The chronic dietary risk estimate for all population subgroups does not exceed the cPAD, all population subgroups are <16% of the cPAD.

° For all populations, the chronic NOAEL of 5.00 mg/ kg/ day was established, based on severe body weight decrement, decreased food consumption, and clinical chemistry changes such as anemia, decreases in RBC counts, hemoglobin, and hematocrit in a one year chronic dog study at the LOAEL of 38 mg/ kg/ day.

° An uncertainty factor (UF) of 100 was applied to the doses selected for the risk assessment to account for interspecies extrapolation (10x) and intraspecies variability (10x).

° For chronic dietary exposure, the FQPA safety factor was reduced to 1X for the same reasons noted above for acute dietary exposure.

° The chronic RfD: 5.0 mg/ kg/ day (NOAEL) ÷ 100 (UF) = 0.05 mg/ kg/ day. The chronic PAD: 0.05 mg/ kg/ day ÷ 1 (FQPA) = 0.05 mg/ kg/ day.

° The chronic dietary exposure analysis is based on the Dietary Exposure Evaluation Model (DEEM ™ ). For chronic dietary (food) assessments, a three day average of consumption for each population subgroup is combined with average residues in commodities to determine average exposures in mg/ kg/ day.

° The chronic dietary (food) exposure assessment for hexazinone was a tier I analysis. This is the most conservative type of analysis the Agency performs and it assumes that residues on foods as consumed are equal to the tolerance levels and that 100% of each crop is treated.

Drinking Water Dietary Risk (For a complete discussion, see section 4.3 of the Human Health Risk Assessment)

Drinking water exposure to pesticides can occur through surface and/ or ground water contamination. EPA considers acute (one day) and chronic (lifetime) drinking water risks and uses 6 either modeling or actual monitoring data, if available, to estimate those risks. Modeling is carried out in tiers of increasing refinement, but is designed to provide a conservative estimate of potential exposure. To determine the maximum allowable contribution from water allowed in the diet, EPA first looks at how much of the overall allowable risk is contributed by food and then determines a Drinking Water Level of Comparison" (DWLOC) to ascertain whether modeled or monitored Estimated Environmental Concentrations (EECs) exceed this level.

The hexazinone drinking water exposure assessment is based upon review of environmental fate studies which suggest that the parent and degradates are likely to be persistent and mobile in the environment. Leaching and runoff are expected to be the primary dissipation routes. Estimated Environmental Concentrations (EECs) in surface waters were estimated using Tier I modeling (FIRST). The EECs in groundwater were estimated using an available small scale prospective groundwater monitoring study from California. In addition, there are monitoring data available from the state of Maine that were used for comparison purposes only.

° The use of hexazinone on alfalfa was modeled for the purpose of assessing surface drinking water exposure to the chemical and its degradates. Alfalfa is the food/ feed item with the greatest percent of crop treated with hexazinone.

° Estimated Environmental Concentrations (EECs) for surface water were estimated using FIRST (Tier I) modeling. This model is a screening tool designed to provide high end estimates of the concentrations that might be found in a small drinking water reservoir due to the use of the pesticides.

° EECs for ground water are based on monitoring data from the small scale prospective groundwater monitoring study in California. The results of this study were compared and confirmed with monitoring done in the State of Maine.

° The parent hexazinone, G3170, and all degradates with conjoined cyclohexyl and triazine rings (specifically, A, A 1, B, C, D, 1 (JS472), and 2 (JT677)) are residues of concern for risk assessment in water. The Agency assumes they have similar toxicity as the parent. Drinking water DWLOCs and EECs are compared in Table 3. 7 Table 3. Acute and Chronic Drinking Water DWLOC and EEC Comparisons Population Subgroup Acute Scenario Chronic Scenario Acute DWLOC Ground Water EEC Surface Water EEC Chronic DWLOC Ground Water EEC Surface Water EEC U. S. General 420 42 47 Females (13 50 years) 120,000 42 130 420 42 47 All infants 420 42 47 Children (1 6 years) 420 42 47 ° For acute drinking water risk, potential (peak) EECs of hexazinone in either ground water (42 ppb) or surface water (130 ppb) are below the acute DWLOC for females (13 50 years) (120,000 ppb).

° For chronic drinking water risk, the potential (average) EECs of hexazinone in either ground water (42 ppb) or surface water (47 ppb) are below the chronic DWLOC for all population subgroups (420 ppb).

Blueberry Use In Maine A significant portion of the wild blueberry crop in the state of Maine is treated with hexazinone. It may be applied pre or post emergence at use rates of 0.5 to 2 lb ai/ acre. Wild blueberries produce a berry crop every other season, with hexazinone being typically applied in the non bearing year. A Special Local Need (SLN) label for Maine, allows use 45 days before harvest. Hexazinone is the primary factor in increasing the wild blueberry crop three fold over the past 15 years. Hexazinone has a half life of 90 days, is highly soluble, and prone to leaching. Because most of the wild blueberry fields are on highly leachable sandy loam soils, there is concern that ground and surface water may be impacted by hexazinone use. Water monitoring has been conducted since 1985 and hexazinone is detected in both ground and surface water. Long term test well data from 1989 1995 found concentrations of hexazinone in the 25 29 ppb. In response, the Maine Board of Pesticides Control implemented a Best Management System in 1996 to reduce surface and groundwater impact. The measures implemented by the State, include classifying hexazinone as a Restricted Use Pesticide. Users must become certified applicators by attending training on proper application techniques. In addition, on going field training is provided for workers using hexazinone. Application is not allowed within 50 feet of a water source or well, airblast application is prohibited, low use rates are suggested except when weed pressure is high, and alternative weed control measures are recommended, such as cutting/ mowing, burning, and hand pulling of weeds. Recent monitoring from 1998 2001 found 8 concentrations from 0.08 3.8 ppb in both ground and surface water which are significant reductions from the levels found in the previous monitoring. The Best Management System implemented by the State appears to be lowering the levels of hexazinone in ground and surface water. The Agency supports these efforts and anticipates their continued modification and improvement may further reduce the levels of hexazinone in ground and surface water from hexazinone application to blueberries. Nonetheless, the levels of hexazinone found in ground and surface water in Maine are well below the acute DWLOC (12,000 ppb) and the chronic DWLOC (430 ppb) and thus, below the Agency's level of concern.

Forestry Use and Tribal Communities About 60% of hexazinone usage is on forestry sites for woody plant and weed control. Shortly following a logging operation, hexazinone may be applied to control brush in preparation for the replanting of tree seedlings. Depending on weed intensity, hexazinone may be applied a second time the next season after the seedlings have been planted. The goal is to suppress the competing vegetation and allow the seedlings the opportunity to establish their root system and help them increase their growth size above the competing vegetation. In Eastern forests, because of the species of trees grown, hexazinone may typically be applied 1 2 times during a 20 to 40 year period. In Western forests, hexazinone may typically be applied 1 2 times during a 60 to 80 year period. In some forested areas where hexazinone is applied, Native Americans gather plant materials that are used in their diets, in the making of traditional basketry, for medicinal purposes, and in ceremonial activities.

USEPA, (Region IX) is working with the California Department of Pesticide Regulation (DPR), the U. S. Forest Service (USFS) and Native American tribes in California to determine the potential exposure to forestry herbicides, including hexazinone, glyphosate, and triclopyr, that may be occurring to Native Americans through their use of forest plant materials. In response to the health concerns raised by the Native American communities, DPR and Region IX launched a risk assessment effort in 1997. This effort includes five steps: DPR measured plant residue and surface water levels following herbicide application; DPR agreed to assess the total exposures and risks involved using, where appropriate, the monitoring data collected; informing tribal physicians of state regulations requiring pesticide illness reporting; participation in mediated meetings with Native American communities to determine the key issues surrounding herbicide use; and a video production about inadvertent exposure to herbicides. In addition, the USFS is working with local Indian tribes, and has established "no spray" zones where plant materials may be gathered free of pesticide residues. They are also working to reduce pesticide usage, prevent runoff, and minimize exposure by posting application sites and providing bulletins alerting the public where applications have, or will occur.

EPA is aware of this ongoing work and will continue to coordinate with the registrant Dupont, Region IX, California DPR, U. S. Forest Service, and other entities, as appropriate, to ensure that potential exposures and risks are better characterized. In addition, the Agency is working to develop risk analysis software that will assess risk from chemicals in food, air, water, and other sources for 9 Native American and Alaska native sub populations whose subsistence ways of life may result in exposures to toxic chemicals that are significantly different from those of other population sub groups.

Residential Risk Hexazinone is not registered for home use nor is it used in and around schools, or parks. Based on present use patterns and labeled uses, there should be no residential exposure to hexazinone. Thus, there is no residential exposure to assess or aggregate with the dietary and drinking water exposure.

Aggregate Risk (For a complete discussion, see section 5.0 of the Human Health Risk Assessment)

Aggregate risk examines the combined risk from exposure through food, drinking water, and residential uses. Using the DWLOC approach, all risks from these exposures must be less than 100% of the aPAD or cPAD. For hexazinone, the aggregate risks are limited to food and water exposure, because there are no residential uses.

° Combining both the acute dietary (food) risk estimates with the surface and ground water EECs (drinking water) for hexazinone, the acute aggregate (food + drinking water) risk is less than 100% of the aPAD; and therefore, is not of concern to the Agency.

° Combining both the chronic dietary (food) risk estimate with the surface and ground water EECs (drinking water) for hexazinone, the chronic aggregate (food + drinking water) risk is less than 100% of the cPAD, and therefore, is not of concern to the Agency.

Occupational and Ecological Risk (For a complete discussion, see section 4.2 of the Human Health Risk Assessment)

Because hexazinone is under review for tolerance reassessment only, no occupational or ecological risk assessment would normally be conducted. Occupational and ecological risk management decisions were made as part of the 1994 Hexazinone RED. The Agency reevaluated labeled uses and determined the personal protective equipment and restricted entry intervals included in the RED are health protective. In addition, ecological tests indicate hexazinone is non toxic to birds, bees, and fish. 10 Tolerance Reassessment Summary (For a complete discussion, see Hexazinone Residue Chemistry Chapter for the Tolerance Reassessment Eligibility Decision (TRED), dated 5/ 20/ 2002.)

The Agency has reassessed all 25 tolerances for hexazinone and can make an FQPA safety determination. Anticipated residues for commodities included in the dietary risk assessment are equal to the tolerance levels and it was assumed that 100% of each crop was treated. Acute and chronic dietary risks from exposure to hexazinone do not exceed the Agency's level of concern. Tolerances for residues of hexazinone in/ on plant, livestock, and processed commodities are currently expressed in terms of the combined residues of hexazinone and its metabolites (calculated as hexazinone). Field trial data for pasture and rangeland grass hay will be required as well as rotational crop studies for corn and wheat, and are considered confirmatory. Final tolerances are being proposed as part of this Tolerance Reassessment Decision (TRED). Additional tolerances may be revised once the field trial data and rotational crop studies have been submitted to and reviewed by the Agency.

Table 4. Tolerance Reassessment Summary for Hexazinone.

Commodity Current Tolerance (ppm) a Tolerance Reassessment (ppm) Comment/ Correct Commodity Definition Tolerances presently listed under 40 CFR §180.396( a):

Alfalfa green forage 2.0 2.0 Alfalfa, forage Alfalfa hay 8.0 4.0 Tolerance should be reduced based on re calculation of expected residues. Alfalfa, hay Blueberries 0.2 0.6 Tolerance should be increased based on the combined LOQ (0.55 ppm) of the enforcement method. Blueberry Cattle, fat 0.1 Revoke b Cattle, mbyp 0.1 0.1 Cattle, meat 0.1 0.1 Goat, fat 0.1 Revoke b Goat, mbyp 0.1 0.1 Goats, meat 0.1 0.1 Grasses, pasture 10 TBD c Grass, forage Commodity Current Tolerance (ppm) a Tolerance Reassessment (ppm) Comment/ Correct Commodity Definition 11 Grasses, rangeland 10 TBD c Grass, hay Hog, fat 0.1 Revoke b Hog, mbyp 0.1 Revoke b Hog, meat 0.1 Revoke b Horses, fat 0.1 Revoke b Horses, mbyp 0.1 0.1 Horses, meat 0.1 0.1 Milk 0.5 0.2 Tolerance should be reduced based on re calculation of expected residues.

Pineapple 0.5 0.6 Tolerance should be increased based on the combined LOQ (0.55 ppm) of the enforcement method.

Sheep, fat 0.1 Revoke b Sheep, mbyp 0.1 0.1 Sheep, meat 0.1 0.1 Tolerances needed under 40 CFR §180.396( a):

Alfalfa, seed 2.0 Tolerances presently listed under 40 CFR §180.396( c):

Sugarcane 0.2 0.6 Tolerance should be increased based on the combined LOQ (0.55 ppm) of the enforcement method.

Sugarcane molasses 5.0 4.0 Tolerance should be reduced based on re calculation of expected residues.

Sugarcane molasses d 5.0 4.0 Tolerance should be reduced based on re calculation of expected residues. a Expressed in terms of the combined residues of hexazinone and its metabolites (calculated as hexazinone). b Tolerances for fat are not required (Category 3, 40 CFR §180.6). c TBD: These tolerances require additional field trial data and may be revised once the data have been submitted to and reviewed by the Agency. d For reassessment counting purposes, the Agency will count the sugarcane molasses tolerances as two reassessments to reflect the tolerances which existed both in 40 CFR Part 185 (185.3575) and Part 186 (186.3575) at the start of FQPA. 12 CODEX HARMONIZATION No maximum residue limits (MRLs) for hexazinone and its metabolites have been established or proposed by Codex for any agricultural commodity. Therefore, no compatibility questions exist with respect to U. S. tolerances.

Summary of Pending Data The Agency is requesting a 28 day inhalation study on a formulation with hexazinone because of the concern for potential inhalation exposure. Additional field trial data for grass hay and rotational crop studies for corn and wheat are required.


[Federal Register Volume 78, Number 10 (Tuesday, January 15, 2013)]
[Notices]
[Pages 3068-3069]
[FR Doc No: 2013-00606]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2012-54]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number involved and must be received on or before February 4, 2013.

ADDRESSES: You may send comments identified by Docket Number FAA-2012-
1212 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to

http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Tyneka Thomas ARM-105,<PHONE_NUMBER>,
FAA, Office of Rulemaking, 800 Independence Ave. SW., Washington, DC
20591. This notice is published pursuant to 14 CFR 11.85.

    Dated: Issued in Washington, DC, on January 9, 2013.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2012-1212.
    Petitioner: Uwe Goehl.
    Section of 14 CFR Affected: 14 CFR 61.109(j)(4).
    Description of Relief Sought: The relief sought would allow Uwe
Goehl to meet solo flight requirements for the issuance of a weight-
shift-control aircraft rating in an aircraft registered in a foreign
state, conducted outside the United States, with an authorized
instructor on board.
[FR Doc. 2013-00606 Filed 1-14-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 173 (Wednesday, September 7, 2011)]
[Rules and Regulations]
[Pages 55261-55264]
[FR Doc No: 2011-22773]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0690]
RIN 1625-AA00

Safety Zone; Corporate Party on Hornblower Yacht, San Francisco,
CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone in the
navigable waters near pier 48 in the San Francisco Bay, San Francisco,
California in support of the Corporate Party on Hornblower Yacht. This
temporary safety zone is established to ensure the safety of
participants and spectators from the dangers associated with the
pyrotechnics. Unauthorized persons or vessels are prohibited from
entering into, transiting through, or remaining in the safety zone
without permission of the Captain of the Port or their designated
representative.

DATES: This rule is effective from 11 a.m. through 9 p.m. on September
17, 2011.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2011-0690 and are available online
by going to http://www.regulations.gov, selecting the Advanced Docket
Search option on the right side of the screen, inserting USCG-2011-0690
in the Docket ID box, pressing Enter, and then clicking the item in the
Docket ID column. They are also available for inspection or copying at
the Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail Ensign William Hawn, U.S. Coast Guard
Sector San Francisco; telephone<PHONE_NUMBER> or e-mail at<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
(202) 366-9826.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment

pursuant to authority under section 4(a) of the Administrative
Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an
agency to issue a rule without prior notice and opportunity to comment
when the agency for good cause finds that those procedures are
``impracticable, unnecessary, or contrary to the public interest.''
Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists
for not publishing a notice of proposed rulemaking (NPRM) with respect
to this rule because it would be impracticable to delay this rule
because the event would occur before the rulemaking process would be
completed. Because of the dangers posed by the pyrotechnics used in
this fireworks display, the safety zone is necessary to provide for the
safety of event participants, spectators, spectator craft, and other
vessels transiting the event area. For the safety concerns noted, it is
in the public interest to have these regulations in effect during the
event.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Any delay in the effective date of
this rule would expose mariners to the dangers posed by the
pyrotechnics used in the fireworks display.

Basis and Purpose

    Hornblower Cruises and Events will sponsor the Corporate Party on
Hornblower Yacht on September 17, 2011, in the navigable waters near
pier 48 of the San Francisco Bay, off of San Francisco, CA. This safety
zone establishes a temporary restricted area on the waters 100 feet
around the fireworks barge during the loading of the barge and transit
of the barge to the launch site. During the fireworks display the
safety zone will extend to 1,000 feet around the launch site. The
fireworks display is meant for entertainment purposes. This safety zone
is issued to establish a temporary restricted area on the waters
surrounding the fireworks barge during the loading, transit, and during
the fireworks display. This restricted area around the launch site is
necessary to protect spectators, vessels, and other property from the
hazards associated with the pyrotechnics. The Coast Guard has granted
the event sponsor a marine event permit for the fireworks display.

Discussion of Rule

    From 11 a.m. until 4 p.m. on September 17, 2011, pyrotechnics will
be loaded onto a barge at Pier 50 near position 37[deg]46'28'' N,
122[deg]23'06'' W (NAD 83). From 7:45 until 7:55 p.m. the loaded barge
will transit from Pier 50 to the launch site located at position
37[deg]46'38.46'' N, 122[deg]23'01.67'' W (NAD 83). The temporary
safety zone will extend 100 feet from the nearest point of the barge
during the loading, transit, and arrival of the pyrotechnics from Pier
50 to position 37[deg]46'38.46'' N, 122[deg]23'01.67'' W (NAD 83). The
fireworks display will occur from 8:45 until 8:55 p.m. on September 17,
2011, during which the safety zone will extend 1,000 feet from the
nearest point of the barge at position 37[deg]46'38.46'' N,
122[deg]23'01.67'' W (NAD 83). At 9 p.m. on September 17, 2011 the
safety zone shall terminate.
    The effect of the temporary safety zone will be to restrict
navigation in the vicinity of the fireworks site until the conclusion
of the scheduled display. Except for persons or vessels authorized by
the Coast Guard Patrol Commander, no person or vessel may enter or
remain in the restricted area. These regulations are needed to keep
spectators and vessels a safe distance from the fireworks display to
ensure the safety of participants, spectators, and transiting vessels.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes and executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of that Executive Order 12866
or under section 1 of Executive Order 13563. The Office of Management
and Budget has not reviewed it under those Orders.
    Although this rule restricts access to the waters encompassed by
the safety zone, the effect of this rule will not be significant
because the local waterway users will be notified via public Broadcast
Notice to Mariners to ensure the safety zone will result in minimum
impact. The entities most likely to be affected are pleasure craft
engaged in recreational activities.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities.
    This rule may affect owners and operators of pleasure craft engaged
in recreational activities and sightseeing. This rule will not have a
significant economic impact on a substantial number of small entities
for several reasons: (i) Vessel traffic can pass safely around the
area, (ii) vessels engaged in recreational activities and sightseeing
have ample space outside of the effected portion of the areas off San
Francisco, CA to engage in these activities, (iii) this rule will
encompass only a small portion of the waterway for a limited period of
time, and (iv) the maritime public will be advised in advance of this
safety zone via Broadcast Notice to Mariners.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and

would either preempt State law or impose a substantial direct cost of
compliance on them. We have analyzed this rule under that Order and
have determined that it does not have implications for federalism.

Unfunded Mandates Reform Act

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

Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule is categorically excluded, under figure 2-1, paragraph (34)(g), of
the Instruction. This rule involves establishing a temporary safety
zone. An environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, and Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50
U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add temporary Sec.  165-T11-438 to read as follows:

Sec.  165-T11-438  Safety zone; corporate party on Hornblower yacht,
San Francisco, CA.

    (a) Location. This temporary safety zone is established for the
specified waters near pier 48, in San Francisco Bay, San Francisco,
California. The temporary safety zone applies to the nearest point of
the barge during the loading, transit, and arrival of the pyrotechnics
from Pier 50, San Francisco, California to the fireworks launch site
located at position 37[deg]46'38.46'' N, 122[deg]23'01.67'' W (NAD 83).
From 11 a.m. until 4 p.m. on September 17, 2011, pyrotechnics will be
loaded onto a barge at Pier 50 near position 37[deg]46'28'' N,
122[deg]23'06'' W (NAD 83). From 7:45 p.m. until 7:55 p.m., the loaded
barge will transit from Pier 50 to the launch site located at position
37[deg]46'38.46'' N, 122[deg]23'01.67'' W (NAD 83). The temporary
safety zone will extend 100 feet from the nearest point of the barge
during the loading, transit, and arrival of the pyrotechnics from Pier
50 to position 37[deg]46'38.46'' N, 122[deg]23'01.67'' W (NAD 83). From
8:45 p.m. until 8:55 p.m. on September 17, 2011, the area to which the
temporary safety zone applies will increase in size to encompass the
navigable waters around the fireworks site within a radius of 1,000
feet.
    (b) Definitions. As used in this section, ``designated
representative'' means a Coast Guard Patrol Commander, including a
Coast Guard coxswain, petty officer, or other officer on a Coast Guard
vessel or a Federal, State, or local officer designated by or assisting
the Captain of the Port San Francisco (COTP) in the enforcement of the
safety zone.
    (c) Regulations. (1) Under the general regulations in 33 CFR part
165, subpart C, entry into, transiting, or anchoring within this safety
zone is prohibited unless authorized by the COTP or the COTP's
designated representative.
    (2) The safety zone is closed to all vessel traffic, except as may
be permitted by the COTP or a designated representative.
    (3) Vessel operators desiring to enter or operate within the safety
zone must

contact the COTP or a designated representative to obtain permission to
do so. Vessel operators given permission to enter or operate in the
safety zone must comply with all directions given to them by the COTP
or a designated representative. Persons and vessels may request
permission to enter the safety zone on VHF-16 or through the 24-hour
Command Center at telephone<PHONE_NUMBER>.
    (d) Effective period. This section is effective from 11 a.m.
through 9 p.m. on September 17, 2011.

    Dated: August 19, 2011.
Cynthia L. Stowe,
Captain, U.S. Coast Guard, Captain of the Port San Francisco.
[FR Doc. 2011-22773 Filed 9-6-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: January 13, 2010 (Volume 75, Number 8)]
[Notices]
[Page 1769-1770]
[DOCID:fr13ja10-50]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Filings

December 30, 2009.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:
    Docket Numbers: RP09-558-002.
    Applicants: Transcontinental Gas Pipe Line Company.
    Description: Transcontinental Gas Pipe Line Company, LLC requests
that the Commission reject as moot Original Sheet 89 and Original Sheet
90 to FERC Gas Tariff, Fourth Revised Volume 1, to be effective 12/15/
09.
    Filed Date: 12/22/2009.
    Accession Number: 20091228-0028.
    Comment Date: 5 p.m. Eastern Time on Monday, January 4, 2010.

    Docket Numbers: RP09-687-003.
    Applicants: Equitrans, L.P.
    Description: Filing Motion of Equitrans, L.P. for Extension of Time
to Comply with Order No. 587-T issued on December 22, 2009.
    Filed Date: 12/22/2009.
    Accession Number: 20091222-5204.

    Comment Date: 5 p.m. Eastern Time on Monday, January 4, 2010.

    Docket Numbers: RP10-147-002.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Emergency Motion of Natural Gas Pipeline Company of
America LLC for Limited Stay of Requirement to File Cost and Revenue
Study.
    Filed Date: 12/22/2009.
    Accession Number: 20091222-5279.
    Comment Date: 5 p.m. Eastern Time on Monday, January 4, 2010.

    Docket Numbers: RP09-614-001.
    Applicants: Cheniere Creole Trail Pipeline, LP.
    Description: Request of Cheniere Creole Trail Pipeline LP for
Limited Waiver of Order No. 712 Electronic Capacity Release
Requirements.
    Filed Date: 12/23/2009.
    Accession Number: 20091223-4009.
    Comment Date: 5 p.m. Eastern Time on Monday, January 4, 2010.

    Docket Numbers: RP10-19-001.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Columbia Gas Transmission, LLC submits Tenth Revised
Sheet 28 et al to its FERC Gas Tariff, Third Volume 1, to be effective
11/1/09.
    Filed Date: 12/23/2009.
    Accession Number: 20091224-0074.
    Comment Date: 5 p.m. Eastern Time on Monday, January 4, 2010.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed on or before 5 p.m. Eastern time on the specified comment
date. Anyone filing a protest must serve a copy of that document on all
the parties to the proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons
unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-459 Filed 1-12-10; 8:45 am]
BILLING CODE 6717-01-P