                    UNITED STATES ENVIRONMENTAL PROTECTION AGENCY                                WASHINGTON, D.C.  20460

                                                 OFFICE OF CHEMICAL SAFETY AND                                                             POLLUTION PREVENTION

MEMORANDUM

DATE:  	August 30, 2011

SUBJECT:	Metsulfuron-Methyl: Registration Review Scoping Document for Human Health Assessments.

PC Code:  122010 DP Barcode: D389257 MRID No.:  NA Registration No.: NA Petition No.: NA Regulatory Action: Registration Review Assessment Type: Single Chemical/ Aggregate Reregistration Case No.: 7205 TXR No.:  NA CAS No.: 74223-64-6

FROM:	Charles Smith, Senior Environmental Scientist/Risk Assessor 		Sheila Piper, Senior Chemist  		Monica Hawkins, Ph.D., M.P.H., Environmental Health Scientist 		Steven Dapson, PhD, Senior Toxicologist 		Risk Assessment Branch VI             Health Effects Division (7509P)

THROUGH:	Felecia Fort, Branch Chief 		Risk Assessment Branch VI 		Health Effects Division (7509P)              TO:		Jill Bloom, Chemical Review Manager 		Risk Management and Implementation Branch II 		Pesticide Re-Evaluation Division (7508P)

Executive Summary The Health Effects Division (HED) Metsulfuron-Methyl Registration Review Team has evaluated the status of the human health assessment for the herbicide metsulfuron-methyl to determine the scope of work necessary to support Registration Review.  Metsulfuron-methyl is registered for use on a number of food and feed crops, on conifers and hardwoods, on industrial sites, and on turf.  It is also the principal degradate of iodosulfuron-methyl (currently registered only on corn) in water.  The Codex Alimentarius Commission and Mexico have not established maximum residue limits (MRLs) for metsulfuron-methyl.  Canada has established MRLs for some plant and livestock commodities.  The most recent exposure and risk assessments for metsulfuron-methyl were completed in 2002 (M. Collantes, D282214, 6/19/02 and W. Cutchin, D281907, 6/26/2002).  Based on the current use profile, exposures can be expected to occur via the dietary (food and drinking water), residential (handler and post-application), and occupational (handler and post-application) routes for metsulfuron-methyl.

The toxicity database for metsulfuron-methyl is nearly complete at the present time with the exception of a neurotoxicity battery (i.e., acute and subchronic neurotoxicity) and an immunotoxicity study.  A 28-day inhalation study was previously required as a condition of registration for the use of metsulfuron-methyl on sorghum (W. Cutchin, D281907, 6/26/2002).  This study has not been submitted to the Agency as this time.  The Agency has classified metsulfuron-methyl as "not likely to be carcinogenic to humans" based on the results of carcinogenicity studies in rats and mice.  Metsulfuron-methyl has low acute toxicity by oral, dermal, and inhalation routes of exposure but it is classified as a severe eye irritant.  No reproductive or developmental effects were observed in metsulfuron-methyl toxicity studies using rats and rabbits.  Upon receipt of the required toxicity studies, HED will reevaluate the points of departure and uncertainty factors for the dietary and occupational exposure assessments.

The existing residue chemistry database for metsulfuron-methyl is adequate for risk assessment purposes.  The qualitative nature of the residue(s) of metsulfuron-methyl in plants and animals has been adequately identified/characterized and is understood.  The current tolerance expression as listed in the 40 CFR§180.428(a) has not been updated to reflect current HED policies and thus will need to be revised during the registration review process.

The dietary exposure database is adequate to support the existing registrations.  New chronic dietary exposure and risk assessments will be required during registration review, which incorporate current consumption information, updated residue values and percent crop treated information while directly incorporating drinking water values into the assessment.  Further, an acute dietary assessment may need to be completed if new toxicity data are identified that indicate the need for an acute dietary risk assessment.

The residential exposure database is adequate to support the registration review process for metsulfuron-methyl.  In the 2002 exposure assessment, all of the non-cancer residential handler and postapplication risk estimates were below the Agency's level of concern.  No new residential handler or postapplication worker studies are needed at this time.  An updated residential exposure assessment may be required under registration review based upon revisions to HED's Residential SOPs which was reviewed by the Scientific Advisory Panel (SAP) in October 2009.  An updated assessment may also be required if new data are identified which impact exposure estimates, new points of departure, a revised FQPA SF, or revisions to exposure policies and procedures are made.

The occupational exposure database is adequate to support the registration review process for metsulfuron-methyl.  In the 2002 exposure assessment, all of the non-cancer occupational handler and postapplication risk estimates were below the Agency's level of concern.  No new occupational handler or postapplication worker studies are needed at this time.  Revised occupational handler and postapplication assessments may be needed if toxicological endpoints change, other new data are received by EPA, or other parameters are modified, such as changes to Standard Operating Procedures or default exposure assessment assumptions.  Determination of the appropriate REI for metsulfuron-methyl should be performed during registration review.

Introduction Metsulfuron-methyl is a herbicide used to control a variety of annual grasses and broadleaf weeds.  It is also the principal degradate of iodosulfuron-methyl (currently registered only on corn) in water.  HED has reviewed the most recent exposure and risk assessments for metsulfuron-methyl, as well as toxicity data, exposure and usage databases, and the latest Agency science policy and risk assessment methodologies to determine if sufficient data are available and if updates are needed to support registration review.  Additionally, the team conducted a screening-level literature search for any information that would aid in assessing human health risks to metsulfuron-methyl.

Chemical Identity Metsulfuron-methyl is a sulfonylurea herbicide registered on a number of food and feed crops, on conifers and hardwoods, on industrial sites, and on turf.  Sulfonylurea compounds inhibit acetolactate synthase (ALS) which is involved in cell division at the root tip.  Registered products containing metsulfuron-methyl include water dispersable granule (WDG)/dry flowable (DF) formulations. These formulations may be applied pre- or post-emergence using aerial and ground equipment.

The current tolerance expression as listed in the 40 CFR §180.416 has not been updated to reflect current HED polices.  The revised tolerance expression should be as follows:   Tolerances are established for the residues of the herbicide metsulfuron-methyl, including its metabolites and degradates, in or on plant commodities.  Compliance with the tolerance levels is to be determined by measuring only the sum of metsulfuron-methyl (methyl 2-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]amino]sulfonyl] benzoate) and its metabolite, methyl 2-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]amino]sulfonyl]-4-(beta-D-glycopyranosyl)benzoate (Metabolite A) and methyl 2-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]amino]sulfonyl]-4-hydroxybenzoate (Metabolite A1), calculated as the stoichiometric equivalent of metsulfuron-methyl, in or on the commodity. Tolerances are established for the residues of the herbicide metsulfuron-methyl, including its metabolites and degradates, in or on livestock commodities.  Compliance with the tolerance levels is to be determined by measuring only metsulfuron-methyl (methyl 2-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]amino]sulfonyl] benzoate), in or on the commodity.

The chemical structure and nomenclature of metsulfuron-methyl and the physicochemical properties of technical grade metsulfuron-methyl are presented in Tables 1 and 2.

Hazard Identification/Toxicology The toxicity database for metsulfuron-methyl is nearly complete at the present time with the exception of a neurotoxicity battery (i.e., acute and subchronic neurotoxicity) and an immunotoxicity study (see Table 3A).  The acute database indicates that metsulfuron-methyl has low acute toxicity by oral, dermal, and inhalation routes of exposure (see Table 3B).  It is a severe eye irritant (Category 1) but does not cause primary dermal irritation.  Metsulfuron-methyl is not a skin sensitizer.

For a summary of the subchronic and chronic toxicity profile, see Table 3C.  In mammals, metsulfuron methyl exhibited generalized, nonspecific toxicity and did not appear to have specific target organ toxicity.  Rats appear to be the most sensitive species tested.  The HED Hazard Identification Assessment Review Committee (HIARC), in accordance with the 1999 Draft Guidance for Carcinogenic Risk Assessment, classified metsulfuron methyl as "not likely to be carcinogenic to humans."  This is based on the lack of evidence of carcinogenicity in mice and rats, no evidence of mutagenicity in several acceptable studies, and the non-carcinogenic potential of structurally related compounds.

Metsulfuron-methyl is well absorbed regardless of dose or treatment regimen (single gavage dose alone or after repeated dietary feeding).  The primary route of excretion is via the urine (71-95%) followed by fecal elimination (4.8-13.3%) and levels remaining in the tissues are negligible.

HED has fully evaluated the toxicity database of metsulfuron methyl with respect to the potential for special sensitivity of infants and children, and concludes that there is no concern for pre- and postnatal susceptibility for infants and children.  The FQPA safety factor has been reduced to 1X because (1) the toxicity database is complete and adequate to characterize potential pre- and postnatal risk for infants and children; and (2) no reproductive or developmental effects were observed in rats and rabbits.

In accordance with the revised 40 CFR Part 158 data requirements, a neurotoxicity battery (i.e., acute and subchronic neurotoxicity) is required for all food and non-food use chemicals. Although the available metsulfuron-methyl toxicity studies showed no neurotoxicity, these studies do not use optimal methods to evaluate the nervous tissue structure and function. Consequently, the neurotoxicity studies are required to detect and more fully characterize the potential neurotoxic effects of metsulfuron-methyl.

An immunotoxicity study is also required as a part of the new data requirements in 40 CFR Part 158 for conventional pesticide registration.  Because the immune system is highly complex, studies not specifically conducted to assess immunotoxic endpoints are inadequate to characterize a pesticide's potential immunotoxicity.  While data from hematology, lymphoid organ weights, and histopathology in routine chronic or sub-chronic toxicity studies may offer useful information on potential immunotoxic effects, these endpoints alone are insufficient to predict immunotoxicity.  Consequently, the immunotoxicity study is required to detect and more fully characterize the potential immunotoxic effects of metsulfuron-methyl.

Once these studies are made available to the Agency, they will be reviewed and HED will reevaluate the points of departure and uncertainty factors used in risk assessment. In the absence of the required studies, EPA may use a database uncertainty factor of up to 10X.   For a summary of the relevant toxicological endpoints used in risk assessment, please see Tables 3D (dietary endpoints) and 3E (occupational endpoints).

Endocrine Disruption As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals.  Collectively, these studies include acute, subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring.  For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups.  As part of registration review, EPA will review these data and select the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database.  However, as required by FFDCA section 408(p), metsulfuron-methyl is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a "naturally occurring estrogen, or other such endocrine effects as the Administrator may designate."  The EDSP employs a two-tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems.  Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine-related effects caused by the substance, and establish a dose-response relationship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals.  Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients.  Metsulfuron-methyl is not among the group of 58 pesticide active ingredients on the initial list to be screened under the EDSP.  Accordingly, as part of registration review, EPA will issue future EDSP orders/data call-ins, requiring the submission of EDSP screening assays for metsulfuron-methyl.  For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website:  http://www.epa.gov/endo/.

Conclusions for Hazard Identification/Toxicology The toxicity database for metsulfuron-methyl is nearly complete at the present time with the exception of a neurotoxicity battery (i.e., acute and subchronic neurotoxicity) and an immunotoxicity study.  A 28-day inhalation study was previously required as a condition of registration for the use of metsulfuron-methyl on sorghum (W. Cutchin, D281907, 6/26/2002).  This study has not been submitted to the Agency as this time.

Residue Chemistry The HED Metabolism Assessment Review Committee (MARC) determined that the residue of concern for plants is metsulfuron-methyl and its metabolite, methyl 2-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]amino]sulfonyl]-4-(beta-D-glycopyranosyl)benzoate (Metabolite A) and methyl 2-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]amino]sulfonyl]-4-hydroxybenzoate (Metabolite A1) (MARC, D279786, 12/17/01).  The residue of concern for livestock is metsulfuron methyl.  The current tolerance expression as listed in the 40 CFR§180.428(a) has not been updated to reflect current HED policies.

Adequate analytical methods (HPLC/UV) exist for data collection and tolerance enforcement.  PAM Vol. II lists Methods I and III which are respectively capable of determining residues of metsulfuron-methyl and the combined residues Metabolites A and A1 in/on wheat RACs.  Method II determines metsulfuron methyl in ruminant tissues and milk.  No additional residue chemistry data are required to support the existing uses of metsulfuron-methyl.

Dietary Exposure and Risks An unrefined chronic dietary (food only) risk assessment was completed for a Section 3 use on grain sorghum (W.Cutchin, D281906, 4/3/02).  HED concluded that there is a reasonable certainty that no harm will result to the general population, infants and children from chronic dietary exposure to metsulfuron-methyl.  Acute and cancer dietary exposure estimates are not required for metsulfuron-methyl.

Drinking Water Metsulfuron-methyl appears not to be persistent and has high mobility in soils. The MARC concluded that only the parent compound needs to be included in the drinking water assessment.  The Environmental Fate and Effects Division (EFED) provided drinking water numbers for use in dietary risk assessments (S.Termes, D279400, 1/9/02) in association with the use on sorghum.  The FIFRA Index Reservoir Screening Tool (FIRST) was used for estimating the concentration of metsulfuron-methyl as a metabolite of iodosulfuron-methyl, since FIRST has been used in estimating the drinking water values for the corn use with the proposed label for iodosulfuron-methyl.  The Screening Concentration in Groundwater (SCI-GROW) model was utilized to estimate the concentration of metsulfuron in ground water as a result of application on turf.

In the 2002 HED risk assessment, risks from potential exposure to metsulfuron-methyl in drinking water from all sources were evaluated by comparing these modeled surface and ground water estimates against calculated drinking water levels of comparison (DWLOCs).  This assessment indicated that the estimated drinking water concentration (EDWC) estimates for metsulfuron-methyl residues in surface and ground water did not exceed the Agency's estimated chronic DWLOC value.

Acute Dietary Exposure and Risk (Food and Drinking Water)  In the 2002 HED risk assessment, an acute dietary assessment was not required for metsulfuron methyl because an appropriate acute dietary endpoint was not available.

Chronic Exposure and Risk (Food and Drinking Water) In the 2002 HED risk assessment, an unrefined, chronic dietary exposure assessment was performed using tolerance level residues, default DEEM processing factors, and assuming 100% crop treated.  This assessment concluded that the chronic dietary exposure estimates did not exceed HED's level of concern (<100% cPAD) for any population subgroup.

Conclusions for Dietary Exposure and Risk The dietary exposure database is adequate to support the existing registrations. However, it will be necessary for HED to conduct a new dietary exposure assessment for metsulfuron-methyl including new and updated information and policies, which includes directly incorporating drinking water estimates into the dietary assessment.  The revised assessment should include updated consumption information and utilize the newest version of DEEM-FCID.  Further, an acute dietary assessment may need to be completed if new toxicity data are identified that indicate the need for an acute dietary risk assessment.

Residential Exposure and Risks Metsulfuron-methyl is registered for use on residential lawns, recreational areas (i.e., parks and sports fields), and on golf courses.  Due to this use profile, adult residential homeowners may experience exposure to metsulfuron-methyl during application of the chemical (i.e., residential handler exposures).  Adults and children may experience exposure to metsulfuron-methyl when contacting previously treated areas (i.e., residential postapplication exposure).

The most recent metsulfuron occupational and residential exposure assessment (M. Collantes, D282214, 6/19/02) addressed the potential residential handler exposures to adults and the potential residential postapplication exposures to adults and children.

Residential Handler The Agency has determined that there is potential for residential handlers to be exposed to metsulfuron-methyl during the following activities:     *	mixing/loading/applying water dispersable granules/dry flowables with low pressure handwand equipment;    *	mixing/loading/applying water dispersable granules/dry flowables with backpack sprayer equipment;    *	mixing/loading/applying water dispersable granules/dry flowables with hose end sprayer equipment; and    *	mixing/loading/applying water dispersable granules/dry flowables with sprinkler can equipment.

The 2002 exposure assessment assessed two residential handler scenarios (i.e., low pressure handwand sprayer and hose end sprayer).  Residential handler exposures were estimated using exposure data from the Pesticide Handler Exposure Database (PHED) and the Outdoor Residential Exposure Task Force (ORETF).

The non-cancer handler risk estimates presented in the 2002 exposure assessment indicate that all of the residential handler scenarios resulted in risks that did not exceed HED's level of concern (i.e., MOEs > 100).

Residential Post-Application  The Agency has determined that there is potential for residential postapplication exposure to children from use of metsulfuron-methyl on residential lawns and to adults from use of metsulfuron-methyl on residential lawns and golf courses.

In the 2002 exposure assessment, a number of postapplication residential exposure scenarios were assessed for adults and children.  These scenarios included playing on a treated lawn (adults and children) and golfing on treated turf (adults only).  For adults, dermal exposures were assessed for all scenarios while for children, dermal and non-dietary ingestion exposures were assessed for all scenarios.  Post-application exposures were calculated using the HED Draft SOP's for Residential Exposure Assessments (12/18/97).  All scenarios for both adults and children had MOEs that did not exceed HED's level of concern (MOE >=100).

Residential bystander inhalation exposures resulting from off-site transport (e.g., spray drift or volatilization) may occur as a result of applications of metsulfuron-methyl.  The Agency is in the process of evaluating these types of exposures and may, as appropriate, develop policies and procedures to identify the need for and, subsequently, the way to incorporate post-application inhalation exposure into the Agency's risk assessments.  The need for a bystander inhalation risk assessment for metsulfuron-methyl should be examined during registration review.

Conclusions for Residential Exposure and Risk Assessment The residential exposure database is adequate to support the registration review process for metsulfuron-methyl.  An updated residential exposure assessment may be required under registration review based upon revisions to HED's Residential SOPs which were reviewed by the Scientific Advisory Panel (SAP) in October 2009.  An updated assessment may also be required if new data are identified which impact exposure estimates, new points of departure, a revised FQPA SF, or revisions to exposure policies and procedures are made.

Aggregate Risk Assessment In the 2002 metsulfuron-methyl risk assessment, HED determined that short-term, intermediate-term, and chronic aggregate risk assessments were appropriate.  The chronic aggregate assessment was equivalent to the chronic dietary risk assessment.  The chronic dietary risk estimates for the general population and all population subgroups were not of concern to HED.

For the short- and intermediate-term aggregate assessment, HED combined residential exposures from turf with the chronic dietary exposures.  HED concluded that the combined residues of metsulfuron-methyl from food and other potential residential exposures do not result in short- and intermediate-term aggregate risks of concern.

As noted above in the dietary section, the 2002 risk assessment did not directly incorporate drinking water into the dietary assessment and thus a new chronic dietary assessment is required during registration review.  As a result, during registration review, new short-term, intermediate-term, and chronic aggregate risk assessments are required.

Conclusions for Aggregate Exposure and Risk Assessment Updated aggregate exposure and risk assessments will be required under registration review based on the need for directly incorporating drinking water into the dietary exposure estimates.

Occupational Exposure and Risks Metsulfuron-methyl is registered as a water dispersable granule (WDG)/dry flowable (DF) for occupational use on a number of agricultural field crops, on conifers and hardwoods, on industrial sites, and on turf.  It may be applied pre- or post-emergence using aerial and ground equipment.

Occupational Handlers The Agency has determined that there is potential for occupational handlers to be exposed to metsulfuron-methyl during the following activities:     *	mixing and loading of water dispersable granule (WDG)/dry flowable (DF) to support groundboom and aerial equipment;    *	applying sprays with groundboom and aerial equipment;    *	mixing/loading/applying water dispersable granules/dryflowables with low pressure handwand equipment, backpack sprayer equipment, and turfgun equipment; and     *	flagging for aerial sprays.     The 2002 exposure assessment assessed a number of occupational handler scenarios.  Occupational handler exposures were estimated using exposure data from PHED and ORETF.

The non-cancer handler risk estimates presented in the 2002 exposure assessment indicate that all of the occupational handler scenarios resulted in risks that did not exceed HED's level of concern (i.e., MOEs > 100) at some level of risk mitigation.

Occupational Postapplication The Agency has determined that there is the potential for occupational postapplication exposures to individuals entering areas treated with metsulfuron-methyl including, agricultural fields, conifers and hardwood forests, industrial sites, and turf.

The 2002 exposure assessment assessed the occupational postapplication exposure resulting from applications of metsulfuron-methyl to sorghum, conifer and hardwoods, industrial sites, and turf.   It did not assess all of the potential postapplication exposures that could result from the other agricultural uses of metsulfuron-methyl (e.g., barley, sugarcane, and wheat).  The 2002 assessment utilized surrogate transfer coefficient data from the Agricultural Reentry Task Force (ARTF) database.  For all postapplication exposure scenarios, non-cancer risks do not exceed HED's level of concern (i.e., MOEs > 100) on the day of application.

Metsulfuron-methyl is classified as Toxicity Category I for primary eye irritation and thus should have a Restricted Entry Interval (REI) of 48 hours based on the Worker Protection Standard.  Current metsulfuron-methyl labels appear to carry either a 4 or 12 hour REI so this issue should be revisited during registration review.

Conclusions The occupational exposure database is adequate to support the registration review process for metsulfuron-methyl.  No new handler or postapplication worker studies are needed at this time.  Revised occupational handler and postapplication assessments may be needed if toxicological endpoints change, other new data are received by EPA, or other parameters are modified, such as changes to Standard Operating Procedures or default exposure assessment assumptions.  Determination of the appropriate REI for metsulfuron-methyl should be performed during registration review.

Human Studies Metsulfuron-methyl risk assessments rely in part on data from studies in which adult human subjects were intentionally exposed to a pesticide or other chemical.  Studies such as PHED, ORETF, and ARTF have been reviewed by the Agency and found on the basis of available evidence to have been neither fundamentally unethical nor significantly deficient relative to standards of ethical research conduct prevailing when they were conducted.  There is no barrier in EPA's "Protection of Human Subjects" regulation to reliance on these studies.

Public Health and Pesticide Epidemiology Data An updated review of metsulfuron-methyl incident reports was recently prepared by HED (K. Oo, D389637, 05/25/2011).  For this evaluation, the OPP Incident Data System (IDS) was consulted for pesticide incident data on the active ingredient metsulfuron-methyl.

The IDS includes reports of alleged human health incidents from various sources, including mandatory Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 6 (a) (2) reports from registrants, other federal and state health and environmental agencies and individual consumers.  IDS contain reports from across the U.S. and most incidents have all relevant product information recorded.  Reports submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in the report.  IDS records incidents resulting in higher severity outcomes in more detail, in a module called the Main IDS module.  This system stores incident data for death, major and moderate incidents, and it includes more details about the location, date and nature of the incident.

For IDS aggregate summaries, from January 1, 2006 to March 31, 2011, there are 37 cases reported for metsulfuron-methyl.  Because it falls within the categories reported as counts (which includes minor, unknown or no effects), there is no unique report that provides details about the incident and single chemical incidents are not distinguished from multiple chemical incidents; however, a high frequency of incidents indicates there is a high potential for exposure and vice versa.  For the Main IDS, from January 1, 2006 to March 31, 2011, there are 12 cases reported that involve the active ingredient metsulfuron-methyl.  However, there are no incidents reported for single chemical metsulfuron-methyl only in the database.

Based on the low frequency and severity of incident cases, there does not appear to be a concern at this time that would warrant further investigation. The Agency will continue to monitor the incident information and if a concern is triggered, additional analysis will be included during registration review.

Tolerance Assessment and International Harmonization Tolerances are established under 40 CFR§180.428(a) for residues of the herbicide metsulfuron-methyl, including its metabolites and degradates, in or on a variety of plant commodities as well as in or on livestock commodities (see Table 4).  The Codex Alimentarius Commission and Mexico have not established maximum residue limits (MRLs) for metsulfuron-methyl.  Canada has established MRLs for some plant and livestock commodities.  Any metsulfruon-methyl tolerances reassessed during the registration review process will be considered for possible harmonization with international MRLs should they be established.

Environmental Justice Potential areas of environmental justice concerns, to the extent possible, will be considered in the registration review human health risk assessment, in accordance with U.S. Executive Order 12898, "Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations," http://www.epa.gov/compliance/resources/policies/ej/exec_order_12898.pdf.  The Office of Pesticide Programs (OPP) typically considers the highest potential exposures from the legal use of a pesticide when conducting human health risk assessments, including, but not limited to, people who obtain drinking water from sources near agricultural areas, the variability of diets within the U.S., and people who may be exposed when harvesting crops.  Should these high exposures indicate potential risks of concern, OPP will further refine the risk assessments to ensure that the risk estimates are based on the best available information.

Cumulative Risk Assessment At this time, EPA does not have available data to determine whether metsulfuron-methyl has a common mechanism of toxicity with other substances.  EPA has not made a common mechanism of toxicity finding as to metsulfuron-methyl and any other substances, and metsulfuron-methyl does not appear to produce a toxic metabolite produced by other substances which have tolerances in the U.S.   Therefore, EPA has not assumed that metsulfuron-methyl has a common mechanism of toxicity with other substances.

Data Requirements HED does not anticipate that additional residue chemistry, toxicology or occupational/residential exposure data will be required for the metsulfuron-methyl registration review process, with the exception of the following studies listed below:    * Immunotoxicity Study (OPPTS 870.7800)    * Neurotoxicity Battery (Acute and Subchronic Studies) (OPPTS 870.6200) The following study was previously required as a condition of registration for the use of metsulfuron-methyl on sorghum.  To date, the Agency has not received this study.    * 28-Day Inhalation Study (OPPTS 870.3465) - The 90-day study protocol should be followed using an exposure duration of 28 days. Table 1.  Metsulfuron-methyl Nomenclature Compound Chemical Structure

Common name AE F075736; metsulfuron-methyl IUPAC name Methyl 2-[3-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)ureidosulphonyl]benzoate CAS name Methyl 2-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]amino]sulfonyl]-benzoate CAS registry number 74223-64-6 Molecular formula C14H15N5O6S

Table 2.  Physicochemical Properties of the Technical Grade Metsulfuron-methyl Parameter Value Reference Melting point/range 158 °C

Water solubility (mg/L at 25°C) 109 at unbuffered, pH 4.1 270 at buffered pH 4.6 1750 at buffered pH 5.4 9500 at buffered pH 6.7

Solvent solubility (mg/L at 20°C) 0.79 in n-hexane 0.79 580 in xylene 2300 in ethanol 7300 in methanol 36000 in acetone 121000 in methylene chloride

Vapor pressure (@ 25°C) 2.5 X 10 -12 mm Hg

Octanol/water partition coefficient Log(KOW) 0.018

Table 3A.  Metsulfuron-methyl Toxicology Data Requirements Test  Technical

Required Satisfied 870.1100	Acute Oral Toxicity	 870.1200	Acute Dermal Toxicity	 870.1300	Acute Inhalation Toxicity	 870.2400	Primary Eye Irritation	 870.2500	Primary Dermal Irritation	 870.2600	Dermal Sensitization	 yes yes yes yes yes yes yes yes yes yes yes yes 870.3100	Oral Subchronic (rodent)	 870.3150	Oral Subchronic (nonrodent)	 870.3200	21/28-Day Dermal	 870.3250	90-Day Dermal	 870.3465	90-Day Inhalation	 yes yes yes no yes[1] yes yes yes --- no 870.3700	Developmental Toxicity (rodent)	 870.3700	Developmental Toxicity (nonrodent)	 870.3800	Reproduction	 yes yes yes yes yes yes 870.4100	Chronic Toxicity (rodent)	 870.4100	Chronic Toxicity (nonrodent)	 870.4200	Oncogenicity (rat)	 870.4200	Oncogenicity (mouse)	 870.4300	Chronic/Oncogenicity (mouse)	 870.4500	Chronic/Oncogenicity (rat)	 yes yes yes yes yes yes yes yes yes yes yes yes 870.5100	Mutagenicity -- Gene Mutation - bacterial	 870.5300	Mutagenicity -- Gene Mutation - mammalian	 870.5375	Mutagenicity -- Structural Chromosomal Aberrations	 870.5385	Mutagenicity -- Structural Chromosomal Aberrations	 870.5395	Mutagenicity -- Other Genotoxic Effects	 870.5550	Mutagenicity -- Other Genotoxic Effects	 yes yes yes yes yes yes yes yes yes yes yes yes 870.6100	Acute Delayed Neurotox. (hen)	 870.6100	90-Day Neurotoxicity (hen)	 870.6200	Acute Neurotox. Screening Battery (rat)	 870.6200	Chronic Neurotox. Screening Battery (rat)	 870.6300	Develop. Neuro	 no no yes yes no --- --- no no --- 870.7485	General Metabolism	 870.7600	Dermal Penetration	 870.7800    Immunotoxity yes no yes yes --- no

[1]	A 28-day inhalation study was previously required as a condition of registration for the use of metsulfuron-methyl on sorghum.  At this time, the Agency has not received this study. Table 3B.  Metsulfuron-methyl Acute Toxicity Profile Guideline No. Study Type MRID(s)                                     Results                                Toxicity Category 870.1100 Acute oral  -  rat 94.9% a.i.                                    42545901 LD50 > 3000 mg/kg (HDT)                                       III 870.1200 Acute dermal  - rabbit 92.9% a.i.                                    00125828 LD50 > 2000 mg/kg (ODT)                                       III 870.1300 Acute inhalation  - rat 92.9% a.i.                                    00125830 LC50 > 5.3 mg/L/4hr (dust inhalation)                                       IV 870.2400 Acute eye irritation  - rabbit 95% a.i.                                    40357801 Moderate to severe irritation                                        I 870.2500 Acute dermal irritation  -  rabbit  95.8% a.i.                                    40858802                                    42559604 Non-irritating                                       IV 870.2600 Skin sensitization  -  guinea pig  95.8% a.i.                                    40858803                                    42559600 Negative dermal sensitizer                                       N/A

Table 3C.  Metsulfuron-methyl Subchronic, Chronic and Other Toxicity Profile                                 Guideline No.                                    Study Type                     MRID No. (year)/ Classification /Doses                                     Results 870.3100

13-Week feeding  -  rat 125834 (1982) Acceptable NOAEL: 68/64 mg/kg/day (M/F) LOAEL: 52 1/659 mg/kg/day (M/F) based on transient decreases in body weight gain 870.3200

21/28-Day dermal toxicity - rabbit 40357803 (1987)  41247801 (1989) Acceptable Dermal NOAEL: 125 mg/kg/day Dermal LOAEL: 500 mg/kg/day (skin lesions characterized by diffuse/multifocal dermatitis Systemic NOAEL: 125 mg/kg/day Systemic LOAEL: 500 mg/kg/day based on increased incidence of diarrhea. 870.3700

Prenatal developmental in the rat 125835 (1982)   153318 (1985)  Acceptable Maternal NOAEL: 250 mg/kg/day Maternal LOAEL: 1000 mg/kg/day based on salivation and decreased body weight gain - compensatory increase after dosing stopped. Developmental NOAEL: 1000 mg/kg/day (HDT) Developmental LOAEL: >1000 mg/kg/day (HDT) 870.3700

Prenatal developmental in the rabbit 125836 (1982) 153319 (1985) Acceptable Maternal NOAEL: 25 mg/kg/day Maternal LOAEL: 100 mg/kg/day based on increased mortality, decreased body weight gains, and clinical signs of anorexia, red/orange urine and/or exudate. Developmental NOAEL: > 700 mg/kg/day (HDT) Developmental LOAEL: >700 mg/kg/day (HDT) 870.3800

Reproduction and fertility effects in the rat

151028 (1985) Acceptable Parental systemic NOAEL: 34/43 mg/kg/day (M/F) Parental systemic LOAEL: 342/475 mg/kg/day (M/F) (decreased premating body weight gains by FO males and females). Offspring/Reproductive NOAEL: > 342/475 mg/kg/day (M/F) Offspring/Reproductive LOAEL: > 342/475 mg/kg/day (M/F) 870.4100

Chronic oral toxicity in the dog

141821 (1984) Acceptable NOAEL: >125 mg/kg/day (M/F) at the HDT  LOAEL: not determined 870.4300

Carcinogenicity in the mouse by the oral route

151135 (1985) Acceptable NOAEL: 666/836 mg/kg/day (M/F) at the HDT  LOAEL: not determined. No evidence of carcinogenic potential of the test material. 870.4500 Combined Chronic/Carcin-ogenicity in the rat by the oral route 154477 (1985) Acceptable NOAEL: 25 mg/kg/day in M/F LOAEL: 250 mg/kg/day in M/F (decreased body weight and body weight gain) No evidence of carcinogenic potential of the test material. 870.5100

Salmonella typhimurium, Ames assay 125837 (1980) Acceptable Not mutagenic under the conditions of the study. 870.5375 In vitro mammalian chromosomal aberrations - CHO cells (2 studies) 125838 (1982)   125839 (1983) Acceptable Metsulfuron methyl is not a clastogen under the conditions of the study. 870.5385

In vivo mammalian chromosome aberrations - rat bone marrow 125840 (1983) Acceptable Metsulfuron methyl did not induce a significant increase in chromosome aberrations in bone marrow cells when compared to the vehicle control group. 870.5395

In vivo mammalian cytogenetics - micronucleus assay in mice 41118002 (1989) Acceptable Metsulfuron methyl was negative at the limit dose for clastogenic activity in the micronucleus assay in bone marrow cells. 870.5550

UDS assay in primary rat hepatocytes/ mammalian cell culture 41773901 (1990) 42545801 (1990) 43035601 (1993) Acceptable Metsulfuron methyl was negative for UDS in mammalian hepatocytes in vivo. 870.7485

Metabolism and pharmaco-kinetics in the rat 141828 (1984) Acceptable The primary route of excretion was via the urine which accounted for approx. 7 1-95% (78-96% if cage wash radioactivity is considered) among the various treatment groups. Fecal elimination was 4.8-13.3%.  Tissue burdens were minimal (generally <0.1% to 1%) regardless of exposure protocol; the gastrointestinal tract, carcass, and skin had the highest concentrations of radioactivity. No evidence for sequestration of the test article or its biotransformation products. Four metabolites and parent were recovered in both urine and feces in all treatment groups. Parent compound accounted for most of the urinary and fecal radioactivity (77-90% and 1.8-6.2% of the administered dose, respectively). Metab. I was consistent with (methyl 2-[(amino)sulfonyl] benzoate); Metab. II - (2-[(amino)sulfonyl]-benzoic acid); and Metab. III was consistent with (methyl 2-[[{(amino)carbonyl]aminoj sulfonyl] benzoate). Metab. I and II appeared to result from sequential hydrolysis reactions terminating in the formation of saccharin while Metab. III was formed by cleavage of the two ring structures. Total metabolites (in urine + feces of each group) accounted for approximately 5.4-8.2% of the administered dose. The metabolite profiles were qualitatively similar for urine and feces in that parent compound and the four metabolites (saccharin, Metabolites I, II, and III) were found in both matrices.

Table 3D.  Metsulfuron-methyl Summary of Toxicological Doses and Endpoints for Use in Dietary Human Health Risk Assessments. Exposure Scenario                               Point of Departure                              Uncertainty/FQPA SFs                  Population Adjusted Dose for Risk Assessment                         Study and Toxicological Effects Acute Dietary All Populations A single dose effect relevant to the general US population including infants and children was not identified in the toxicity studies conducted with metsulfuron-methyl. Chronic Dietary (All Populations) NOAEL = 25 mg/kg/day UFA = 10x UFH =10x FQPA SF= 1x cPAD = 0.25 mg/kg/day Rat, Oral Chronic/Carcinogenicity  Toxicity Study LOAEL = 250 mg/kg/day based on decreased body weight and body weight gain. Incidental oral (short- & intermediate-term) NOAEL = 34 mg/kg/day (parental) UFA = 10x UFH =10x FQPA SF= 1x Residential LOC for MOE = 100 Rat, 2 Generation Reproduction Study LOAEL = 342 mg/kg/day based on decreased premating (FO) body weights. Dermal exposure (all durations) NOAEL = 125 mg/kg/day UFA = 10x UFH =10x FQPA SF= 1x Residential LOC for MOE = 100 Rabbit, 21 Day Dermal Exposure Study LOAEL = 500 mg/kg/day based on increased incidences of diarrhea.

Inhalation exposure (short- & intermediate term) NOAEL = 34 mg/kg/day (parental) Oral study UFA = 10x UFH =10x FQPA SF= 1x IA = 100% Residential LOC for MOE = 100 Rat, 2 Generation Reproduction Study LOAEL = 342 mg/kg/day based on decreased premating (FO) body weights. Inhalation exposure (long term) NOAEL = 25 mg/kg/day Oral study UFA = 10x UFH =10x FQPA SF= 1x IA = 100% Residential LOC for MOE = 100 Rat, Oral Chronic/Carcinogenicity  Toxicity Study LOAEL = 250 mg/kg/day based on decreased body weight and body weight gain. Cancer (oral, dermal, inhalation) Metsulfuron methyl is classified as "not likely to be carcinogenic to humans." This is based on the lack of evidence of carcinogenicity in mice and rats, no evidence of mutagenicity in acceptable studies, and the non-carcinogenic potential of structurally related compounds. Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and  used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.  NOAEL = no observed adverse effect level.  LOAEL = lowest observed adverse effect level.  UF = uncertainty factor.  UFA = extrapolation from animal to human (interspecies).  UFH = potential variation in sensitivity among members of the human population (intraspecies).  FQPA SF = FQPA Safety Factor.  PAD = population adjusted dose (a = acute, c = chronic).

Table 3E.  Metsulfuron-methyl Summary of Toxicological Doses and Endpoints for Metsulfuron methyl for Use in Occupational Human Health Risk Assessments Exposure/ Scenario Point of Departure Uncertainty Factors Level of Concern for Risk Assessment Study and Toxicological Effects Dermal exposure (all durations) NOAEL = 125 mg/kg/day UFA = 10x UFH =10x Occupational LOC for MOE = 100 Rabbit, 21 Day Dermal Exposure Study LOAEL = 500 mg/kg/day based on increased incidences of diarrhea. Inhalation exposure (Short- & intermediate term) NOAEL = 34 mg/kg/day (parental) Oral study UFA = 10x UFH =10x IA = 100% Occupational LOC for MOE = 100 Rat, 2 Generation Reproduction Study LOAEL = 342 mg/kg/day based on decreased premating (FO) body weights. Inhalation exposure (long term) NOAEL = 25 mg/kg/day Oral study UFA = 10x UFH =10x IA = 100% Occupational LOC for MOE = 100 Rat, Oral Chronic/Carcinogenicity  Toxicity Study LOAEL = 250 mg/kg/day based on decreased body weight and body weight gain. Cancer (oral, dermal, inhalation) Metsulfuron methyl is classified as "not likely to be carcinogenic to humans." This is based on the lack of evidence of carcinogenicity in mice and rats, no evidence of mutagenicity in acceptable studies, and the non-carcinogenic potential of structurally related compounds. Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and  used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.  NOAEL = no observed adverse effect level.  LOAEL = lowest observed adverse effect level.  UF = uncertainty factor.  UFA = extrapolation from animal to human (interspecies).  UFH = potential variation in sensitivity among members of the human population (intraspecies).  UFL = use of a LOAEL to extrapolate a NOAEL.  UFS = use of a short-term study for long-term risk assessment.  UFDB = to account for the absence of key date (i.e., lack of a critical study).  MOE = margin of exposure.  LOC = level of concern.  N/A = not applicable.  IA = inhalation absorption factor

Table 4.  Metsulfuron-methyl International Residue Limits  Summary of US and International Tolerances and Maximum Residue Limits  Residue Definition: US  Canada Mexico[2] Codex[3] 40 CFR 180.428(a)1:  Plants: combined residues of the herbicide metsulfuron methyl (methyl 2-[[[[(4-methoxy-6-methyl-1,3,5- triazin- 2-yl)amino]carbonyl]amino] sulfonyl] benzoate) and its metabolite methyl 2-[[[[(4-methoxy-6-methyl-1-,3,5- triazin-2-yl)amino]carbonyl]amino] sulfonyl]-4-hydroxybenzoate

methyl 2-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl) amino]carbonyl]amino]sulfonyl]benzoate, including the metabolite methyl 2-[[[[(4-methoxy-6-methyl-1,3,5- triazin-2-yl)amino]carbonyl]amino]sulfonyl] 4- hydroxybenzoate

None Commodity[1] Tolerance (ppm) /Maximum Residue Limit (mg/kg)

US Canada Mexico[2] Codex[3] Barley, grain 0.1 0.1

Barley, hay 20.0

Barley, straw 0.3

Grass, forage 15.0

Grass, hay 15.0

Grass, straw 15.0

Sorghum, grain, forage 0.2

Sorghum, grain, grain 0.1

Sorghum, grain, stover 0.2

Sugarcane, cane 0.05

Wheat, forage 5.0

Wheat, grain 0.1 0.1

Wheat, hay 20.0

Wheat, straw 0.3

2 Canada Mexico[2] Codex[3]  metsulfuron methyl (methyl-2[[[[(4-methoxy- 6-methyl-1,3,5-triazin-2- yl)amino]carbonyl]amino] sulfonyl] benzoate) Same as above

None Commodity[1] Tolerance (ppm) /Maximum Residue Limit (mg/kg)

US Canada Mexico[2] Codex[3] Cattle, fat 0.1 0.1

Cattle, kidney 0.5 0.5

Cattle, meat 0.1 0.1

Cattle, meat byproducts 0.1 0.1

Goat, fat 0.1 0.1

Goat, kidney 0.5 0.5

Goat, meat 0.1 0.1

Goat, meat byproducts 0.1 0.1

Hog, fat 0.1 0.1

Hog, kidney 0.5 0.5

Hog, meat 0.1 0.1

Hog, meat byproducts 0.1 0.1

Horse, fat 0.1

Horse, kidney 0.5

Horse, meat 0.1

Horse, meat byproducts 0.1

Milk 0.05 0.05

Sheep, fat 0.1

Sheep, kidney 0.5

Sheep, meat 0.1

Sheep, meat byproducts 0.1

[1] Includes only commodities of interest for this action.  Tolerance values should be the HED recommendations and not those proposed by the applicant. 2 Mexico adopts US tolerances and/or Codex MRLs for its export purposes. 3 * = absent at the limit of quantitation; Po = postharvest treatment, such as treatment of stored grains.  PoP = processed postharvest treated commodity, such as processing of treated stored wheat. (fat) = to be measured on the fat portion of the sample. MRLs indicated as proposed have not been finalized by the CCPR and the CAC.

Table 5: HED Memoranda Relevant to Registration Review  Author Barcode/TXR # Date Title M. Collantes

                                    D282214                                         6/19/2002	                                         Occupational and Residential Exposure and Risk for the Proposed Use of Metsulfuron-Methyl on Sorghum.

W. Cutchin, S. Williams-Foy, M. Collantes

                                    D281907                                         6/26/2002                                         Human Health Risk Assessment for the Section 3 Registration of Metsulfuron Methyl on Grain Sorghum.


[Federal Register Volume 78, Number 238 (Wednesday, December 11, 2013)]
[Rules and Regulations]
[Pages 75249-75251]
[FR Doc No: 2013-29369]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2013-0902]
RIN 1625-AA00

Safety Zone: Google's Night at Sea Fireworks Display, San
Francisco Bay, Alameda, CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing temporary safety zones in the
navigable waters of the San Francisco Bay near the breakwater in
Alameda, CA in support of Google's Night at Sea Fireworks Displays on
December 7, 2013 and December 14, 2013. These safety zones are
established to help protect the participants and spectators from the
dangers associated with pyrotechnics. Unauthorized persons or vessels
are prohibited from entering into, transiting through, or remaining in
the safety zones without permission of the Captain of the Port or their
designated representative.

DATES: This rule is effective on December 7, 2013 and December 14,
2013. This rule will be enforced from 12:01 p.m. to 10:45 p.m. on
December 7, 2013 and from 12:01 p.m. to 11:30 p.m. on December 14,
2013.

ADDRESSES: Documents mentioned in this preamble are part of docket
USCG-2013-0902. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 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 rule,
call or email Lieutenant Junior Grade William Hawn, U.S. Coast Guard
Sector San Francisco; telephone<PHONE_NUMBER> or email at<EMAIL_ADDRESS>If you have questions on viewing or submitting
material to the docket, call Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NOAA National Oceanic and Atmospheric Administration
NPRM Notice of Proposed Rulemaking

A. Regulatory History and 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 the event would occur before the
rulemaking process would be completed. Because of the dangers posed by
the pyrotechnics used in these fireworks displays, the safety zones are
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.

B. Basis and Purpose

    The legal basis for the proposed rule is 33 U.S.C 1231; 46 U.S.C
Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1,
6.04-6, 160.5; Public Law 107-295, 116 Stat. 2064; Department of
Homeland Security Delegation No. 0170.1, which collectively authorize
the Coast Guard to establish safety zones.
    Google will sponsor the Google's Night at Sea Fireworks Displays on
December 7, 2013 and December 14, 2013 near the breakwater in Alameda,
CA in approximate position 37[deg]46'07'' N, 122[deg]19'10'' W (NAD83)
as depicted in National Oceanic and Atmospheric Administration (NOAA)
Chart 18650. These safety zones establish a temporary restricted area
on the waters 100 feet surrounding the fireworks barges during the
loading, transit and arrival of the pyrotechnics from the loading site
to the launch site until the commencement of the fireworks displays.
Upon the commencement of the fireworks displays, the safety zones will
increase in size and encompass the navigable waters around the
fireworks barges within a radius of 420 feet. The fireworks displays
are meant for entertainment purposes. The restricted area around the
fireworks barges is necessary to protect spectators, vessels, and other
property from the hazards associated with pyrotechnics.

C. Discussion of the Final Rule

    The Coast Guard will enforce safety zones in navigable waters
around and under the fireworks barges within a radius of 100 feet
during the loading, transit, and arrival of the fireworks barges to the
display location until the start of the fireworks displays. From 12:01
p.m. until 9 p.m. on December 7, 2013 and from 12:01 p.m. until 8 p.m.
on December 14, 2013 the fireworks

barges will be loaded at Pier 50 in San Francisco, CA. From 9 p.m.
until 9:45 p.m. on December 7, 2013 and from 8 p.m. until 8:45 p.m. on
December 14, 2013 the loaded fireworks barges will transit from Pier 50
to the launch site near the breakwater in Alameda, CA in approximate
position 37[deg]46'07'' N, 122[deg]19'10'' W (NAD 83) where they will
remain until the commencement of the fireworks displays. Upon the
commencement of the fireworks display, scheduled to take place from
10:15 p.m. to 10:45 p.m. on December 7, 2013; from 9:15 p.m. to 9:20
p.m. on December 14, 2013; and from 11:15 p.m. to 11:30 p.m. on
December 14, 2013, the safety zones will increase in size and encompass
the navigable waters around and under the fireworks barges within a
radius 420 feet in approximate position 37[deg]46'07'' N,
122[deg]19'10'' W (NAD 83) for the Google's Night at Sea Fireworks
Displays. At the conclusion of the fireworks displays the safety zones
shall terminate.
    The effect of the temporary safety zones will be to restrict
navigation in the vicinity of the fireworks barges while the fireworks
are set up, and until the conclusion of the scheduled displays. Except
for persons or vessels authorized by the Coast Guard Patrol Commander,
no person or vessel may enter or remain in the restricted areas. These
regulations are needed to keep spectators and vessels away from the
immediate vicinity of the fireworks barges to ensure the safety of
participants, spectators, and transiting vessels.

D. 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.

1. 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 Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders.
    We expect the economic impact of this rule will not rise to the
level of necessitating a full Regulatory Evaluation. The safety zones
are limited in duration, and are limited to a narrowly tailored
geographic area. In addition, although this rule restricts access to
the waters encompassed by the safety zones, 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
zones will result in minimum impact. The entities most likely to be
affected are waterfront facilities, commercial vessels, and pleasure
craft engaged in recreational activities.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. 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 waterfront facilities,
commercial vessels, and pleasure craft engaged in recreational
activities and sightseeing. These safety zones would not have a
significant economic impact on a substantial number of small entities
for the following reasons. The safety zones will be activated, and thus
subject to enforcement, for a limited duration. When the safety zones
are activated, vessel traffic will be able to navigate around the
safety zones. The maritime public will be advised in advance of this
safety zones via Broadcast Notice to Mariners.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    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.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. 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 determined
that 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 involves safety zones of limited size and
duration. This rule is categorically excluded from further review under
paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An
environmental analysis checklist supporting this determination and a
Categorical Exclusion Determination are available in the docket where
indicated under ADDRESSES. We seek any comments or information that may
lead to the discovery of a significant environmental impact from this
rule.

E. 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. 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-T11-609 to read as follows:

Sec.  165-T11-609  Safety zone; Google's Night at Sea Fireworks
Display, San Francisco Bay, Alameda, CA.

    (a) Location. These temporary safety zones are established in the
navigable waters of the San Francisco Bay near the breakwater in
Alameda, CA as depicted in National Oceanic and Atmospheric
Administration (NOAA) Chart 18650. From 12:01 p.m. until 10:15 p.m. on
December 7, 2013, from 12:01 p.m. until 9:15 p.m. on December 14, 2013,
and from 9:20 p.m. until 11:15 p.m. on December 14, 2013, the temporary
safety zones apply to the nearest point of the fireworks barges within
a radius of 100 feet during the loading, transit, and arrival of the
fireworks barges from Pier 50 to the launch site near the breakwater in
Alameda, CA in approximate position 37[deg]46'07'' N, 122[deg]19'10'' W
(NAD83). From 10:15 p.m. until 10:45 p.m. on December 7, 2013, from
9:15 p.m. until 9:20 p.m. on December 14, 2013, and from 11:15 p.m.
until 11:30 p.m. on December 14, 2013, the temporary safety zones will
increase in size and encompass the navigable waters around and under
the fireworks barges in approximate position 37[deg]46'07'' N,
122[deg]19'10'' W (NAD83) within a radius of 420 feet.
    (b) Enforcement Period. The zones described in paragraph (a) of
this section will be enforced from 12:01 p.m. through 10:45 p.m. on
December 7, 2013 and from 12:01 p.m. through 11:30 p.m. on December 14,
2013. The Captain of the Port San Francisco (COTP) will notify the
maritime community of periods during which these zones will be enforced
via Broadcast Notice to Mariners in accordance with 33 CFR 165.7.
    (c) 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 COTP in the enforcement of the safety zones.
    (d) Regulations. (1) Under the general regulations in 33 CFR Part
165, Subpart C, entry into, transiting or anchoring within these safety
zones is prohibited unless authorized by the COTP or a designated
representative.
    (2) The safety zones are 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
zones 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 zones 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 zones on VHF-23A or through
the 24-hour Command Center at telephone<PHONE_NUMBER>.

    Dated: November 26, 2013.
Gregory G. Stump,
Captain, U.S. Coast Guard, Captain of the Port San Francisco.
[FR Doc. 2013-29369 Filed 12-10-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 106 (Tuesday, June 2, 2020)]
[Rules and Regulations]
[Pages 33536-33537]
[FR Doc No: 2020-11522]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-0085; Airspace Docket No. 20-ASO-2]
RIN 2120-AA66

Amendment of Class D Airspace, Jacksonville NAS, FL; and,
Amendment of Class D and Class E Airspace, Mayport, FL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends Class D airspace for Jacksonville NAS, FL,
by updating the name and geographical coordinates of Jacksonville NAS
(Towers Field) (previously Jacksonville NAS) and Herlong Recreational
Airport (previously Herlong Airport). This action would also amend
Class D airspace and Class E airspace designated as an extension to
Class D or E surface area by updating the name and geographic
coordinates of Mayport Naval Station (ADM David L McDonald Field),
(previously Mayport Naval Air Station), and the name and geographic
coordinates of Jacksonville Executive Airport at Craig, (previously
Craig Municipal Airport). Controlled airspace is necessary for the
safety and management of instrument flight rules (IFR) operations in
the area. This action also would make an editorial change replacing the
term Airport/Facility Directory with the term Chart Supplement in the
legal descriptions of associated Class D and E airspace.

DATES: Effective 0901 UTC, July 16, 2020. The Director of the Federal
Register approves this incorporation by reference action under Title 1
Code of Federal Regulations part 51, subject to the annual revision of
FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11D, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed on line at http://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11D at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Avenue, College Park, GA 30337; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. 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 Class D and E airspace in Jacksonville NAS, FL, and
Mayport, FL, to support IFR operations in the area.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (85 FR 8212, February 13, 2020) for Docket No. FAA-2020-0085,
to amend Class D airspace for Jacksonville NAS, FL by updating the name
and geographical coordinates of the airport, and the name of Herlong
Recreational Airport. The FAA also proposed to update the geographic
coordinates of Mayport NS (ADM David L McDonald Field), Mayport, FL,
under Class D airspace and Class E surface airspace designated as an
extension to a Class D surface area, as well as the name and geographic
coordinates of Jacksonville Executive Airport at Craig. In addition,
the FAA proposed to replace the outdated term Airport/Facility
Directory with the term Chart Supplement in the associated Class D
airspace and Class E surface airspace designated as an extension to a
Class D surface area in the legal descriptions for

Mayport NS (ADM David L McDonald Field), Mayport, FL.
    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 D and Class E airspace designations are published in
Paragraphs 5000 and 6004, respectively, of FAA Order 7400.11D, dated
August 8, 2019, and effective September 15, 2019, which is incorporated
by reference in 14 CFR part 71.1. The Class E airspace designation
listed in this document will be published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11D, Airspace Designations and
Reporting Points, dated August 8, 2019, and effective September 15,
2019. FAA Order 7400.11D is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11D lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    The amendment to Title 14 Code of Federal Regulations (14 CFR) part
71 amends Class D airspace at Jacksonville NAS (Towers Field),
Jacksonville NAS, FL, by updating the name and geographical coordinates
of the airport, and the name of Herlong Recreational Airport. Also, the
name and geographic coordinates of Mayport NS (ADM David L McDonald
Field), Mayport, FL, are updated under Class D airspace and Class E
surface airspace designated as an extension to a Class D surface area,
as well as the name and geographic coordinates of Jacksonville
Executive Airport at Craig to coincide with the FAA's aeronautical
database. In addition, the FAA replaces the outdated term Airport/
Facility Directory with the term Chart Supplement in the associated
Class D airspace and Class E surface airspace designated as an
extension to a Class D surface area in the legal descriptions for
Mayport NS (ADM David L McDonald Field), Mayport, FL.
    These changes are necessary for continued safety and management of
IFR operations at these airports.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    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.
It, therefore: (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
only affects air traffic procedures and air navigation, it is certified
that this rule, when promulgated, does not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    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 part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 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 71.1 of FAA Order 7400.11D,
Airspace Designations and Reporting Points, dated August 8, 2019,
effective September 15, 2019, is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

ASO FL D Jacksonville NAS, FL [Amended]

Jacksonville NAS (Towers Field), FL
    (Lat. 30[deg]14'01'' N, long. 81[deg]40'34'' W)
Jacksonville TACAN
    (Lat. 30[deg]14'05'' N, long. 81[deg]40'30'' W)
Herlong Recreational Airport, FL
    (Lat. 30[deg]16'40'' N, long. 81[deg]48'21'' W)

    That airspace extending upward from the surface of the Earth, to
and including 2,600 feet MSL, within a 5.3-mile radius of
Jacksonville NAS (Towers Field) and within 1 mile north and 2.5
miles south of the Jacksonville TACAN 270 radial, extending from the
5.3-mile radius to 6.5 miles west of the TACAN; excluding that
airspace within a 1.8-mile radius of the Herlong Recreational
Airport.

ASO FL D Mayport, FL [Amended]

Mayport NS (ADM David L McDonald Field), FL
    (Lat. 30[deg]23'29'' N, long. 81[deg]25'28'' W)
Jax Executive Airport at Craig
    (Lat. 30[deg]20'11'' N, long. 81[deg]30'52'' W)

    That airspace extending upward from the surface to and including
2,500 feet MSL within a 4.2-mile radius of Mayport NS (ADM David L
McDonald Field), excluding the portion southwest of a line
connecting the two points of intersection with a 4.2-mile radius
circle centered on Jacksonville Executive Airport at Craig. This
Class D airspace area is effective during the specific dates and
times established in advance by a Notice to Airmen. The effective
date and time will thereafter be continuously published in the Chart
Supplement.

Paragraph 6004 Class E Airspace Designated as an Extension to Class
D or E Surface Area.

* * * * *

ASO FL E4 Mayport, FL [Amended]

Mayport NS (ADM David L McDonald Field), FL
    (Lat. 30[deg]23'29'' N, long. 81[deg]25'28'' W)
Mayport (Navy) TACAN
    (Lat. 30[deg]23'19'' N, long. 81[deg]25'23'' W)

    That airspace extending upward from the surface within 3.2-miles
each side of the Mayport (Navy) TACAN 035[deg] radial extending from
the 4.2-mile radius of Mayport NS (ADM David L McDonald Field) to 5
miles northeast of the TACAN. This Class E airspace is effective
during the dates and times established in advance by a Notice to
Airmen. The effective date and time will thereafter be continuously
published in the Chart Supplement.

    Issued in College Park, Georgia, on May 22, 2020.
Andreese C. Davis,
Manager, Airspace & Procedures Team South, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2020-11522 Filed 6-1-20; 8:45 am]
BILLING CODE 4910-13-P