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[BASF Corporation]

[Insert petition number]

	EPA has received a pesticide petition ([ insert petition number]) from [BASF Corporation], [P.O. Box 13528, Research Triangle Park, NC 27709] proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.

   	1. by establishing a tolerance for residues of

	[metaflumizone] in or on the raw agricultural commodity [apple] at [1] ppm, [coffee] at [0.15] ppm, [crop group 9A: melon subgroup] at [1] parts per million (ppm), [crop group 10-10A: orange subgroup] at [3] ppm,), [citrus oil ] at [42] ppm,  [crop group 10-10B: lemon/lime subgroup] at [3] ppm,  [crop group 13-07G: grape] at [5] ppm, [Raisin] at [10] ppm, [cattle fat] at [0.05] ppm, [sheep fat] at [0.05] ppm, [goat fat] at [0.05] ppm, [horse fat] at [0.05] ppm and [milk fat] at [0.1] ppm .  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of the FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. [In three plant metabolism studies (cabbage, tomato and cotton), the major component of the residue was metaflumizone.  The major degradate was the ketone, M320I04 and an oxidized and cyclized metabolite, M320I23, was present in lesser amounts.  These four compounds were defined as the residues of concern and were incorporated into an analytical method.  In the confined rotational crop studies plant uptake was very limited and the residues were a mixture of minor and polar components.]

	2. Analytical method. [BASF Analytical Method No. 531/1 was developed to determine residues of metaflumizone and its metabolites M320I04 and M320I23 in crop matrices.  In this method, residues of metaflumizone are extracted from plant matrices with methanol/water (70:30; v/v) and then partitioned into dichloromethane.  Clean up steps were used only when necessary. The final determination of metaflumizone and its metabolites is performed by LC/MS/MS.]

	3. Magnitude of residues.  [Field trials were conducted on multiple crops and crop groups in Brazil to support the foliar use of metaflumizone product.  Residue field trials were conducted for apple, coffee, citrus fruit (oranges and lemons), grape and melon. The number and locations of field trials are in accordance with NAFTA Guidance Document on Data Requirements for Tolerances on Imported Commodities in the United States and Canada. Field trials were carried out using the maximum label rates, the maximum number of applications, the minimum retreatment interval and the minimum pre-harvest interval (PHI) for all the crops. Detected residues of metaflumizone in all crops support the proposed tolerances.  Processing factors were determined for all processed commodities per OPPTS Guideline 860.1520.  Processing studies for citrus and grape commodities were also conducted.
Values for tolerances/MRLs were determined for each commodity using parent residues (isomers E and Z) plus metabolite M320I04 and the OECD MRL calculator.]

B. Toxicological Profile

	1. Acute toxicity.  [Based on the available acute toxicity data, metaflumizone and its formulated product do not pose acute toxicity risks.  For metaflumizone:

Oral LD50                 Rat	      LD50 > 5000 mg/kg b.w.        category IV
Oral LD50                 Mouse	      LD50 > 5000 mg/kg b.w.        category IV
Dermal LD50            Rat	      LD50 > 5000 mg/kg b.w.        category IV
Inhalation LC50       Rat	      > 5.2 mg/L                               category IV
Eye Irritation           Rabbit	      Not irritating                          category IV
Skin Irritation          Rabbit	      Not irritating                          category IV
Skin Sensitization    Guinea pig   Not sensitizing (Maximization Test)]

	2. Genotoxicty. [In a battery of three in vitro and two in vivo mutagenicity assays consisting of all required end-points (point mutation, chromosomal damage, and DNA damage and repair), the weight-of-the-evidence for metaflumizone indicates a lack of potential genotoxicity.

Specifically, for the battery of three in vitro mutagenicity assays with metaflumizone, no positive responses were observed for increased revertant frequencies with and without metabolic activation [bacterial reverse mutation assay] or for increased mutant frequencies with and without metabolic activation [HGPRT locus assay].  Although there was a positive result for a statistically increased number of structurally aberrant metaphases in the chromosomes, which indicates clastogenic potential under in vitro conditions, this result was only observed without metabolic activation [cytogenicity study with V79 cells.

Importantly, the potential biological significance of this apparent chromosome damage observed in vitro only without metabolic activation, was evaluated in vivo using the mouse micronucleus assay.  Testing in the in vivo micronucleus study with NMRI mice was conducted at a high dose level (2000 mg/kg b.w.) that demonstrated clinical symptoms of toxicity, including piloerection and poor general state, in 5 of 5 animals.  No significant or dose-related increases in chromosomal damage were observed in this in vivo test, indicating that metaflumizone does not cause chromosomal aberrations in intact animals.

Moreover, it has also been recognized by U.S. EPA that more weight should be placed on in vivo systems than in vitro systems as expressed in the Agency's weight-of-evidence for genotoxic evaluation of a chemical included in the "Guidelines for Mutagenicity Risk Assessment" (Federal Register, September 24, 1986, Vol. 51: 34006-34012).  Thus, the negative in vivo results (non-clastogenicity for chromosomal aberrations) observed in the mouse micronucleus assay and the rat hepatocytes assay, should override the positive results obtained in the in vitro assay only without metabolic activation.  Furthermore, it has been noted that in vitro systems may simulate abnormal physiological conditions from prolonged exposure to a chemical in the absence of S-9 metabolic activation [Brusick, D.J. (editor) 1987. Genotoxicity Produced in Cultured Mammalian Cell Assay by Treatment Conditions. Mutation Research, Vol. 189, No.1: 1-69] and [Sofuni, T. 1993. Japanese Guidelines for Mutagenicity Testing. Environmental and Molecular Mutagenesis, Vol. 21, No.1: 2-7].  Consequently, based on the weight-of-the-evidence presented above, metaflumizone does not pose a genotoxic concern.]

	3. Reproductive and developmental toxicity. [Potential reproductive toxicity of metaflumizone was investigated in a two-generation reproduction toxicity study in Wistar rats by oral gavage administration.  Originally, the highest dose tested by oral gavage was 75 mg/kg b.w../day, which induced both excessive maternal toxicity (very high incidences of poor general health in females during premating, gestation, and lactation; and statistically decreased food consumption, body weights, and body weight gain) as well as excessive developmental toxicity (statistically impaired pup body weights and body weight gain), which altogether resulted in high pup mortality.  Consequently, a meaningful assessment of the potential reproductive toxicity of the test compound at this excessively toxic dose level was not possible.  Thereafter, for the next two successive parental generations of rats, which were originally derived from the parents treated at 75 mg/kg b.w./day, the highest dose tested was 50 mg/kg b.w./day.

Subsequently, the NOAEL for parental toxicity was 20 mg/kg b.w./day, based on the following effects for females at 50 mg/kg b.w./day (highest dose tested for two consecutive generations) -- increased incidences of poor general health in females during premating, gestation, and lactation; 3 of 25 dams with complete litter losses; and statistically significantly reduced body weights during premating, gestation, and lactation.

The NOAEL for offspring/pup toxicity was 20 mg/kg b.w./day, based on a slight increased incidence of pup mortality at 50 mg/kg b.w./day.  Whereas the NOAEL for fertility in this study was 50 mg/kg b.w./day (highest dose tested for two generations), the NOAEL for reproductive performance was considered to be 20 mg/kg b.w./day, based on 3 of 25 dams with complete litter losses, of which 2 of these 3 dams had indications of poor nursing for their first generation of pups.  It is noteworthy that because most of the pup mortality was due to poor nursing in only 2 of 25 dams, this finding may be considered to be incidental.  Importantly, no comparable impairment of reproductive performance occurred for the succeeding parental generation treated by oral gavage administration at 50 mg/kg b.w./day.

In a developmental (teratology) toxicity study in the Wistar rat, the results indicated that the NOAEL for maternal toxicity was 40 mg/kg b.w./day, based on statistically decreased food consumption and body weight gains at 120 mg/kg b.w./day (highest dose tested).  The NOAEL for fetal (prenatal)/developmental toxicity was 120 mg/kg b.w./day (highest dose tested).  In addition, there were no indications of any teratogenic effects in the rat fetuses at 120 mg/kg b.w./day (highest dose tested).  Therefore, metaflumizone is considered to be neither a developmental toxicant nor a teratogenic agent in the rat.

In a developmental (teratology) toxicity study in the Himalayan rabbit, the results indicated that the NOAEL for maternal toxicity was 100 mg/kg b.w./day, based on several clinical symptoms of toxicity (including ataxia and poor general state) occurring in 4 of 25 does at 300 mg/kg b.w./day, for which 2 of these 4 does had abortions prior to being sacrificed early, with a third doe at 300 mg/kg b.w./day being sacrificed moribund.  Similarly, the NOAEL for fetal (prenatal) / developmental toxicity was 100 mg/kg b.w./day, based on slightly decreased mean fetal body weights as well as an increased rate for a certain skeletal variation, namely incomplete ossification of sternabrae.  Because developmental toxicity was only observed at dose levels that were maternally toxic, metaflumizone is not selectively toxic to the fetal rabbit.

Lastly, in this rabbit developmental toxicity study, there were no indications of any teratogenic effects in the rabbit fetuses at 300 mg/kg b.w./day (highest dose tested).  Therefore, metaflumizone is not teratogenic in the rabbit.

An acute dietary endpoint was not established for the general population, including infants and children, since an endpoint of concern (effect) attributable to a single dose was not identified in the database.  Studies considered for this endpoint included the acute neurotoxicity study for which a LOAEL was not observed.

An acute dietary endpoint was established for females 13-49 years old based on a developmental effect observed in the rabbit developmental toxicity study that can be potentially due to a single dose of metaflumizone.  The effects consisted of an absent subclavian artery in the offspring at the LOAEL of 300 mg/kg b.w./day metaflumizone (NOAEL = 100 mg/kg b.w./day).  A combined uncertainty factor (UF) of 300 was applied to account for interspecies and intraspecies extrapolation (100) and a 3X FQPA safety factor was retained because the rabbit developmental toxicity study was performed via oral gavage dosing, resulting in an ARfD of 0.33 mg/kg b.w./day.]

	4. Subchronic toxicity. [In the Sprague-Dawley rat, treatment by oral gavage with metaflumizone for a subchronic duration (90-day timepoint in the chronic toxicity/carcinogenicity study) resulted in reduced food consumption and/or decreased mean body weight and/or body weight gains in males and females at 300 mg/kg b.w./day and in increased incidences of hepatocellular centrilobular hypertrophy in the livers of males at 300 mg/kg b.w./day.  Under the conditions of the study, the NOAEL for oral administration of metaflumizone for 90 days was 60 mg/kg b.w./day.

In the beagle dog, treatment by oral gavage with metaflumizone for a subchronic duration (90-day timepoint in the chronic toxicity study) resulted in reduced body weight gain and/or decreased food consumption in several dogs at 30 mg/kg b.w./day and slightly decreased mean MCHC at 30 mg/kg b.w./day.  Under the conditions of the study, the NOAEL for oral administration of metaflumizone for 90 days was 12 mg/kg b.w./day.

For a subchronic (90-day) dermal toxicity study conducted with metaflumizone in Wistar rats, the results support a NOAEL of 100 mg/kg b.w./day, based on decreased food consumption (females) and decreased body weight gain in males and females at 300 mg/kg b.w./day, the next highest dose tested.  Several microscopic changes were observed in female animals at 300 mg/kg b.w./day and above, but these morphologic changes were regarded to be indirect effects of the impaired body weight gain.

For a subacute (28-day) inhalation toxicity study conducted with metaflumizone in Wistar rats, the results support a NOAEL of 0.03 mg/L, based on decreased food consumption (females) and decreased body weight / body weight gain (females) and several microscopic changes in the respiratory tract at 0.10 mg/L, the next highest dose tested.  Several microscopic changes in non-respiratory tract tissues were observed in animals at these two dose levels, but these morphologic changes were regarded to be indirect effects of the impaired body weight / body weight gain.

Testing for metaflumizone's potential immunotoxicity, two studies were conducted, namely "28-Day Oral Immunotoxicity Study [by Thymic-Dependent Antibody Response (TDAR) Assay] in the Female Wistar Rat"  and  "28-Day Oral Immunotoxicity Study [by Natural Killer (NK) Cell Assay] in the Female Wistar Rat."   Results from both studies indicate a lack of immunotoxic potential for metaflumizone (BAS 320 I) up to the highest dose tested (HTD).  Both Study Reports have been submitted to U.S. EPA (in 2011).

	5. Chronic toxicity. [In the Sprague-Dawley rat, treatment by oral gavage with metaflumizone for a 2-year chronic duration resulted in dose-related increased incidences of hepatocellular centrilobular hypertrophy in the livers of males and females at 60 mg/kg b.w./day and at 300/200 mg/kg b.w./day and hepatocellular basophilic alteration in males at 60 and 300 mg/kg b.w./day.  [NOTE:  Beginning the first day of Week 3, the dose level of the high-dose females was lowered from 300 to 200 mg/kg b.w./day, due to an adverse effect of -71% decreased body weight gain as compared to controls.]

Therefore, the no-observable-adverse-effect-level (NOAEL) for systemic toxicity following oral administration of metaflumizone for 24 months to Sprague-Dawley rats was 30 mg/kg b.w./day for males and females.  Importantly, treatment with metaflumizone to rats for 2 years resulted in no test substance-related neoplastic findings, and therefore, the NOAEL for oncogenicity was 300/200 mg/kg b.w./day (highest dose tested).

In the CD-1 mouse, treatment by oral gavage with metaflumizone for an 18-month chronic duration resulted in a treatment-related increased incidence of increased brown pigment in the spleens of male and female animals administered 1000 mg/kg b.w./day (highest dose tested), as compared to controls.  Under the conditions of the study, the NOAEL for systemic toxicity following oral administration of metaflumizone for 18 months to CD-1 mice was 250 mg/kg b.w./day (the next highest dose tested) for males and females.  Importantly, treatment with metaflumizone to mice for 18 months resulted in no test substance-related neoplastic findings, and therefore, the NOAEL for oncogenicity was 1000 mg/kg b.w./day (highest dose tested).

In the beagle dog, treatment via gelatin capsules with metaflumizone for a 12-month chronic duration resulted in reduced body weight gain and/or decreased food consumption in several dogs at 30 mg/kg b.w./day and slightly decreased mean MCHC at 30 mg/kg b.w./day.  Under the conditions of the study, the NOAEL for oral administration of metaflumizone for 12 months was 12 mg/kg b.w./day.

Threshold Effect.  For estimated chronic exposure, the calculation of the chronic reference dose (chronic RfD) is based on the results of the chronic toxicity studies in the rat, mouse, and dog, and the two-generation reproduction study in the rat.  For metaflumizone, the lowest NOAEL for chronic toxic effects is 12 mg/kg b.w./day from the 12-month dog study.  A safety factor of 100 and an additional FQPA safety factor of 3 was applied to the NOAEL to account for the higher absorption observed with dietary exposures, resulting in a chronic RfD of 0.04 mg/kg b.w./day.

Non-Threshold Effect.  Since there were no test substance-related neoplastic findings following long-term treatment with metalfumizone to mice for 18 months or to rats for 24 months, the NOAEL for oncogenicity in both studies was established at the respective highest doses tested.  Therefore, metaflumizone should be classified as "not likely to be a human carcinogen."]

	6. Animal metabolism. [In the rat, goat and hen metabolism studies, the majority of the dose was rapidly excreted in the feces.  The low levels that were absorbed were distributed throughout various tissues.  Metaflumizone was the major component of the extractable residues in all tissues, milk, eggs and is the only residue of concern.  Metabolism of metaflumizone occurs by hydroxylation and conjugation on either of the phenyl rings or at the ethylene bridge and are the major routes of detoxification.  Cleavage of the semicarbazide bond to yield M320I04 also occurs, usually with accompanying conjugation.  The only residue of concern is metaflumizone.]

	7. Metabolite toxicology. [Toxicity of the metabolites of metaflumizone with potential exposure to humans was concurrently evaluated during toxicity testing of the parent except for the metabolite M320I23 that was not observed in the rat metabolism study.  The Z-isomer (M320I02) of metaflumizone was evaluated in additional toxicity tests to confirm no differences between the minor Z-isomer component and metaflumizone with a 9 to 1 E-isomer to Z-isomer ratio, respectively.  The results show no toxicological concerns:

Toxicity Studies with the metabolite M320I23 of metaflumizone
(a)  Acute Toxicity Study with Metabolite M 320I023
The metabolite M 320I023 of metaflumizone demonstrates low acute toxicity via the oral route of exposure in the rat.
Oral LD50  > 2000 mg/kg b.w. (category III).

(b)  Subchronic Toxicity Study with Metabolite M 320I023
In the Sprague-Dawley rat, treatment by oral gavage with metabolite M 320I023 of metaflumizone for a subchronic (90-day) duration resulted in systemic toxicity effects of increased relative liver weights (females) and increased incidences of liver hepatocellular centrilobular hypertrophy in males and females at 1000 mg/kg b.w./day (highest dose tested), as compared to controls.  Under the conditions of the study, the NOAEL for oral administration of the metabolite M 320I023 of metaflumizone for 90 days was 200 mg/kg b.w./day (next highest dose tested) in males and females.

(c)  Mutagenicity/Genotoxicity Studies with Metabolite M 320I023
In a battery of three in vitro and one in vivo mutagenicity assays consisting of all required end-points (point mutation, chromosomal damage, and DNA damage and repair), the weight-of-the-evidence for the metabolite M 320I023 (parent ketone) of metaflumizone insecticide indicates a lack of potential genotoxicity.

Specifically, for the battery of three in vitro mutagenicity assays with metabolite M 320I023 of metaflumizone, no positive responses were observed for increased revertant frequencies with and without metabolic activation [bacterial reverse mutation assay] or for increased mutant frequencies with and without metabolic activation [HGPRT locus assay].  Although there was a positive result for a statistically increased number of structurally aberrant metaphases in the chromosomes, which indicates clastogenic potential under in vitro conditions, this result was only observed with metabolic activation [cytogenicity study with V79 cells].

Importantly, the potential biological significance of this apparent chromosome damage observed in vitro only with metabolic activation, was evaluated in vivo using the mouse micronucleus assay.  Testing in this in vivo micronucleus study with NMRI mice was conducted at a high dose level (2000 mg/kg b.w.), that demonstrated no clinical symptoms of toxicity but which represents the limit dose for this assay.  No significant or dose-related increases in in vivo chromosomal damage were observed, indicating that the metabolite M 320I023 of metaflumizone does not cause chromosomal aberrations in intact animals.

Moreover, it has also been recognized by U.S. EPA that more weight should be placed on in vivo systems than in vitro systems as expressed in the Agency's weight-of-evidence for genotoxic evaluation of a chemical included in the "Guidelines for Mutagenicity Risk Assessment" (Federal Register, September 24, 1986, Vol. 51: 34006-34012).  Thus, the negative in vivo results (non-clastogenicity for chromosomal aberrations) observed in the mouse micronucleus assay should override the positive results obtained in the in vitro assay only with metabolic activation.  Furthermore, it has been noted that in vitro systems may simulate abnormal physiological conditions [Brusick, D.J. (editor) 1987. Genotoxicity Produced in Cultured Mammalian Cell Assay by Treatment Conditions. Mutation Research, Vol. 189, No.1: 1-69].  Additionally, it has been reported in the literature that S-9 metabolic activation does not often have adequate cofactors for activating detoxifying mechanisms found in the whole animal system [Ashby, J. 1983. The unique role of rodents in the detection of possible human carcinogens and mutagens. Mutation Research, Vol. 115: 117-213] [Galloway, S.M. 1994. Chromosome Aberrations Induced In Vitro:  Mechanisms. Delayed Expression, and Intriguing Questions.  Environmental and Molecular Mutagenesis, Vol. 23, Supplement 24: 44-53].  Consequently, based on the weight-of-the-evidence presented above, the metabolite M 320I023 of metaflumizone does not pose a genotoxic concern.

Therefore, as indicated from the results of the mammalian toxicity studies as well as the mutagenicity assays, metabolite M 320I023 of metaflumizone does not demonstrate more adverse toxicity when compared to metaflumizone.

Toxicity Studies with the Z-Isomer of metaflumizone
(a)  Acute Toxicity Study with Z-Isomer
The Z-isomer of metaflumizone demonstrates low acute toxicity via the oral route of exposure in the rat.
Oral LD50 > 5000 mg/kg b.w. (category IV).

(b)  Subchronic Toxicity Study with Z-Isomer
In the Sprague-Dawley rat, treatment by oral gavage with the Z-isomer of metaflumizone for a subchronic (90-day) duration resulted in impaired body weight gain only in females at the mid-dose (300 mg/kg b.w./day) and the high-dose (1000 mg/kg b.w./day), as compared to controls.  Several microscopic changes were observed in female animals at these two dose levels, but all morphologic changes were regarded to be indirect effects of the impaired body weight gain.  Under the conditions of the study, the NOAEL for oral administration of the Z-isomer of metaflumizone for 90 days was 1000 mg/kg b.w./day (highest dose tested) in males and 100 mg/kg b.w./day (lowest dose tested) in females.

(c)  Mutagenicity/Genotoxicity Study with Z-Isomer
In an in vitro mutagenicity assay with the Z-isomer of metaflumizone, there were no positive responses observed for increased revertant frequencies with and without metabolic activation [bacterial reverse mutation assay].

Therefore, as indicated from the results of the mammalian toxicity studies as well as the mutagenicity assay, the minor isomer of metaflumizone, namely the Z isomer, does not demonstrate more adverse toxicity when compared to metaflumizone.]

	8. Endocrine disruption. [Data from the reproduction / developmental toxicity and short-and long-term repeated dose toxicity studies with metaflumizone in the rat, rabbit, mouse, or dog, do not suggest any endocrine disruption activity.  This information is based on the absence of any treatment-related effects from the histopathological examination of reproductive organs as well as a low level of concern for possible effects on fertility, reproductive performance, or any other aspect of reproductive function, or on growth and development of the offspring.]

C. Aggregate Exposure

	1. Dietary exposure.

 Food. [
Metaflumizone and its metabolite M320I04 are expressed as the parent compound (metaflumizone). A dietary exposure analysis was conducted for all registered uses of Metaflumizone at the tolerance values and apple at the pending tolerance value of 1 ppm (including processing factors of 0.2 for dried apple and 0.5 for juice), crop group 9A at the pending tolerance of 1 ppm, crop group 10-10A and 10-10 B at the pending tolerance value of 3 ppm (including oil at 42 ppm and processing factors of 0.02 for juice), coffee at the pending tolerance value of 0.15 ppm, crop group 13-07G at pending tolerance of 5 ppm (including raisin at 10 ppm and processing factors of 0.1 for wine and 1.2 for juice, the last one based on default value). Fat from cattle, goat, sheep and horse at 0.05 ppm, as well as milk fat at 0.1 ppm was also included to account for livestock feed items associated with these crops.

Acute Dietary Food Exposure:  The Health Effects Division (HED) of EPA has determined that there are no toxic effects attributable to a single dose of metaflumizone for the general populations including infants and children.  Therefore, a quantitative acute dietary exposure and risk assessment for these sub-populations is not required.

An acute dietary assessment was conducted to evaluate the potential risk due to acute dietary exposure to females 13  -  49 years old.  The ARfD for metaflumizone is 1.0 mg/kg bw/day.  The FQPA safety factor for metaflumizone has been set to 3; therefore, the aPAD is 0.33 mg/kg bw/day.  The tier 1 acute dietary exposure estimate was based on established and proposed tolerance values in crops (including citrus oil), proposed tolerances in meat fat and milk fat, 100 percent crop treated values and experimental and default concentration/processing factors.  Residues in fish/shellfish were included based on the Aquatic Bioaccumulation Model (KABAM) piscivorous fish residue estimate for fish/shellfish.   The Dietary Exposure Evaluation Module (DEEM-FCID) software, version 4.02 updated with the USDA NHANES 2-day food consumption data for 2005-2010 and the EPA Food Commodity Ingredient Database (FCID) as of August 2014 was used for the assessment.  Drinking water exposure was included in the dietary exposure analysis.

The exposure estimate for the metaflumizone acute dietary assessment was well below U.S. EPA's level of concern (See table below).  The estimated acute dietary exposure for females 13  -  49 years old was 4.2%.  Additional refinements such as the use of anticipated residues and predicted percent crop treated would further reduce the estimated acute dietary exposure.

Table 1. Summary of Acute Dietary Exposure and Risk for Metaflumizone considering registered crops, new uses (all pending) and drinking water.
                                  Population
                               Exposure Estimate
                                     %aPAD
                                   Subgroups
                               (mg/kg b.w./day)

                           Females (13-49 years old)
                                    0.01397
                                      4.2
aPAD = acute population adjusted dose (aPAD = 0.33 mg/kg bw/day)

Chronic Dietary Food Exposure:
A tier 1 dietary exposure assessment was conducted for all sub-populations including infants and children.  The cRfD for metaflumizone is 0.12 mg/kg bw/day.  The FQPA safety factor for metaflumizone has been set to 3; therefore, the cPAD is 0.04 mg/kg bw/day.  The tier 1 chronic dietary exposure estimates were based on established and proposed tolerance values in crops (including citrus oil), proposed tolerances in meat fat and milk fat, 100 percent crop treated values and experimental and default concentration/processing factors. Residues in fish/shellfish were included based on the Aquatic Bioaccumulation Model (KABAM) piscivorous fish residue estimate for fish/shellfish.   The Dietary Exposure Evaluation Module (DEEM-FCID) software, version 4.02 updated with the USDA NHANES 2-day food consumption data for 2005-2010 and the EPA Food Commodity Ingredient Database (FCID) as of August 2014 was used for the assessment.  Drinking water exposure was included in the dietary exposure analysis.

Exposure estimates for the metaflumizone chronic dietary assessments were well below U.S. EPA's level of concern (See table below.  The most highly exposed sub-group was children 1-2 years old and the exposure accounted for 76.5% of the cPAD.  Additional refinements such as the use of anticipated residues and predicted percent crop treated would further reduce the estimated chronic dietary exposure.

Table 2.  Summary of Chronic Dietary Exposure and Risk for Metaflumizone considering registered crops, new uses (all pending) and drinking water.
                                  Population
                               Exposure Estimate
                                     %cPAD
                                   Subgroups
                               (mg/kg b.w./day)

                                U.S. Population
                                    0.00554
                                     13.9
                         All Infants (< 1 year old)
                                    0.01031
                                     25.8
                           Children (1-2 years old)
                                    0.03059
                                     76.5
                           Children (3-5 years old)
                                    0.01882
                                     47.0
                           Children (6-12 years old)
                                    0.00822
                                     20.6
                            Youth (13-19 years old)
                                    0.00341
                                      8.5
                           Adults (20-49 years old)
                                    0.00353
                                      8.8
                                Adults 50+ yrs
                                    0.00384
                                      9.6
                           Females (13-49 years old)
                                    0.00358
                                      9.0
   cPAD = chronic  population adjusted dose (cPAD = 0.04 mg/kg bw/day)]

   	ii. Drinking Water. [The estimated drinking water concentrations (EDWCs) used in this assessment were from the HED human health assessment of metaflumizone, December 21, 2011.  PRZM-EXAMS modeling resulted in the highest surface water values.  The model was run using the fly bait application scenario to turf to represent application to use sites such as recreational facilities and outdoor recreational areas including parks, picnic grounds, and camp grounds.  The acute and chronic surface water EDWCs were 1.14 and 0.597 ppb, respectively.  The acute and chronic ground water EDWC was 2.1 x 10[-][3] ppb.  The drinking water exposure was included in the dietary assessment.]

	2. Non-dietary exposure. [
Metaflumizone is registered in the U.S. for use as a fire ant bait and a fly bait.  These uses can result in residential exposure.  The exposure and MOE values for these uses were estimated using EPA's 2012 Residential SOPs. The MOE values were calculated using a short-term dermal NOAEL of 100 mg ai/kg bw/day and short-term incidental oral NOAEL of 20 mg ai/kg bw/day.  The calculated MOEs for all adult and infant exposures are greater than 100 and therefore do not exceed EPA's level of concern.

Table 3.  Summary of Residential and Recreational Post-Application Exposure and Risks from use of Fire Ant Bait.

                                 Fire Ant Bait
                            Population and activity
                               Route of Exposure
                              Dose (mg/kg bw/day)
                                      MOE
Adult -- Residential Handler
                                    Dermal
                                    0.00012
                                    833,000

                                  Inhalation
                                  0.000000013
                                  185,000,000

                                   Combined
                                      --
                                  ARI = 7,973
Adult  -  Residential Post-application
                                    Dermal
                                    0.00008
                                   1,250,000
Adult  -  Golfer Post-application
                                    Dermal
                                   5.90E-06
                                  16,900,000
Adolescent  -  Golfer Post-application
                                    Dermal
                                   6.86E-06
                                  14,600,000
Children (1 to <2 year olds)  -
Post-application
                                    Dermal
                                    0.00016
                                    625,000

                         Incidental oral hand-to-mouth
                                   1.50E-06
                                  13,000,000

                        Incidental oral object-to-mouth
                                   4.00E-07
                                  50,000,000

                        Combined oral h-t-m and dermal
                                      --
                                  ARI = 5479

Table 4.  Summary of Recreational Post-Application Exposure and Risks from use of Metaflumizone Fly Bait.

                                   Fly Bait
                            Population and activity
                               Route of Exposure
                              Dose (mg/kg bw/day)
                                      MOE
Adult  -  Post-application
                                    Dermal
                                    0.00117
                                    86,000
Children (1 to <2 years old)  -  Post-application
                                    Dermal
                                    0.00229
                                    44,000

                         Incidental oral hand-to-mouth
                                   0.0000210
                                    950,000

                        Incidental oral object-to-mouth
                                   0.0000013
                                  15,000,000

                    Combined oral hand-to-mouth and dermal
                                      --
                                   ARI = 384

	3. Aggregate exposure.
    [Acute Aggregate Risk:
    No acute residential/recreational exposures are expected.  The acute aggregate risk includes only exposure to females 13-49 years old from food and water.  The food and drinking water exposure accounts for less than 5% aPAD which is below HED's level of concern.

    Short-/Intermediate Term Aggregate Risk:
    There is the potential for short-term, non-dietary exposure of children and adults to metaflumizone from the use as a fire ant bait and a fly bait.   Therefore, the short-term aggregate exposure includes residential/recreational exposure, food and water exposure.   Because the level of concern (LOC) for oral exposure is different than the LOC for dermal exposure, an Aggregate Risk Index (ARI) is used.  An ARI >1 indicates an acceptable exposure. In the tables below, the incidental oral exposure for the hand-to-mouth exposure was aggregated with the dietary and post-application dermal exposure for both the fire ant and fly bait uses.

    Table 5.  Summary of Short-/Intermediate Term Aggregate Risk from Fire Ant Bait Use and Imported Commodities.

                                 Food + water
                               Non-dietary oral
                                    Dermal
                                   Aggregate
                             Population Sub-Group
                                      MOE
                                      MOE
                                      MOE
                                      ARI
US population
                                     3681
                                      NA
                                    833,000
                                     12.3
Children 1-2
                                      674
                                  13,300,000
                                    625,000
                                      2.2

    Table 6.  Summary of Short-/Intermediate Term Aggregate Risk from Fly Bait Use and Imported Commodities.

                                 Food + water
                               Non-dietary oral
                                    Dermal
                                   Aggregate
                             Population Sub-Group
                                      MOE
                                      MOE
                                      MOE
                                      ARI
US population
                                     3681
                                      NA
                                    85,500
                                     12.1
Children 1-2
                                      673
                                    952,000
                                    43,700
                                      2.2

The ARI values are all greater than 1 which indicates  acceptable exposures.

Chronic Aggregate Risk:

No chronic residential/recreational exposure is expected.  The chronic aggregate risk includes only exposure from food and water.  The chronic food and drinking water exposure for all sub-populations are below HED's level of concern.]

D. Cumulative Effects>  [Section 408(b)(2)(D)(v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ``available information'' concerning the cumulative effects of a particular pesticide's residues and ``other substances that have a common mechanism of toxicity.

The EPA is currently developing methodology to perform cumulative risk assessments.  At this time, there is no available data to determine whether metaflumizone has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment.]

E. Safety Determination

	1. U.S. population. [Using the conservative exposure assumptions described above and based on the completeness and the reliability of the toxicity data, BASF has estimated the aggregate exposure to metaflumizone is well below the EPA's level of concern.  ]

	2. Infants and children. [All subpopulations based on age were considered. Infants and children aggregate risk is well below EPA's level of concern.  BASF, considering a worst-case situation, concludes with reasonable certainty that no harm will result to infants or children from aggregate exposure to metaflumizone residues.]

F. International Tolerances

	[Maximum residue levels (MRLs) have been established for metaflumizone by the Codex Alimentarius Commision (CODEX) in potato, tomato, pepper, eggplant, Brussels sprout, Chinese cabbage, lettuce, and animal products.  Harmonized EU MRLs have been established for metaflumizone in several crops and animal products.

Codex (based on parent only)
Potato
0.02
Tomato
0.6
Pepper, inc chili pepper
0.6
Peppers chili, dried
6
Eggplant
0.6
Brussels sprout
0.8
Chinese cabbage
6
Lettuce
7
Swine (all)
0.02
Bovine (meat, kidney, liver, fat, offal)
0.02
Sheep, goat (meat, kidney, liver, fat, offal)
0.02
Milk
0.01
Cream
0.02

EU harmonized (based on parent only)
Fruiting vegetables
(a) solanacea
Tomatoes
0.6
Sweet peppers/bell peppers
1
Aubergines/eggplants
0.6
(b) cucurbits with edible peel
Cucumbers
0.4
Gherkins
0.4
Courgettes
0.4
Others
0.4
Brassica vegetables (excluding brassica roots and brassica baby leaf crops)
(a) flowering brassica
Broccoli
3
Cauliflowers
1.5
(b) head brassica
Brussels sprouts
1
Head cabbages
1
(c) leafy brassica
Chinese cabbages/pe-tsai
7
Leaf vegetables, herbs and edible flowers
(a) lettuces and salad plants
Lamb's lettuces/corn salads
10
Lettuces
5
Cresses and other sprouts and shoots
10
Land cresses
10
Roman rocket/rucola
10
Red mustards
10
Baby leaf crops (including brassica species)
10
Others
10
Legume vegetables
Beans (with pods)
0.9
Peas (with pods)
1.5
Stem vegetables
Globe artichokes
0.9
Oilseeds
Cotton seeds
0.07
Swine (all)
0.02
Bovine (meat, kidney, liver, fat, offal)
0.02
Sheep, goat (meat, kidney, liver, fat, offal)
0.02
Equine (meat, kidney, liver, fat, offal)
0.02
Other farmed terrestrial animals (meat, kidney, liver, fat, offal)
0.02
Poultry (meat, liver, kidney, offal)
0.02
Poultry fat
0.1
Milk and cream
0.02
Eggs
0.02


[Federal Register: November 7, 2005 (Volume 70, Number 214)]
[Notices]
[Page 67469]
[DOCID:fr07no05-70]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP05-317-001]

Texas Gas Transmission, LLC; Motion To Place Suspended Tariff
Sheets Into Effect

November 1, 2005.
    Take notice that on October 27, 2005, Texas Gas Transmission, LLC,
Texas Gas tendered for filing as part of its FERC Gas Tariff, Second
Revised Volume No. 1.
    Texas Gas states that this motion rate filing is being made to
place the suspended revised tariff sheets in Appendix A to the filing,
into effect on November 1, 2005, in compliance with the Commission's
Order issued May 31, 2005, in Docket No. RP05-317 at 111 FERC Paragraph
] 61,302 (2005). Texas Gas requests an effective date of November 1,
2005, for the proposed tariff sheets.
    Texas Gas further states that it has served copies of this filing
upon the company's jurisdictional customers, interested State
commission, and all parties appearing on the official restricted
service list.
    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 the date as indicated below. 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>.
    Comment Date: 5 p.m. eastern time on November 7, 2005.

Magalie R. Salas,
Secretary.
[FR Doc. E5-6161 Filed 11-4-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 213 (Tuesday, November 3, 2020)]
[Rules and Regulations]
[Pages 69492-69493]
[FR Doc No: 2020-24279]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0744; Project Identifier 2019-CE-056-AD; Amendment
39-21285; AD 2020-21-12]
RIN 2120-AA64

Airworthiness Directives; Pilatus Aircraft Ltd. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Pilatus Aircraft Ltd Model PC-24 airplanes. This AD was
prompted by mandatory continuing airworthiness information (MCAI)
issued by the aviation authority of another country to identify and
correct an unsafe condition on an aviation product. The MCAI describes
the unsafe condition as the vinyl grommets on the upper panel assembly
on the left-hand (LH) and right-hand (RH) emergency exits becoming
rigid after exposure to low temperatures, which could result in failure
of the emergency exits to open during an evacuation. This AD requires
replacing the grommets. The FAA is issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective December 8, 2020.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of December 8,
2020.

ADDRESSES: For service information identified in this final rule,
contact Pilatus Aircraft Ltd., Customer Technical Support (MCC), P.O.
Box 992, CH-6371 Stans, Switzerland; telephone: +41 (0)41 619 67 74;
exception occurred on : 2020-24279.htm
exception occurred on : 2020-24279.htm
fax: +41 (0)41 619 67 73; email: aircraft.com">[email protected]aircraft.com;
internet: https://www.pilatus-aircraft.com/en. You may view this
service information at the FAA, Airworthiness Products Section,
Operational Safety Branch, 901 Locust, Kansas City, MO 64106. For
information on the availability of this material at the FAA, call 816-
329-4148. It is also available on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0744.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0744 or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the MCAI, any comments received, and other
information. The address for Docket Operations is U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Doug Rudolph, Aerospace Engineer, FAA,
General Aviation & Rotorcraft Section, International Validation Branch,
901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816)
329-4059; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to Pilatus Aircraft Ltd
Model PC-24 airplanes with an emergency exit grommet part number (P/N)
9<IP_ADDRESS> installed. The NPRM published in the Federal Register on
August 7, 2020 (85 FR 47919). The NPRM proposed to correct an unsafe
condition of the specified products and was based on MCAI originated by
the European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Union. EASA
issued AD No. 2019-0293, dated December 4, 2019 (referred to after this
as ``the MCAI''), which states:

    After exposure to low temperatures, the vinyl grommets which
hold the upper panel assembly in position on the left-hand and
right-hand emergency exits were found to become rigid.
    This condition, if not corrected, could result in failure of the
emergency exits to open during an evacuation, possibly resulting in
injury to occupants.
    To address this potential unsafe condition, Pilatus issued the
[service bulletin] SB to provide modification instructions.
    For the reason described above, this [EASA] AD requires
replacement of affected parts with serviceable parts, as defined in
this AD, and prohibits (re-)installation of affected parts.

    You may obtain further information by examining the MCAI in the AD
docket on the internet at https://www.regulations.gov by searching for
and locating Docket No. FAA-2020-0744.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The FAA received no comments on the NPRM or
on the determination of the cost to the public.

Conclusion

    The FAA reviewed the relevant data and determined that air safety
and the public interest require adopting this final rule as proposed.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Pilatus PC-24 Service Bulletin No. 25-005, dated
August 12, 2019. The service information contains procedures for
replacing the grommets that are used to hold the upper panel assembly
in position on the LH and RH emergency exits with different part-
numbered grommets. This service information is reasonably available
because the interested parties have access to it through their normal
course of business or by the means identified in the ADDRESSES section.

Costs of Compliance

    The FAA estimates that this AD affects 39 products of U.S.
registry. The FAA also estimates that it will take 1.0 work-hour per
product to comply with the requirements of this AD. The average labor
rate is $85 per work-hour. Required parts will cost about $30 per
product.
    Based on these figures, the FAA estimates the cost of the AD on
U.S. operators to be $4,485, or $115 per product.
    According to the manufacturer, some of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. The FAA does not control warranty coverage for affected
individuals. As a result, the FAA has included all costs in this cost
estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more

detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2020-21-12 Pilatus Aircraft Ltd: Amendment 39-21285; Docket No. FAA-
2020-0744; Project Identifier 2019-CE-056-AD.

(a) Effective Date

    This AD is effective December 8, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Pilatus Aircraft Ltd. Model PC-24 airplanes,
all serial numbers, with an emergency exit grommet part number (P/N)
9<IP_ADDRESS> installed, certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC) Code 52: Doors.

(e) Unsafe Condition

    This AD was prompted by a report that after exposure to low
temperatures, the vinyl grommets that hold the upper panel assembly
in position on the left-hand (LH) and right-hand (RH) emergency
exits can become rigid. This unsafe condition, if not addressed,
could result in failure of the emergency exits to open during an
evacuation.

(f) Actions and Compliance

    Unless already done, do the following actions in paragraphs
(f)(1) and (2) of this AD.
    (1) Within 3 months after the effective date of this AD, replace
each grommet P/N 9<IP_ADDRESS> holding the upper panel assembly in
position on the LH and RH emergency exits with grommet P/N
5<IP_ADDRESS> in accordance with the Accomplishment Instructions,
section 3.B., of Pilatus Aircraft Ltd PC-24 Service Bulletin No. 25-
005, dated August 12, 2019.
    (2) As of the effective date of this AD, do not install a
grommet P/N 9<IP_ADDRESS> on any airplane.

(g) Alternative Methods of Compliance (AMOCs)

    The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. Send information to ATTN: Doug
Rudolph, Aerospace Engineer, FAA, General Aviation & Rotorcraft
Section, International Validation Branch, 901 Locust, Room 301,
Kansas City, Missouri 64106; telephone:<PHONE_NUMBER>; fax: (816)
329-4090; email<EMAIL_ADDRESS>Before using any approved
AMOC on any airplane to which the AMOC applies, notify your
appropriate principal inspector (PI) in the FAA Flight Standards
District Office (FSDO), or lacking a PI, your local FSDO. Before
using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office.

(h) Related Information

    Refer to European Union Aviation Safety Agency (EASA) AD No.:
2019-0293, dated December 4, 2019, for more information. You may
examine the EASA AD in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-
2020-0744.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Pilatus PC-24 Service Bulletin No. 25-005, dated August 12,
2019.
    (ii) [Reserved]
    (3) For Pilatus Aircraft Ltd service information identified in
this AD, contact Pilatus Aircraft Ltd., Customer Technical Support
(MCC), P.O. Box 992, CH-6371 Stans, Switzerland; telephone: +41
(0)41 619 67 74; fax: +41 (0)41 619 67 73; email:
exception occurred on : 2020-24279.htm
exception occurred on : 2020-24279.htm
aircraft.com">[email protected]aircraft.com; internet: https://www.pilatus-aircraft.com/en.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 901
Locust, Kansas City, Missouri 64106. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on October 5, 2020.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2020-24279 Filed 11-2-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 250 (Thursday, December 29, 2011)]
[Notices]
[Pages 81927-81928]
[FR Doc No: 2011-33318]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL12-15-000]

Shiloh III Wind Project, LLC; Notice of Petition for Declaratory
Order

    Take notice that on December 15, 2011, pursuant to section 201 of
the Federal Power Act, 16 U.S.C. 824, Shiloh III Wind Project, LLC
filed a Petition for Declaratory Order, requesting that the Federal
Energy Regulatory Commission (Commission) disclaim jurisdiction over
the Owner-Lessor in a structure lease financing transaction for wind
powered generation and related interconnection facilities located in
Solano County, California, as set forth in the above-referenced
proceeding.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests 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. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and

interventions 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 or intervention 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 email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on January 20, 2012.

    Dated: December 21, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-33318 Filed 12-28-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 7 (Wednesday, January 11, 2017)]
[Notices]
[Pages 3372-3375]
[FR Doc No: 2017-00369]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79746; File No. SR-DTC-2016-014]

Self-Regulatory Organizations; The Depository Trust Company;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change,
as Modified by Amendment No. 1, Regarding the Update of Its Corporate
Action Service for the Processing of Redemptions Events and the
Transition to International Organization for Standardization 20022
Messaging for Corporate Action Announcements

January 5, 2017.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') and Rule 19b-4 \2\ thereunder, notice is hereby given
that on December 22, 2016, The Depository Trust Company (``DTC'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II and III below, which
Items have been prepared by DTC. DTC filed the proposed rule change
pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(4)
thereunder.\4\ On January 4, 2017, DTC filed Amendment No. 1 to the
proposed rule change.\5\ The proposed rule change was effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change, as modified by Amendment
No. 1, from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(4).
    \5\ In Amendment No. 1, DTC modified the Implementation Date
section to correctly describe the effective date of the filing as
January 1, 2017. DTC did not propose any other changes to the filing
in Amendment No. 1.

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

I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The proposed rule change by DTC would revise its Procedures \6\ set
forth in the Guide to: (1) Update its corporate action service by
transitioning corporate action \7\ functions on its Participant
Terminal System (``PTS'') and its Participant Browser Service (``PBS'')
systems \8\ for the processing of Redemptions to its Corporate Action
Web (``CA Web'') system; (2) reflect the transition from DTC's
proprietary Computer-to-Computer Facility (``CCF'') \9\ files to
International Organization for Standardization (``ISO'') 20022
messaging to communicate corporate action announcements
(``Announcements''); (3) establish the start date (``Fee Start Date'')
for the fee associated with CCF Reorganization Announcement files and
the dates for the retirement of all CCF Announcement files; and (4)
make other ministerial changes as more fully described below.
---------------------------------------------------------------------------

    \6\ Each capitalized term not otherwise defined herein has its
respective meaning as set forth in the Rules, By-Laws and
Organization Certificate of DTC (``DTC Rules''), available at http://www.dtcc.com/legal/rules-and-procedures.aspx in the Redemptions
Service Guide (``Guide''), available at http://www.dtcc.com/~/media/
Files/Downloads/legal/service-guides/Redemptions.pdf?la=en; and in
the Guide to the 2016 DTC Fee Schedule (``Fee Schedule''), available
at http://www.dtcc.com/~/media/Files/Downloads/legal/fee-guides/
dtcfeeguide.pdf?la=en.
    \7\ DTC offers an array of services for processing corporate
action events. The services fall into three categories of corporate
action events: (i) Distributions, such as cash and stock dividends,
principal and interest, and capital gain distributions
(collectively, ``Distributions''); (ii) redemptions such as full and
partial calls, final paydowns, and maturities (collectively,
``Redemptions''); and (iii) reorganizations, which include both
mandatory and voluntary reorganizations such as exchange offers,
conversions, Dutch auctions, mergers, puts, reverse stock splits,
tender offers, and warrant exercises (collectively,
``Reorganizations'').
    \8\ PTS and PBS are user interfaces for DTC's Settlement and
Asset Services functions. PTS is mainframe-based and PBS is web-
based with a mainframe back-end. Participants may use either PTS or
PBS, as they are functionally equivalent. References to a particular
PTS function in this rule filing include the corresponding PBS
function.
    \9\ CCF is a transmission system for input and output based on
various protocols between the mainframe computer facility of a user
of DTC's services and DTC's mainframe computer facility.
---------------------------------------------------------------------------

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, DTC included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. DTC has prepared summaries, set forth in sections A, B,
and C below, of the most significant aspects of such statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

1. Purpose
    The proposed rule change by DTC would revise its Procedures set
forth in the Guide to: (1) Update its corporate action service by
transitioning corporate action functions on its PTS and PBS systems for
the processing of Redemptions events to CA Web; (2) reflect the
transition from DTC's proprietary CCF files to ISO 20022 messaging to
communicate Announcements; (3) establish the Fee Start Date associated
with CCF Reorganizations Announcement files, and the dates for the
retirement of CCF files for all Announcements; and (4) make other
ministerial changes as more fully described below.
(i) Background
    Beginning in 2011, DTC has filed a series of rule changes to update
its corporate action services by migrating the corporate action
functions for Distributions from PTS/PBS to CA Web, a then new browser
user interface,\10\ and to implement ISO 20022 messaging to replace
DTC's CCF Announcement files.\11\ After a Participant testing phase,
PTS/PBS functions for Distributions were retired in 2015, and the use
of CA Web for processing Distributions became mandatory for all
Participants.\12\
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    \10\ See Securities Exchange Act Release No. 68114 (October 26,
2012); 77 FR 66497 (November 5, 2012) (SR-DTC-2012-08).
    \11\ See Securities Exchange Act Release No. 63886 (February 10,
2011), 76 FR 9070 (February 16, 2011) (SR-DTC-2011-02); Securities
Exchange Act Release No. 68114 (October 26, 2012), 77 FR 66497
(November 5, 2011) (SR-DTC-2012-08).
    \12\ See Securities Exchange Act Release No. 73864 (December 17,
2014); 79 FR 77063 (December 23, 2014) (SR-DTC-2014-12).
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(ii) Transition to CA Web for Redemptions
    With this proposed rule change, DTC would transition PTS/PBS
functions for Redemptions to CA Web,\13\ and update the Guide to add
the appropriate references. The proposed rule change would establish a
parallel testing period for CA Web Redemptions functions beginning in
Q4 of 2016 which would conclude in Q1 of 2017, at which time
Redemptions activity within the following PTS and corresponding PBS
functions would be retired and transitioned to CA Web: ADJI (Adjustment
Inquiries), RIPS (Reorganization Inquiry for Participants), and SDAR
Dept. R (Same Day Allocation Reporting).\14\ DTC has been communicating
this change to Participants through weekly CA Web review sessions,
Important Notices, and industry outreach.\15\
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    \13\ In PTS/PBS, corporate actions are announced using DTC
proprietary codes to signify event types. CA Web replaces DTC's
proprietary codes with market standard language. For example, a cash
dividend payment that PTS/PBS identifies as a ``08'' function code
is identified in CA Web as a ``Cash Dividend'' event. Additionally,
CA Web incorporates the entire lifecycle of an event into one
platform with a unique corporate action identifier that follows the
event through its lifecycle. CA Web gives Participants the ability
to customize screen displays and offers flexible methods for event
search, neither of which is available in the PTS/PBS systems.
    \14\ See PTS/PBS Function Guides, available at http://www.dtcc.com/matching-settlement-and-asset-services/edl-ptspbs-function-guides.
    \15\ See Important Notice B 3253-16 (April 25, 2016); SIFMA
Corporate Actions Section Newsletter (June 2015), available at
http://www.sifma.org/uploadedfiles/societies/sifma_corporate_actions_section/cas-newsletter-june2015.pdf?n=65777.
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(iii) CCF Files and ISO 20022
    Since 2011, DTC has been encouraging Participants to migrate from
CCF Announcement files to ISO 20022 messaging \16\ by providing
parallel production testing access, an online learning center, hosting
ISO specific monthly calls and offering a dedicated mailbox for client
inquiries. Certain Participants nonetheless had asked whether DTC could
continue supporting CCF Files while they migrated to ISO 20022
messaging, and indicated that they were willing to pay for the
continued use of the CCF Files.
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    \16\ ISO 20022 is a business-model-based standard for the
development of messages for the international financial services
industry and can support different messaging syntaxes. It provides
the financial industry with a common language to capture business
transactions and associated message flows. The use of ISO 20022
messaging improves transparency and adds efficiency in Announcements
and the processing of corporate actions. In contrast, CCF files use
DTC proprietary functions and activity codes that differ from the
market standard. With ISO 20022 messaging, Announcements are event
based and identified by a unique corporate action ID. ISO 20022
messages provide more data elements than the CCF files and they are
available in near real time throughout the day.
---------------------------------------------------------------------------

    In response to these Participant requests, on December 24, 2015,
DTC filed a rule change postponing the date for the retirement of CCF
Announcement files for Distributions, Redemptions, and Reorganizations,
and, in order to encourage the transition to ISO 20022, implementing,
in phases, a fee (``CCF File Fee'') for Participants that have not
migrated to ISO 20022 messaging and continue to receive the

CCF Announcement files.\17\ The CCF File Fee is $50,000 per event
group, per twelve month period. Pursuant to that rule change, the CCF
File Fee for Distributions Announcements became effective on January 1,
2016, and the CCF File Fee for Redemptions Announcements became
effective on July 1, 2016. The rule change did not provide a CCF Fee
Start Date for Reorganizations Announcements.
---------------------------------------------------------------------------

    \17\ See Securities Exchange Act Release No. 76811 (December 31,
2015), 81 FR 826 (January 7, 2016) (SR-DTC-2015-013).
---------------------------------------------------------------------------

    This proposed rule change would amend the Fee Schedule to reflect a
Fee Start Date of January 1, 2018 for Reorganizations Announcements. In
addition, the proposed rule change would provide for the retirement of
all corporate action CCF files for Announcements in accordance with the
schedule below. DTC has communicated with its Participants about the
retirement of CCF Announcement files for corporate action events
through several DTC Important Notices, industry conferences and monthly
industry calls.\18\
---------------------------------------------------------------------------

    \18\ See Important Notice B3089-16 (April 1, 2016), available at
http://www.dtcc.com/~/media/Files/pdf/2016/4/1/3089-16.pdf.
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    The retirement of CCF Announcement files would be implemented in
the following phases:

----------------------------------------------------------------------------------------------------------------
        Announcements CCF files                    Fee start date                  CCF file retirement date
----------------------------------------------------------------------------------------------------------------
Distributions.........................  January 1, 2016....................  January 1, 2017.
Redemptions...........................  July 1, 2016.......................  July 1, 2017.
Reorganizations.......................  January 1, 2018....................  December 31, 2018.
----------------------------------------------------------------------------------------------------------------

    Finally, in order to align the Guide to Participants' use of ISO
20022 messaging for Redemptions Announcements, the Guide would be
updated to add the appropriate references to ISO 20022.
(iv) Ministerial Changes
    The proposed rule change would update the Guide to make ministerial
updates to reflect current terminology and practice, and to remove
references to outdated functions which had been replaced, as set forth
below. The Guide would be updated to:
    (1) Remove references to the functions of PTS that had been
replaced by other functions over the past several years: Completion
Flash (RIPS provides the same functionality), SDAL (replaced by SDAR),
ACLP (replaced by RIPS), PTSI (replaced by dtcc.com and REOG
(Reorganization Selection Menu)), and the PTS Network (replaced by
RIPS).
    (2) Remove references to the use of PTS Printers, PTS tickets, and
PTS Flash. Similar functionality is available electronically on PTS/
PBS, and would be available on CA Web.\19\
---------------------------------------------------------------------------

    \19\ See Important Notice B5007-09 (April 27, 2009), available
at http://www.dtcc.com/~/media/Files/pdf/2009/4/27/5007-09.pdf; see
Important Notice B7046-10 (August 6, 2010), available at http://
www.dtcc.com/~/media/Files/pdf/2010/8/2/7046-10.pdf.
---------------------------------------------------------------------------

    (3) Remove references to the PTS Manual, which has been
superseded.\20\
---------------------------------------------------------------------------

    \20\ See Securities Exchange Act Release No. 44719 (August 17,
2001), 66 FR 44656 (August 24, 2001) (SR-DTC-2001-01).
---------------------------------------------------------------------------

    (4) Remove reference to hard copy monthly bills. Hardcopy bills for
corporate actions services were discontinued several years ago. Bills
are sent via email and are available on iBill on the DTCC Portal.\21\
---------------------------------------------------------------------------

    \21\ See Important Notice B7586-10 (November 8, 2010), available
at www.dtcc.com/~/media/Files/pdf/2010/11/8/7586-10.pdf.
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    (5) Remove the provision that states that the Guide does not cover
procedures relating to maturities and redemptions of commercial paper
(``CP'') as it is no longer accurate. Currently, DTC does announce CP
maturities, and therefore the Guide is applicable.
    (6) Remove references to Next Day Funds Settlement (``NDFS'')
service and related processes, which were superseded by DTC's Same Day
Funds Settlement (``SDFS'') Service.\22\ NDFS and SDFS ran concurrently
until 1996.
---------------------------------------------------------------------------

    \22\ See Securities Exchange Act Release Nos. 24689 (July 9,
1987), 52 FR 26613 (SR-DTC-87-04) (order granting temporary approval
to DTC's SDFS settlement service); 26051 (August 31, 1988), 53 FR
34853 (SR-DTC-88-06) (order granting permanent approval of DTC's
SDFS settlement service).
---------------------------------------------------------------------------

    (7) Replace references to Reorganization Notice (REORGN) CCF File,
which had been replaced with the REOGN2 CCF File.
    (8) In the section under the heading About Charge-Backs and
Adjustments, replace the statement ``After crediting you with a
redemption payment, DTC occasionally determines that this credit was
improper due to an issuer's default on the payment, an error on the
part of DTC, or some other reason'' with ``DTC does not credit proceeds
to Participants until it is funded by the issuer/agent. Occasionally,
it is determined that the proceeds credited were incorrect.'' to
reflect the fact that DTC does not credit redemption proceeds to
Participants until DTC is funded by the issuer/agent.
    (9) In the section under the heading Reorg Deposit Service, correct
the statement that DTC's Reorg Deposits Service allows Participants to
deposit Eligible Securities ``that are undergoing or have undergone
within the last two years, redemptions, maturity or mandatory
reorganization maturity processing'' to (a) reflect that the Reorg
Deposits Service accepts deposits of Eligible Securities that have
undergone such processing at any point in time, and (b) remove the
reference to ``mandatory reorganization maturity processing'' as it is
duplicative of ``maturity''.
    (10) Move screenshots of the ``Impartial Lottery Method for
Allocating Called Securities'' and related images to Appendix A.
    (11) Remove duplicative text.
    (12) Update the text to reflect book-entry and FAST inventory, in
addition to physical certificates.
    (13) Clarify and streamline the text to improve readability.
    (14) Add the title of the Guide and update the `Important Legal
Information' to align with other DTC service guides.
    (15) Add background information on Redemptions services.
    (16) Correct spelling, grammatical and typographical errors
throughout.
    (17) Update other text, including address, phone numbers, Web site
information, and methods of delivering information.
Implementation Date
    The proposed rule change would take effect on January 1, 2017.
2. Statutory Basis
    DTC believes that the proposed rule change is consistent with the
requirements of Section 17A(b)(3)(F) of the Act.\23\
---------------------------------------------------------------------------

    \23\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    Section 17A(b)(3)(F) of the Act requires, inter alia, that the DTC
Rules be designed to promote the prompt and accurate clearance and
settlement of securities transactions.\24\ DTC believes that the
proposed rule change would (a) promote efficiencies with a newer and

more flexible interface for Participants to access Redemptions
services, process their Redemptions allocations, and view event
information, replacing the less efficient PTS/PBS interface for
Redemptions with CA Web, and (b) provide clarity to Participants by
updating and streamlining the Guide to better reflect DTC's Redemptions
services and practices, including the migration to ISO 20022 messaging
and the transition to CA Web, and by making ministerial updates and
corrections. Therefore, by promoting efficiencies for Participants'
processing of Redemptions at DTC, and updating the Guide to reflect the
current state of DTC's services in this regard, the proposed rule
change promotes the prompt and accurate clearance and settlement of
securities transactions consistent with the requirements of the Act, in
particular Section 17A(b)(3)(F), cited above.
---------------------------------------------------------------------------

    \24\ Id.
---------------------------------------------------------------------------

    In addition, by establishing the Fee Start Date for the
Reorganizations CCF File Fee and the retirement dates for CCF files for
Distributions, Redemptions, and Reorganizations Announcements, the
proposed rule change would require Participants to complete their
transition to ISO 20022 messaging by a date certain. ISO 20022
messaging provides Participants with (a) more data fields than are in
CCF files, increasing transparency about the events being announced,
and (b) near real-time industry standard messaging, which is not
available for CCF files, providing consistency for Participants and
accelerating the flow of information, therefore increasing efficiency.
Ultimately, DTC expects that Participants would better process their
announcements, instructions, entitlements and allocations, promoting
the prompt and accurate clearance and settlement of securities
transactions consistent with the requirements of the Act, in particular
Section 17A(b)(3)(F), cited above.

(B) Clearing Agency's Statement on Burden on Competition

    DTC does not believe that the proposed rule change would have any
impact on competition, because the transition from PTS/PBS functions
for the processing of Redemptions to CA Web would only enhance and
simplify a current service and process, and the retirement of the CCF
Announcement files would remove an outdated process and replace it with
an improved standard of messaging. Both the CA Web and ISO 20022
messaging would be available to Participants without additional costs.
In addition, since Participants have been aware of these forthcoming
changes, and any related operational impact on their systems, for
several years, DTC believes that, they have had sufficient time to
mitigate any implementation costs.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants, or Others

    Written comments relating to the proposed rule change have not been
solicited or received. DTC will notify the Commission of any written
comments received by DTC.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) \25\ of the Act and subparagraph (f)(4) of Rule 19b-4 \26\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \25\ 15 U.S.C. 78s(b)(3)(A).
    \26\ 17 CFR 240.19b-4(f)(4).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change, as modified by Amendment No. 1, is consistent with the Act.
Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-DTC-2016-2016-014 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-DTC-2016-014. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of DTC and on DTCC's
Web site (http://dtcc.com/legal/sec-rule-filings.aspx). All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-DTC-2016-014 and should be
submitted on or before February 1, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\27\
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    \27\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-00369 Filed 1-10-17; 8:45 am]
 BILLING CODE 8011-01-P