Table 1b. Acute Toxicity of Copper to Saltwater Animals Speciesa Age, Size, or Lifestage of Test Organism Test Methodb Chemicalc Salinity ( g/ kg) Reported LC50 or EC50d ( Total µ g/ L) Reported LC50 or EC50e ( Diss. µ g/ L) LC50 or EC50 Used in SMAV Calculationsf ( Diss. µ g/ L) SMAVg ( Diss.

µ g/ L) Reference Nematode, Caenorhabditis elegans 3 4 d S, U S 5.5 260  217.9 217.9 Williams & Dusenbery 1990 Polychaete worm,

Phyllodoce maculata  S, U S  120  100.6 100.6 McLusky & Phillips 1975 Polychaete worm, adult F, M, T N 31 77  69.99 136.9 Pesch & Morgan 1978 Neanthes arenaceodentata adult F, M, T N 31 200  181.8 Pesch & Morgan 1978  F, M, T N 31 222  201.8 Pesch & Hoffman 1982 Polychaete worm,  S, U S  200  167.6 318.3 Jones et al. 1976 Hediste diversicolor  S, U S  445  372.9 Jones et al. 1976  S, U S  480  402.2 Jones et al. 1976  S, U S  410  343.6 Jones et al. 1976 2.0 cm R, U N 7.3 357  299.2 Ozoh 1992a 2.0 cm R, U N 7.3 357  299.2 Ozoh 1992a 2.0 cm R, U N 7.3 247  207.0 Ozoh 1992a 2.0 cm R, U N 14.6 307  257.3 Ozoh 1992a 2.0 cm R, U N 14.6 400  335.2 Ozoh 1992a 2.0 cm R, U N 14.6 462  387.2 Ozoh 1992a 2.0 cm R, U N 21.9 375  314.3 Ozoh 1992a 2.0 cm R, U N 21.9 362  303.4 Ozoh 1992a 2.0 cm R, U N 21.9 480  402.2 Ozoh 1992a 2.0 cm R, U N 29.2 512  429.1 Ozoh 1992a 2.0 cm R, U N 29.2 360  301.7 Ozoh 1992a 2.0 cm R, U N 29.2 500  419.0 Ozoh 1992a mature R, U N 7.6 394  NU Ozoh 1992b mature R, U N 22.8 949  NU Ozoh 1992b mature R, U N 30.5 858  NU Ozoh 1992b mature R, U N 7.6 479  NU Ozoh 1992b mature R, U N 15.25 628  NU Ozoh 1992b mature R, U N 22.8 742  NU Ozoh 1992b mature R, U N 30.5 738  NU Ozoh 1992b mature R, U N 7.6 360  NU Ozoh 1992b mature R, U N 15.25 648  NU Ozoh 1992b mature R, U N 22.8 1,090  NU Ozoh 1992b mature R, U N 30.5 857  NU Ozoh 1992b Black abalone,

Haliotis cracherodii 6.2 17.0 cm S, U S 33 50  41.90 41.90 Martin et al. 1977 Red abalone, 17.3 20.4 cm S, U S 33 65  54.47 72.14 Martin et al. 1977 Haliotsis rufescens 48 h larva S, U S 30.4 114  95.53 Martin et al. 1977 36 Table 1b. Acute Toxicity of Copper to Saltwater Animals Speciesa Age, Size, or Lifestage of Test Organism Test Methodb Chemicalc Salinity ( g/ kg) Reported LC50 or EC50d ( Total µ g/ L) Reported LC50 or EC50e ( Diss. µ g/ L) LC50 or EC50 Used in SMAV Calculationsf ( Diss. µ g/ L) SMAVg ( Diss.

µ g/ L) Reference Mussel, embryo S, U S  5.8  NU 6.188 Martin et al. 1981 Mytilus spp. embryo S, U S 33 7.21  NU ToxScan 1991a embryo S, U S 32 6.4  NU ToxScan 1991b embryo S, U S 32 5.84  NU ToxScan 1991c embryo S, M, D S 27  5.787 5.787 ToxScan 1991a embryo S, M, D S 28  8.889 8.889 ToxScan 1991b embryo S, M, D S 26  6.278 6.278 ToxScan 1991c embryo S, M, D C 30  12.45 12.45 SAIC 1993 embryo S, M, D C 30  14.1 14.10 SAIC 1993 embryo S, M, D C 30  11.3 11.30 SAIC 1993 embryo S, M, D C 30  11.9 11.90 SAIC 1993 embryo S, M, T, D S 28 7.159 5.95 5.950 City of San Jose 1998 embryo S, M, T, D S 28 5.847 5.208 5.208 City of San Jose 1998 embryo S, M, T, D S 28 5.028 5.054 5.054 City of San Jose 1998 embryo S, M, T, D S 28 3.821 3.752 3.752 City of San Jose 1998 embryo S, M, T, D S 28 4.696 3.803 3.803 City of San Jose 1998 embryo S, M, T, D S 28 6.418 4.965 4.965 City of San Jose 1998 embryo S, M, T, D S 28 6.215 5.724 5.724 City of San Jose 1998 embryo S, M, T, D S 28 6.205 5.838 5.838 City of San Jose 1998 embryo S, M, T, D S 28 5.874 5.439 5.439 City of San Jose 1998 embryo S, M, T, D S 28 5.404 4.746 4.746 City of San Jose 1998 embryo S, M, T, D S 28 5.998 5.099 5.099 City of San Jose 1998 embryo S, M, T, D S 28 9.049 8.302 8.302 City of San Jose 1998 embryo S, M, T, D S 28 7.194 5.024 5.024 City of San Jose 1998 embryo S, M, T, D S 28 8.019 6.822 6.822 City of San Jose 1998 embryo S, M, T, D S 28 7.291 5.591 5.591 City of San Jose 1998 embryo S, M, T, D S 28 8.932 6.351 6.351 City of San Jose 1998 embryo S, M, T, D S 28 7.194 5.024 5.024 City of San Jose 1998 embryo S, M, T, D S 28 5.56 4.392 4.392 City of San Jose 1998 embryo S, M, T, D S 28 8.479 7.497 7.497 City of San Jose 1998 embryo S, M, T, D S 28 7.362 6.789 6.789 City of San Jose 1998 embryo S, M, T, D S 28 8.019 6.822 6.822 City of San Jose 1998 embryo S, M, T, D S 28 9.5 7.806 7.806 City of San Jose 1998 Blue mussel, < 4 hr embryo S, M, T, D S 20 17.46 17.83 17.830 21.497927 CH2MHill 1999b Mytilus edulis < 4 hr embryo S, M, T, D S 20 22.81 21.35 21.350 CH2MHill 1999b < 4 hr embryo S, M, T, D S 20 27.37 26.1 26.100 CH2MHill 1999b 1.58 cm R, U C 25 122  NU Nelson et al. 1988 Bay scallop,

Argopecten irradians 2.12 cm R, U C 25 29  24.30 24.30 Nelson et al. 1988 37 Table 1b. Acute Toxicity of Copper to Saltwater Animals Speciesa Age, Size, or Lifestage of Test Organism Test Methodb Chemicalc Salinity ( g/ kg) Reported LC50 or EC50d ( Total µ g/ L) Reported LC50 or EC50e ( Diss. µ g/ L) LC50 or EC50 Used in SMAV Calculationsf ( Diss. µ g/ L) SMAVg ( Diss.

µ g/ L) Reference Pacific oyster, embryo S, M, T C 30 12.06  10.963 10.96254 Harrison et al. 1981 Crassostrea gigas  S, U S  5.3  NU Martin et al. 1981 embryo S, U S 33 11.5  NU Coglianese & Martin 1981 13 17 cm adult F, M, T S 33 560  NU Okazaki 1976 Eastern oyster, embryo S, U C 26 15.1  12.65 14.488 MacInnes & Calabrese 1978 Crassostrea virginica embryo S, U C 26 18.7  15.67 MacInnes & Calabrese 1978 embryo S, U C 26 18.3  15.34 MacInnes & Calabrese 1978 Common rangia,  S, U  5.5 8,000  6,704 6,448 Olson & Harrel 1973 Rangia cuneata  S, U  22 7,400  6,201 Olson & Harrel 1973 Surf clam,

Spisula solidissima 1.59 cm R, U C 25 51  42.74 42.74 Nelson et al. 1988 Soft shell clam,

Mya arenaria  S, U C 30 39  32.68 32.68 Eisler 1977 Coot clam,  S, M, D C 30  21 21.00 17.69 SAIC 1993 Mulina lateralis  S, M, D C 30  19.25 19.25 SAIC 1993  S, M, D C 30  14.93 14.93 SAIC 1993  S, M, D C 30  17.28 17.28 SAIC 1993  S, M, D C 30  16.85 16.85 SAIC 1993  S, M, D C 30  17.44 17.44 SAIC 1993 Squid,

Loligo opalescens larva S, M, T C 30 309  280.9 280.9 Dinnel et al. 1989 Copepod, Pseudodiaptomus coronatus  S, U C 30 235.4  197.3 197.3 Gentile 1982 Copepod,  S, U C 30 928  NU 25.83 Gentile 1982 Eurytemora affinis 24 h R, M, T   30.6  27.82 Sullivan et al. 1983 24 h R, M, T   31.1  28.27 Sullivan et al. 1983 24 h R, M, T   28.7  26.09 Sullivan et al. 1983 24 h R, M, T   7.5  6.818 Sullivan et al. 1983 24 h R, M, T   33.7  30.63 Sullivan et al. 1983 24 h S, M, D C 15 16  69.4 69.40 Hall et al. 1997 Copepod,

Acartia clausi  S, U C 30 48.8  40.89 40.89 Gentile 1982 Copepod,  S, U C 10 17  14.25 25.74 Sosnowski & Gentile 1978 Acartia tonsa  S, U C 10 55  46.09 Sosnowski & Gentile 1978  S, U C 30 31  25.98 Sosnowski & Gentile 1978 Copepod, egg R, U N 35 229  191.9 196.2 O'Brien et al. 1988 Tigriopus californicus 1st nauplius R, U N 35 76  63.69 O'Brien et al. 1988 2nd nauplius R, U N 35 19  15.92 O'Brien et al. 1988 3rd nauplius R, U N 35 159  133.2 O'Brien et al. 1988 4th nauplius R, U N 35 184  154.2 O'Brien et al. 1988 38 Table 1b. Acute Toxicity of Copper to Saltwater Animals Speciesa Age, Size, or Lifestage of Test Organism Test Methodb Chemicalc Salinity ( g/ kg) Reported LC50 or EC50d ( Total µ g/ L) Reported LC50 or EC50e ( Diss. µ g/ L) LC50 or EC50 Used in SMAV Calculationsf ( Diss. µ g/ L) SMAVg ( Diss.

µ g/ L) Reference 5th nauplius R, U N 35 261  218.7 O'Brien et al. 1988 6th nauplius R, U N 35 305  255.6 O'Brien et al. 1988 1st copepodite R, U N 35 375  314.3 O'Brien et al. 1988 2nd copepodite R, U N 35 496  415.6 O'Brien et al. 1988 3rd copepodite R, U N 35 413  346.1 O'Brien et al. 1988 4th copepodite R, U N 35 394  330.2 O'Brien et al. 1988 5th copepodite R, U N 35 394  330.2 O'Brien et al. 1988 6th copepodite R, U N 35 762  638.6 O'Brien et al. 1988 Copepod,

Tigriopus furcata < 24 h R, M, D S   178 178.0 178.0 Bechmann 1994 Mysid, Holmesimysis costata 3 d S, M, T C 35 38 17  15.45 15.45 Martin et al. 1989 Mysid, 24 h R, U C 25 153  NU 164.529 Cripe 1994 Americamysis bahia 24 h F, M, T N 30 181  164.5 Lussier et al. 1985; Gentile 1982 Mysid, Americamysis bigelowi 24 h F, M, T N 30 141  128.2 128.2 Gentile 1982 Mysid, < 5 d F, M, T S 2 71  64.54 123.4 Brandt et al. 1993 Neomysis mercedis > 15 d F, M, T S 2 220  200.0 Brandt et al. 1993 > 15 d F, M, T S 2 160  145.4 Brandt et al. 1993 Amphipod, Corophium insidiosum 0.8 1.2 cm S, U C  600  502.8 502.8 Reish 1993 Amphipod, Elasmopus bampo 0.8 1.2 cm S, U C  250  209.5 209.5 Reish 1993 Sand shrimp,

Crangon spp. 6.1 cm adult F, M, T C 30.1 898  816.3 816.3 Dinnel et al. 1989 American lobster,

Homarus americanus 24 h larva S, U N 30.5 48  40.22 40.22 Johnson & Gentile 1979 Dungeness crab, larva S, U S  49  41.06 41.06 Martin et al. 1981 Cancer magister zooea S, M, T C 30 96  NU Dinnel et al. 1989 Green crab,

Carcinus maenas larva S, U S  600  502.8 502.8 Connor 1972 Sea urchin,

Arbacia punctulata embryo S, M, D C 30  21.4 21.4 21.4 SAIC 1993 Sea urchin, embryo S, M, T S 28 13.4  12.18 12.81 City of San Jose 1998 Strongylocentrotus S, M, T, D S 28 14.383 13.515 13.52 City of San Jose 1998 purpuratus S, M, T, D S 28 15.048 12.765 12.77 City of San Jose 1998 Coho salmon, Oncorhynchus kisutch smolt F, M, T C 28.6 601  546.3 546.3 Dinnel et al. 1989 Mangrove rivulus, 4 6 wks F, M, D S 14  1,250 1,250 1,419 Lin & Dunson 1993 Rivulus marmoratus 4 6 wks F, M, D S 14  1610 1,610 Lin & Dunson 1993 39 Table 1b. Acute Toxicity of Copper to Saltwater Animals Speciesa Age, Size, or Lifestage of Test Organism Test Methodb Chemicalc Salinity ( g/ kg) Reported LC50 or EC50d ( Total µ g/ L) Reported LC50 or EC50e ( Diss. µ g/ L) LC50 or EC50 Used in SMAV Calculationsf ( Diss. µ g/ L) SMAVg ( Diss.

µ g/ L) Reference Sheepshead minnow,

Cyprinodon variegatus  R, M, T C or S 30 368  334.5 334.5 Hughes et al. 1989 Killifish,  S, U C 5.5 3,100  NU 1,690 Dorfman 1977 Fundulus heteroclitus  S, U C 23.6 2,000  NU Dorfman 1977  S, U C 6.1 2,300  NU Dorfman 1977  S, U C 24 400  NU Dorfman 1977 4 6 wks F, M, D S 14  1,690 1,690 Lin & Dunson 1993 Topsmelt, 8 d larva S, M, T C 33 288  261.8 220.9 Anderson et al. 1991 Atherinops affinis 8 d larva S, M, T C 33 212  192.7 Anderson et al. 1991 8 d larva S, M, T C 33 235  213.6 Anderson et al. 1991 Inland silverside,  S, M, D S   115.4 115.4 111.1 ToxScan 1991a Menidia beryllina  S, M, D S   96.5 96.50 ToxScan 1991b  S, M, D S   123 123.0 ToxScan 1991c Atlantic silverside, 3 wk larva F, M, T N 31 66.6  60.54 123.3 Cardin 1982 Menidia menidia 1 wk larva F, M, T N 30.4 216.5  196.8 Cardin 1982 1 d larva F, M, T N 30.4 101.8  92.54 Cardin 1982 3 d larva F, M, T N 31 97.6  88.72 Cardin 1982 2 wk larva F, M, T N 30 155.9  141.7 Cardin 1982 1 d larva F, M, T N 30 197.6  179.6 Cardin 1982 juvenile F, M, T N 30 190.9  173.5 Cardin 1982 Tidewater silverside,

Menidia peninsulae 19 d larva S, U N 20 140  117.3 117.3 Hansen 1983 Striped bass, 1 2 mo S, U S 5 2,680  2,246 4648.0 Reardon & Harrell 1990 Morone saxatilis 1 2 mo S, U S 10 8,080  6,771 Reardon & Harrell 1990 1 2 mo S, U S 15 7,880  6,603 Reardon & Harrell 1990 Florida pompano,  S, U S 10 360  301.7 345.0 Birdsong & Avavit 1971 Trachinotus carolinus  S, U S 20 380  318.4 Birdsong & Avavit 1971  S, U S 30 510  427.4 Birdsong & Avavit 1971 Sheepshead,

Archosargus probatocephalus 18 21 cm S, U C 30 1,140  955.3 955.3 Steele 1983a Pinfish, Langodon rhomboides 13 17 cm S, U C 30 2,750  2,305 2,305 Steele 1983a Spot, Leiostomus xanthurus adult S, U N 20 280  234.6 234.6 Hansen 1983 Atlantic croaker,

Micropogon undulatus 16 19 cm S, U C 30 5,660  4,743 4,743 Steele 1983a Cabezon, Scorpaenichthys marmoratus larva S, M, T C 27 95  86.36 86.36 Dinnel et al. 1989 Shiner perch, Cymatogaster aggregata 9.7 cm adult F, M, T C 29.5 418  380.0 380.0 Dinnel et al. 1989 40 Table 1b. Acute Toxicity of Copper to Saltwater Animals Speciesa Age, Size, or Lifestage of Test Organism Test Methodb Chemicalc Salinity ( g/ kg) Reported LC50 or EC50d ( Total µ g/ L) Reported LC50 or EC50e ( Diss. µ g/ L) LC50 or EC50 Used in SMAV Calculationsf ( Diss. µ g/ L) SMAVg ( Diss.

µ g/ L) Reference Summer flounder,

Paralichthys dentatus 46 d, 1.8 2.2 cm, 0.03

0.05 g S, M, T, D S 22 610 586 NU 12.66 CH2MHill 1999a 48 d, 2.0 2.4 cm, 0.04

0.08 g S, M, T, D S 22 1,029 928 NU CH2MHill 1999a 57 d, 2.4 2.8 cm, 0.07

0.12 g S, M, T, D S 22 606 597 NU CH2MHill 1999a early cleavage embryo F, M, T N 30 16.3  14.82 Cardin 1982 early cleavage embryo F, M, T N 30 11.9  10.82 Cardin 1982 blastula stage embryo F, M, T N 30 111.8  NU Cardin 1982 blastula stage embryo F, M, T N 30 77.5  NU Cardin 1982 Winter flounder, blastula F, M, T N 30 167.3  152.1 124.9 Cardin 1982 Pseudopleuronectes american pre cleavage zygote F, M, T N 30 52.7  47.90 Cardin 1982 blastula F, M, T N 28 158  143.6 Cardin 1982 blastula F, M, T N 30 173.7  157.9 Cardin 1982 pre cleavage zygote F, M, T N 28 271  246.3 Cardin 1982 pre cleavage zygote F, M, T N 30 132.8  120.7 Cardin 1982 blastula F, M, T N 30 148.2  134.7 Cardin 1982 early cleavage embryo F, M, T N 30 98.2  89.26 Cardin 1982 aSpecies appear in order taxonomically, with invertebrates listed first and fish listed last. Species within each genus are ordered alphabetically. Within each species, tests are ordered by test method ( static, renewal, flow through) and date.

bS = static, R = renewal, F = flow through, U = unmeasured, M = measured, T = exposure concentrations were measured as total copper, D = exposure concentrations were measured as dissolved copper cS = copper sulfate, N = copper nitrate, C = copper chloride dValues in this column are total copper LC50 or EC50 values as reported by the author.

eValues in this column are dissolved copper LC50 or EC50 values as reported by the author.

fIf author did not report a dissolved copper LC50 value, then a conversion factor ( CF) was applied to the total copper LC50 to estimate dissolved copper values. For tests in which copper was not measured, the total copper LC50 was multiplied by a CF of 0.838, and for tests in which copper concentrations were measured, the total copper LC50 was multiplied by a CF of 0.909 see discussion in Section 4 and Appendix E). ' NU' indicates that a test result was not used in the SMAV calculation, typically because data for a more sensitive life stage were used preferentially.

gThe species mean acute value ( SMAV) is calculated as the geometric mean of the tabulated LC50 or EC50 values for each species ( Stephan et al. 1985).

41 Table 3b. Ranked Saltwater Genus Mean Acute Values with Species Mean Acute Chronic Ratios GMAV Rank GMAV ( µ g/ L) Species SMAV ( µ g/ L) ACR 44 6,448 Common rangia, Rangia cuneata 6,448 43 4,743 Atlantic croaker, Micropogon undulatus 4,743 42 4,648 Striped bass, Morone saxatilis 4,648 41 2,305 Pinfish, Langodon rhomboides 2,305 40 1,690 Killifish, Fundulus heteroclitus 1,690 39 1,419 Mangrove rivulus, Rivulus marmoratus 1,419 38 955.3 Sheepshead, Archosargus probatocephalus 955.3 37 816.3 Sand shrimp, Crangon spp. 816.3 36 546.3 Coho salmon, Oncorhynchus kisutch 546.3 35 502.8 Green crab, Carcinus maenas 502.8 34 502.8 Amphipod, Corophium insidiosum 502.8 33 380.0 Shiner perch, Cymatogaster aggregata 380.0 32 345.0 Florida pompano, Trachinotus carolinus 345.0 31 334.5 Sheepshead minnow, Cyprinodon variegatus 334.5 1.48 30 318.3 Polychaete worm, Hediste diversicolor 318.3 29 280.9 Squid, Loligo opalescens 280.9 28 234.6 Spot, Leiostomus xanthurus 234.6 27 220.9 Topsmelt, Atherinops affinis 220.9 26 217.9 Nematode, Caenorhabditis elegans 217.9 25 209.5 Amphipod, Elasmopus bampo 209.5 24 197.3 Copepod, Pseudodiaptomus coronatus 197.3 23 186.9 Copepod, Tigriopus furcata 178.0 Copepod, Tigriopus californicus 196.2 22 145.2 Mysid, Americamysis bahia 164.5 Mysid, Mysidopsis bigelowi 128.2 21 136.9 Polychaete worm, Neanthes arenaceodentata 136.9 20 124.9 Winter flounder, Pseudopleuronectes americanus 124.9 19 123.4 Mysid, Neomysis mercedis 123.4 18 117.1 Tidewater silverside, Menidia peninsulae 117.3 Atlantic silverside, Menidia menidia 123.3 Inland silverside, Menidia beryllina 111.1 17 100.6 Polychaete worm, Phyllodoce maculata 100.6 16 86.4 Cabezon, Scorpaenichthys marmoratus 86.36 15 54.98 Black abalone, Haliotis cracherodii 41.90 Red abalone, Haliotsis rufescens 72.14 14 42.74 Surf clam, Spisula solidissima 42.74 13 41.06 Dungeness crab, Cancer magister 41.06 12 40.22 American lobster, Homarus americanus 40.22 11 32.68 Soft shell clam, Mya arenaria 32.68 47 Table 3b. Ranked Saltwater Genus Mean Acute Values with Species Mean Acute Chronic Ratios GMAV Rank GMAV ( µ g/ L) Species SMAV ( µ g/ L) ACR 10 32.45 Copepod, Acartia tonsa 25.74 Copepod, Acartia clausi 40.89 9 25.83 Copepod, Eurytemora affinis 25.83 8 24.30 Bay scallop, Argopecten irradians 24.30 7 21.40 Sea urchin, Arbacia punctulata 21.40 6 17.69 Coot clam, Mulina lateralis 17.69 5 15.45 Mysid, Holmesimysis costata 15.45 4 12.81 Sea urchin, Strongylocentrotus purpuratus 12.81 3 12.66 Summer flounder, Paralichthys dentatus 12.66 2 12.60 Eastern oyster, Crassostrea virginica 14.49 Pacific oyster, Crassostrea gigas 10.96 1 11.53 Blue mussel, Mytilus edulis 21.50 Mussel, Mytilus sp. 6.19 48


[Federal Register Volume 81, Number 11 (Tuesday, January 19, 2016)]
[Notices]
[Page 2856]
[FR Doc No: 2016-00816]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER16-711-000]

Pio Pico Energy Center, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Pio Pico Energy Center, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is February 1, 2016.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
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email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
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    Dated: January 12, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-00816 Filed 1-15-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 88 (Wednesday, May 7, 2014)]
[Notices]
[Pages 26252-26255]
[FR Doc No: 2014-10414]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0539]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Prescription Drug Labeling Improvement and Enhancement
Initiative

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection for the Prescription
Drug Labeling Improvement and Enhancement Initiative (the initiative);
specifically, information collection associated with the use of
Government contractor-assisted labeling conversion resources and
services for certain older drug and biological products (approved
before June 30, 2001). The intent of the initiative is to enhance the
safe and effective use of prescription drugs by facilitating optimal
communication through labeling.

DATES: Submit either electronic or written comments on the collection
of information by July 7, 2014.

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

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Prescription Drug Labeling Improvement and Enhancement Initiative--(OMB
Control Number 0910--NEW)

    In the Federal Register of January 24, 2006 (71 FR 3922), FDA
published the final rule ``Requirements on Content and Format of
Labeling for Human Prescription Drug and Biological Products,'' which
revised the content and format requirements to make labeling easier to
access, read, and use. This final rule is commonly referred to as the
physician labeling rule (PLR) because it addresses prescription drug
labeling used by prescribers, including physicians and other health
care practitioners.\1\
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    \1\ In this Federal Register document, the term ``PLR format''
refers to labeling that meets the content and format requirements in
Sec. Sec.  201.56(d) and 201.57 (21 CFR 201.56(d) and 201.57).
---------------------------------------------------------------------------

    The PLR applies to products for which a new drug application (NDA),
biologics license application (BLA), or efficacy supplement (ES) to an
NDA or BLA was approved between June 30, 2001, and June 30, 2006; was
pending on June 30, 2006; or was submitted after June 30, 2006. Older
drug and biological products (approved before June 30, 2001) are not
subject to the mandatory PLR conversion requirements, but the NDA or
BLA holder may voluntarily convert the labeling to PLR format. If
application holders have not voluntarily converted labeling to PLR
format, labeling for older drug and biological products must be in
compliance with the requirements under 21 CFR 201.56(e) and 201.80.
    The PLR established a staggered implementation schedule under which
cohorts of drugs, from newest to oldest, would be converted to the PLR
labeling format over time.\2\ The staggered implementation for
conversion to PLR format expired on June 30, 2013.\3\ As of November
2013, approximately 15 percent of all prescription drugs and biological
products have labeling in the PLR format.\4\ If no further action is
taken, the only additional drug products with labeling in the PLR
format will be new NDAs, BLAs, and ESs, which are required to be
submitted in PLR format, and labeling for older drug products for which
the NDA or BLA holder voluntarily converts to PLR format.
---------------------------------------------------------------------------

    \2\ See Sec.  201.56(c). The Agency adopted this approach
because research conducted during the PLR's development indicated
that this was the ``most reasonable approach to maximizing the
public health benefit and best utilizing available resources.'' See
71 FR 3922 at 3962, January 24, 2006.
    \3\ For the last cohort of drugs approved from June 30, 2001, to
June 29, 2002, applicants were required to submit PLR conversion
supplements to FDA by June 30, 2013.
    \4\ Data obtained from http://labels.fda.gov.
---------------------------------------------------------------------------

    To address this issue, FDA proposed the Prescription Drug Labeling
Improvement and Enhancement Initiative in the Federal Register of
February 6, 2013 (78 FR 8446), and solicited public comments.
Specifically, FDA sought feedback on various issues related to the
feasibility and implementation of the initiative, including the
following:
     Approaches for identifying and prioritizing drugs and/or
drug classes for voluntary PLR conversions;
     approaches that application holders would find helpful in
facilitating voluntary PLR conversions for the specified drugs or drug
classes;
     approaches for harmonizing labeling for generic drugs for
which approval of the NDA for the reference listed drug (RLD) has been
withdrawn;
     use of a Government contractor to provide PLR conversion
resources and services; and
     overall interest in participating in the initiative.
    In general, public comments posted to the docket (Docket No. FDA-
2013-N-0059) supported the initiative, including the use of a
Government contractor to ease the resource burden on application
holders and to facilitate conversion to the PLR format. Some comments
stated that having FDA (through a Government contractor) facilitate
conversion of labeling to PLR format for the application holder may:
(1) Allow for greater clarity and a better understanding of FDA's
expectations, (2) result in a more efficient review process, and (3)
expedite the availability of labeling in the PLR format. Thus, as part
of the initiative, FDA intends to provide PLR conversion resources and
services, including preparation of draft PLR format labeling, through
the use of a Government contractor. For this part of the initiative, in
a phased approach over 5 years, FDA proposes to identify and prioritize
for PLR conversion approximately 750 prescription drug products not
subject to the mandatory requirements under Sec. Sec.  201.56(d) and
201.57 based on criteria that would maximize the benefit to the public
health, including volume of prescriptions, clinical relevance, and
risk-based considerations. This part of the initiative includes the
following two collections of information: (1) The application holder's
submission of its proposed PLR format labeling to FDA in a supplement
to its application for products identified by FDA for the initiative
and (2) the abbreviated new drug application (ANDA) holder's submission
of a labeling supplement to

FDA with conforming revisions for generic drug products affected by
FDA's approval of a labeling change for the corresponding RLD.

Submitting a Supplement to FDA for the Proposed PLR Format Labeling

    FDA will identify labeling to be converted to PLR based on the
criteria established and, as recommended in comments submitted to the
public docket, FDA will send an inquiry letter to the respective
application holders to request their voluntary participation in this
part of the initiative. The request will include information about the
initiative, the labeling identified for PLR conversion, and a request
for participation. FDA intends to provide Government contractor-
assisted PLR conversion resources and services to application holders
who participate. FDA will review the draft PLR format labeling prepared
by the contractor for content and format, and send a draft version to
the application holder for review. FDA will request that the
application holder review the draft labeling and submit a supplement to
its application to FDA with its proposed PLR format labeling, which may
include proposed revisions to the draft labeling. It should be
emphasized that the application holder always bears responsibility for
the content of its product labeling, and FDA's provision of contract
resources is intended to facilitate conversion to the PLR format.

Submitting a Labeling Supplement to FDA for Generic Drug Products
Affected by the RLD Labeling Change

    After FDA approves a supplement to an NDA as a result of this part
of the initiative, ANDA holders that relied on the NDA as their RLD
will be required to revise the generic drug product labeling so that it
conforms to the approved PLR-converted labeling of the RLD (see 21 CFR
314.94(a)(8)(iv) and 314.150(b)(10)). The guidance for industry
entitled ``Revising ANDA Labeling Following Revision of the RLD
Labeling'' provides information to ANDA holders on how to submit
conforming labeling changes as a Special Supplement--Changes Being
Effected.\5\
---------------------------------------------------------------------------

    \5\ This guidance is available on the Internet at http://www.fda.gov//Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm under Guidances (Drugs).
---------------------------------------------------------------------------

    Description of Respondents: The respondents to this collection of
information are persons and businesses, including small businesses and
manufacturers.
    Burden Estimates: FDA currently has OMB approval for the submission
of labeling supplements under 21 CFR 314.70 and 314.97 (OMB control
number 0910-0001) and approval for the design, testing, and production
of prescription drug labeling under Sec. Sec.  201.56 and 201.57 (OMB
control number 0910-0572). This notice provides burden estimates
associated with submitting additional labeling supplements as a result
of this initiative.
    Table 1 of this document provides an estimate of the reporting
burden for: (1) Submitting a supplement to FDA for the proposed PLR
format labeling and (2) submitting a labeling supplement to FDA for
generic drug products affected by an FDA-approved change to the RLD
labeling. In table 1, the estimated averages for the number of
respondents and the hours per response were obtained using the
collections of information described in the PLR (71 FR 3922, January
24, 2006).

Submitting a Supplement to FDA for the Proposed PLR Format

    Based on the labeling conversion of approximately 750 prescription
drug products not subject to the mandatory requirements under
Sec. Sec.  201.56 and 201.57, we estimate that 375 application holders
will be contacted for voluntary participation in this part of the
initiative, which is intended to occur in a phased approach over 5
years. Some application holders may receive more than one request to
participate based on the process to identify and prioritize labeling.
    The hours per response is the estimated number of hours an
application holder would spend reviewing and responding to the request
to participate, reviewing the draft PLR format labeling, modifying the
labeling as appropriate, and submitting a supplement to FDA. We
estimate that approximately 196 hours on average would be needed per
submission, totaling 147,000 hours (see row 1 of table 1).

Submitting a Labeling Supplement to FDA for Generic Drug Products
Affected by the RLD Labeling Change

    FDA estimates that 1,864 generic drug products \6\ will require
labeling supplements from approximately 233 application holders, based
on approved PLR-converted RLD labeling from this part of the
initiative. The hours per response is the estimated number of hours a
generic drug application holder would spend revising the ANDA labeling
so that it conforms to the PLR-converted RLD labeling and submitting a
labeling supplement to FDA. We estimate that approximately 27 hours on
average would be needed per submission, totaling 50,328 hours (see row
2 of table 1).
---------------------------------------------------------------------------

    \6\ Estimate based on the ratio of ANDA to NDA labeling in
http://labels.fda.gov.
---------------------------------------------------------------------------

Capital Costs

    In 2006, the PLR described that a small number of carton-enclosed
products may require new packaging to accommodate longer inserts for
labeling in PLR format (71 FR 3922 at 3966). The PLR indicates that up
to 5 percent of existing products affected by the rule may require
equipment changes at an estimated cost of $200,000 for each product.
Because the PLR has been in effect since 2006, we estimate that
equipment changes may only be required for up to 1 percent of existing
products that may be involved with this initiative. Therefore, we
estimate that approximately 26 existing products could incur capital
costs as a result of participating in the initiative, at a current cost
of $245,400 per product. The estimated cost of changes to equipment
totals $6.4 million.
    In 2006, the PLR also estimated $8,700 as the average cost to a
firm to: (1) Redesign the labeling of an existing drug (e.g., drug-
specific decisions regarding exactly which adverse reactions should be
listed in the highlights section), (2) test the redesigned labeling
(e.g., to ensure that the larger labeling will still fit in carton-
enclosed products), and (3) prepare and submit the labeling to FDA for
approval. The PLR estimated $6,190 as the average cost to design
labeling for new applications and efficacy supplements (71 FR 3922 at
3978). Thus, the 2006 estimated average cost to test the redesigned
labeling and to prepare and submit the labeling to FDA for approval is
calculated as $2,510 ($8,700 minus $6,190). For this part of the
initiative, the Government contractor will provide a draft redesign of
the labeling for application holders. Therefore, we estimate that
approximately 608 application holders could incur capital costs as a
result of participating in the initiative, at a current cost of $2,952
per product. The estimated cost of testing, preparing, and submitting
the labeling to FDA for approval totals $7.7 million.

Operating and Maintenance Costs

    In 2006, the PLR described that manufacturers may incur incremental
printing costs because the content and format requirements of the final
rule will lengthen labeling (71 FR 3922 at 3979). The PLR estimated
that the annual per-product cost for innovator and generic products was
$1,165 and $700, respectively. For this initiative,

we estimate the current annual per-product cost for innovator and
generic products as $1,429 and $859, respectively. Therefore, we
estimate that the total incremental printing costs for innovator and
generic products are approximately $1.1 million and $1.6 million,
respectively, over the 5-year period of the program.
    FDA estimates the burden of this collection of information as
follows:

                                               Table 1--Estimated Reporting Burden Over a 5-Year Period 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Total
                                                             Number of                    Average burden                   Total capital   operating and
 Prescription drug labeling improvement      Number of     responses per       Total       per response     Total hours        costs        maintenance
       and enhancement initiative           respondents     respondent       responses        (hours)                       ($million)         costs
                                                                                ($million)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitting a supplement to FDA for the               375               2             750             196         147,000            $4.0            $1.1
 proposed PLR format labeling...........
Submitting a labeling supplement to FDA              233               8           1,864              27          50,328            10.1             1.6
 for generic drug products affected by
 the RLD labeling change................
                                         ---------------------------------------------------------------------------------------------------------------
    Total...............................  ..............  ..............  ..............  ..............         197,328            14.1             2.7
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Numbers may not sum due to rounding.

    Dated: May 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-10414 Filed 5-6-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 75 (Thursday, April 20, 2017)]
[Rules and Regulations]
[Pages 18574-18580]
[FR Doc No: 2017-07816]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0087; FRL-9959-54]

Deltamethrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
deltamethrin in or on orange; citrus, dried pulp; citrus, oil. Bayer
CropScience requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 20, 2017. Objections and
requests for hearings must be received on or before June 19, 2017, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2016-0087, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP
test guidelines referenced in this document electronically, please go
to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2016-0087 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
June 19, 2017. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your

objection or hearing request, identified by docket ID number EPA-HQ-
OPP-2016-0087, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of October 18, 2016 (81 FR 71668) (FRL-
9952-19), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
5E8431) by Bayer CropScience, 2 T.W. Alexander Dr., Research Triangle
Park, NC. The petition requested that 40 CFR 180.435 be amended by
establishing tolerances for residues of the insecticide deltamethrin,
(S)-cyano(3-phenoxyphenyl)methyl (1R,3R)-3-(2,2-dibromoethenyl)-2,2-
dimethylcyclopropanecarboxylate, in or on orange, fruit at 0.3 parts
per million (ppm); orange, dried pulp at 3 ppm; orange, oil at 50 ppm.
That document referenced a summary of the petition prepared by Bayer
CropScience, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
    Based upon review of the data supporting the petition, EPA has
revised the commodity definitions and tolerances as follows: ``Orange
fruit'' proposed at 0.3 ppm shall be ``Orange'' at 0.30 ppm; ``Orange
Dried Pulp'' at 3 ppm shall be ``Citrus, dried pulp'' at 3.0 ppm; and
``Orange Oil'' at 50 ppm shall be ``Citrus, oil'' at 50 ppm. The reason
for these changes is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
. .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for deltamethrin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with deltamethrin follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Deltamethrin is classified as a Type II pyrethroid. Type II
pyrethroids include an alpha-cyano moiety and induce a syndrome that
includes pawing, burrowing, salivation, hypothermia, and coarse tremors
leading to choreoathetosis. Neurotoxicity was observed throughout the
database, and clinical signs characteristic of Type II pyrethroids,
such as increased salivation, altered mobility/gait, and tremors, were
the most common effects observed. Other observed neurotoxic effects
included increased sensitivity to external stimuli, abnormal
vocalization, and decreased fore- and hind-limb grip strength.
    Chronic exposure does not result in accumulation or increased
potency as a result of deltamethrin's rapid absorption, metabolism, and
elimination. No observed adverse effect levels (NOAELs) for the acute
and chronic studies are similar, and the acute endpoint is protective
of the endpoints from repeat-dose studies. Only single-day risk
assessments need to be conducted for purposes of endpoint selection and
exposure assessment.
    There were no indications of fetal toxicity in any of the guideline
studies. Evidence of increased juvenile qualitative sensitivity was
observed in the developmental neurotoxicity and 2-generation
reproduction studies. However, the observations of increased
sensitivity were at doses that were considered to be relatively high
(i.e., near lethal doses), whereas at doses near the point of
departure, no effects on parental animals or offspring were observed in
either the developmental neurotoxicity (DNT) or 2-generation
reproduction study and, therefore, there is no susceptibility at these
doses.
    Deltamethrin is classified as ``not likely to be carcinogenic to
humans.'' There was no evidence of carcinogenicity in either the rat or
mouse long-term dietary studies up to the highest dose tested, nor was
there any mutagenic activity in bacteria or cultured mammalian cells.
    Specific information on the studies received and the nature of the
adverse effects caused by deltamethrin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Deltamethrin: Human Health Risk
Assessment for the Proposed Use of Deltamethrin on Oranges Without a
U.S. Registration at page 24 in docket ID number EPA-HQ-OPP-2016-0087.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a

reference dose (RfD)--and a safe margin of exposure (MOE). For non-
threshold risks, the Agency assumes that any amount of exposure will
lead to some degree of risk. Thus, the Agency estimates risk in terms
of the probability of an occurrence of the adverse effect expected in a
lifetime. For more information on the general principles EPA uses in
risk characterization and a complete description of the risk assessment
process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for deltamethrin used for
human risk assessment is shown in the Table of this unit.

  Table--Summary of Toxicological Doses and Endpoints for Deltamethrin for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                  Uncertainty/   RfD, PAD, level
      Exposure scenario            Point of       FQPA safety     of concern for      Study and toxicological
                                  departure         factors      risk assessment              effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (>=6 years old)  Wolansky         UFA = 10X......  Acute RfD =      Wolansky BMD1SD = 2.48 mg/kg
                                BMDL1SD = 1.49  UFH = 10X......   0.015 mg/kg.     based on decreased motor
                                mg/kg.          FQPA SF = 1X...  aPAD = 0.015 mg/  activity.
                                                                  kg/day.
Acute Dietary (<6 years old).  Wolansky         UFA = 10X......  Acute RfD =      Wolansky BMD1SD = 2.48 mg/kg
                                BMDL1SD = 1.49  UFH = 10X......   0.015 mg/kg.     based on decreased motor
                                mg/kg.          FQPA SF = 3X...  aPAD = 0.005 mg/  activity.
                                                                  kg/day.
                              ----------------------------------------------------------------------------------
Chronic dietary (All           A chronic endpoint is not necessary since increased toxicity is not observed with
 populations).                  repeated dosing. The acute endpoint and doses are protective of longer-term
                                exposure and risk.
                              ----------------------------------------------------------------------------------
Incidental Oral (Short-term).  Wolansky         UFA = 10X......  Residential LOC  Wolansky BMD1SD = 2.48 mg/kg
                                BMDL1SD = 1.49  UFH = 10X......   for MOE = 300.   based on decreased motor
                                mg/kg.          FQPA SF = 3X...                    activity.
                              ----------------------------------------------------------------------------------
Dermal (short-term; all        A dermal assessment was not conducted based on the lack of effects in a 21-day
 populations).                  dermal study and low potential for dermal absorption for deltamethrin.
                              ----------------------------------------------------------------------------------
* Inhalation (Short-term; >=6  Wolansky         UFA = 10X......  Residential LOC  Wolansky BMD1SD = 2.48 mg/kg
 years old).                    BMDL1SD = 1.49  UFH = 10X......   for MOE = 100.  based on decreased motor
                                mg/kg.          FQPA SF = 1X...                    activity.
* Inhalation (Short-term; <6   Wolansky         UFA = 10X......  Residential LOC  Wolansky BMD1SD = 2.48 mg/kg
 years old).                    BMDL1SD = 1.49  UFH = 10X......   for MOE = 300.   based on decreased motor
                                mg/kg.          FQPA SF = 3X...                    activity.
                              ----------------------------------------------------------------------------------
Cancer (oral, dermal,          Classification: ``Not likely to be Carcinogenic to Humans'' based on the absence
 inhalation).                   of treatment related tumors in two adequate rodent carcinogenicity studies.
----------------------------------------------------------------------------------------------------------------
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). RfD = reference dose. MOE = margin of exposure. LOC =
  level of concern. * Inhalation absorption is assumed to be equivalent to oral absorption. BMD1SD = The central
  estimate of the dose that results in decreased motor activity compared to control animals based upon a 1
  standard deviation using Benchmark Dose Analysis. BMDL1SD = The 95% lower confidence limit of the central
  estimate. Wolansky = Reference to Wolansky et al. Acute Oral Toxicity in Rats, MRID #47885701.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to deltamethrin, EPA considered exposure under the petitioned-
for tolerances as well as all existing deltamethrin tolerances in 40
CFR 180.435. EPA assessed dietary exposures from deltamethrin in food
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for deltamethrin. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) 2003-2008 National Health and
Nutrition Examination Surveys, What We Eat in America (NHANES/WWEIA).
As to residue levels in food, EPA acute dietary exposure is partially
refined. Residues could result from agricultural uses and adulticide
uses. Excluding the new orange tolerances, residue-level and percent
crop treated assumptions have not changed since the previous rule, and
those are discussed in the final rule published in the Federal Register
of March 27, 2015 (80 FR 16296). For oranges, EPA used field trial
values and the empirical processing factors for orange juice and citrus
oil. In addition, HED used a percent crop treated estimate of 9%.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the Dietary Exposure
Evaluation Model software with the Food Commodity Intake Database
(DEEM-FCID) Version 3.16. This software uses 2003-2008 food consumption
data from the USDA's NHANES/WWEIA. Although a chronic dietary endpoint
was not identified for deltamethrin, a chronic dietary exposure
assessment was performed to provide background exposure for aggregation
with short-term residential exposure. Residues could result from three
different sources: Agricultural uses, food handling establishment uses,
and adulticide uses. Assumptions about residue levels in food and
percent crop treated for crops

except for oranges have not changed since the previous rule and are
explained in the final rule published in the Federal Register of March
27, 2015 (80 FR 16296). For oranges, EPA used average field trial
values and assumed 100% of imported oranges are treated with
deltamethrin.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that deltamethrin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency estimated the PCT for acute exposure for existing uses
as follows:
    Apples: 2.5%; cantaloupes: 2.5%, carrots: 2.5%, cucumbers: 5%,
pears: 5%, soybeans: 2.5%, tomatoes: 2.5%, watermelons: 2.5%.
    The Agency estimated the PCT for chronic exposure for existing uses
as follows:
    Almonds: 1%; apples: 1%; globe artichokes: 40%; canola: 5%;
cantaloupes: 1%; carrots: 1%; cotton: 1%; cucumbers: 2.5%; leeks: 2.5%;
onions: 2.5%; pears: 2.5%; peppers: 5%; pistachios: 1%; potatoes: 1%;
pumpkin: 1%; radishes: 1%; soybeans: 1%; squash: 1%; sunflowers: 2.5%;
sweet corn: 1%; tomatoes: 1%; turnips: 1%; walnuts: 1%; watermelons:
1%.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%,
except for those situations in which the maximum PCT is less than one.
In those cases, 2.5% is used as the maximum PCT. EPA uses an average
PCT for chronic dietary risk analysis. The average PCT figure for each
existing use is derived by combining available public and private
market survey data for that use, averaging across all observations, and
rounding to the nearest 5%, except for those situations in which the
average PCT is less than one. In those cases, 1% is used as the average
PCT.
    The Agency estimated that 9% of domestically consumed oranges would
be treated with deltamethrin as a result of the approval of the
tolerances on oranges. Because there is currently no domestic use of
deltamethrin on oranges, the Agency estimated the percentage of the
domestic consumption of oranges that are imported. This calculation is
based on three years of data (2011-2013) from USDA's Economic Research
Service and assumes 100 percent of imported oranges are treated with
deltamethrin. Because it is unlikely that all imported oranges will be
treated with deltamethrin, the Agency believes that assuming 9% of
oranges consumed have been treated with deltamethrin will not
underestimate deltamethrin exposure on oranges.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. As to Conditions b and c, regional
consumption information and consumption information for significant
subpopulations is taken into account through EPA's computer-based model
for evaluating the exposure of significant subpopulations including
several regional groups. Use of this consumption information in EPA's
risk assessment process ensures that EPA's exposure estimate does not
understate exposure for any significant subpopulation group and allows
the Agency to be reasonably certain that no regional population is
exposed to residue levels higher than those estimated by the Agency.
Other than the data available through national food consumption
surveys, EPA does not have available reliable information on the
regional consumption of food to which deltamethrin may be applied in a
particular area.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for deltamethrin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of deltamethrin. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the First Index Reservoir Screening Tool (FIRST),
Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models,
the estimated drinking water concentrations (EDWCs) of deltamethrin for
acute exposures are estimated to be 0.20 parts per billion (ppb) for
surface water and 0.20 ppb for ground water and chronic exposures for
non-cancer assessments are estimated to be 0.20 ppb for surface water
and 0.20 ppb for ground water. Both the acute and chronic surface and
ground drinking water concentration were limited by the solubility of
deltamethrin.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model.
    For acute dietary risk assessment and chronic dietary exposure
assessment, the water concentration value of 0.20 ppb was used to
assess the contribution to drinking water.
    Although a chronic dietary endpoint was not identified for
deltamethrin, a chronic dietary exposure assessment was performed to
provide background exposure for aggregation with short-term residential
exposure.

    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Deltamethrin is currently registered for the following uses that
could result in residential exposures: Indoor (spot, crack and crevice)
and outdoor (turf, garden and trees) environments, pet collars, paint
preservative, impregnated mosquito net, and wide area mosquito and fly
control. EPA assessed residential exposure using the Agency's 2012
Residential Standard Operating Procedures (SOPs) along with updates in
policy regarding body weight in addition to the following assumptions:
Since no treatment-related effects were observed at the limit dose, a
dermal point of departure (POD) was not selected, and neither a handler
nor a post-application dermal exposure assessment is required.
    i. Residential handler exposures. Short-term residential handler
inhalation exposure is anticipated from indoor and outdoor
environments, and paint preservatives. Because no intermediate-term
adverse effect was identified, deltamethrin is not expected to pose an
intermediate-term risk.
    ii. Residential post-application exposures. Post-application
inhalation exposure for adults and children is anticipated to be
negligible for indoor (spot, crack and crevice) and outdoor (turf,
garden and trees) environments, pet collars and paints; therefore, a
quantitative assessment was not performed. EPA assessed post-
application short-term incidental oral exposures to children for
representative indoor/outdoor and pet incidental oral scenarios
including hand-to-mouth, object-to-mouth, soil ingestion, and episodic
granule ingestion scenarios. Further information regarding EPA standard
assumptions and generic inputs for residential exposures may be found
at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA 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.''
    Deltamethrin is included in the pyrethroid/pyrethrin cumulative
risk assessment (CRA). The new tolerances to cover residues of
deltamethrin on imported oranges, citrus oil and citrus pulp has an
insignificant impact on the CRA. In the cumulative assessment,
residential exposure was the greatest contributor to the total
exposure. Although there are residential uses for deltamethrin, the
proposed use will have no impact on the residential component of the
cumulative risk estimates. Dietary exposures make a minor contribution
to the total pyrethroid exposure, and as a result, the new use on
oranges would have an insignificant impact on the cumulative dietary
risk.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X, or uses a different additional
safety factor when reliable data available to EPA support the choice of
a different factor.
    2. Prenatal and postnatal sensitivity. There is no quantitative
and/or qualitative evidence of increased susceptibility of rat or
rabbit fetuses to in utero exposure to deltamethrin. However, potential
qualitative susceptibility was observed at high doses in the DNT and 2-
generation reproduction study for juveniles. In addition, pyrethroid
pharmacokinetics literature indicates an increased quantitative
susceptibility for children less than 6 years of age.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF reduced to 1X for assessing risks to adults and children 6
years of age and older and to 3X for assessing risks to children less
than 6 years of age. That decision is based on the following findings:
    i. The toxicity database is considered complete for deltamethrin
with respect to guideline studies; it includes, among other studies,
developmental toxicity studies in rats and rabbits, a reproduction
study in rats, and acute neurotoxicity (ACN), subchronic neurotoxicity
(SCN), and developmental neurotoxicity (DNT) studies. Nevertheless, EPA
lacks additional data to fully characterize the potential for juvenile
sensitivity to many pyrethroids, including deltamethrin. For this
assessment, EPA considered the standard guideline studies as well as
numerous studies from the scientific literature that describe the
pharmacodynamic (PD) and pharmacokinetic (PK) profile of the
pyrethroids in general. Many of these studies were conducted with
deltamethrin.
    ii. As with other pyrethroids, deltamethrin causes neurotoxicity
from interaction with sodium channels leading to clinical signs of
neurotoxicity. These effects are well characterized and adequately
assessed by the body of data available to the Agency.
    iii. Evidence of increased juvenile qualitative sensitivity was
observed in the developmental neurotoxicity and 2-generation
reproduction studies. However, the observations of increased
sensitivity were at doses that were considered to be relatively high
(i.e., near lethal doses), whereas at doses near the point of
departure, no effects on parental animals or offspring were observed in
either the DNT or 2-generation reproduction study, and therefore, there
is no susceptibility at these doses. The Agency has retained a 3X
uncertainty factor to protect for exposures of children less than 6
years of age based on increased quantitative susceptibility seen in
studies on pyrethroid pharmacokinetics (primarily conducted with
deltamethrin) and the increased quantitative juvenile susceptibility
observed in high dose guideline and literature studies with
deltamethrin and other pyrethroids. The Agency has no residual
uncertainties regarding age-related sensitivity for women of child
bearing age as well as for all adult populations and children 6 years
of age and older, based on the absence of pre-natal sensitivity
observed in 76 guideline studies for 24 pyrethroids and the scientific
literature. Additionally, no evidence of increased quantitative or
qualitative susceptibility was seen in the pyrethroid scientific
literature related to pharmacodynamics.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary exposure assessments are based on reasonable to
high-end residue levels (that account for parent and metabolites of
concern), processing factors, and percent crop treated assumptions.
Furthermore, conservative, upper-bound assumptions were used to
determine exposure

through drinking water and residential sources, such that these
exposures have not been underestimated. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to deltamethrin in drinking water. EPA used
similarly conservative assumptions to assess post-application exposure
of children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
deltamethrin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to deltamethrin will occupy 86% of the aPAD for children 3-5 years old,
the population group receiving the greatest exposure.
    2. Chronic risk. Based on the data summarized in Unit III.A., there
is no increase in hazard with increasing dosing duration. Furthermore,
chronic dietary exposures will be lower than acute exposures.
Therefore, the acute aggregate assessment is protective of potential
chronic aggregate exposures.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Deltamethrin
is currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to deltamethrin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures, including inhalation and hand-to-mouth (for
children only), result in aggregate MOEs of 2,300 for the U.S.
Population; 2,600 for females ages 13-49; and 490 for children 1-2
years old. Because EPA's level of concern for deltamethrin is a MOE of
100 for the U.S. population and females 13-49, and 300 for children 1-2
years old or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Because no intermediate-term adverse effect was identified,
deltamethrin is not expected to pose an intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, deltamethrin is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to deltamethrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with electron
capture detection (GC/ECD)) is available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has established MRLs for deltamethrin in or on citrus
fruits at 0.02 ppm. These MRLs are different than the tolerances being
established for deltamethrin in the United States. Harmonization of the
0.30 ppm tolerance with the lower Codex MRL of 0.02 ppm is not possible
because the maximum residue value in oranges was 0.18 ppm, which is
considerably higher than the Codex MRL.

C. Revisions to Petitioned-For Tolerances

    The Agency added a significant figure to the proposed tolerance
level for orange and citrus, dried pulp to prevent violative samples
from being considered non-violative. For example, if a sample contained
a residue level of 0.34 ppm, it would have a violative residue if the
tolerance is set at 0.30 ppm. In addition, the Agency is revising the
commodity terminology to be consistent with the Agency's commodity
vocabulary.

V. Conclusion

    Therefore, tolerances are established for residues of deltamethrin,
(S)-cyano(3-phenoxyphenyl)methyl (1R,3R)-3-(2,2-dibromoethenyl)-2,2-
dimethylcyclopropanecarboxylate, in or on orange at 0.30 ppm; citrus,
dried pulp at 3.0 ppm; citrus, oil at 50 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as

the tolerance in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: March 21, 2017.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.435, paragraph (a)(1):
0
i. Add alphabetically the entries ``Citrus, dried pulp,'' ``Citrus,
oil,'' and ``Orange'' to the table; and
0
ii. Revise the footnote at the end of the table.
    The additions and revision read as follows:

Sec.  180.435  Deltamethrin; tolerance for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Citrus, dried pulp *.......................................          3.0
Citrus, oil *..............................................           50

                                * * * * *
Orange *...................................................         0.30

                                * * * * *
------------------------------------------------------------------------
* There are no U.S. registrations.

* * * * *
[FR Doc. 2017-07816 Filed 4-19-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 238 (Wednesday, December 12, 2018)]
[Notices]
[Page 63849]
[FR Doc No: 2018-26894]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP19-19-000]

Magnolia LNG, LLC; Notice of Application

    Take notice that on November 19, 2018, Magnolia LNG, LLC (Magnolia
LNG), 1001 McKinney, Suite 600, Houston, Texas 77002, filed an
application in Docket No. CP19-19-000, pursuant to Section 3(a) of the
Natural Gas Act and the Federal Energy Regulatory Commission's
(Commission) regulations seeking an amendment to the authorization
granted by the Commission on April 15, 2016, in Docket No. CP14-347-
000. Through its amendment application, Magnolia LNG seeks
authorization from the Commission to increase the total liquefied
natural gas production capacity of its liquefaction project from the
currently authorized 8 million tons per annum (MTPA) to 8.8 MTPA, or
1.4 billion cubic feet per day. The facilities are located in Lake
Charles, Calcasieu Parish, Louisiana, as more fully described in the
application which is on file with the Commission and open to public
inspection. The filing may also be viewed on the web at http://www.ferc.gov using the eLibrary link. Enter the docket number excluding
the last three digits in the docket number field to access the
document. For assistance, contact FERC at<EMAIL_ADDRESS>or
call toll-free,<PHONE_NUMBER> or TTY,<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
Kinga Doris, Magnolia LNG, LLC, 1001 McKinney, Suite 600, Houston,
Texas 77002,<PHONE_NUMBER>; or David L. Wochner, K&L Gates LLP, 1601 K
Street, NW, Washington, DC 20006,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below file with the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 3 copies of filings made in the proceeding with the Commission
and must provide a copy to the applicant and to every other party. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, and will be
notified of any meetings associated with the Commission's environmental
review process. Environmental commentors will not be required to serve
copies of filed documents on all other parties. However, the non-party
commentors will not receive copies of all documents filed by other
parties or issued by the Commission and will not have the right to seek
court review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
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 3 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426.
    Comment Date: December 27, 2018.

    Dated: December 6, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-26894 Filed 12-11-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 204 (Tuesday, October 22, 2013)]
[Notices]
[Pages 62784-62785]
[FR Doc No: 2013-24569]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70613; File No. SR-FINRA-2013-036]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Designation of a Longer Period for
Commission Action on a Proposed Rule Change Relating to Wash Sale
Transactions and FINRA Rule 5210 (Publication of Transactions and
Quotations)

October 4, 2013.

I. Introduction

    On August 15, 2013, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend FINRA Rule 5210. The proposed rule change
was published for comment in the Federal Register on September 4,
2013.\3\ The Commission received five comments on the proposal.\4\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 70276 (August 28,
2013), 78 FR 54502 (``Notice'').
    \4\ See letter from Anonymous to Elizabeth M. Murphy, Secretary,
Commission, dated September 9, 2013; letter from William A.
Jacobson, Clinical Professor of Law, and Director, Cornell
Securities Law Clinic, and Jimin Lee, Cornell University Law School,
to Elizabeth M. Murphy, Secretary, Commission, dated September 25,
2013; letter from Stuart J. Kaswell, Executive Vice President,
Managing Director and General Counsel, Managed Funds Association, to
Elizabeth M. Murphy, Secretary, Commission, dated September 25,
2013; letter from Manisha Kimmel, Executive Director, Financial
Industry Forum, to Elizabeth M. Murphy, Secretary, Commission, dated
September 25, 2013; and letter from Theodore R. Lazo, Managing
Director and Associate General Counsel, SIFMA, to Elizabeth M.
Murphy, Secretary, Commission, dated October 4, 2013.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \5\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents,

the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day for this filing is October 19, 2013.
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    \5\ 15 U.S.C. 78s(b)(2).
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    The Commission is hereby extending the 45-day period for Commission
action on the proposed rule change. The Commission has determined that
it is appropriate to designate a longer period within which to take
action on the proposed rule change. In particular, the extension of
time will ensure that the Commission has sufficient time to consider
and take action on FINRA's proposal in light of, among other things,
the comments received on the proposal.
    Accordingly, pursuant to Section 19(b)(2)(A)(ii)(I) of the Act \6\
and for the reasons stated above, the Commission designates December 3,
2013, as the date by which the Commission should either approve or
disapprove, or institute proceedings to determine whether to
disapprove, the proposed rule change File No. SR-FINRA-2013-036.
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    \6\ 15 U.S.C. 78s(b)(2)(A)(ii)(I).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(31).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-24569 Filed 10-21-13; 8:45 am]
BILLING CODE 8011-01-P