junk junk2 species. orig species 1 dummy dummy dummy 1 dummy acipenseridae other. forage 1 dummy alabama. shad menhaden. spp 1 dummy alewife alewife 1 dummy alligator. gar other. forage 1 dummy clupeidae herrings 1 dummy alosa. spp herrings 1 dummy ambloplites. rupestris sunfish 1 dummy american. eel other. rec. com 1 dummy american. shad american. shad 1 dummy anchovy bay. anchovy 1 dummy aplodinotus freshwater. drum 1 dummy banded. darter darter. spp 1 dummy banded. killifish other. forage 1 dummy banded. sculpin other. rec 1 dummy bass. spp smallmouth. bass 1 dummy bigmouth. buffalo bigmouth. buffalo 1 dummy black. bass white. bass 1 dummy black. buffalo bigmouth. buffalo 1 dummy black. bullhead black. bullhead 1 dummy black. crappie black. crappie 1 dummy black. redhorse golden. redhorse 1 dummy blacknose. dace bluntnose. minnow 1 dummy blackside. darter darter. spp 1 dummy blackstripe. topminnow bluntnose. minnow 1 dummy blue. catfish channel. catfish 1 dummy blue. crab not. modeled 1 dummy blueback. herring blueback. herring 1 dummy bluegill bluegill 1 dummy bluegill. sunfish bluegill 1 dummy bluegill. sunfish. hybrid bluegill 1 dummy bluespotted. sunfish sunfish 1 dummy bluntnose. minnow bluntnose. minnow 1 dummy bluntnose. shiner shiner. spp 1 dummy bowfin carp 1 dummy brindled. madtom bullhead. spp 1 dummy brook. silverside silversides 1 dummy brook. stickleback threespine. stickleback 1 dummy brook. trout whitefish 1 dummy brown. bullhead brown. bullhead 1 dummy brown. trout whitefish 1 dummy buffalo bigmouth. buffalo 1 dummy bullhead bullhead. spp 1 dummy bullhead. minnow bluntnose. minnow 1 dummy bullhead. spp bullhead. spp 1 dummy bullheads bullhead. spp 1 dummy bullheads. catfish bullhead. spp 1 dummy burbot burbot 1 dummy gambusia other. forage 1 dummy non. ris. forage other. forage 1 dummy non. ris. rec other. rec 1 dummy non. ris. com other. com 1 dummy non. ris. rec. com other. rec. com 1 dummy cambusia other. forage 1 dummy carp carp 1 dummy carp. goldfish carp 1 dummy carpoides sucker. spp 1 dummy carps. minnows carp 1 dummy carpsucker river. carpsucker 1 dummy carpsucker. spp river. carpsucker 1 dummy catfish channel. catfish 1 dummy catfish. spp channel. catfish 1 dummy catostomidae sucker. spp 1 dummy catostomus. commersoni sucker. spp 1 dummy centrarchid sunfish 1 dummy centrarchidae sunfish 1 dummy chain. pickerel muskellunge 1 dummy channel. catfish channel. catfish 1 dummy chestnut. lamprey other. forage 1 dummy chinook. salmon chinook. salmon 1 dummy chub. spp bluntnose. minnow 1 dummy coastal. shiner shiner. spp 1 dummy coho. salmon salmon 1 dummy common. carp carp 1 dummy common. shiner shiner. spp 1 dummy coregonids whitefish 1 dummy crappie crappie 1 dummy crappie. spp crappie 1 dummy creek. chub bluntnose. minnow 1 dummy cyprinidae carp 1 dummy cypriniformes carp 1 dummy cyprinus. carpio carp 1 dummy cyrinidae other. forage 1 dummy dace bluntnose. minnow 1 dummy darter darter. spp 1 dummy darters darter. spp 1 dummy dollar. sunfish sunfish 1 dummy dorosoma gizzard. shad 1 dummy drum freshwater. drum 1 dummy emerald. shiner emerald. shiner 1 dummy etheostominae darter. spp 1 dummy ethestoma. nigrum darter. spp 1 dummy fallfish bluntnose. minnow 1 dummy fat. sleeper other. forage 1 dummy fathead. minnow bluntnose. minnow 1 dummy flathead. catfish channel. catfish 1 dummy flathead. chub bluntnose. minnow 1 dummy flier sunfish 1 dummy flounder flounders 1 dummy forage. fishes other. forage 1 dummy freckled. madtom bullhead. spp 1 dummy freshwater. drum freshwater. drum 1 dummy game. food. fishes other. rec 1 dummy gar other. forage 1 dummy gars other. forage 1 dummy ghost. shiner shiner. spp 1 dummy gizzard. shad gizzard. shad 1 dummy golden. redhorse golden. redhorse 1 dummy golden. shiner shiner. spp 1 dummy golden/ shiner shiner. spp 1 dummy goldeye other. forage 1 dummy goldfish carp 1 dummy grass. pickerel muskellunge 1 dummy grass. shrimp forage. shrimp 1 dummy gray. snapper other. com 1 dummy green. sunfish sunfish 1 dummy greenside. darter darter. spp 1 dummy gulf. menhaden menhaden. spp 1 dummy herring herrings 1 dummy herrings herrings 1 dummy highfin. carpsucker sucker. spp 1 dummy hogchoker hogchoker 1 dummy hornyhead. chub bluntnose. minnow 1 dummy hybrid. sunfish sunfish 1 dummy ictalurus. melas bullhead. spp 1 dummy ictalurus. natalis bullhead. spp 1 dummy ictalurus. punctatus channel. catfish 1 dummy inland. silverside silversides 1 dummy johnny. darter darter. spp 1 dummy lake. trout whitefish 1 dummy lamprey. spp other. forage 1 dummyreys. shiners. minnows. stonecats other. forage 1 dummy largemouth. bass smallmouth. bass 1 dummy least. brook. lamprey other. forage 1 dummy lepomis sunfish 1 dummy lepomis. cyanellus sunfish 1 dummy lepomis. spp sunfish 1 dummy logperch logperch 1 dummy longear. sunfish sunfish 1 dummy longnose. dace bluntnose. minnow 1 dummy longnose. gar other. forage 1 dummy machrobrachium. spp other. forage 1 dummy madtom bullhead. spp 1 dummy menidia silversides 1 dummy micropterus. dolomieue smallmouth. bass 1 dummy micropterus. salmoides smallmouth. bass 1 dummy micropterus. spp smallmouth. bass 1 dummy mimic. shiner emerald. shiner 1 dummy minnow bluntnose. minnow 1 dummy minnow. spp bluntnose. minnow 1 dummy minnows bluntnose. minnow 1 dummy mooneye other. forage 1 dummy mooneyes other. forage 1 dummy morone white. perch 1 dummy morone. spp white. perch 1 dummy mosquitofish other. forage 1 dummy mottled. sculpin other. rec 1 dummy mountain. madtom bullhead. spp 1 dummy moxostoma golden. redhorse 1 dummy mud. crab com. crabs 1 dummy mudminnow bluntnose. minnow 1 dummy mummichog striped. killifish 1 dummy needlefish other. forage 1 dummy ninespine. stickleback threespine. stickleback 1 dummy northern. hogsucker sucker. spp 1 dummy northern. pike muskellunge 1 dummy northern. redbelly. dace bluntnose. minnow 1 dummy northern. redhorse golden. redhorse 1 dummy notropis. spp emerald. shiner 1 dummy orangespotted. sunfish sunfish 1 dummy other. fish other. forage 1 dummy other. spp other. forage 1 dummy ouachita. map. turtle not. modeled 1 dummy paddlefish paddlefish 1 dummy pallid. shiner shiner. spp 1 dummy pallid. sturgeon pallid. sturgeon 1 dummy perch. spp white. perch 1 dummy perches white. perch 1 dummy percidae white. perch 1 dummy percina. caprodes logperch 1 dummy percina. spp logperch 1 dummy petromyzontidae other. forage 1 dummy pickerel. spp muskellunge 1 dummy pikes muskellunge 1 dummy pimephales. notatus bluntnose. minnow 1 dummy pirate. perch other. forage 1 dummy pomoxis. spp sunfish 1 dummy popeye. shiner shiner. spp 1 dummy pugnose. shiner shiner. spp 1 dummy pumpkinseed sunfish 1 dummy quillback sucker. spp 1 dummy quillback. carpsucker sucker. spp 1 dummy rainbow. darter darter. spp 1 dummy rainbow. smelt rainbow. smelt 1 dummy rainbow. trout whitefish 1 dummy red. shiner shiner. spp 1 dummy redbreast. sunfish sunfish 1 dummy redear. sunfish sunfish 1 dummy redfin. pickerel muskellunge 1 dummy redfin. shiner shiner. spp 1 dummy redhorse. spp golden. redhorse 1 dummy river. carpsucker river. carpsucker 1 dummy river. darter darter. spp 1 dummy river. redhorse golden. redhorse 1 dummy river. shiner emerald. shiner 1 dummy rock. bass sunfish 1 dummy rock. bass. bluegill. bass. bluegill 1 dummy rosyface. shiner emerald. shiner 1 dummy rough. fishes other. forage 1 dummy round. whitefish whitefish 1 dummy salmon salmon 1 dummy salmonidae salmon 1 dummy salmonid salmon 1 dummy sand. shiner emerald. shiner 1 dummy satinfin. shiner shiner. spp 1 dummy sauger sauger 1 dummy sauger. walleye sauger 1 dummy sculpin sculpin. spp 1 dummy sculpin. spp sculpin. spp 1 dummy shad gizzard. shad 1 dummy shad. spp gizzard. shad 1 dummy shiner shiner. spp 1 dummy shiner. spp shiner. spp 1 dummy shiners shiner. spp 1 dummy shorthead. redhorse golden. redhorse 1 dummy shortnose. gar other. forage 1 dummy shovelnose. sturgeon sturgeon. spp 1 dummy sicklefin. chub bluntnose. minnow 1 dummy silver. chub bluntnose. minnow 1 dummy silver. lamprey other. forage 1 dummy silver. redhorse golden. redhorse 1 dummy silver. shiner shiner. spp 1 dummy silverjaw. minnow bluntnose. minnow 1 dummy silvery. minnow bluntnose. minnow 1 dummy skipjack. herring skipjack. herring 1 dummy slender. sleeper other. forage 1 dummy slenderhead. darter darter. spp 1 dummy slimy. sculpin other. rec 1 dummy smallmouth. bass smallmouth. bass 1 dummy smallmouth. buffalo bigmouth. buffalo 1 dummy smelt smelts 1 dummy southern. flounder other. rec 1 dummy spanish. sardine herrings 1 dummy speckled. chub bluntnose. minnow 1 dummy spoonhead. sculpin sculpin. spp 1 dummy spotfin. red. shiner shiner. spp 1 dummy spotfin. shiner shiner. spp 1 dummy spottail. shiner shiner. spp 1 dummy spotted. bass rec. sea. basses 1 dummy spotted. sucker spotted. sucker 1 dummy spotted. sunfish sunfish 1 dummy stizostedion. spp walleye 1 dummy stonecat bullhead. spp 1 dummy stoneroller bluntnose. minnow 1 dummy striped. anchovy bay. anchovy 1 dummy striped. bass striped. bass 1 dummy striped. shiner shiner. spp 1 dummy sturgeon. spp sturgeon. spp 1 dummy sucker sucker. spp 1 dummy sucker. spp sucker. spp 1 dummy suckermouth. minnow bluntnose. minnow 1 dummy suckers sucker. spp 1 dummy sunfish sunfish 1 dummy sunfish. hybrid sunfish 1 dummy sunfish. spp sunfish 1 dummy sunfishes sunfish 1 dummy tadpole. madtom bullhead. spp 1 dummy tessalated. darters darter. spp 1 dummy threadfin. shad herrings 1 dummy tiger. muskellunge muskellunge 1 dummy topeka. shiner shiner. spp 1 dummy trout whitefish 1 dummy troutperch other. forage 1 dummy unknown other. forage 1 dummy unknown. fish other. forage 1 dummy walleye walleye 1 dummy walleye. pike walleye 1 dummy walleye. sauger walleye 1 dummy warmouth sunfish 1 dummy warmouth. sunfish sunfish 1 dummy white. bass white. bass 1 dummy white. bass. striped. bass white. bass 1 dummy white. catfish other. rec 1 dummy white. crappie crappie 1 dummy white. longnose. sucker sucker. spp 1 dummy white. shrimp pink. shrimp 1 dummy white. sucker sucker. spp 1 dummy yellow. bass white. perch 1 dummy yellow. bullhead bullhead. spp 1 dummy yellow. perch yellow. perch 1 dummy . not. modeled 1 dummy deepwater. sculpin sculpin. spp 1 dummy lake. chub bluntnose. minnow 1 dummy bloater other. forage 1 dummy lake. whitefish whitefish 1 dummy longnose. sucker sucker. spp 1 dummy pacific. salmon salmon 1 dummy atlantic. salmon salmon 1 dummy tiger. trout whitefish 1 dummy bay. anchovy bay. anchovy 1 dummy grubby grubby 1 dummy unidentified other. forage 1 dummy windowpane windowpane 1 dummy american. sandlance other. forage 1 dummy atlantic. herring atlantic. herring 1 dummy naked. goby gobies 1 dummy northern. pipefish northern. pipefish 1 dummy sciaenidae. spp freshwater. drum 1 dummy seahorse northern. pipefish 1 dummy smallmouth. flounder windowpane 1 dummy spot other. com 1 dummy striped. searobin searobin 1 dummy weakfish weakfish 1 dummy winter. flounder winter. flounder 1 dummy atlantic. croaker atlantic. croaker 1 dummy atlantic. menhaden atlantic. menhaden 1 dummy atlantic. silverside atlantic. silverside 1 dummy blenniidae other. forage 1 dummy fundulus. spp striped. killifish 1 dummy gobiidae gobies 1 dummy menidia. spp silversides 1 dummy rough. silverside silversides 1 dummy tautog tautog 1 dummy northern. puffer other. rec 1 dummy butterfish butterfish 1 dummy silver. hake silver. hake 1 dummy cunner cunner 1 dummy gadidae. spp atlantic. tomcod 1 dummy bluefish bluefish 1 dummy red. hake red. hake 1 dummy feather. blenny other. forage 1 dummy striped. killifish striped. killifish 1 dummy threespine. stickleback threespine. stickleback 1 dummy white. perch white. perch 1 dummy anguilla. rostrata other. rec. com 1 dummy conger. oceanicus other. rec. com 1 dummy alosa. aestivalis blueback. herring 1 dummy alosa. pseudoharengus alewife 1 dummy alosa. sapidissima american. shad 1 dummy brevoortia. tyrannus atlantic. menhaden 1 dummy dorosoma. cepedianum gizzard. shad 1 dummy anchoa. sp bay. anchovy 1 dummy anchoa. hepsetus bay. anchovy 1 dummy anchoa. mitchilli bay. anchovy 1 dummy osmerus. mordax rainbow. smelt 1 dummy carrassius. auratus carp 1 dummy hybognathus. nuchalis bluntnose. minnow 1 dummy merluccius. bilinearis silver. hake 1 dummy microgadus. tomcod atlantic. tomcod 1 dummy urophycis. chuss red. hake 1 dummy urophycis. regius red. hake 1 dummy urophycis. tenuis silver. hake 1 dummy fundulus. heteroclitus striped. killifish 1 dummy menidia. beryllina silversides 1 dummy menidia. menidia silversides 1 dummy apeltes. quadracus threespine. stickleback 1 dummy gasterosteus. aculeatus threespine. stickleback 1 dummy hippocampus. erectus northern. pipefish 1 dummy sygnathus. fuscus northern. pipefish 1 dummy morone. americana white. perch 1 dummy morone. saxatilis striped. bass 1 dummy lepomis. gibbosus sunfish 1 dummy lepomis. macrochirus sunfish 1 dummy poxomis. niromaculatus black. crappie 1 dummy pomatomus. saltatrix bluefish 1 dummy selene. vomer other. forage 1 dummy bairdiella. chrysura silver. perch 1 dummy cynoscion. regalis weakfish 1 dummy stenotomus. chrysops scup 1 dummy tautoga. onitus tautog 1 dummy gobiosoma. sp gobies 1 dummy gobiosoma. bosci gobies 1 dummy peprilus. triacanthus butterfish 1 dummy prionotus. carolinus searobin 1 dummy prionotus. evolans searobin 1 dummy myoxocephalus. aenaeus grubby 1 dummy scophthalmus. aquosus windowpane 1 dummy etropus. microstomus windowpane 1 dummypseudopleuronectes. americanus winter. flounder 1 dummy sphoeroides. maculatus other. rec 1 dummy muskellunge muskellunge 1 dummy centrarchid. spp sunfish 1 dummy etheostoma. spp darter. spp 1 dummy iowa. darter darter. spp 1 dummy redbelly. dace bluntnose. minnow 1 dummy notropis shiner. spp 1 dummy pimephales. spp bluntnose. minnow 1 dummy stickleback threespine. stickleback 1 dummy coregonidae whitefish 1 dummy lucania. parva other. forage 1 dummy microgobius. gulosus gobies 1 dummy flathead. minnow bluntnose. minnow 1 dummy gar. species other. forage 1 dummy cyprinid. spp other. forage 1 dummy moxostoma. spp golden. redhorse 1 dummy catostomid. spp sucker. spp 1 dummy ictiobinae. spp sucker. spp 1 dummy ammocrypta. spp darter. spp 1 dummy fantail. darter darter. spp 1 dummy rainbow. banded. darter darter. spp 1 dummy percid. spp yellow. perch 1 dummy unknown. fish. spp other. forage 1 dummy gar. spp other. forage 1 dummy mississippi. silvery. minnow other. forage 1 dummy steelcolor. shiner shiner. spp 1 dummy hybrid. bass white. bass 1 dummy ictiobinae sucker. spp 1 dummy central. stoneroller bluntnose. minnow 1 dummy etheostoma darter. spp 1 dummy ictaluridae channel. catfish 1 dummy micropterus other. rec 1 dummy noturus. spp other. forage 1 dummy carpsuckers sucker. spp 1 dummy cisco. spp whitefish 1 dummy sunfishes. rock. bass sunfish 1 dummy catfishes other. rec 1 dummy troutperches logperch 1 dummy atherinidae other. forage 1 dummy percichthyidae other. rec 1 dummy polyodon. spathula paddlefish 1 dummy sciaenidae spotted. seatrout notes dummy . . .

. . . . . . gulf. killifish? . . . . . . . . forage? . . . . . . . . . . . . forage? . .

.

. . . . . . .

mosquito fish . . . . . . . . . . . . . . . . . . . . . . . . . . . . . forage? . . . . . . . . Max. size is in between carp & bluntnose . . . . . . . forage? . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . forage? . . forage? . . . . . . . . . . . . . . forage? . . . . . . . . forage? . . . . . . . . T& E species . . . . . lampreys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . .

. . . . . . . . . . . . . . .

. . . . . . . . . . . . . .

. . . . . . . . forage? .

. .

. . . . . . . . . . . . . . . . . . . . . . . . . . .

Originally entered as brevootia. tyrannus Originally entered as anchos. sp Originally entered as urophycis chuss Originally entered as morone. americna Originally entered as stenotomus. chysops Originally entered as pimiephales. spp Originally entered as cregonidae Originally entered as polyodon spathula Lookup table for Phase 3 species. A. Gage, 12/ 12/ 2003 Updated May 12, 2004 to include groupings to use in life history table footnotes. group species atlantic. tomcod gadidae. spp microgadus. tomcod bay. anchovy anchoa. hepsetus anchoa. mitchilli anchoa. sp anchovy striped. anchovy bigmouth. buffalo bigmouth. buffalo black. buffalo buffalo smallmouth. buffalo bluegill bluegill bluegill. sunfish bluegill. sunfish. hybrid rock. bass. bluegill. bass. bluntnose. minnow blacknose. dace blackstripe. topminnow bluntnose. minnow bullhead. minnow central. stoneroller chub. spp creek. chub dace fallfish fathead. minnow flathead. chub flathead. minnow hornyhead. chub hybognathus. nuchalis lake. chub longnose. dace minnow minnow. spp minnows mudminnow northern. redbelly. dace pimephales. notatus pimephales. spp redbelly. dace sicklefin. chub silver. chub silverjaw. minnow silvery. minnow speckled. chub stoneroller suckermouth. minnow bullhead. spp brindled. madtom bullhead bullhead. spp bullheads bullheads. catfish freckled. madtom ictalurus. melas ictalurus. natalis madtom mountain. madtom stonecat tadpole. madtom yellow. bullhead carp bowfin carp. goldfish carps. minnows carrassius. auratus common. carp cyprinidae cypriniformes cyprinus. carpio goldfish channel. catfish blue. catfish catfish catfish. spp flathead. catfish ictaluridae com. crabs mud. crab crappie crappie crappie. spp white. crappie darter. spp ammocrypta. spp banded. darter blackside. darter darter darters etheostoma etheostoma. spp etheostominae ethestoma. nigrum fantail. darter greenside. darter iowa. darter johnny. darter rainbow. banded. darter rainbow. darter river. darter slenderhead. darter tessalated. darters emerald. shiner emerald. shiner mimic. shiner notropis. spp river. shiner rosyface. shiner sand. shiner forage. shrimp grass. shrimp freshwater. drum aplodinotus drum freshwater. drum sciaenidae. spp gizzard. shad dorosoma shad shad. spp gobies gobiidae gobiosoma. bosci gobiosoma. sp microgobius. gulosus naked. goby golden. redhorse black. redhorse golden. redhorse moxostoma moxostoma. spp northern. redhorse redhorse. spp river. redhorse shorthead. redhorse silver. redhorse herrings alosa. spp clupeidae herring herrings spanish. sardine threadfin. shad logperch logperch percina. caprodes percina. spp troutperches menhaden. spp alabama. shad gulf. menhaden muskellunge chain. pickerel grass. pickerel muskellunge northern. pike pickerel. spp pikes redfin. pickerel tiger. muskellunge northern. pipefish hippocampus. erectus northern. pipefish seahorse sygnathus. fuscus other. com gray. snapper non. ris. com spot other. forage acipenseridae alligator. gar american. sandlance atherinidae banded. killifish blenniidae bloater cambusia chestnut. lamprey cyprinid. spp cyrinidae fat. sleeper feather. blenny forage. fishes gambusia gar gar. species gar. spp gars goldeye lamprey. spp lampreys. shiners. minnows. stonecats least. brook. lamprey longnose. gar lucania. parva machrobrachium. spp mississippi. silvery. minnow mooneye mooneyes mosquitofish needlefish non. ris. forage noturus. spp other. fish other. spp pallid. sturgeon petromyzontidae pirate. perch rough. fishes selene. vomer shortnose. gar silver. lamprey slender. sleeper sturgeon. spp troutperch unidentified unknown unknown. fish unknown. fish. spp other. rec banded. sculpin catfishes game. food. fishes micropterus mottled. sculpin non. ris. rec northern. puffer percichthyidae shovelnose. sturgeon slimy. sculpin southern. flounder sphoeroides. maculatus white. catfish other. rec. com american. eel anguilla. rostrata conger. oceanicus non. ris. rec. com pink. shrimp white. shrimp rainbow. smelt osmerus. mordax rainbow. smelt rec. sea. basses spotted. bass red. hake urophycis. regius river. carpsucker carpsucker carpsucker. spp river. carpsucker salmon atlantic. salmon coho. salmon pacific. salmon salmon salmonid salmonidae sauger sauger. walleye sculpin. spp deepwater. sculpin sculpin sculpin. spp spoonhead. sculpin searobin prionotus. carolinus prionotus. evolans striped. searobin shiner. spp bluntnose. shiner coastal. shiner common. shiner ghost. shiner golden. shiner golden/ shiner notropis pallid. shiner popeye. shiner pugnose. shiner red. shiner redfin. shiner satinfin. shiner shiner shiner. spp shiners silver. shiner spotfin. red. shiner spotfin. shiner spottail. shiner steelcolor. shiner striped. shiner topeka. shiner silver. hake merluccius. bilinearis silver. hake urophycis. tenuis silversides brook. silverside inland. silverside menidia menidia. beryllina menidia. menidia menidia. spp rough. silverside smallmouth. bass bass. spp largemouth. bass micropterus. dolomieue micropterus. salmoides micropterus. spp smallmouth. bass spotted. seatrout sciaenidae striped. killifish fundulus. heteroclitus fundulus. spp mummichog striped. killifish sucker. spp carpoides carpsuckers catostomid. spp catostomidae catostomus. commersoni highfin. carpsucker ictiobinae ictiobinae. spp longnose. sucker northern. hogsucker quillback quillback. carpsucker sucker sucker. spp suckers white. longnose. sucker white. sucker sunfish ambloplites. rupestris bluespotted. sunfish centrarchid centrarchid. spp centrarchidae dollar. sunfish flier green. sunfish hybrid. sunfish lepomis lepomis. cyanellus lepomis. gibbosus lepomis. macrochirus lepomis. spp longear. sunfish orangespotted. sunfish pomoxis. spp pumpkinseed redbreast. sunfish redear. sunfish rock. bass spotted. sunfish sunfish sunfish. hybrid sunfish. spp sunfishes sunfishes. rock. bass warmouth warmouth. sunfish threespine. stickleback apeltes. quadracus brook. stickleback gasterosteus. aculeatus ninespine. stickleback stickleback walleye stizostedion. spp walleye walleye. pike walleye. sauger white. bass black. bass hybrid. bass white. bass white. bass. striped. bass white. perch morone morone. americana morone. spp perch. spp perches percidae white. perch yellow. bass whitefish brook. trout brown. trout cisco. spp coregonidae coregonids lake. trout lake. whitefish rainbow. trout round. whitefish tiger. trout trout windowpane etropus. microstomus scophthalmus. aquosus smallmouth. flounder yellow. perch percid. spp List of modelled species that do not appear in Phase 3 ( yet)

american. plaice american. sand. lance anchovies atlantic. cod atlantic. croaker atlantic. herring atlantic. mackerel atlantic. menhaden atlantic. silverside atlantic. tomcod black. drum blennies blue. crab bluefish butterfish cabezon california. halibut california. scorpionfish chain. pipefish com. sea. basses com. shrimp cunner delta. smelt drums. croakers dummy dungeness fourbeard. rockling gobies goby. spp grubby gulf. killifish junk. species leatherjacket longfin. smelt lumpfish mackerels northern. anchovy northern. pipefish other. com. crabs pacific. herring pinfish pollock radiated. shanny red. drum red. hake rock. gunnel rockfishes sacramento. splittail scaled. sardine sculpins scup sea. basses seaboard. goby searobin sheepshead silver. hake silver. perch skate. species spot spotted. seatrout starry. flounder steelhead stone. crab striped. mullet summer. flounder surfperches tautog tidewater. silverside weakfish windowpane winter. flounder species added? alewife yes american. shad yes bay. anchovy yes bigmouth. buffalo yes black. bullhead yes black. crappie yes blueback. herring yes bluegill yes bluntnose. minnow yes brown. bullhead yes bullhead. spp yes burbot yes carp yes channel. catfish yes chinook. salmon yes com. crabs yes crappie yes darter. spp yes emerald. shiner yes flounders yes forage. shrimp yes freshwater. drum yes gizzard. shad yes golden. redhorse yes herrings yes hogchoker yes logperch yes menhaden. spp yes muskellunge yes non. ris. com yes non. ris. forage yes non. ris. rec yes non. ris. rec. com yes not. modeled yes paddlefish yes pink. shrimp yes rainbow. smelt yes rec. sea. basses yes river. carpsucker yes salmon yes sauger yes sculpin. spp yes shiner. spp yes silversides yes skipjack. herring yes smallmouth. bass yes smelts yes spotted. sucker yes striped. bass yes striped. killifish yes sucker. spp yes sunfish yes threespine. stickleback yes walleye yes white. bass yes white. perch yes whitefish yes yellow. perch yes


[Federal Register: August 20, 2007 (Volume 72, Number 160)]
[Notices]
[Page 46523-46525]
[DOCID:fr20au07-104]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56251; File No. SR-Amex-2004-27]

Self-Regulatory Organizations; American Stock Exchange LLC;
Notice of Filing of Amendment No. 4 to a Proposed Rule Change and Order
Granting Accelerated Approval to a Proposed Rule Change, as Modified by
Amendment Nos. 2, 3, and 4 Thereto, Relating to the Listing and Trading
of Fixed Return Options

August 14, 2007.

I. Introduction

    On April 29, 2004, the American Stock Exchange LLC (``Amex'' or
``Exchange'') 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 list and trade Fixed Return Options (``FROs'').
Amex filed Amendment Nos. 1, 2, 3, and 4 to the proposal on September
26, 2006, April 19, 2007, May 23, 2007, and August 14, 2007,
respectively.\3\ The proposed rule change, as modified by Amendment
Nos. 2 and 3, was published for comment in the Federal Register on June
7, 2007.\4\ The Commission received no comment letters regarding the
proposed rule change, as modified by Amendment Nos. 2 and 3. This order
provides notice and solicits comments from interested persons regarding
Amendment No. 4 and approves the proposed rule change, as amended, on
an accelerated basis.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 2 replaced the original filing and Amendment
No. 1 in their entirety. Amendment No. 3 revised the rule text
relating to margin requirements. Amendment No. 4 corrected minor
errors in the text of the proposed rules, provided representations
concerning surveillance procedures and systems capacity, clarified
the use of composite prices in calculating the volume weighted
average price (``VWAP''), and clarified the proposed position
reporting requirements.
    \4\ See Securities Exchange Act Release No. 55843 (June 1,
2007), 72 FR 31636.
---------------------------------------------------------------------------

II. Description of the Proposal

A. FROs Generally

    Amex proposes to list and trade cash-settled, European-style FROs
on individual stocks and exchange-traded funds (``ETFs'') that satisfy
specified listing criteria. FROs are binary options and, as such,
differ from the options currently traded on U.S. options exchanges by
providing a discontinuous or non-linear payout. An in-the-money FRO
will pay a fixed sum at expiration regardless of the magnitude of the
difference between the option's exercise price and the settlement
price. Amex proposes to list Finish High\SM\ (``Finish High'') FROs,
which will return $100 per contract if the settlement price of the
underlying security is above the strike price at expiration, and Finish
Low\SM\ (``Finish Low'') FROs, which will return $100 per contract if
the settlement price of the underlying security is below the strike
price at expiration.\5\ Any in-the-money FRO will be exercised
automatically at expiration.\6\
---------------------------------------------------------------------------

    \5\ See Amex Rule 900FRO(b)(2) and (3).
    \6\ See Amex Rule 980FRO.
---------------------------------------------------------------------------

B. Listing Standards

    The initial listing criteria for FROs require that an individual
stock underlying an FRO meet the criteria for underlying securities in
Amex Rule 915, ``Criteria for Underlying Securities,'' and, in
addition, have: (1) Minimum market capitalization of at least $40
billion; (2) minimum trading volume, in all markets in which the
security trades, of at least one billion shares in the preceding 12
months; (3) minimum average daily trading volume of four million
shares; (4) minimum average daily trading value of at least $200
million during the previous six months; and (5) a minimum market price
per share of at least $10, as measured by the closing price reported in
the primary listed market in which the security is traded, over the
previous five consecutive business days preceding the date on which
Amex submits a certificate to the Options Clearing Corporation
(``OCC'') for listing and trading.\7\ An ETF underlying an FRO would
have to meet these five additional criteria along with the requirements
of Amex Rule 915, except for the minimum market capitalization
requirement.\8\
---------------------------------------------------------------------------

    \7\ See Amex Rule 915FRO, Commentary .01.
    \8\ See Amex Rule 915FRO, Commentary .02.
---------------------------------------------------------------------------

    The continued listing criteria for FROs require that an individual
stock underlying an FRO satisfy the requirements of Amex Rule 916,
``Withdrawal of Approval of Underlying Securities,'' and, in addition,
have: (1) Minimum market capitalization of at least $30 billion; (2)
minimum trading volume, in all markets trading the security, of at
least one billion shares in the preceding 12 months; (3) minimum
average daily trading volume of four million shares; (4) minimum
average daily trading value of at least $125 million during the last
six months; and (5) an underlying market price per share of at least $5
at the time additional series are listed for trading.\9\ An ETF
underlying an FRO would have to meet these five additional criteria
along with the requirements of Amex Rule 916, except for the minimum
market capitalization requirement.\10\
---------------------------------------------------------------------------

    \9\ See Amex Rule 916FRO, Commentary .01.
    \10\ See Amex Rule 916FRO, Commentary .03.
---------------------------------------------------------------------------

C. Role of OCC

    The OCC plans to file a proposal to issue, clear, and settle FROs.
According to Amex, the OCC also plans to file a proposal to revise the
Options Disclosure Document (``ODD'') required under Rule 9b-1 of the
Act \11\ to incorporate FROs.
---------------------------------------------------------------------------

    \11\ 17 CFR 240.9b-1.
---------------------------------------------------------------------------

D. Volume Weighted Average Price Settlement

    To reduce concerns regarding potential price manipulation at
expiration due to the ``all-or-nothing'' return provided by an FRO,
Amex proposes to settle FROs using an all-day volume weighted average
price (``VWAP'') based on trading in the underlying security on the
last trading day prior to expiration.\12\ To calculate the VWAP, Amex
will use composite prices during regular trading hours as reported by
industry price vendors.\13\ If the security underlying an FRO does not
trade or is unavailable during regular trading hours at expiration, the
settlement price may be fixed pursuant to the OCC's rules on a basis
that the OCC believes is appropriate under the circumstances, including
using the last sale price during regular trading hours on the most
recent trading day for which a last sale price is available.\14\
---------------------------------------------------------------------------

    \12\ See Amex Rule 910FRO(a). The VWAP for an underlying
security is the sum of the dollar value of reported trades (price
multiplied by the number of shares traded), divided by the total
number of shares traded during the entire last day of trading prior
to expiration. See Amex Rule 900FRO(b)(4).
    \13\ See Amex Rule 910FRO(a). Composite prices are prices
reported to the consolidated tape from any participating exchange or
market. Amex notes that the OCC currently uses composite pricing in
connection with the settlement of expiring equity options. The
composite closing price is the last reported sale price from any
eligible trade source (i.e., primary listing market or participating
regional market). It is not an average price. See Securities
Exchange Act Release No. 49045 (January 8, 2004), 69 FR 2377
(January 15, 2004) (notice of filing and immediate effectiveness of
File No. SR-OCC-2003-01).
    \14\ See Amex Rule 910FRO(a), Commentary .01.
---------------------------------------------------------------------------

    Amex will publish and disseminate the current value of the VWAP
calculation for FROs at least every 15 seconds throughout the last
trading day prior to expiration. Amex will disseminate the VWAP
settlement price as the official settlement price for FROs and will
make it publicly available

through various market data vendors and on the Amex Web site at http://www.amex.com
.

E. Position and Exercise Limits

    The position limits for FROs will be 25,000 contracts on the same
side of the market, and positions in FROs will not be aggregated with
positions in other options on the same underlying stock or ETF for
purposes of determining compliance with the position limits.\15\ Amex
is not proposing exercise limits for FROs because FROs will be
exercised automatically at expiration if the settlement price of the
underlying security is greater than the strike price of a Finish High
FRO or less than the strike price of a Finish Low FRO.\16\ FROs will
not be subject to any qualified hedge exemptions from position limits.
---------------------------------------------------------------------------

    \15\ See Amex Rule 904FRO(a) and (b).
    \16\ See Amex Rule 980FRO.
---------------------------------------------------------------------------

    Positions in FROs must be reported to Amex when an account
establishes an aggregate position on the same side of the market of 200
or more contracts,\17\ and the provisions of Amex Rule 906, ``Reporting
of Options Positions,'' will apply to FROs.\18\ Amex Rule 906(b)
requires that a member, other than an Amex market maker, that maintains
an FRO position in excess of 10,000 contracts on the same side of the
market, for its own account or the account of its customer, report
certain information to Amex, including whether the position is hedged,
a description of the hedge, and, if applicable, a description of the
collateral. Amex believes that the reporting requirements under Amex
Rule 906 and the surveillance procedures for hedged positions will
enable Amex to closely monitor sizable FRO positions and corresponding
hedges.\19\
---------------------------------------------------------------------------

    \17\ See Amex Rule 906FRO.
    \18\ See Amex Rule 906FRO.
    \19\ Amex notes that hedge information for member firm and
customer accounts with 200 or more contracts are reported
electronically via the Large Options Position Report. In addition,
Amex notes that specialist and registered options trader account
information is reported to Amex by the member's clearing firm.
---------------------------------------------------------------------------

F. Margin

    The minimum margin on any FRO carried short in a customer's account
is the difference between $100 and the proceeds from the sale of the
FRO, which must remain in the customer's account.\20\ A customer
account with a long position in an FRO must initially deposit and
maintain margin equal to at least 100% of the purchase price of the
FRO.\21\
---------------------------------------------------------------------------

    \20\ See Amex Rule 462(d)(10)(D).
    \21\ See Amex Rule 462(d)(10)(B).
---------------------------------------------------------------------------

    No margin is required for an FRO position carried short against an
existing long position in the same FRO, or when the writer's obligation
is secured by a specific deposit or escrow deposit meeting the entire
$100 obligation under the FRO.\22\
---------------------------------------------------------------------------

    \22\ See Amex Rule 462(d)(10)(F).
---------------------------------------------------------------------------

G. Bid-Ask Differentials and Minimum Price Variations

    A specialist or registered trader is expected to quote with no more
than $0.25 between the bid and the offer for each FRO contract, except
during the last trading day prior to expiration, when the maximum width
may be $0.50.\23\ In addition, when the bid/ask differential in the
underlying security is greater than $0.25, or $0.50 on the last trading
day prior to expiration, the permissible quote width for an in-the-
money FRO series may be identical to the quote width in the underlying
security.\24\
---------------------------------------------------------------------------

    \23\ See Amex Rule 958FRO.
    \24\ See Amex Rule 958FRO.
---------------------------------------------------------------------------

    Amex Rule 952, ``Minimum Price Variations,'' generally provides
that the minimum price variation (``MPV'') for an option is: (i) $0.05
for options quoted under $3 a contract; and (ii) $0.10 for options
quoted at $3 a contract or greater. For the options classes included in
the Penny Quoting Pilot Program, the MPV is: (i) $0.01 for options
quoted under $3 a contract; and (ii) $0.05 for options quoted at $3 a
contract or greater.\25\ The MPV for FROs in classes not included in
the Penny Quoting Pilot Program will be $0.05, and $0.01 for classes in
the Penny Quoting Pilot Program.
---------------------------------------------------------------------------

    \25\ See Securities Exchange Act Release No. 55162 (January 24,
2007), 72 FR 5738 (February 1, 2007). In addition, options on the
Power Shares QQQ Trust trade at an MPV of $0.01 for all options
premiums.
---------------------------------------------------------------------------

    Amex will apply to FROs the existing industry convention of
multiplying an option's quoted price by $100 to determine its premium.
For example, for an FRO that is quoted at $0.50, an investor would pay
$50.00 ($0.50 x 100).

H. Other Considerations

    Amex Rule 903, ``Series of Options Open for Trading,'' will apply
to FROs.\26\ Pursuant to Amex Rule 903, Amex generally opens up to four
expiration months for an options class when it initially lists the
class for trading. Amex will use the same expiration cycle for FROs as
it uses for traditional options.
---------------------------------------------------------------------------

    \26\ See Amex Rule 903FRO.
---------------------------------------------------------------------------

    Similarly, Amex will use the strike price intervals provided in
Amex Rule 903, ``Series of Options Open for Trading,'' and the related
commentaries for FROs. Securities underlying options classes included
in the $1 strike price pilot program \27\ and the 2\1/2\-point strike
price program \28\ may underlie FROs, provided that they meet the
listing standards for FROs.
---------------------------------------------------------------------------

    \27\ See Amex Rule 903, Commentary .06.
    \28\ See Amex Rule 903, Commentary .07.
---------------------------------------------------------------------------

    Amex represents that symbols will be created for FROs that
represent the underlying security, the fact that the option is an FRO
rather than a traditional put or call, the expiration date, strike
price, and the exchange(s) trading the FRO.

III. Discussion

    The Commission finds that the proposed rule change, as amended, is
consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities
exchange.\29\ Specifically, the Commission finds that the proposal is
consistent with Section 6(b)(5) of the Act,\30\ which requires, among
other things, that the rules of a national securities exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general, to protect investors and the public
interest. The Commission believes that FROs will provide investors with
a potentially useful investment choice. The proposal will extend to
certain binary options the benefits of a listed exchange market, which
include: A centralized forum for price discovery; pre- and post-trade
transparency; standardized contract specifications; and the guarantee
of the OCC.
---------------------------------------------------------------------------

    \29\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \30\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission believes that the proposal is reasonably designed to
address potential manipulation concerns associated with FROs' non-
linear return. The initial and continuing listing standards for FROs
should ensure that only highly capitalized, actively traded stocks and
ETFs are eligible to underlie FROs, and the settlement price for FROs
is based on an all-day VWAP during the last trading day prior to
expiration. These elements should reduce the potential for manipulating
the stock or ETF underlying an FRO to benefit an FRO position.

    The Commission believes that the proposed position limits and
margin rules for FROs are reasonable and consistent with the Act. The
proposed position limit of 25,000 contracts in any FRO class appears to
reasonably balance the promotion of a free and open market for these
securities with minimization of incentives for market manipulation. The
proposed margin rules appear reasonably designed to deter a member or
its customer from assuming an imprudent position in FROs.
    In support of this proposal, Amex made the following
representations:
     Amex has in place an adequate surveillance program to
monitor trading in FROs and intends to largely apply its existing
surveillance program for options to the trading of FROs; and
     Amex has the necessary systems capacity to support the new
options series that would result from the introduction of FROs.
    This approval order is based on Amex's representations.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning Amendment No. 4, including whether Amendment No. 4
is consistent with the Act. Comments may be submitted by any of the
following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-Amex-2004-27 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Amex-2004-27. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of Amex. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-Amex-2004-27 and should be
submitted on or before September 10, 2007.

V. Accelerated Approval

    The Commission finds good cause for approving the proposed rule
change, as amended, prior to the thirtieth day after the date of
publication of notice of filing of Amendment No. 4 in the Federal
Register. In Amendment No. 4, Amex provided representations regarding
surveillance and systems capacity and corrected minor errors in the
text of the proposed rules. In addition, Amendment No. 4 clarified the
use of composite prices in calculating the all-day VWAP that will be
used to establish the settlement price for FROs, and clarified that
positions of 10,000 contracts, rather than 25,000 contracts, will be
subject to certain reporting requirements. The Commission believes that
Amendment No. 4 clarifies and strengthens the proposal and raises no
new regulatory issues. Accordingly, the Commission finds good cause for
approving the proposal, as amended, on an accelerated basis, pursuant
to Section 19(b)(2) of the Act.

VI. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\31\ that the proposed rule change (SR-Amex-2004-27), as amended,
is approved, on an accelerated basis.
---------------------------------------------------------------------------

    \31\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\32\
Florence E. Harmon,
Deputy Secretary.
---------------------------------------------------------------------------

    \32\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

 [FR Doc. E7-16330 Filed 8-17-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: August 31, 2007 (Volume 72, Number 169)]
[Notice]
[Page 50348]
[DOCID:fr31au07-69]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL03-180-000; Docket No. EL03-154-000; Docket No. EL02-114-
000; Docket No. EL02-115-000; Docket No. EL02-113-000]

Enron Power Marketing, Inc. and Enron Energy Services, Inc.;
Enron Power Marketing, Inc. and Enron Energy Services, Inc.; Portland
General Electric Company; Enron Power Marketing, Inc.; El Paso Electric
Company, Enron Power Marketing, Inc., and Enron Capital & Trade
Resources Corp.; Notice Shortening Answer Period

July 13, 2007.
    On July 13, 2007, Enron Power Marketing, Inc., Enron Energy
Services, Inc. and Enron North America Corp. (collectively, ``Enron'')
filed a motion for an extension of time to file briefs on exceptions
and briefs opposing exceptions to the Initial Decision issued June 21,
2007, in the above-referenced proceeding Enron Power Mktg., Inc., 119
FERC ] 63,013 (2007) (July 13 Motion). Among other things, Enron
requests that the date for filing answers to its July 13 Motion be
shortened in order to allow for an expedited schedule in this
proceeding.
    By this notice, the date for filing answers to Enron's July 13
Motion is shortened to and including July 16, 2007.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-17309 Filed 8-30-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Rules and Regulations]
[Pages 7445-7446]
[FR Doc No: 2016-02884]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 /
Rules and Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 601

[Docket No. FDA-2015-N-2103]

Removal of Review and Reclassification Procedures for Biological
Products Licensed Prior to July 1, 1972

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
removing two regulations that prescribe procedures for FDA's review and
classification of biological products licensed before July 1, 1972. FDA
is taking this action because the two regulations are obsolete and no
longer necessary in light of other statutory and regulatory authorities
established since 1972, which allow FDA to evaluate and monitor the
safety and effectiveness of all biological products. In addition, other
statutory and regulatory authorities authorize FDA to revoke a license
for biological products because they are not safe and effective, or are
misbranded. FDA is taking this action as part of its retrospective
review of its regulations to promote improvement and innovation.

DATES: This rule is effective March 14, 2016.

ADDRESSES: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number found in brackets in the heading of this final rule into
the ``Search'' box and follow the prompts, and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1062, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jessica T. Walker, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Purpose of the Final Rule

    FDA is removing two regulations that prescribe procedures for FDA's
review and classification of biological products licensed before July
1, 1972, because the two regulations are obsolete and no longer
necessary in light of other statutory and regulatory authorities
established since 1972. These other statutory and regulatory
authorities allow FDA to evaluate and monitor the safety and
effectiveness of all biological products and authorize FDA to revoke a
license for products because they are not safe and effective, or are
misbranded.

B. Summary of the Major Provisions of the Final Rule

    The final rule removes Sec. Sec.  601.25 and 601.26 (21 CFR 601.25
and 601.26), which prescribe procedures for FDA's review and
classification of biological products licensed before July 1, 1972.

C. Legal Authority

    FDA is taking this action under the biological products provisions
of the Public Health Service Act (the PHS Act), and the drugs and
general administrative provisions of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act).

D. Costs and Benefits

    Because this final rule would not impose any additional regulatory
burdens, this regulation is not anticipated to result in any compliance
costs and the economic impact is expected to be minimal.

II. Background

A. History of the Rulemaking

    In the Federal Register of July 2, 2015 (80 FR 38145), FDA proposed
to remove regulations that prescribe procedures for FDA's review and
classification of biological products licensed before July 1, 1972. As
discussed in the preamble to the proposed rule, these regulations were
originally issued after the Director of the National Institutes of
Health (NIH) announced in the Federal Register on March 15, 1972, that
the Division of Biologics Standards, NIH, would review the
effectiveness of all licensed biologicals (37 FR 5404). In the Federal
Register of June 29, 1972 (37 FR 12865), FDA announced the transfer of
regulatory authority over biological products from the Division of
Biologics Standards, NIH, to FDA. After obtaining regulatory authority
over biological products, the Commissioner of FDA proposed procedures
for reviewing the safety, effectiveness, and labeling of all biological
products licensed at the time of the transfer on July 1, 1972 (37 FR
16679, August 18, 1972). The procedures for review of biological
products licensed before July 1, 1972, were codified in 21 CFR 273.245
(38 FR 4319 at 4321, February 13, 1973) and later redesignated to Sec.
601.25 (38 FR 32048, November 20, 1973). The procedures for review of
biological products licensed before July 1, 1972, were supplemented by
procedures codified in Sec.  601.26 (47 FR 44062, October 5, 1982).

B. Current Methods for Ensuring the Safety and Effectiveness of
Biological Products

    Since establishing the procedures under Sec. Sec.  601.25 and
601.26, FDA developed new regulations to assess and ensure the safety
and efficacy of biological products. FDA issued the Current Good
Manufacturing Practice (cGMP) regulations, which contain the minimum
cGMP for preparation of drug products, including biological products.
The cGMP regulations help FDA ensure that such products meet the
requirements for product safety, effectiveness, and labeling. FDA also
helps ensure the safety and effectiveness of biological products
through application of other regulations, such as the reporting of
biological product deviations by licensed manufacturers (see 21 CFR
600.14), postmarketing reporting of adverse experiences (21 CFR
600.80), and labeling regulations (for example, 21 CFR part 201).
Biological products that do not meet the requirements under these
regulations are subject to license revocation under 21 CFR 601.5, which
allows FDA to revoke any biologics license for a product that fails to
meet applicable standards and fails to comply with

regulations designed to help ensure the safety, purity, and potency of
the licensed product, and that the product is not misbranded.
    In addition, FDA continues to help ensure the safety and
effectiveness of licensed biological products through the development
and application of additional standards and mechanisms. These
mechanisms assist FDA in evaluating and monitoring the safety and
effectiveness of biological products.

C. Summary of Comments to the Proposed Rule

    FDA did not receive any comments on the proposed rule.

D. General Overview of the Final Rule

    The final rule removes Sec. Sec.  601.25 and 601.26 of the
regulations, which prescribe procedures for FDA's review and
classification of biological products licensed before July 1, 1972. FDA
is taking this action because these regulations are obsolete and no
longer necessary in light of other statutory and regulatory authorities
established since 1972, which allow FDA to evaluate and monitor the
safety and effectiveness of all biological products.

III. Legal Authority

    FDA is issuing this regulation under the biological products
provisions of the PHS Act (42 U.S.C. 262 and 264) and the drugs and
general administrative provisions of the FD&C Act (sections 201, 301,
501, 502, 503, 505, 510, 701, and 704 (21 U.S.C. 321, 331, 351, 352,
353, 355, 360, 371, and 374)). Under these provisions of the PHS Act
and the FD&C Act, we have the authority to issue and enforce
regulations designed to ensure that biological products are safe, pure,
and potent; and to prevent the introduction, transmission, and spread
of communicable disease.

IV. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). We believe that this final rule is not a significant
regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this final rule removes regulations that are
obsolete and no longer necessary in light of other current statutory
and regulatory authorities, FDA certifies that the final rule will not
have a significant economic impact on a substantial number of small
entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $144
million, using the most current (2014) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in any 1-year
expenditure that would meet or exceed this amount.

V. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
adverse effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.

VI. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore,
clearance by OMB under the Paperwork Reduction Act of 1995 is not
required.

VII. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that would have substantial direct effects on
the States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the Agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.

List of Subjects in 21 CFR Part 601

    Administrative practice and procedure, Biologics, Confidential
business information.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, 21 CFR part 601 is amended as follows:

PART 601--LICENSING

0
1. The authority citation for 21 CFR part 601 continues to read as
follows:

    Authority:  15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353,
355, 356b, 360, 360c-360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C.
216, 241, 262, 263, 264; sec 122, Pub. L. 105-115, 111 Stat. 2322
(21 U.S.C. 355 note).

Sec.  601.25  [Removed]

0
2. Remove Sec.  601.25.

Sec.  601.26  [Removed]

0
3. Remove Sec.  601.26.

    Dated: February 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02884 Filed 2-11-16; 8:45 am]
 BILLING CODE 4164-01-P


Page of 2 1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES February 28, 2006 MEMORANDUM SUBJECT: Dicloran: HED Response to Public Comments Phase 4. PC Code: 031301, Case #: 0113, DP Barcode: D325652. Regulatory Action: Phase 4  HED Response to Registrant's Public Comments Risk Assessment Type: Single Chemical Aggregate FROM: Toiya Goodlow, Risk Assessor Byong Han Chin, Ph. D., Toxicologist Christine L. Olinger, Chemist Matthew G. Lloyd, M. S., Industrial Hygienist Reregistration Branch 1 Health Effects Division ( 7509C)

THROUGH: Whang Phang, Ph. D., Branch Senior Scientist Reregistration Branch 1 Health Effects Division ( 7509C)

TO: James Parker, Chemical Review Manager Special Review and Reregistration Division ( 7508C)

This document was written in response to public comments submitted for the Human Health Risk Assessment for the Dicloran Reregistration Eligibility Decision Document ( RED). All comments have been reviewed by RRB1/ HED and incorporated into the Revised Human Health Risk Assessment for the Dicloran RED ( D325653, 2/ 28/ 06, T. Goodlow) as deemed appropriate by the Agency.

Changes include the following:

Toxicology Page of 2 2 ° After reevaluation, HED has determined that the developmental neurotoxicity study requirement will remain, in addition to a 10X FQPA database uncertainty factor. The risk assessment has been revised to reflect a total uncertainty factor of 1000 for acute and chronic reference doses ( 10x for intraspecies variation; 10x for interspecies extrapolation; 10X for database uncertainty factor).

Occupational/ Residential Exposure Although, public comments were not submitted, HED addressed several issues during this phase.

° The submission of new label information permitted HED to perform an assessment for greenhouse seed potatoes or transplants.

° The inclusion of revised product label information resulted in the elimination of chronic exposure scenarios for cut flowers.

° Newly submitted application rate data from SRRD was included in the worker postapplication risk assessments for those crops where postapplication risks exceeded HED's level of concern at Day 0.

Chemistry ° The addition of the 10X database uncertainty safety factor warranted a new dietary assessment. Updated dietary exposure and risk estimates are included in the dicloran revised risk assessment.

References Goodlow, Toiya. DP Barcode: D325653. February 28, 2006. Dicloran: Revised HED Chapter of the Reregistration Eligibility Decision Document ( RED), Phase 3 Public Comments.

7509C: RRB1: TGoodlow: CM# 2: Rm 722H: 308 0070: 2/ 28/ 06 WPhang: 2/ 28/ 06


[ Federal Register: June 3, 2002 ( Volume 67, Number 106)] [ Notices] [ Page 38276 38279] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr03jn02 51]

ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0078; FRL 7179 2]

Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain [[ Page 38277]]

pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket control number OPP 2002 0078, must be received on or before July 3, 2002.

ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. C. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP 2002 0078 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Shaja Brothers, Registration Support Branch, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 308 3194 and e mail address: brothers. shaja@ epa. gov.

SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me?

You may be affected by this action if you are an agricultural producer, food manufacturer or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

 Examples of Categories NAICS codes potentially affected entities  Industry 111 Crop production 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select    Laws and Regulations,''    Regulations and Proposed Rules,'' and then look up the entry for this document under the    Federal Register'' Environmental Documents. You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. 2. In person. The Agency has established an official record for this action under docket control number OPP 2002 0078 official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall i2, 1921 Jefferson Davis Highway, Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305 5805.

C. How and to Whom Do I Submit Comments?

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP 2002 0078 in the subject line on the first page of your response. 1. By mail. Submit your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall i2, 1921 Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305 5805. 3. Electronically. You may submit your comments electronically by e mail to: opp docket@ epa. gov, or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in Wordperfect 6.1/ 8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPP 2002 0078. Electronic comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Make sure to submit your comments by the deadline in this notice. 7. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your [[ Page 38278]]

response. You may also provide the name, date, and Federal Register citation.

II. What Action is the Agency Taking?

EPA has received a pesticide petition as follows proposing the establishment and/ or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in section 408( d)( 2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: May 17,2002. Robert Forrest, Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition The petitioner summary of the pesticide petition is printed below as required by section 408( d)( 3) of the FFDCA. The summary of the petition was prepared by the Interregional Research Project Number 4, and represents the view of the Interreional Research Project. EPA is publishing the petition summary verbatim without editing it in any way. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.

PP 1E6322 EPA has received a pesticide petition ( 1E6322) from the Interregional Research Project Number 4, 681 U. S. Highway 1 South, North Brunswick, New Jersey 08902 3390] proposing, pursuant to section 408( d) of the FFDCA, 21 U. S. C. 346a( d), to amend 40 CFR 180.479 by establishing a tolerance for residues of the herbicide [ halosulfuron, methyl 5[( 4,6 dimethoxy 2 pyrimidinyl) amino] carbonylaminosulfonyl 3 chloro 1 methyl 1H pyrazole 4 carboxylate] in or on the raw agricultural commodities ( RAC) dry bean and succulent snap bean at 0.05 parts per million ( ppm). EPA has determined that the petition contains data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition. This notice includes a summary of the petition prepared by Gowan Company, Yuma, Arizona 85366.

A. Residue Chemistry 1. Plant metabolism. The metabolism of halosulfuron methyl as well as the nature of the residues in plants is adequately understood for purposes of this tolerance. 2. Analytical method. A practical analytical method, gas chromatography with a nitrogen specific detector ( TSD) which detects and measures residues of halosulfuron methyl, is available for enforcement purposes with a limit of detection that allows monitoring of food with residues at or above the levels set in these tolerances. This enforcement method has been submitted to the Food and Drug Administration for publication in the Pesticide Analytical Manual ( PAM II). It has undergone independent laboratory validation and validation at the Beltsville laboratory. 3. Magnitude of residues. In snap and dry bean residue studies, there were no quantifiable residues found in the RAC using an analytical method with limit of quantitation ( LOQ) of 0.05 ppm.

B. Toxicological Profile The nature of the toxic effects caused by halosulfuron methyl is discussed in unit II. B of the Federal Register on April 31, 2001 ( 66 FR 45993) ( FRL 6796 1).

C. Aggregate Exposure 1. Dietary exposure. Tolerances have been established ( 40 CFR 180.479) for residues of halosulfuron methyl in or on a variety of plant and animal RACs. i. Food a. Acute exposure. For purposes of assessing the potential dietary exposure from food under existing and proposed tolerances, the aggregate exposure is based on the Theoretical Maximum Residue Contribution ( TMRC) which is an estimate of the level of residues consumed daily if each food item contained pesticide residues equal to the tolerance. The calculated TMRC value using the 99.9th percentile consumption data was 0.006 milligrams/ kilograms bodyweight day ( mg/ kg bwt day) or 1.2% acute Reference Dose ( aRfD) for the general U. S. population. TMRC is obtained by multiplying the tolerance levels for each commodity by the daily consumption of the food forms of that commodity eaten by the U. S. population and various population subgroups. In conducting this exposure assessment, conservative assumptions were made resulting in a large overestimate of human exposure. Thus, the dietary exposures to halosulfuron methyl are less 3.0% aRfD for all sub populations. Food consumption data from DEEM software were used in the calculation. b. Chronic exposure. The chronic Reference Dose ( cRfD) is 0.1 mg/ kg/ day. For all established and proposed tolerances of halosulfuron methyl, the calculated TMRC value for the U. S. population is 0.00049 mg/ kg/ day or 0.5% RfD. ii. Drinking water. The estimated environmental concentrations ( EECs) in ground water ( acute and chronic) is 0.008 [ mu] g/ L. The estimated EECs ( acute and chronic) for surface water are 4.3 [ mu] g/ L and 1.1 [ mu] g/ L, respectively. These estimates are based on a maximum application rate of 0.063 lbs. active per acre, which may be applied twice per season. There is no Maximum Contaminant Level ( MCL) established for residues of halosulfuron methyl. 2. Non dietary exposure. The non dietary exposure assessment for halosulfuron methyl is discussed in unit II. C of the Federal Register on April 31, 2001 ( 66 FR 45993) ( FRL 6796 1).

D. Cumulative Effects The potential for cumulative effects for halosulfuron methyl is discussed in unit II. D of the Federal Register on April 31, 2001 ( 66 FR 45993) ( FRL 6796 1).

E. Safety Determination 1. U. S. population. Aggregate chronic exposure to halosulfuron methyl from    food only'' utilizes less than 1% of the chronic populated adjusted dose ( cPAD) for the most sensitive subgroup, children ( 1 6 years). The lowest drinking water level of concern ( DWLOC) calculated was 1,000 [ mu] g/ L for infants and children which is significantly higher than the EEC for chronic ground water ( 0.008 [ mu] g/ L) and surface water ( 1.1 [ mu] g/ L). As a result, the aggregate risk from chronic exposure to halosulfuron methyl residues from all anticipated dietary exposures does not pose appreciable risks to human health. Short term risk short term aggregate exposure takes into account chronic dietary food and water plus short term residential exposure. For halosulfuron methyl, the EPA has determined that it is appropriate to aggregate exposure via [[ Page 38279]]

oral exposure route ( food and water) with those via oral and dermal exposure routes from residential uses. The MOEs for    food only'' and residential exposure routes are 113, 600, and 330 for females 13+ years. Short term DWLOC for females 13+ is 10,000 [ mu] g/ L which is substantially higher than the EECs for acute surface water ( 4.3 [ mu] g/ L). The food only and residential ( oral and dermal) MOEs are well above the acceptable short term aggregate MOE of 100. Therefore, exposure to halosulfuron methyl residues resulting from current and proposed uses does not pose a short term aggregate risk. Intermediate term risk intermediate term aggregate exposure takes into account chronic dietary food and water plus intermediate term residential exposure. The MOEs for    food only'' and residential exposure routes are 22,800 and 120 for adult males, and 23,000 and 100 for females 13+ years. The intermediate term DWLOCs are 590 [ mu] g/ L and 57 [ mu] g/ L, respectively, for adult males and females 13+. Intermediate term DWLOCs are substantially higher than the EEC for chronic surface water ( 1.1 [ mu] g/ L). The food only and residential ( dermal) MOEs are above the acceptable short term aggregate MOE of 100. Therefore, exposure to halosulfuron methyl residues resulting from current and proposed uses does not pose a intermediate term aggregate risk. Halosulfuron methyl has been classified as a Group E chemical based upon the lack of evidence of carcinogenicity in mice and rats, and has been classified as not likely to be a human carcinogen. Therefore based upon this risk assessment, there is reasonable certainty that no harm will result from aggregate exposure to halosulfuron methyl residues resulting from current and proposed uses. 2. Infants and children. FFDCA section 408 provides that EPA may apply an additional safety factor ( up to 10) in the case of threshold effects for infants and children to account for pre natal and post natal toxicity and the completeness of the data base. Except for the pending request for a developmental neurotoxicity study, the toxicity data base is complete for halosulfuron methyl. The chronic RfD was determined to be 0.1 mg/ kg/ day based upon the chronic dog study. The percent of RfD occupied is 0.9% for the most sensitive population subgroup, children ( 1 6 years old). The DWLOC for chronic exposure for infants and children is 1,000 [ mu] g/ L and is significantly greater than the maximum concentration of halosulfuron methyl in drinking water ( 0.008 [ mu] g/ L in ground water and 1.1 [ mu] g/ L in surface water). Based upon reliable toxicity data, the use of an additional 10X safety factor is not warranted. Dietary assessments do not indicate a level of concern for potential risks to infants and children based upon the low use rates of halosulfuron methyl, and the results of field and animal RAC studies conclude that detectable residues are not expected in human foods. Therefore, based on complete and reliable toxicity data and the conservative exposure assessment, it is concluded that there is reasonable certainty that no harm will result to infants and children from aggregate exposure to halosulfuron methyl residues with respect to the proposed new uses on dry and succulent snap beans.

F. International Tolerances Maximum residue levels have not been established for residues of halosulfuron methyl on any food or feed crop by the Codex Alimentarius Commission. [ FR Doc. 02 13814 Filed 5 31 02 8: 45 am] BILLING CODE 6560 50 S


[Federal Register Volume 81, Number 17 (Wednesday, January 27, 2016)]
[Notices]
[Page 4724]
[FR Doc No: 2016-01536]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76955; File No. SR-NYSEArca-2015-93]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of
Designation of a Longer Period for Commission Action on Proposed Rule
Change, as Modified by Amendment No. 1, Relating To Listing and Trading
of Shares of the Cumberland Municipal Bond ETF Under NYSE Arca Equities
Rule 8.600

January 21, 2016.
    On November 24, 2015, NYSE Arca, Inc. 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 list and trade shares of the
Cumberland Municipal Bond ETF, a series of the ETF is Series Trust I.
The proposed rule change was published for comment in the Federal
Register on December 14, 2015.\3\ On December 29, 2015, the Exchange
submitted Amendment No. 1 to the proposed rule change.\4\ The
Commission received no comment letters on the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 76590 (December 8,
2015), 80 FR 77384 (``Notice'').
    \4\ In Amendment No. 1, which replaces and supersedes the
original filing in its entirety, the Exchange made clarifying
changes, added a representation regarding municipal bonds, deleted a
sentence regarding redemption, and clarified pricing information for
certain assets. Amendment No. 1 is not subject to notice and comment
because it is a technical amendment that does not materially alter
the substance of the proposed rule change or raise any novel
regulatory issues. It is available at: http://www.sec.gov/comments/sr-nysearca-2015-93/nysearca201593-1.pdf.
---------------------------------------------------------------------------

    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
Commission is extending this 45-day time period. The Commission finds
that it is appropriate to designate a longer period within which to
take action on the proposed rule change so that it has sufficient time
to consider the proposed rule change.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\6\ designates April 27, 2016, 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 Number
SR-NYSEArca-2015-93), as modified by Amendment No. 1.
---------------------------------------------------------------------------

    \6\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

Brent J. Fields,
 Secretary.
[FR Doc. 2016-01536 Filed 1-26-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 120 (Friday, June 21, 2019)]
[Rules and Regulations]
[Pages 29078-29080]
[FR Doc No: 2019-13208]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2019-0421]
RIN 1625-AA00

Safety Zone; Ohio River, Miles 90.7 to 91.2, Wheeling, WV

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters of the Ohio River from mile 90.7 to mile 91.2. The
safety zone is needed to protect personnel, vessels, and the marine
environment from potential hazards created by a land based fireworks
display. Entry of vessels or persons into this zone is prohibited
unless specifically authorized by Captain of the Port Marine Safety
Unit Pittsburgh.

DATES: This rule is effective from 9 p.m. through 10:30 p.m. on June
22, 2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2019-0421 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email MST1 Jennifer Haggins, Marine Safety Unit Pittsburgh,
U.S. Coast Guard, at telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable. It is
impracticable to complete the full NPRM process for this safety zone
because we must establish the safety zone by June 22, 2019 and lack
sufficient time to provide a reasonable comment period and then
consider those comments before issuing the rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying this rule would be
contrary to the public interest because immediate action is necessary
to respond to the safety hazards associated with the fireworks display.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Marine
Safety Unit Pittsburgh (COTP) has determined that a safety zone is
needed to protect personnel, vessels, and the marine environment from
potential hazards created from a land based firework display.

IV. Discussion of the Rule

    This rule establishes a safety zone on June 22, 2019, from 9 p.m.
through 10:30 p.m. The safety zone will cover all navigable waters on
the Ohio River from mile 90.7 to mile 91.2. The duration of the safety
zone is intended to protect personnel, vessels, and the marine
environment from potential hazards created by a land based firework
display.

    No vessel or person is permitted to enter the safety zone without
obtaining permission from the COTP or a designated representative. A
designated representative is a commissioned, warrant, or petty officer
of the U.S. Coast Guard (USCG) assigned to units under the operational
control of the COTP. To seek permission to enter, contact the COTP or a
designated representative via VHF-FM channel 16, or through Marine
Safety Unit Pittsburgh at<PHONE_NUMBER>. Persons and vessels permitted
to enter the safety zone must comply with all lawful orders or
directions issued by the COTP or designated representative. The COTP or
a designated representative will inform the public of the effective
period for the safety zone as well as any changes in the dates and
times of enforcement through Local Notice to Mariners (LNMs), Broadcast
Notices to Mariners (BNMs), and/or Marine Safety Information Bulletins
(MSIBs), as appropriate.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, and duration of the safety zone. This safety zone impacts a
one mile stretch of the Ohio River for a limited duration of less than
two hours. Vessel traffic will be informed about the safety zone
through local notices to mariners. Moreover, the Coast Guard will issue
LNMs, MSIBs, and BNMs via VHF-FM marine channel 16 about the zone and
the rule allows vessels to seek permission to transit the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
temporary safety zone may be small entities, for the reasons stated in
section V.A above, this rule will not have a significant economic
impact on any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have
determined that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves a safety zone lasting less than two
hours that will prohibit entry on the Ohio River from mile 90.7 to mile
91.2 during a land based firework event. It is categorically excluded
from further review under paragraph L60(a) of Table 3-1 of U.S. Coast
Guard Environmental Planning Implementing Procedures 5090.1. A Record
of Environmental Consideration supporting this determination is
available in the docket where indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.

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

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T08-0421 to read as follows:

Sec.  165.T08-0421  Safety Zone; Ohio River, Miles 90.7--91.2,
Wheeling, WV.

    (a) Location. The following area is a safety zone: all navigable
waters of the Ohio River from mile 90.7 to mile 91.2
    (b) Effective period. This section is effective from 9p.m. through
10:30 p.m. on June 22, 2019.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, entry of persons and vessels into this zone is prohibited
unless authorized by the Captain of the Port Marine Safety Unit
Pittsburgh (COTP) or a designated representative.
    (2) Persons or vessels requiring entry into or passage through the
zone must request permission from the COTP or a designated
representative. The COTP's representative may be contacted at 412-221-
0807.
    (3) All persons and vessels shall comply with the instructions of
the COTP or a designated representative. Designated COTP
representatives include United States Coast Guard commissioned,
warrant, and petty officer.
    (d) Information broadcasts. The Captain COTP or a designated
representative will inform the public through Local Notice to Mariners
(LNMs), Broadcast Notices to Mariners (BNMs), and/or Marine Safety
Information Bulletins (MSIBs), as appropriate.

A.W. Demo,
Commander, U.S. Coast Guard, Captain of the Port Marine Safety Unit
Pittsburgh.
[FR Doc. 2019-13208 Filed 6-20-19; 8:45 am]
 BILLING CODE 9110-04-P