§ 316( b) Regional Case Studies, Part B: North AtlanticChapter B5: Recreational Fishing Benefits 1 See Chapter A 10 of the Proposed Rule Case Study Report ( http:// www. epa. gov/ ost/ 316b) or " Marine Recreational Fisheries Statistics: Data user's Manual," NMFS, http:// www. st. nmfs. gov. recreational/ index. html) for general discussion of the MRFSS.

NODA Version  March 12, 2003B5 1 Chapter B5: Recreational Fishing Benefits INTRODUCTION This regional case study estimates the effects of improved fishing opportunities due to reduced impingement and entrainment ( I& E) in the North Atlantic region. The case study focuses on marine fishing sites in the Atlantic coastal areas of Maine, New Hampshire, Massachusetts, Rhode Island, and Connecticut. This study utilizes the fishing site choice model developed by Robert Hicks from the National Marine Fisheries Service, Office of Science and Technology ( Hicks, Steinback, Gautam, Thunberg, 1999).

Cooling Water Intake Structures ( CWISs) withdrawing water from the Atlantic Ocean impinge and entrain many of the species sought by recreational anglers. These species include winter flounder, tautog, Atlantic cod, striped bass, bluefish, scup, and other less prominent species. Some of these species ( e. g., weakfish, flounder, and striped bass) inhabit a wide range of coastal waters spanning several states ( e. g., striped bass can be caught throughout the whole North Atlantic region). The main assumption of this analysis is that, all else being equal, anglers will get greater satisfaction and thus greater economic value from sites with a higher catch rate. This benefit may occur in two ways:

< first, an angler may get greater enjoyment from a given fishing trip with higher catch rates, yielding a greater value per trip; < second, anglers may take more fishing trips when catch rates are higher, resulting in greater overall value for fishing in the region.

Section B5 2 describes the Hicks et al. ( 1999) model and the resulting estimated coefficients. Section B5 3 focuses on the method of estimating welfare and the results stemming from changes in catch rates as a result of eliminating I& E. The following section describes the data set used in the analysis and analytic results.

B5 1 DATA SUMMARY The Hicks et al. ( 1999) analysis of improvements in recreational fishing opportunities in the New England and Mid Atlantic region relies on a subset of the National Marine Fisheries Service's ( NMFS) Marine Recreational Fishery Statistics Survey ( MRFSS), combined with the 1994 Add on MRFSS Economic Survey ( NMFS, 1999; QuanTech, 1998). 1 The model of recreational fishing behavior developed in the study relies on a subset of the survey respondents which includes only single day trips to sites located along the Atlantic coast. This section provides a summary of anglers' characteristics who took one day trips to fishing sites in the five North Atlantic states. This analysis is based a sample of 9,314 respondents to the MRFSS survey. CHAPTER CONTENTS B5 1 Data Summary.............................. B5 1 B5 1.1 Summary of Anglers' Characteristics....... B5 2 B5 1.2 Recreational Fishing Choice Sets .......... B5 5 B5 1.3 Site Attributes......................... B5 5 B5 1.4 Travel Cost........................... B5 6 B5 2 The Nested Random Utility Model of Recreational Demand...................... B5 7 B5 3 Welfare Estimates............................ B5 8 B5 3.1 Estimating Changes in the Quality of Fishing Sites............................. B5 8 B5 3.2 Estimating Losses from I& E in the North Atlantic Region..................... B5 9 B5 4 Limitations and Uncertainty................... B5 12 B5 4.1 Considering Only Recreational Values..... B5 12 Glossary....................................... B5 13 Acronyms...................................... B5 14 References..................................... B5 15 § 316( b) Regional Case Studies, Part B: North AtlanticChapter B5: Recreational Fishing Benefits 2 Note that bottom species targeted by offshore anglers and charter boat anglers are different. target tautog, black sea bass, and drums, while offshore anglers target white perch, catfish, and dogfish sharks.

3 Income was not reported by most survey respondents. Median household income data by zip code, from the U. S. Census, was used to provide income information for respondents not reporting income.

4 All costs are in 1994$, which represent the MRFSS survey year. All costs/ benefits will be updated to 2002$ later in this analysis ( e. g., for welfare estimation).

NODA Version  March 12, 2003B5 2 B5 1.1 a. Based on the data set used in developing the NMFS model, a majority of the interviewed anglers ( 62 percent) fish from either a private or a rental boat ( see Table B5 1, below). ately 24 percent fish from the shore; the remaining 14 percent fish from a party or charter boat. ode of fishing, the MRFSS contains information on the specific species targeted on the surveyed trip. ost popular species group, targeted by 56 percent of all anglers, is small game. second most popular species group, targeted by 18 percent of all anglers, is bottom fish. ately 12 percent of anglers did not have a designated target species. aining anglers, ten, two, and one percent target flatfish, other species group, and big game, respectively.

The distribution of target species is not uniform by fishing mode. ple, more than 76 percent of the anglers fishing from private/ rental boats target either small game fish ( 59.33 percent) or bottom fish ( 16.87 percent). ajority of the anglers fishing from shore, on the other hand, target small game fish ( 59.12 percent) or do not have a targeted species ( 16.64 percent). all game and bottom fish remain the most popular species groups among anglers fishing from a charter/ party boat ( 37.67 and 40.19 percent respectively). 2 A relatively large percentage of charter boat anglers target big game species ( 4.18 percent), compared to a small percentage of anglers targeting big game species from either private or rental boats ( 0.95 percent) or shore ( 0.35 percent).

Table B5 1: Species Group Choice by Mode of Fishing in the North Atlantic Region Species All ModesPrivate/ Rental BoatParty/ Charter BoatShore FrequencyPercentFrequencyPercent by ModeFrequencyPercent by ModeFrequencyPercent by Mode Small game5,24656.32% 3,42959.33% 47837.67% 1,33959.12%

Bottom fish1,70518.31% 97516.87% 51040.19% 2209.71%

Flatfish9149.81% 73812.77% 100.79% 1667.33%

Big game1161.25% 550.95% 534.18% 80.35%

No target1,13612.20% 5419.36% 21817.18% 37716.64%

Other1972.12% 420.73% 00.00% 1556.84%

All species9,314100.00% 5,78062.00% 1,26914.00% 2,265 24.00%

Source: U. S. EPA analysis.

b. This section presents a summary of angler characteristics for the North Atlantic region as defined above. summarizes characteristics of the sample anglers fishing the NMFS sites in the North Atlantic region.

The average income of the respondent anglers was $ 47,994 ( 1994$). 3,4 Ninety five percent of the anglers are white, with an average age of about 43 years. ent information indicates that 41 percent of the anglers had received a high school diploma, while only 18 percent had graduated from college.

Charter boat anglers usually Summary of Anglers  Characteristics Fishing modes and targeted species Approxim In addition to the m The mThe Approximall Of the rem For exam The m Sm Anglers  characteristics Table B5 2 Educational attainm The average household size was three individuals. § 316( b) Regional Case Studies, Part B: North Atlantic Chapter B5: Recreational Fishing Benefits Nearly 15 percent of the anglers are retired, while79 percent are employed. Sixty nine percent of the anglers indicated that they had flexible time when setting their work schedule.

Table B5 2 shows that on average anglers spent 31 days fishing during the past year. The average duration of a fishing trip was about 4 hours per day. Anglers made an average of 6.2 trips to the current site, with an average trip cost of $ 38.12 ( 1994$). 5 Average round trip travel time was about two and a half hour. Fifty five percent of the North Atlantic anglers own their own boat. Finally, the average number of years of fishing experience was 21. This analysis does not include anglers under the age of 16, which may result in overestimation of the average age of recreational anglers and years of experience.

5 All costs are in 1994$, which represent the MRFSS survey year. All costs/ benefits will be updated to 2002$ later in this analysis ( e. g., for welfare estimation).

NODA Version  March 12, 2003 B5 3 § 316( b) Regional Case Studies, Part B: The North Atlantic RegionChapter B5: Recreational Fishing Benefits NODA Version  March 12, 2003B5 4 Table B5 2: ta Summary for the North Atlantic Coast Anglers Variable All ModesPrivate/ Rental BoatParty/ Charter BoatShore NMeanaStd DevNMeanaStd DevNMeanaStd DevNMeanaStd Dev Trip 8,16538.1259.925,182$ 33.36$ 51.541,050$ 72.34$ 92.111,933$ 32.30$ 52.08 Travel 8,6892.553.135,5012.242.681,1294.644.322,0592.233.03 Visits1,4466.158.979346.388.721352.075.473777.0510.17 Own a boat1,8800.550.501,1040.750.432980.190.394780.290.45 High School1,8580.410.491,0930.410.492930.370.484720.430.50 College Degree1,8580.180.391,0930.200.402930.190.394720.150.36 Retired1,8730.150.351,1000.130.342960.140.344770.190.39 Employed1,8730.790.411,1000.820.382960.790.414770.710.45 Age1,85943.3113.951,09243.7412.9729441.3814.6047343.5015.56 Years Fishing1,91420.7215.301,13121.1914.6230317.9815.9348021.3416.25 Household Size1,8643.031.341,0973.011.312943.161.334732.981.40 Flexible Time1,4560.690.468920.690.462300.700.463340.680.47 Male1,8800.940.251,1040.940.232980.900.304780.940.24 White1,8440.950.221,0830.960.202900.930.254710.930.26 Household Income1,667$ 47,994$ 29,233990$ 51,129$ 29,229265$ 51,047$ 29,554412$ 38,501$ 26,967 Average trip length in hours 8,6763.952.125,4994.222.131,1284.651.962,0492.841.73 Annual trips9,25431.4643.935,74131.6340.131,2639.5324.362,25043.3355.55 a For dummy variables, such as   Own a Boat,  that take the value of 0 or 1, the reported value represents a portion of the survey respondents possessing the relevant characteristic.

example, 55 percent of the surveyed anglers own a boat.

Source: U. S. EPA analysis. Da Cost Time For § 316( b) Regional Case Studies, Part B: North Atlantic Chapter B5: Recreational Fishing Benefits B5 1.2 Recreational Fishing Choice Sets For consistency with Hicks et al. ( 1999), the Agency aggregated NMFS intercept sites to the county level, resulting in 26 sites from Maine through Connecticut. The 26 fishing sites, along with the angler s state of residence, define the individual s choice set. The choice set is defined according to the approach developed by Hicks et al. ( 1999). If the closest site is within 30 miles from the angler s home, then all sites within 150 miles are assumed to be in their choice set; otherwise, all sites within 400 miles are assumed to be in their choice set. Distances in the original study were estimated using PCMiler software. EPA used ArcView 3.2a software to determine the distance from an anglers residence to each NMFS intercept site. Further discussion of distance estimation is presented in Section B5 1.4. Based on this method of site choice construction, EPA concluded that residents of the five states have 4 to 26 fishing sites in their choice sets.

B5 1.3 Site Attributes This analysis assumes that the angler chooses between site alternatives by comparing his indirect utility function for each alternative and choosing the one that maximizes his utility. Following Hicks et al. ( 1999), this assumption states that the individual first chooses fishing mode and target species and then, conditional on his choice, chooses the recreational site.

Catch rate is the most important attribute of a fishing site from the angler s perspective ( McConnell and Strand, 1994; Haab et al., 2000). This attribute is also a policy variable of concern as catch rate is a function of fish abundance, which is affected by fish mortality due to I& E. The catch rate variable in the model provides a means to measure baseline losses from I& E and changes in anglers  welfare attributed to changes from I& E due to the 316( b) rule.

To specify the baseline fishing quality of the case study sites EPA followed the approach used by Hicks et al. ( 1999). The Agency calculated average historic catch rates based on the NMFS intercept survey data from 1990 to 1994 for recreationally important species, such as striped bass, bluefish, summer flounder, Atlantic cod, tautog, and winter flounder ( McConnell and Strand, 1994; Hicks et al., 1999). 6 EPA aggregated all species into five species groups   big game fish, bottom fish, flatfish, small game fish, and no target   and calculated the average group specific historic catch rates. Following the species groups definitions in Hicks et al. ( 1999), the following species are included in the four specific groups listed below. The   No target  category covers all species caught by anglers that are not included in big game, bottom fish, small fish, or flatfish.

< Big game: Albacore, Blue Shark, Bluefin Tuna, Shortfin Mako Shark, Tuna, Smooth Hammerhead, Thresher Shark, Billfish, Cobia, Great Hammerhead, Tiger Shark, Scalloped Hammer, Sailfish, Wahoo, Marlin, Swordfish, White Shark, Tarpon, and Dolphin.

< Bottom fish: Atlantic Cod, Atlantic Wolffish, Black Sea Bass, Blue Angelfish, Butterfish, Codfishes, Cunner, Dwarf Sand Perch, Gray Triggerfish, Haddock, Perch Family, Pollock, Porgies, Reef bass, Scup, Skate, Snapper, Snowy Grouper, Spiny Dogfish Shark, Striped Searobin, Tautog, White Perch, Sandbar Shark, Sand Tiger Shark, Catfish, Kingfish, Black Drum, Dogfish Shark, Smooth Dog Shark, Toadfish, Hake, Sawfish, Mullett, Nurse Shark, Sheepshead, Cat Shark, Carp, Grunt, and Pinfish.

< Flatfish: Atlantic Halibut, Killifishes, Flounders, Mummichog, Windowpane, and Sole.

< Small game: Atlantic Bonito, Mackerels, Atlantic Salmon, Bluefish, Brown Trout, Cero, Hickory Shad, Little Tunny, Striped Bass, Weakfish, Pompano, Barracuda, Snook, Jack, Bonefish, and Red Drum.

The species listed above inhabit waters from Maine through Virginia, the region covered in the Hicks et al. ( 1999) study. Not all of the listed species are present in the North Atlantic region, which includes only Maine, New Hampshire, Massachusetts, Rhode Island, and Connecticut. The catch rates represent the number of fish caught on a fishing trip per angler by aggregated species group. The estimated catch rates are averaged across all anglers by wave, mode, target species group, and site over the five year period ( 1990 1994). 7 Catch rates for earlier years were not included in the analysis due to significant changes in species populations for recreational fisheries.

6 For the final rule, EPA will also perform a sensitivity analysis based on more recent data on catch rates ( i. e., 1997 2001).

7   Wave  is a two month period ( e. g., May June). Fishing conditions such as catch rates may differ significantly across six waves.

NODA Version  March 12, 2003 B5 5 § 316( b) Regional Case Studies, Part B: North AtlanticChapter B5: Recreational Fishing Benefits 8 The Federal Travel Regulations set the reimbursement rate at $ 0.30 per mile in 1994.

NODA Version  March 12, 2003B5 6 The catch rate variables include total catch, which includes both fish caught and kept and fish released. Several NMFS studies use only the catch and keep measure as the relevant catch rate. Although a greater error may be associated with the measured number of fish not kept, the total catch measure is more appropriate because a large number of anglers catch and release fish. As noted above, EPA followed Hicks et al. ( 1999) in estimating the total catch rate variable. The total catch rate variable includes only targeted fish catch and not incidental catch. r example, flatfish catch rates include flatfish caught only by anglers targeting flatfish and do not include flatfish caught by anglers targeting another species group ( e. g. small game.) an angler targeted a species group and caught no fish or caught fish of an other species group their catch rate was set to zero. Aggregated sites for which no historic catch rate was available were assigned an average historic catch rate of zero.

Anglers who target particular species groups generally catch more fish in the targeted category because of specialized equipment and skills than anglers who don t target these species. Of the anglers who target particular species groups, bottom fish anglers catch the largest number of fish per hour ( 1.28), followed by anglers who catch small game ( 0.65). target big game fish catch fewer fish than anglers targeting any other species group. marizes average catch rates by species for all sites in the study area.

Table B5 4: Average Catch Rate by Species Group for the North Atlantic Region Sites a Species GroupAverage Catch Rate ( fish per angler per trip)

Big game0.07 Bottom fish1.28 Flatfish0.24 Small game0.65 No target0.35 a This includes aggregated sites ( counties) in Maine, New Hampshire, Massachusetts, Rhode Island, and Connecticut.

Source: U. S. EPA analysis.

B5 1.4 EPA used ArcView 3.2a software to estimate distances from the household zip code to each NMFS fishing site in the individual opportunity sets. locations from the Master Site Register supplied by the NMFS. The Master Site Register includes both a unique identifier that corresponds to the visited site used in the angler survey, and latitude and longitude coordinates. e sites the latitude and longitude coordinates were missing or demonstrably incorrect, in which case the town point, as identified in the U. S. Geological Survey ( USGS) Geographic Names Information System, was used as the site location if a town was reported in the site address. program measured the distance in miles of the shortest route, using state and U. S. highways, from the household zip code to each fishing site, then added the distances from the zip location to the closest highway and from the site location to the closest highway. distance to the visited site is 58.6 miles.

Based on the procedure described in Hicks et al. ( 1999), EPA estimated trip   price  as the sum of travel costs plus the opportunity cost of time. ate consumers  travel costs, EPA multiplied round trip distance by average motor vehicle cost per mile ($ 0.30, 1994$). 8 To estimate the opportunity cost of travel time, EPA first divided round trip distance by 40 miles per hour to estimate trip time, and used the household s wage to yield the opportunity cost of time. ated household wage by dividing household income by 2,040 ( i. e., the number of full time hours potentially worked). Fo If Anglers who Table B5 4 sum Travel Cost The Agency obtained fishing site For som The Arc View The average one way To estim EPA estim § 316( b) Regional Case Studies, Part B: North Atlantic Chapter B5: Recreational Fishing Benefits Only those respondents who reported that they can work extra hours for extra pay ( FLEXHR= 1) are assigned a time cost in the trip cost variable. was calculated based on the round trip distance and the reimbursement rate of $. 30 per mile.

( B5 1)

For those respondents who cannot work extra hours for extra pay, the time cost is accounted for in an additional variable equal to the amount of time spent on travel. timated time cost as the round trip distance divided by 40 mph:

( B5 2)

B5 2 THE NESTED RANDOM UTILITY MODEL OF RECREATIONAL DEMAND For the purpose of this analysis, EPA did not estimate its own random utility model ( RUM) and relied on the study completed by Hicks et al. ( 1999) from the NMFS Office of Science and Technology ( Volume II: The Economic Value of New England and Mid Atlantic Sportfishing in 1994). e Hicks et al. ( 1999) approach, each angler selects fishing mode and target species first and, given this choice, selects the recreation site. model in detail. odel includes 10 variables: travel cost, travel time, five variables for catch rates ( one for each species group), the log of the number of NMFS intercept sites contained in an aggregated site, private/ rental dummy, and cold  private/ rental dummy. mmy equals 1 if the angler chose the private/ rental fishing mode and owns their own boat and 0 otherwise. The cold private/ rental dummy equals 1 if the private/ rental dummy equals one and the angler took his/ her fishing trip in November and December ( i. e., during cold months). 9 The model estimates are shown in Table B5 5. Otherwise, the trip cost variable EPA calculated visit price as:

EPA therefore es Based on th Chapter 3 of the NMFS study describes the The Hicks et al. ( 1999) m The private/ rental du 9 Data are not collected for January and February in the North Atlantic region due to cold weather and, as a result, very low participation in recreational fishing.

NODA Version  March 12, 2003 B5 7 § 316( b) Regional Case Studies, Part B: North AtlanticChapter B5: Recreational Fishing Benefits NODA Version  March 12, 2003B5 8 Table B5 5: Estimated Coefficients for the Conditional Site Choice VariableMean of the VariableEstimated Coefficient ( t statistic)

Travel Cost ($) 61.84 0.036 ( 10.46)

Travel Time ( hours) 3.69 1.141 ( 16.12)

Log of number of NMFS interview sites in aggregated sites 3.111.247 ( 33.99)

Big Game Fish Catch0.0030.974 ( 2.69)

Small Game Fish Catch0.390.579 ( 8.68)

Bottom Fish Catch0.190.572 ( 100.68)

Flatfish Catch0.260.665 ( 58.23)

No Target Catch0.200.324 ( 15.23)

Mode/ Species Choice Model Inclusive Value4.900.612 ( 19.99)

Private/ Rental Dummy0.152.490 ( 42.02)

Cold Private/ Rental Dummy0.20 0.553 ( 4.08)

Source: U. S. EPA analysis.

Table B5 5 shows that the coefficients have the expected signs. e have a negative effect on the probability of selecting a site, indicating that anglers prefer to visit sites closer to their homes ( other things being equal). positive sign on the private/ rental dummy indicates that anglers who own a boat are more likely to go fishing. of a site visit increases as the historic catch rate for fish species increases. s verify this assumption. my has a negative sign suggesting that cold months ( November and December) negatively affect the probability of site selection for boat anglers ( i. e., boat anglers are less likely to visit a site during cold weather, all else being equal). EPA used the coefficients presented in Table B5 5 to calculate welfare gains from reduced I& E in the North Atlantic region. describes the welfare estimation method and the results.

B5 3 WELFARE ESTIMATES This section presents estimates of welfare losses to recreational anglers from fish mortality due to I& E, and potential welfare gains as a result of the 316( b) rule. lt from improvements in fishing opportunities due to reduced fish mortality.

B5 3.1 To estimate changes in the quality of fishing sites due to reduced I& E, EPA relied on the recreational fishery landings data by state and estimates of recreational losses from I& E on the relevant species. Travel cost and travel tim A The probability The positive signs on the catch rate variable Cold Private/ Rental Dum The following section These gains would resu Estimating Changes in the Quality of Fishing Sites The NMFS provided recreational fishery landings § 316( b) Regional Case Studies, Part B: North AtlanticChapter B5: Recreational Fishing Benefits 10 Note that the Agency followed Hicks et al. ( 1999) and used 1990 1994 data to characterize site specific cath rates. cy used the most recent data on total recreational landings ( 1997 2001) to reflect the current conditions in estimating the expected change in total catch rate from changes in impingement and entrainment.

11 State waters include sounds, inlets, tidal portions of rivers, bays, estuaries, and other areas of salt or brackish water; and ocean waters to three nautical miles offshore ( NMFS, 2001a).

NODA Version  March 12, 2003B5 9 data for the states of the North Atlantic region. ated the losses to recreational fisheries using the physical impacts of I& E on the relevant fish species and the percentage of total fishery landings attributed to recreational fishery, as described in Chapter B4 of this document.

The Agency measured changes in the quality of recreational fishing sites in terms of a percentage change applied to the historic catch rate. ed that catch rates will change uniformly across all marine fishing sites along the North Atlantic coast because species considered in this analysis ( i. e., striped bass, bluefish, and flounder) inhabit a wide range of states ( e. g., from North Carolina to Maine). To estimated the expected change in catch rates EPA used the most recent data on total recreational landings in the North Atlantic region. 10 EPA used a five year average of recreational landing data ( 1997 through 2001) for sites within state waters to calculate an average number of landings per year. 11 EPA then divided baseline losses to the recreational fishery from I& E by the total recreational landings to derive the percentage change in historic catch rates from completely eliminating I& E losses. ates the complete elimination of I& E losses to increase small game catch rates by 0.01 percent, bottom fish catch rates by 1.05 percent, flatfish catch rates by 12.5 percent, and no target catch rates by 1.45 percent.

EPA also estimated percentage changes to species group historic catch rates resulting from reduced I& E losses resulting from the proposed rule. Dividing the reduced I& E losses by the 5 year average recreational landings leads to increases in the historic catch rates of , 3.64 percent for flatfish, 0.40 percent for no target, and 0.0007 percent for small game. loss estimates, and percentage changes in historic catch rates.

Table B5 6: Estimated Changes in Historic Catch Rates from Eliminating and Reducing I& E in the North Atlantic Region Species Group Total Recreational Landings for Five States Combined ( fish per year) a Baseline LossesReduced Losses under Preferred Option Total Recreational Losses from I& E Percent Increase in Recreational Catch from Elimination of I& E Combined I& EPercent Increase in Recreational Catch from Elimination of I& E Small game15,678,3521,0200.01% 1050.0007%

Bottom fish8,869,06493,1111.05% 20,5350.23%

Flatfish2,525,530315,70312.50% 91,9953.64%

No target b28,280,214409,9601.45% 112,6520.40%

a Source: The Marine Recreational Fishery Statistics Survey, 1997 2001. Total recreational landings are calculated as a five year average ( 1997 2001) for state waters. b No target includes small game, bottom fish, and flatfish as well as other fish not included in those groupings. The other fish represent only a small number of impinged and entrained species and combined I& E for these other fish are 126 fish in the baseline and 16 fish under the proposed rule.

B5 3.2 The recreational behavior model described in the preceding sections provides a means for estimating the economic effects of changes in recreational fishery losses from I& E in the North Atlantic region. ated welfare gain to recreational anglers from eliminating fishery losses due to I& E. This estimate represents economic damages to recreational The Agen EPA estim EPA assum EPA estim 0.23 percent for bottom Table B5 6 presents the recreational landings, I& E Estimating Losses from I& E in the North Atlantic Region First, EPA estim § 316( b) Regional Case Studies, Part B: North AtlanticChapter B5: Recreational Fishing Benefits 12 A compensating variation equates the expected value of realized utility under the baseline and post compliance conditions. or more detail see the Proposed Section 316( b) Phase II Existing Facilities Rule Case Study Analysis..

NODA Version  March 12, 2003B5 10 anglers from I& E of recreational fish species under the baseline scenario. ate per trip welfare gain, the Agency combined the Hick s model coefficients with the estimated percentage changes in historic catch rates from eliminating or reducing I& E losses at the cooling water intake structures located in the North Atlantic Region EPA estimated anglers  willingness to pay for improvements in the quality of recreational fishing due to changes in I& E by calculating an average per trip welfare gain based on the expected changes in catch rates from eliminating and reducing I& E. Table B5 7 presents the compensating variation per trip ( averaged over all anglers in the sample) associated with reduced fish mortality from changes in 12 The estimated per trip welfare gain resulting from eliminating all I& E at the cooling water intake structures is $ 0.34, $ 0.02, and $ 0.02 for flatfish, bottom fish, and no target respectively ( in 2002$). ated per trip welfare gain from reducing I& E at the cooling water intake structures under the proposed rule is $ 0.10, $ 0.005, and $ 0.004 for flatfish, bottom fish, and no target respectively ( in 2002$). As shown in Table B5 7, EPA expects anglers visiting the North Atlantic fishing sites to experience the greatest welfare gain from changes in I& E losses at the cooling water intake structures in the North Atlantic. On the other hand, the estimated welfare gain from either eliminating or reducing recreational fishery losses from I& E for small game was negligible.

The results presented in Table B5 7 are not surprising. ore desirable the fish, the greater the per trip welfare gain as evidenced by the willingness to pay for catching one additional fish per trip. Of the species groups affected by I& E reductions, anglers value flatfish the most ($ 3.57 for an additional fish), followed by small game ($ 2.53). Anglers targeting big game, not surprisingly, place the highest value on catching an additional fish of $ 5.90. ated values of WTP for an additional fish per trip ailable from previous studies ( see Table B4 2 in this document).

Table B5 7: Per Trip Welfare Gain from Eliminating and Reducing I& E in the North Atlantic Region ( 2002$)

Targeted SpeciesBaseline Per Trip Welfare Gain Reduced Losses Under the Proposed Rule Per Trip Welfare Gain WTP for an Additional Fish per Trip Small game$ 0.0003$ 0.00003$ 2.53 Bottom fish$ 0.02$ 0.005$ 1.06 Flatfish$ 0.34$ 0.10$ 3.57 Big gameaN/ AN/ A$ 5.90 No target$ 0.02$ 0.004$ 1.66 a. Not estimated due to limitations of I& E data.

Source: U. S. EPA analysis.

EPA calculated the total economic value of eliminating and reducing I& E in the North Atlantic region by combining the estimated per trip welfare gain with the total number of fishing days at coastal sites in the North Atlantic region. provided information on the total number of fishing trips by state and by fishing mode; this total number of fishing days includes both single and multiple day trips. esents the NMFS number of fishing days by state and fishing mode.

F To estim I& E for each fish species of concern.

The estim The m estimThese are consistent with those av NMFS Table B5 8 pr § 316( b) Regional Case Studies, Part B: North AtlanticChapter B5: Recreational Fishing Benefits NODA Version  March 12, 2003B5 11 Table B5 8: Recreational Fishing Participation by Fishing Mode, Species Group, and State State Private/ Rental Boat Big gameBottom fishFlatfishSmall gameOther No targetTotal CT15,894143,246252,741494,5914,90669,759981,137 ME6,88662,061109,500214,2822,12530,223425,078 MA32,168289,906511,5051,000,9709,928141,1801,985,657 NH1,88116,95429,91358,5375818,256116,122 RI9,59986,507152,631298,6852,96342,128592,512 Subtotal66,428598,6741,056,2902,067,06520,503291,5464,100,506 Party/ Charter Boat CT1,99915,4988,79915,118N/ A4,84846,262 ME85657373641N/ A2061,961 MA1,68513,0637,41712,743N/ A4,08738,994 NH6675,1732,9375,046N/ A1,61815,441 RI2922,2631,2852,207N/ A7086,754 Subtotal4,72836,65420,81135,755N/ A11,467109,412 Shore CT1,53056,189148,121362,44642,69884,422695,406 ME1,03237,89499,893244,43228,79556,934468,980 MA4,007147,173387,967949,336111,837221,1231,821,442 NH2198,06121,25152,0006,12612,11299,770 RI1,73563,731168,003411,09448,42995,754788,745 Subtotal8,523313,048825,2352,019,308237,885470,3453,874,343 Total79,679948,3761,902,3364,122,128258,388773,3588,084,261 Source: Marine Recreational Fishery Statistics Survey, 1997 2001.

The Agency assumed that the welfare gain per day of fishing is independent of the fishing mode and the number of days fished per trip and therefore equivalent for all modes ( i. e., private or rental boat, shore, and charter boat) for both single and multiple day trips. The model developed by Hicks et al. ( 1999) includes the fishing mode choice as well as the targeted species group choice. Thus, for every angler, regardless of mode or species choice, changes in historic catch rates for a particular species group offer a gain in welfare. Every fishing trip taken is the result of a choice decision affected by the changes in I& E. Therefore, all fishing trips taken should be included in estimating total losses from I& E.

EPA calculated total recreational losses to the North Atlantic anglers by multiplying the estimated per trip welfare gain from eliminating I& E for a given species group by the total number of recreational fishing trips in 2001. ber of trips in the North Atlantic region in 2001 reported by NMFS is 8,084,261. marizes calculation results. value of recreational losses for all species impinged and entrained at the cooling water intake structures in the North Atlantic is $ 3,074,444 per year ( 2002$), for all anglers not discounted. The discounted recreational losses are $ 2,638,614 and $ 2,252,016 ( 2002$) per year, discounted at three and seven percent, respectively. discount factors used to discount I& E losses by the discount rates three and seven percent. discount factors for species groups based on the species specific discount factors and the proportion of each species in the The total num Table B5 9 sumThe total EPA obtained the data on species specific The Agency calculated weighted § 316( b) Regional Case Studies, Part B: North AtlanticChapter B5: Recreational Fishing Benefits NODA Version  March 12, 2003B5 12 group. actors into account when calculating welfare losses to recreational anglers.

Total recreational losses based on reduced I& E from cooling water intake structures were also estimated. Multiplying the per trip welfare changes from reduced I& E under the proposed rule by the total number of fishing trips in 2001 yielded an undiscounted value of $ 881,427. Discounting the welfare gain by three and seven percent results in total welfare gains of $ 758,811 and $ 646,991, respectively.

Table B5 9: Estimated Total Welfare Gain to Recreational Anglers from Eliminating and Reducing I& E in the North Atlantic Region ( 2002$)

Species Group Eliminating Recreational Fishery Losses from I& EReduced Losses under the Preferred Option Undiscounted3% Discount Factor 7% Discount Factor Undiscounted3% Discount Factor 7% Discount Factor Small game$ 2,425.28$ 1,527.93$ 1,358.16$ 242.53$ 184.32$ 169.77 Bottom fish$ 161,685.22$ 88,926.87$ 77,608.91$ 40,421.31$ 21,019.08$ 18,189.59 Flatfish$ 2,748,648.74$ 2,418,810.89$ 2,061,486.56$ 808,426.10$ 711,414.97$ 606,319.58 Big gameN/ AN/ AN/ AN/ AN/ AN/ A No target$ 161,685.22$ 129,348.18$ 111,562.80$ 32,337.04$ 26,193.01$ 22,312.56 All species$ 3,074,444.46$ 2,638,613.86$ 2,252,016.42$ 881,426.98$ 758,811.37$ 646,991.49 Source: U. S. EPA analysis.

B5 4 LIMITATIONS AND UNCERTAINTY B5 4.1 This study understates the total benefits of improvements in fishing site quality because estimates are limited to recreation benefits. s of benefits, such as habitat values for a variety of species ( in addition to recreational fish), nonuse values, etc., are also likely to be important. EPA took group specific discount f Considering Only Recreational Values Many other form § 316( b) Regional Case Studies, Part B: North Atlantic Chapter B5: Recreational Fishing Benefits GLOSSARY Cooling Water Intake Structures ( CWISs) : the total physical structure and any associated constructed waterways used to withdraw water from waters of the U. S. The cooling water intake structure extends from the point at which water is withdrawn from the surface water source to the first intake pump or series of pumps.

Impingement and Entrainment ( I& E) : impingement is the entrapment of aquatic organisms on the outer part of an intake structure or against a screening device during periods of intake water withdrawal; entrainment is the incorporation of fish, eggs, larvae, and other plankton with intake water flow entering and passing through a cooling water intake structure and into a cooling water system.

Marine Recreational Fishery Statistics Survey ( MRFSS) : a long term monitoring program that provides estimates of effort, participation, and finfish catch by recreational anglers. The MRFSS survey consists of two independent, but complementary, surveys: a random digit dial telephone survey of households and an intercept survey of anglers at fishing access sites. Sampling is stratified by state, fishing mode ( shore, private/ rental boat, party/ charter boat), and wave, and allocated according to fishing pressure. Fishing sites are randomly selected from an updated list of access sites.

National Marine Fisheries Service ( NMFS) : a division of the National Oceanic and Atmospheric Administration ( NOAA), NMFS is the primary fisheries service in the U. S., responsible for fisheries management and marine ecosystem health.

Random Utility Model ( RUM): a model of consumer behavior. The model contains observable determinants of consumer behavior and a random element.

NODA Version  March 12, 2003 B5 13 § 316( b) Regional Case Studies, Part B: North Atlantic Chapter B5: Recreational Fishing Benefits ACRONYMS CWISs: Cooling Water Intake Structures I& E: impingement and entrainment MRFSS: Marine Recreational Fishery Statistics Survey NMFS: National Marine Fisheries Service RUM: random utility model NODA Version  March 12, 2003 B5 14 § 316( b) Regional Case Studies, Part B: North Atlantic Chapter B5: Recreational Fishing Benefits REFERENCES ArcView Spatial Analyst 2.0. 2000. Environmental Systems Research Institute, Inc, Redlands, CA.

Greene, William H. 1995. Limdep Version 7 User s Manual. Plainview, NY: Econometric Software, Inc.

Haab, Timothy C.; John C. Whitehead; and Ted McConnell. 2000. The Economic Value of Marine Recreational Fishing in the Southeast United States: 1997 Southeast Economic Data Analysis. Final Report, July.

Hicks, Rob, Scott Steinback, Amy Gautam, and Eric Thunberg. 1999. Volume II: The Economic Value of New England and Mid Atlantic Sportfishing in 1994. U. S. Department of Commerce, National Oceanic and Atmospheric Administration, National Marine Fisheries Service. NOAA Technical Memorandum NMFS F/ SPO 38.

McConnell, K. and I. Strand. 1994. The Economic Value of Mid and South Atlantic Sportfishing: Volume 2. Cooperative Agreement # CR 811043 01 0 between the University of Maryland at College Park, the Environmental Protection Agency, the National Marine Fisheries Service, and the National Oceanic and Atmospheric Administration.

National Marine Fisheries Service, Office of Science and Technology, Fisheries Statistics and Economics Division. 1999. Marine Recreational Fisheries Statistics: Data User s Manual. http:// www. st. nmfs. gov/ st1/ recreational/ research/ procedures. html, July 12.

National Marine Fisheries Service, Office of Science and Technology, Fisheries and Economics Division. 2001a. Marine Recreational Fisheries Statistics Survey ( MRFSS), Snapshot Query. http:// www. st. nmfs. gov/ recreational/ queries/ catch/ snapshot. html. Accessed in November 2002.

National Marine Fisheries Service, Office of Science and Technology, Fisheries Statistics and Economics Division. 2001b. Marine Recreational Fisheries Statistics ( 1996 2001). http:// www. st. nmfs. gov/ st1/ recreational/ research . Accessed in November 2002.

QuanTech, Survey Research Center. 1998. 1997 AMES Telephone Follow Up Survey Coding Handbook.

NODA Version  March 12, 2003 B5 15


[Federal Register: June 16, 2010 (Volume 75, Number 115)]
[Notices]
[Page 34114-34115]
[DOCID:fr16jn10-56]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0425; FRL-8828-8]

Pesticide Products; Registration Applications

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has received applications to register pesticide products
containing active ingredients not included in any previously registered
pesticide products. Pursuant to the provisions of section 3(c)(4) of
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is
hereby providing notice of receipt and opportunity to comment on these
applications.

DATES: Comments must be received on or before July 16, 2010.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2010-0425, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2010-0425. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Marianne Lewis, Registration Division
(7505), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    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 this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

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

     1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes 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 docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
     ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a

Code of Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
     iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
     viii. Make sure to submit your comments by the comment period
deadline identified.

II. Registration Applications

    EPA has received applications to register pesticide products
containing active ingredients not included in any previously registered
pesticide products. Pursuant to the provisions of section 3(c)(4) of
FIFRA, EPA is hereby providing notice of receipt and opportunity to
comment on these applications. Notice of receipt of these applications
does not imply a decision by the Agency on these applications.
    1. File Symbol: 264-RRRI. Docket Number: EPA -HQ-OOP-2010-0425.
Applicant: Bayer CropScience LP2, T.W. Alexander Dr., Research Triangle
Park, NC 27709. Product name: Penflufen TC. Active ingredient:
Fungicide with Penflufen at 98.72%. Proposed classification/Use:
Manufacturing use product. For formulation into an end-use fungicide
for terrestrial food use for in-furrow potato use and seed piece
treatment on vegetable, turberous and corm, (CSG1); for use as seed
treatment fungicide on alfalfa, grains, cereal (CG15 & 16); vegetables,
legume, including soybeans (CG 6 & 7); canola, borage, crambe, cuphea,
echium, flax seed, gold of pleasure, hare's ear mustard, lesquerella,
lunaria, meadowfoam, milkweed, mustard seed, oil radish, poppy seed,
rapeseed, sesame, sweet rocket, calendula, castor oil plant, Chinese
tallowtree, euphorbia, evening primrose, jojoba, niger seed, rose hip,
safflower, stokes aster, sunflower, tallowwood, tea oil plant, veronia,
cottonseed. Contact: Marianne Lewis,<PHONE_NUMBER>,
<EMAIL_ADDRESS>     2. File Symbol: 264-RRRO. Docket Number: EPA-HQ-OOP-2010-0425.
Applicant: Bayer CropScience LP2, T.W. Alexander Dr., Research Triangle
Park, NC 27709. Product name: PEN 240FS. Active ingredient: Fungicide
with Penflufen at 22.7%. Proposed classification/Use: Terrestrial food
use for in-furrow application on potato and other tuberous and corm
vegetables (CSG1C), seed piece application on potato; for use as seed
treatment on alfalfa, beans and peas including soybean and legume (CG 6
& 7); cotton, cereal grains (CG 15 & 16); corn, rice, canola, borage,
crambe, cuphea, echium, flax seed, gold of pleasure, hare's ear
mustard, lesquerella, lunaria, meadowfoam, milkweed, mustard seed, oil
radish, poppy seed, rapeseed, sesame, sweet rocket, calendula, castor
oil plant, Chinese tallowtree, euphorbia, evening primrose, jojoba,
niger seed, rose hip, safflower, stokes aster, sunflower, tallowwood,
tea oil plant, veronia, cottonseed. Contact: Marianne Lewis, (703) 308-
8043<EMAIL_ADDRESS>     3. File Symbol: 264-RREN. Docket Number: EPA-HQ-OOP-2010-0425.
Applicant: Bayer CropScience LP2, T.W. Alexander Dr., Research Triangle
Park, NC 27709. Product name: PENRED 240FS. Active ingredient:
Fungicide with Penflufen at 22.4%. Proposed classification/Use:
Terrestrial food use for in-furrow application on potato and other
tuberous and corm vegetables (CSG1C), seed piece application on potato;
for use as seed treatment on alfalfa, beans and peas including soybean
and legume (CG 6 & 7); cotton, cereal grains (CG 15 & 16); corn, rice,
canola, borage, crambe, cuphea, echium, flax seed, gold of pleasure,
hare's ear mustard, lesquerella, lunaria, meadowfoam, milkweed, mustard
seed, oil radish, poppy seed, rapeseed, sesame, sweet rocket,
calendula, castor oil plant, Chinese tallowtree, euphorbia, evening
primrose, jojoba, niger seed, rose hip, safflower, stokes aster,
sunflower, tallowwood, tea oil plant, veronia, cottonseed. Contact:
Marianne Lewis,<PHONE_NUMBER><EMAIL_ADDRESS>     4. File Symbol: 264-RREL. Docket Number: EPA-HQ-OOP-2010-0425.
Applicant: Bayer CropScience LP2, T.W. Alexander Dr., Research Triangle
Park, NC 27709. Product name: PENCLO 273.5FS. Active ingredient:
Fungicide with Penflufen at 6.0% and Clothianidin at 18.6%. Proposed
classification/Use: Seed treatment on cotton. Contact: Marianne Lewis,
(703) 308-8043<EMAIL_ADDRESS>     5. File Symbol: 264-RREU. Docket Number: EPA-HQ-OOP-2010-0425.
Applicant: Bayer CropScience LP2, T.W. Alexander Dr., Research Triangle
Park, NC 27709. Product name: PENTRI 308FS. Active ingredient:
Fungicide with Penflufen at 13.3% and Trifloxystrobin at 13.3%.
Proposed classification/Use: Seed treatment on alfalfa, beans and peas
including soybean (CG 6) rice, corn, cotton and wheat. Contact:
Marianne Lewis,<PHONE_NUMBER><EMAIL_ADDRESS>     6. File Symbol: 264-RRER. Docket Number: EPA-HQ-OOP-2010-0425.
Applicant: Bayer CropScience LP2, T.W. Alexander Dr., Research Triangle
Park, NC 27709. Product name: PENCLOTRIME 310.68FS. Active ingredient:
Fungicide with Penflufen at 0.82%, Clothiandin at 22.3%, Metalaxyl at
0.55%, and Trifloxystrobin at 0.55%, Proposed classification/Use: Seed
treatment on canola, mustard seed, and rapeseed. Contact: Marianne
Lewis,<PHONE_NUMBER><EMAIL_ADDRESS>     7. File Symbol: 264-RREE. Docket Number: EPA-HQ-OOP-2010-0425.
Applicant: Bayer CropScience LP2, T.W. Alexander Dr., Research Triangle
Park, NC 27709. Product name: PENPROME 177FS. Active ingredient:
Fungicide with Penflufen at 3.59%, Metalaxyl at 5.74%, and
Prothioconazole at 7.18%. Proposed classification/Use: Seed treatment
on alfalfa, beans and peas (dried) including soybean (CG 6), rice,
wheat, barley, and triticale. Contact: Marianne Lewis,<PHONE_NUMBER>,
<EMAIL_ADDRESS>     8. File Symbol: 264-RREG. Docket Number: EPA-HQ-OOP-2010-0425.
Applicant: Bayer CropScience LP2, T.W. Alexander Dr., Research Triangle
Park, NC 27709. Product name: PENPRO 118FS. Active ingredient:
Fungicide with Penflufen at 9.35% and Prothioconazole at 1.68%.
Proposed classification/Use: Seed piece application on potato and seed
treatment on wheat. Contact: Marianne Lewis,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
List of Subjects

    Environmental protection, Pesticides and pest.

    Dated: June 7, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2010-14521 Filed 6-15-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 85, Number 180 (Wednesday, September 16, 2020)]
[Notices]
[Page 57864]
[FR Doc No: 2020-20387]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0026]

Issuance of Priority Review Voucher; Rare Pediatric Disease
Product

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of a priority review voucher to the sponsor of a rare
pediatric disease product application. The Federal Food, Drug, and
Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration
Safety and Innovation Act (FDASIA), authorizes FDA to award priority
review vouchers to sponsors of approved rare pediatric disease product
applications that meet certain criteria. FDA is required to publish
notice of the award of the priority review voucher. FDA has determined
that KOSELUGO (selumetinib, AZD6244), manufactured by AstraZeneca
Pharmaceuticals, LP, meets the criteria for a priority review voucher.

FOR FURTHER INFORMATION CONTACT: Althea Cuff, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>, Fax: 301-
796-9856, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a priority
review voucher to the sponsor of an approved rare pediatric disease
product application. Under section 529 of the FD&C Act (21 U.S.C.
360ff), which was added by FDASIA, FDA will award priority review
vouchers to sponsors of approved rare pediatric disease product
applications that meet certain criteria. FDA has determined that
KOSELUGO (selumetinib, AZD6244), manufactured by AstraZeneca
Pharmaceuticals, LP, meets the criteria for a priority review voucher.
    KOSELUGO (selumetinib, AZD6244) is indicated for the treatment of
pediatric patients 2 years of age and older with neurofibromatosis type
1 who have symptomatic, inoperable plexiform neurofibromas.
    For further information about the Rare Pediatric Disease Priority
Review Voucher Program and for a link to the full text of section 529
of the FD&C Act, go to http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further
information about KOSELUGO (selumetinib, AZD6244), go to the
``[email protected]'' website at http://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: September 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-20387 Filed 9-15-20; 8:45 am]
BILLING CODE 4164-01-P