/* DETERMINE COUNTIES AFFECTED BY REACH */ data facs; set mpm2. fac_ info; run;

proc sort data= facs; by siteid; quit;

data cnty; set facs;

cntyfip1= stco1; cntyfip2= stco2; cntyfip3= stco3; cntyfip4= stco4; cntyfip5= stco5; cntyfip6= stco6; cntyfip7= stco7; cntyfip8= stco8;

keep reachnmb cntyfip1 cntyfip8; run; 100 proc sort nodupkey data= cnty; by reachnmb; quit;

proc transpose data= cnty out= cnty2; by reachnmb; var cntyfip1 cntyfip8; quit;

data cnty3; set cnty2; cntyfip = col1/ 1; if cntyfip=. then delete; keep reachnmb cntyfip; run;

proc sort data= cnty3; by cntyfip; quit;

/* OBTAIN REACH MILES BY COUNTY */

data rchmile; set mpm2. us_ rchmi; cntyfip= fips; keep countymi cntyfip; run;

proc sort data= rchmile; by cntyfip;

/* PULL TOGETHER OUR REACHES WITH ASSOCIATED COUNTIES */

data tot_ mile; merge cnty3 rchmile; by cntyfip;

if reachnmb=. then delete; run;

proc sort data= tot_ mile; by reachnmb cntyfip; quit;

/* SUM REACH MILES OVER COUNTIES CONTAINING THE SAME REACH FINISHED DATA SET CONTAINS TOTAL NUMBER OF REACH MILES IN COUNTIES CONTAINING A GIVEN REACH. BRING IN THE FISHING LICNESE DATA BY COUNTY. */

proc sql;

create table miles as select tot_ mile. reachnmb, sum( countymi) as denom, min( segl) as leng, sum( fw_ lic) as fwlictot, sum( sw_ lic) as swlictot from tot_ mile, facs, licens where tot_ mile. reachnmb = facs. reachnmb and tot_ mile. cntyfip = licens. cntyfip group by tot_ mile. reachnmb order by tot_ mile. reachnmb; quit; 101 proc sort data= miles; by reachnmb; quit;

/* Merge in Fishing Advisory Data with County mile data */ proc sort data= mpm2. fishadv1; by reachnmb; quit;

data miles2; merge miles mpm2. fishadv1; by reachnmb;

/* Hard Wire Statewide Advisories */ if st = ' MI' or st = ' NJ' or st = ' RI' or st = ' MS' then advisory = ' yes';

/* Multiplier for 20% reduction in fishermen due to advisory */ if advisory = ' yes' or advisory = ' A yes' then advmult = 0.80; else advmult = 1.00; run;

/* ESTIMATE SPORT AND SUBSISTANCE FISHING POPULATIONS */

data pops; set miles2; by reachnmb; if first. reachnmb;

if leng=. then fwspt = fwlictot* 0.06* 2.62* advmult; else fwspt = fwlictot*( leng/ denom)* 2.62* advmult; fwsub = 0.05* fwspt;

if leng=. then swspt = swlictot* 0.06* 2.62* advmult; else swspt = swlictot*( leng/ denom)* 2.62* advmult; swsub = 0.05* swspt;

fwsptpop = round( fwspt); fwsubpop = round( fwsub); swsptpop = round( swspt); swsubpop = round( swsub);

keep reachnmb fwsptpop fwsubpop swsptpop swsubpop; run;

proc sort data= pops; by reachnmb; quit; proc sort data= rundat. cnc_ hh; by reachnmb; quit;

/* MERGE CONCENTRATION DATA BY REACH WITH THE NUMBER OF SPORT AND SUBSISTENCE ANGLERS */

data canc; merge rundat. cnc_ hh pops; by reachnmb;

if cnc_ base = . or cnc_ base = 0 then delete; if fwsptpop=. then delete; run; 102 proc sort data= canc; by reachnmb casno event_ wt; quit;

/* BRING IN SLOPE FACTOR, REFERENCE DOSE, AND BIOCONCENTRATION FROM CHEMDATA */

proc sql;

create table canc1 as select reachnmb, canc. casno, cnc_ base as base, cnc_ trt1 as treat1, cnc_ trt2 as treat2, fwsptpop, fwsubpop, swsptpop, swsubpop, slope_ fa as sf, referenc as rfd, bioconce as bcfval, event_ wt as weight, liver, kidney, eyes, gastro, bodywght, central, mort, other from canc, mpm2. chemdata where canc. casno = chemdata. casno order by reachnmb, canc. casno, weight; quit;

/* ESTIMATE SYSTEMIC EQUATIONS AND CALCULATE CANCER RISK DUE TO FISH CONSUMPTION */

data canc2; set canc1; if bcfval and rfd;

/* DEFINE CONSTANTS */

cf1 = 0.001; /* conversion milligrams per microgram */ cf2 = 365; /* conversion 365 days per year */ cr1 = 0.007; /* consumption rate 1 child : 7.27 ( rec.) grams/ day*/ cr2 = 0.017; /* consumption rate 2 adult: 17.5 ( rec.) grams/ day */ cr3 = 0.061; /* consumption rate 3 child: 60.58 ( sub.) grams/ day*/ cr4 = 0.142; /* consumption rate 4 adult: 142.4 ( sub.) grams/ day*/ ef = 365; /* exposure frequency: 365 days per year */ ed1 = 18; /* exposure duration 1 child: 18 years ( rec.) */ ed2 = 52; /* exposure duration 2 adult: 52 years ( rec.) */ ed3 = 18; /* exposure duration 3 child: 18 years ( sub.) */ ed4 = 52; /* exposure duration 4 adult: 52 years ( sub.) */ bw1 = 30; /* body weight 1 child: 30 kg */ bw2 = 70; /* body weight 2 adult: 70 kg */ lt = 70; /* lifetime: 70 years */

/* CALCULATE SYSTEMIC EFFECTS */

/* base values */ bsptrisk = ((( base * cf1 * cr1 * bcfval * ef * ed1) / ( bw1 * lt * cf2)) + (( base * cf1 * cr2 * bcfval * ef * ed2) / ( bw2 * lt * cf2))) / rfd;

bsubrisk = ((( base * cf1 * cr3 * bcfval * ef * ed3) / ( bw1 * lt * cf2)) + (( base * cf1 * cr4 * bcfval * ef * ed4) / ( bw2 * lt * cf2))) / rfd;

/* treatment values */ sptrisk1 = ((( treat1 * cf1 * cr1 * bcfval * ef * ed1) / ( bw1 * lt * cf2)) + 103 (( treat1 * cf1 * cr2 * bcfval * ef * ed2) / ( bw2 * lt * cf2))) / rfd;

subrisk1 = ((( treat1 * cf1 * cr3 * bcfval * ef * ed3) / ( bw1 * lt * cf2)) + (( treat1 * cf1 * cr4 * bcfval * ef * ed4) / ( bw2 * lt * cf2))) / rfd;

sptrisk2 = ((( treat2 * cf1 * cr1 * bcfval * ef * ed1) / ( bw1 * lt * cf2)) + (( treat2 * cf1 * cr2 * bcfval * ef * ed2) / ( bw2 * lt * cf2))) / rfd;

subrisk2 = ((( treat2 * cf1 * cr3 * bcfval * ef * ed3) / ( bw1 * lt * cf2)) + (( treat2 * cf1 * cr4 * bcfval * ef * ed4) / ( bw2 * lt * cf2))) / rfd;

sptpop = fwsptpop + swsptpop; subpop = fwsubpop + swsubpop;

format bsptrisk bsubrisk sptrisk1 subrisk1 sptrisk2 subrisk2 e12.; run;

data rundat. hz_ chem; set canc2; run;

data canc3; set canc2;

type1 = " Liver"; type2=" Kidney"; type3=" Eyes"; type4=" Gastrointenstinal"; type5=" Body weight"; type6=" Central Nervous System"; type7=" Mortality"; type8=" Other Systemic health";

array cats[ 8] liver kidney eyes gastro bodywght central mort other; array cat_ text[ 8] type1 type2 type3 type4 type5 type6 type7 type8;

do i = 1 to 8; spthaz_ b = bsptrisk* cats[ i]; subhaz_ b = bsubrisk* cats[ i]; spthaz_ 1 = sptrisk1* cats[ i]; subhaz_ 1 = subrisk1* cats[ i]; spthaz_ 2 = sptrisk2* cats[ i]; subhaz_ 2 = subrisk2* cats[ i]; hlth_ cat = cat_ text[ i]; output; end; run;

/* sum hazard scores by reach and event_ wt*/

proc sql;

create table hazard_ a as select reachnmb, min( sptpop) as sptpopl, min( subpop) as subpopl, weight as wght, hlth_ cat, sum( spthaz_ b) as spthaz_ b, sum( subhaz_ b) as subhaz_ b, sum( spthaz_ 1) as spthaz_ 1, sum( subhaz_ 1) as subhaz_ 1, sum( spthaz_ 2) as spthaz_ 2, sum( subhaz_ 2) as subhaz_ 2 104 from canc3 group by reachnmb, weight, hlth_ cat order by reachnmb, wght, hlth_ cat;

create table hazard as select reachnmb, min( sptpopl) as sptpopl, min( subpopl) as subpopl, wght, max( spthaz_ b) as spthaz_ b, max( subhaz_ b) as subhaz_ b, max( spthaz_ 1) as spthaz_ 1, max( subhaz_ 1) as subhaz_ 1, max( spthaz_ 2) as spthaz_ 2, max( subhaz_ 2) as subhaz_ 2 from hazard_ a group by reachnmb, wght order by reachnmb, wght; quit;

data haz1; set hazard; format spthaz_ b subhaz_ b spthaz_ 1 subhaz_ 1 spthaz_ 2 subhaz_ 2 e12.; run;

/* Keep hazard ratios */ data rundat. hazrats; set haz1; run;

data overb; set haz1;

if spthaz_ b> 1 then sptb = 1; else sptb= 0; if subhaz_ b> 1 then subb = 1; else subb= 0; if spthaz_ 1> 1 then spt1 = 1; else spt1= 0; if subhaz_ 1> 1 then sub1 = 1; else sub1= 0; if spthaz_ 2> 1 then spt2 = 1; else spt2= 0; if subhaz_ 2> 1 then sub2 = 1; else sub2= 0; run;

proc means sum data= overb; var sptb subb spt1 sub1 spt2 sub2; title3 ' Sample Number of Reaches with Ratios > 1'; label sptb = ' Sport ( BL)' subb = ' Subsistence ( BL)' spt1 = ' Sport ( Opt 1)' sub1 = ' Subsistence ( Opt 1)' spt2 = ' Sport ( Opt 2)' sub2 = ' Subsistence ( Opt 2)'; quit;

proc means sum data= overb; weight wght; var sptb subb spt1 sub1 spt2 sub2; title3 ' National Number of Reaches with Ratios > 1'; label 105 sptb = ' Sport ( BL)' subb = ' Subsistence ( BL)' spt1 = ' Sport ( Opt 1)' sub1 = ' Subsistence ( Opt 1)' spt2 = ' Sport ( Opt 2)' sub2 = ' Subsistence ( Opt 2)'; quit;

proc sql; create table sportpop as select distinct reachnmb, sptpopl, wght from overb where sptb >= 1;

create table subpop as select distinct reachnmb, subpopl, wght from overb where subb >= 1; quit;

proc means sum data= sportpop; var sptpopl; title3 ' Exposed Sport Population'; title4 ' Sample'; quit;

proc means sum data= sportpop; weight wght; var sptpopl; title3 ' Exposed Sport Population'; title4 ' National'; quit;

proc means sum data= subpop; var subpopl; title3 ' Exposed Subsistence Population'; title4 ' Sample'; quit;

proc means sum data= subpop; weight wght; var subpopl; title3 ' Exposed Subsistence Population'; title4 ' National'; quit;

/* End Systemic Cancer ( Sub 5). sas */ 106 Program Output 107 MP& M National Benefits Preferred( Opt1= Pref, Opt2= NULL) 36 Systemic Cancer ( Sub 5) 00: 44 Sunday, February 9, 2003 National Number of Reaches with Ratios > 1 The MEANS Procedure Variable Label Sum                                                 sptb Sport ( BL) 34.4220190 subb Subsistence ( BL) 113.6603806 spt1 Sport ( Opt 1) 8.7818644 sub1 Subsistence ( Opt 1) 91.8115096 spt2 Sport ( Opt 2) 0 sub2 Subsistence ( Opt 2) 0                                                 108 " Hazard ratio Tables. sas" Produces tables of populations exposed to varying levels of systemic health risk based on Fish Consumption and Drinking Water. 109 /* Program: Hazard Ratio Tables. sas Author: Stuart Smith Date: 06/ 26/ 2000 This program takes the hazard ratio output datasets and categorizes the ratios into ranges. The populations within these ranges are summed together and a final set containing the populations exposed to ratios within a given range are printed.

Hazard Ratio Range Value r = 0 1 0 < r <= 10 9 2 10 9 < r <= 10 8 3 10 8 < r <= 10 7 4 10 7 < r <= 10 6 5 10 6 < r <= 10 5 6 10 5 < r <= 10 4 7 10 4 < r <= 10 3 8 10 3 < r <= 10 2 9 10 2 < r <= 10 1 10 10 1 < r <= 1 11 r > 1 12 */

* Static Library; libname mpm2 ' H:\ ENVR\ Triton05 MP& M\ Benefits\ MP& M Phase 2 Analysis\ Data\ SAS Sets for Analysis\';

* Run Specific Library; libname rundat ' H:\ ENVR\ Triton05 MP& M\ Benefits\ MP& M Phase 2 Analysis\ Data\ Runs\ td\ Prefered\';

title ' Fish Consumption Hazard Ratios'; data haz; set rundat. hazrats; run;

/* MACRO to assign a ratio to a range */ % macro asgnRng( ratio=, rnge=); if & ratio = 0 then & rnge= 1; if & ratio > 0 and & ratio <= 10** 9 then & rnge= 2; if & ratio > 10** 9 and & ratio <= 10** 8 then & rnge= 3; if & ratio > 10** 8 and & ratio <= 10** 7 then & rnge= 4; if & ratio > 10** 7 and & ratio <= 10** 6 then & rnge= 5; if & ratio > 10** 6 and & ratio <= 10** 5 then & rnge= 6; if & ratio > 10** 5 and & ratio <= 10** 4 then & rnge= 7; if & ratio > 10** 4 and & ratio <= 10** 3 then & rnge= 8; if & ratio > 10** 3 and & ratio <= 10** 2 then & rnge= 9; if & ratio > 10** 2 and & ratio <= 10** 1 then & rnge= 10; if & ratio > 10** 1 and & ratio <= 1 then & rnge= 11; if & ratio > 1 then & rnge= 12; % mend asgnRng;

/* MACRO to generate a summed set by a range variable */ % macro prcSum( theset=, thevar=, theout=, outvar=); proc sort data = & theset; by & thevar; 110 proc means noprint sum data= & theset; by & thevar; var pop; output out = & theout sum=& outvar; quit; data & theout; set & theout; rang = & thevar; keep rang & outvar; run; % mend prcSum;

/* Read in the hazard ratios and assign range values */ data all; set haz;

% asgnRng( ratio= spthaz_ b, rnge= sptb_ rng); % asgnRng( ratio= subhaz_ b, rnge= subb_ rng); % asgnRng( ratio= spthaz_ 1, rnge= spt1_ rng); % asgnRng( ratio= subhaz_ 1, rnge= sub1_ rng); % asgnRng( ratio= spthaz_ 2, rnge= spt2_ rng); % asgnRng( ratio= subhaz_ 2, rnge= sub2_ rng);

keep reachnmb sptpopl subpopl wght sptb_ rng subb_ rng spt1_ rng sub1_ rng spt2_ rng sub2_ rng;

run;

/* Pull the sport populations and ranges into a set */ data spt; set all;

pop = sptpopl; rng_ b = sptb_ rng; rng_ 1 = spt1_ rng; rng_ 2 = spt2_ rng; clas = ' sport';

keep pop rng_ b rng_ 1 rng_ 2 clas; run;

/* Pull the subsistence populations and ranges into a set */ data sub; set all;

pop = subpopl; rng_ b = subb_ rng; rng_ 1 = sub1_ rng; rng_ 2 = sub2_ rng; clas = ' subsis';

keep pop rng_ b rng_ 1 rng_ 2 clas; run;

/* Combine the sport and subsistence into one set, stacked */ 111 data both; set spt sub; run;

/***********************************************************/ /* Generate output datasets for combined sport and sub */ /* populations. Create set for base and selected option */ /* then combine into one set and print out. */ /***********************************************************/

/* Create the sets */ % prcSum( theset= both, thevar= rng_ b, theout= all_ b, outvar= pop_ b); % prcSum( theset= both, thevar= rng_ 1, theout= all_ 1, outvar= pop_ 1); % prcSum( theset= both, thevar= rng_ 2, theout= all_ 2, outvar= pop_ 2);

/* Merge them by range value */ data totrng; merge all_ b all_ 1 all_ 2; by rang;

if pop_ b=. then pop_ b= 0; if pop_ 1=. then pop_ 1= 0; if pop_ 2=. then pop_ 2= 0; run;

/* Print out the hazard table */ proc tabulate data= totrng; class rang; var pop_ b pop_ 1; table rang all, pop_ b pctsum* pop_ b=' '* all pop_ 1 pctsum* pop_ 1=' '* all; keylabel pctsum=' Percentage of Total'; label pop_ b = ' Population ( Base)' pop_ 1 = ' Population ( Pref)'; title2 ' Hazard Ratio Ranges and Populations'; title3 ' Combined Sport and Subsistence'; run;

/***********************************************************/ /* Generate output datasets for combined sport */ /* populations. Create set for base and selected option */ /* then combine into one set and print out. */ /***********************************************************/

/* Create the sets */ % prcSum( theset= spt, thevar= rng_ b, theout= spt_ b, outvar= pop_ b); % prcSum( theset= spt, thevar= rng_ 1, theout= spt_ 1, outvar= pop_ 1); % prcSum( theset= spt, thevar= rng_ 2, theout= spt_ 2, outvar= pop_ 2);

/* Merge them by range value */ data sptrng; merge spt_ b spt_ 1 spt_ 2; by rang; 112 if pop_ b=. then pop_ b= 0; if pop_ 1=. then pop_ 1= 0; if pop_ 2=. then pop_ 2= 0; run;

/* Print out the hazard table */ proc tabulate data= sptrng; class rang; var pop_ b pop_ 1; table rang all, pop_ b pctsum* pop_ b=' '* all pop_ 1 pctsum* pop_ 1=' '* all; keylabel pctsum=' Percentage of Total'; label pop_ b = ' Population ( Base)' pop_ 1 = ' Population ( Pref)'; title2 ' Hazard Ratio Ranges and Populations'; title3 ' Sport ONLY'; run;

/***********************************************************/ /* Generate output datasets for combined sport */ /* populations. Create set for base and selected option */ /* then combine into one set and print out. */ /***********************************************************/

/* Create the sets */ % prcSum( theset= sub, thevar= rng_ b, theout= sub_ b, outvar= pop_ b); % prcSum( theset= sub, thevar= rng_ 1, theout= sub_ 1, outvar= pop_ 1); % prcSum( theset= sub, thevar= rng_ 2, theout= sub_ 2, outvar= pop_ 2);

/* Merge them by range value */ data subrng; merge sub_ b sub_ 1 sub_ 2; by rang;

if pop_ b=. then pop_ b= 0; if pop_ 1=. then pop_ 1= 0; if pop_ 2=. then pop_ 2= 0; run;

/* Print out the hazard table */ proc tabulate data= subrng; class rang; var pop_ b pop_ 1; table rang all, pop_ b pctsum* pop_ b=' '* all pop_ 1 pctsum* pop_ 1=' '* all; keylabel pctsum=' Percentage of Total'; label pop_ b = ' Population ( Base)' pop_ 1 = ' Population ( Pref)'; title2 ' Hazard Ratio Ranges and Populations'; title3 ' Subsistence ONLY'; run;

/***************************************************/ 113 /* DRINKING WATER */ /***************************************************/

title ' Drinking Water Hazard Ratios'; data dw; set rundat. dwhazrat; run;

/* Read in the hazard ratios and assign range values */ data alldw; set dw;

% asgnRng( ratio= haz_ b, rnge= rng_ b); % asgnRng( ratio= haz_ 1, rnge= rng_ 1); % asgnRng( ratio= haz_ 2, rnge= rng_ 2);

keep reachnmb pop wght rng_ b rng_ 1 rng_ 2;

run;

/* Create the sets */ % prcSum( theset= alldw, thevar= rng_ b, theout= dw_ b, outvar= pop_ b); % prcSum( theset= alldw, thevar= rng_ 1, theout= dw_ 1, outvar= pop_ 1); % prcSum( theset= alldw, thevar= rng_ 2, theout= dw_ 2, outvar= pop_ 2);

/* Merge them by range value */ data totdw; merge dw_ b dw_ 1 dw_ 2; by rang;

if pop_ b=. then pop_ b= 0; if pop_ 1=. then pop_ 1= 0; if pop_ 2=. then pop_ 2= 0; run;

/* Print out the hazard table */ proc tabulate data= totdw; class rang; var pop_ b pop_ 1; table rang all, pop_ b pctsum* pop_ b=' '* all pop_ 1 pctsum* pop_ 1=' '* all; keylabel pctsum=' Percentage of Total'; label pop_ b = ' Population ( Base)' pop_ 1 = ' Population ( Pref)'; title2 ' Hazard Ratio Ranges and Populations'; title3 ' Drinking Water Based'; run;

/* End Hazard Ratio Tables. sas */ 114 Program Output 115 Fish Consumption Hazard Ratios 1 Hazard Ratio Ranges and Populations 05: 12 Sunday, February 9, 2003 Combined Sport and Subsistence                                                                                *     Population   Percentage   Population   Percentage       ( Base)   of Total   ( Pref)   of Total     *              $              $              $                  Sum   All   Sum   All   *                        $              $              $              $                rang           *                                   1   0.00  0.00  342040.00  8.17  *                        $              $              $              $                2   33860.00  0.81  68945.00  1.65  *                        $              $              $              $                3   174604.00  4.17  166696.00  3.98  *                        $              $              $              $                4   238898.00  5.70  193904.00  4.63  *                        $              $              $              $                5   424641.00  10.14  366458.00  8.75  *                        $              $              $              $                6   655544.00  15.65  737980.00  17.62  *                        $              $              $              $                7   786940.00  18.79  701184.00  16.74  *                        $              $              $              $                8   779240.00  18.60  871212.00  20.80  *                        $              $              $              $                9   730905.00  17.45  509828.00  12.17  *                        $              $              $              $                10   265200.00  6.33  167970.00  4.01  *                        $              $              $              $                11   58522.00  1.40  59514.00  1.42  *                        $              $              $              $                12   40630.00  0.97  3253.00  0.08  *                        $              $              $              $                All   4188984.00  100.00  4188984.00  100.00  S                                                                              ÿ Fish Consumption Hazard Ratios 2 Hazard Ratio Ranges and Populations 05: 12 Sunday, February 9, 2003 Sport ONLY                                                                                *     Population   Percentage   Population   Percentage       ( Base)   of Total   ( Pref)   of Total     *              $              $              $                  Sum   All   Sum   All   *                        $              $              $              $                rang           *                                   1   0.00  0.00  325751.00  8.17  *                        $              $              $              $                2   33094.00  0.83  68179.00  1.71  116 *                        $              $              $              $                3   173715.00  4.35  164053.00  4.11  *                        $              $              $              $                4   229967.00  5.76  185456.00  4.65  *                        $              $              $              $                5   412584.00  10.34  357307.00  8.96  *                        $              $              $              $                6   632375.00  15.85  717173.00  17.98  *                        $              $              $              $                7   754193.00  18.90  664096.00  16.65  *                        $              $              $              $                8   740924.00  18.57  832636.00  20.87  *                        $              $              $              $                9   694896.00  17.42  474675.00  11.90  *                        $              $              $              $                10   233299.00  5.85  147378.00  3.69  *                        $              $              $              $                11   47986.00  1.20  52185.00  1.31  *                        $              $              $              $                12   36468.00  0.91  612.00  0.02  *                        $              $              $              $                All   3989501.00  100.00  3989501.00  100.00  S                                                                              ÿ Fish Consumption Hazard Ratios 3 Hazard Ratio Ranges and Populations 05: 12 Sunday, February 9, 2003 Subsistence ONLY                                                                                *     Population   Percentage   Population   Percentage       ( Base)   of Total   ( Pref)   of Total     *              $              $              $                  Sum   All   Sum   All   *                        $              $              $              $                rang           *                                   1   0.00  0.00  16289.00  8.17  *                        $              $              $              $                2   766.00  0.38  766.00  0.38  *                        $              $              $              $                3   889.00  0.45  2643.00  1.32  *                        $              $              $              $                4   8931.00  4.48  8448.00  4.23  *                        $              $              $              $                5   12057.00  6.04  9151.00  4.59  *                        $              $              $              $                6   23169.00  11.61  20807.00  10.43  *                        $              $              $              $                7   32747.00  16.42  37088.00  18.59  *                        $              $              $              $                8   38316.00  19.21  38576.00  19.34  *                        $              $              $              $                9   36009.00  18.05  35153.00  17.62  *                        $              $              $              $              117   10   31901.00  15.99  20592.00  10.32  *                        $              $              $              $                11   10536.00  5.28  7329.00  3.67  *                        $              $              $              $                12   4162.00  2.09  2641.00  1.32  *                        $              $              $              $                All   199483.00  100.00  199483.00  100.00  S                                                                              ÿ Drinking Water Hazard Ratios 4 Hazard Ratio Ranges and Populations 05: 12 Sunday, February 9, 2003 Drinking Water Based                                                                                *     Population   Percentage   Population   Percentage       ( Base)   of Total   ( Pref)   of Total     *              $              $              $                  Sum   All   Sum   All   *                        $              $              $              $                rang           *                                   1   0.00  0.00  4308351.66  10.95  *                        $              $              $              $                2   23810247.44  60.53  21729748.55  55.24  *                        $              $              $              $                3   4427997.68  11.26  3969950.06  10.09  *                        $              $              $              $                4   5845099.85  14.86  5250581.84  13.35  *                        $              $              $              $                5   2468997.63  6.28  2716883.28  6.91  *                        $              $              $              $                6   2389045.94  6.07  1359865.88  3.46  *                        $              $              $              $                7   394053.73  1.00  61.00  0.00  *                        $              $              $              $                All   39335442.28  100.00  39335442.28  100.00  S                                                                              ÿ 118 Systemic Risk from Drinking Water 119 " Data for Brad preferred. sas" Generates a data set of pollutant loadings discharged to RF1 reaches from direct dischargers and POTWs ( with removals) for the water quality modeling program. See Cancer from Drinking Water for program code. 120 Water Quality Modeling Pollutant in stream concentrations on RF1 reaches containing drinking water intakes downstream from MP& M facilities and POTWs are estimated for six carcinogens not covered by EPA drinking water criteria. The water quality model used is the Risk Screening Environmental Indicators developed for the EPA OPPT ( See DCN 37554). 121 " Systemic Cancer Assoc DW ( Sub 14). sas" Data from the water quality modeling is used to estimate systemic risk using pollutant specific reference doses. The overall hazard ratio for each RF1 reach is then estimated. 122 /* Program: Systemic Cancer Assoc DW ( Sub 14). sas Authors: Abt Associates Inc; Rob Sartain, Elena Besedin, Stuart Smith Date: 05/ 04/ 2000 Updated: 10/ 31/ 2002 This program calculates systemic hazard scores for drinking water consumption. Only reaches with intakes on them are evaluated. Downstream reaches are not included in the analysis. */

title2 ' Systemic Cancer Associated with DW ( Sub 14)';

/* Grab reach information from Brad's Output file */

data brad; set rundat. bradout; if intakect > 0;

keep reachnmb intakect casno baseconc t1conc t2conc weight dwpop siteid; run;

proc sort data= brad; by reachnmb casno; quit;

/* BRING IN SLOPE FACTOR, REFERENCE DOSE, AND BIOCONCENTRATION FROM CHEMDATA */

proc sql;

create table canc1 as select reachnmb, brad. casno, baseconc as base, t1conc as treat1, t2conc as treat2, dwpop, slope_ fa as sf, referenc as rfd, bioconce as bcfval, weight, liver, kidney, eyes, gastro, bodywght, central, mort, other from brad, mpm2. chemdata where brad. casno = chemdata. casno order by reachnmb, brad. casno, weight; quit;

/* ESTIMATE SYSTEMIC EQUATIONS AND CALCULATE CANCER RISK DUE TO FISH CONSUMPTION */

data canc2; set canc1; if rfd;

/* DEFINE CONSTANTS */

cf1 = 0.001; /* conversion milligrams per microgram */ cf2 = 365; /* conversion: day per year */ cr = 1.24; /* consumption rate: liters of water per day */ ef = 350; /* exposure frequency: 350 days per year */ ed = 70; /* exposure duration: 70 years */ bw = 70; /* body weight: 70 kg */ 123 lt = 70; /* lifetime: 70 years */

/* CALCULATE SYSTEMIC EFFECTS */

/* base values */ brisk = (( base * cf1 * cr * ef * ed) / ( bw * lt * cf2)) / rfd;

/* treatment values */ risk1 = (( treat1 * cf1 * cr * ef * ed) / ( bw * lt * cf2)) / rfd;

risk2 = (( treat2 * cf1 * cr * ef * ed) / ( bw * lt * cf2)) / rfd;

totpop = dwpop;

format brisk risk1 risk2 e12.; run;

data canc3; set canc2;

type1 = " Liver"; type2=" Kidney"; type3=" Eyes"; type4=" Gastrointenstinal"; type5=" Body weight"; type6=" Central Nervous System"; type7=" Mortality"; type8=" Other Systemic health";

array cats[ 8] liver kidney eyes gastro bodywght central mort other; array cat_ text[ 8] type1 type2 type3 type4 type5 type6 type7 type8;

do i = 1 to 8; hazdb = brisk* cats[ i]; hazd1 = risk1* cats[ i]; hazd2 = risk2* cats[ i]; hlth_ cat = cat_ text[ i]; output; end; run;

/* sum hazard scores by reach and event_ wt ( summing over all pollutants) */

proc sql;

create table hazard_ a as select reachnmb, avg( totpop) as pop, weight as wght, hlth_ cat, sum( hazdb) as haz_ b, sum( hazd1) as haz_ 1, sum( hazd2) as haz_ 2 from canc3 group by reachnmb, weight, hlth_ cat order by reachnmb, wght;

create table hazard as select reachnmb, min( pop) as pop, min( wght) as wght, max( haz_ b) as haz_ b, max( haz_ 1) as haz_ 1, max( haz_ 2) as haz_ 2 124 from hazard_ a group by reachnmb, wght order by reachnmb, wght; quit;

data haz1; set hazard; format haz_ b haz_ 1 haz_ 2 e12.; run;

/* Keep hazard ratios */ data rundat. dwhazrat; set haz1; run;

data overb; set haz1;

if haz_ b> 1 then ovrb = 1; else ovrb= 0; if haz_ 1> 1 then ovr1 = 1; else ovr1= 0; if haz_ 2> 1 then ovr2 = 1; else ovr2= 0; run;

proc means sum data= overb; var ovrb ovr1 ovr2 pop; title3 ' Sample Number of Reaches with Ratios > 1'; label ovrb = ' Sport ( BL)' ovr1 = ' Subsistence ( BL)' ovr2 = ' Sport ( Opt 1)' pop = ' Exposed Population'; quit;

proc means sum data= overb; weight wght; var ovrb ovr1 ovr2; title3 ' National Number of Reaches with Ratios > 1'; label ovrb = ' Sport ( BL)' ovr1 = ' Subsistence ( BL)' ovr2 = ' Sport ( Opt 1)'; quit;

/* End Systemic Cancer Assoc DW ( Sub 14). sas */ 125 Program Output 126 MP& M National Benefits Preferred( Opt1= Pref, Opt2= NULL) 55 Systemic Cancer Associated with DW ( Sub 14) National Number of Reaches with Ratios > 1 00: 44 Sunday, February 9, 2003 The MEANS Procedure Variable Label Sum                                              ovrb Sport ( BL) 0 ovr1 Subsistence ( BL) 0 ovr2 Sport ( Opt 1) 0                                              127 " Hazard ratio Tables. sas" Produces tables of populations exposed to varying levels of systemic health risk based on Fish Consumption and Drinking Water. See Systemic Risk from Fish Consumption for program code and output. 128 Lead Benefits for Adults 129 " Cancer fish ( Sub 4). sas" From the data set of pollutant concentrations for each RF1 reach, observations for in stream lead concentrations are outputed into a separate data set. See Cancer from Fish Consumption for program code and output.


[Federal Register Volume 75, Number 248 (Tuesday, December 28, 2010)]
[Notices]
[Pages 81616-81617]
[FR Doc No: 2010-32603]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0447]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices;
Third Party Review Program Under the Food and Drug Administration
Modernization Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by January
27, 2011.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0375.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Medical Devices; Third Party Review Program Under the Food and Drug
Administration Modernization Act--(OMB Control Number 0910-0375)--
Extension

    Section 210 of the Food and Drug Administration Modernization Act
(FDAMA) established section 523 of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360m), directing FDA to accredit persons
in the private sector to review certain premarket notifications
(510(k)s). Participation in this third-party review program by
accredited persons is entirely voluntary. A third party wishing to
participate will submit a request for accreditation to FDA. Accredited
third-party reviewers have the ability to review a manufacturer's
510(k) of the FD&C Act (21 U.S.C. 360) submission for selected devices.
After reviewing a submission, the reviewer will forward a copy of the
510(k) submission, along with the reviewer's documented review and
recommendation to FDA. Third-party reviewers should maintain records of
their 510(k) reviews and a copy of the 510(k) for a reasonable period
of time, usually a period of 3 years.
    This information collection will allow FDA to continue to implement
the accredited person review program established by FDAMA and improve
the efficiency of 510(k) review for low- to moderate-risk devices.
    Respondents to this information collection are businesses or other
for-profit organizations.

I. Reporting

510(k) Reviews Conducted by Accredited Third Parties

    According to FDA's data in 2009, the Agency has experienced that
the number of 510(k)s submitted for third-party review is approximately
260 annually, which is 26 annual reviews per each of the 10 accredited
reviewers.

II. Recordkeeping

    Third party reviewers are required to keep records of their review
of each submission. According to FDA's in 2009, the Agency anticipates
approximately 260 submissions of 510(k)s for third-party review per
year.
    In the Federal Register of September 22, 2010 (75 FR 57801), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment; however, it was
not PRA related.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
   Section 523 of the FD&C Act        No. of       frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
----------------------------------------------------------------------------------------------------------------
Requests for accreditation......               1               1               1              24              24
510(k) reviews conducted by                   10              26             260              40          10,400
 accredited third parties.......
    Total.......................  ..............  ..............  ..............  ..............          10,424
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Annual
                    Section 523 of the FD&C Act                           No. of       frequency per     Total annual      Hours  per      Total hours
                                                                      recordkeepers    recordkeeping       records           record
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) reviews.....................................................              10               26              260               10            2,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: December 21, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-32603 Filed 12-27-10; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: March 11, 2010 (Volume 75, Number 47)]
[Rules and Regulations]
[Page 11451-11452]
[DOCID:fr11mr10-8]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2010-N-0002]

New Animal Drugs for Use in Animal Feeds; Zilpaterol

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

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

SUMMARY:  The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of three abbreviated new animal
drug applications (ANADAs) filed by Ivy Laboratories, Div. of Ivy
Animal Health, Inc. The ANADAs provides for use of single-ingredient
Type A medicated articles containing zilpaterol, melengestrol,
monensin, and tylosin to make two-way, three-way, and four-way
combination drug Type B and Type C medicated feeds for heifers fed in
confinement for slaughter.

DATES:  This rule is effective March 11, 2010.

FOR FURTHER INFORMATION CONTACT:  John K. Harshman, Center for
Veterinary Medicine (HFV-170), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Ivy Laboratories, Div. of Ivy Animal Health,
Inc., 8857 Bond St., Overland Park, KS 66214, filed ANADA 200-483 for
use of ZILMAX (zilpaterol hydrochloride) and HEIFERMAX 500
(melengestrol acetate) Liquid Premix single-ingredient Type A medicated
articles to make dry and liquid, two way combination drug Type B and
Type C medicated feeds for heifers fed in confinement for slaughter.
Ivy Laboratories' ANADA 200-483 is approved as a generic copy of
Intervet, Inc.'s combination medicated feed use of ZILMAX and MGA 500
(melengestrol acetate), approved under NADA 141-284.
    Ivy Laboratories also filed ANADA 200-479 for use of ZILMAX,
HEIFERMAX 500 Liquid Premix, and RUMENSIN (monensin USP) single-
ingredient Type A medicated articles to make dry and liquid, three-way
combination drug Type B and Type C medicated feeds for heifers fed in
confinement for slaughter. Ivy Laboratories' ANADA 200-479 is approved
as a generic copy of Intervet, Inc.'s combination medicated feed use of
ZILMAX, MGA 500, and RUMENSIN, approved under NADA 141-282.
    Ivy Laboratories also filed ANADA 200-480 for use of ZILMAX,
HEIFERMAX 500 Liquid Premix, RUMENSIN, and TYLAN (tylosin phosphate)
single-ingredient Type A medicated articles to make dry and liquid,
four-way combination drug Type C medicated feeds for heifers fed in
confinement for slaughter. Ivy Laboratories' ANADA 200-480 is approved
as a generic copy of Intervet, Inc.'s combination medicated feed use of
ZILMAX, MGA 500, RUMENSIN, and TYLAN, approved under NADA 141-280.
    The abbreviated applications are approved as of December 30, 2009,
and the regulations are amended in 21 CFR 558.665 to reflect the
approval.
    In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
each application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33 that these actions are
of a type that do not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subject in 21 CFR Part 558

    Animal drugs, Animal feeds.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for 21 CFR part 558 continues to read as
follows:

    Authority:  21 U.S.C. 360b, 371.

Sec.  558.665   [Amended]

0
2. In Sec.  558.665, in the table in paragraphs (e)(2), (e)(4), and
(e)(6), in the ``Limitations'' column remove ``No. 000009'' and add in
its place ``Nos. 000009 or 021641'' and in the ``Sponsor''

column add in numerical sequence ``021641''.

    Dated: March 8, 2010.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2010-5224 Filed 3-10-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 80, Number 155 (Wednesday, August 12, 2015)]
[Notices]
[Pages 48385-48386]
[FR Doc No: 2015-19764]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75634; File No. SR-ICC-2015-012]

Self-Regulatory Organizations; ICE Clear Credit, LLC; Order
Approving Proposed Rule Change To Correct Inconsistent Provisions
Regarding the Risk Management Subcommittee

August 6, 2015.

I. Introduction

    On June 10, 2015, ICE Clear Credit LLC (``ICC'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to amend the ICC
Clearing Rules (``Rules'') to correct inconsistent provisions regarding
the Risk Management Subcommittee (SR-ICC-2015-012). The proposed rule
change was published for comment in the Federal Register on June 22,
2015.\3\ The Commission did not receive comments on the proposed rule
change. For the reasons discussed below, the Commission is granting
approval of the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 34-75179 (Jun. 16,
2015), 80 FR 35689 (Jun. 22, 2015) (SR-ICC-2015-012).
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change

    ICC has stated that the proposed rule change is intended to correct
inconsistent provisions regarding the Risk Management Subcommittee,
described in detail as follows. ICC has stated that, in describing the
independence requirements for certain Risk Management Subcommittee
members in Rule 511(a)(iii), the rule mistakenly referred to U.S.
Commodity Futures Trading Commission (``CFTC'') Regulation 1.3(ccc), a
proposed regulation that, to date, the CFTC has not adopted. ICC
proposes revising Rule 511(a)(iii) to remove the improper reference to
CFTC Regulation 1.3(ccc) and replace the rule cite with a reference to
ICC's Independence Requirements, which are defined in Rule 503.
    Additionally, Independent Risk Management Subcommittee managers
were previously defined as ``Independent Public Directors'' in Rules
511 and 512. ICC proposes re-defining such independent Risk Management
Subcommittee managers to ``Independent ICE Subcommittee Managers'' and
updating references in Rules 511 and 512 to reflect the new defined
term. ICC also proposes clarifying language to specify that such
Independent ICE Subcommittee Managers are appointed by the ICC Board.
Finally, ICC proposes revising Rule 512 to clarify that for purposes of
Rule 507(a), which sets forth meeting frequency requirements, the Risk
Management Subcommittee shall meet when deemed necessary or desirable
by the Risk Management Subcommittee or its chairperson.

III. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Act \4\ directs the Commission to
approve a proposed rule change of a self-regulatory organization if the
Commission finds that such proposed rule change is consistent with the
requirements of the Act and the rules and regulations thereunder
applicable to such self-regulatory organization. Section 17A(b)(3)(F)
of the Act \5\ requires, among other things, that the rules of a
clearing agency are designed to protect investors and the public
interest. Rule 17Ad-22(d)(8) \6\ further requires a registered clearing
agency that performs central counterparty services to establish,
implement, maintain and enforce written policies and procedures
reasonably designed to, among other things, have governance
arrangements that are clear and transparent to fulfill the public
interest requirements in Section 17A of the Act \7\ applicable to
clearing agencies and to promote the effectiveness of the clearing
agency's risk management procedures.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2)(C).
    \5\ 15 U.S.C. 78q-1(b)(3)(F).
    \6\ 17 CFR 240.17Ad-22(d)(8).
    \7\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

    Currently, the independence requirements in ICC Rule 511 for
certain Risk Management Subcommittee members incorrectly reference a
CFTC regulation that has not been adopted. The proposed rule change
would replace the incorrect CFTC rule citation with the requirement
that certain members of the Risk Management Subcommittee meet ICC's
Independence Requirements as defined in ICC Rule 503 \8\ (the
Independent ICE Subcommittee Managers). Additionally, the proposed rule
change would clarify that the Independent ICE Subcommittee Managers are
appointed by the ICC Board. Finally, the proposed rule

change clarifies that the Risk Management Subcommittee shall meet when
deemed necessary or desirable by the Risk Management Subcommittee or
its chairperson. The Commission believes that these proposed
clarifications are reasonably designed to ensure that ICC's governance
arrangements are clear and transparent to fulfill the public interest
requirements in Section 17A of the Act.\9\ Accordingly, the Commission
finds that the proposed rule change is consistent with Section 17A of
the Act \10\ and the rules thereunder applicable to ICC.
---------------------------------------------------------------------------

    \8\ ICC Rule 503 defines the ICC ``Independence Requirements''
to include the requirements of each of the New York Stock Exchange
listing standards, the U.S. Securities Exchange Act of 1934, as
amended, and Intercontinental Exchange, Inc.'s Board of Director
Governance Principles.
    \9\ 15 U.S.C. 78q-1.
    \10\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposal is consistent with the requirements of the Act and in
particular with the requirements of Section 17A of the Act \11\ and the
rules and regulations thereunder.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\12\ that the proposed rule change (File No. SR-ICC-2015-012) be,
and hereby is, approved.\13\
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(2).
    \13\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition and
capital formation. 15 U.S.C. 78c(f).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-19764 Filed 8-11-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 58 (Friday, March 25, 2022)]
[Proposed Rules]
[Page 17057]
[FR Doc No: 2022-06291]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2022-0221; FRL-9598-01-R9]

Approval and Promulgation of Implementation Plans; California;
Correcting Amendments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: On August 28, 2009, the Environmental Protection Agency (EPA)
issued a final rule titled ``Revisions to the California State
Implementation Plan, Antelope Valley Air Quality Management District.''
That publication inadvertently omitted regulatory text rescinding four
previously approved rules for the Antelope Valley Air Quality
Management District portion of the California State Implementation Plan
(SIP). On September 20, 2016, the EPA issued a final rule titled
``Approval of California Air Plan Revisions, Department of Pesticide
Regulations.'' That publication listed the wrong EPA approval dates and
Federal Register citations for certain rules. The EPA is proposing
action to correct these errors.

DATES: Comments from be received on or before April 25, 2022.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2022-0221 at https://www.regulations.gov. For comments submitted at
Regulations.gov, follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. The EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to make. The EPA will generally not
consider comments or comment contents located outside of the primary
submission (i.e., on the web, cloud, or other file sharing system). For
additional submission methods, please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section. For the full EPA public
comment policy, information about CBI or multimedia submissions, and
general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets. If you need assistance in a
language other than English or if you are a person with disabilities
who needs a reasonable accommodation at no cost to you, please contact
the person identified in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Kevin Gong, EPA Region IX, 75
Hawthorne St., San Francisco, CA 94105. By phone:<PHONE_NUMBER> or by
email at [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document, wherever ``we'',
``us'' or ``our'' are used, we mean the EPA. In the Rules and
Regulations section of this Federal Register, we are correcting the
inadvertent omission in our August 28, 2009 direct final rule of
regulatory text removing four rules from the Antelope Valley Air
Quality Management District (AQMD) portion of the California SIP. We
are also correcting the EPA approval dates and Federal Register
citations for certain rules adopted by the California Department of
Pesticide Regulations that we approved in a September 20, 2016 final
rule. We are taking these actions in a direct final action without
prior proposal because we believe this error correction action is not
controversial. If we receive adverse comments, however, we will publish
a timely withdrawal of the direct final rule and address the comments
in a subsequent action based on this proposed rule.
    We do not plan to open a second comment period, so anyone
interested in commenting should do so at this time. If we do not
receive adverse comments, no further activity is planned. For further
information, please see the direct final action.

    Dated: March 20, 2022.
Martha Guzman Aceves,
Regional Administrator, Region IX.
[FR Doc. 2022-06291 Filed 3-24-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 149 (Tuesday, August 4, 2015)]
[Rules and Regulations]
[Pages 46192-46194]
[FR Doc No: 2015-19074]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 874

[Docket No. FDA-2015-N-2525]

Medical Devices; Ear, Nose, and Throat Devices; Classification of
the External Upper Esophageal Sphincter Compression Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA) is classifying the
external upper esophageal sphincter (UES) compression device into class
II (special controls). The special controls that will apply to the
device are identified in this order and will be part of the codified
language for the external UES compression device's classification. The
Agency is classifying the device into class II (special controls) in
order to provide a reasonable assurance of safety and effectiveness of
the device.

DATES: This order is effective August 4, 2015. The classification was
applicable on March 6, 2015.

FOR FURTHER INFORMATION CONTACT: Sunny Park, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2432, Silver Spring, MD, 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i), to a predicate device that does not
require premarket approval. The Agency determines whether new devices
are substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to
classify a device under the criteria set forth in section 513(a)(1).
Under the first procedure, the person submits a premarket notification
under section 510(k) of the FD&C Act for a device that has not
previously been classified and, within 30 days of receiving an order
classifying the device into class III under section 513(f)(1), the
person requests a classification under section 513(f)(2) of the FD&C
Act. Under the second procedure, rather than first submitting a
premarket notification under section 510(k) of the FD&C Act and then a
request for classification under the first procedure, the person
determines that there is no legally marketed device upon which to base
a determination of substantial equivalence and requests a
classification under section 513(f)(2) of the FD&C Act.

If the person submits a request to classify the device under this
second procedure, FDA may decline to undertake the classification
request if FDA identifies a legally marketed device that could provide
a reasonable basis for review of substantial equivalence with the
device or if FDA determines that the device submitted is not of ``low-
moderate risk'' or that general controls would be inadequate to control
the risks and special controls to mitigate the risks cannot be
developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device. On
November 22, 2013, Somna Therapeutics, LLC, submitted a request for
classification of the REZA BAND UES Assist Device under section
513(f)(2) of the FD&C Act. The manufacturer recommended that the device
be classified into class II (Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1). FDA classifies devices
into class II if general controls by themselves are insufficient to
provide reasonable assurance of safety and effectiveness, but there is
sufficient information to establish special controls to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use. After review of the information submitted in the
request, FDA determined that the device can be classified into class II
with the establishment of special controls. FDA believes these special
controls, in addition to general controls, will provide reasonable
assurance of the safety and effectiveness of the device.
    Therefore, on March 6, 2015, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 874.5900.
    Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for an external
UES compression device will need to comply with the special controls
named in this final order. The device is assigned the generic name
external UES compression device, and it is identified as a prescription
device used to apply external pressure on the cricoid cartilage for the
purpose of reducing the symptoms of laryngopharyngeal reflux disease.
    FDA has identified the following risks to health associated
specifically with this type of device, as well as the mitigation
measures required to mitigate these risks, in table 1.

 Table 1--External UES Compression Device Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risk                     Mitigation method
------------------------------------------------------------------------
Adverse tissue reaction................  Biocompatibility assessment.
Risk of overcompression................  Clinical study.
                                         Labeling.
                                         Technical specifications.
Device misuse/incorrect fitting/         Technical specifications.
 malfunctions.                           Clinical study.
                                         Labeling.
                                         Performance testing (mechanical
                                          integrity and shelf life
                                          testing).
------------------------------------------------------------------------

    FDA believes that the following special controls, in combination
with the general controls, address these risks to health and provide
reasonable assurance of the safety and effectiveness:
    1. The patient contacting components must be demonstrated to be
biocompatible.
    2. Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be demonstrated:
    a. Mechanical integrity testing (e.g., tensile strength testing,
fatigue testing) and
    b. shelf life testing
    3. The technical specifications must include pressure measurement
accuracy to characterize device performance.
    4. Clinical performance testing must document any adverse events
observed during clinical use, and demonstrate that the device performs
as intended under anticipated conditions of use.
    5. Labeling must include the following:
    a. Appropriate warnings and precautions.
    b. A detailed summary of the clinical testing pertinent to use of
the device including a detailed summary of the device-related
complications or adverse events.
    c. Detailed instructions on how to fit the device to the patient.
    d. Instructions for reprocessing of any reusable components.
    6. Patient labeling must be provided and must include:
    a. Relevant warnings, precautions, and adverse effects/
complications.
    b. Information on how to correctly wear the device.
    c. The potential risks and benefits associated with the use of the
device.
    d. Alternative treatments.
    e. Reprocessing instructions.
    The external UES compression device is a prescription device
restricted to patient use only upon the authorization of a practitioner
licensed by law to administer or use the device; see 21 CFR 801.109
(Prescription devices).
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k), if FDA determines that premarket notification is not necessary
to provide reasonable assurance of the safety and effectiveness of the
device. For this type of device, FDA has determined that premarket
notification is necessary to provide reasonable assurance of the safety
and effectiveness of the device. Therefore, this device type is not
exempt from premarket notification requirements. Persons who intend to
market this type of device must submit to FDA a premarket notification,
prior to marketing the device, which contains information about the
external UES compression device they intend to market.

II. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21
CFR part 807, subpart E, regarding premarket notification submissions,
have been approved under OMB control number 0910-0120, and the
collections of information in 21 CFR part 801, regarding labeling, have
been approved under OMB control number 0910-0485.

IV. Reference

    The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and is available electronically at http://www.regulations.gov.

1. DEN130046: De Novo Request per 513(f)(2) from Somna Therapeutics,
LLC, dated November 11, 2013.

List of Subjects in 21 CFR Part 874

    Medical devices.

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

PART 874--EAR, NOSE, AND THROAT DEVICES

0
1. The authority citation for 21 CFR part 874 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Add Sec.  874.5900 to subpart F to read as follows:

Sec.  874.5900  External upper esophageal sphincter compression device.

    (a) Identification. An external upper esophageal sphincter
compression device is a prescription device used to apply external
pressure on the cricoid cartilage for the purpose of reducing the
symptoms of laryngopharyngeal reflux disease.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The patient contacting components must be demonstrated to be
biocompatible.
    (2) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be demonstrated:
    (i) Mechanical integrity testing (e.g., tensile strength testing,
fatigue testing) and
    (ii) Shelf life testing.
    (3) The technical specifications must include pressure measurement
accuracy to characterize device performance.
    (4) Clinical performance testing must document any adverse events
observed during clinical use, and demonstrate that the device performs
as intended under anticipated conditions of use.
    (5) Labeling must include the following:
    (i) Appropriate warnings and precautions,
    (ii) A detailed summary of the clinical testing pertinent to use of
the device including a detailed summary of the device-related
complications or adverse events,
    (iii) Detailed instructions on how to fit the device to the
patient, and
    (iv) Instructions for reprocessing of any reusable components.
    (6) Patient labeling must be provided and must include:
    (i) Relevant warnings, precautions, and adverse effects/
complications,
    (ii) Information on how to correctly wear the device,
    (iii) The potential risks and benefits associated with the use of
the device,
    (iv) Alternative treatments, and
    (v) Reprocessing instructions.

    Dated: July 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-19074 Filed 8-3-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 184 (Tuesday, September 22, 2020)]
[Notices]
[Pages 59554-59555]
[FR Doc No: 2020-20872]

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

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2007-0083]

Applied Research Laboratories of South Florida LLC. Application
for Expansion of Recognition

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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

SUMMARY: In this notice, OSHA announces the application of Applied
Research Laboratories of South Florida LLC., for expansion of
recognition as a Nationally Recognized Testing Laboratory (NRTL) and
presents the agency's preliminary finding to grant the application.

DATES: Submit comments, information, and documents in response to this
notice, or requests for an extension of time to make a submission, on
or before October 7, 2020.

ADDRESSES: Submit comments by any of the following methods:
    Electronically: You may submit comments and attachments
electronically at https://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit a copy of your comments and
attachments to the OSHA Docket Office, Docket No. OSHA-2007-0083,
Occupational Safety and Health Administration, U.S. Department of
Labor, Room N-3653, 200 Constitution Avenue NW, Washington, DC 20210;
telephone:<PHONE_NUMBER>. OSHA's TTY number is<PHONE_NUMBER>. Please
note: While OSHA's docket office is continuing to accept and process
submissions by regular mail, due to the COVID-19 pandemic, the Docket
Office is closed to the public and not able to receive submissions to
the rulemaking record by express delivery, hand delivery, and messenger
service.
    Instructions: All submissions must include the agency name and OSHA
docket number (OSHA-2007-0083). OSHA places comments and other
materials, including any personal information, in the public docket
without revision, and these materials will be available online at
http://www.regulations.gov. Therefore, the agency cautions commenters
about submitting statements they do not want made available to the
public, or submitting comments that contain personal information
(either about themselves or others) such as Social Security numbers,
birth dates, and medical data.
    Docket: To read or download comments or other material in the
docket, go to https://www.regulations.gov or the OSHA Docket Office at
the above address. All documents in the docket (including this Federal
Register notice) are listed in the https://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download through the website. All submissions,
including copyrighted material, are available for inspection through
the OSHA Docket Office.
    Extension of comment period: Submit requests for an extension of
the comment period on or before October 7, 2020 to the Office of
Technical Programs and Coordination Activities, Directorate of
Technical Support and Emergency Management, Occupational Safety and
Health Administration, U.S. Department of Labor, 200 Constitution
Avenue NW, Room N-3653, Washington, DC 20210, or by fax to (202) 693-
1644.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor, telephone:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor, phone:
(202) 693-2110 or email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Notice of the Application for Expansion

    OSHA is providing notice that Applied Research Laboratories of
South Florida LLC. (ARL), is applying for expansion of recognition as a
NRTL. ARL requests the addition of two test standards to the NRTL scope
of recognition.
    OSHA recognition of a NRTL signifies that the organization meets
the requirements specified in 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within the
scope of recognition. Each NRTL's scope of recognition includes (1) the
type of products the NRTL may test, with each type specified by the
applicable test standard; and (2) the recognized site(s) that has/have
the technical capability to perform the product-testing and product-
certification activities for test standards within the NRTL's scope.
Recognition is not a delegation or grant of government authority;
however, recognition enables employers to use products approved by the
NRTL to meet OSHA standards that require product testing and
certification.
    The agency processes applications by a NRTL for initial recognition
and for an expansion or renewal of this recognition, following
requirements in Appendix A to 29 CFR 1910.7. This appendix requires
that the agency publish two notices in the Federal Register in
processing an application. In the first notice, OSHA announces the
application and provides a preliminary finding. In the second notice,
the agency provides the final decision on the application. These
notices set forth the NRTL's scope of recognition or modifications of
that scope. OSHA maintains an informational web page for each NRTL,
including ARL, which details the NRTL's scope of recognition. These
pages are available from the OSHA website at http://www.osha.gov/dts/otpca/nrtl/index.html.
    ARL currently has one facility (site) recognized by OSHA for
product testing and certification, with headquarters located at:
Applied Research Laboratories of South Florida LLC, 5371 NW 161st
Street, Miami, Florida 33014. A complete list of ARL's scope of
recognition is available at https://www.osha.gov/dts/otpca/nrtl/arl.html.

II. General Background on the Application

    ARL submitted an application, dated June 13, 2019 (OSHA-2007-0083-
0055), to expand recognition to include two additional test standards.
OSHA staff performed a detailed analysis of the application packet and
reviewed other pertinent information. OSHA did not perform any on-site
reviews in relation to this application.
    Table 1 lists the appropriate test standard found in ARL's
application to expand for testing and certification of products under
the NRTL Program.

  Table 1--Proposed List of Appropriate Test Standards for Inclusion in
                     ARL's NRTL Scope of Recognition
------------------------------------------------------------------------
             Test standard                     Test standard title
------------------------------------------------------------------------
ANSI/UL 399............................  Standard for Drinking-Water
                                          Coolers.
ANSI/UL 471............................  Standard for Commercial
                                          Refrigerators and Freezers.
------------------------------------------------------------------------

III. Preliminary Findings on the Application

    ARL submitted an acceptable application for expansion of
recognition. OSHA's review of the application file, and pertinent
documentation, indicates ARL can meet the requirements prescribed by 29
CFR 1910.7 for expanding recognition to include the addition of these
two test standards for NRTL testing and certification listed above.
This preliminary finding does not constitute an interim or temporary
approval of ARL's application.
    OSHA welcomes public comment as to whether ARL meets the
requirements of 29 CFR 1910.7 for expansion of recognition as a NRTL.
Comments should consist of pertinent written documents and exhibits.
Commenters needing more time to comment must submit a request in
writing, stating the reasons for the request. Commenters must submit
the written request for an extension by the due date for comments. OSHA
will limit any extension to 10 days unless the requester justifies a
longer period. OSHA may deny a request for an extension if the request
is not adequately justified. To obtain or review copies of the exhibits
identified in this notice, as well as comments submitted to the docket,
contact the Docket Office at the above address. These materials also
are available online at http://www.regulations.gov under Docket No.
OSHA-2007-0083.
    OSHA staff will review all comments to the docket submitted in a
timely manner. After addressing the issues raised by these comments,
the agency will make a recommendation to the Assistant Secretary for
Occupational Safety and Health whether to grant ARL's application for
expansion of recognition. The Assistant Secretary will make the final
decision on granting the application. In making this decision, the
Assistant Secretary may undertake other proceedings prescribed in
Appendix A to 29 CFR 1910.7.
    OSHA will publish a public notice of the final decision in the
Federal Register.

IV. Authority and Signature

    Loren Sweatt, Principal Deputy Assistant Secretary of Labor for
Occupational Safety and Health, authorized the preparation of this
notice. Accordingly, the agency is issuing this notice pursuant to 29
U.S.C. 657(g)(2), Secretary of Labor's Order No. 1-2012 (77 FR 3912,
Jan. 25, 2012), and 29 CFR 1910.7.

    Signed at Washington, DC, on September 15, 2020.
Loren Sweatt,
Principal Deputy Assistant Secretary of Labor for Occupational Safety
and Health.
[FR Doc. 2020-20872 Filed 9-21-20; 8:45 am]
BILLING CODE 4510-26-P