United States Court of Appeals, Tenth Circuit.

AMERICAN WILDLANDS; Pacific Rivers Council; Montana Environmental Information Center and Northern Plains Resource Council, Inc., Plaintiffs Appellants, v. Carol BROWNER, in her official capacity as the Administrator of the U. S. Environmental Protection Agency; Bill Yellowtail, in his official capacity as the Regional Administrator of the U. S. Environmental Protection Agency, Region VIII and Environmental Protection Agency, an agency of the United States Government, Defendants Appellees. and Western Environmental Trade Association, on behalf of its members and State of Montana, Department of Environmental Quality, Intervenors Appellees.

No. 00 1224.

Aug. 8, 2001.

Environmental organization brought action challenging Environmental Protection Agency's ( EPA) approval pursuant to Clean Water Act of certain of Montana's water quality standards. The United States District Court for the District of Colorado, Kane, Senior Judge, 94 F. Supp. 2d 1150, < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 4637& FindType= Y& SerialNum= 2000299575> held in favor of EPA, and organization appealed. The Court of Appeals, Tacha, Chief Judge, held that: ( 1) state was not required to regulate nonpoint sources at antidegradation stage, and ( 2) water quality standard exempting mixing zones from compliance with narrative water quality criteria did not violate Clean Water Act.

Affirmed.

West Headnotes [ 1] Environmental Law 682 149Ek682 < http:// www. westlaw. com/ KeyNumber/ Default. wl? rs=++++ 1.0& vr= 2.0& CMD= KEY& DocName= 149EK682> ( Formerly 199k25.15( 8) Health and Environment)

Environmental Protection Agency's ( EPA) approval of state's water quality standards pursuant to Clean Water Act is entitled to deference, and will be upheld if its action is permissible construction of statute. Federal Water Pollution Control Act Amendments of 1972, § 303, 33 U. S. C. A. § 1313 < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000546& DocName= 33USCAS1313& FindType= L>.

[ 2] Environmental Law 175 149Ek175 < http:// www. westlaw. com/ KeyNumber/ Default. wl? rs=++++ 1.0& vr= 2.0& CMD= KEY& DocName= 149EK175> ( Formerly 199k25.7( 3) Health and Environment)

Environmental Protection Agency ( EPA) did not have authority under Clean Water Act to regulate nonpoint source pollution. Federal Water Pollution Control Act Amendments of 1972, § 303, 33 U. S. C. A. § 1313 < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000546& DocName= 33USCAS1313 & FindType= L>.

[ 3] Environmental Law 191 149Ek191 < http:// www. westlaw. com/ KeyNumber/ Default. wl? rs=++++ 1.0& vr= 2.0& CMD= KEY& DocName= 149EK191> ( Formerly 199k25.7( 6.1) Health and Environment)

State was not required under Clean Water Act to regulate nonpoint sources at antidegradation stage. Federal Water Pollution Control Act Amendments of 1972, § 303, 33 U. S. C. A. § 1313 < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000546& DocName= 33USCAS1313 & FindType= L>; 40 C. F. R. § 131.12( a)( 2) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000547& DocName= 40CFRS131.12& FindType= L>.

[ 4] Environmental Law 191 149Ek191 < http:// www. westlaw. com/ KeyNumber/ Default. wl? rs=++++ 1.0& vr= 2.0& CMD= KEY& DocName= 149EK191> ( Formerly 199k25.7( 12) Health and Environment)

[ 4] Environmental Law 190 149Ek190 < http:// www. westlaw. com/ KeyNumber/ Default. wl? rs=++++ 1.0& vr= 2.0& CMD= KEY& DocName= 149EK190> ( Formerly 199k25.7( 12) Health and Environment)

Montana's water quality standard exempting mixing zones from compliance with narrative water quality criteria and state's antidegradation rules did not violate Clean Water Act ( CWA), where state provided number of safeguards to ensure that mixing zones did not damage water quality of entire water body. Federal Water Pollution Control Act Amendments of 1972, § 303, 33 U. S. C. A. § 1313 < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0 & DB= 1000546& DocName= 33USCAS1313& FindType= L>; 40 C. F. R. § 131.13 < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000547& DocName= 40CFRS131.13 & FindType= L>; MCA 75 5 301( 4). * 1193 Kristen L. Boyles, < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= WLDPEOPLECITE DocName= 0212045001& FindType= h> Earthjustice Legal Defense Fund, ( Stephen D. Mashuda, Earthjustice Legal Defense Fund, Seattle, WA, and James S. Angell, Earthjustice Legal Defense Fund, Denver, CO, with her on the briefs), for Appellants.

Robert H. Oakley, ( Lois J. Schiffer, Assistant Attorney General, David A. Carson and Greer S. Goldman, with him on the brief), United States Department of Justice, Environment & Natural Resources Division, Washington, DC, for Appellee Environmental Protection Agency.

Claudia L. Massman, Special Assistant Attorney General, Department of Environmental Quality, Helena, MT, for Appellee State of Montana.

Rebecca W. Watson, Gough, Shanahan, Johnson & Waterman, and John Bloomquist < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= WLD PEOPLECITE& DocName= 0253484101& FindType= h>, Doney, Crowley, Bloomquist & Uda, Helena, MT, filed a brief, on behalf of Appellee Western Environmental Trade Association.

Before TACHA < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= WLDPEOPLECITE DocName= 0209742301& FindType= h>, Chief Judge, REAVLEY < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= WLD PEOPLECITE& DocName= 0247561501& FindType= h>, [ FN*] and LUCERO < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0 & DB= WLD PEOPLECITE& DocName= 0255848601& FindType= h>, Circuit Judges.

FN* Honorable Thomas M. Reavley, Senior Circuit Judge, United States Court of Appeals for the Fifth Circuit, sitting by designation.

TACHA < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= WLD PEOPLECITE& DocName= 0209742301& FindType= h>, Chief Circuit Judge. This appeal presents a challenge by Appellant American Wildlands to the Environmental Protection Agency's (" the EPA") approval pursuant to the Clean Water Act of certain of Montana's water quality standards. Specifically, two questions are presented to this court for review: ( 1) whether the EPA properly approved Montana's statutory exemption from antidegradation review of nonpoint sources of pollution; and ( 2) whether the EPA properly approved Montana's mixing zone policies and procedures. The district court held in favor of the EPA. We exercise jurisdiction pursuant to 28 U. S. C. § 1291 < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000546& DocName= 28USCAS1291& FindType= L> and affirm.

I. Statutory and Regulatory Scheme A. Point and Nonpoint Source Discharges The Clean Water Act (" the Act") was adopted " to restore and maintain the chemical, physical, and biological integrity of the Nation's waters." 33 U. S. C. § 1251( a) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0 & vr= 2.0& DB= 1000546& DocName= 33USCAS1251& FindType= L>. To achieve this goal, Congress prohibited the discharge from a point source of any pollutant into the waters of the United States unless that discharge met specific requirements set forth in the Act. 33 U. S. C. § 1311( a) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000546& DocName= 33USCAS1311& FindType= L>. " Point source" is defined by the Act to mean: " any discernible, confined and discrete conveyance ... from which pollutants are or may be discharged." 33 U. S. C. § 1362( 14) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000546& DocName= 33USCAS1362& FindType= L>. Further, a " pollutant" is defined as " dredged spoil, solid waste, incinerator residue, sewage, garbage, sewage sludge, munitions, chemical wastes, biological materials, radioactive materials, heat, wrecked or discarded equipment, rock, sand, cellar dirt and industrial, municipal, and agricultural waste discharged into water." 33 U. S. C. § 1362( 6) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0 & DB= 1000546& DocName= 33USCAS1362& FindType= L>.

In order for point source discharges to be in compliance with the Act, such discharges must adhere to the terms of a National Pollutant Discharge Elimination System (" NPDES") permit issued pursuant to the Act. 33 U. S. C. § 1342 < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000546& DocName= 33USCAS1342 & FindType= L>. NPDES permits are issued by the EPA or, in certain jurisdictions, by state agencies authorized to do so by the EPA. 33 U. S. C. § 1342( a)( d) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000546& DocName= 33USCAS1342& FindType= L>. Unlike point source discharges, nonpoint source discharges are not defined by the Act. One court has described nonpoint source pollution as " nothing more that a [ water] pollution problem not involving a discharge from a point source." * 1194Nat'l Wildlife Federation v. Gorsuch, < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 350 & FindType= Y& ReferencePositionType= S& SerialNum= 1982148238& ReferencePosition= 166> 693 F. 2d 156, 166 n. 28 ( D. C. Cir. 1982) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 350 & FindType= Y& ReferencePositionType= S& SerialNum= 1982148238& ReferencePosition= 166> ( internal quotation marks omitted).

Rather than vest the EPA with authority to control nonpoint source discharges through a permitting process, Congress required states to develop water quality standards for intrastate waters. 33 U. S. C. § 1313 < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000546& DocName= 33USCAS1313 & FindType= L>. Water quality standards consist of three elements: first, each water body must be given a " designated use," such as recreation or the protection of aquatic life; second, the standards must specify for each body of water the amounts of various pollutants or pollutant parameters that may be present without impairing the designated use; and finally, each state must adopt an antidegradation review policy which will allow the state to assess activities that may lower the water quality of the water body. 33 U. S. C. § 1313( c)( 2)( A) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000546& DocName= 33USCAS1313 & FindType= L>; 40 C. F. R. § § 130.3 < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000547& DocName= 40CFRS130.3& FindType= L>, 130.10( d)( 4) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000547& DocName= 40CFRS130.10& FindType= L>, 131.6 < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000547& DocName= 40CFRS131.6 & FindType= L>, 131.10 < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000547 & DocName= 40CFRS131.10& FindType= L>, 131.11 < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000547& DocName= 40CFRS131.11& FindType= L>. Further, each state is required to identify all of the waters within its borders not meeting water quality standards and establish " total maximum daily loads" (" TMDL") for those waters. 33 U. S. C. § 1313( d) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000546& DocName= 33USCAS1313& FindType= L>. A TMDL defines the specified maximum amount of a pollutant which can be discharged into a body of water from all sources combined. Dioxin/ Organochlorine Ctr. v. Clarke, < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 506 & FindType= Y& ReferencePositionType= S& SerialNum= 1995133453& ReferencePosition= 1520> 57 F. 3d 1517, 1520 ( 9th Cir. 1995) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 506 & FindType= Y& ReferencePositionType= S& SerialNum= 1995133453& ReferencePosition= 1520>.

B. The EPA's Approval Role Whenever a state revises or adopts a water quality standard, the state must submit the standard to the EPA's Regional Administrator for a determination as to whether the new standard is consistent with the Act. 33 U. S. C. § 1313( c)( 2) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000546& DocName= 33USCAS1313& FindType= L>; 40 C. F. R. § 131.21( a) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0 & vr= 2.0& DB= 1000547& DocName= 40CFRS131.21& FindType= L>. The EPA must either approve the standard within sixty days of submission or if the EPA determines that the standard is inconsistent with the Act disapprove the standard and notify the state of any changes necessary to gain the EPA's approval. 33 U. S. C. § 1313( c)( 3) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000546& DocName= 33USCAS1313 & FindType= L>. If the state fails to make the changes required by the EPA, the agency must promptly promulgate and impose replacement standards upon the state. 33 U. S. C. § 1313( c)( 3)( 4)( A) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000546& DocName= 33USCAS1313 & FindType= L>.

" '[ S] tates have the primary role, under § 303 of the CWA ( 33 U. S. C. § 1313) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000546& DocName= 33USCAS1313 & FindType= L>, in establishing water quality standards. EPA's sole function, in this respect, is to review those standards for approval.' " City of Albuquerque v. Browner, < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 506& FindType= Y& ReferencePositionType= S& SerialNum= 1996226465& ReferencePosition= 425> 97 F. 3d 415, 425 ( 10th Cir. 1996) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 506 & FindType= Y& ReferencePositionType= S& SerialNum= 1996226465& ReferencePosition= 425> ( quoting Natural Res. Def. Council, Inc. v. EPA, < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 506 & FindType= Y& ReferencePositionType= S& SerialNum= 1994048161& ReferencePosition= 1401> 16 F. 3d 1395, 1401 ( 4th Cir. 1993) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 506 & FindType= Y& ReferencePositionType= S& SerialNum= 1994048161& ReferencePosition= 1401>). Therefore, the EPA has a limited role in reviewing water quality standards. Id. < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& FindType= Y& SerialNum= 1996226465> (" Congress clearly intended the EPA to have a limited, non rulemaking role in the establishment of water quality standards by states....").

C. Antidegradation The antidegradation review policies adopted by the states as a part of their water quality standards must be consistent with the federal antidegradation policy. 40 C. F. R. § 131.12 < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000547& DocName= 40CFRS131.12& FindType= L>. The EPA's regulations establish three levels of water quality protection: Tier I, Tier II, and Tier III. Tier I protection establishes the minimum water quality standard for all waters and requires that "[ e] xisting instream water uses and the level of water quality necessary to protect the existing uses shall be maintained and protected." 40 C. F. R. < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000547& DocName= 40CFRS131.12 & FindType= L> § 131.12( a)( 1) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000547 & DocName= 40CFRS131.12& FindType= L>. Tier II protection provides that, where the water quality of a water body exceeds that necessary to support aquatic life and recreation, that level of water quality shall be maintained unless the state determines that " allowing lower water quality is necessary to accommodate important economic or social development in the area in which the waters are located." 40 C. F. R. § 131.12( a)( 2) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000547& DocName= 40CFRS131.12 & FindType= L>. Tier III protection provides that, where a water body " constitute[ s] an outstanding National resource, such as waters of National and State parks and wildlife refuges and waters * 1195 of exceptional recreational or ecological significance, that water quality shall be maintained and protected." 40 C. F. R. § 131.12( a) ( 3) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000547& DocName= 40CFRS131.12 & FindType= L>.

D. Mixing Zones Pursuant to the EPA's regulations, a state may, at its discretion, include within its water quality standards " policies generally affecting ... mixing zones." 40 C. F. R. § 131.13 < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0 & vr= 2.0& DB= 1000547& DocName= 40CFRS131.13& FindType= L>. Mixing zones are " areas where an effluent discharge undergoes initial dilution and are extended to cover the secondary mixing in the ambient water body. A mixing zone is an allocated impact zone where acute and chronic water quality criteria can be exceeded as long as a number of protections are maintained." Environmental Protection Agency, Water Quality Standards Handbook § 5.1.1, at 5 5 ( 2d ed. 1994) ( hereinafter Handbook ). The protections that must be maintained include the absence of " toxic conditions to aquatic life," " objectionable deposits," " floating debris," " objectionable color, odor, taste, or turbidity," and substances resulting in " a dominance of nuisance species." Id. at 5 5 to 5 6. Mixing zones are allowable as a practical necessity because "[ i] t is not always necessary to meet all water quality criteria within the discharge pipe to protect the integrity of the water body as a whole. Sometimes it is appropriate to allow for ambient concentrations above the criteria in small areas near outfalls." Id. § 5.1, at 5 1. Should a state decide to include " policies generally affecting ... mixing zones" within their water quality standards, those policies are subject to review and approval by the EPA. 40 C. F. R. § 131.13 < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0 & vr= 2.0& DB= 1000547& DocName= 40CFRS131.13& FindType= L>.

E. Montana's Policies 1. Montana's Exemption of Nonpoint Source Pollution from Antidegradation Review In drafting its water quality standards, the Montana legislature exempted " existing activities that are nonpoint sources of pollution as of April 29, 1993" from antidegradation review with respect to Tier II waters. Mont. Code Ann. § 75 5 317( 2)( a) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1002018 & DocName= MTST75 5 317& FindType= L>. Further, nonpoint sources initiated after April 29, 1993 are exempted from antidegradation review with respect to Tier II waters " when reasonable land, soil, and water conservation practices are applied and existing and anticipated beneficial uses will be fully protected." Mont. Code Ann. § 75 5 317( 2)( b) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1002018 & DocName= MTST75 5 317& FindType= L>.

2. Montana's Mixing Zone Policies and Procedures Montana's antidegradation rules provide that, where degradation to a water body at the edge of a mixing zone is not significant, no antidegradation review of the mixing zone itself is required. Mont. Admin. R. § 17.30.715( 1)( c) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1012680& DocName= MTADC17.30.715 & FindType= L>, 17.30.505( 1)( b) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1012680 & DocName= MTADC17.30.505& FindType= L>. Montana does, however, impose a number of other requirements on mixing zones designed to limit their impact on the receiving water body. Montana requires that mixing zones have "( a) the smallest practicable size, ( b) a minimum practicable effect on water uses, and ( c) definable boundaries." Mont. Code Ann. § 75 5 301( 4) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0 & DB= 1002018& DocName= MTST75 5 301& FindType= L>. A mixing zone may not " threaten or impair existing beneficial uses." Mont. Admin. R. § 17.30.506( 1) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0 & DB= 1012680& DocName= MTADC17.30.506& FindType= L>. A discharge permit may not be renewed if " there is evidence that the previously allowed mixing zone will impair existing or anticipated uses." Mont. Admin. R. § 17.30.505( 1)( c) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1012680 & DocName= MTADC17.30.505& FindType= L>. The Montana Department of Environmental Quality is required to consider various factors in deciding whether or not to grant a mixing zone, such as the toxicity and persistence of the substance being discharged and the cumulative effects of multiple mixing zones. Mont. Admin. R. § 17.30.506 ( 2) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1012680& DocName= MTADC17.30.506 & FindType= L>. Finally, the water quality within the mixing zone itself is regulated to prohibit discharge from blocking passage of aquatic organisms or from causing the death of * 1196 organisms passing through the mixing zone. Mont. Admin. R. § 17.30.602( 14) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1012680& DocName= MTADC17.30.602& FindType= L>. II. Proceedings Below American Wildlands filed this lawsuit in 1998, alleging that the EPA had failed to take timely action under section 303( c) of the Act to approve or disapprove Montana's new and revised water quality standards. The original complaint alleged that the EPA violated the Act by: ( 1) failing to approve or disapprove Montana's new and revised water quality standards; and ( 2) by failing to promptly prepare and promulgate replacement standards for those Montana standards that failed to meet the requirements of the Act. In October 1998, American Wildlands moved for summary judgment. The parties stayed briefing of that motion, however, when the EPA stipulated that it would complete its review of Montana's water quality standards by January 15, 1999.

On December 24, 1998, the EPA disapproved some of Montana's revised standards and approved others. The EPA addressed the remaining standards on January 26, 1999, again disapproving some and approving others. On March 31, 1999, American Wildlands amended its complaint to challenge the EPA's approval of several of Montana's standards. The district court affirmed each of the EPA's actions. Am. Wildlands v. Browner, < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 4637& FindType= Y& SerialNum= 2000299575> 94 F. Supp. 2d 1150 ( D. Colo. 2000) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0 & DB= 4637& FindType= Y& SerialNum= 2000299575>. This appeal followed. Specifically, American Wildlands appeals the district court's conclusion that: ( 1) the EPA properly approved Montana water quality standards that exempt nonpoint source pollution from antidegradation review; and ( 2) the EPA properly approved Montana mixing zone policies and procedures exempting the areas within the mixing zone from antidegradation review.

III. Standard of Review " Our standard of review of the lower court's decision in an APA case is de novo." N. M. Cattle Growers Ass'n v. United States Fish & Wildlife Serv., < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 506 & FindType= Y& ReferencePositionType= S& SerialNum= 2001419877& ReferencePosition= 1281> 248 F. 3d 1277, 1281 ( 10th Cir. 2001) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 506 & FindType= Y& ReferencePositionType= S& SerialNum= 2001419877& ReferencePosition= 1281>. We will not overturn an agency action unless it " fails to meet statutory, procedural or constitutional requirements, or unless it is arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law." Sac & Fox Nation v. Norton, < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 506 & FindType= Y& ReferencePositionType= S& SerialNum= 2001180097& ReferencePosition= 1260> 240 F. 3d 1250, 1260 ( 10th Cir. 2001) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 506 & FindType= Y& ReferencePositionType= S& SerialNum= 2001180097& ReferencePosition= 1260> ( citing 5 U. S. C. § 706( 2)( A)( D) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000546& DocName= 5USCAS706& FindType= L>). Specifically, we review the EPA's decision to approve state water quality standards under the arbitrary and capricious standard. City of Albuquerque, < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 506& FindType= Y& ReferencePositionType= S& SerialNum= 1996226465 & ReferencePosition= 426> 97 F. 3d at 426 < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 506& FindType= Y& ReferencePositionType= S& SerialNum= 1996226465& ReferencePosition= 426> ( reviewing the EPA's approval of water quality standards proposed by an Indian tribe treated as a state under the Clean Water Act under the arbitrary and capricious standard); accord Natural Res. Def. Council, Inc., < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 506 & FindType= Y& ReferencePositionType= S& SerialNum= 1994048161& ReferencePosition= 1403> 16 F. 3d at 1403 04 < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 506 & FindType= Y& ReferencePositionType= S& SerialNum= 1994048161& ReferencePosition= 1403> ( reviewing the EPA's approval of state water quality standards under the arbitrary and capricious standard); Natural Res. Def. Council, Inc. v. Fox, < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 345 & FindType= Y& ReferencePositionType= S& SerialNum= 1995243787& ReferencePosition= 161> 909 F. Supp. 153, 161 ( S. D. N. Y. 1995) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 345 & FindType= Y& ReferencePositionType= S& SerialNum= 1995243787& ReferencePosition= 161> ( same).

[ 1] American Wildlands argues, however, that due to the unique approval role played by the EPA, any approval decision by the EPA necessarily implicates purely legal questions of when water quality standards are consistent with the Act which we must review with no deference to the agency. We disagree. In Chevron, U. S. A., Inc. v. Natural Resources Defense Council, Inc., < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 708& FindType= Y& SerialNum= 1984130736> 467 U. S. 837, 842 43, 104 S. Ct. 2778, 81 L. Ed. 2d 694 ( 1984) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 708& FindType= Y& SerialNum= 1984130736>, the Supreme Court created a two step approach to judicial review of agency interpretations of acts of Congress. First, if a statute is clear and unambiguous, the language of the statute controls. Id. < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& FindType= Y& SerialNum= 1984130736> However, " if the statute is silent or ambiguous with respect to the specific issue," then " the question * 1197 for the court is whether the agency's answer is based on a permissible construction of the statute." Id. < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 708& FindType= Y& SerialNum= 1984130736> at 843, 104 S. Ct. 2778. < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 708 & FindType= Y& SerialNum= 1984130736> Before granting the EPA's approval determination Chevron < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& FindType= Y& SerialNum= 1984130736> deference, however, we must ask whether " Congress delegated authority to the agency generally [ to make such determinations] carrying the force of law," and whether " the agency interpretation claiming deference was promulgated in the exercise of that authority." United States v. Mead Corp., < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 708 & FindType= Y& ReferencePositionType= S& SerialNum= 2001518724& ReferencePosition= 2171> 533 U. S. 218, 121 S. Ct. 2164, 2171, 150 L. Ed. 2d 292 ( 2001) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0 & DB= 708& FindType= Y& ReferencePositionType= S& SerialNum= 2001518724& ReferencePosition= 2171>.

It is clear that Congress delegated authority to the EPA to make determinations as to when water quality standards are consistent with the Act. 33 U. S. C. § 1313 < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0 & DB= 1000546& DocName= 33USCAS1313& FindType= L>. As if presaging the Mead < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& FindType= Y& SerialNum= 2001518724> refinement of the traditional Chevron < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0 & FindType= Y& SerialNum= 1984130736> analysis, this court specifically held in City of Albuquerque < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& FindType= Y& SerialNum= 1996226465> that the EPA has been charged by Congress with the authority to administer and interpret the Act. 97 F. 3d at 422 < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 506 & FindType= Y& ReferencePositionType= S& SerialNum= 1996226465& ReferencePosition= 422> (" The EPA ... is entitled to considerable deference in its interpretation of the Clean Water Act because it is charged with administering the Act"); see also Arkansas v. Oklahoma, < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0 & vr= 2.0& DB= 708& FindType= Y& SerialNum= 1992046720> 503 U. S. 91, 112, 112 S. Ct. 1046, 117 L. Ed. 2d 239 ( 1992) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 708& FindType= Y& SerialNum= 1992046720> ( criticizing this court for failing to afford the EPA's interpretation of the Act " an appropriate level of deference"); id. < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 708 & FindType= Y& SerialNum= 1992046720> at 112, 112 S. Ct. 1046 < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 708& FindType= Y& SerialNum= 1992046720> ( holding that Congress delegated to the EPA " substantial statutory discretion" under the Act). Further, it is clear that the EPA's action in this case was taken in the exercise of that authority. Thus, the Mead < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& FindType= Y& SerialNum= 2001518724> threshold requirements are met. We therefore conduct a Chevron < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& FindType= Y& SerialNum= 1984130736> analysis.

The Act is silent on the specific questions of statutory interpretation raised by this case. Thus, we will accord Chevron < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& FindType= Y& SerialNum= 1984130736> deference to the EPA's interpretation of the Act when it makes decisions to approve state water quality standards. We therefore review the agency action at issue here under the arbitrary and capricious standard and, in conjunction, will ask only whether the EPA's interpretation of the Act implicit in its action is a permissible construction of the statute. " This standard of review is a narrow one, and we are not empowered to substitute our judgment for that of the EPA." City of Albuquerque, < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0 & vr= 2.0& DB= 506& FindType= Y& ReferencePositionType= S& SerialNum= 1996226465& ReferencePosition= 424> 97 F. 3d at 424 < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 506 & FindType= Y& ReferencePositionType= S& SerialNum= 1996226465& ReferencePosition= 424>.

IV. The EPA's Approval of Montana's Water Quality Standards A. Montana's Standard Exempting Nonpoint Source Pollution from Antidegradation Review It is the position of American Wildlands in this case that Montana's Tier II antidegradation policy, which does not consider nonpoint source pollution, is not consistent with the Act and must be disapproved by the EPA. The EPA maintains that the Act does not grant it authority to regulate nonpoint sources of pollution, and therefore, it is powerless to disapprove state antidegradation review policies on the basis of how those policies deal with nonpoint source pollution.

[ 2] The district court, ruling in favor of the EPA, held that " nothing in the CWA demands that a state adopt a regulatory system for nonpoint sources." Am. Wildlands, < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0 & vr= 2.0& DB= 4637& FindType= Y& ReferencePositionType= S& SerialNum= 2000299575& ReferencePosition= 1161> 94 F. Supp. 2d at 1161. < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 4637 & FindType= Y& ReferencePositionType= S& SerialNum= 2000299575& ReferencePosition= 1161> We agree. In the Act, Congress has chosen not to give the EPA the authority to regulate nonpoint source pollution. See Kennecott Copper Corp. v. EPA, < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 350 & FindType= Y& ReferencePositionType= S& SerialNum= 1979140029& ReferencePosition= 1243> 612 F. 2d 1232, 1243 ( 10th Cir. 1979) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 350 & FindType= Y& ReferencePositionType= S& SerialNum= 1979140029& ReferencePosition= 1243> ( holding that the EPA lacks authority to regulate nonpoint sources of pollution); Appalachian Power Co. v. Train, < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 350 & FindType= Y& ReferencePositionType= S& SerialNum= 1976125601& ReferencePosition= 1373> 545 F. 2d 1351, 1373 ( 4th Cir. 1976) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 350 & FindType= Y& ReferencePositionType= S& SerialNum= 1976125601& ReferencePosition= 1373> (" Congress consciously distinguished between point source and nonpoint source discharges, giving EPA authority under the [ Clean Water] Act to regulate only the former.").

* 1198 [ 3] Because the Act nowhere gives the EPA the authority to regulate nonpoint source discharges, the EPA's determination that Montana's water quality standards exempting nonpoint source discharges from antidegradation review are consistent with the Act is a permissible construction of the Act. It is true that states are required to " assure that there shall be achieved ... cost effective and reasonable best management practices for nonpoint source control." 40 C. F. R. § 131.12( a)( 2) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000547 & DocName= 40CFRS131.12& FindType= L>. It is also true that the standard setting process in 33 U. S. C. § 1313 < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000546& DocName= 33USCAS1313 & FindType= L> applies generally to waters polluted by both point source and nonpoint source pollution. 33 U. S. C. § 1313 < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000546& DocName= 33USCAS1313& FindType= L> ( making no distinction between pollution from point and nonpoint sources). However, this does not mean, as American Wildlands argues, that states are required to regulate nonpoint sources at the antidegradation stage. Rather, the effect of nonpoint source discharges on water bodies will be diminished by state adoption of TMDLs for water bodies not meeting state water quality standards. Consequently, we find that the EPA did not act arbitrarily or misinterpret the Act when it approved Montana's antidegradation review rules.

B. Montana's Mixing Zone Policies and Procedures [ 4] American Wildlands argues that Montana's mixing zone policy allowing point source discharges to degrade water quality within the mixing zone so long as the discharge does not degrade the water quality outside the zone is inconsistent with the Act because it allows point source pollution to escape antidegradation review within certain areas of Montana's water bodies. The EPA maintains that the Act's antidegradation requirements apply to the waterbody as a whole, not specifically to the mixing zone. We find the EPA's interpretation of the Act to be permissible.

The use of mixing zones is widespread. Indeed, the water quality regulations specifically allow for their use. 40 C. F. R. § 131.13 < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 1000547& DocName= 40CFRS131.13& FindType= L>. " Practically every state and Puerto Rico have adopted mixing zone criteria...." P. R. Sun Oil < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 506 & FindType= Y& ReferencePositionType= S& SerialNum= 1993198848& ReferencePosition= 75> Co. v. EPA, < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 506 & FindType= Y& ReferencePositionType= S& SerialNum= 1993198848& ReferencePosition= 75> 8 F. 3d 73, 75 ( 1st Cir. 1993) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 506 & FindType= Y& ReferencePositionType= S& SerialNum= 1993198848& ReferencePosition= 75>. As noted above, mixing zones are allowable as a practical necessity because "[ i] t is not always necessary to meet all water quality criteria within the discharge pipe to protect the integrity of the water body as a whole. Sometimes it is appropriate to allow for ambient concentrations above the criteria in small areas near outfalls." Handbook § 5.1, at 5 1. While " the entire extent of the water body is not required to be given full existing use protection," all effects " on the existing use must be limited to the area of the regulatory mixing zone." Id. § 4.4.4, at 4 6.

Moreover, courts have previously recognized that the reality of mixing zones makes measuring water quality standards at the edge of the zone a necessity. P. R. Sun Oil Co., < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 506& FindType= Y& ReferencePositionType= S& SerialNum= 1993198848 & ReferencePosition= 75> 8 F. 3d at 75 < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 506 & FindType= Y& ReferencePositionType= S& SerialNum= 1993198848& ReferencePosition= 75> ("[ M] easuring pollutants at the edge of the mixing zone is widespread in the application of the Clean Water Act."); Marathon Oil Co. v. EPA, < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 350 & FindType= Y& ReferencePositionType= S& SerialNum= 1987126999& ReferencePosition= 1349> 830 F. 2d 1346, 1349 ( 5th Cir. 1987) < http:// www. westlaw. com/ Find/ Default. wl? rs=++++ 1.0& vr= 2.0& DB= 350 & FindType= Y& ReferencePositionType= S& SerialNum= 1987126999& ReferencePosition= 1349> (" By definition, the effluent itself [ within the mixing zone] does not meet water quality standards.... It necessarily follows, then, that the edge or outer circumference of the mixing zone is defined as the boundary at which water quality standards are first met."). Finally, as mentioned above, Montana has provided a number of safeguards to ensure that mixing zones do not damage the water quality of the entire water body. Consequently, we find that the EPA did not act arbitrarily or misinterpret the Act when it approved Montana's mixing zone policies.

V. Conclusion In sum, we hold that the EPA's approval of Montana's water quality standards was * 1199 not done arbitrarily or capriciously. Furthermore, the EPA's interpretation of the Clean Water Act implicit in its decision to approve those standards is permissible. [ FN1] Therefore, we AFFIRM.

FN1. Western Environmental Trade Association's " Motion to Supplement the Administrative Record, or, alternatively, to have Judicial Notice taken of EPA Guidance Document Excerpts" is denied.

260 F. 3d 1192, 52 ERC 2033, 31 Envtl. L. Rep. 20,860, 2001 DJCAR 4049 END OF DOCUMENT


[Federal Register Volume 80, Number 235 (Tuesday, December 8, 2015)]
[Notices]
[Pages 76282-76283]
[FR Doc No: 2015-30845]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC16-45-000
    Applicants: NRG Wholesale Generation LP, Seward Generation, LLC
    Description: Joint Application of NRG Wholesale Generation LP and
Seward Generation, LLC for Approval Under Section 203 of the Federal
Power Act and Request for Expedited Action.
    Filed Date: 12/1/15.
    Accession Number: 20151201-5357.
    Comments Due: 5 p.m. ET 12/22/15.

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER11-2105-001.
    Applicants: Oklahoma Gas and Electric Company.
    Description: Supplement to June 30, 2015 Updated Market Power
Analysis for Southwest Power Pool, Inc. Balancing Area Authority of
Oklahoma Gas and Electric Company.
    Filed Date: 12/1/15.
    Accession Number: 20151201-5356.
    Comments Due: 5 p.m. ET 12/22/15.

    Docket Numbers: ER14-2666-003.
    Applicants: Avalon Solar Partners, LLC.
    Description: Notice of Non-Material Change in Status of Avalon
Solar Partners, LLC.
    Filed Date: 12/2/15.
    Accession Number: 20151202-5132.
    Comments Due: 5 p.m. ET 12/23/15.

    Docket Numbers: ER15-762-004.
    Applicants: Sierra Solar Greenworks LLC.
    Description: Notice of Non-Material Change in Status of Sierra
Solar Greenworks LLC.
    Filed Date: 12/1/15.
    Accession Number: 20151201-5351.
    Comments Due: 5 p.m. ET 12/22/15.

    Docket Numbers: ER15-1026-002.
    Applicants: Utah Red Hills Renewable Park, LLC.
    Description: Notice of Non-Material Change in Status of Utah Red
Hills Renewable Park, LLC.
    Filed Date: 12/1/15.
    Accession Number: 20151201-5349.
    Comments Due: 5 p.m. ET 12/22/15.

    Docket Numbers: ER15-2594-003.
    Applicants: South Central MCN, LLC.
    Description: Compliance Filing [including Pro Forma sheets] of
South Central MCN, LLC.
    Filed Date: 11/30/15.
    Accession Number: 20151130-5489.
    Comments Due: 5 p.m. ET 12/21/15.

    Docket Numbers: ER15-2728-000; ER15-2728-001.
    Applicants: Maricopa West Solar PV, LLC.
    Description: Supplement to September 25, 2015 and October 13, 2015
Maricopa West Solar PV, LLC tariff filings to be effective 11/12/2015.
    Filed Date: 11/12/15.
    Accession Number: 20151112-5408.
    Comments Due: 5 p.m. ET 12/3/15.

    Docket Numbers: ER16-445-000.
    Applicants: San Diego Gas & Electric Company.
    Description: Third Annual Informational Filing [Cycle 3] of Fourth
Transmission Owner Rate Formula rate mechanism of San Diego Gas &
Electric Company.
    Filed Date: 12/1/15.
    Accession Number: 20151201-5347.
    Comments Due: 5 p.m. ET 12/22/15.

    Docket Numbers: ER16-446-000.
    Applicants: ISO New England Inc., New England Power Pool.
    Description: ISO New England Inc., et. al. submits Installed
Capacity Requirement, Hydro Quebec Interconnection Capability Credits
and Related Values for the 2016/2017, 2017/2018 & 2018/2019 Capacity
Commitment Period.
    Filed Date: 12/1/15..
    Accession Number: 20151201-5353.
    Comments Due: 5 p.m. ET 12/22/15.

    Docket Numbers: ER16-447-000.
    Applicants: Owensboro Municipal Utilities.
    Description: Request for Limited Waiver of Owensboro Municipal
Utilities.
    Filed Date: 12/1/15.
    Accession Number: 20151201-5355.
    Comments Due: 5 p.m. ET 12/22/15.

    Docket Numbers: ER16-448-000.
    Applicants: Public Service Company of Colorado.
    Description: Sec.  205(d) Rate Filing: 2015-12-2_PSC-TSGT-NC-BASA
409-0.0.0-Filing to be effective 12/1/2015.
    Filed Date: 12/2/15.
    Accession Number: 20151202-5065.
    Comments Due: 5 p.m. ET 12/23/15.

    Docket Numbers: ER16-449-000.
    Applicants: RE Camelot LLC.
    Description: Compliance filing: Compliance Filing--Removal of

Affiliate Waiver to be effective 11/1/2015.
    Filed Date: 12/2/15.
    Accession Number: 20151202-5116.
    Comments Due: 5 p.m. ET 12/23/15.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: December 2, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-30845 Filed 12-7-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 62 (Thursday, March 31, 2016)]
[Notices]
[Page 18618]
[FR Doc No: 2016-07253]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER16-1154-000]

Parrey, LLC; Supplemental Notice That Initial Market-Based Rate
Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Parrey, LLC's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is April 11, 2016.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: March 22, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-07253 Filed 3-30-16; 8:45 am]
 BILLING CODE 6717-01-P


                                EPA/HQ Summary
              Facility Visit  -  S.C. Johnson Distribution Center

Attendees

S.C. Johnson Participants:
Tracy Pellicori, Paul Hiam, Joshua Mishleau, Paul Burkhead, Bob Bradley, Chianne Shields
EPA/HQ Participants:
Jessica Young, Drew Lausch, Jim O'Leary, Kristin Fitzgerald, Josh Smeraldi, Kathy Lett, Ricardo Jones
PADEP Participants:
Tom Mellott, Carrie Fleming, Joe Jones

Date:  November 30, 2015

Location:  5 True Temper Drive, Carlisle, PA 17015

Summary

As part of ongoing outreach efforts associated with development of EPA's Retail RCRA Strategy, the Agency met with S.C. Johnson and other representatives and toured the distribution center.  Discussions focused on:  (1) the role played by manufacturers/suppliers, such as S.C. Johnson, in the management and ultimate disposition of consumer goods that have become unsalable at retail stores and are moving through the reverse distribution process and (2) regulatory efforts already underway, such as the proposed Hazardous Waste Pharmaceuticals and Generator Improvements rules and planned guidance, to address RCRA-related issues, including retail sector challenges in terms of complying with RCRA regulations.


[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Notices]
[Pages 49538-49542]
[FR Doc No: 2021-19061]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0609]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Drug Supply Chain Security Act Implementation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection associated with the
Federal Food, Drug, and Cosmetic Act (FD&C Act).

DATES: Submit either electronic or written comments on the collection
of information by November 2, 2021.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 2, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 2, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-D-0609 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Drug Supply Chain Security Act
Implementation.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential

information that you do not wish to be made publicly available, submit
your comments only as a written/paper submission. You should submit two
copies total. One copy will include the information you claim to be
confidential with a heading or cover note that states ``THIS DOCUMENT
CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy,
including the claimed confidential information, in its consideration of
comments. The second copy, which will have the claimed confidential
information redacted/blacked out, will be available for public viewing
and posted on https://www.regulations.gov. Submit both copies to the
Dockets Management Staff. If you do not wish your name and contact
information to be made publicly available, you can provide this
information on the cover sheet and not in the body of your comments and
you must identify this information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Drug Supply Chain Security Act Implementation

OMB Control Number 0910-0806--Revision

    This information collection helps to support implementation of
section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360eee-1). Enacted in 2013, the Drug Supply Chain Security Act
(DSCSA) (Title II of Pub. L. 113-54) amended section 582 of the FD&C
Act and outlines steps to build an electronic, interoperable system to
identify and trace certain prescription drugs as they are distributed
in the United States. The DSCSA is intended to enhance FDA's ability to
help protect consumers from exposure to drugs that may be counterfeit,
stolen, contaminated, or otherwise harmful. Respondents to the
information collection are manufacturers, wholesalers, dispensers, and
repackagers, as defined in section 581 of the FD&C Act (21 U.S.C.
360eee), of pharmaceutical drug products.
    To assist respondents with statutory requirements set forth in
section 582 pertaining to notifications of illegitimate products or
products with a high risk of illegitimacy, we developed Form FDA 3911
entitled ``Drug Notification'' along with the corresponding
instructional document ``INSTRUCTIONS FOR COMPLETION OF FORM FDA 3911--
DRUG NOTIFICATION.'' Form FDA 3911 and the instructions are available
from, and may be completed using, our website at https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-notifications-frequently-asked-questions. Form FDA 3911 is intended to facilitate
notifications governed by section 582 by providing a uniform format for
initial notifications, followup notifications, and requests for the
termination of a notification.
    Section 582 of the FD&C Act also provides for FDA issuance of
guidance documents to facilitate implementation of the DSCSA. To that
end, we continue to develop guidance documents to assist respondents
with information collection provisions set forth in section 582. The
procedural guidance document entitled ``Drug Supply Chain Security Act
Implementation: Identification of Suspect Product and Notification''
(June 2021; available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-supply-chain-security-act-implementation-identification-suspect-product-and-notification) is
intended to assist respondents in identifying suspect products, as
defined at section 581, and with terminating notifications of
illegitimate product or products with a high risk of illegitimacy. As
explained in the guidance document, beginning January 1, 2015, certain
trading partners (i.e., manufacturers, repackagers, wholesale
distributors, or dispensers), upon determining that a product in their
possession or control is a suspect product, must quarantine the product
while they promptly conduct an investigation to determine whether the
product is an illegitimate product, must notify FDA if they determine
that the product is illegitimate product, and must notify certain
trading partners of the illegitimate product as prescribed by section
582. Manufacturers must also notify FDA and certain immediate trading
partners after determining that a product in their possession or
control has a high risk of being illegitimate product.
    Similarly, we developed the draft guidance document ``Waivers,
Exceptions, and Exemptions From the Requirements of Section 582 of the
Federal Food, Drug, and Cosmetic Act'' (May 2018; available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/waivers-exceptions-and-exemptions-requirements-section-582-federal-food-drug-and-cosmetic-act). The draft guidance explains Agency
established processes by which: (1) A trading partner may request a
waiver from certain requirements in section 582 if it would result in
an undue economic hardship or for emergency medical reasons; (2) a
manufacturer or repackager may request an exception to

the section 582 requirements related to product identifiers if a
product is packaged in a container too small or otherwise unable to
accommodate a label with sufficient space to bear the required
information; and (3) FDA may determine other products or transactions
that shall be exempt from requirements of section 582.
    FDA has recently published the draft guidance document ``Enhanced
Drug Distribution Security at the Package Level Under the Drug Supply
Chain Security Act'' (June 2021; available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security-act). The draft guidance clarifies the enhanced system requirements
listed in section 582(g)(1) of the FD&C Act. This draft guidance also
outlines and provides recommendations on the system attributes
necessary for enabling the secure tracing of product at the package
level, including allowing for the use of verification, inference, and
aggregation, as necessary. FDA has also published a draft guidance
document entitled ``DSCSA Standards for the Interoperable Exchange of
Information for Tracing of Certain Human, Finished, Prescription Drugs:
How to Exchange Product Tracing Information'' (November 2014; available
at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dscsa-standards-interoperable-exchange-information-tracing-certain-human-finished-prescription-drugs). This draft guidance
establishes initial standards for the interoperable exchange of product
tracing information, in paper or electronic format, for compliance with
sections 582(a) through (e) of the FD&C Act.
    Two additional guidance documents help to further explain the
statutory requirements of section 582. The ``Product Identifiers under
the Drug Supply Chain Security Act--Questions and Answers'' guidance
for industry (June 2021; available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/product-identifiers-under-drug-supply-chain-security-act-questions-and-answers) is intended to
address anticipated questions regarding product identifiers that are
required under section 582 for packages and homogenous cases of certain
drug products. The ``Verification Systems Under the Drug Supply Chain
Security Act for Certain Prescription Drugs'' draft guidance (October
2018; available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/verification-systems-under-drug-supply-chain-security-act-certain-prescription-drugs) provides recommendations for a
robust verification system for the determination, quarantine, and
investigation of suspect products, as well as the quarantine,
notification, and disposition of illegitimate products. The guidance
also addresses FDA's recommendation that trading partners submit
cleared product notifications. Finally, the guidance addresses the
statutory requirements for verification, including verification of
saleable returns, at the package level for product identifiers on
packages and homogenous cases intended to be introduced in a
transaction into commerce.
    FDA guidance documents are issued consistent with requirements
found in section 582, as well as our Good Guidance Practice regulations
found in 21 CFR 10.115, which provide for public comment at any time.
In addition, since enactment of the DSCSA, our Center for Drug
Evaluation and Research has developed and continues to maintain a
website communicating DSCSA implementation activity, including relevant
resources at: https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa.
    We estimate the burden of this collection of information as
follows:

                      Table 1--Estimated Annual Reporting Burden--Notifications to FDA \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
       Type of respondent            Number of     responses per   Total annual    Average time     Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers...             100               1             100               1             100
Wholesale Distributors..........             138               1             138               1             138
Dispenser.......................              12               1              12               1              12
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............             250  ..............             250
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

Table 2--Estimated Annual Third-Party Disclosure Burden for Notifications to Trading Partners of an Illegitimate
                                                   Product \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
       Type of respondent            Number of      disclosures        Total       Average time     Total hours
                                    respondents   per respondent    disclosures   per disclosure
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers...             100              30           3,000          * 0.20             600
Wholesale Distributors..........             138           1,175         162,150          * 0.20          32,430
Dispensers......................              12               2              24          * 0.20               5
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............         165,174  ..............          33,035
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
* (12 minutes.)

    Table 3--Estimated Annual Reporting Burden for Consultation With FDA and Termination of Notification \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
       Type of respondent            Number of     responses per   Total annual    Average time     Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers...             100               1             100               1             100
Wholesale Distributors..........             138               1             138               1             138
Dispensers......................              12               1              12               1              12
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............             250  ..............             250
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

Table 4--Estimated Annual Third-Party Disclosure Burden for Notifications to Trading Partners of an Illegitimate
                                             Product Termination \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
       Type of respondent            Number of      disclosures        Total       Average time     Total hours
                                    respondents   per respondent    disclosures   per disclosure
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers...             100              30           3,000          * 0.20             600
Wholesale Distributors..........             138           1,175         162,150          * 0.20          32,430
Dispensers......................              12               2              24          * 0.20               5
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............         165,174  ..............          33,035
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
* (12 minutes.)

       Table 5--Estimated Annual Reporting Burden for Requests for Waivers, Exceptions, or Exemptions \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
       Type of respondent            Number of     responses per   Total annual    Average time     Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Requests to FDA for a Waiver,                 20               1              20              80           1,600
 Exception, or Exemption........
Notifications to FDA of a                      1               1               1              16              16
 Material Change in
 Circumstances Warranting the
 Waiver, Exception, or Exemption
Requests to FDA to Renew a                     1               1               1              16              16
 Waiver, Exception, or Exemption
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............              22  ..............           1,632
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on illegitimate product notifications already received, we
estimate a total of 250 respondents to the information collection. Our
database for establishment and drug product listing suggests that many
companies perform activities of both manufacturers and repackagers and
therefore we have combined our estimated number of respondent
manufacturers and repackagers. In addition, because statutory
provisions specifically define ``dispensers'' to include retail
pharmacies, hospital pharmacies, and groups of chain pharmacies, our
estimate of the number of dispensers is intended to reflect the overall
estimated number of respondents we believe to be subject to the
requirements under section 582(d) of the FD&C Act. Because
manufacturers, repackagers, and wholesale distributors are collectively
responsible for prescription drugs from the point of manufacturing
through distribution in the drug supply chain, we assume that these
three trading partners submit most notifications of illegitimate
products. Upon evaluation of those notifications received in fiscal
year (FY) 2020 and, thus far, in FY 2021, we assume those 250
respondents are comprised of 40 percent manufacturers (100), 55 percent
wholesale distributors (138), and 5 percent pharmacies (12). We assume
that annual notifications will vary from zero to two for manufacturers
and repackagers, as well as from pharmacies, but that most of companies
will make no notifications. Although our establishment and drug product
listing database currently reflects approximately 1,400 manufacturers
and repackagers, we estimate only 100 manufacturers and repackagers
will notify us of illegitimate products an average of one time per
year.
    Relying on data from the National Association of Chain Drug Stores,
the National Community Pharmacists Association, and the American
Hospital Association, we assume there are approximately 67,000 pharmacy
sites in the United States. Based on a review of data, we estimate 12
pharmacies will notify FDA of illegitimate product an average of 1 time
per year.
    According to the Healthcare Distribution Alliance (formerly known
as Healthcare Distribution Management Association), approximately 30
wholesale distributors are responsible for over 90 percent of drug
distributions. Based on sales, and because FDA is estimating that over
1,570 small wholesale distributors may be responsible for the remaining
10 percent of drug sales, we estimate that wholesale distributors will
be responsible for making approximately an average of 1 notification
per year to account for the estimated 138 notifications that FDA will
receive regarding illegitimate product. We

assume wholesale distributors will expend 1 hour for each notification.
    Because the extent of distribution of any illegitimate product will
vary, we assume a wide distribution for each illegitimate product for
purposes of establishing our burden estimate. We estimate that, for
each notification that a manufacturer or repackager makes to FDA, the
manufacturer or repackager will notify approximately 30 trading
partners (relying on the number of distributors). This formula results
in approximately 3,000 notifications annually to trading partners of
manufacturers and repackagers. This estimate includes the notifications
by manufacturers and repackagers who have determined that an
illegitimate product is in their possession or control, as well as
notifications by manufacturers who have determined that a product poses
a high risk of illegitimacy.
    We assume that a large wholesale distributor may have up to 4,500
trading partners, where a small wholesale distributor may have 200
trading partners, averaging approximately 2,350. We had originally
estimated that a wholesale distributor would notify all 2,350 trading
partners for each of the illegitimate products identified. However, as
a result of our experience with the collection and informal feedback
from industry, we have lowered our estimate to reflect that 138
respondents will make 1,175 disclosures for a total of 162,150
disclosures annually and that each disclosure will require
approximately 12 minutes, for a total of 32,430 hours annually.
    We estimate that a pharmacy purchases prescription drugs from an
average of two wholesale distributors. Therefore, a pharmacy would
notify 2 trading partners for each of the 12 illegitimate products
identified. This estimate results in in approximately 24 notifications
annually to pharmacy trading partners.
    We estimate that the burden for notifying trading partners of an
illegitimate product and the number of trading partners notified will
be the same as the estimates for notification of termination. The
estimated total burden hours to notify trading partners that the
notification is terminated is approximately 33,035 hours annually.
    We assume a comparable amount of time is required to provide the
information necessary for requesting to terminate a notification. The
time required to investigate and resolve an illegitimate product
notification will vary, but we assume that each notification will
eventually be terminated. We assume that the number of requests for
termination of a notification per year will be the same as the original
number of notifications for a given year. The estimated total burden
hours to make requests for termination of notifications to FDA is 250
hours annually.
    Based on communications we have had with trading partners and
stakeholders since the 2013 enactment of the DSCSA, we estimate that 20
trading partners or stakeholders will submit approximately 20 requests
for a waiver, an exception, or an exemption. Also based on feedback
from industry stakeholders, we estimate that respondents will expend an
average of 80 hours to prepare and submit each request and to submit
any additional followup information that we may request. We estimate
the total burden as approximately 1,600 hours.
    We estimate that we will receive from approximately one respondent
approximately one notification or other information informing us that
there has or has not been a material change in the circumstances that
warranted the waiver, exception, or exemption and that each
notification will require approximately 16 hours to prepare and submit
to us. We estimate the total burden as approximately 16 hours.
    We estimate that we will receive approximately one renewal request
from approximately one respondent and that each request will require
approximately 16 hours to prepare and submit to us. We estimate the
total burden as approximately 16 hours.
    Our estimated burden for the information collection reflects an
overall increase of 56,116 hours and a corresponding increase of
271,638 responses annually. We attribute this adjustment to an increase
in the number of illegitimate product notification submissions we
received in the last couple of years and the number of such submissions
we have received so far this fiscal year.

    Dated: August 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19061 Filed 9-2-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: September 25, 2006 (Volume 71, Number 185)]
[Rules and Regulations]
[Page 55742-55743]
[DOCID:fr25se06-5]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[FRL-8222-9]

National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List Update

AGENCY: Environmental Protection Agency.

ACTION: Notice of deletion of the Nineteenth (19th) Avenue Landfill
Superfund Site from the National Priorities List.

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

SUMMARY: The Environmental Protection Agency (EPA) announces the
deletion of the Nineteenth (19th) Avenue Landfill Site (Site), located
in Phoenix, Maricopa County, Arizona, from the National Priorities List
(NPL). The NPL is Appendix B of 40 CFR part 300 which is the National
Oil and Hazardous Substances Pollution Contingency Plan (NCP), which
EPA promulgated pursuant to Section 105 of the Comprehensive
Environmental Response, Compensation, and Liability Act (CERCLA) of
1980, as amended. EPA and the State of Arizona have determined that the
Site poses no significant threat to public health or the environment
and, therefore, no further remedial measures pursuant to CERCLA are
appropriate.

DATES: Effective Date: September 25, 2006.

FOR FURTHER INFORMATION CONTACT: Nadia Hollan, Remedial Project
Manager, Mail Code: SFD-8-2, U.S. EPA Region 9, 75 Hawthorne Street,
San Francisco, California 94105-3901<EMAIL_ADDRESS>(415) 972-
3187 OR 1-800-231-3075 (message line), or William DePaul, Remedial
Project Manager, Arizona Department of Environmental Quality, 1110 West
Washington Street, Phoenix Arizona, 85007<EMAIL_ADDRESS>
(602) 771-4654.

SUPPLEMENTARY INFORMATION: The site to be deleted from the NPL is:
Nineteenth (19th) Avenue Landfill Site, Phoenix, Maricopa County,
Arizona.
    A Notice of Intent to Delete for this Site was published in the
Federal Register on August 14, 2006 (71 FR 46429). The closing date for
comments on the Notice of Intent to Delete was September 13, 2006. Two
written comments were received; therefore EPA has prepared a
Responsiveness Summary (See Appendix 1 below). In addition, EPA
received a request from a community group representative to extend the
public comment period. This is also addressed in the Responsiveness
Summary. EPA has considered all public comments in its final decision
to delete the Site from the NPL.
    EPA identifies sites that appear to present a significant risk to
public health, welfare, or the environment and it maintains the NPL as
the list of those sites. Any site deleted from the NPL remains eligible
for Fund-financed remedial actions in the unlikely event that
conditions at the site warrant such action. Section 300.425(e)(3) of
the NCP states that Fund-financed actions may be taken at sites deleted
from the NPL. Deletion of a site from the NPL does not affect
responsible party liability or impede agency efforts to recover costs
associated with response efforts.

Appendix 1--Responsiveness Summary

    The Responsiveness Summary has been prepared to provide responses
to comments submitted to EPA during the 30-day public comment period
regarding the Notice of Intent to Delete (71 FR 46429) for the 19th
Avenue Landfill Superfund Site. The original comments are summarized
below and available at http://www.regulations.gov, Docket ID No. EPA-

HQ-SFUND-1983-0002, with the support materials under document type
``public submissions'', and at the information repositories at the
following addresses: Arizona Department of Environmental Quality
Records Center, 1110 West Washington Street, Phoenix, Arizona 85007,
(602) 771-4380 or 1<PHONE_NUMBER>, ext. 771-4380, Hours: M-F 8:30
a.m.-4:30 p.m.; City of Phoenix Public Library, Government Documents
Section, 1221 North Central Avenue, Phoenix, Arizona 85004, (602) 262-
4636, Hours: M-Th 10 a.m.-9 p.m., Fr&Sa 10 a.m.-6 p.m., Su 12 p.m.-6
p.m.; and U.S. EPA Superfund Records Center, 95 Hawthorne Street, San
Francisco, California 94105,<PHONE_NUMBER>, Hours: M-F 8 a.m.-5 p.m.
    Summary of Comment #1, Letter from Stephen M. Brittle, President,
Don't Waste Arizona, Inc. (DWAZ): The majority of the comments are
concerns regarding the impact of the Site to groundwater contamination.
Mr. Brittle stated that the delisting ``will remove the appropriate
protections that the Superfund program is supposed to provide''.
Specifically, there is a concern that during the landfill cleanup in
the 1990's barrels of hazardous waste were left in the landfill and
could ultimately leak, impacting groundwater in the future. There is
also a concern regarding ``plumes of chemical contamination moving off
the landfill site'' and DWAZ believes it has received conflicting
information regarding the source of the contamination. It also appears
to the group that EPA has allowed the plumes to migrate and fall below
action levels rather than taking appropriate action to clean them up.
    Response to Comment #1: The landfill contains a variety of
contaminants which have the potential to leach into the groundwater.
Since removing all of the landfill contamination was not feasible, the
EPA and ADEQ selected the remedy to include leaving the refuse in
place, preventing the landfill from eroding during flood seasons with
levees and a soil cap, and controlling the soil gas produced with a
landfill gas collection and treatment system. The landfill cap also
reduces infiltration of rainwater, which will reduce the potential for
leaching. Also as part of the remedy, the City of Phoenix is required
to monitor groundwater at the landfill in perpetuity, and required to
implement a ``groundwater contingency plan'' should any constituent due
to landfill contamination exceed action levels. This plan involves
follow-up sampling to confirm the results, and an evaluation of
remedial alternatives for groundwater cleanup should the contamination
pose a threat to human health and the environment. The deletion does
not affect this requirement, nor does it prevent EPA or ADEQ from
requiring cleanup of groundwater should there be an impact in the
future. As explained later in this response, EPA acknowledges that
there are elevated levels of contaminants in the groundwater at the
landfill, however it has been determined that the landfill is not a
source of this contamination based on the review of monitoring data
that has been collected quarterly for almost 20 years.
    Regarding the allegations of buried barrels, a letter was sent to
ADEQ in August 1996, complaining that barrels were improperly handled.
Potentially hazardous material was drained out of leaking drums, mixed
with surrounding soil/debris, excavated and stored in roll-off
containers, and then re-buried in the landfill. Therefore, the material
was already taken out of the drums. The complaint gave rise to the
question of whether the material was hazardous and whether it was
handled appropriately, and this was investigated by ADEQ and EPA at the
time. The conclusions of the investigation were provided by EPA to the
complainant in February 1998.
    Regarding groundwater contamination in the area, only three
constituents have ever exceeded action levels on multiple occasions in
the landfill monitoring well network: 1,1-dichloroethylene (1,1-DCE),
vinyl chloride, and arsenic. There is a known plume of 1,1-DCE moving

under the landfill, however, EPA and ADEQ have determined that the 1,1-
DCE plume is from an upgradient source, and that the 19th Avenue
Landfill is not contributing (Assessment of Upgradient 1,1-DCE for City
of Phoenix 19th Avenue Landfill, Dames & Moore, November 1998). Vinyl
chloride was detected above the action level in one of the monitoring
wells and was also from off-site sources unrelated to the landfill.
Vinyl chloride has not been above the action level since 2002 (19th
Avenue Landfill Exceedence Report for Vinyl Chloride, URS, June 2002,
and Response to Agency Comments to the June 2002 Report, URS, April
2003). Arsenic has been detected above action levels in two of the on-
site wells, however arsenic is below levels of concern outside the
boundaries of the landfill. EPA and ADEQ determined that the source of
the arsenic is not contamination from the landfill itself, but native
arsenic present in the soils. The arsenic is being mobilized into
groundwater over a small area due to the oxygen low conditions near the
landfill. (Exceedence Report for Arsenic at Monitoring Well I-4, URS,
December 2003, Technical Memorandum of Arsenic Concentrations in
Groundwater Monitor Wells, Hugh Rieck, ADEQ, April 2004, and Exceedence
Report for Arsenic at Monitoring Well I-4, URS, June 2006, reference
arsenic report). Again, if in the future it is determined that
groundwater is impacted by the landfill, the protections will remain in
place to compel cleanup. The supporting information that is referenced
above is available in the deletion docket and site repositories and can
also be provided to DWAZ.
    Summary of Comment #2, Request from Michael Pops, President,
Concerned Residents of South Phoenix: Mr. Pops contacted EPA and ADEQ
by telephone with a request to extend the public comment period. He
believed the community outreach EPA conducted regarding the notice was
inadequate and requested that EPA and ADEQ conduct an outreach campaign
to fully inform the affected community of the proposed action. He also
was concerned with future use of the Site, and that the community would
be unable to provide input or ensure that redevelopment plans would be
acceptable to the community.
    Response to Comment #2: EPA decided not to extend the timeframe for
comment on this action beyond the required 30 days. EPA believes there
was adequate time for the community to raise significant concerns
regarding the deletion, and that the deletion action itself will not
impact the community's ability to comment on issues regarding the Site.
EPA had issued a fact sheet to the Site mailing list and published a
notice in the local paper, The Arizona Republic. We will work with ADEQ
and the City of Phoenix to update the Community Involvement Plan and
add other local newspapers and community groups to the outreach
strategy as suggested for future actions. The public will continue to
have an opportunity to comment to ADEQ, the lead agency, on any actions
or activities associated with the Site even after deletion,
particularly during the statutory Five-Year Review process.
    Regarding future development at the Site, any plans would still
need to follow all the applicable criteria under CERCLA and the NCP,
and be protective of human health and the environment. In addition, the
City of Phoenix filed a Declaration of Environmental Use Restriction on
the property title in July 2006, prohibiting residential use and
ensuring a process by which no landowner will be allowed to interfere
with the remedy.
    Summary of Comment #3, Letter from Karen O'Regan, City of Phoenix,
Environmental Programs: This comment is in ``support and concurrence''
with the deletion action, and an expression of the commitment the City
has to ensuring the remedy will be maintained and the groundwater
monitored. The City will work with ADEQ on any ``viable reuse
proposals''.
    Response to Comment #3: EPA appreciates the concurrence, and on-
going commitment to ensure the remedy will be maintained. EPA
encourages the City to consider community concerns regarding the Site
in the future, particularly as associated with the issues expressed by
the community during this public comment period, and any input that may
be provided during additional community involvement activities.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous substances, Hazardous waste, Intergovernmental relations,
Penalties, Reporting and recordkeeping requirements, Superfund, Water
pollution control, Water supply.

    Dated: September 18, 2006.
Laura Yoshii,
Acting Regional Administrator, Region 9.

0
For the reasons set out in this document, 40 CFR part 300 is amended as
follows:

PART 300--[AMENDED]

0
1. The authority citation for part 300 continues to read as follows:

    Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. 9601-9657; E.O.
12777, 56 FR 54757, 3 CFR, 1991 Comp., p.351; E.O. 12580, 52 FR
2923, 3 CFR, 1987 Comp., p. 193.

Appendix B--[Amended]

0
2. Table 1 of Appendix B to Part 300 is amended under [Arizona]
(``AZ'') by removing the entry for the Nineteenth Avenue Landfill site
in Phoenix, Arizona.

[FR Doc. 06-8175 Filed 9-22-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 80 (Friday, April 25, 2014)]
[Notices]
[Page 22962]
[FR Doc No: 2014-09448]

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

ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9014-6]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or http://www.epa.gov/compliance/nepa/.

Weekly Receipt of Environmental Impact Statements

Filed 04/14/2014 Through 04/18/2014
Pursuant to 40 CFR 1506.9.

    Notice: Section 309(a) of the Clean Air Act requires that EPA make
public its comments on EISs issued by other Federal agencies. EPA's
comment letters on EISs are available at: http://www.epa.gov/compliance/nepa/eisdata.html.

EIS No. 20140125, Final EIS, FHWA, CA, California High-Speed Train
(HST): Fresno to Bakersfield Section High-Speed Train, Review Period
Ends: 05/27/2014, Contact: Stephanie Perez<PHONE_NUMBER>.
EIS No. 20140126, Final Supplement, USN, 00, Introduction of the P-8A
Multi-Mission Maritime Aircraft into the U.S. Navy Fleet, Review Period
Ends: 05/27/2014, Contact: Cory Zahm<PHONE_NUMBER>.
EIS No. 20140127, Final EIS, NPS, CA, Golden Gate National Recreation
Area and Muir Woods National Monument Final General Management Plan/
Environmental Impact Statement, Review Period Ends: 05/27/2014,
Contact: Tom Gibney<PHONE_NUMBER>.
EIS No. 20140128, Draft EIS, USFS, CA, Tule River Reservation
Protection Project, Comment Period Ends: 06/09/2014, Contact: Richard
Stevens<PHONE_NUMBER>.
EIS No. 20140129, Final EIS, USACE, CO, Moffat Collection System
Project, Review Period Ends: 06/09/2014, Contact: Rena Brand 303-979-
4120.

Amended Notices

EIS No. 20140065, Draft EIS, USFS, OR, Proposed Revised Land Management
Plans for the Malheur, Umatilla, and Wallowa-Whitman National Forests,
Comment Period Ends: 08/15/2014, Contact: Sabrina Stadler<PHONE_NUMBER>.

    Revision to the FR Notice Published 03/14/2014; Extending the
Comment Period from 06/16/2014 to 08/15/2014.

    Dated: April 22, 2014.
Cliff Rader,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2014-09448 Filed 4-24-14; 8:45 am]
BILLING CODE 6560-50-P