Utility Solid Waste Activities Group , c/ o Edison Electric Institute , 701 Pennsylvania Avenue, NW 1 Washington, DC 20004 2696 1 202 508 5645 www. uswag. org May 8,2003 Hand Deliverv Mr. Richard J. Kinch Mr. Dennis C. Ruddy U. S. Environmental Protection Agency Office of Solid Waste Ariel Rios Building ( Mail Code 5306W) 1200 Pennsylvania Avenue, NW Washington , D. C. 20460 2696 Re: Concept To Fossil Fuel Combustion Waste Proposal to Apply Uniquely Associated Dear Mr. Kinch and Mr. Ruddy:

I am writing on behalf of the Utility Solid Waste Activities Group (" USWAG")' to renew our request that EPA formally withdraw its proposal to replace the long standing Dietrich Policy2 on the scope of co management of fossil fuel combustion (" FFC") waste under the Bevill Amendment exclusion with the " uniquely associated wastes" concept that EPA proposed in its Bevill Regulatory Determination on Wastes from the Combustion of Fossil Fuels, 65 Fed. Reg. 32214, 3221 9 20 ( May 22, 2000) (" Regulatory 1 Electric Institute (" EEI"), the American Public Power Association (" APPA"), the National Rural Electric Cooperative Association (" NRECA"), and approximately 80 electric utility operating companies located throughout the country. EEI is the principal national association of investor owned electric power and light companies. APPA is the national association of publicly owned electric utilities. NRECA is the national association of rural electric cooperatives. Together, USWAG members represent more than 85 percent of the total electric generating capacity of the United States and service more than 95 percent of the nation's consumers of electricity and over 93 percent of the nation's consumers of natural gas. The Utility Solid Waste Activities Group (" USWAG") is an informal consortium of the Edison 2 Jr., USWAG Chairman ( Jan. 13, 1981) (" Dietrich Policy"). Letter from Gary N. Dietrich, EPA Associate Deputy Administrator for Solid Waste to Paul Emler, Mr. Richard J. Kinch Mr. Dennis C. Ruddy May 8,2003 Page 2 Determination"). As you know, USWAG submitted detailed comments to the Agency on September 19, 2000, which, among other things, urged EPA not to proceed with the proposed revocation of the Dietrich Policy. See USWAG Comments on the Regulatory Determination (" Comments"), pp. 8 31 ( Sept. 19, 2000).

USWAG strongly believes that, in the context of FFC waste management, the " uniquely associated wastes" concept is fatally flawed. As discussed in detail in our Comments, the proposed replacement of the Dietrich Policy with the " uniquely associated" approach would be inconsistent with congressional intent to include within the scope of the Bevill Amendment certain low volume wastes that are co managed with high volume FFC wastes;

fails to justify abandoning the long standing Dietrich Policy which has proven to be an environmentally protective and workable approach since enactment of the Bevill Amendment in 1980;

contradicts EPA's own conclusions in the Regulatory Determination ( and the related March 1999 Report to Congress) that co managed wastes covered by the Dietrich Policy do not warrant regulation under RCRA Subtitle C;

forces a new and significantly different regulatory paradigm on FFC co management that will result in needless confusion, potential litigation, and an unending stream of requests to the Agency for clarification; and would impose significant costs and increased risk to public safety with little or no environmental benefit.

Because our Comments fully address the major flaws of the " uniquely associated wastes" proposal, we are attaching the relevant portion of those Comments for your convenience.

At a USWAG meeting in Memphis last October, you indicated that EPA is still considering whether to implement the " uniquely associated" approach and invited USWAG to present any additional information that might assist EPA in deciding whether to adopt the proposal. You acknowledged that the concept applies only to low volume wastes that exhibit a RCRA hazardous characteristic, but this limitation does not alter the basis for our objection to the proposal.

During the meeting, some of our members asked you about the factors that led the Agency to propose this major interpretive shift of the Bevill Amendment` s FFC waste clause. Your response suggested several considerations unrelated to FFC co management experience: Mr. Richard J. Kinch Mr. Dennis C. Ruddy May 8,2003 Page 3 0 The " uniquely associated concept" had been previously applied to oil and gas refining wastes and to mining wastes and establishing a uniform approach to all Bevill wastes seemed to some at EPA to be sound policy;

0 There is a concern among some EPA staff that the Dietrich Policy could apply to an unlimited range of wastes that by themselves would be regulated under Subtitle C of RCRA, including future wastes not generated today and therefore not capable of identification and assessment today.

Neither of these considerations justifies abandonment of the Dietrich Policy.

First, as we explained in our September 2000 comments, the plain language of the statutory clauses identifying the categories of wastes covered by the Bevill Amendment preclude a policy of uniform application of the " uniquely associated" concept. Compare RCRA Q 3001 ( b)( 3)( A)( i) ( FFC waste clause) with id. Q 3001 ( b)( 3)( A)( ii) ( mining waste clause) and id. Q 3001 ( b)( 2)( A) ( oil and gas production waste clause). See Comments, p. 14 (" Whereas for fossil fuel combustion, Congress specified the four principal waste streams by name as they were actually managed at the time ( i. e., co managed with the wastes identified in the Dietrich Policy), Congress simply referred generally to wastes from the mining and mineral processing industry sectors."). The legislative history of the Amendment  particularly Rep. Bevill's discussion of the language used in the FFC clause  explains the significance of the textual differences among the Bevill clauses. See 126 Cong. Rec. 3361  62 ( 1 980). USWAG's September 2000 Comments analyze these legislative materials in detail, and rather than repeating that analysis here, we respectfully refer you to pages 9 17 of those Comments. The conclusion to be drawn from this legislative analysis is that EPA's quest for uniformity among Bevill wastes is simply contrary to the text, structure, and purposes of the Bevill Amendment clauses.

In addition, our Comments demonstrate that EPAs attempt to use the " uniquely associated wastes" concept for defining permissible co management of non Bevill wastes with FFC Bevill wastes is wholly unprecedented. In the previous application of the " uniquely associated wastes" concept to mining and petroleum wastes,  PA was defining the scope of wastes eligible for the Bevill exclusion without regard to whether those wastes were separately managed or co managed with other wastes. See Comments, p. 13. The Dietrich Policy explicitly limits the Bevill exclusion to co management of certain qualified " low volume wastes" with FFC wastes. Id. at pp. 9 10 ( quoting Dietrich Policy, p. 5). These low volume wastes when separately managed are not Bevill wastes. Dietrich Policy, p. 6 (" If any of these [ low volume] wastes are segregated and disposed of or treated separately from combustion wastes and they are hazardous wastes, they are not covered by the exclusion."). Thus, the " uniquely associated" proposal for FFC wastes is not in reality an attempt to establish a uniform policy among Bevill wastes. Rather, it is an improper attempt to transform the concept from one previously used to identify the outer boundaries of the universe of Bevill Mr. Richard J. Kinch Mr. Dennis C. Ruddy May 8,2003 Page 4 excluded wastes in the mining and oil and gas waste categories to one that defines permissible co management practices for FFC wastes under the Bevill exclusion.

Second, you observed that some EPA staff are concerned that the Dietrich Policy would potentially apply to an unlimited range of wastes, including wastes not generated today or in the past but which may be generated in the future whose identity and characteristics are unknown. This concern is based on a misunderstanding of the Dietrich Policy. The Policy on its face applies to a finite number of wastes that are generated in conjunction with electric power generation and have been traditionally co managed with FFC wastes. Specifically, two conditions must be met for a " low volume" waste to qualify for co management with FFC waste:

1. The waste must stem from the power generation process. Dietrich Policy, p. 6 (" We do not intend to exempt hazardous wastes that are generated by activities that are not directly associated with fossil fuel combustion, steam generation or water cooling processes."), and 2. The waste was traditionally co managed with FF C wastes. bid. (" The interpretation on [ low volume] wastes is also limited to wastes that traditionally have been and which actually are mixed with or codisposed or co treated with combustion wastes" ( emphasis added).).

To leave no doubt as to the scope of eligible wastes, the Policy contains a list specifying the types of low volume wastes that qualify  " boiler cleaning solutions, boiler blowdown, demineralizer regenerant, pyrites and cooling tower blowdown"  and those that do not  " pesticides or herbicide wastes, spent solvents, waste oils or other wastes that might be generated in construction or maintenance activities" and listed hazardous wastes under 40 C. F. R QQ 261.31. 33. bid. Thus, the staffs concern that the Policy may potentially apply " to an unlimited range of wastes" is unfounded because a strict set of criteria must be met before low volume wastes may be co managed with high volume FFC wastes.

Again, the legislative history of the Bevill Amendment is the key to understanding the limited scope of the Dietrich Policy. Rep. Bevill was explicit in explaining that the objective of the Bevill Amendment was to maintain the regulatory status quo that existed for FFC waste management in 1980 until EPA determined through its study of those waste streams and how they are managed whether a change in regulatory status was warranted. See, e. g., 126 Cong. Rec. 3361 ( 1980) ( The amendment " would require EPA to defer imposition of regulatory requirements on the waste disposal of the byproducts of fossil fuel combustion . . . until after EPA has completed studies to determine whether, if at all, these materials present any hazard to human health or the environment."). In the context of co management of FFC wastes with qualified low volume wastes, both Rep. Bevill and Rep. Rahall stressed that EPA should not alter the regulatory status of existing FFC management practices without a demonstrated need Mr. Richard J. Kinch Mr. Dennis C. Ruddy May 8,2003 Page 5 for increased regulation based on the Bevill study and the statutory process for making a regulatory determination. Addressing his remarks directly to EPA, Rep. Bevill explained on the House floor when he offered his amendment:

EPA should recognize that these " waste streams" often include not only the byproducts of the combustion of coal and other fossil fuels, but also relatively small proportions of other materials produced in conjunction with the combustion, even if not derived directly from these fuels. EPA should not regulate these waste streams because of the presence of these materials, if there is no evidence of any substantial environmental danger from these mixtures.

Id. at 3362. Rep. Bevill's remarks were echoed later in the debate in a similar message to EPA by Rep. Rahall:

In the real world, these waste materials [ fly ash waste, bottom ash waste, slag waste, and flue gas emission control wastes] do not include solely fly ash, bottom ash, slag, or scrubber sludge. Quite often, other materials are mixed with these large volume waste streams, with no environmental harmful effects, and often with considerable benefit  as when, for example, boiler cleaning acids are neutralized by being mixed with alkaline fly ash. These appear to me to be environmentally beneficial practices, which EPA should encourage. At the very least, however, the Agency should take no steps to discourage them until it has developed a full factual understanding of the situation.

Id. at 3364. In other words, the management practices in existence in 1980 were not to be set aside unless EPA's Bevill study demonstrated a need for redefining the scope of permissible co management. Of course, the Agency's Bevill Study did not make this demonstration, but in fact reached just the opposite conclusion by finding that such co management practices do not warrant RCRA Subtitle C regulation.

In sum, the " uniquely associated wastes" proposal neither honors congressional intent nor enhances environmental protection. It imposes significant costs, while increasing risks to public health and safety. It is poor public policy because it unnecessarily blurs a clear bright line policy that has been well understood for more than 20 years by imposing a set of confusing guidelines certain to generate a barrage of requests for clarification to the Agency for years to come and the potential for litigation. It appears to be a solution in search of a problem with none of the attributes that suggest that it would benefit the environment or streamline administration of the RCRA Bevill Amendment program for FFC wastes.

Accordingly, we request that EPA retain the existing Dietrich Policy on the scope of Bevill co management and to formally withdraw its proposal to adopt the " uniquely Mr. Richard J. Kinch Mr. Dennis C. Ruddy May 8,2003 Page 6 associated wastes" approach for FFC wastes. We are prepared to meet with the Agency to discuss this important issue. Please call me if you have any questions.

Sincerely yours,

u James R. Roewer Executive Director Enclosure Excerpt From Comments of the Utility Solid Waste Activities Group, the Edison Electric Institute, the American Public Power Association, and the National Rural Electric Cooperative Association On:

EPA S REGULATORY D ETERM I NATION ON WASTES FROM THE COMBUSTION OF FOSSIL FUELS, 65 Fed. Reg. 32214 ( May 22,2000)

Comments Originally Submitted To EPA Docket No. F 2OOO FF2F FFFFF On September 19,2000 TABLE OF CONTENTS I NTRODUCTI ON .................................................................................................... 1 I. General Comments on the Regulatory Determination. ................................ 3 A.

B. Additional Federal Re Mine Placement National Subtitle D Regulations Are Not Warranted .......................... 4 Is Not Warranted ............. ........................................................ 6 C. EPA Appropri ly Determined No Fu Regulation of d ........................ 7 II. Uniquely Associated Wastes Concept ......................................................... 8 A.

B.

C.

D.

E. The Dietrich Policy Correctly Interprets Congressional Intent to Exempt Certain Low Volume FFC Wastes That Are Co Managed with High Volume FFC Wastes. .................... 9 EPA Has Not Justified for Imposing on FFC Wastes a Framework Designed for Other Bevill Waste Categories. .............. 12 The Uniquely Associated Wastes Proposal Contradicts the Regulatory Determination and Report to Congress ..................... 17 The Dietrich Policy Clearly Delineates the Scope of the Bevill Combustion Waste Exemption, Whereas the Uniquely Associated Proposal Creates Needless Confusion. ........... 19 EPA's Proposed Reinterpretation Would Impose Significant Costs and Increase Risk to Public Safety with Little or No Environmental Benefit. ............................................ 23 Ill. Mill Rejects Co Management Guidance Document ..................................... 31 IV. Response to Request for Economic Information .......................................... 33 CONCLUSION ........................................................................................................ 37 APPENDIX A.

B. Letter from Gary N. Dietrich, EPA Associate Deputy Administrator for Solid Waste, to Paul Emler, Jr., USWAG Chairman ( Jan. 13, 1981)

The EOP Group, Inc., Economic Analysis of the Regulatory Determination on Wastes from Combustion of Fossil Fuels ( Sept. 2000) II. Uniquely Associated Wastes Concept.

EPA's proposal to impose the " uniquely associated wastes" framework on Bevill fossil fuel combustion wastes ( 65 Fed. Reg. at 32219 20) is a complete mismatch that neither honors congressional intent nor advances environmental performance. Rather,

it would impose significant costs and risks to public health and safety, and from the standpoint of sound public administration replaces a clear bright line policy that has been well understood for nearly 20 years with a confusing guideline certain to generate an endless stream of inquiries to the Agency for clarification and the possibility of litigation for many years. EPA should retain the existing Dietrich Policy on the scope of BeviII co management ( Letter from Gary N. Dietrich, EPA Associate Deputy Administrator for Solid Waste to Paul Emler, Jr., USWAG Chairman ( Jan. 13, 1981)

(" Dietrich Policy") ( copy attached as Appendix A)), which has proven to be an environmentally protective and workable approach since shortly after enactment of the Bevill Amendment. EPA has presented no justification whatsoever for this significant  8  WASH 1 : 3 1 4660: 5: 91 1 9/ 00 change of course that contradicts congressional intent and the findings presented in the Report to Congress and the Regulatory Determination.

A. The Dietrich Policy Correctly Interprets Congressional Intent to Exempt Certain Low Volume FFC Wastes that Are Co Managed with High Volume FFC Wastes.

Nearly 20 years ago, EPA articulated in the Dietrich Policy its interpretation of the scope of the Bevill " wastes produced in conjunction with the combustion of fossil fuels,

which are necessarily associated with the production of energy" and therefore are included within the scope of the Bevill FFC exemption when co managed with high volume FFC wastes. Dietrich Policy at 7. In so doing, the Agency's Dietrich Policy presents a proven framework for determining which low volume wastes Congress intended to allow to be co managed with the specified exempt high volume wastes and retain the BeviII exemption. EPA supplied the clarification in response to a request from the electric utility industry submitted October 10, 1980 in which USWAG sought clarification of the recently enacted Bevill Amendment. Letter from Paul Emler, Jr.,

USWAG Chairman ( Oct. 10, 1980). EPA's deliberations and opinion were thus contemporaneous with enactment and implementation of the Bevill Amendment.

The Agency's interpretation of legislative intent was unequivocal and supported with legislative history citations:

The legislative history on this matter clearly indicates that the Congress intended that these other wastes be exempted from Subtitle C regulation provided that they are mixed with and co disposed or co treated with the combustion wastes and further provided that " there is no evidence of any substantial environmental danger from these mixtures." ( See Congressional Record, February 20, 1980, p. H I 102, remarks of Congressman Bevill; also see remarks of Congressman Rahall, Congressional Record, February 20, 1980, p. H I 104.)

 9  WASH1 : 314660: 5: 9/ 19/ 00 Dietrich Policy at 5 ( emphasis in original). EPA explained further that Congress intended that such low volume wastes that " traditionally have been, and which actually are, mixed with and co disposed or co treated with" the four enumerated high volume waste are included within the scope of the Bevill amendment. u. at 7.

EPA's policy was not only a valid interpretation of congressional intent, it was the only permissible interpretation. The Bevill Amendment's FFC clause addresses " fly ash waste, bottom ash waste, slag waste, and flue gas emission control waste generated primarily from the combustion of coal or other fossil fuels." RCRA § 3001( b)( 3)( A)( i). In presenting his amendment on the House floor, Rep. Bevill explicitly explained his intention that the list of waste materials in the amendment be read broadly, to incorporate the waste products generated in the real world as a result of the combustion of fossil fuels. . . . EPA should recognize that these " waste streams" often include not only the byproducts of the combustion of coal and other fossil fuels, but also relatively small proportions of other materials produced in coniunction with the combustion, even if not derived directly from these fuels. EPA should not regulate these waste streams because of the presence of these materials, if there is no evidence of any substantial environmental danger from these mixtures.

126 Cong. Rec. 3362 ( 1980) ( emphasis added). In other words, the phrase " fly ash waste, bottom ash waste, slag waste, and flue gas emission control waste" was not limited to fly ash, bottom ash, slag, and flue gas desulfurization sludge, but referred broadly to waste mixtures that consisted primarily of those high volume combustion wastes but also included non combustion wastes " produced in conjunction with . . .

combustion" of fossil fuels. M. Rep. Bevill left no doubt as to the scope of the exemption.

 10 WASH1 : 314660: 5: 9/ 19/ 00 There is no room for Agency interpretation where `` Congress has directly spoken to the precise question at issue." Chevron USA, Inc. v. NRDC, Inc., 467 U. S. 837, 842 ( 1984); NRDC v. Browner, 57 F. 3d 1122, 1125 ( D. C. Cir. 1995). In step 1 of the Chevron analysis, "[ llf a court, employing traditional tools of statutory construction,

ascertains that Congress had an intention on the precise question at issue, that intention is the law and must be given effect." Chevron, 467 U. S. at 843 n. 9 ( 1984).

Congressman Bevill's floor statement quoted above is precisely focused on the co management issue. Congressman Rahall provided additional detail and demonstrated a keen awareness of the significance of utility waste co management to the purposes of the Bevill Amendment: I In the real world, these waste materials do not include solely fly ash, bottom ash, slag, or scrubber sludge. Quite often, other materials are mixed with these large volume waste streams, with no environmental harmful effects, and often with considerable benefit  as when, for example, boiler cleaning acids are neutralized by being mixed with alkaline fly ash.

126 Cong. Rec. 3364 ( 1 980).` Congressman Rahall stated further that the " Amendment would assure that EPA allows persons burning coal to avoid unnecessary regulation of the byproducts produced by that combustion, as those byproducts are currently being managed in the real world, by real people, with real sense." M.

There is nothing to the contrary in the legislative history applicable to combustion wastes that would justify a departure from the Dietrich Policy's conclusion that Congress 1 The proposed uniquely associated waste framework explicitly excludes from the Bevill exemption the very example of an eligible low volume waste stream identified by Congressman Rahall  boiler chemical cleaning wastes  a direct contradiction of this unequivocal indication of congressional intent.

 11  WASH1 : 314660: 5: 9/ 19/ 00 intended that the Bevill FFC exemption should extend to certain low volume wastes provided they are co managed with high volume wastes and further provided they do not pose a " substantial environmental danger." Dietrich Policy at 5. The proposed uniquely associated waste policy, if applied to FFC wastes, would be contrary to law.

B. EPA Has Not Justified Imposing on FFC Wastes a Framework Designed for Other Bevill Waste Categories.

The Federal Register discussion simply presents the unsupported and circular argument that EPA must " define appropriate boundaries for the Bevill exemption,

because there is no authority to grant Bevill status to wastes that are not uniquely associated." 2 65 Fed. Reg. at 32220. However, the term " uniquely associated" appears nowhere in the combustion waste clause of the Bevill Amendment. Use of this concept is not a legislative imperative as EPA suggests; rather, as discussed above, the uniquely associated waste concept contradicts congressional intent to recognize historic fossil fuel combustion waste co management practices.

The low volume wastes addressed in the Dietrich Policy are not currently and were never intended to be exempt when managed separately. The Bevill exemption for these wastes is contingent upon co management with the four specified high volume wastes. In sharp contrast, EPA's proposed uniquely associated waste approach ignores the co management concept entirely, failing to even acknowledge the existing Dietrich Policy. Rather, the uniquely associated waste approach was designed for other Bevill waste categories that do not share the co management concept with FFC wastes.

2 As discussed in detail in subsection 1I. D. below, EPA has indeed already clearly delineated the boundaries of the Bevill FCC Exemption.

 12 WASH 1 : 314660: 5: 9/ 19/ 00 Concurrent with development of the Dietrich Policy to address the FFC specific issue of co management, EPA began to develop the uniquely associated waste concept as it grappled with the scope of the Bevill exemptions applicable to other Bevill wastes.

These paths have diverged for nearly 20 years as the result of separate statutory language and legislative history for the different categories of Bevill wastes. It is inappropriate and illogical for EPA now to force the management of Bevill FFC waste onto that other path.

On November 19, 1980, the effective date of the Bevill Amendment, EPA issued an interim final amendment to codify the Bevill exemptions applicable to "[ slolid waste from the extraction, beneficiation, and processing of ores and minerals, including phosphate rock and overburden from the mining of uranium ore." 45 Fed. Reg. 76618,

76619 ( Nov. 19, 1980) ( implementing RCRA § 3001 ( b)( 3)( A)( ii)).' In that notice, without elaborate discussion, EPA introduced the term " uniquely associated" to describe the limits on the scope of the Bevill exemption applicable to those wastes. u. EPAs task was to determine which wastes were exempt from Subtitle C and which were not included within the scope of the applicable Bevill exemption. The concept of co

management was not mentioned because EPA was interpreting the scope of "[ slolid waste from the extraction, beneficiation, and processing of ores and minerals," not what other wastes may be co managed with Bevill exempt wastes without jeopardizing the exemption.

3 The Federal Register notice also addressed the Bevill cement kiln dust clause, RCRA § 300 1 ( b) ( 3) ( A) ( i i i) .

WASH1 : 314660: 5: 9/ 19/ 00  13  As discussed above, EPA was concurrently and independently considering the scope of the Bevill exemption applicable to co managed fossil fuel combustion wastes.

A separate path was clearly necessary since the legislative history of the other Bevill waste streams includes no indication that Congress was aware of or desired to include within the scope of the exemption the concept of co management. 4 Whereas for fossil fuel combustion, Congress specified the four principal waste streams by name as they were actually managed at the time ( k, co managed with the wastes identified in the Dietrich Policy), Congress simply referred generally to wastes from the mining and mineral processing industry sectors. EPA has explicitly stated that, contrary to Rep.

Bevill's statement that the FFC waste streams " be read broadly" ( 126 Cong. Rec. 3362),

" there is nothing in either the amendments themselves or in the legislative record supporting them to suggest that Congress construed the term ` mineral processing'

broadly." 54 Fed. Reg. 15321 ( April 17, 1989). 5 In the context of subsequent regulatory actions focused on the mining and mineral processing and oil and gas production industries, EPA reiterated the term " uniquely associated". Through the years, EPA has engaged in a resource intensive case by case series of interpretations of this term through informal interpretative letters.

See, e. a, Letter from Dan Derkics, Chief, EPA Large Volume Waste Section to Julie 4 EPA does indicate recognition of the co management issue in at least one reference to other Bevill wastes. In the Oil and Gas Regulatory Determination, EPA provided a list of " other wastes associated" and stated that "[ dlrill cutttings and rigwash are generally co mingled with drilling muds, and the Agency therefore has grouped them with large volume wastes for purposes of discussion in this determination." 53 Fed. Reg. 25446, 25453 54 ( July 6, 1988).

This statement appears to have overlooked a contrary statement by Rep. Bevill. See 126 Cong. Rec. 29982 ( 1 980). 5  14 WASH1 : 314660: 5: 9/ 19/ 00 Wanslow, NMEID ( June 6, 1989); Letter from J. Winston Porter, EPA Assistant Administrator, to James Nugent, Texas Railroad Commission ( Jan. 13, 1987);

Memorandum from Sylvia Lowrance, Director, EPA Office of Solid Waste, to Jeffrey Zelikson, Director, Hazardous Waste Management Division, EPA Region 9 ( June 30,

1993).

Only recently, in the 1998 Phase IV LDR rule and background documents did EPA formally elaborate upon the concept as applicable to mining and mineral processing wastes. 63 Fed. Reg. 28556, ( May 26, 1998); EPA, Technical Background Document: Identification and Description of Mineral Processing Sectors and Waste Streams 43 46 ( April 1998). Those documents contain a description of the uniquely associated waste concept that is in large part identical to the discussion used in the May 2000 FFC Bevill Regulatory Determination. However, EPA explicitly stated that the discussion of uniquely associated wastes in the Phase IV rulemaking " does not affect any Bevill Exempt wastes other than mining and mineral processing wastes." EPA,

Comment and Response Document for the January 25, 1996 Supplemental Proposed Rule, Land Disposal Restrictions at 4 16 ( April 1998); EPA, Response to Comments Document, Land Disposal Restrictions Phase IV: Final Rule, vol. 14, at 3 30 ( April 30,

1998) (" Today's rule does not in any way affect the RCRA BeviII regulatory status of wastes from the combustion of fossil fuels."). Despite this statement, EPA cites the Phase IV LDR rule as authority for application of this concept to combustion wastes.

EPA, Public Comment Summary and Response Document for the Regulatory Determination at X 9 , X 14 ( April 25,2000) (" FFC Response Document"). No other authority is provided anywhere in the record. I 0  1 5  WASH1 : 314660: 5: 9/ 19/ 00 EPA's " uniquely associated" concept was designed to tackle the task of determining whether a given mining waste  or later oil and gas production waste ( see 53 Fed. Reg. 25446, 25454 ( July 6, 1988))  qualified for the Bevill exemption, with no consideration of co management. EPA improperly assumes that its interpretation of the Bevill FFC exemption must be " entirely consistent with the Agency's current policies and practices with regard to other Bevill exempt wastes." FFC Response Document at X 9. Where Congress has established a separate and distinct standard for Bevill eligibility standard among the various Bevill waste categories, the quest for consistency among these separate wastes is wholly arbitrary and unlawful. EPA has lost sight of clear legislative policy and the Agency's own 20 year policy of treating these different Bevill wastes according to the different congressional standards encompassed in the legislative record.

As justification for the uniquely associated waste proposal, EPA has stated that it must " define appropriate boundaries for the Bevill exemption, because there is no authority to grant Bevill status to wastes that are not uniquely associated." M. As we have already demonstrated, that statement is legal error because there is nothing in the combustion waste portion of the Bevill Amendment ( or corresponding legislative history)

that introduces the phrase " uniquely associated" or the definition EPA has given to that phrase.

Perhaps if EPA is determined to apply the label " uniquely associated" to utility combustion waste co management, it could apply that label to the universe of eligible wastes as defined by the Dietrich Policy. But given the clear evidence that Congress intended a broad universe of eligible co managed wastes, EPA may bring about more  1 6  WASH1 : 314660: 5: 9/ 19/ 00 confusion than clarification by using the uniquely associated waste concept in the combustion waste context. Clearly, whatever label EPA ultimately chooses, EPA is on solid legal ground in recognizing the BeviII status of co managed wastes within the boundaries described in the Dietrich Policy.

C. The Uniquely Associated Wastes Proposal Contradicts the Regulatory Determination and Report to Congress.

Although the Federal Register notice presents the uniquely associated waste gh the Agency were writing on a blank slate, it is in fact a reversal of the Regulatory Determination's fundamental conclusion that the co managed wastes studied by EPA during the Bevill Phase II FFC Study do not warrant regulation under RCRA Subtitle C. There is no justification in the Report to Congress or elsewhere for this part of the Determination. I ,

I I Even though EPA acknowledged when it issued the Dietrich Policy in 1981 that it lacked " definitive information about the hazardous properties of these other wastes or i their mixtures with combustion wastes," EPA understood clearly that Congress intended to include them within the exemption so that their future regulatory status could be determined by the results of EPA's study of these waste management practices.

Dietrich Policy at 5. The mandate to perform a study of Bevill exempt wastes and issue a Regulatory Determination was intended to test the congressional hypothesis that these co management practices were appropriate and did not pose a " substantial environmental danger." 126 Cong. Rec. 3362. The Agency fully understood this intention since 1981 and indicated in the Dietrich Policy that only eyidence of environmental danger from particular co management activities could lead to reexamination of the scope of the Bevill FFC Exemption. Dietrich Policy at 5.

WASH1: 314660: 5: 9119/ 00  1 7  Based upon the statutory language and legislative intent as explained in the Dietrich Policy, EPA delineated specific exempt co management practices that were subject to evaluation in the Phase II Bevill FFC Study. These waste streams are listed in a judicial consent decree ( Gearhart v. Reillv, No. 91 2345, Consent Decree 4 ( D. D. C. 1992)) and in EPA's Phase I Regulatory Determination ( 58 Fed. Reg. 42466,

42470 ( Aug. 9, 1993)):

Discharge of boiler blowdown to a large volume waste impoundment,

Discharge of demineralizer regenerant to a large volume waste impoundment,

Discharge of metal cleaning wastes to a large volume waste impoundment,

0 Discharge of boiler chemical cleaning wastes to a large volume waste impoundment,

0 Discharge of plant wastewater treatment effluent to a large volume waste impoundment,

Discharge of coal mill rejects to a large volume waste impoundment,

0 Discharge of oil ash in a large volume waste landfill or impoundment,

Disposal of plant wastewater treatment sludge to a large volume waste landfill,

Disposal of coal mill rejects in a large volume waste landfill, and 0 Reuse of metal cleaning wastewaters in a FGD feedwater system.

 Id. EPA pursued an extensive data collection and analysis effort to assess the environmental risks associated with these co managed waste streams. In the 1999 Report to Congress the Agency concluded that these wastes do not pose a substantial danger to human health or the environment and do not warrant Subtitle C regulation.

1999 RTC at 3 73  3 74. The 2000 Regulatory Determination confirmed that recommendation. 65 Fed. Reg. at 32215.

 18 WASH1 : 314660: 5: 9/ 19/ 00 Nonetheless, the proposed " uniquely associated wastes" concept, in effect,

would overturn the Bevill exempt status of a significant number of the very waste streams studied, including co managed boiler blowdown, cooling tower blowdown and sludges, water treatment regeneration wastes, boiler waterside chemical cleaning wastes, and laboratory wastes. H. at 32220. The proposed policy reversal is simply an unlawful end run around the Bevill process for determining the regulatory status of Bevill wastes.

D. The Dietrich Policy Clearly Delineates the Scope of the BeviII Combustion Waste Exemption, Whereas the Uniquely Associated Proposal Creates Needless Confusion.

I I The most important reason to retain the Dietrich Policy interpretation is that it has proven itself effective in furthering congressional intent to recognize certain historic co

management practices provided they are not environmentally harmful. The policy has succeeded because it provides clearly delineated guidance on what practices are and are not appropriate. ~

The Dietrich Policy articulates the clear constraints on co management of FFC waste. To summarize these requirements:

0 the wastes must be generated in conjunction with the combustion of fossil fuels;

0 the wastes must be co managed with one or more of the four specified combustion wastes;

0 there must be no evidence of substantial environmental danger from the I I particular co management practice; I 0 the exemption extends on1 wastes that traditionally have been and which 1 I actually are co managed high volume FFC wastes; and I 0 the wastes must not be listed hazardous wastes. ~

I I  19 WASH1 : 314660: 5: 9/ 19/ 00 The Bevill FFC Exemption does not extend to co managed " pesticides or herbicide wastes; spent solvents, waste oils or other wastes that might be generated in construction or maintenance activities typically carried out at utility or industrial plants;

or any of the commercial chemicals listed in § 261.33 which are discarded or intended to be discarded and therefore are hazardous wastes." Dietrich Policy at 6.

Within this framework, the Dietrich Policy provides exceptional policy clarity and boundaries through its delineation of acceptable co management practices.` It is currently relied upon not only by the industry but by state regulatory agencies.'

Regulators and the regulated community have a clear understanding of the applicable rules, and, as a result, co management does not present compliance issues. The imposition of a new and significantly different approach would result in needless confusion, litigation, and unending requests for clarification.

6 In contrast, EPA proposes to use the following " qualitative criteria" to determine  on a 0 case by case basis  whether a waste is " uniquely associated":

Wastes from ancillary operations are not " uniquely associated"; and The classification depends upon " the extent to which the waste originates or derives from the fossil fuels, the combustion process, or combustion residuals, and the extent to which these operations impart chemical characteristics to the waste."

65 Fed. Reg. at 32220.

Dietrich Policy by reference in the Aquifer Protection Permit ( APP) to Arizona Public Service Company's Cholla facility. The APP specifies the materials that may be disposed in coal ash impoundments as follows: 7 For example, the Arizona Department of Environmental Quality ( ADEQ) incorporated the The materials listed above authorized for disposal shall not contain any hazardous wastes, as defined in 40 CFR 261, except for those wastes which are co disposed in accordance with 42 USC 6921( b)( 3)( A) and 40 CFR 261.4( b)( 4) and further clarified by the January 13, 1981 EPA letter from Gary N. Dietrich to Mr. Paul Elmer Jr. known as the " Dietrich Letter."

 20  WASH 1 : 3 1 4660: 5: 9/ 19/ 00 Perhaps because EPA developed the uniquely associated waste concept for other industries and not in consideration of FFC waste co management, the proposed list of " uniquely associated" and " not uniquely associated" wastes is inconsistent with the current waste management practices, state and federal regulatory approaches, the Phase Ii Study, the Report to Congress, and the Regulatory Determination. The first four of the wastes on the " not uniquely associated list" ( boiler blowdown, cooling tower blowdown and sludges, regeneration wastes, and boiler waterside cleaning wastes) are specifically identified in the Dietrich Policy as " necessarily associated" with the combustion of fossil fuel and Bevill exempt when co managed. Dietrich Policy at 4 5, 8.

However, EPA now proposes to consider these wastes not " uniquely associated" with the combustion of fossil fuel  presumably because EPA believes that these waste streams do not come into contact with FFC wastes and hence there is no transfer of chemical characteristics from FFC wastes to the waste streams on the " not uniquely associated" list. But EPA has never explained the relevance of the " physical touching"

requirement or its scope. Indeed, by definition, co managed wastes are in contact with high volume combustion wastes and the chemical characteristics of the mixture are dominated by the high volume wastes.

It is particularly strange that EPA proposes to remove the Bevill exemption from co managed " boiler waterside cleaning wastes." 65 Fed. Reg. at 32220. Indeed, as discussed above, Congressman Rahall specifically referred to co m " boiler cleaning acids" ( 126 Cong Rec. 3364) and in turn the Dietrich Policy included I " boiler cleaning solutions" within the scope of the co management bxemption. Dietrich Policy at 4. Subsequently, in the Report to Congress, EPA reported on the study of  21  WASH1 : 314660: 5: 9/ 19/ 00 these wastes and defined " boiler chemical cleaning wastes" as " wastes resulting from the periodic cleaning of the inside ( waterside) of boiler tubes with chemical solutions."

1999 RTC at 3 3 ( emphasis added). EPA would retain a part of the boiler chemical cleaning waste stream  what it now calls " Boiler Fireside Chemical Cleaning Wastes"

within the Bevill universe under the " uniquely associated wastes" framework. 65 Fed.

Reg. at 32220. However, those wastes were referred to in the Report to Congress as " air heater and precipitator washwater," defined as " wastes resulting from the periodic cleaning of the outside ( fireside) of heat exchanging surfaces". 1999 RTC at 3 3 ( emphasis added). What is clear from this progression is that terminology that may have served well in the context of other industries' waste streams is mismatched when applied to FFC wastes.

The application of the " ancillary" criterion to FFC wastes as set out in the uniquely associated waste proposal is an arbitrary construction that will require endless clarification. Indeed, in the Report to Congress, EPA described that " comanagement occurs when a waste management unit receives both large volume [ FFC wastes] and other wastes that are generated ancillary to, but as a necessary part of, the combustion and power generation processes."

these wastes alternately as " directly associated" ( Dietrich Policy at 6) and " necessarily associated" ( a. at 7). It would be arbitrary for EPA now to declare certain co managed wastes " not uniquely associated" because they are from " ancillary" processes based upon nothing more than a redefinition of terminology. at 3 1. In the Dietrich Policy, EPA describes EPA's application of the uniquely associated concept  the lists of " uniquely associated wastes" and " not uniquely associated wastes"  seems to confuse the  22  WASH1 : 314660: 5: 9/ 19/ 00 combustion chamber for the complex, extended industrial process of fossil fuel combustion for electricity generation. The process at issue with fossil fuel combustion wastes is the entire combustion process necessary to generate electricity. That process is not narrowly limited to the combustion chamber. Cooling towers, heat exchangers and water treatment are essential sub processes necessary for the generation of electricity  electricity cannot be generated by the combustion chamber alone. Thus the sub processes from which the co managed wastes are generated are not " ancillary"

as EPA seems to interpret that term in the uniquely associate waste proposal. The co

managed wastes at issue in the Dietrich Policy should also qualify as " uniquely associated wastes" under the proposed new framework.

E. EPA's Proposed Reinterpretation Would Impose Significant Costs and Increase Risk to Public Safety With Little or No Environmental Benefit.

The specific waste management practices in jeopardy under the uniquely associated waste proposal are historic utility industry co management practices that are environmentally protective and cost effective. Their elimination would impose significant economic costs on the industry with little or no environmental benefit.

Specifically, EPA proposes that the following wastes would not be uniquely associated and therefore would not be eligible for BeviII status whether or not co managed:

0 Boiler waterside cleaning wastes;

0 Boiler blowdown;

0 Cooling tower blowdown and sludges;

0 Intake or. makeup water treatment and regeneration wastes;

Laboratory wastes;

General construction and demolition debris;

 23  WASH1 : 314660: 5: 9/ 19/ 00 0 General maintenance wastes: and 0 Spillage or leakage of materials used in processes that generate non uniquely associated wastes.

65 Fed. Reg. at 32220. The first four waste streams identified on the proposed " not uniquely associated" list were explicitly included in the scope of the Dietrich Policy as exempt when co managed with fossil fuel combustion wastes.

As a threshold matter, it is important to acknowledge that the Bevill co

management exemption is of practical importance only when the low volume waste stream would test characteristically hazardous. A non hazardous low volume waste may be co managed with a Bevill exempt FFC waste stream without regard to the Bevill exemption to the same extent as two ordinary nonhazardous wastes may be co

managed without running afoul of EPA regulations.

EPA correctly acknowledged that most co managed low volume waste streams are not expected to exhibit hazardous characteristics. 1999 RTC at 3 16. However, the low frequency of testing hazardous does not indicate that a reclassification of the scope of permissible Bevill co management would have insignificant impacts. To the contrary,

responses to a preliminary USWAG questionnaire indicate that the cost impacts of the proposal reach the significant rulemaking threshold. The potential for several significant affected waste streams to test characteristically hazardous under EPA's proposal,

combined with the cost of necessary process changes and the cost of hazardous waste management, translate to significant additional economic burdens. Even though these wastes may test hazardous only occasionally at some plants, utilities would be forced to implement costly process changes to prepare for the contingency of segregated hazardous waste management. Given the low probability that a particular stream will  24  WASH1 : 314660: 5: 9/ 19/ 00 test hazardous after any generation event and the low environmental risk from traditional co management practices, such modifications would not be cost effective.

EPA seems ready t administrative uniformity, without any acknowledgement th significant consequences of its proposal. Indeed, it is astonishing that the proposal was not even mentioned as a possible option in the 1999 Report to Congre economic analyses supportin Determination. he Report to Congress and the Regulatory Historically co managed low volume wastes are integral to the combustion of fossil fuels to generate electricity. Reliable electric service is dependent upon sub

processes that generate these streams. The most significant low volume waste streams that would be affected by the proposal (

i.

e.,

waste streams that potentially could test hazardous when separately managed) are boiler chemical cleaning wastes and water treatment demineralizer regeneration wastes. In the following subsections we seek to provide insight into traditional generation and management practices for these waste streams, including the cost and risk impacts of EPAs proposal.

1. Boiler Chemical Cleaninn Wastes Boiler chemical cleaning wastes (" BCCW") are generated during scheduled cleaning of the boiler water contact surfaces ( m, tubes, drums, headers) with chemical solutions to remove minerals and metals ( a calcium, copper, iron, magnesium, nickel,

zinc, etc.) to increase heat transfer efficiency. Iron and copper deposits are the greatest concerns due to their adverse effects on equipment performance. If left unchecked,

oxides of these metals accumulate and reduce heat transfer, restrict flow and promote  25  WASH 1 : 3 14660: 5: 9/ 19/ 00 corrosion of the underlying base metal. Periodic cleaning is therefore necessary to maintain boiler thermodynamic efficiency and structural integrity.

The frequency of boiler cleaning is dependent upon boiler size, configuration,

and operating conditions. Because cleaning involves significant scheduled boiler down time, there is a strong incentive to extend the interval between cleanings, thus minimizing waste generation. USWAG members report cleaning frequencies between 2 and 10 years, across the wide range of boiler types, operating conditions, and maintenance procedures.

Drum type boilers are typically cleaned using chelate chemicals. The resulting waste stream has the potential to exhibit the toxicity characteristic for chromium and lead, with chromium being the most significant issue. Initial rinses frequently exceed the toxicity characteristic (" TC") level for chromium,' while the necessary subsequent rinses contain significantly lower concentrations. Generally, USWAG members generate between approximately 100,000 and 500,000 gallons of BCCW waste per cleaning, depending upon the size of the boiler unit.

8 The chromium present has been demonstrated to be generally trivalent, and these wastes would therefore be candidates for the Cr ( Ill) exclusion in 40 C. F. R. § 261.4( b)( 6). In any event, EPA should recognize that BCCW that exceeds the TC level for chromium does not present the environmental risks of concern with hexavalent chromium containing wastes. See, 45 Fed. Reg. 72029 ( Oct. 30, 1980) ( Proposal to amend the hazardous waste toxicity characteristic to apply to hexavalent rather than total chromium); 45 Fed. Reg. 72035 ( Oct. 30, 1985) ( Interim Final Rule adopting § 261.4 Cr ( Ill) exclusion). EPA has stated that "[ gliven the relatively low toxicity of trivalent chromium, its low migratory potential, and the lack of indication of potential for oxidation under usual land disposal conditions, the Agency does not believe that land disposal of trivalent chromium containing wastes in common landfill or impoundment situations poses a present or potential hazard to human health or the environment via soil migration to groundwater." 45 Fed. Reg. at 72030.

 26  WASH1 : 314660: 5: 9/ 19/ 00 Chemical cleanings on supercritical boilers are generally not chelate based and the TC for chromium is not an issue. The resulting waste is typically nonhazardous,

although there is the potential to exhibit the characteristic of corrosivity. These cleanings can yield up to 1.75 million gallons of waste.

EPA has clarified that the point of generation of BCCW occurs with the aggregation of the various rinses. 62 Fed. Reg. 25998, 26006 ( May 12, 1997). The resulting aggregated waste is expected to exceed the TC level for chromium much less frequently than the initial rinse. It is difficult to estimate the frequency the stream might test hazardous on an industry wide basis since it is dependent upon numerous factors related to metallurgy, boiler design, operating conditions, and maintenance procedures.

One utility reported that 50% of the BCCW generated since 1994 has tested hazardous for chromium after permissible aggregation of rinses. Thus, it is clear that the point of generation clarification will not render insignificant the proposed elimination of the co

management exemption.

Furthermore, aggregation of rinses is not an available option at many utility plants. For smaller boilers, aggregation of rinses would require approximately five 20,000 gallon tanks to be staged on site and interconnected for recirculation. There is simply insufficient space available in many units to accommodat, e this approach. The only option for ny facilities would be to run temporary piping considerable distances between the boilers and the tanks. For some of the largest boilers, aggregation would require approximately twenty five 20,000 gallon tanks, which would be difficult to stage and interconnect in any proximity to the boilers. ,

 27  WASH1 : 314660: 5: 9/ 19/ 00 In the absence of the Bevill co management exemption, utilities that currently co

manage BCCW would have three basic management options: ( 1) collect the first rinse ( likely TC hazardous for chromium) and treat on site; ( 2) collect the first rinse ( likely TC hazardous for chromium) and transport it off site to a treatment, storage and disposal facility (" TSDF"); or ( 3) aggregate rinses in a recirculating interconnected tank system,

with on site or off site treatment and disposal, depending upon TCLP results.

For non chelate cleanings, the volume of waste would likely steer the choice of treatment options to off site treatment and disposal. Because of the volumes of waste at issue, transportation and disposal fees could increase by as much as $ 1,000,000 per cleaning if the waste exhibits a hazardous waste characteristic. As a baseline, one utility reported current cleaning costs of $ 200,000 to $ 250,000 with on site co

management.

For chelate based cleanings, costs would be significant whether the waste is treated on site or transported off site. If the aggregated rinses exhibit the TC for chromium, treatment on site to remove the hazardous characteristic and satisfy the land disposal restrictions may not be possible in some cases. One utility reports that its contractor has thus far been unsuccessful in chemically treating BCCW to remove chromium so as to render the wastewater nonhazardous. On site treatment and discharge to a P O W or under an NPDES permit may be a potential option for some affected utilities. However, on site treatment prior to NPDES/ POTW discharge would require significant process changes as well as increased risk, liability, and regulatory obligations related to storage and use of treatment chemicals on site ( a risk of release, OSHA hazard communication requirements, and EPCRA reporting  28  WASH1 : 314660: 5: 9/ 19/ 00 requirements). Furthermore, not all plants are authorized or permitted to discharge these wastes via an NPDES permitted outfall or to a POW. Utilities remain concerned , I 1 I , that the trend towards increased restrictions in NPDES permits will eliminate this option completely over time.

, I The cost of aggregating rinses in a recirculating interconnected tank system is , estimated at $ 10,000 to $ 30,000 for rental of temporary tanks alone. One utility estimated the recurring costs of on site treatment at $ 0.50 to $ 1 . OO per gallon. In , I I addition, process modifications would be necessary since BCCW discharges are typically hard piped directly to the coal combustion waste disposal unit at plants that co I manage this waste stream.

~

, , One USWAG member company reported that it has traditionally treated its BCCW on site and does not utilize the co management exemption for BCCW.

However, the treatment sludge generally exceeds TC levels for chromium, and the company co manages that waste stream with high volume coal combustion wastes. For this company, the proposed modification to the co management policy would increase its costs associated with management of the treatment sludge as a hazardous waste by $ 80,000 per boiler cleaning event. ~

~

Many utilities will have no choice but to transport hazardous BCCW off site for , treatment and disposal.

transportation of large numbers of tanker trucks ( 35 60 per cleaning) to treatment and disposal facilities, which are often hundreds of miles away from utility plants. Member ff site treatment and disposal involves the highway I I I I companies indicated a range of costs for off site transportation and disposal of $ 1.25

$ 1.50 per gallon, or approximately $ 125,000 to $ 750,000 per cleaning. In addition,

I I  29  WASH1 : 314660: 5: 9/ 19/ 00 significant process modifications would be necessary for many plants. The risk to public safety from unnecessary off site transportation should not be minimized. Many major transportation corridors across the country are operating at capacity and the periodic strain of an additional 35 to 60 tanker trucks should be avoided.

Yet another cost associated with EPAs proposal would be costs associated with the extension of boiler downtime resulting from a change in current co management practices. One USWAG member anticipates an increase in downtime of 8 and 12 hours per cleaning with associated lost revenue of $ 65,000 to $ 135,000.

2. Demineralizer Reseneration Waste The production of high purity water is essential to the operation of utility boilers.

Utilities must regenerate the demineralizers used in the water purification process using both sulfuric acid and caustic. The regeneration process generates both low pH and high pH wastes that are frequently co managed in coal ash surface impoundments where neutralization occurs. One utility reported generation of 500,000 to 1,000,000 gallons of demineralizer regeneration waste per month.

In the absence of the Bevill co management exemption, treatment of both characteristically hazardous waste streams would be necessary to neutralize the acidic and caustic wastes. Modifications would require process changes and possibly state treatment permits. One utility estimated the process changes would cost $ 3 million. In addition, increased on site handling would increase the potential for release and exposure to employees and the environment.

 30  WASH1 : 314660: 5: 9/ 19/ 00


[Federal Register Volume 79, Number 7 (Friday, January 10, 2014)]
[Notices]
[Pages 1877-1879]
[FR Doc No: 2014-00258]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1658]

Characterizing and Communicating Uncertainty in the Assessment of
Benefits and Risks in Drug Regulatory Decision-Making; Public Workshop;
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of Public Workshop; request for public comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the following workshop convened by the Institute of Medicine
(IOM): ``Characterizing and Communicating Uncertainty in the Assessment
of Benefits and Risks in Drug Regulatory Decision-Making.'' The purpose
of the workshop is twofold: To explore potential approaches to
addressing and communicating uncertainty and to identify key
considerations on developing, evaluating, and incorporating potential
approaches for addressing uncertainty into the assessment of benefits
and risks in the human drug review process. The format of the meeting
consists of a series of presentations on topics related to uncertainty
in the assessment of benefits

and risks, followed by a discussion on those topics with invited
panelists and audience members. This workshop satisfies an FDA
commitment that is part of the fifth authorization of the Prescription
Drug User Fee Act (PDUFA V).

DATES: The public workshop will be held on February 12, 2014, from 8:30
a.m. to 4:30 p.m. and February 13, 2014, from 8:30 a.m. to 3:30 p.m.
Registration to attend the public workshop must be received by January
31, 2014. See the SUPPLEMENTARY INFORMATION section for information on
how to register for the workshop. Submit either electronic or written
comments by March 14, 2014.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Building 31 Conference Center, Rm. 1503A,
Silver Spring, MD 20993-0002. Entrance for public workshop attendees
(non-FDA employees) is through Building 1 where routine security check
procedures will be performed. For parking and security information,
please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. Identify all comments with the docket number found in brackets
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Sara Eggers, Food and Drug
Administration, Center for Drug Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1166, Silver Spring, MD 20993-0002, 301-
796-4904, FAX:<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On July 9, 2012, the President signed into law the Food and Drug
Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144).
Title I of FDASIA reauthorizes PDUFA and provides FDA with the user fee
resources necessary to maintain an efficient review process for human
drug and biological products. The reauthorization of PDUFA includes
performance goals and procedures for the Agency that represents FDA's
commitments during fiscal years 2013-2017. These commitments are fully
described in the document entitled ``PDUFA Reauthorization Performance
Goals and Procedures Fiscal Years 2013 through 2017'' (PDUFA Goals
Letter), available on FDA's Web site at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf.
    Section X of the PDUFA Goals Letter, entitled ``Enhancing Benefit-
Risk Assessment in Regulatory Decision-Making,'' includes development
of a plan to further develop and implement a structured approach to
benefit-risk assessment in the human drug review process. As part of
this enhancement, FDA committed to holding two public workshops on
benefit-risk considerations from the regulator's perspective that will
begin by the first quarter of fiscal year 2014. The public workshop
announced in this notice will fulfill the first of the two workshop
commitments.
    As part of its commitment, FDA has published the ``Structured
Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making:
Draft PDUFA V Implementation Plan,'' available on FDA's Web site at
http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM329758.pdf. In this plan, FDA identified as
an area of further development the exploration of structured approaches
to evaluate and communicate the uncertainty in the assessment of
benefits and risks. FDA's human drug regulatory decisions are informed
by an extensive body of evidence on the safety and efficacy of a drug
product. In many cases, this evidence is subject to uncertainty arising
from many sources. One example is the uncertainty in the degree to
which premarket clinical trial data translates to the postmarket
setting after the drug is approved and used in a much wider patient
population. Another example is uncertainty about a potential safety
signal that emerges in the postmarket setting, where the basis for the
finding comes from multiple evidence sources of varying levels of
rigor. Drawing conclusions in the face of uncertainty can be a complex
and challenging task. Furthermore, being explicit about the impact of
uncertainty on decision-making is an important part of communicating
regulatory decisions.

II. Purpose and Scope of the Workshop

    This 2-day public workshop is being convened by IOM. The public
workshop will explore more systematic and structured approaches to
evaluate and communicate: (1) The sources of uncertainty in the
assessment of benefits and risks and (2) their implications on human
drug regulatory decisions. Specifically, the workshop will explore
potential analytical and communication approaches to addressing and
communicating uncertainty and identify key considerations on
developing, evaluating, and incorporating potential approaches for
addressing uncertainty into the assessment of benefits and risks in the
human drug review process. This public workshop will consider the
entire drug development life cycle, including premarket drug review and
postmarket safety surveillance. The format of the meeting consists of a
series of presentations on topics related to uncertainty in the
assessment of benefits and risks, followed by a discussion on those
topics with invited panelists and audience members.

III. Attendance and Registration

    FDA's Conference Center at the White Oak location is a Federal
facility with security procedures and limited seating. Persons
interested in attending the public workshop must register online by
January 31, 2014. To register for the public workshop, please visit
FDA's workshop Web site at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm378861.htm. Early registration is
recommended. Registration is free and will be on a first-come, first-
served basis. However, the number of participants from each
organization may be limited based on space limitations. Registrants
will receive confirmation once they have been accepted. Onsite
registration on the day of the workshop will be based on space
availability. If you need special accommodations because of disability,
please contact Sara Eggers (see FOR FURTHER INFORMATION CONTACT) at
least 7 days before the workshop. More information will be made
available on FDA's workshop Web site at least 5 days before the
workshop date.
    A live Webcast of this workshop will be viewable on FDA's workshop
Web site at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm378861.htm on the day of the workshop. A
video recording of the workshop will be available on FDA's workshop Web
site approximately 1 week following the workshop. IOM will
independently prepare a summary of the workshop, and the summary will
be available on FDA's workshop Web site approximately 10 months
following the workshop.

IV. Comments

    Regardless of attendance at the public workshop, interested persons
may submit either electronic comments or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of

comments. Identify comments with the docket number found in brackets in
the heading of this document. To ensure consideration, submit comments
by March 14, 2014. Received comments may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday,
and will be posted to the docket at http://www.regulations.gov.

    Dated: January 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-00258 Filed 1-9-14; 8:45 am]
BILLING CODE 4160-01-P