Current regulatory issues

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Current Regulatory Issues Chris Bryant David Mentall <;LEANUPSUNDER ANEW- The 103rd Congress considered legislation reauthorizing the Com- prehensive EnvironmentalResponse, Compensation, and Liability Act (CERCLA or Superfund). Entitled the Superfund Reform Act of 1994 (H.R. 38OO/S. 18341, the bill would have enacted sweeping reform to the ail- ing Superfund program. In its 14 years of existence, Superfund has achieved significant successes, particularly in the area of emergency removal actions. Despite this success, however, there is wide- spread recognition that the program is inherently flawed.The major issues that have catalyzed and shaped the current Superfund reauthorization are these flaws and inequities in the existing statute. It is generally ac- cepted that the existing Superfund program is beset with six chief flaws, the repair of which is the basic tenet of reauthorization efforts and has been the primary force in shapingthe debate. The flaws are (1) high rernediation costs and slow cleanups, (2) excessive transaction costs, (3) an unfair liability scheme, (4) a "dual master"scheme, (5) inadequate com- munity involvement, and (6) adverse economic impacts on property OM- ers and redevelopment. Although the bill failed, the core components of its remedy selection provisions will likely survive reautho- rization efforts in the 104th Congress. Consequently, this column summa- rizes the seven major deanup provi- sions of the Superfund Reform Act of 1994: National Goals, Establishmentof Cleanup Standards, Protective Con- centration Levels, Site-Specific Risk Assessments, National Risk Protocol, Federal and State ARARs, and Ground- water. NATIONAL GOALS Section 121 of CERCLA requires EPA to choose remedies at Superfund sites that at a minimum will "attain a degree of cleanup of hazardous sub- stances,pollutants,and contaminants . . . which assures protection of hu- man health and the environment." The statute goes no further, however, in defining how EPA is to quantify the degree of protectiveness after a cleanup has been completed. As a result, in the National Contingency Plan (NCP), EPA defined the level of protectiveness that a successful cleanup must achieve as a range, allowing an acceptable residual risk level of 10' (one in IO,OOO) to lo4 (one in 1,000,000). The NCP states: "For known or suspected carcino- gens, acceptable exposure levels are generally concentration levels that represent an excess upper bound lifetime cancer risk to an individual of between 10' and 10" using informa- tion on the relationshipbetween dose and response." The significance of a risk goal is that it underlies the estab- lishment of concentration levels ac- ceptable to leave at the facility with no management controls following CCC 1051-5658/94/0501131-6 Q 1994 John Wiley 8 Sons, Inc. 131

Transcript of Current regulatory issues

Page 1: Current regulatory issues

Current Regulatory Issues Chris Bryant David Mentall

<;LEANUPSUNDER ANEW-

The 103rd Congress considered legislation reauthorizing the Com- prehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund). Entitled the Superfund Reform Act of 1994 (H.R. 38OO/S. 18341, the bill would have enacted sweeping reform to the ail- ing Superfund program.

In its 14 years of existence, Superfund has achieved significant successes, particularly in the area of emergency removal actions. Despite this success, however, there is wide- spread recognition that the program is inherently flawed. The major issues that have catalyzed and shaped the current Superfund reauthorization are these flaws and inequities in the existing statute. It is generally ac- cepted that the existing Superfund program is beset with six chief flaws, the repair of which is the basic tenet of reauthorization efforts and has been the primary force in shaping the debate. The flaws are (1) high rernediation costs and slow cleanups, (2) excessive transaction costs, (3) an unfair liability scheme, (4) a "dual master" scheme, (5 ) inadequate com- munity involvement, and (6) adverse economic impacts on property OM-

ers and redevelopment. Although the bill failed, the core

components of its remedy selection provisions will likely survive reautho- rization efforts in the 104th Congress. Consequently, this column summa-

rizes the seven major deanup provi- sions of the Superfund Reform Act of 1994: National Goals, Establishment of Cleanup Standards, Protective Con- centration Levels, Site-Specific Risk Assessments, National Risk Protocol, Federal and State ARARs, and Ground- water.

NATIONAL GOALS Section 121 of CERCLA requires

EPA to choose remedies at Superfund sites that at a minimum will "attain a degree of cleanup of hazardous sub- stances, pollutants, and contaminants . . . which assures protection of hu- man health and the environment." The statute goes no further, however, in defining how EPA is to quantify the degree of protectiveness after a cleanup has been completed. As a result, in the National Contingency Plan (NCP), EPA defined the level of protectiveness that a successful cleanup must achieve as a range, allowing an acceptable residual risk level of 10' (one in IO,OOO) to lo4 (one in 1,000,000). The NCP states: "For known or suspected carcino- gens, acceptable exposure levels are generally concentration levels that represent an excess upper bound lifetime cancer risk to an individual of between 10' and 10" using informa- tion on the relationship between dose and response." The significance of a risk goal is that it underlies the estab- lishment of concentration levels ac- ceptable to leave at the facility with no management controls following

CCC 1051-5658/94/0501131-6 Q 1994 John Wiley 8 Sons, Inc.

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remediation. EPA has described the risk range as useful in maintaining the flexibility the agency needs in selecting remedies appropriately tai- lored to the circumstances of particu- lar Superfund facilities.

Even though many potentially responsible parties (PRps) have found the risk range an acceptable way to measure protectiveness, citizens af- fected by Superfund sites and mem- bers of the environmental and public interest communities have been less satisfied.

Although it is sensitive to EPAs need for flexibility in carrying out its remedy selection responsibilities, Congress believes that the risk range currently being used by the agency is flawed and should be replaced with one single-point risk level for car- cinogens and one for noncarcinogens. However, the bill stopped short of setting that new single-point stan- dard by statute. Instead, H.R. 3800 would have required EPA to estab- lish, in a consensus-based rulemaking, the new national goals for protection of human health and the environ- ment, with the goals to be defined as single numerical levels for carcino- gens and noncarcinogenic effects. The purpose of the national goal is to promote consistent and equivalent protection of human health and the environment from the risks posed by Superfund sites, in terms that can be more clearly understood by the pub- lic. EPA will retain the flexibility to select remedies to achieve the goals at Superfund sites through a combi- nation of remedial measures.

Radioactive materials released into the environment are currently subject to CERCLA, with the exception of two specific types of radioactive releases: those from a nuclear incident subject to Price Anderson liability coverage

pursuant to Section 170 of the Atomic Energy Act of 1954 and the Uranium Mill Tailings Radiation Control Act of 1978. Radionuclides are not excluded from the terms chemical carcinogen and noncarcinogen as used in the national goals provision of Section 121(d) of CERCLA as amended by the bill. Nothing in the bill is intended to affect the application of the Atomic Energy Act to any facility licensed by the Nuclear Regulatory Commission.

ESTABLISHMENT OF CLEANUPSTANDARDS

Under current law, Section 121 governs the establishment of cleanup standards for Superfund remedial actions. That section sets forth the so- called ARARs provisions (the acro- nym ARAR derives from the terms "applicable or relevant and appropri- ate requirements"). ARAB are

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2.

A

Any standard or requirement established under any federal environmental law, such as the Safe Drinking Water Act, Clean Air Act, Clean Water Act, or RCRA, and Any promulgated standard or requirement established under a state environmental law that is more stringent than a federal standard or requirement, that is legally applicable to the haz- ardous substance concerned or is relevant and appropriate under the circumstances of the release.

set of ARARs must be devel- oped for the cleanup at each Superfund facility. EPA does this on a site-by-site basis, first identifying and analyzing all potential federal and state standards, requirements, or cri- teria that might be legally applicable

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or relevant or appropriate, and then determining which should be used to establish facility cleanup levels. This is a timeconsuming and often con- troversial process.

ARARs have failed to provide cleanup standards for many media. For example, there are no federal standards for contaminated soils and relatively few state soil standards. And, as with virtually all other aspects of the Superfund program, ARARs are criticized for being inconsistently applied. Some PRps argue that ARARs serve to "goldplate" cleanups. Envi- ronmentalists contend that they were meant to be standards, but EPA often sets entirely different cleanup levels for the same contaminants in similar circumstances at different sites, with- out adequate justification.

Using the Clinton administration's proposal and the recommendations of the Keystone Commission as building blocks, Congress attempted to negoti- ate a new method of establishing cleanup standards that would balance the competing demands of site-by-site flexibility and program-wide consis- tency. Subsequently, on April 25,1993, the administration issued a modified version of its remedy selection pro- posal, which included the agreements reached in the negotiating group con- vened by Representative Swift, Chair of the Subcommittee on Transporta- tion and Hazardous Materials. Con- gress has adopted this new approach to establishing cleanup standards. The remedy selection provisions of the bill were adopted as Title V of Representa- tive Swift's amendment in the nature of a substitute to H.R. 3800 at the sub- committee markup on May 11, 19%. These provisions were adopted with very minimal change at both the sub- committee markup and the full com- mittee markup.

PROTECIWE CONCENTRATION LEVELS

The setting of deanup standards at Superfund sites will be streamlined by the development of standardized for- mulas and methodologies. EPA will use the formulas to set protective con- centration Ievels insod and toset levels in groundwater where protective con- centration levels have not already been established under other laws (such as the Safe Drinking Water Ad> for par- ticular contaminants. The formulas will be developed for the 100 contaminants most frequently found at Superfund sites and will be based on national constants as well as variable factors to account for site-specific information.

The national constant factors in the formulas will include, for example, chemical characteristics not expected to vary from facility to facility, possibly including, but not limited to, such factors as toxicity, solubility, volatility, and boiling point. Factors that vary from site to site, such as depth to groundwater, particle size, and poros- ity of soils, would be expected to be identified as variables in the formulas, provided the factor can be objectively measured, its effeas are scientifically well understood, and its impact on estimations of risk or protective con- centration levels is significant. Certain exposure factors related to demograph- ics, activity patterns, and natural con- straints at Superfund sites will be estab Iished by EPA in the form of defaults or ranges of default values. If any person presents verifiable data that the de- faults do not represent actual condi- tions at the facility, however, EPA would determine that value on a sire- specific basis.

SITE-SPECIFIC RISK ASSESSMENTS

In addition to requiring develop

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ment of standardized formulas for setting cleanup levels, the bill would preserve an important role for site- specific risk assessments. A site-spe- cific evaluation will always have to be made to determine which stan- dardized tool will apply at a given facility; site-specific risk assessment would be used to establish the pro- tective concentration levels. For ex- ample, ecological risks'andrisks posed at highly complex sites, where there are multiple, and perhaps atypical, exposure pathways, will likely be evaluated through a site-specific risk assessment.

NATIONAL RISK PROTOCOL Risk assessment plays many im-

portant roles in the Superfund pro- gram. These include "baseline" risk assessments to determine the need for remedial action, analysis of the risks that may be posed by imple- mentation of a particular type of remedy, and site-specific risk assess- ments to establish certain cleanup levels that a remedy will have to meet. And, as just discussed, site- specific risk assessment will also play a part in the application of the newly developed formulaic approach to setting cleanup levels at Superfund sites.

The use of site-specific risk as- sessment in the Superfund program has been the subject of much debate. Many members of the PRP commu- nity have argued that all Superfund cleanups should be driven solely by site-specific risk assessment (rather than a consistent approach to setting cleanup standards) and that assess- ments of risk to human health and the environment should be based on "realistic" assumptions rather than overly conservative, hypothetical sce- narios. Those who disagree with this

view, however, argue that risk assess- ments are inherently flawed because of statistical and scientific failings in the risk assessment process, which can result in an underestimation of the real risks.

Currently, EPA performs risk as- sessments for the Superfund program under the protocol established by its published "Risk Assessment Guid- ance for Superfund" and agency memoranda related thereto. The vari- ous Superfund stakeholders have not participated in developing this risk assessment guidance; it has not been subjected to public notice and com- ment.

Accordingly, under the bill, EPA would be required to develop and promulgate by rule a new National Risk Protocol that will govern all the uses of risk assessment in Superfund, including the formulaic approach to setting cleanup standards. Like the rulemaking that will establish the new national goals for Superfund cleanups, the risk protocol rulemak- ing will be consensus-based, con- ducted pursuant to the Negotiated Rulemaking Act. During this negoti- ated rulemaking process, issues con- cerning "realistic" assumptions about risks to human health and the envi- ronment and under what circum- stances to use site-specific risk as- sessment to set cleanup levels would be debated and resolved in the ap- propriate technical context.

The bill also would require that the national risk protocol establish guidelines "by which protective con- centration levels are established, which result in final protection at the 90th exposure percentile of the af- fected population defined by the Presi- dent." This language will provide protection for all the nation's citizens and concerns itself with establish-

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CUBRENT REGVIATORY 1-

ing reasonable estimates of high-end exposure that do not exaggerate the risks by inappropriately compound- ing multiple conservative assump- tions. This does not mean the naked person standing at the facility fence line breathing contaminated air for 70 years. Rather, the bill calls for the consideration of plausible high- end exposure, not the highest pos- sible hypothetical, worst-case expo- sure.

Federal lawmakers intend that the new risk protocol will create greater consistency and predictabil- ity in the way risks are estimated at Superfund facilities and provide greater understanding of those esti- mates and how they are used to ensure that protection is achieved.

FEDERAL AND STATE ARARS The bill would substantially alter

the way cleanup standards are set under current law. Under the bill’s remedy selection process, the federal and state A R A B requirements have been streamlined but not eliminated. In particular, Superfund cleanups will no longer be held to nonapplicable (“relevant and appropriate”) federal requirements (though EPA may still choose to use nonapplicable stan- dards as a reference point in deter- mining what is protective under the circumstances of the facility). Fur- thermore, the legislation distinguishes between the applicable law that re- lates to the conduct and operation of the remedy, and requirements hav- ing to do with the level of cleanup to be attained, or cleanup levels.

Under the bill, other federal laws generally would not be looked to as a source of cleanup level-type stan- dards. Instead, the program will rely on the protective concentration lev- els established under the formulaic

approach and the Safe Drinking wa- ter Act standards that are made appli- cable to groundwater cleanups by the committee amendment. However, Superfund cleanups would have to comply with those federal require- ments that are applicable to the con- duct or operation of a remedy (such as laws that regulate emissions Or

discharges from treatment units, limit activities conducted in wetlands, or regulate the design and construction of disposal units). More stringentstate standards that are legally applicable either to a cleanup level or the con- duct or operation of a remedy will continue to apply.

The requirement of current law that remedies selected by EPA com- ply with state environmental stan- dards that are more stringent than the comparable federal standards has been an important element of the Superfund reauthorization de- bate. It has been argued that requir- ing federal Superfund cleanups to meet state “relevant and appropriate” cleanup standards (as opposed to legally applicable state standards) results in higher costs for cleanup and dissimilarity of remedies across the nation for comparable sites, and turns a federal program into one capable of being directed by indi- vidual states. Local citizens, how- ever, who are concerned that EPA’S federal bureaucracy is often insensi- tive to their needs, and environmen- talists who have pointed to rem- edies they believe are inadequately protective of human health and the environment have taken issue with the argument that state relevant and appropriate standards are at fault.

The states believe very StrondY in their responsibility to protect their citizens through enforcement of their

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cleanup standards when these are more stringent than the comparable federal standards. However, the bill recognizes the need to streamline the ARARs process. Accordingly, under the bill, federal Superfund cleanups would no longer be required to com- ply with state relevant and appropri- ate requirements except when a state demonstrates that such requirements are consistently applied to remedial actions under state law, and makes a determination pursuant to a promul- gation process that includes public notice and comment and opportunity for judicial review, that such require- ments apply to remedial actions. In addition, a state must identify to the President in a timely manner each state standard that the state intends to apply to a cleanup at a facility, pub- lish a comprehensive list of all the standards that the state intends to apply to a cleanup at a facility, pub- lish a comprehensive list of all the standards that the state may apply to remedial actions, and revise the list periodically or as requested by the President.

GROUNDWATER In the United States, 50 percent of

the population relies on groundwater for dr i i ing water, including 97 per- cent of rural America and more than one-third of the 100 largest U.S. cities. The main source of water in an esti- mated 50 percent of our nation’s lakes is groundwater, not surface water.

Recognizing the importance of groundwater as a national resource, the bill codifies current EPA policy with respeato deanupstandards forground- water remediation. This policy speci- fies maximum contaminant levels and maximum contaminant level goals (when these are set at levels higher than zero) established under the Safe Drinking Water Act as the cleanup standards for groundwater or surface waters that may be used for drii ing water or are hydraulically connected to current or potential sources of drinking water. In adopting this policy, the bill rejected the contention that only groundwater that is actually being used, or is currently planned for use, as a drinking water source is appropriate for restoration.

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