[Code of Federal Regulations]
[Title 40 Volume 25]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR300.430]

[Page 66-77]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 300--NATIONAL OIL AND HAZARDOUS SUBSTANCES POLLUTION CONTINGENCY PLAN--
Table of Contents
 
                 Subpart E--Hazardous Substance Response
 
Sec. 300.430  Remedial investigation/feasibility study and selection of remedy.

    (a) General--(1) Introduction. The purpose of the remedy selection 
process is to implement remedies that eliminate, reduce, or control 
risks to human health and the environment. Remedial actions are to be 
implemented as soon as site data and information make it possible to do 
so. Accordingly, EPA has established the following program goal, 
expectations, and program management principles to assist in the 
identification and implementation of appropriate remedial actions.
    (i) Program goal. The national goal of the remedy selection process 
is to select remedies that are protective of human health and the 
environment, that maintain protection over time, and that minimize 
untreated waste.
    (ii) Program management principles. EPA generally shall consider the 
following general principles of program management during the remedial 
process:
    (A) Sites should generally be remediated in operable units when 
early actions are necessary or appropriate to achieve significant risk 
reduction quickly, when phased analysis and response is necessary or 
appropriate given the size or complexity of the site, or to expedite the 
completion of total site cleanup.
    (B) Operable units, including interim action operable units, should 
not be inconsistent with nor preclude implementation of the expected 
final remedy.
    (C) Site-specific data needs, the evaluation of alternatives, and 
the documentation of the selected remedy should reflect the scope and 
complexity of the site problems being addressed.
    (iii) Expectations. EPA generally shall consider the following 
expectations in developing appropriate remedial alternatives:
    (A) EPA expects to use treatment to address the principal threats 
posed by a site, wherever practicable. Principal threats for which 
treatment is most likely to be appropriate include liquids, areas 
contaminated with high concentrations of toxic compounds, and highly 
mobile materials.
    (B) EPA expects to use engineering controls, such as containment, 
for waste that poses a relatively low long-term threat or where 
treatment is impracticable.

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    (C) EPA expects to use a combination of methods, as appropriate, to 
achieve protection of human health and the environment. In appropriate 
site situations, treatment of the principal threats posed by a site, 
with priority placed on treating waste that is liquid, highly toxic or 
highly mobile, will be combined with engineering controls (such as 
containment) and institutional controls, as appropriate, for treatment 
residuals and untreated waste.
    (D) EPA expects to use institutional controls such as water use and 
deed restrictions to supplement engineering controls as appropriate for 
short- and long-term management to prevent or limit exposure to 
hazardous substances, pollutants, or contaminants. Institutional 
controls may be used during the conduct of the remedial investigation/
feasibility study (RI/FS) and implementation of the remedial action and, 
where necessary, as a component of the completed remedy. The use of 
institutional controls shall not substitute for active response measures 
(e.g., treatment and/or containment of source material, restoration of 
ground waters to their beneficial uses) as the sole remedy unless such 
active measures are determined not to be practicable, based on the 
balancing of trade-offs among alternatives that is conducted during the 
selection of remedy.
    (E) EPA expects to consider using innovative technology when such 
technology offers the potential for comparable or superior treatment 
performance or implementability, fewer or lesser adverse impacts than 
other available approaches, or lower costs for similar levels of 
performance than demonstrated technologies.
    (F) EPA expects to return usable ground waters to their beneficial 
uses wherever practicable, within a timeframe that is reasonable given 
the particular circumstances of the site. When restoration of ground 
water to beneficial uses is not practicable, EPA expects to prevent 
further migration of the plume, prevent exposure to the contaminated 
ground water, and evaluate further risk reduction.
    (2) Remedial investigation/feasibility study. The purpose of the 
remedial investigation/feasibility study (RI/FS) is to assess site 
conditions and evaluate alternatives to the extent necessary to select a 
remedy. Developing and conducting an RI/FS generally includes the 
following activities: project scoping, data collection, risk assessment, 
treatability studies, and analysis of alternatives. The scope and timing 
of these activities should be tailored to the nature and complexity of 
the problem and the response alternatives being considered.
    (b) Scoping. In implementing this section, the lead agency should 
consider the program goal, program management principles, and 
expectations contained in this rule. The investigative and analytical 
studies should be tailored to site circumstances so that the scope and 
detail of the analysis is appropriate to the complexity of site problems 
being addressed. During scoping, the lead and support agencies shall 
confer to identify the optimal set and sequence of actions necessary to 
address site problems. Specifically, the lead agency shall:
    (1) Assemble and evaluate existing data on the site, including the 
results of any removal actions, remedial preliminary assessment and site 
inspections, and the NPL listing process.
    (2) Develop a conceptual understanding of the site based on the 
evaluation of existing data described in paragraph (b)(1) of this 
section.
    (3) Identify likely response scenarios and potentially applicable 
technologies and operable units that may address site problems.
    (4) Undertake limited data collection efforts or studies where this 
information will assist in scoping the RI/FS or accelerate response 
actions, and begin to identify the need for treatability studies, as 
appropriate.
    (5) Identify the type, quality, and quantity of the data that will 
be collected during the RI/FS to support decisions regarding remedial 
response activities.
    (6) Prepare site-specific health and safety plans that shall 
specify, at a minimum, employee training and protective equipment, 
medical surveillance requirements, standard operating procedures, and a 
contingency plan

[[Page 68]]

that conforms with 29 CFR 1910.120 (l)(1) and (l)(2).
    (7) If natural resources are or may be injured by the release, 
ensure that state and federal trustees of the affected natural resources 
have been notified in order that the trustees may initiate appropriate 
actions, including those identified in subpart G of this part. The lead 
agency shall seek to coordinate necessary assessments, evaluations, 
investigations, and planning with such state and federal trustees.
    (8) Develop sampling and analysis plans that shall provide a process 
for obtaining data of sufficient quality and quantity to satisfy data 
needs. Sampling and analysis plans shall be reviewed and approved by 
EPA. The sampling and analysis plans shall consist of two parts:
    (i) The field sampling plan, which describes the number, type, and 
location of samples and the type of analyses; and
    (ii) The quality assurance project plan, which describes policy, 
organization, and functional activities and the data quality objectives 
and measures necessary to achieve adequate data for use in selecting the 
appropriate remedy.
    (9) Initiate the identification of potential federal and state ARARs 
and, as appropriate, other criteria, advisories, or guidance to be 
considered.
    (c) Community relations. (1) The community relations requirements 
described in this section apply to all remedial activities undertaken 
pursuant to CERCLA section 104 and to section 106 or section 122 consent 
orders or decrees, or section 106 administrative orders.
    (2) The lead agency shall provide for the conduct of the following 
community relations activities, to the extent practicable, prior to 
commencing field work for the remedial investigation:
    (i) Conducting interviews with local officials, community residents, 
public interest groups, or other interested or affected parties, as 
appropriate, to solicit their concerns and information needs, and to 
learn how and when citizens would like to be involved in the Superfund 
process.
    (ii) Preparing a formal community relations plan (CRP), based on the 
community interviews and other relevant information, specifying the 
community relations activities that the lead agency expects to undertake 
during the remedial response. The purpose of the CRP is to:
    (A) Ensure the public appropriate opportunities for involvement in a 
wide variety of site-related decisions, including site analysis and 
characterization, alternatives analysis, and selection of remedy;
    (B) Determine, based on community interviews, appropriate activities 
to ensure such public involvement, and
    (C) Provide appropriate opportunities for the community to learn 
about the site.
    (iii) Establishing at least one local information repository at or 
near the location of the response action. Each information repository 
should contain a copy of items made available to the public, including 
information that describes the technical assistance grants application 
process. The lead agency shall inform interested parties of the 
establishment of the information repository.
    (iv) Informing the community of the availability of technical 
assistance grants.
    (3) For PRP actions, the lead agency shall plan and implement the 
community relations program at a site. PRPs may participate in aspects 
of the community relations program at the discretion of and with 
oversight by the lead agency.
    (4) The lead agency may conduct technical discussions involving PRPs 
and the public. These technical discussions may be held separately from, 
but contemporaneously with, the negotiations/settlement discussions.
    (5) In addition, the following provisions specifically apply to 
enforcement actions:
    (i) Lead agencies entering into an enforcement agreement with de 
minimis parties under CERCLA section 122(g) or cost recovery settlements 
under section 122(h) shall publish a notice of the proposed agreement in 
the Federal Register at least 30 days before the agreement becomes 
final, as required

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by section 122(i). The notice must identify the name of the facility and 
the parties to the proposed agreement and must allow an opportunity for 
comment and consideration of comments; and
    (ii) Where the enforcement agreement is embodied in a consent 
decree, public notice and opportunity for public comment shall be 
provided in accordance with 28 CFR 50.7.
    (d) Remedial investigation. (1) The purpose of the remedial 
investigation (RI) is to collect data necessary to adequately 
characterize the site for the purpose of developing and evaluating 
effective remedial alternatives. To characterize the site, the lead 
agency shall, as appropriate, conduct field investigations, including 
treatability studies, and conduct a baseline risk assessment. The RI 
provides information to assess the risks to human health and the 
environment and to support the development, evaluation, and selection of 
appropriate response alternatives. Site characterization may be 
conducted in one or more phases to focus sampling efforts and increase 
the efficiency of the investigation. Because estimates of actual or 
potential exposures and associated impacts on human and environmental 
receptors may be refined throughout the phases of the RI as new 
information is obtained, site characterization activities should be 
fully integrated with the development and evaluation of alternatives in 
the feasibility study. Bench- or pilot-scale treatability studies shall 
be conducted, when appropriate and practicable, to provide additional 
data for the detailed analysis and to support engineering design of 
remedial alternatives.
    (2) The lead agency shall characterize the nature of and threat 
posed by the hazardous substances and hazardous materials and gather 
data necessary to assess the extent to which the release poses a threat 
to human health or the environment or to support the analysis and design 
of potential response actions by conducting, as appropriate, field 
investigations to assess the following factors:
    (i) Physical characteristics of the site, including important 
surface features, soils, geology, hydrogeology, meteorology, and 
ecology;
    (ii) Characteristics or classifications of air, surface water, and 
ground water;
    (iii) The general characteristics of the waste, including 
quantities, state, concentration, toxicity, propensity to bioaccumulate, 
persistence, and mobility;
    (iv) The extent to which the source can be adequately identified and 
characterized;
    (v) Actual and potential exposure pathways through environmental 
media;
    (vi) Actual and potential exposure routes, for example, inhalation 
and ingestion; and
    (vii) Other factors, such as sensitive populations, that pertain to 
the characterization of the site or support the analysis of potential 
remedial action alternatives.
    (3) The lead and support agency shall identify their respective 
potential ARARs related to the location of and contaminants at the site 
in a timely manner. The lead and support agencies may also, as 
appropriate, identify other pertinent advisories, criteria, or guidance 
in a timely manner (see Sec. 300.400(g)(3)).
    (4) Using the data developed under paragraphs (d)(1) and (2) of this 
section, the lead agency shall conduct a site-specific baseline risk 
assessment to characterize the current and potential threats to human 
health and the environment that may be posed by contaminants migrating 
to ground water or surface water, releasing to air, leaching through 
soil, remaining in the soil, and bioaccumulating in the food chain. The 
results of the baseline risk assessment will help establish acceptable 
exposure levels for use in developing remedial alternatives in the FS, 
as described in paragraph (e) of this section.
    (e) Feasibility study. (1) The primary objective of the feasibility 
study (FS) is to ensure that appropriate remedial alternatives are 
developed and evaluated such that relevant information concerning the 
remedial action options can be presented to a decision-maker and an 
appropriate remedy selected. The lead agency may develop a feasibility 
study to address a specific site problem or the entire site. The 
development and evaluation of alternatives

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shall reflect the scope and complexity of the remedial action under 
consideration and the site problems being addressed. Development of 
alternatives shall be fully integrated with the site characterization 
activities of the remedial investigation described in paragraph (d) of 
this section. The lead agency shall include an alternatives screening 
step, when needed, to select a reasonable number of alternatives for 
detailed analysis.
    (2) Alternatives shall be developed that protect human health and 
the environment by recycling waste or by eliminating, reducing, and/or 
controlling risks posed through each pathway by a site. The number and 
type of alternatives to be analyzed shall be determined at each site, 
taking into account the scope, characteristics, and complexity of the 
site problem that is being addressed. In developing and, as appropriate, 
screening the alternatives, the lead agency shall:
    (i) Establish remedial action objectives specifying contaminants and 
media of concern, potential exposure pathways, and remediation goals. 
Initially, preliminary remediation goals are developed based on readily 
available information, such as chemical-specific ARARs or other reliable 
information. Preliminary remediation goals should be modified, as 
necessary, as more information becomes available during the RI/FS. Final 
remediation goals will be determined when the remedy is selected. 
Remediation goals shall establish acceptable exposure levels that are 
protective of human health and the environment and shall be developed by 
considering the following:
    (A) Applicable or relevant and appropriate requirements under 
federal environmental or state environmental or facility siting laws, if 
available, and the following factors:
    (1) For systemic toxicants, acceptable exposure levels shall 
represent concentration levels to which the human population, including 
sensitive subgroups, may be exposed without adverse effect during a 
lifetime or part of a lifetime, incorporating an adequate margin of 
safety;
    (2) For known or suspected carcinogens, acceptable exposure levels 
are generally concentration levels that represent an excess upper bound 
lifetime cancer risk to an individual of between 10-4 and 
10-6 using information on the relationship between dose and 
response. The 10-6 risk level shall be used as the point of 
departure for determining remediation goals for alternatives when ARARs 
are not available or are not sufficiently protective because of the 
presence of multiple contaminants at a site or multiple pathways of 
exposure;
    (3) Factors related to technical limitations such as detection/
quantification limits for contaminants;
    (4) Factors related to uncertainty; and
    (5) Other pertinent information.
    (B) Maximum contaminant level goals (MCLGs), established under the 
Safe Drinking Water Act, that are set at levels above zero, shall be 
attained by remedial actions for ground or surface waters that are 
current or potential sources of drinking water, where the MCLGs are 
relevant and appropriate under the circumstances of the release based on 
the factors in Sec. 300.400(g)(2). If an MCLG is determined not to be 
relevant and appropriate, the corresponding maximum contaminant level 
(MCL) shall be attained where relevant and appropriate to the 
circumstances of the release.
    (C) Where the MCLG for a contaminant has been set at a level of 
zero, the MCL promulgated for that contaminant under the Safe Drinking 
Water Act shall be attained by remedial actions for ground or surface 
waters that are current or potential sources of drinking water, where 
the MCL is relevant and appropriate under the circumstances of the 
release based on the factors in Sec. 300.400(g)(2).
    (D) In cases involving multiple contaminants or pathways where 
attainment of chemical-specific ARARs will result in cumulative risk in 
excess of 10-4, criteria in paragraph (e)(2)(i)(A) of this 
section may also be considered when determining the cleanup level to be 
attained.
    (E) Water quality criteria established under sections 303 or 304 of 
the Clean Water Act shall be attained where relevant and appropriate 
under the circumstances of the release.

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    (F) An alternate concentration limit (ACL) may be established in 
accordance with CERCLA section 121(d)(2)(B)(ii).
    (G) Environmental evaluations shall be performed to assess threats 
to the environment, especially sensitive habitats and critical habitats 
of species protected under the Endangered Species Act.
    (ii) Identify and evaluate potentially suitable technologies, 
including innovative technologies;
    (iii) Assemble suitable technologies into alternative remedial 
actions.
    (3) For source control actions, the lead agency shall develop, as 
appropriate:
    (i) A range of alternatives in which treatment that reduces the 
toxicity, mobility, or volume of the hazardous substances, pollutants, 
or contaminants is a principal element. As appropriate, this range shall 
include an alternative that removes or destroys hazardous substances, 
pollutants, or contaminants to the maximum extent feasible, eliminating 
or minimizing, to the degree possible, the need for long-term 
management. The lead agency also shall develop, as appropriate, other 
alternatives which, at a minimum, treat the principal threats posed by 
the site but vary in the degree of treatment employed and the quantities 
and characteristics of the treatment residuals and untreated waste that 
must be managed; and
    (ii) One or more alternatives that involve little or no treatment, 
but provide protection of human health and the environment primarily by 
preventing or controlling exposure to hazardous substances, pollutants, 
or contaminants, through engineering controls, for example, containment, 
and, as necessary, institutional controls to protect human health and 
the environment and to assure continued effectiveness of the response 
action.
    (4) For ground-water response actions, the lead agency shall develop 
a limited number of remedial alternatives that attain site-specific 
remediation levels within different restoration time periods utilizing 
one or more different technologies.
    (5) The lead agency shall develop one or more innovative treatment 
technologies for further consideration if those technologies offer the 
potential for comparable or superior performance or implementability; 
fewer or lesser adverse impacts than other available approaches; or 
lower costs for similar levels of performance than demonstrated 
treatment technologies.
    (6) The no-action alternative, which may be no further action if 
some removal or remedial action has already occurred at the site, shall 
be developed.
    (7) As appropriate, and to the extent sufficient information is 
available, the short- and long-term aspects of the following three 
criteria shall be used to guide the development and screening of 
remedial alternatives:
    (i) Effectiveness. This criterion focuses on the degree to which an 
alternative reduces toxicity, mobility, or volume through treatment, 
minimizes residual risks and affords long-term protection, complies with 
ARARs, minimizes short-term impacts, and how quickly it achieves 
protection. Alternatives providing significantly less effectiveness than 
other, more promising alternatives may be eliminated. Alternatives that 
do not provide adequate protection of human health and the environment 
shall be eliminated from further consideration.
    (ii) Implementability. This criterion focuses on the technical 
feasibility and availability of the technologies each alternative would 
employ and the administrative feasibility of implementing the 
alternative. Alternatives that are technically or administratively 
infeasible or that would require equipment, specialists, or facilities 
that are not available within a reasonable period of time may be 
eliminated from further consideration.
    (iii) Cost. The costs of construction and any long-term costs to 
operate and maintain the alternatives shall be considered. Costs that 
are grossly excessive compared to the overall effectiveness of 
alternatives may be considered as one of several factors used to 
eliminate alternatives. Alternatives providing effectiveness and 
implementability similar to that of another alternative by employing a 
similar method of treatment or engineering control, but at greater cost, 
may be eliminated.

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    (8) The lead agency shall notify the support agency of the 
alternatives that will be evaluated in detail to facilitate the 
identification of ARARs and, as appropriate, pertinent advisories, 
criteria, or guidance to be considered.
    (9) Detailed analysis of alternatives. (i) A detailed analysis shall 
be conducted on the limited number of alternatives that represent viable 
approaches to remedial action after evaluation in the screening stage. 
The lead and support agencies must identify their ARARs related to 
specific actions in a timely manner and no later than the early stages 
of the comparative analysis. The lead and support agencies may also, as 
appropriate, identify other pertinent advisories, criteria, or guidance 
in a timely manner.
    (ii) The detailed analysis consists of an assessment of individual 
alternatives against each of nine evaluation criteria and a comparative 
analysis that focuses upon the relative performance of each alternative 
against those criteria.
    (iii) Nine criteria for evaluation. The analysis of alternatives 
under review shall reflect the scope and complexity of site problems and 
alternatives being evaluated and consider the relative significance of 
the factors within each criteria. The nine evaluation criteria are as 
follows:
    (A) Overall protection of human health and the environment. 
Alternatives shall be assessed to determine whether they can adequately 
protect human health and the environment, in both the short- and long-
term, from unacceptable risks posed by hazardous substances, pollutants, 
or contaminants present at the site by eliminating, reducing, or 
controlling exposures to levels established during development of 
remediation goals consistent with Sec. 300.430(e)(2)(i). Overall 
protection of human health and the environment draws on the assessments 
of other evaluation criteria, especially long-term effectiveness and 
permanence, short-term effectiveness, and compliance with ARARs.
    (B) Compliance with ARARs. The alternatives shall be assessed to 
determine whether they attain applicable or relevant and appropriate 
requirements under federal environmental laws and state environmental or 
facility siting laws or provide grounds for invoking one of the waivers 
under paragraph (f)(1)(ii)(C) of this section.
    (C) Long-term effectiveness and permanence. Alternatives shall be 
assessed for the long-term effectiveness and permanence they afford, 
along with the degree of certainty that the alternative will prove 
successful. Factors that shall be considered, as appropriate, include 
the following:
    (1) Magnitude of residual risk remaining from untreated waste or 
treatment residuals remaining at the conclusion of the remedial 
activities. The characteristics of the residuals should be considered to 
the degree that they remain hazardous, taking into account their volume, 
toxicity, mobility, and propensity to bioaccumulate.
    (2) Adequacy and reliability of controls such as containment systems 
and institutional controls that are necessary to manage treatment 
residuals and untreated waste. This factor addresses in particular the 
uncertainties associated with land disposal for providing long-term 
protection from residuals; the assessment of the potential need to 
replace technical components of the alternative, such as a cap, a slurry 
wall, or a treatment system; and the potential exposure pathways and 
risks posed should the remedial action need replacement.
    (D) Reduction of toxicity, mobility, or volume through treatment. 
The degree to which alternatives employ recycling or treatment that 
reduces toxicity, mobility, or volume shall be assessed, including how 
treatment is used to address the principal threats posed by the site. 
Factors that shall be considered, as appropriate, include the following:
    (1) The treatment or recycling processes the alternatives employ and 
materials they will treat;
    (2) The amount of hazardous substances, pollutants, or contaminants 
that will be destroyed, treated, or recycled;
    (3) The degree of expected reduction in toxicity, mobility, or 
volume of the waste due to treatment or recycling and the specification 
of which reduction(s) are occurring;
    (4) The degree to which the treatment is irreversible;

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    (5) The type and quantity of residuals that will remain following 
treatment, considering the persistence, toxicity, mobility, and 
propensity to bioaccumulate of such hazardous substances and their 
constituents; and
    (6) The degree to which treatment reduces the inherent hazards posed 
by principal threats at the site.
    (E) Short-term effectiveness. The short-term impacts of alternatives 
shall be assessed considering the following:
    (1) Short-term risks that might be posed to the community during 
implementation of an alternative;
    (2) Potential impacts on workers during remedial action and the 
effectiveness and reliability of protective measures;
    (3) Potential environmental impacts of the remedial action and the 
effectiveness and reliability of mitigative measures during 
implementation; and
    (4) Time until protection is achieved.
    (F) Implementability. The ease or difficulty of implementing the 
alternatives shall be assessed by considering the following types of 
factors as appropriate:
    (1) Technical feasibility, including technical difficulties and 
unknowns associated with the construction and operation of a technology, 
the reliability of the technology, ease of undertaking additional 
remedial actions, and the ability to monitor the effectiveness of the 
remedy.
    (2) Administrative feasibility, including activities needed to 
coordinate with other offices and agencies and the ability and time 
required to obtain any necessary approvals and permits from other 
agencies (for off-site actions);
    (3) Availability of services and materials, including the 
availability of adequate off-site treatment, storage capacity, and 
disposal capacity and services; the availability of necessary equipment 
and specialists, and provisions to ensure any necessary additional 
resources; the availability of services and materials; and availability 
of prospective technologies.
    (G) Cost. The types of costs that shall be assessed include the 
following:
    (1) Capital costs, including both direct and indirect costs;
    (2) Annual operation and maintenance costs; and
    (3) Net present value of capital and O&M costs.
    (H) State acceptance. Assessment of state concerns may not be 
completed until comments on the RI/FS are received but may be discussed, 
to the extent possible, in the proposed plan issued for public comment. 
The state concerns that shall be assessed include the following:
    (1) The state's position and key concerns related to the preferred 
alternative and other alternatives; and
    (2) State comments on ARARs or the proposed use of waivers.
    (I) Community acceptance. This assessment includes determining which 
components of the alternatives interested persons in the community 
support, have reservations about, or oppose. This assessment may not be 
completed until comments on the proposed plan are received.
    (f) Selection of remedy--(1) Remedies selected shall reflect the 
scope and purpose of the actions being undertaken and how the action 
relates to long-term, comprehensive response at the site.
    (i) The criteria noted in paragraph (e)(9)(iii) of this section are 
used to select a remedy. These criteria are categorized into three 
groups.
    (A) Threshold criteria. Overall protection of human health and the 
environment and compliance with ARARs (unless a specific ARAR is waived) 
are threshold requirements that each alternative must meet in order to 
be eligible for selection.
    (B) Primary balancing criteria. The five primary balancing criteria 
are long-term effectiveness and permanence; reduction of toxicity, 
mobility, or volume through treatment; short-term effectiveness; 
implementability; and cost.I11(C) Modifying criteria. State and 
community acceptance are modifying criteria that shall be considered in 
remedy selection.
    (ii) The selection of a remedial action is a two-step process and 
shall proceed in accordance with Sec. 300.515(e). First, the lead 
agency, in conjunction with the support agency, identifies a preferred 
alternative and presents it to the public in a proposed plan, for review 
and comment. Second, the lead

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agency shall review the public comments and consult with the state (or 
support agency) in order to determine if the alternative remains the 
most appropriate remedial action for the site or site problem. The lead 
agency, as specified in Sec. 300.515(e), makes the final remedy 
selection decision, which shall be documented in the ROD. Each remedial 
alternative selected as a Superfund remedy will employ the criteria as 
indicated in paragraph (f)(1)(i) of this section to make the following 
determination:
    (A) Each remedial action selected shall be protective of human 
health and the environment.
    (B) On-site remedial actions selected in a ROD must attain those 
ARARs that are identified at the time of ROD signature or provide 
grounds for invoking a waiver under Sec. 300.430(f)(1)(ii)(C).
    (1) Requirements that are promulgated or modified after ROD 
signature must be attained (or waived) only when determined to be 
applicable or relevant and appropriate and necessary to ensure that the 
remedy is protective of human health and the environment.
    (2) Components of the remedy not described in the ROD must attain 
(or waive) requirements that are identified as applicable or relevant 
and appropriate at the time the amendment to the ROD or the explanation 
of significant difference describing the component is signed.
    (C) An alternative that does not meet an ARAR under federal 
environmental or state environmental or facility siting laws may be 
selected under the following circumstances:
    (1) The alternative is an interim measure and will become part of a 
total remedial action that will attain the applicable or relevant and 
appropriate federal or state requirement;
    (2) Compliance with the requirement will result in greater risk to 
human health and the environment than other alternatives;
    (3) Compliance with the requirement is technically impracticable 
from an engineering perspective;
    (4) The alternative will attain a standard of performance that is 
equivalent to that required under the otherwise applicable standard, 
requirement, or limitation through use of another method or approach;
    (5) With respect to a state requirement, the state has not 
consistently applied, or demonstrated the intention to consistently 
apply, the promulgated requirement in similar circumstances at other 
remedial actions within the state; or
    (6) For Fund-financed response actions only, an alternative that 
attains the ARAR will not provide a balance between the need for 
protection of human health and the environment at the site and the 
availability of Fund monies to respond to other sites that may present a 
threat to human health and the environment.
    (D) Each remedial action selected shall be cost-effective, provided 
that it first satisfies the threshold criteria set forth in 
Sec. 300.430(f)(1)(ii)(A) and (B). Cost-effectiveness is determined by 
evaluating the following three of the five balancing criteria noted in 
Sec. 300.430(f)(1)(i)(B) to determine overall effectiveness: long-term 
effectiveness and permanence, reduction of toxicity, mobility, or volume 
through treatment, and short-term effectiveness. Overall effectiveness 
is then compared to cost to ensure that the remedy is cost-effective. A 
remedy shall be cost-effective if its costs are proportional to its 
overall effectiveness.
    (E) Each remedial action shall utilize permanent solutions and 
alternative treatment technologies or resource recovery technologies to 
the maximum extent practicable. This requirement shall be fulfilled by 
selecting the alternative that satisfies paragraph (f)(1)(ii)(A) and (B) 
of this section and provides the best balance of trade-offs among 
alternatives in terms of the five primary balancing criteria noted in 
paragraph (f)(1)(i)(B) of this section. The balancing shall emphasize 
long-term effectiveness and reduction of toxicity, mobility, or volume 
through treatment. The balancing shall also consider the preference for 
treatment as a principal element and the bias against off-site land 
disposal of untreated waste. In making the determination under this 
paragraph, the modifying criteria of state acceptance and community 
acceptance described

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in paragraph (f)(1)(i)(C) of this section shall also be considered.
    (2) The proposed plan. In the first step in the remedy selection 
process, the lead agency shall identify the alternative that best meets 
the requirements in Sec. 300.430(f)(1), above, and shall present that 
alternative to the public in a proposed plan. The lead agency, in 
conjunction with the support agency and consistent with Sec. 300.515(e), 
shall prepare a proposed plan that briefly describes the remedial 
alternatives analyzed by the lead agency, proposes a preferred remedial 
action alternative, and summarizes the information relied upon to select 
the preferred alternative. The selection of remedy process for an 
operable unit may be initiated at any time during the remedial action 
process. The purpose of the proposed plan is to supplement the RI/FS and 
provide the public with a reasonable opportunity to comment on the 
preferred alternative for remedial action, as well as alternative plans 
under consideration, and to participate in the selection of remedial 
action at a site. At a minimum, the proposed plan shall:
    (i) Provide a brief summary description of the remedial alternatives 
evaluated in the detailed analysis established under paragraph (e)(9) of 
this section;
    (ii) Identify and provide a discussion of the rationale that 
supports the preferred alternative;
    (iii) Provide a summary of any formal comments received from the 
support agency; and
    (iv) Provide a summary explanation of any proposed waiver identified 
under paragraph (f)(1)(ii)(C) of this section from an ARAR.
    (3) Community relations to support the selection of remedy. (i) The 
lead agency, after preparation of the proposed plan and review by the 
support agency, shall conduct the following activities:
    (A) Publish a notice of availability and brief analysis of the 
proposed plan in a major local newspaper of general circulation;
    (B) Make the proposed plan and supporting analysis and information 
available in the administrative record required under subpart I of this 
part;
    (C) Provide a reasonable opportunity, not less than 30 calendar 
days, for submission of written and oral comments on the proposed plan 
and the supporting analysis and information located in the information 
repository, including the RI/FS. Upon timely request, the lead agency 
will extend the public comment period by a minimum of 30 additional 
days;
    (D) Provide the opportunity for a public meeting to be held during 
the public comment period at or near the site at issue regarding the 
proposed plan and the supporting analysis and information;
    (E) Keep a transcript of the public meeting held during the public 
comment period pursuant to CERCLA section 117(a) and make such 
transcript available to the public; and
    (F) Prepare a written summary of significant comments, criticisms, 
and new relevant information submitted during the public comment period 
and the lead agency response to each issue. This responsiveness summary 
shall be made available with the record of decision.
    (ii) After publication of the proposed plan and prior to adoption of 
the selected remedy in the record of decision, if new information is 
made available that significantly changes the basic features of the 
remedy with respect to scope, performance, or cost, such that the remedy 
significantly differs from the original proposal in the proposed plan 
and the supporting analysis and information, the lead agency shall:
    (A) Include a discussion in the record of decision of the 
significant changes and reasons for such changes, if the lead agency 
determines such changes could be reasonably anticipated by the public 
based on the alternatives and other information available in the 
proposed plan or the supporting analysis and information in the 
administrative record; or
    (B) Seek additional public comment on a revised proposed plan, when 
the lead agency determines the change could not have been reasonably 
anticipated by the public based on the information available in the 
proposed plan or the supporting analysis and information in the 
administrative record. The lead agency shall, prior to adoption of the 
selected remedy in the ROD, issue a revised proposed plan, which

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shall include a discussion of the significant changes and the reasons 
for such changes, in accordance with the public participation 
requirements described in paragraph (f)(3)(i) of this section.
    (4) Final remedy selection. (i) In the second and final step in the 
remedy selection process, the lead agency shall reassess its initial 
determination that the preferred alternative provides the best balance 
of trade-offs, now factoring in any new information or points of view 
expressed by the state (or support agency) and community during the 
public comment period. The lead agency shall consider state (or support 
agency) and community comments regarding the lead agency's evaluation of 
alternatives with respect to the other criteria. These comments may 
prompt the lead agency to modify aspects of the preferred alternative or 
decide that another alternative provides a more appropriate balance. The 
lead agency, as specified in Sec. 300.515(e), shall make the final 
remedy selection decision and document that decision in the ROD.
    (ii) If a remedial action is selected that results in hazardous 
substances, pollutants, or contaminants remaining at the site above 
levels that allow for unlimited use and unrestricted exposure, the lead 
agency shall review such action no less often than every five years 
after initiation of the selected remedial action.
    (iii) The process for selection of a remedial action at a federal 
facility on the NPL, pursuant to CERCLA section 120, shall entail:
    (A) Joint selection of remedial action by the head of the relevant 
department, agency, or instrumentality and EPA; or
    (B) If mutual agreement on the remedy is not reached, selection of 
the remedy is made by EPA.
    (5) Documenting the decision. (i) To support the selection of a 
remedial action, all facts, analyses of facts, and site-specific policy 
determinations considered in the course of carrying out activities in 
this section shall be documented, as appropriate, in a record of 
decision, in a level of detail appropriate to the site situation, for 
inclusion in the administrative record required under subpart I of this 
part. Documentation shall explain how the evaluation criteria in 
paragraph (e)(9)(iii) of this section were used to select the remedy.
    (ii) The ROD shall describe the following statutory requirements as 
they relate to the scope and objectives of the action:
    (A) How the selected remedy is protective of human health and the 
environment, explaining how the remedy eliminates, reduces, or controls 
exposures to human and environmental receptors;
    (B) The federal and state requirements that are applicable or 
relevant and appropriate to the site that the remedy will attain;
    (C) The applicable or relevant and appropriate requirements of other 
federal and state laws that the remedy will not meet, the waiver 
invoked, and the justification for invoking the waiver;
    (D) How the remedy is cost-effective, i.e., explaining how the 
remedy provides overall effectiveness proportional to its costs;
    (E) How the remedy utilizes permanent solutions and alternative 
treatment technologies or resource recovery technologies to the maximum 
extent practicable; and
    (F) Whether the preference for remedies employing treatment which 
permanently and significantly reduces the toxicity, mobility, or volume 
of the hazardous substances, pollutants, or contaminants as a principal 
element is or is not satisfied by the selected remedy. If this 
preference is not satisfied, the record of decision must explain why a 
remedial action involving such reductions in toxicity, mobility, or 
volume was not selected.
    (iii) The ROD also shall:
    (A) Indicate, as appropriate, the remediation goals, discussed in 
paragraph (e)(2)(i) of this section, that the remedy is expected to 
achieve. Performance shall be measured at appropriate locations in the 
ground water, surface water, soils, air, and other affected 
environmental media. Measurement relating to the performance of the 
treatment processes and the engineering controls may also be identified, 
as appropriate;

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    (B) Discuss significant changes and the response to comments 
described in paragraph (f)(3)(i)(F) of this section;
    (C) Describe whether hazardous substances, pollutants, or 
contaminants will remain at the site such that a review of the remedial 
action under paragraph (f)(4)(ii) of this section no less often than 
every five years shall be required; and
    (D) When appropriate, provide a commitment for further analysis and 
selection of long-term response measures within an appropriate time-
frame.
    (6) Community relations when the record of decision is signed. After 
the ROD is signed, the lead agency shall:
    (i) Publish a notice of the availability of the ROD in a major local 
newspaper of general circulation; and
    (ii) Make the record of decision available for public inspection and 
copying at or near the facility at issue prior to the commencement of 
any remedial action.