Subpart E -- Hazardous
Substance Response
Sec.
300.400 General. (Not
included)
300.405 Discovery or notification. (Not included)
300.410 Removal site evaluation. (Not included)
300.415 Removal action.
300.420 Remedial site evaluation.
300.425 Establishing remedial
priorities.
300.430 Remedial
investigation/feasibility study and selection of remedy.
300.435 Remedial design/remedial
action, operation and maintenance.
300.440 Procedures for planning and
implementing off-site response actions. (Reserved)
Return to 40 CFR 300 - Main Menu
40 CFR §300.415
(2) For actions where, based on the site evaluation, the lead
agency determines that a removal is appropriate, and that less
than six months exists before on-site removal activity must
begin, the lead agency shall:
(i) Publish a notice of availability of the administrative record
file established pursuant to §300.820 in a major local newspaper
of general circulation within 60 days of initiation of on-site
removal activity;
(ii) Provide a public comment period, as appropriate, of not less
than 30 days from the time the administrative record file is made
available for public inspection, pursuant to §300.820(b)(2); and
(iii) Prepare a written response to significant comments pursuant
to §300.820(b)(3).
(3) For removal actions where on-site action is expected to
extend beyond 120 days from the initiation of on-site removal
activities, the lead agency shall by the end of the 120-day
period:
(i) Conduct interviews with local officials, community residents,
public interest groups, or other interested or affected parties,
as appropriate, to solicit their concerns, information needs, and
how or when citizens would like to be involved in the Superfund
process;
(ii) Prepare 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 response; and
(iii) Establish at least one local information repository at or
near the location of the response action. The information
repository should contain items made available for public
information. Further, an administrative record file established
pursuant to subpart I for all removal actions shall be available
for public inspection in at least one of the repositories. The
lead agency shall inform the public of the establishment of the
information repository and provide notice of availability of the
administrative record file for public review. All items in the
repository shall be available for public inspection and copying.
(4) Where, based on the site evaluation, the lead agency
determines that a removal action is appropriate and that a
planning period of at least six months exists prior to initiation
of the on-site removal activities, the lead agency shall at a
minimum:
(i) Comply with the requirements set forth in paragraphs
(m)(3)(i), (ii), and (iii) of this section, prior to the
completion of the engineering evaluation/cost analysis (EE/CA),
or its equivalent, except that the information repository and the
administrative record file will be established no later than when
the EE/CA approval memorandum is signed;
(ii) Publish a notice of availability and brief description of
the EE/CA in a major local newspaper of general circulation
pursuant to §300.820;
(iii) Provide a reasonable opportunity, not less than 30 calendar
days, for submission of written and oral comments after
completion of the EE/CA pursuant to 300.820(a). Upon timely
request, the lead agency will extend the public comment period by
a minimum of 15 days; and
(iv) Prepare a written response to significant comments pursuant
to §300.820(a).
RETURN TO THE TOP
§300.420
(a) General. The purpose of this section is to describe the
methods, procedures, and criteria the lead agency shall use to
collect data, as required, and evaluate releases of hazardous
substances, pollutants, or contaminants. The evaluation may
consist of two steps: a remedial preliminary assessment (PA) and
a remedial site inspection (SI).
(b) Remedial preliminary assessment. (1) The lead agency shall
perform a remedial PA on all sites in CERCLIS as defined in
§300.5 to:
(i) Eliminate from further consideration those sites that pose no
threat to public health or the environment;
(ii) Determine if there is any potential need for removal action;
(iii) Set priorities for site inspections; and
(iv) Gather existing data to facilitate later evaluation of the
release pursuant to the Hazard Ranking System (HRS) if warranted.
(2) A remedial PA shall consist of a review of existing
information about a release such as information on the pathways
of exposure, exposure targets, and source and nature of release.
A remedial PA shall also include an off-site reconnaissance as
appropriate. A remedial PA may include an on-site reconnaissance
where appropriate.
(3) If the remedial PA indicates that a removal action may be
warranted, the lead agency shall initiate removal evaluation
pursuant to §300.410.
(4) In performing a remedial PA, the lead agency may complete the
EPA Preliminary Assessment form, available from EPA regional
offices, or its equivalent, and shall prepare a PA report, which
shall include:
(i) A description of the release;
(ii) A description of the probable nature of the release; and
(iii) A recommendation on whether further action is warranted,
which lead agency should conduct further action, and whether an
SI or removal action or both should be undertaken.
(5) Any person may petition the lead federal agency (EPA or the
appropriate federal agency in the case of a release or suspected
release from a federal facility), to perform a PA of a release
when such person is, or may be, affected by a release of a
hazardous substance, pollutant, or contaminant. Such petitions
shall be addressed to the EPA Regional Administrator for the
region in which the release is located, except that petitions for
PAs involving federal facilities should be addressed to the head
of the appropriate federal agency.
(i) Petitions shall be signed by the petitioner and shall contain
the following:
(A) The full name, address, and phone number of petitioner;
(B) A description, as precisely as possible, of the location of
the release; and
(C) How the petitioner is or may be affected by the release.
(ii) Petitions should also contain the following information to
the extent available:
(A) What type of substances were or may be released;
(B) The nature of activities that have occurred where the release
is located; and
(C) Whether local and state authorities have been contacted about
the release.
(iii) The lead federal agency shall complete a remedial or
removal PA within one year of the date of receipt of a complete
petition pursuant to paragraph (b)(5) of this section, if one has
not been performed previously, unless the lead federal agency
determines that a PA is not appropriate. Where such a
determination is made, the lead federal agency shall notify the
petitioner and will provide a reason for the determination.
(iv) When determining if performance of a PA is appropriate, the
lead federal agency shall take into consideration:
(A) Whether there is information indicating that a release has
occurred or there is a threat of a release of a hazardous
substance, pollutant, or contaminant; and
(B) Whether the release is eligible for response under CERCLA.
(c) Remedial site inspection. (1) The lead agency shall perform a
remedial SI as appropriate to:
(i) Eliminate from further consideration those releases that pose
no significant threat to public health or the environment;
(ii) Determine the potential need for removal action;
(iii) Collect or develop additional data, as appropriate, to
evaluate the release pursuant to the HRS; and
(iv) Collect data in addition to that required to score the
release pursuant to the HRS, as appropriate, to better
characterize the release for more effective and rapid initiation
of the RI/FS or response under other authorities.
(2) The remedial SI shall build upon the information collected in
the remedial PA. The remedial SI shall involve, as appropriate,
both on- and off-site field investigatory efforts, and sampling.
(3) If the remedial SI indicates that removal action may be
appropriate, the lead agency shall initiate removal site
evaluation pursuant to §300.410.
(4) Prior to conducting field sampling as part of site
inspections, the lead agency shall develop sampling and analysis
plans that shall provide a process for obtaining data of
sufficient quality and quantity to satisfy data needs. The
sampling and analysis plans shall consist of two parts:
(i) The field sampling plan, which describes the number, type,
and of samples, and the type of analyses, and
(ii) The quality assurance project plan (QAPP), which describes
policy, organization, and functional activities, and the data
quality objectives and measures necessary to achieve adequate
data for use in site evaluation and hazard ranking system
activities.
(5) Upon completion of a remedial SI, the lead agency shall
prepare a report that includes the following:
(i) A description/history/nature of waste handling;
(ii) A description of known contaminants;
(iii) A description of pathways of migration of contaminants;
(iv) An identification and description of human and environmental
targets; and
(v) A recommendation on whether further action is warranted.
RETURN TO THE TOP
§300.425
(a) General. The purpose of this section is to identify the
criteria as well as the methods and procedures EPA uses to
establish its priorities for remedial actions.
(b) National Priorities List. The NPL is the list of priority
releases for long-term remedial evaluation and response.
(1) Only those releases included on the NPL shall be considered
eligible for Fund-financed remedial action. Removal actions
(including remedial planning activities, RI/FSs, and other
actions taken pursuant to CERCLA section 104(b)) are not limited
to NPL sites.
(2) Inclusion of a release on the NPL does not imply that monies
will be expended, nor does the rank of a release on the NPL
establish the precise priorities for the allocation of Fund
resources. EPA may also pursue other appropriate authorities to
remedy the release, including enforcement actions under CERCLA
and other laws. A site's rank on the NPL serves, along with other
factors, including enforcement actions, as a basis to guide the
allocation of Fund resources among releases.
(3) Federal facilities that meet the criteria identified in
paragraph (c) of this section are eligible for inclusion on the
NPL. Except as provided by CERCLA sections 111(e)(3) and 111(c),
federal facilities are not eligible for Fund-financed remedial
actions.
(4) Inclusion on the NPL is not a precondition to action by the
lead agency under CERCLA sections 106 or 122 or to action under
CERCLA section 107 for recovery of non-Fund-financed costs or
Fund-financed costs other than Fund-financed remedial
construction costs.
(c) Methods for determining eligibility for NPL. A release may be
included on the NPL if the release meets one of the following
criteria:
(1) The release scores sufficiently high pursuant to the Hazard
Ranking System described in Appendix A to this part.
(2) A state (not including Indian tribes) has designated a
release as its highest priority. States may make only one such
designation; or
(3) The release satisfies all of the following criteria:
(i) The Agency for Toxic Substances and Disease Registry has
issued a health advisory that recommends dissociation of
individuals from the release;
(ii) EPA determines that the release poses a significant threat
to public health; and
(iii) EPA anticipates that it will be more cost-effective to use
its remedial authority than to use removal authority to respond
to the release.
(d) Procedures for placing sites on the NPL. Lead agencies may
submit candidates to EPA by scoring the release using the HRS and
providing the appropriate backup documentation.
(1) Lead agencies may submit HRS scoring packages to EPA anytime
throughout the year.
(2) EPA shall review lead agencies' HRS scoring packages and
revise them as appropriate. EPA shall develop any additional HRS
scoring packages on releases known to EPA.
(3) EPA shall compile the NPL based on the methods identified in
paragraph (c) of this section.
(4) EPA shall update the NPL at least once a year.
(5) To ensure public involvement during the proposal to add a
release to the NPL, EPA shall:
(i) Publish the proposed rule in the Federal Register and solicit
comments through a public comment period; and
(ii) Publish the final rule in the Federal Register, and make
available a response to each significant comment and any
significant new data submitted during the comment period.
(6) Releases may be categorized on the NPL when deemed
appropriate by EPA.
(e) Deletion from the NPL. Releases may be deleted from or
recategorized on the NPL where no further response is
appropriate.
(1) EPA shall consult with the state on proposed deletions from
the NPL prior to developing the notice of intent to delete. In
making a determination to delete a release from the NPL, EPA
shall consider, in consultation with the state, whether any of
the following criteria has been met:
(i) Responsible parties or other persons have implemented all
appropriate response actions required;
(ii) All appropriate Fund-financed response under CERCLA has been
implemented, and no further response action by responsible
parties is appropriate; or
(iii) The remedial investigation has shown that the release poses
no significant threat to public health or the environment and,
therefore, taking of remedial measures is not appropriate.
(2) Releases shall not be deleted from the NPL until the state in
which the release was located has concurred on the proposed
deletion. EPA shall provide the state 30 working days for review
of the deletion notice prior to its publication in the Federal
Register.
(3) All releases deleted from the NPL are eligible for further
Fund-financed remedial actions should future conditions warrant
such action. Whenever there is a significant release from a site
deleted from the NPL, the site shall be restored to the NPL
without application of the HRS.
(4) To ensure public involvement during the proposal to delete a
release from the NPL, EPA shall:
(i) Publish a notice of intent to delete in the Federal Register
and solicit comment through a public comment period of a minimum
of 30 calendar days;
(ii) In a major local newspaper of general circulation at or near
the release that is proposed for deletion, publish a notice of
availability of the notice of intent to delete;
(iii) Place copies of information supporting the proposed
deletion in the information repository, described in
300.430(c)(2)(iii), at or near the release proposed for deletion.
These items shall be available for public inspection and copying;
and
(iv) Respond to each significant comment and any significant new
data submitted during the comment period and include this
response document in the final deletion package.
(5) EPA shall place the final deletion package in the local
information repository once the notice of final deletion has been
published in the Federal Register.
RETURN TO THE TOP
§300.430
(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.
(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 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:
(l) 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 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 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 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 §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 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
§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
§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.
(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 method of treatment or engineering control, but at
greater cost, may be eliminated.
(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 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 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;
(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.
RETURN TO THE TOP
§300.430(f)
(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.
(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 §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 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 §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 §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 300.430(f)(1)(ii) (A) and (B). Cost-effectiveness is
determined by evaluating the following three of the five
balancing criteria noted in §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 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 §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 §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 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 §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 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 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;
(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.
RETURN TO THE TOP
§300.435
(a) General. The remedial design/remedial action (RD/RA) stage
includes the development of the actual design of the selected
remedy and implementation of the remedy through construction. A
period of operation and maintenance may follow the RA activities.
(b) RD/RA activities. (1) All RD/RA activities shall be in
conformance with the remedy selected and set forth in the ROD or
other decision document for that site. Those portions of RD/RA
sampling and analysis plans describing the QA/QC requirements for
chemical and analytical testing and sampling procedures of
samples taken for the purpose of determining whether cleanup
action levels specified in the ROD are achieved, generally will
be consistent with the requirements of §300.430(b)(8).
(2) During the course of the RD/RA, the lead agency shall be
responsible for ensuring that all federal and state requirements
that are identified in the ROD as applicable or relevant and
appropriate requirements for the action are met. If waivers from
any ARARs are involved, the lead agency shall be responsible for
ensuring that the conditions of the waivers are met.
(c) Community relations. (1) Prior to the initiation of RD, the
lead agency shall review the CRP to determine whether it should
be revised to describe further public involvement activities
during RD/RA that are not already addressed or provided for in
the CRP.
(2) After the adoption of the ROD, if the remedial action or
enforcement action taken, or the settlement or consent decree
entered into, differs significantly from the remedy selected in
the ROD with respect to scope, performance, or cost, the lead
agency shall consult with the support agency, as appropriate, and
shall either:
(i) Publish an explanation of significant differences when the
differences in the remedial or enforcement action, settlement, or
consent decree significantly change but do not fundamentally
alter the remedy selected in the ROD with respect to scope,
performance, or cost. To issue an explanation of significant
differences, the lead agency shall:
(A) Make the explanation of significant differences and
supporting information available to the public in the
administrative record established under §300.815 and the
information repository; and
(B) Publish a notice that briefly summarizes the explanation of
significant differences, including the reasons for such
differences, in a major local newspaper of general circulation;
or
(ii) Propose an amendment to the ROD if the differences in the
remedial or enforcement action, settlement, or consent decree
fundamentally alter the basic features of the selected remedy
with respect to scope, performance, or cost. To amend the ROD,
the lead agency, in conjunction with the support agency, as
provided in §300.515(e), shall:
(A) Issue a notice of availability and brief description of the
proposed amendment to the ROD in a major local newspaper of
general circulation;
(B) Make the proposed amendment to the ROD and information
supporting the decision available for public comment;
(C) Provide a reasonable opportunity, not less than 30 calendar
days, for submission of written or oral comments on the amendment
to the ROD. 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 public comment period at or near the facility at issue;
(E) Keep a transcript of comments received at the public meeting
held during the public comment period;
(F) Include in the amended ROD a brief explanation of the
amendment and the response to each of the significant comments,
criticisms, and new relevant information submitted during the
public comment period;
(G) Publish a notice of the availability of the amended ROD in a
major local newspaper of general circulation; and
(H) Make the amended ROD and supporting information available to
the public in the administrative record and information
repository prior to the commencement of the remedial action
affected by the amendment.
(3) After the completion of the final engineering design, the
lead agency shall issue a fact sheet and provide, as appropriate,
a public briefing prior to the initiation of the remedial action.
(d) Contractor conflict of interest. (1) For Fund-financed RD/RA
and O&M activities, the lead agency shall:
(i) Include appropriate language in the solicitation requiring
potential prime contractors to submit information on their
status, as well as the status of their subcontractors, parent
companies, and affiliates, as potentially responsible parties at
the site.
(ii) Require potential prime contractors to certify that, to the
best of their knowledge, they and their potential subcontractors,
parent companies, and affiliates have disclosed all information
described in §300.435(d)(1)(i) or that no such information
exists, and that any such information discovered after submission
of their bid or proposal or contract award will be disclosed
immediately.
(2) Prior to contract award, the lead agency shall evaluate the
information provided by the potential prime contractors and:
(i) Determine whether they have conflicts of interest that could
significantly impact the performance of the contract or the
liability of potential prime contractors or subcontractors.
(ii) If a potential prime contractor or subcontractor has a
conflict of interest that cannot be avoided or otherwise
resolved, and using that potential prime contractor or
subcontractor to conduct RD/RA or O&M work under a
Fund-financed action would not be in the best interests of the
state or federal government, an offeror or bidder contemplating
use of that prime contractor or subcontractor may be declared
nonresponsible or ineligible for award in accordance with
appropriate acquisition regulations, and the contract may be
awarded to the next eligible offeror or bidder.
(e) Recontracting. (1) If a Fund-financed contract must be
terminated because additional work outside the scope of the
contract is needed, EPA is authorized to take appropriate steps
to continue interim RAs as necessary to reduce risks to public
health and the environment. Appropriate steps may include
extending an existing contract for a federal-lead RA or amending
a cooperative agreement for a state-lead RA. Until the lead
agency can reopen the bidding process and recontract to complete
the RA, EPA may take such appropriate steps as described above to
cover interim work to reduce such risks, where:
(i) Additional work is found to be needed as a result of such
unforeseen situations as newly discovered sources, types, or
quantities of hazardous substances at a facility; and
(ii) Performance of the complete RA requires the lead agency to
rebid the contract because the existing contract does not
encompass this newly discovered work.
(2) The cost of such interim actions shall not exceed $2 million.
(f) Operation and maintenance. (1) Operation and maintenance
(O&M) measures are initiated after the remedy has achieved
the remedial action objectives and remediation goals in the ROD,
and is determined to be operational and functional, except for
ground- or surface-water restoration actions covered under
§300.435(f)(4). A state must provide its assurance to assume
responsibility for O&M, including, where appropriate,
requirements for maintaining institutional controls, under
§300.510(c).
(2) A remedy becomes "operational and functional'' either
one year after construction is complete, or when the remedy is
determined concurrently by EPA and the state to be functioning
properly and is performing as designed, whichever is earlier. EPA
may grant extensions to the one-year period, as appropriate.
(3) For Fund-financed remedial actions involving treatment or
other measures to restore ground- or surface-water quality to a
level that assures protection of human health and the
environment, the operation of such treatment or other measures
for a period of up to 10 years after the remedy becomes
operational and functional will be considered part of the
remedial action. Activities required to maintain the
effectiveness of such treatment or measures following the 10-year
period, or after remedial action is complete, whichever is
earlier, shall be considered O&M. For the purposes of federal
funding provided under CERCLA section 104(c)(6), a restoration
activity will be considered administratively "complete''
when:
(i) Measures restore ground- or surface-water quality to a level
that assures protection of human health and the environment;
(ii) Measures restore ground or surface water to such a point
that reductions in contaminant concentrations are no longer
significant; or
(iii) Ten years have elapsed, whichever is earliest.
(4) The following shall not be deemed to constitute treatment or
other measures to restore contaminated ground or surface water
under §300.435(f)(3):
(i) Source control maintenance measures; and
(ii) Ground- or surface-water measures initiated for the primary
purpose of providing a drinking-water supply, not for the purpose
of restoring ground water.
300.440 Procedures for planning and
implementing off-site response actions (Reserved).
RETURN TO THE TOP
Return
to 40 CFR 300 - Main Menu