[Code of Federal Regulations]
[Title 40, Volume 27]
[Revised as of July 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR300.400]

[Page 55-58]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 300_NATIONAL OIL AND HAZARDOUS SUBSTANCES POLLUTION CONTINGENCY PLAN--
 
                 Subpart E_Hazardous Substance Response
 
Sec.  300.400  General.

    Source: 55 FR 8839, Mar. 8, 1990, unless otherwise noted.


    (a) This subpart establishes methods and criteria for determining 
the appropriate extent of response authorized by CERCLA and CWA section 
311(c):
    (1) When there is a release of a hazardous substance into the 
environment; or
    (2) When there is a release into the environment of any pollutant or 
contaminant that may present an imminent and substantial danger to the 
public health or welfare of the United States.
    (b) Limitations on response. Unless the lead agency determines that 
a release constitutes a public health or environmental emergency and no 
other person with the authority and capability to respond will do so in 
a timely manner, a removal or remedial action under section 104 of 
CERCLA shall not be undertaken in response to a release:
    (1) Of a naturally occurring substance in its unaltered form, or 
altered solely through naturally occurring processes or phenomena, from 
a location where it is naturally found;
    (2) From products that are part of the structure of, and result in 
exposure within, residential buildings or business or community 
structures; or
    (3) Into public or private drinking water supplies due to 
deterioration of the system through ordinary use.
    (c) Fund-financed action. In determining the need for and in 
planning or undertaking Fund-financed action, the lead agency shall, to 
the extent practicable:
    (1) Engage in prompt response;
    (2) Provide for state participation in response actions, as 
described in subpart F of this part;
    (3) Conserve Fund monies by encouraging private party response;
    (4) Be sensitive to local community concerns;
    (5) Consider using treatment technologies;
    (6) Involve the Regional Response Team (RRT) in both removal and 
remedial response actions at appropriate decision-making stages;
    (7) Encourage the involvement and sharing of technology by industry 
and other experts; and
    (8) Encourage the involvement of organizations to coordinate 
responsible party actions, foster site response, and provide technical 
advice to the public, federal and state governments, and industry.
    (d) Entry and access. (1) For purposes of determining the need for 
response, or choosing or taking a response action, or otherwise 
enforcing the provisions of CERCLA, EPA, or the appropriate federal 
agency, and a state or political subdivision operating pursuant to a 
contract or cooperative agreement under CERCLA section 104(d)(1), has 
the authority to enter any vessel, facility, establishment or other 
place, property, or location described in paragraph (d)(2) of this 
section and conduct, complete, operate, and maintain any

[[Page 56]]

response actions authorized by CERCLA or these regulations.
    (2)(i) Under the authorities described in paragraph (d)(1) of this 
section, EPA, or the appropriate federal agency, and a state or 
political subdivision operating pursuant to a contract or cooperative 
agreement under CERCLA section 104(d)(1), may enter:
    (A) Any vessel, facility, establishment, or other place or property 
where any hazardous substance or pollutant or contaminant may be or has 
been generated, stored, treated, disposed of, or transported from;
    (B) Any vessel, facility, establishment, or other place or property 
from which, or to which, a hazardous substance or pollutant or 
contaminant has been, or may have been, released or where such release 
is or may be threatened;
    (C) Any vessel, facility, establishment, or other place or property 
where entry is necessary to determine the need for response or the 
appropriate response or to effectuate a response action; or
    (D) Any vessel, facility, establishment, or other place, property, 
or location adjacent to those vessels, facilities, establishments, 
places, or properties described in paragraphs (d)(2)(i)(A), (B), or (C) 
of this section.
    (ii) Once a determination has been made that there is a reasonable 
basis to believe that there has been or may be a release, EPA, or the 
appropriate federal agency, and a state or political subdivision 
operating pursuant to a contract or cooperative agreement under CERCLA 
section 104(d)(1), is authorized to enter all vessels, facilities, 
establishments, places, properties, or locations specified in paragraph 
(d)(2)(i) of this section, at which the release is believed to be, and 
all other vessels, facilities, establishments, places, properties, or 
locations identified in paragraph (d)(2)(i) of this section that are 
related to the response or are necessary to enter in responding to that 
release.
    (3) The lead agency may designate as its representative solely for 
the purpose of access, among others, one or more potentially responsible 
parties, including representatives, employees, agents, and contractors 
of such parties. EPA, or the appropriate federal agency, may exercise 
the authority contained in section 104(e) of CERCLA to obtain access for 
its designated representative. A potentially responsible party may only 
be designated as a representative of the lead agency where that 
potentially responsible party has agreed to conduct response activities 
pursuant to an administrative order or consent decree.
    (4)(i) If consent is not granted under the authorities described in 
paragraph (d)(1) of this section, or if consent is conditioned in any 
manner, EPA, or the appropriate federal agency, may issue an order 
pursuant to section 104(e)(5) of CERCLA directing compliance with the 
request for access made under Sec.  300.400(d)(1). EPA or the 
appropriate federal agency may ask the Attorney General to commence a 
civil action to compel compliance with either a request for access or an 
order directing compliance.
    (ii) EPA reserves the right to proceed, where appropriate, under 
applicable authority other than CERCLA section 104(e).
    (iii) The administrative order may direct compliance with a request 
to enter or inspect any vessel, facility, establishment, place, 
property, or location described in paragraph (d)(2) of this section.
    (iv) Each order shall contain:
    (A) A determination by EPA, or the appropriate federal agency, that 
it is reasonable to believe that there may be or has been a release or 
threat of a release of a hazardous substance or pollutant or contaminant 
and a statement of the facts upon which the determination is based;
    (B) A description, in light of CERCLA response authorities, of the 
purpose and estimated scope and duration of the entry, including a 
description of the specific anticipated activities to be conducted 
pursuant to the order;
    (C) A provision advising the person who failed to consent that an 
officer or employee of the agency that issued the order will be 
available to confer with respondent prior to effective date of the 
order; and
    (D) A provision advising the person who failed to consent that a 
court may impose a penalty of up to $25,000 per

[[Page 57]]

day for unreasonable failure to comply with the order.
    (v) Orders shall be served upon the person or responsible party who 
failed to consent prior to their effective date. Force shall not be used 
to compel compliance with an order.
    (vi) Orders may not be issued for any criminal investigations.
    (e) Permit requirements. (1) No federal, state, or local permits are 
required for on-site response actions conducted pursuant to CERCLA 
sections 104, 106, 120, 121, or 122. The term on-site means the areal 
extent of contamination and all suitable areas in very close proximity 
to the contamination necessary for implementation of the response 
action.
    (2) Permits, if required, shall be obtained for all response 
activities conducted off-site.
    (f) Health assessments. Health assessments shall be performed by 
ATSDR at facilities on or proposed to be listed on the NPL and may be 
performed at other releases or facilities in response to petitions made 
to ATSDR. Where available, these health assessments may be used by the 
lead agency to assist in determining whether response actions should be 
taken and/or to identify the need for additional studies to assist in 
the assessment of potential human health effects associated with 
releases or potential releases of hazardous substances.
    (g) Identification of applicable or relevant and appropriate 
requirements. (1) The lead and support agencies shall identify 
requirements applicable to the release or remedial action contemplated 
based upon an objective determination of whether the requirement 
specifically addresses a hazardous substance, pollutant, contaminant, 
remedial action, location, or other circumstance found at a CERCLA site.
    (2) If, based upon paragraph (g)(1) of this section, it is 
determined that a requirement is not applicable to a specific release, 
the requirement may still be relevant and appropriate to the 
circumstances of the release. In evaluating relevance and 
appropriateness, the factors in paragraphs (g)(2)(i) through (viii) of 
this section shall be examined, where pertinent, to determine whether a 
requirement addresses problems or situations sufficiently similar to the 
circumstances of the release or remedial action contemplated, and 
whether the requirement is well-suited to the site, and therefore is 
both relevant and appropriate. The pertinence of each of the following 
factors will depend, in part, on whether a requirement addresses a 
chemical, location, or action. The following comparisons shall be made, 
where pertinent, to determine relevance and appropriateness:
    (i) The purpose of the requirement and the purpose of the CERCLA 
action;
    (ii) The medium regulated or affected by the requirement and the 
medium contaminated or affected at the CERCLA site;
    (iii) The substances regulated by the requirement and the substances 
found at the CERCLA site;
    (iv) The actions or activities regulated by the requirement and the 
remedial action contemplated at the CERCLA site;
    (v) Any variances, waivers, or exemptions of the requirement and 
their availability for the circumstances at the CERCLA site;
    (vi) The type of place regulated and the type of place affected by 
the release or CERCLA action;
    (vii) The type and size of structure or facility regulated and the 
type and size of structure or facility affected by the release or 
contemplated by the CERCLA action;
    (viii) Any consideration of use or potential use of affected 
resources in the requirement and the use or potential use of the 
affected resource at the CERCLA site.
    (3) In addition to applicable or relevant and appropriate 
requirements, the lead and support agencies may, as appropriate, 
identify other advisories, criteria, or guidance to be considered for a 
particular release. The ``to be considered'' (TBC) category consists of 
advisories, criteria, or guidance that were developed by EPA, other 
federal agencies, or states that may be useful in developing CERCLA 
remedies.
    (4) Only those state standards that are promulgated, are identified 
by the state in a timely manner, and are more stringent than federal 
requirements

[[Page 58]]

may be applicable or relevant and appropriate. For purposes of 
identification and notification of promulgated state standards, the term 
promulgated means that the standards are of general applicability and 
are legally enforceable.
    (5) The lead agency and support agency shall identify their specific 
requirements that are applicable or relevant and appropriate for a 
particular site. These agencies shall notify each other, in a timely 
manner as described in Sec.  300.515(d), of the requirements they have 
determined to be applicable or relevant and appropriate. When 
identifying a requirement as an ARAR, the lead agency and support agency 
shall include a citation to the statute or regulation from which the 
requirement is derived.
    (6) Notification of ARARs shall be according to procedures and 
timeframes specified in Sec.  300.515 (d)(2) and (h)(2).
    (h) Oversight. The lead agency may provide oversight for actions 
taken by potentially responsible parties to ensure that a response is 
conducted consistent with this part. The lead agency may also monitor 
the actions of third parties preauthorized under subpart H of this part. 
EPA will provide oversight when the response is pursuant to an EPA order 
or federal consent decree.
    (i) Other. (1) This subpart does not establish any preconditions to 
enforcement action by either the federal or state governments to compel 
response actions by potentially responsible parties.
    (2) While much of this subpart is oriented toward federally funded 
response actions, this subpart may be used as guidance concerning 
methods and criteria for response actions by other parties under other 
funding mechanisms. Except as provided in subpart H of this part, 
nothing in this part is intended to limit the rights of any person to 
seek recovery of response costs from responsible parties pursuant to 
CERCLA section 107.
    (3) Activities by the federal and state governments in implementing 
this subpart are discretionary governmental functions. This subpart does 
not create in any private party a right to federal response or 
enforcement action. This subpart does not create any duty of the federal 
government to take any response action at any particular time.

[55 FR 8839, Mar. 8, 1990, as amended at 59 FR 47447, Sept. 15, 1994]