Applicable or relevant and appropriate requirements

The design and construction requirements, as defined in the RCRA regulations, may also be applied under cleanup programs, such as Superfund31 or state cleanup programs, as part of a remedy for hazardous waste sites such as abandoned dumps. In these instances, the RCRA regulations for conventional covers are usually identified as applicable or relevant and appropriate requirements for the site. 

The USEPA established a National Remedy Review Board in 1995 to review all remedies. This board has saved an estimated 31 million, and future cost reductions of more than 725 million are expected (USEPA, 1998b). The remedial investigation (RI) will also include identification of "applicable or relevant and appropriate requirements" (ARARs). These are remediation standards, standards of control, or other criteria or limitations developed by federal or state law. Applicable requirements are those that have been previously used at a CERCLA site for the same waste. Relevant and appropriate requirements are those not formerly used for waste at a CERCLA site but which address the problem. Advisories and guidance to be considered can also be issued, but they are not as binding. 

The passage of SARA in 1986 resulted in the development of applicable or relevant and appropriate requirements (ARARs), which are used as de facto values for cleanup end points. The ARARs are usually based on other environmental laws, such as the SDWA or the RCRA. 

In addition, the cleanup process is required to meet all other environmental requirements during its operation. These are referred to as applicable or relevant and appropriate requirements. 

The NCP contains several criteria that are Intended to guide decisions on the standards to be achieved in Individual remedial actions. Among these the most important are the threshold criteria, which include (1) a general requirement to protect human health and the environment and (2) cleanup standards which have applicable or relevant and appropriate requirements (ARAR). Under the ARAR approach, EPA can use standards from other federal and state statutes (e.g., CWA, SDWA, RCRA) on a case-by-case basis when these requirements are applicable or relevant and appropriate. For example, RCRA land-disposal restorations (LDR) may be relevant and applicable" if a CERCLA remedial action involves RCRA hazardous waste and the waste or its hazardous residue is to be land disposed. In this case, the RCRA LDR standards that are based on the best demonstrated available technology (BDAT) may apply. 

EPA (1997b). Clarification of the Role of Applicable or Relevant and Appropriate Requirements in Establishing Preliminary Remediation Goals under CERCLA. OSWER No. 9200.4-23. Office of SoUd Waste and Emergency Response, US Environmental Protection Agency, Washington, D.C. Accessed at http //www.epa.gov/superfund/health/contaminants/radiation/pdfs/aras.pdf. 

State water quality standards will frequently be "applicable" or "relevant and appropriate" requirements for a Superfund site. For most states and chemicals, the particular standards that apply to a water body depend upon the designation of the water body as a member of a particular class, with the set of classes varying among states. Risk Assistant contains an automated procedure to help the user in selecting the most appropriate water body classifications for her or his particular site. 

Selection of response actions that result in the recovery, or maintenance, of healthy local populations/communities of ecological receptors that are (or should be) present at the site furthermore, in support of proper risk management, risk assessors are advised to select assessment endpoints and measures (as defined in ERAGS) that are ecologically relevant to the site and include species that are exposed and sensitive to response to site contaminants, such as explosives. In addition, if individual threatened or endangered (T E) species or critical habitats for such species are present at a site, the Endangered Species Act may be declared an applicable or relevant and appropriate requirement (ARAR) within the ERA of the site. 

Rather than establish individual cleanup standards, CERCLA assures that remedies are based on cleanup standards established by other laws (e.g. CAA, CWA, and RCRA). In conjunction with site-specific risk factors, CERCLA requires that remedies attain any legally applicable or relevant and appropriate requirements (ARARs). ARARs are standards, criteria, or limitations under federal and state environmental laws. For example, if electrokinetic remediation involves the on-site treatment, storage, or disposal of hazardous wastes, the remediation activity must meet RCRA standards for such treatment, storage, and disposal. ARARs relative to electrokinetic remediation include (a) the CERCLA, (b) the RCRA, (c) the CAA, (d) the CWA, (e) the SDWA, and (f) Occupational Safety and Health Administration (OSHA) regulations (ERA SITE Program, 2003). These six general requirements are discussed in the sections that follow. 

Regulatory and U.S. Department of Energy Order Compliance—This section briefly describes those promulgated regulations, DOE orders, and consent order agreements between DOE, EPA, and Ecology that are considered applicable or relevant and appropriate requirements (ARAR) to the Hanford Site remediation and cleanup activities. 

For nonpharmacopeial materials a full specification should be included in the application. This should include appropriate tests and requirements for physical characteristics, identification, relevant purity tests, and performance-related tests. Characteristics likely to influence bioavailability of the finished product should be controlled. Routine tests and specifications should be described. Methods should be validated. The material should be fully characterized, with full data on the chemistry concerned and including consideration of the safety of the excipient. Any relevant European Directive requirements or other international specifications should be met, but additional requirements might apply depending on the intended use of the product—e.g., for materials to be used in sterile products. 

Evaluation of appropriateness requires a detailed description of the conditions, study designs and methods under which data were collected or information was developed, so that the exposure assessor or other users of the data can judge their relevance for their purposes. An exposure assessor must further document any additional assumptions and simplifications made when using the data in a particular assessment. The determination of appropriateness therefore requires the application of one of the other hallmarks of data quality discussed below, transparency (see section 3.4). 

The investigator has the responsibility to notify the sponsor immediately he/she has knowledge of an SAE. Where applicable, the lEC and relevant authorities should be also be informed either by the sponsor or by the investigator. This will allow the appropriate measures to be taken to safeguard the study subjects. Although the timeframes below provide more time than originally was required by regulatory authorities (for example, the... 

The amount of process plant that can be defined accurately as automatic is relatively small, and manual intervention is often involved at some stage. The relevant design criteria are therefore often IM/12 or IM/18. In practice, fully automatic burner controllers tested and certified by British Gas are available that comply with the requirements of BS 5885. Although these have features which may not be applicable to non-automatic plant, it may be more appropriate to use such a controller, particularly as its safety is well proven. It may also be less expensive than buying and installing separate timers, relays, etc. For some processes (for example, those that do not need and cannot tolerate a long purge) such controllers may not be appropriate. 

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