US-EPA Risk Assessment Guidelines

US-EPA s Risk Assessment Guidehnes set forth recommended principles and procedures to guide US-EPA scientists in assessing the risks from chemicals or other agents in the environment. They also inform US-EPA decision-makers and the public about these procedures. 

Guidelines for Carcinogen Risk Assessment Guidelines for Chemical Mixtures Risk Assessment 

2005 Cancer Guidelines and Supplemental Guidance 2000 Supplementary guidance and 1986 guidelines, 

Source National Center for Environmental Assessment (NCEA), 2006. Available at http /cfpub.epa.gov/ncea/index.cfm 

Toxicological Risk Assessments of Chemicals A Practical Guide 

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A specific guidance document for irritation/corrosion has not been published by WHO/IPCS. The series of US-EPA Risk Assessment Guidelines does not include a guideline regarding risk assessment of irritation/corrosion. 

Risk assessment is an empirically based process that estimates the risk of adverse effects from exposure of an individual or population to a chemical, physical or biological agent. The OECD test guidelines, the US EPA risk assessment guidelines and additional risk assessment procedures for new and existing chemicals have been published and put into use by many different countries in Europe, the Americas and Asia (United Kingdom Department of Health, 1991,1995 EC, 1994,1996 Health Canada, 1994 IPCS, 1994 Hertel, 1996). A list of assessments produced by various national and international agencies on specific chemicals is included in ECETOC/UNEP (1996). 

US-EPA has formed the Risk Assessment Forum, a standing committee of senior US-EPA scientists, to promote US-EPA consensus on difficult and controversial risk assessment issues and to ensure that this consensus is incorporated into appropriate US-EPA risk assessment guidance. To fulhil this purpose, the Forum assembles US-EPA risk assessment experts in a formal process to study and report on issues from a US-EPA scientific perspective. Major Fomm guidance documents are developed in accordance with the US-EPA s regulatory and policy development process and become US-EPA pohcy upon approval by the Administrator or the Deputy Administrator. The Risk Assessment Forum products include risk assessment guidelines, technical panel reports on special risk assessment issues, and peer consultation and peer review workshops addressing controversial risk assessment topics. 

The series of Risk Assessment Guidelines includes a guideline for neurotoxicity risk assessment (US-EPA 1998), see Section 4.7.7.3. 

The series of Risk Assessment Guidelines includes a guideline for neurotoxicity risk assessment (US-EPA 1998). This Guideline sets forth principles and procedures to guide US-EPA scientists in evaluating environmental contaminants that may pose neurotoxic risks, and inform US-EPA decision-makers and the public about these procedures. The Guideline includes a discussion of general dehnitions and issues, an overview of test methods, and the interpretation of data within the U.S. framework for risk assessment. 

US-EPA. 1996. Proposed Guidelines for Carcinogen Risk Assessment (April 23, 1996). Eederal Register 61(79) 17960-18011. Washington, DC Office of Research and Development. U.S. Environmental Protection Agency. http /www.epa.gov/ncea/raf/pdfs/propcra 1996.pdf... 

US Environmental Protection Agency (1998) Guidelines for neurotoxicity risk assessment. Federal Register 63 26926-26954 http //www.epa.gov/raf/publications/pdfs/NEUROTOX. PDF Accessed 15 Feb 2011... 

US EPA (United States of America Environmental Protection Agency). (1998). Guidelines for Ecological Risk Assessment. Washington, DC U.S. Environmental Protection Agency. 

The Guidelines for Reproductive Toxicity Risk Assessment (US-EPA 1996) discuss the scientific basis for concern about exposure to agents that cause reproductive toxicity and describe the principles and procedures to be followed in conducting risk assessments for reproductive toxicity. They include the female (nonpregnant and pregnant) and male reproductive systems. 

The Guidelines for Developmental Toxicity Risk Assessment (US-EPA 1991) outline principles and methods for evaluating data from animal and human studies, exposure data, and other information to characterize risk to human development, growth, survival, and function because of exposure prior to conception, prenatally, or to infants and children. 

US-EPA. 1986a. Guidelines for mutagenicity risk assessment. Federal Register 51(185) 34006-34012. http // cfpub.epa.gov/ncea/raf/rafguid.cfm... 

US-EPA. 2005. Guidelines for carcinogen risk assessment. U.S. Environmental Protection Agency, Risk Assessment Forum, Washington, DC, 630/P-03/001F, 2005. 

The most widely used of the many mathematical models proposed for extrapolation of carcinogenicity data from animal studies to low-dose human exposures (i.e., low-dose extrapolation) is the LMS model. This has, in effect, become the default approach for quantitative risk assessment and has been used by, e.g., the US-EPA for many years as well as by the WHO in relation to derivation of drinking-water guideline values for potential carcinogens (WHO 1996) (see Section 9.2.1.2 for drinking-water guideline values). 

In its 1986 Guidelines for Carcinogen Risk Assessment, the US-EPA introduced the LMS model into the U.S. regulatory framework. The multistage model was chosen for regulatory... 

The US-EPA has in its 1996 Proposed Guidelines for Carcinogen Risk Assessment (US-EPA 1996) adopted the dose descriptor LEDio (the 95% lower confidence limit on a dose associated with a 10% extra tumor risk) whereas in its 2005 Guidelines for Carcinogen Risk Assessment (US-EPA 2005), no defined incidence has been recommended (see Section 6.3.2). Within the EU chemical s regulation, the dose descriptor T25 has been proposed (see Section 6.3.3). In the newly proposed MOE approach, the JECFA and the EFSA have recommended the dose descriptor BMDLio (see Section 6.4). 

In 1996, the US-EPA published their Proposed Guidelines for Carcinogen Risk Assessment (US-EPA 1996). These Proposed Guidelines were a revision of the 1986 Guidelines for Carcinogen Risk Assessment (US-EPA 1986) and introduced, among others, a new approach for the quantitative risk assessment. A revised draft Guidelines was launched in 1999 (US-EPA 1999) and the final version was published in 2005 (US-EPA 2005). 

The following overview of the US-EPA revised quantitative approach for cancer risk assessment is based on the final version of the Guidelines for Carcinogen Risk Assessment (US-EPA 2005). 

US-EPA guidelines for endpoint-specific risk assessments contain guidance on exposure issues of relevance for the particular endpoint. For example, in the US-EPA Guidelines for Reproductive Toxicity Risk Assessment (US-EPA 1996) exposure issues important to reproductive toxicity risk assessment are addressed, and a number of unique considerations regarding the exposure assessment for reproductive toxicity are discussed. 

US Environmental Protection Agency (EPA) (1991) Guidelines for developmental toxicity risk assessment. Fed Regist 56 63798-63826... 

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