Risk, Safety, Introduction to Risk Assessment.
So you should now infer that a "risk assessment" is just the calculation, evaluation, cogitation, devining, or somehow expressing (choose one or several) the probability and severity of some harm. In this course we will focus on the health hazards due to chemicals in the environment, but term "risk assessment" could include any type of harm from any source. What constitutes a professional risk assessment? That's what the next 14 weeks are all about. But first a digression or two:
References: We will use several outside references that are available to you via the web. The first is Understanding RISK Analysis by the American Chemical Society and Resources for the Future. It is a relatively short document, about 40 pages, in pdf format. They recently took it off the web, but gave us a copy, you can get it here and pull it down and print it. [Use the back button on your pdf browser window to return here.] You could also pull it into your machine's memory. Unlike paper, you cannot highlight or markup pages, if you get a document in pdf or html format. You can "cut" from the document and "paste" somewhere else. So one method of study is to open a study sheet in your word processing program, and cut and paste sections that you would have highlighted in a paper document. The second document is Risk Assessment Guidance for Superfund by the EPA. That is a longer document and the EPA keeps it in separate documents. You do not need this for a few weeks, but you might want to skim some of it now, to get a flavor of what's there. Note how large some of the files are. http://www.epa.gov/oswer/riskassessment/ragsa/index.htm
In high school civics we learned that we are governed by a federal constitution that dictates a separation of powers. The power is divided into a legislative branch that makes laws, an executive branch that enforces laws and a judicial branch that interprets laws. The constitutions of the states have similar divisions into branches. If a law made by congress is specific about a detail, that's the end of the matter. For example, a law might say, "the speed limit on federally funded roads shall not exceed 65 mph." But congress often passes laws that say, "the speed limit on federally funded roads shall not be unsafe, as determined by the Secretary (or whoever)." The Secretary in that case would be the Secretary of the Department of Transportation, who would in turn delegate the decision regarding speed limits on the Richardson Highway to a technical expert in the Department. Realize what has happened, the congress has made a law, but the law delegated the determination of a technical detail to the Executive Branch. Congress could have decided the speed limit on the Rich, but instead delegated it to the executive. This is very common. The general matter of executive branch-made law is called Administrative Law. The laws that are made (promulgated is a better term) by the executive are called regulations. This course is not devoted to teaching regulations. But, the environmental field is saturated with regulations and most of your day to day decisions are bound by regulations. So, I will attempt to teach sound science and engineering, but will need to refer to laws and regulations as needed.
Congress passes "bills" that have a number based on the session of Congress. These bills are "law" when they are signed by the president, but are shortly codified or referenced in the United States Code, USC. The USC has various "titles" similar to volumes. Look at these titles. Where would you expect to find laws about environmental risks? Hint, it's in the 40's but is not "40." Now click here and look at all the chapters of that title. The "superfund" law is found in Chapter 103 of that title.
How about regulations? When a new regulation is promulgated, it will be codified in the Code of Federal Regulations (CFR). The CFR is likewise divided into Titles. Here is a site that has those CFR titles . (Click on Search or browse your choice of CFR titles and/or volumes (current and/or historical data) from that site.) Many CFR titles have the same number as the USC titles, but not all of them. What CFR title holds the EPA regulations?
The Administrator of the EPA, or whoever congress designated to promulgate the regulations, has two significant legal constraints. First, the new regulation must conform to the law that enabled it. Second, the regulation must promulgated according to a law known as the Administrative Procedures Act. The Act specifies the steps that the Administrator must go through. Publication of the proposed regulations and other such notices, accepting and reviewing public comment are required and there are various deadlines and time constraints. For federal regulations, the notices must be published in a document called the Federal Register (FR), which is published every business day. Here you can glance at the latest FR. Often a change to a regulation is a very small amount of text, a sentence or two, that can have enormous significance. The earlier drafts of the proposed regulation usually had a substantial preamble text, explaining the Administration's rational for the change. Often public comment, which includes scientific comments, are reproduced in this preamble as well.
So, once regulations are promulgated, they are law too. But there is one more level of authority we need to know about, "guidance documents." The RAGS document you glanced at above is a guidance document that is called that. There are many other types of guidance documents, such as laboratory procedures, internal agency manuals and procedures that are also guidance documents. Are these law? Here the lawyers and legal scholars can have some fun, but we don't need to go there. Presumably these guidance documents follow the regulations and are just an exposition or explanation of what the regulations say or require. As a practical matter, once a guidance is published by an agency, the agency feels bound to follow it. Also as a practical matter, those doing business with the agency are also bound by them. Here is page that has several guidance documents published by the Alaska Department of Environmental Conservation (ADEC). You can see the types of detail they provide. ADEC
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