Sub-module 2A, Page 1
| Sub-module 2A | Overview of laws and reg.'s, uses of risk assessment. | 
Learning Goals: 
Understand:
While the risk assessment process outlined in Module 1 is quite 
  general, in this sub-module we will spend some time with environmental contaminants 
  in the mode where most of us deal with them. Let's start with some philosophy. 
  Most health risks from chemicals in the environment stem from releases. Releases 
  might be intentional (or permitted, accent on the first syllable) or unintentional. 
  The risks we are calculating might be due to future releases or past releases. 
  
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  Examples:
  1.) Insecticides such as DDT were released into the environment
  in large quantities. (Intentional, Past)
  2.) A local electroplating operation asks the city's wastewater
  treatment facility for permission to discharge water containing
  cadmium into the city's sewers. (Intentional, Future)
  3.) An inspection reveals that a gasoline service station's tanks
  have been leaking for several years (Unintentional, Past)
  4.) A manufacturing company wants to set up chemical storage tanks
  on a hill overlooking a school. (Unintentional, Future)
  
  Risk assessments are required in all four cases. For the unintentional
  future release, the probability of the harm is related to the
  probably of the release. Will the tank burst? These are chiefly
  engineering decisions relating to the design of the tank. Once
  the engineers have analyzed the probability of a release, a human
  health risk assessment is needed in a "what-if" analysis
  of the consequences of possible future failure. In performing
  the human health risk assessment, the risk analyst would be given
  exact quantities of chemicals that would be released in order
  to perform the risk analysis, but the quantities would be hypothetical.
  
  For the intentional future releases, we have a similar situation. Here the analyst would be given an exact number for the release, or the party that 
    plans to release the chemical would be given an upper limit on the quantity that 
    will be permitted. Perhaps some of you did not realize that the release of toxic 
    chemicals is permitted (again, I mean a permit is given by the government(s) to 
    release the toxic chemicals into the environment). We should digress from philosophy 
    to reality. Go to this site TRI and read a little about the Toxic 
    Release Inventory. The "TRI Explorer" is a tool to sift the EPA database 
    regarding toxic chemicals released to the environment. Go to https://iaspub.epa.gov/triexplorer/tri_release.chemicall 
  then go to Release Reports at 
  https://iaspub.epa.gov/triexplorer/tri_release.chemical 
  . Use the menu box to choose 
    a state other than the state you live in, then use the other menu box to choose 
    an industry. After you click on the "generate report" button, you should 
    get a matrix of toxic compounds by the media they were released to (air, water, 
    land). Most of these releases were quite legal. Bookmark the TRI site.
  
  For all the past releases, both intentional and unintentional,
  Hazard Identification is much more difficult. We generally do
  not know the amounts of chemical released, and often we do not
  even know the chemical. Often there are several chemicals. We
  receive notice of them through a phone call (worse, a phone call
  from a reporter) or a worker/neighbor/ member of the public shows
  up with a Ziploc bag filled with something, or a well water sample
  that smells like a dry cleaning store. Perhaps a notice that "this
    is from the area behind the storage shed," or "this
    is from the place where all the vegetation is dead." What
    next? 
  
  Following some type of initial notice, often times as informal as described above, 
  a chain of events will follow. Illogical as it sounds to the uninitiated, the 
  details of what follows will depend on the regulatory matrix: what the substance 
  is, the location where it was found, and the nature of the party who likely put 
  it there. 100 kg of benzene from a chemical plant is different than 100 kg of 
  benzene from an oil spill. 100 kg of fresh benzene on its way to factory is different 
  from 100 kg of contaminated benzene on its way to a recycler. We will try to avoid 
  those details, but two Federal laws for which you need to know their relations 
  to risk assessment are CERCLA and RCRA.
  
  CERCLA is the "superfund law." That's pronounced "cerk lah" 
  and stands for the Comprehensive Environmental Response, Compensation, and Liability 
  Act, which was enacted in 1980. It was overhauled in 1986 by SARA (pronounced 
  like the female name, Sarah), which stands for the Superfund Amendments and Reauthorization 
  Act. (I won't say much about SARA as separate from CERCLA, unless some distinction 
  is necessary.) Here is a brief explanation of CERCLA. https://www.epa.gov/superfund/superfund-cercla-overview, then at the bottom of that 
    page a link to SARA https://www.epa.gov/superfund/superfund-amendments-and-reauthorization-act-sara . Please read both those pages, then use your Back Button to come 
      back here.
  
    When congress passed superfund in 1980, the original law had a provision for a 
    risk assessment, called a Hazard Ranking Score (HRS). The idea was simple, since 
    there were many sites competing for superfund money, proponents of cleaning a 
    particular site would fill out a simple form. The form had a numbering system, 
    the higher numbers indicating increased risk to human receptors. The EPA (who 
    might also be a proponent) would arrange these into a priorities list, with the 
    highest score funded first. (I worked with a HRS in the early 1980's and I remember 
    it was 3 or 4 pages long. The instructions were about 10 pages.) What happened 
    was thousands of contaminated sites were discovered, the cognoscenti realized 
    that the system could easily result in errors. Today the HRS regulations are almost 
    200 pages long. Here's a little about it https://www.epa.gov/superfund/introduction-hazard-ranking-system-hrs 
  
  RCRA (pronounced "reck rah") stands for the Resource Conservation and 
    Recovery Act. This 1976 law was modified in 1984 by the Hazardous and Solid Waste 
    Amendments (HSWA) again, no need for me to talk about HSWA as distinct from RCRA. 
    RCRA is the "hazardous waste law." It provides cradle to grave control 
    of hazardous waste. You don't need to know any details about RCRA for this course, 
    but you should know that RCRA deals with producers of hazardous waste and transporters 
    and treatment facilities that handle hazardous wastes and finally store it. You 
    should also know that RCRA has its own set of regulations that deal with clean 
    up of chemical spills and their associated risk assessments. But on the whole, 
    the procedure is similar to what we learn about CERCLA below. Here's a capsule 
    on RCRA.  
  https://www.epa.gov/rcra/resource-conservation-and-recovery-act-rcra-overview. 
  The key difference between RCRA 
    and CERCLA is that RCRA usually deals with current or ongoing pollution events 
    and usually there is some sort of viable economic entity that is responsible and 
    heavily involved. CERCLA usually deals with past events, sometimes long ago, and 
    either there is not an economically viable entity available, or finding that entity, 
    and making them pay, is part of the process.
  
  
  Back to your friend/client/public with the Ziploc bag. Clearly
  you want to investigate the situation some more. In most situations,
  the next thing you need to do is find the money and time to do
  an investigation. You certainly want the substance in the bag
  analyzed to determine what it is, and probably go out to the site
  and observe the situation. When you have done these things, you
  are in the middle of the Hazard Identification part
      of a risk assessment. Let's assume the soil in the bag was saturated
      with a chemical and your quick review of the site indicates there
      may be a lot of soil so contaminated. Let's ignore issues of budget
      and regulatory matrix, but we'll use the nomenclature from the
      superfund process. What happens next?
  
  You can find a more detailed discussion of the process in Chapter
  1 of RAGS http://www.epa.gov/oswer/riskassessment/ragsa/index.htm 
  
  1.) You need to "scope" the situation. Your analysis
  of the gunk in the Ziploc bag and tour of the site is the start
  of a scoping. Depending on what you find, the next step would
  be,
  2.) A more formal approach follows and is called a Preliminary Assessment 
  and Site Investigation (PA/SI). This step usually requires extensive sampling 
  of soils and materials and a thorough investigation of the situation. Elaborate 
  preparations and chemical analysis procedures and quality control are required. 
  This step would determine if a significant release of contaminant occurred. 
  If it did, the next step is called,
  3.) Remedial Investigation. This step is often combined with a feasibility 
  study and the acronym RI/FS is commonly used for this process (pronounced 
  "riff is") The RI is now done in great detail, but the nature of the 
  investigation is keyed to the expected cleanup alternatives. For example if 
  the PA/SI indicated extensive groundwater contamination, the RI/FS would involve 
  many test wells to sample the groundwater. If the PA/SI indicted the contaminants 
  were bound up in the surface soil, the RI/FS would not drill many wells. The 
  feasibly study is the first step in designing the remediation.
  4.) Following the RI/FS, if this were a superfund site (and there is usually 
  an analogous procedure for non-superfund clean ups) a Record of Decision 
  is issued by the EPA. The record of decision or ROD follows public comment 
  and deliberation by the EPA and firms up what will be done with the site.
  5.) The next steps are called Remedial Design and Remedial Action, 
  the later is when the site actually gets cleaned up, or monitored or whatever. 
  The key acronyms in order are:
  Initial scope > PA/SI >RI/FS > ROD > RD and RA
  Back to the Ziploc bag and its chemical(s) and your evaluation of the situation. 
  Here you do a risk assessment to determine if the matter is even worth pursuing. 
  Your report will mention the chemicals that were in the bag. Are these chemicals 
  toxic in the doses people are likely to be exposed to? Is the site a playground 
  or an industrial storage yard? Based on this preliminary risk assessment, you 
  will try to get your boss to budget the money to go to a PA/SI or try to get 
  your friend to agree and leave the office. You might call this a back-of-the-envelope 
  risk assessment.
  Following the PA/SI a preliminary screening risk assessment is done if 
  the PA/SI indicates that there is significant contamination at the site. This 
  will be a formal document that is as thorough a risk assessment as is practical, 
  given the preliminary nature of the information the PA/SI produces. This preliminary 
  screening risk assessment will identify the Chemicals of Potential Concern 
  (COPCs), that is the chemicals we are interested in. In Course Documnets is a 20 meg pdf file of the Fox River RI. Just read the Executive Summary. Save the file.
  
  
  During the RI, enough information becomes available to do a much more accurate 
  risk assessment, and this is called the Baseline Risk Assessment. It's 
  characterization of the risk is based on the information collected during the 
  RI. During the FS, different scenarios (by that I mean sets of design alternatives) 
  of cleanup are considered. For each of these, there is a risk assessment of 
  the alternatives, based on the likely effect of the cleanup alternative considered.
  
  As part of the ROD, the risk assessments of all the various options studied 
  are presented to the public. Note that the baseline risk assessment is now the 
  risk assessment for the "do-nothing" alternative.