Updated September 2009
*** Q. The muddiest issue for me was the concept of guidance documents. Is this just another term for regulation?
A. No. Regulations are “law” and must go through a definite process to become law. Guidance documents are not law and might go through any type of review and scrutiny, stringent or lax. However, these guidance documents are sometimes incorporated in regulations and/or adopted by an agency. For example, in defining worker exposure to airborne asbestos fibers, an agency might specify a particular microscope procedure be used. If they say “latest revision” that means that whoever wrote that procedure could, in effect, change the regulation. A more common problem is that no particular procedure is called for in the law, but the agency adopts one as “standard.” As a practical matter, the procedure become laws, but never went through the legal process.
***Q. The “muddlist” thing I found in Module 2 was the reporting of the chemicals in the EPA’s Toxic Release Inventory (TRI). Often releases were listed as “cobalt compounds”, “nickel compounds” or some other metal compound. This made it difficult to find what pollutant and how much was actually released. I didn’t like how they would lump these groups together.
A. You will see some more of this in Module 3 with the waste types. The “waste” is often listed by its “chemical of concern,” but the waste is seldom a pure compound, and often the other gunk besides the CoC is hazardous too. What we see is a balance between scientific exactitude, economy of data gathering and analysis, and legal issues of enforceability.
*** Q. If you work for a company and are in charge of certain federal regulations, how do you know when they are updated unless you subscribe to a service that you pay and hope will provide you with this information or unless you check and read them every say 6 months or so?
A. It would be impractical for most workaday scientists and engineers to read the Federal Register. The only way to “stay current” is to join professional and trade organizations that have full-time people whose job it is to read the FR and, for most of those organizations, lobby the agencies about the proposed regulations. These organizations produce monthly magazines and newsletters that will be your best source of information on proposed and new regulations that affect your work.
***Q. How are regulations are changed. It would be nice to go into a bit more detail about the process, especially concerning the role of lobbyists.
A. Regulations are changed in exactly the same way they are promulgated in the first place, according to the APA. Some changes are mandated by the enabling laws or some aspect of the reg become obviously out of date. Rarely, a court finding will drive a modification to the regulation. Unlike congress and the legislature, where lobbyists play a big role, in regulation making and changing, technical input into the process via the public hearings and comment process is the more common way of influencing regulation.
** Q. As you stated in the closure section, all of our environmental and occupational exposures are probably less than what some/most people voluntarily consume with tobacco or alcohol. That said, is incidental exposure to pesticides on my vegetables or through bug repellent really going to have an effect? I can definitely see how spraying thousand of tons of DDT can and will have an effect; however, are we currently protected or do have further to go?
A. That depends 99% on your culture [attitudes, values, aspirations, religion, mores, peers, media] and 1% on science. Farmers use pesticides because they can produce more food cheaper. If they cannot use pesticides, the cost of food goes up. There is some good scientific research that indicates that eating more fresh fruits and vegetables is good for you – specifically with colon cancer. So increasing the cost of fruit and vegetable might perhaps increase the incidence of colon cancer. Anyhow, if you had the science, one would need to weigh the cost of the colon cancer versus the cost of the diseases caused by the pesticides. In general there is no evidence that the level (dose) of pesticides in American produce causes any diseases. There are certainly high and chronic levels of pesticide exposure (dose), for example in agricultural workers, which can cause disease. And also there are occasionally accidental poisoning of people by adulteration of foods with chemicals. But these are both rare and a violation of current laws.
** Q. It was unclear if proposed regulations from agencies were published in the Federal Registrar (FR) or if the registrar was only for the final documents.
A. The FR is used to publish notices of proposed regulations, draft regulations, and final regulations. Exactly what must be published in the FR depends on where the regulation fits within the Administrative Procedures Act and agencies have some options. Today most agencies tend to publish more, i.e., give more notices, rather than less. They never try to “sneak something by.” Hence you will see many “corrections” and other mini notices in the FR. There are many other official notices besides proposed regulations that are likewise in the FR.
* Q. One of the chemicals I selected had little information on the health effects on humans, while the others had long list of effects from short term and long term exposure. Aside from using laboratory rats to determine potential adverse health effects is there another way that actual data is collected on humans? For example medical records?
A. Medical and death records are notoriously inaccurate. And remember, dose is a critical parameter. Estimating historical exposures (doses) is guesswork. We go into this area – epidemiology – in the Toxicology class, ENVE 652. The effects of some chemicals in heavy industrial use are well known, also from certain specialized chemicals. Some occupations have their own diseases – “popcorn workers lung” http://www.webmd.com/news/20070426/7-new-cases-of-popcorn-workers-lung is a current one. However for many known toxic substances, there is a tremendous variation in the effects, some individuals are very susceptible and some are very resistant. Also, many of the effects (disease) have other causes besides the specified chemical. Often it takes many years of exposure or the effects don’t occur until years after the exposure. For all cancers and lung disease studies, it is very important to separate smokers and non-smokers. Generally, the serious effects of smoking will obscure effects of other chemicals that may cause cancer or harm the lungs.
* Q. I understand there are financial consequences if a state does create laws or enforce laws that are as stringent as federal regulations, but is this the only consequence the state would face? Are there examples of states that have less stringent laws then the federal government?
A. Under the federal constitution, states did certain things and the federal government did certain things. There was always some overlap and since the 1960s, there has been a trend for the federal government to get involved with issues that, prior to the 1960s, were strictly done by the states. One way for the feds to do this is to allow the states to manage a portion of the law (or “program” that enforces the law) and give the states money to do so. One typical proviso of that system is that the state’s laws and its enforcement program must be no less stringent than the federal. If the states had a less stringent program, all they would loose is the federal money. The feds would then start enforcing the federal law and the state program, being less stringent, would have no effect. An interesting variation on that theme is our Fairbanks air pollution (which is trivial and, being from New Jersey, I find it hard to call “pollution”). Since that required some regional action by the state or local government, in a sense, the government was the culprit. The feds then demand state or local government action and threatened to cut off all federal highway funding, if the state or local government did not pass the required laws.
Question: Obviously this varies depending on where a person lives and what kind of job they have, but do you have a rough idea how much of the toxic/carcinogenic/other types of chemical hazard exposures are from food and water relative to air and other exposures?
Answer. That is a difficult question to answer. One could computer mg of some carcinogen, but you would have to calculate the potency of each type of carcinogen in order to do the analsis you suggest. In general, “environmental” exposures are an order of magnitude less than “occupational” exposures. And, in my opinion, the sum of environmental and occupation exposures are much less then many people take willingly via tobacco and alcohol use.