This is one of the shorter sections we are looking at, and this deals with regulation and government agencies, particularly in regulation of occupational safety and health, but also in the environment via the EPA. We'll talk very briefly about the legal framework for public health practice, follow that on by a brief overview of the regulatory agencies, particularly OSHA and the EPA, look at some of the broad OSHA standards, not the specific workplace standards, and some of its compliance directives, and then lastly we'll look at how the EPA regulates some environmental hazards. Regulation of public health practice can occur at both the federal and state level, with also some public health practice functions reserved to the county or to cities. At the federal level, the Centers for Disease Control and Prevention is responsible for much regulation of public health, with NASH sitting within the CDC and responsible to some extent for regulation of occupational health and safety, although OSHA, which is within the Department of Labor rather than the CDC, is the prime agency responsible for inspection and citation of workplaces. At the state level, the state can, based on statewide commerce, police workplaces, and it has the right to shut down plants or other known hazards, as well as to quarantine individuals. It can also regulate public health via building codes. Some towns will also have health codes, for example restaurants and other health inspections of food can occur at the city or town level, as well as additional building codes. So where does the regulatory process begin? First of all, Congress will authorize the creation of an agency. This can be the Environmental Protection Agency or the Occupational Safety and Health Administration, i.e. OSHA. That brings that agency into being, and there's enabling legislation and a Congressional Oversight Committee, which monitors its actions. And lastly, there's an Appropriations Committee, which doles out the money to the agency for its activities. Congress itself doesn't pass an OSHA-led standard or asbestos standard. What happens is that the agency or administration is empowered to write its own rules and standards. These have to go through public comment and can be overruled or modified by legislation. So fundamentally what Congress is doing is bringing into being an agency that has the authority to write the rules rather than pass specific laws or regulations for each workplace or environmental hazard. This is just a brief list of the most relevant public health legislation. The Pure Food and Drug Act, precursors of which appeared after about 1906, after publication of The Jungle and The Scandal of the Meatpacking Industry, and then this was subsequently modified in 1938. The Public Health Service Act is the big post-war act. This brings into being the CDC, as well as the National Institutes of Health, and NIOSH becomes part of the CDC after the OSHA Act in 1970. Most environmental and workplace safety legislation, as you can see, takes place in about a three to four year period in the late 1960s and early 1970s. This was a result of environmental consciousness, such as the first Earth Day occurring about the time, and also as a result of several severe major occupational accidents and tragedies, such as the Farmington Mine disaster in 1969, which led to passage of specific legislation protecting workplace health and safety. So occupational health and safety standards are regulated by two main administrations, OSHA and NIOSH. OSHA is situated in the Department of Labor, along with MSHA, which regulates underground and surface mining. OSHA can promulgate and issue workplace health and safety regulations and set standards, along with permissible exposure limits, can regulate how much workers can be exposed to, can regulate the need for surveillance examinations and related functions, and they are responsible for enforcement, so they have the right of entry, they can inspect unhealthy workplaces, and issue fines and citations depending on what they find within. NIOSH, by contrast, is sited within CDC, which together are within the Department of Health and Human Services, as opposed to the Department of Labor. So CDC, as we mentioned before, is concerned with general public health practice. NIOSH within the CDC is responsible for that as workplace function. What NIOSH mainly does is to research and gather data to set OSHA standards in the form of criteria documents. NIOSH is the main branch that funds intramural and extramural research. So much occupational health research is funded by NIOSH, either within its walls or through grants outside, and can conduct health hazard evaluations so that if workers suspect an unhealthy workplace, NIOSH can visit the workplace, take samples and the like, although they don't have the right of entry for citations or police functions that OSHA does. Also within the Department of Health and Human Services are the National Institutes of Health, in general, of which you could somewhat think of NIOSH as being similar, although it's housed within the CDC instead of the NIH and the Food and Drug Administration. So if you want to make some distinction here, OSHA are the cops and NIOSH are the nerds. Concerned with regulation of the environment is the Environmental Protection Agency, or EPA. This came into being in about 1970 with the passage of a variety of other environmental protection acts, including the Clean Water Act and the Clean Air Act, subsequently Superfund and the Toxic Substances Control Act. EPA is its own cabinet-level agency, although it's not housed in any department. We'll look at the EPA's regulations later on in the last set of slides in this lecture. OSHA standards, as I mentioned before, are set after review of evidence for promulgating a standard. The NIOSH criteria documents generally outline the evidence and review the extent of evidence and the evidence that's needed to set protective limits. This has to go through a federal rulemaking process, which involves comment by all stakeholders. This can be the public, unions, companies, and anyone else who wants to offer an opinion. OSHA standards vary, again, depending on which standard and which process is being regulated, and it can overall require that workplaces adopt work practices, methods, or working processes that are necessary and appropriate to protect workers. They can require that employers provide and that workers use personal protective equipment, and they can require that employees comply with regulations that apply to their own actions and conduct. So, for example, if personal protective equipment, such as hearing protective devices, are required, the employees have to comply with these regulations. It's down to the company to see that they're complying with it, and it's doubtful that OSHA would specifically find or cite employees. Rather, it would look at the company and indicate whether or not the company is in compliance or not with workers being able to use these materials. OSHA, as you can readily understand, does not and cannot write a specific standard for every chemical, metal, or toxicant that might be in use in the United States. Therefore, OSHA states that employers are responsible for compliance with its general duty clause. What the general duty clause requires is that an employer has to furnish a place of employment to its workers, which is free from recognized hazards that will cause, can cause, or might cause death or serious physical harm to employees. This becomes the major mechanism for OSHA to cite workplaces which are unhealthy but are not in compliance with any specific standard. This slide outlines some of the areas in which OSHA can use the general duty as a tool where it doesn't have a specific standard in which to cite unhealthy or hazardous workplaces, where there's poor control of hazardous lifting, for example, in nursing homes or hospitals or repetitive tasks, particularly the upper arms and hands. OSHA can cite or find those workplaces for providing an unhealthy workplace. OSHA also uses the general duty clause to cite more egregious cases of poor indoor air quality, and the general duty clause also becomes a tool that OSHA can use in an attempt to control workplace violence, such as we see in this daily news item here where a worker was trampled after a stampede on a Black Friday sale. In addition to the general duty clause, OSHA has some general standards which apply across workplaces. These include these four, the recording and reporting standard, the personal protective equipment standard, which applies mainly to respiratory protection, a standard on access to exposure and medical records, and the hazard communication standard. We'll look at three of these four in the next couple of slides and look at the respiratory protection standard when we get on to the more specific OSHA standards in another lecture. The OSHA recording and reporting standard, which gives rise to the OSHA 300 log, is one of the major cross-industry standards. This states that a injury or illness that arose at work is OSHA recordable if it's a new injury or illness and an event or exposure in the work environment was a cause or contributor to that injury or illness. Of note, the work exposure doesn't have to be the sole cause or the predominant cause of it, it just has to be contributed to by work. And the general recording criteria are whether the event or exposure caused death, which has to be reported very quickly, whether it caused the employee to take days away from work or to have restricted work or transfer, whether medical treatment beyond first aid was required, whether there was loss of consciousness, or whether there was an injury or illness that was significant enough to need diagnosis by a doctor or other licensed health care professional. There are a few specific mandates in the record-keeping standard that it behooves one to remember. Needlestick and sharps injuries that are contaminated by blood or potentially infectious materials such as body fluids need to be reported even if the employee does not become ill with a blood-borne pathogen infection. These have to be reported. If there is significant aggravation of a pre-existing injury, in other words, there was some event or exposure in the workplace which made the employee's illness or disorder measurably worse, again, death, loss of consciousness, or days away, and of occupational hearing loss. And this involves whether a standard threshold shift has been detected in audiometric screening. We'll talk a little bit about this last point in the noise and hearing lecture. I think it's important not to get too deeply into the weeds about the OSHA record-keeping standard. I've sort of quoted your chapter and verse in the last two slides because those are the things that are going to show up on the boards, but there also is a lot of debate within companies as to what might be OSHA recordable. So, for example, mental illness is not recordable because of difficulties in ascertaining the cause. Accidents that occur in the parking lots or travel or in eating, drinking, preparing food or drink aren't reportable as are common colds and flu. If you're in the company bowling league and you drop the ball on your foot and fracture your foot, that's not OSHA recordable because it's really off work time and personal grooming by the same token. Another good point to remember is that OSHA recordability does not imply that it's workers compensable or vice versa, so that a case in which a worker files a workers compensation claim may or may not be OSHA recordable, and an OSHA recordable event may not be appropriate for a workers compensation case. So, recall that these are two different systems. The OSHA record-keeping standard has requirements for record-keeping and logging in of injuries. All work-related injuries and illnesses have to be kept track on the OSHA 300 form, oftentimes known as the OSHA log. The Bureau of Labor Statistics will use these data for workplace injury statistics. Illness and injury incident reports also have to be completed for each recordable injury. These are kept by the company, copies have to be provided to the employee and to union representatives and other of the employees representative, and once a year during the period from February 1st to the end of April, the company has to post a aggregate summary of work-related injuries and illnesses that has to be certified, and it gives a picture of the injury experience of the company, and this has to be publicly available. Now it can be mainly online, but in the old days it used to have to be posted in and around the workplace itself. I'm just briefly putting this slide in here about the OSHA personal protective standard. We will talk much more about this in the following lecture when we get into more detail on the OSHA standards. I put this slide up to show you that there is a lot more to the requirements of the personal protective standard. We tend to think of ourselves as medical professionals doing medical clearance for respirator use, but there's a lot of work that has to proceed the medical clearance and fit testing of respirators. For example, there has to be a hazard assessment and then a selection and decision as to which respirators are going to be used so that they are appropriate for the types of hazards that are involved in a particular workplace. There also have to be protocols for cleaning and storage, there has to be fit testing, there has to be worker training, and there has to be protocols for replacement and storage of respirators when they're not being used. This next OSHA standard mandates that employees have access to their medical records at the company and to exposure records if any have been taken. These records generally pertain to surveillance or periodic examinations or other exams done for fitness and health related to exposures at the company. They should be kept from non-occupational medical records such as treatment of minor illnesses or other conditions that don't relate to employment and certainly kept separate from insurance records. The standard mandates that the company maintain these records for the duration of the worker's employment plus an additional 30 years so that they can be accessed if the worker presents with late or long latency illnesses. These have normal privacy protections as do any other medical records and designated representatives which may be union reps or even physicians may have access depending upon the employee's designation. Exposure records such as industrial hygiene surveys and analyses need to be kept for 30 years and in some way in a way that's able to relate to specific employees on those exposed jobs. The OSHA hazard communication standard is a standard that requires employers to develop and issue safety data sheets or SDSs formerly known as material safety data sheets and we oftentimes still see them referred to as MSDSs. If a chemical manufacturer makes a product they must develop a safety data sheet or SDS and they must send this downstream to the employers who are using those materials, label the containers, and provide the sheets. The employers who are using these materials have to keep and maintain access in a log book to all the safety data sheets and these must be made available to the employee and to their authorized representatives. This is one of the means by which we as physicians can serve as the employee's representative if we're assessing the health effects of some potential exposure. At the patient's request we can contact the company and demand to see these materials. The hazard communication program also includes training on SDSs and access. Just a brief story in the bad old days when I was a resident, SDSs were kept in a book on paper and they were very difficult. Oftentimes there would be a lot of stalling or difficulty in finding proper SDSs. This has gotten much easier with the internet now. Many responsible chemical manufacturers will keep these in a library online and they can just be looked for in a simple search and accessed very easily. As well, employees can take a picture of the materials they're working with and by that you get the brand name, the chemical name, possibly the cast number or numbers, and you can look it up online here. So it's much much easier than again it used to be in the olden days when I was training and had to assess chemical exposures in this way. Okay, so that finishes the OSHA standards. We're going to move on to environmental protection and environmental regulation and two sets of environmental regulations. We're going to see regulations of emissions, in other words air and water pollution and its regulation, and then environmental management system, which involves disposal of toxic or hazardous waste. The first of EPA's management systems regulation is the Resource Conservation and Recovery Act, known generally by its acronym of RCRA. For every EPA law regulation, I like to think there's a simple buzzword or buzzphrase by which we can remember what the law is supposed to do. In the case of RCRA, this is cradle-to-grave tracking and management of hazardous waste. So remember cradle-to-grave. What this means is that a company that generates toxic waste, something that it's going to dispose of, not send to the general market, once it's generated it has to be accounted for. And this generally takes the form of creating a manifest saying what's the material, what's the toxic waste, how much of it there is. Then that gets passed on to transportation sources, down to a treatment facility, which is oftentimes in a different location than the company that generated it. And disposal, for example incineration, burning or burying, or if that's not happening, in storage of the material. And all of this has to be accounted for every step down the line from the time the toxic waste is created, which is the cradle, down to where it's either stored or incinerated or otherwise disposed of the grave. One thing to remember that this refers to currently active and future hazardous waste sites. So this has effect from 1976 when many of these laws were passed. Prior to 1976 there was a lot of unregulated disposal of hazardous waste. This was meant to be dealt with by RCRA proactively going forward from that date. What we're going to look at in the next slide is CERCLA or Superfund, which regulates the abandoned or older hazardous waste sites. So as I mentioned for the last slide, CERCLA, universally known as Superfund, is the law that enables the EPA to clean up abandoned or unmanaged waste sites and to recover costs from the former owners. As I mentioned earlier, these are sites that prior to the 1970s were sites of unregulated dumping of hazardous waste, and in many cases they've been abandoned and no one is responsible for them. Superfund allows the government via the EPA to go after the prior owners and prior users or dumpers on these sites to recover costs of the cleanup. So this is where the concept of joint and several liability comes in, which means that anyone who can be identified as using that hazardous waste site is at least in part responsible for the cost of cleanup. Superfund or CERCLA also authorized the creation of the Agency for Toxic Substances and Disease Registry or ATSDR. This studies the hazards of the site, particularly the hazards to human health, puts out criteria documents outlining the hazards of these materials, and also comes to risk assessment calculations as to the priority sites in which Superfund will be involved in cleaning up. So moving off of hazardous waste now, we move on to the Toxic Substances Control Act. This involves chemicals that are in use, in other words, reach the consumer market, either in manufacturing or in selling to consumers in the United States, and it requires that these chemicals be tested, screened for their health effects, and if necessary, regulated. Generally, this means that the manufacturer has to submit some type of toxicologic testing data, the extent of which depends upon the chemical, the potential hazards, and the potential for its use. They submit that, and generally an approval is given, or there may be regulations put in place, which is somewhat rarer. There are six substances that get special attention under TSCA, and these are priorities for reducing their use and cleanup. Polychlorinated biphenyls or PCBs were banned in the 1970s and 1980s. These were used in electrical transformers and a variety of other materials, and generally the worry there is that there were persistent organic pollutants, which may have ongoing toxicity and possibly could be carcinogenic. Lead from paint and old housing was banned in the 1970s and 80s, as well as taken out of gasoline later on. TSCA helps to regulate and assists with the removal of asbestos used in schools. Elemental mercury has been removed from a number of sources, for example, medical equipment such as thermometers and blood pressure equipment in which it was formally used, so this reduces greatly the use of mercury into the consumer market. TSCA also helps to regulate radon in homes. We'll see a little bit more of that in the lecture on radiation and formaldehyde and its use in wood products, for example, things like medium density fiberboard is also regulated by TSCA. Regulation of pesticides in general terms is performed by the EPA under FFRA. This law mandates that all pesticides used in the United States have to have toxicity data submitted, and they have to be registered and licensed by EPA. Depending on the toxicity of the material and users, such as persons in agriculture or workers in utilities, have to register to purchase and use these pesticides. And again, depending on the toxicity, users have to take an exam to qualify as applicators. Some of the EPA mandates require good personal hygiene amongst applicators. This, for example, mandates the provision of hand washing stations, lavatories or toilets, and washing of uniforms. And in agriculture, this can be one of the few major protections for migrant farm workers. OSHA tends not to regulate these workers very well because they have no fixed place of work, instead following the harvest and crop growing seasons. And so through the EPA, if there are pesticides in use, many of these protections have to be afforded to migrant workers and becomes one of the few means of protecting them across their work. There are two EPA laws that deal with water, and I think it's important to keep them separate. There's the Clean Water Act and the Safe Drinking Water Act, both passed about the same time in the 1970s. The Clean Water Act, although it sounds like it may deal with drinking water, in fact is established to maintain the quality of surface and recreational waters. These are waters principally that people would swim in, would go fishing in, use for boating and other recreational purposes. So what the Clean Water Act does here is to regulate pollution discharge, generally from point sources, and this is either industrial or manufacturing dumping or sewage outflow from cities and towns, municipalities. The Clean Water Act has funded sewage treatment plants, and the creation of those plants has greatly reduced the amount of raw sewage effluent and human waste that are discharged into recreational waters. It also mandates minimum effluent guidelines that these plants need to follow. Here on the other hand is the Safe Drinking Water Act from 1974, and this does regulate public drinking water, as you can see on the name. The important point here is this is public drinking water that's supplied to homes and not into private wells. The Safe Drinking Water Act establishes a number of maximum contaminant levels, or MCLs, which are enforceable standards and specify the maximum that suppliers need to comply with. Numerous materials are in the drinking water standards as MCLs, including metals such as lead and arsenic, pesticide residues, nitrates from fertilizer runoff, and many organic chemicals, for example, those that may have been dumped and gotten into groundwater or in surface waters. Importantly, the Safe Drinking Water Act regulates coliform counts. Many of you may recall municipalities that have had a warning about boiling water because the water was contaminated. High coliform counts are an indicator of fecal contamination, and these have to be monitored essentially on a daily basis or nearly so. Disinfection byproducts such as halomethanes, which are materials or small organic molecules formed by chlorination, are also regulated. These are potential carcinogens as well as possible reproductive hazards. Lastly is the Clean Air Act of 1970. This is designed to control and abate air pollution and is the major regulation for pollution sources in the United States. This sets out standards of the criteria air pollutants, particularly primary standards, which are to protect human health, and on the next slide we'll see the major criteria air pollutants. There are also some secondary standards which protect public welfare, such as the soil and the water. The EPA, both here in the Clean Air Act and in the Safe Drinking Water Act, has a mandate to protect sensitive groups. In other words, children, the elderly, and those with chronic diseases. This is different than, for example, OSHA, which is mandated to protect most workers, but here in this case the most sensitive are the people for whom the standards are designed. These also require states to have a control plan to enforce the EPA's standards. This slide outlines the six criteria air pollutants covered by the Clean Air Act. Particulates, initially respirable particulates, those 10 microns or less in diameter, were originally regulated by the Clean Air Act. Subsequently, in 2004, regulation of fine particulates, or PM 2.5, those that get deep down into the alveoli and are associated more with pulmonary inflammation and also cardiovascular disease, were added to the Clean Air Act regulations. Oxides of nitrogen generally come from mobile sources like automobiles and combustion of gasoline. Sulfur dioxide, by the opposite token, comes from point sources, particularly burning of coal, but may also come from oil burning. Ozone is a photochemical product of degradation of volatile organic hydrocarbons that come out automobile tailpipes, and therefore comes from mobile sources. It's not a pollutant in and of itself coming from the car, but is a product of sunlight acting on these VOCs on hot summer days. Ozone is oftentimes the reason why there are air quality warnings in the summertime. Carbon monoxide is likely produced mainly by automobile sources, and lead is one of the great success stories of the Clean Air Act, having been taken out of gasoline in the 1970s and 1980s, and leading to an 80 to 90 percent reduction in blood lead levels in the American population. This concludes the lecture on regulation and government agencies.

regulation

occupational safety

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government agencies

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EPA

public health legislation