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4.5: Independent Executive Agencies

  • Page ID
    2030
  • An independent executive agency is created by Congress to address concerns that go beyond the scope of ordinary legislation. These agencies are responsible for keeping the government and the economy running smoothly. These agencies are not represented in the cabinet and are not part of the Executive Office of the president. They deal with government operations, the economy, and regulatory oversight.

    3553678-1555300472-5885599-41-nasa-florida.jpg
    Figure 4.5.1: NASA Florida

    NASA

    President Dwight D. Eisenhower established the National Aeronautics and Space Administration (NASA) in 1958 with a distinctly civilian (rather than military) orientation encouraging peaceful applications in space science. The National Aeronautics and Space Act was passed on July 29, 1958, disestablishing NASA's predecessor, the National Advisory Committee for Aeronautics (NACA). The new agency became operational on October 1, 1958.

    Since that time, most U.S. space exploration efforts have been led by NASA, including the Apollo moon-landing missions, the Skylab space station, and later the Space Shuttle. Currently, NASA is supporting the International Space Station and is overseeing the development of the Orion Multi-Purpose Crew Vehicle, the Space Launch System and Commercial Crew vehicles. The agency is also responsible for the Launch Services Program (LSP), which provides oversight of launch operations and countdown management for unmanned NASA launches. The organizational structure of NASA is shown in the following chart.

    NASA'S Organizational Structure
    Figure 4.5.2: * In accordance with law, the OEOP and SDBU maintain reporting relationships to the Deputy and the Administrator. ** Including a new emphasis on internal communicationsRevised: 6/24/04 Note that the administrative staff must also work side by side with advisory committees and the inspector general’s office who independently provides accounting and oversight for the actions of the agency. In addition, while the agency does not directly report to the President, it does report to Congress for oversight and funding.

    Video: The 50th Anniversary of NASA (2008)

    Important NASA Contributions

    Beginning in the last half of the 20th century and continuing today, the research and exploration efforts of NASA have contributed to discovery and development of many important technological innovations.

    Health and Medicine

    Light-Emitting Diodes (LEDs): Red light-emitting diodes are growing plants in space and healing humans on Earth. The LED technology used in NASA space shuttle plant growth experiments has contributed to the development of medical devices such as award-winning WARP 10, a hand-held, high-intensity, LED unit developed by Quantum Devices Inc. The WARP 10 is intended for the temporary relief of minor muscle and joint pain, arthritis, stiffness, and muscle spasms, and also promotes muscle relaxation and increases local blood circulation. The WARP 10 is being used by the U.S. Department of Defense and U.S. Navy as a noninvasive “soldier self-care” device that aids front-line forces with first aid for minor injuries and pain, thereby improving endurance in combat. The next-generation WARP 75 has been used to relieve pain in bone marrow transplant patients, and will be used to combat the symptoms of bone atrophy, multiple sclerosis, diabetic complications, Parkinson’s disease, and in a variety of ocular applications. (Spinoff 2005, 2008)

    Infrared ear thermometers: Diatek Corporation and NASA developed an aural thermometer, which weighs only 8 ounces and uses infrared astronomy technology to measure the amount of energy emitted by the eardrum, the same way the temperature of stars and planets is measured. This method avoids contact with mucous membranes, virtually eliminating the possibility of cross infection, and permits rapid temperature measurement of newborn, critically-ill, or incapacitated patients. NASA supported the Diatek Corporation, a world leader in electronic thermometry, through the Technology Affiliates Program. (Spinoff 1991)

    Artificial limbs: NASA’s continued funding, coupled with its collective innovations in robotics and shock-absorption/comfort materials are inspiring and enabling the private sector to create new and better solutions for animal and human prostheses. Advancements such as Environmental Robots Inc.’s development of artificial muscle systems with robotic sensing and actuation capabilities for use in NASA space robotic and extravehicular activities are being adapted to create more functionally dynamic artificial limbs (Spinoff 2004). Additionally, other private-sector adaptations of NASA’s temper foam technology have brought about custom-moldable materials offering the natural look and feel of flesh, as well as preventing friction between the skin and the prosthesis, and heat/moisture buildup. (Spinoff 2005)

    Ventricular assist device: Collaboration between NASA, Dr. Michael DeBakey, Dr. George Noon, and MicroMed Technology Inc. resulted in a lifesaving heart pump for patients awaiting heart transplants. The MicroMed DeBakey ventricular assist device (VAD) functions as a “bridge to heart transplant” by pumping blood throughout the body to keep critically ill patients alive until a donor heart is available. Weighing less than four ounces and measuring one by three inches, the pump is approximately one-tenth the size of other currently marketed pulsatile VADs. This makes it less invasive and ideal for smaller adults and children. Because of the pump’s small size, less than 5 percent of the patients implanted developed device-related infections. It can operate up to 8 hours on batteries, giving patients the mobility to do normal, everyday activities. (Spinoff 2002)

    Transportation

    Airplane anti-icing systems: NASA funding under the Small Business Innovation Research (SBIR) program and work with NASA scientists advanced the development of the certification and integration of a thermoelectric deicing system called Thermawing, a DC-powered air conditioner for single-engine aircraft called Thermacool, and high-output alternators to run them both. Thermawing, a reliable anti-icing and deicing system, allows pilots to safely fly through ice encounters and provides pilots of single-engine aircraft the heated wing technology usually reserved for a larger, jet-powered craft. Thermacool, an innovative electric air conditioning system, uses a new compressor whose rotary pump design runs off an energy-efficient, brushless DC motor and allows pilots to use the air conditioner before the engine even starts. (Spinoff 2007)

    Grooves in concrete: Safety grooving, the cutting of grooves in concrete to increase traction and prevent injury, was first developed to reduce aircraft accidents on wet runways. Represented by the International Grooving and Grinding Association, the industry expanded into highway and pedestrian applications. The technique originated at Langley Research Center, which assisted in testing the grooving at airports and on highways. Skidding was reduced, stopping distance decreased, and a vehicle’s cornering ability on curves was increased. The process has been extended to animal holding pens, steps, parking lots, and other potentially slippery surfaces. (Spinoff 1985)

    Radial tires: Goodyear Tire and Rubber Company developed a fibrous material, five times stronger than steel, for NASA to use in parachute shrouds to soft-land the Vikings on the Martian surface. The fiber’s chain-like molecular structure gave it incredible strength in proportion to its weight. Recognizing the increased strength and durability of the material, Goodyear expanded the technology and went on to produce a new radial tire with a tread life expected to be 10,000 miles greater than conventional radials. (Spinoff 1976)

    Chemical detection: NASA contracted with Intelligent Optical Systems (IOS) to develop moisture- and pH-sensitive sensors to warn of potentially dangerous corrosive conditions in aircraft before significant structural damage occurs. This new type of sensor, using a specially manufactured optical fiber whose entire length is chemically sensitive, changes color in response to contact with its target. After completing the work with NASA, IOS was tasked by the U.S. Department of Defense to further develop the sensors for detecting chemical warfare agents and potential threats, such as toxic industrial compounds and nerve agents, for which they proved just as successful. IOS has additionally sold the chemically sensitive fiber optic cables to major automotive and aerospace companies, who are finding a variety of uses for the devices such as aiding experimentation with nontraditional power sources, and as an economical “alarm system” for detecting chemical release in large facilities. (Spinoff 2007)

    Public Safety

    Video enhancing and analysis systems: Integraph Government Solutions developed its Video Analyst System (VAS) by building on Video Image Stabilization and Registration (VISAR) technology created by NASA to help FBI agents analyze video footage. Originally used for enhancing video images from nighttime videotapes made with hand-held camcorders, VAS is a state-of-the-art, simple, effective, and affordable tool for video enhancement and analysis offering benefits such as support of full-resolution digital video, stabilization, frame-by-frame analysis, conversion of analog video to digital storage formats, and increased visibility of filmed subjects without altering underlying footage. Aside from law enforcement and security applications, VAS has also been adapted to serve the military for reconnaissance, weapons deployment, damage assessment, training, and mission debriefing. (Spinoff 2001)

    Land mine removal device: Due to arrangements such as the one between Thiokol Propulsion and NASA that permits Thiokol to use NASA’s surplus rocket fuel to produce a flare that can safely destroy land mines, NASA is able to reduce propellant waste without negatively impacting the environment, and Thiokol is able to access the materials needed to develop the Demining Device flare. The Demining Device flare uses a battery-triggered electric match to ignite and neutralize land mines in the field without detonation. The flare uses solid rocket fuel to burn a hole in the mine’s case and burn away the explosive contents so the mine can be disarmed without hazard. (Spinoff 2000)

    Fire-resistant insulation over steel: Built and designed by Avco Corporation, the Apollo heat shield was coated with a material whose purpose was to burn and thus dissipate energy during reentry while charring, to form a protective coating to block heat penetration. NASA subsequently funded Avco’s development of other applications of the heat shield, such as fire-retardant paints and foams for aircraft, which led to the world’s first intumescent epoxy material, which expands in volume when exposed to heat or flames, acting as an insulating barrier and dissipating heat through burn-off. Further innovations based on this product include steel coatings devised to make high-rise buildings and public structures safer by swelling to provide a tough and stable insulating layer over the steel for up to four hours of fire protection, ultimately to slow building collapse and provide more time for escape. (Spinoff 2006)

    Firefighter gear: Firefighting equipment widely used throughout the United States is based on a NASA development that coupled Agency design expertise with lightweight materials developed for the U.S. Space Program. A project that linked NASA and the National Bureau of Standards resulted in a lightweight breathing system including a face mask, frame, harness, and air bottle, using an aluminum composite material developed by NASA for use on rocket casings. Aerospace technology has been beneficially transferred to civil-use applications for years, but perhaps the broadest fire-related technology transfer is the breathing apparatus worn by firefighters for protection from smoke inhalation injury. Additionally, radio communications are essential during a fire to coordinate hose lines, rescue victims, and otherwise increase efficiency and safety. NASA’s inductorless electronic circuit technology contributed to the development of a lower-cost, more rugged, short-range two-way radio now used by firefighters. NASA also helped develop a specialized mask weighing less than three ounces to protect the physically impaired from injuries to the face and head, as well as flexible, heat-resistant materials—developed to protect the space shuttle on reentry—which are being used both by the military and commercially in suits for municipal and aircraft-rescue firefighters. (Spinoff 1976)

    Consumer, Home, and Recreation

    Temper foam: As the result of a program designed to develop a padding concept to improve crash protection for airplane passengers, Ames Research Center developed a foam material with unusual properties. The material is widely used and commonly known as temper foam or “memory foam.” The material has been incorporated into a host of widely used and recognized products including mattresses, pillows, military and civilian aircraft, automobiles and motorcycles, sports safety equipment, amusement park rides and arenas, horseback saddles, archery targets, furniture, and human and animal prostheses. Its high-energy absorption and soft characteristics not only offer superior protection in the event of an accident or impact but enhanced comfort and support for passengers on long flights or those seeking restful sleep. Today, temper foam is being employed by NASCAR to provide added safety in racecars. (Spinoff 1976, 1977, 1979, 1988, 1995, 2002, 2005)

    Enriched Baby Food/Baby bottle: Commercially available infant formulas now contain a nutritional enrichment ingredient that traces its existence to NASA-sponsored research that explored the potential of algae as a recycling agent for long-duration space travel. The substance, formulated into the products life’s DHA and life’s ARA, can be found in over 90 percent of the infant formulas sold in the United States, and are added to the infant formulas sold in more than 65 additional countries. The products were developed and are manufactured by Martek Biosciences Corporation, which has pioneered the commercial development of products based on microalgae; the company’s founders and principal scientists acquired their expertise in this area while working on the NASA program. (Spinoff 1996, 2008)

    Portable Cordless Vacuums: Apollo and Gemini space mission technologies created by Black & Decker have helped change the way we clean around the house. For the Apollo space mission, NASA required a portable, self-contained drill capable of extracting core samples from below the lunar surface. Black & Decker was tasked with the job and developed a computer program to optimize the design of the drill’s motor and insure minimal power consumption. That computer program led to the development of a cordless miniature vacuum cleaner called the Dustbuster. (Spinoff 1981)

    Freeze dried food technology: In planning for the long-duration Apollo missions, NASA conducted extensive research into space food. One of the techniques developed was freeze drying—Action Products commercialized this technique, concentrating on snack food. The foods are cooked, quickly frozen, and then slowly heated in a vacuum chamber to remove the ice crystals formed by the freezing process. The final product retains 98 percent of its nutrition and weighs only 20 percent of its original weight. Today, one of the benefits of this advancement in food preparation includes simple nutritious meals available to handicapped and otherwise homebound senior adults unable to take advantage of existing meal programs sponsored by government and private organizations. (Spinoff 1976, 1994)

    Environmental and Agricultural Resources

    Silicon solar power cells: Homes across the country are now being outfitted with modern, high-performance, low-cost, single crystal silicon solar power cells that allow them to reduce their traditional energy expenditures and contribute to pollution reduction. The advanced technology behind these solar devices—which are competitively-priced and provide up to 50 percent more power than conventional solar cells—originated with the efforts of a NASA-sponsored 28-member coalition of companies, government groups, universities, and nonprofits forming the Environmental Research Aircraft and Sensor Technology (ERAST) Alliance. ERAST’s goal was to foster the development of remotely piloted aircraft intended to fly unmanned at high altitudes for days at a time, requiring advanced solar power sources that did not add weight. As a result, SunPower Corporation created the most advanced silicon-based cells available for terrestrial or airborne applications. (Spinoff 2005)

    Pollution Remediation

    A product using NASA’s microencapsulating technology is available to consumers and industry enabling them to safely and permanently clean petroleum-based pollutants from water. The microencapsulated wonder, Petroleum Remediation Product or “PRP,” has revolutionized the way oil spills are cleaned. The basic technology behind PRP is thousands of microcapsules—tiny balls of beeswax with hollow centers. Water cannot penetrate the microcapsule’s cell, but oil is absorbed right into the beeswax spheres as they float on the water’s surface. Contaminating chemical compounds that originally come from crude oil (such as fuels, motor oils, or petroleum hydrocarbons) are caught before they settle, limiting damage to ocean beds. (Spinoff 1994, 2006)

    Water purification: NASA engineers are collaborating with qualified companies to develop a complex system of devices intended to sustain the astronauts living on the International Space Station and, in the future, those who go on to explore the Moon. This system, tentatively scheduled for launch in 2008, will make use of available resources by turning wastewater from respiration, sweat, and urine into drinkable water. Commercially, this system is benefiting people all over the world who need affordable, clean water. By combining the benefits of chemical adsorption, ion exchange, and ultra-filtration processes, products using this technology yield safe, drinkable water from the most challenging sources, such as in underdeveloped regions where well water may be heavily contaminated. (Spinoff 1995, 2006)

    Software

    Better Software: From real-time weather visualization and forecasting, high-resolution 3-D maps of the Moon and Mars, to real-time tracking of the International Space Station and the space shuttle, NASA is collaborating with Google Inc. to solve a variety of challenging technical problems ranging from large-scale data management and massively distributed computing, to human-computer interfaces—with the ultimate goal of making the vast, scattered ocean of data more accessible and usable. With companies like InterSense, NASA continues to fund and collaborate on other software advancement initiatives benefiting such areas as photo/video image enhancement, virtual-reality/design, simulation training, and medical applications. (Spinoff 2005)

    Computer-generated car modeling/structural analysis software: NASA software engineers have created thousands of computer programs over the decades equipped to design, test, and analyze stress, vibration, and acoustical properties of a broad assortment of aerospace parts and structures (before prototyping even begins). The NASA Structural Analysis Program, or NASTRAN, is considered one of the most successful and widely-used NASA software programs. It has been used to design everything from Cadillacs to roller coaster rides. Originally created for spacecraft design, NASTRAN has been employed in a host of non-aerospace applications and is available to industry through NASA’s Computer Software Management and Information Center (COSMIC). COSMIC maintains a library of computer programs from NASA and other government agencies and offers them for sale at a fraction of the cost of developing a new program, benefiting companies around the world seeking to solve the largest, most difficult engineering problems. (Spinoff 1976, 1977, 1978, 1979, 1980, 1981, 1982, 1986, 1988, 1990, 1991, 1998)

    Internet-connected technology applications: Embedded Web Technology (EWT) software—originally developed by NASA for use by astronauts operating experiments on available laptops from anywhere on the International Space Station—lets a user monitor and/or control a device remotely over the Internet. NASA supplied this technology and guidance to TMIO LLC, who went on to develop a low-cost, real-time remote control and monitoring of a new intelligent oven product named “ConnectIo.” With combined cooling and heating capabilities, ConnectIo provides the convenience of being able to store cold food where it will remain properly refrigerated until a customized pre-programmable cooking cycle begins. The menu allows the user to simply enter the dinner time, and the oven automatically switches from refrigeration to the cooking cycle, so that the meal will be ready as the family arrives home for dinner. (Spinoff 2005)

    Industrial Productivity

    Powdered lubricants: NASA’s scientists developed a solid lubricant coating material that is saving the manufacturing industry millions of dollars. Developed as a shaft coating to be deposited by thermal spraying to protect foil air bearings used in oil-free turbomachinery, like gas turbines, this advanced coating, PS300, was meant to be part of a larger project: an oil-free aircraft engine capable of operating at high temperatures with increased reliability, lowered weight, reduced maintenance, and increased power. PS300 improves efficiency, lowers friction, reduces emissions, and has been used by NASA in advanced aeropropulsion engines, refrigeration compressors, turbochargers, and hybrid electrical turbogenerators. ADMA Products has found widespread industrial applications for the material. (Spinoff 2005)

    Tension and high-pressure monitoring for mine safety: An ultrasonic bolt elongation monitor developed by a NASA scientist for testing tension and high-pressure loads on bolts and fasteners has continued to evolve over the past three decades. Today, the same scientist and Luna Innovations are using a digital adaptation of this same device for a plethora of different applications, including non-destructive evaluation of railroad ties, groundwater analysis, radiation dosimetry, and as a medical testing device to assess levels of internal swelling and pressure for patients suffering from intracranial pressure and compartment syndrome, a painful condition that results when pressure within muscles builds to dangerous levels. The applications for this device continue to expand. (Spinoff 1978, 2005, 2008)

    Food safety systems: Faced with the problem of how and what to feed an astronaut in a sealed capsule under weightless conditions while planning for human space flight, NASA enlisted the aid of the Pillsbury Company to address two principal concerns: eliminating crumbs of food that might contaminate the spacecraft’s atmosphere and sensitive instruments, and assuring absolute freedom from potentially catastrophic disease-producing bacteria and toxins. Pillsbury developed the Hazard Analysis and Critical Control Point (HACCP) concept, potentially one of the most far-reaching space spinoffs, to address NASA’s second concern. HACCP is designed to prevent food safety problems rather than to catch them after they have occurred. The U.S. Food and Drug Administration has applied HACCP guidelines for the handling of seafood, juice, and dairy products. (Spinoff 1991)

    MORE INFORMATION:

    For more information on NASA’s technological contributions, check out the following Internet resources:

    https://www.nasa.gov/50th/50th_magazine/benefits.html

    http://spinoff.nasa.gov/

    http://www.independent.co.uk/news/science/50-years-50-giant-leaps-how-nasa-rocked-our-world-879377.html

    https://scepticalprophet.wordpress.com/2012/10/24/why-spend-money-on-science-nasas-contributions-to-society/

    http://www.post-gazette.com/life/lifestyle/2009/07/20/From-cell-phones-to-computers-technology-from-NASA-s-space-program-continues-to-touch-everyday-life/stories/200907200146

    Video: 25 NASA Discoveries that Changed Your Life

    DEBATE ACTIVITY - THE FUTURE OF NASA

    Recently, there has been a call to radically change the overall mission of NASA and reduce or eliminate its manned space flight missions. Cutting NASA's annual funding would result in at least $17 billion per year in annual savings. Is this a wise fiscal policy decision? Explain your answer using evidence from online resources and articles including the links provided below.

    http://tech.mit.edu/V130/N18/nasap.html http://news.nationalgeographic.com/news/2014/05/140530-space-politics-planetary-science-funding-exploration/

    www.popsci.com/tags/nasa-budget

    http://dbp.idebate.org/en/index.php/Debate:_Funding_for_space_exploration

    http://www.pbs.org/newshour/bb/science-jan-june10-nasa_02-02/

    http://www.huffingtonpost.com/howard-steven-friedman/nasa-funding-federal-budget_b_1464070.html

    http://www.space.com/22023-nasa-authorization-bill-debate.html

    http://www.c-span.org/video/?205561-4/house-debates-nasa-funding

    Figure 4.5.3: The United States Post Office is an independent agency of the federal government that is responsible for providing postal service.

    Regulatory Agencies

    Unlike independent executive agencies like NASA, the Environmental Protection Agency (EPA) and others like it act as regulatory agencies in order to implement and enforce specific Congressional laws. Other regulatory agencies that we will examine in this section include the Occupational Safety and Health Administration (OSHA), the Food and Drug Administration (FDA), and the Federal Communications Commission (FCC). Each of these agencies acts independently and reports directly to Congress for oversight and funding. In addition, these agencies have tremendous police and law enforcement powers, which accompany the Congressional statutes they are charged to enforce.

    Figure 4.5.4

    The Environmental Protection Agency

    The United States Environmental Protection Agency (EPA or sometimes USEPA) is an agency of the U.S. federal government, which was created for the purpose of protecting human health and the environment by writing and enforcing regulations based on laws passed by Congress. The EPA was proposed by President Richard Nixon and began operation on December 2, 1970, after Nixon signed an executive order. The order establishing the EPA was ratified by committee hearings in the House and Senate. The agency is led by its administrator, who is appointed by the president and approved by Congress. The current administrator is Gina McCarthy. The EPA is not a cabinet department, but the administrator is normally given cabinet rank.

    The EPA has its headquarters in Washington, D.C., regional offices for each of the agency's 10 regions, and 27 laboratories. The agency conducts environmental assessment, research, and education. It has the responsibility of maintaining and enforcing national standards under a variety of environmental laws, in consultation with state, tribal, and local governments. It delegates some permitting, monitoring, and enforcement responsibility to U.S. states and the federally recognized tribes. EPA enforcement powers include fines, sanctions, and other measures. The agency also works with industries and all levels of government in a wide variety of voluntary pollution prevention programs and energy conservation efforts.

    The agency has approximately 15,193 full-time employees and engages many more people on a contractual basis. More than half of EPA human resources are engineers, scientists, and environmental protection specialists; other groups include legal, public affairs, financial, and information technologists.

    The EPA oversees a number of important programs and enforces a great number of federal statutes regarding the quality of air, water, and soil in the United States. Some of its most important and most highly visible programs include:

    Energy Star: In 1992 the EPA launched the Energy Star program, a voluntary program that fosters energy efficiency.

    Pesticide oversight and regulation: The EPA administers the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (which is much older than the agency) and registers all pesticides legally sold in the United States.

    Environmental Impact Statement Review: EPA is responsible for reviewing Environmental Impact Statements of other federal agencies' projects, under the National Environmental Policy Act (NEPA).

    Safer Detergents Stewardship Initiative: Through the Safer Detergents Stewardship Initiative (SDSI), [29] EPA's Design for the Environment (DfE) recognizes environmental leaders who voluntarily commit to the use of safer surfactants. Safer surfactants are the ones that break down quickly to non-polluting compounds and help protect aquatic life in both fresh and salt water.

    The Design for the Environment has identified safer alternative surfactants through partnerships with industry and environmental advocates. These safer alternatives are comparable in cost and are readily available. CleanGredients is a source of safer surfactants.

    Fuel economy: Manufacturers selling automobiles in the USA are required to provide EPA fuel economy test results for their vehicles and the manufacturers are not allowed to provide results from alternate sources. The fuel economy is calculated using the emissions data collected during two of the vehicle's Clean Air Act certification tests by measuring the total volume of carbon captured from the exhaust during the tests.

    The current testing system was originally developed in 1972 and used driving cycles designed to simulate driving during rush-hour in Los Angeles during that era. Prior to 1984, the EPA reported the exact fuel economy figures calculated from the test. In 1984, the EPA began adjusting city (aka Urban Dynamometer Driving Schedule or UDDS) results downward by 10% and highway (aka HighWay Fuel Economy Test or HWFET) results by 22% to compensate for changes in driving conditions since 1972 and to better correlate the EPA test results with real-world driving. In 1996, the EPA proposed updating the Federal Testing Procedure to add a new higher speed test (US06) and an air-conditioner test (SC03) to further improve the correlation of fuel economy and emission estimates with real-world reports. The updated testing methodology was finalized in December, 2006 for implementation with model year 2008 vehicles and set the precedent of a 12-year review cycle for the test procedures.

    In February 2005, the organization launched a program called "Your MPG" that allows drivers to add real-world fuel economy statistics into a database on the EPA's fuel economy website and compare them with others and the original EPA test results.

    It is important to note that the EPA actually conducts these tests on very few vehicles. "While the public mistakenly presumes that this federal agency is hard at work conducting complicated tests on every new model of truck, van, car, and SUV, in reality, just 18 of the EPA's 17,000 employees work in the automobile-testing department in Ann Arbor, Michigan, examining 200 to 250 vehicles a year, or roughly 15 percent of new models. As to that other 85 percent, the EPA takes automakers at their word—without any testing-accepting submitted results as accurate." Two-thirds of the vehicles the EPA tests themselves are selected randomly, and the remaining third are tested for specific reasons.

    Although originally created as a reference point for fossil fuelled vehicles, driving cycles have been used for estimating how many miles an electric vehicle will do on a single charge. [35]

    Air quality: The Air Quality Modeling Group (AQMG) is in the EPA's Office of Air and Radiation (OAR) and provides leadership and direction on the full range of air quality models, air pollution dispersion models and other mathematical simulation techniques used in assessing pollution control strategies and the impacts of air pollution sources.

    The AQMG serves as the focal point on air pollution modeling techniques for other EPA headquarters staff, EPA regional Offices, and State and local environmental agencies. It coordinates with the EPA's Office of Research and Development (ORD) on the development of new models and techniques, as well as wider issues of atmospheric research. Finally, the AQMG conducts modeling analyses to support the policy and regulatory decisions of the EPA's Office of Air Quality Planning and Standards (OAQPS).

    Oil pollution: SPCC: Spill Prevention, Control, and Countermeasure Rule. Applies to all facilities that store, handle, process, gather, transfer, store, refine, distribute, use or consume oil or oil products. Oil products include petroleum and non-petroleum oils as well as: animal fats, oils and greases; fish and marine mammal oils; and vegetable oils, (including oils from seeds, nuts, fruits, and kernels). Mandates that a written plan is required for facilities that store more than 1,320 gallons of fuel above ground or more than 42,000 gallons below-ground, and may reasonably be expected to discharge to navigable waters(as defined in the Clean Water Act)or adjoining shorelines. Secondary Containment mandated at oil storage facilities. Oil release containment is required at oil development sites.

    WaterSense: is an EPA program designed to encourage water efficiency in the United States through the use of a special label on consumer products. It was launched in June 2006.[38] Products include high-efficiency toilets (HETs), bathroom sink faucets (and accessories), and irrigation equipment. WaterSense is a voluntary program, with EPA developing specifications for water-efficient products through a public process and product testing by independent laboratories. [39]

    Drinking water: The EPA ensures safe drinking water for the public, by setting standards for more than 160,000 public water systems throughout the United States. EPA oversees states, local governments, and water suppliers to enforce the standards, under the Safe Drinking Water Act. The program includes regulation of injection wells in order to protect underground sources of drinking water. Select readings of amounts of certain contaminants in drinking water, precipitation, and surface water, in addition to milk and air, are reported on EPA's Rad Net web site in a section entitled Envirofacts. In certain cases, readings exceeding EPA MCL levels are deleted or not included despite mandatory reporting regulations. A draft of revised EPA regulations relaxes the regulations for radiation exposure through drinking water, stating that current standards are impractical to enforce. The EPA is recommending that intervention is not necessary until drinking water is contaminated with radioactive iodine 131 at a concentration of 81,000 picocuries per liter (the limit for short term exposure set by the International Atomic Energy Agency), which is 27,000 times the current EPA limit of 3 picocuries per liter for long-term exposure. [42]

    Radiation protection: The EPA has the following seven project groups to protect the public from radiation. These include:

    • Radioactive Waste Management
    • Emergency Preparedness and Response Programs
    • Protective Action Guides and Planning Guidance for Radiological Incidents. EPA developed the manual to provide guidelines for local and state governments to protect the public from a nuclear accident.
    • EPA Cleanup and Multi-Agency Program.
    • Risk Assessment and Federal Guidance Programs [48]
    • Naturally-Occurring Radioactive Materials Program [49]
    • Air and Water Programs [50]
    • Radiation Source Reduction and Management [51]

    Research Vessel (OSV Bold): On March 3, 2004, the United States Navy transferred USNS Bold, a Stalwart class ocean surveillance ship, to the EPA, now known as OSV Bold. The ship, previously used in anti-submarine operations during the Cold War, is equipped with side-scan sonar, underwater video, water and sediment sampling instruments, used in the study of ocean and coastline. One of the major missions of the Bold was to monitor for ecological impact sites where materials are dumped from dredging operations in U.S. ports. [52] In 2013, the Bold was awarded to Seattle Central Community College (SCCC) by the General Services Administration. SCCC demonstrated in a competition that they would put it to the highest and best purpose, and acquired the ship at a cost of $5,000. [53]

    Advance identification: Advance identification, or ADID, is a planning process used by the EPA to identify wetlands and other bodies of water and their respective suitability for the discharge of dredged and fill material. The EPA conducts the process in cooperation with the U.S. Army Corps of Engineers and local states or Native American Tribes. As of February 1993, 38 ADID projects had been completed and 33 were ongoing. [54]

    Superfund: Superfund is the federal government's program to clean up the nation's uncontrolled hazardous waste sites. Those sites that are so dangerous as to be placed on the “National Priorities List” are overseen and monitored intensely and are cleaned up to protect the environment and the health of all Americans.

    Figure 4.5.5: The Occupational Safety and Health Act was signed by President Nixon to assure safe and healthful working conditions for working men and women by setting and enforcing standards and by providing training, outreach, education, and assistance.

    The Occupational Safety and Health Administration (OSHA)

    OSHA is an agency of the United States Department of Labor. Congress established the agency under the Occupational Safety and Health Act, which President Richard M. Nixon signed into law on December 29, 1970. OSHA's mission is to "assure safe and healthful working conditions for working men and women by setting and enforcing standards and by providing training, outreach, education, and assistance". The agency is also charged with enforcing a variety of whistleblower statutes and regulations. OSHA is currently headed by Assistant Secretary of Labor David Michaels.

    OSHA officially formed on April 28, 1971, the date that the OSH Act became effective. George Guenther was appointed as the agency's first director.

    Rights and Responsibilities Under OSHA

    Employers have the responsibility to provide a safe workplace. By law, employers must provide their workers with a workplace that does not have serious hazards and must follow all OSHA safety and health standards. Employers must find and correct safety and health problems. OSHA further requires that employers must first try to eliminate or reduce hazards by making feasible changes in working conditions rather than relying on personal protective equipment such as masks, gloves, or earplugs. Switching to safer chemicals, enclosing processes to trap harmful fumes, or using ventilation systems to clean the air are examples of effective ways to eliminate or reduce risks.

    Employers must also:

    • Inform workers about chemical hazards through training, labels, alarms, color-coded systems, chemical information sheets, and other methods.
    • Provide safety training to workers in a language and vocabulary they can understand.
    • Keep accurate records of work-related injuries and illnesses.
    • Perform tests in the workplace, such as air sampling, required by some OSHA standards.
    • Provide required personal protective equipment at no cost to workers. (Employers must pay for most types of required personal protective equipment.)
    • Provide hearing exams or other medical tests when required by OSHA standards.
    • Post OSHA citations and annually post injury and illness summary data where workers can see them.
    • Notify OSHA within eight hours of a workplace fatality. Notify OSHA within 24 hours of all work-related inpatient hospitalizations, all amputations, and all losses of an eye (1-800-321-OSHA [6742]).
    • Prominently display the official OSHA Job Safety and Health – It’s the law poster that describes rights and responsibilities under the OSH Act.
    • Not retaliate or discriminate against workers for using their rights under the law, including their right to report a work-related injury or illness.

    Workers have the right to:

    • Working conditions that do not pose a risk of serious harm.
    • File a confidential complaint with OSHA to have their workplace inspected.
    • Receive information and training about hazards, methods to prevent harm, and the OSHA standards that apply to their workplace. The training must be done in a language and vocabulary workers can understand.
    • Receive copies of records of work-related injuries and illnesses that occur in their workplace.
    • Receive copies of the results from tests and monitoring done to find and measure hazards in their workplace.
    • Receive copies of their workplace medical records.
    • Participate in an OSHA inspection and speak in private with the inspector.
    • File a complaint with OSHA if they have been retaliated or discriminated against by their employer as the result of requesting an inspection or using any of their other rights under the OSH Act.
    • File a complaint if punished or retaliated against for acting as a “whistleblower” under the 21 additional federal laws for which OSHA has jurisdiction.

    Temporary workers must be treated like permanent employees. Staffing agencies and host employers share joint accountability over temporary workers. Both entities are therefore bound to comply with workplace health and safety requirements and to ensure worker safety and health. OSHA could hold both the host and temporary employers responsible for the violation of any condition.

    Health and Safety Standards

    The Occupational Safety and Health Act grants OSHA the authority to issue workplace health and safety regulations. These regulations include limits on hazardous chemical exposure, employee access to hazard information, requirements for the use of personal protective equipment, and requirements to prevent falls and hazards from operating dangerous equipment.

    OSHA’s current Construction, General Industry, Maritime and Agriculture standards are designed to protect workers from a wide range of serious hazards. Examples of OSHA standards include requirements for employers to: provide fall protection such as a safety harness/line or guardrails; prevent trenching cave-ins; prevent exposure to some infectious diseases; ensure the safety of workers who enter confined spaces; prevent exposure to harmful chemicals; put guards on dangerous machines; provide respirators or other safety equipment; and provide training for certain dangerous jobs in a language and vocabulary workers can understand.

    Employers must also comply with the General Duty Clause of the OSH Act. This clause requires employers to keep their workplaces free of serious recognized hazards and is generally cited when no specific OSHA standard applies to the hazard.

    In its first year of operation, OSHA was permitted to adopt regulations based on guidelines set by certain standards organizations, such as the American Conference of Governmental Industrial Hygienists, without going through all of the requirements of a typical rulemaking. OSHA is granted the authority to promulgate standards that prescribe the methods employers are legally required to follow to protect their workers from hazards. Before OSHA can issue a standard, it must go through a very extensive and lengthy process that includes substantial public engagement, notice, and comment. The agency must show that a significant risk to workers exists and that there are feasible measures employers can take to protect their workers.

    In 2000, OSHA issued an ergonomics standard. In March 2001, Congress voted to repeal the standard through the Congressional Review Act. The repeal, one of the first major pieces of legislation signed by President George W. Bush, is the only instance that Congress has successfully used the Congressional Review Act to block a regulation.

    Regulatory Enforcement

    OSHA is responsible for enforcing its standards on regulated entities. Compliance Safety and Health Officers carry out inspections and assess fines for regulatory violations. Inspections are planned for worksites in particularly hazardous industries. Inspections can also be triggered by a workplace fatality, multiple hospitalizations, worker complaints, or referrals.

    OSHA is a small agency, given the size of its mission: with its state partners, OSHA has approximately 2,400 inspectors covering more than 8 million workplaces where 130 million workers are employed. In Fiscal Year 2012 (ending Sept. 30), OSHA and its state partners conducted more than 83,000 inspections of workplaces across the United States — just a fraction of the nation’s worksites. [19] According to a report by AFL–CIO, it would take OSHA 129 years to inspect all workplaces under its jurisdiction.

    Enforcement plays an important part in OSHA’s efforts to reduce workplace injuries, illnesses, and fatalities. Inspections are initiated without advance notice, conducted using on-site or telephone and facsimile investigations, performed by trained compliance officers and scheduled based on the following priorities [highest to lowest]: imminent danger; catastrophes – fatalities or hospitalizations; worker complaints and referrals; targeted inspections – particular hazards, high injury rates; and follow-up inspections.

    Current workers or their representatives may file a complaint and ask OSHA to inspect their workplace if they believe that there is a serious hazard or that their employer is not following OSHA standards. Workers and their representatives have the right to ask for an inspection without OSHA telling their employer who filed the complaint. It is a violation of the OSH Act for an employer to fire, demote, transfer or in any way discriminate against a worker for filing a complaint or using other OSHA rights.

    When an inspector finds violations of OSHA standards or serious hazards, OSHA may issue citations and fines. A citation includes methods an employer may use to fix a problem and the date by which the corrective actions must be completed. OSHA’s fines are very low compared with other government agencies. The maximum OSHA fine for a serious violation is $7,000, and the maximum fine for a repeat or willful violation is $70,000. In determining the amount of the proposed penalty, OSHA must take into account the gravity of the alleged violation and the employer’s size of the business, good faith, and history of previous violations. Employers have the right to contest any part of the citation, including whether a violation actually exists. Workers only have the right to challenge the deadline by which a problem must be resolved. Appeals of citations are heard by the independent Occupational Safety and Health Review Commission (OSHRC).

    OSHA carries out its enforcement activities through its 10 regional offices and 90 area offices. OSHA’s regional offices are located in Boston, New York City, Philadelphia, Atlanta, Chicago, Dallas, Kansas City metropolitan area, Denver, San Francisco, and Seattle.

    Video: Introduction to OSHA

    Figure 4.5.6: The FDA consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

    The Food and Drug Administration (FDA or USFDA)

    The FDA is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

    The FDA was empowered by the United States Congress to enforce the Federal Food, Drug, and Cosmetic Act, which serves as the primary focus for the Agency; the FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs. These include regulating lasers, cellular phones, condoms and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction.

    The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services. Dr. Scott Gottlieb is the current acting commissioner.

    The FDA has its headquarters in unincorporated White Oak, Maryland. The agency also has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico. In addition, the FDA began posting employees in foreign countries such as China, India, Costa Rica, Chile, Belgium, and the United Kingdom in 2008.

    Video: A Brief History & Overview of the FDA

    Facilities

    While most of the Centers are located in the Washington, D.C. area as part of the Headquarters divisions, two offices – the Office of Regulatory Affairs (ORA) and the Office of Criminal Investigations (OCI) – are primarily field offices with a workforce spread across the country.

    The Office of Regulatory Affairs is considered the "eyes and ears" of the agency, conducting the vast majority of the FDA's work in the field. Consumer Safety Officers, more commonly called Investigators, are the individuals who inspect production and warehousing facilities, investigate complaints, illnesses, or outbreaks, and review documentation in the case of medical devices, drugs, biological products, and other items where it may be difficult to conduct a physical examination or take a physical sample of the product.

    The Office of Regulatory Affairs is divided into five regions, which are further divided into 20 districts. Districts are based roughly on the geographic divisions of the federal court system. Each district comprises a main district office and a number of Resident Posts, which are FDA remote offices that serve a particular geographic area. ORA also includes the Agency's network of regulatory laboratories, which analyze any physical samples taken. Though samples are usually food-related, some laboratories are equipped to analyze drugs, cosmetics, and radiation-emitting devices.

    The Office of Criminal Investigations was established in 1991 to investigate criminal cases. Unlike ORA Investigators, OCI Special Agents are armed and don't focus on technical aspects of the regulated industries. OCI agents pursue and develop cases where individuals and companies have committed criminal actions, such as fraudulent claims, or knowingly and willfully shipping known adulterated goods in interstate commerce. In many cases, OCI pursues cases involving Title 18 violations (e.g., conspiracy, false statements, wire fraud, mail fraud), in addition to prohibited acts as defined in Chapter III of the FD&C Act. OCI Special Agents often come from other criminal investigations backgrounds and work closely with the Federal Bureau of Investigation, Assistant Attorney General, and even Interpol. OCI receives cases from a variety of sources—including ORA, local agencies, and the FBI—and works with ORA Investigators to help develop the technical and science-based aspects of a case. OCI is a smaller branch, comprising about 200 agents nationwide.

    The FDA frequently works with other federal agencies, including the Department of Agriculture, Drug Enforcement Administration, Customs and Border Protection, and Consumer Product Safety Commission. Often local and state government agencies also work with the FDA to provide regulatory inspections and enforcement action.

    The FDA regulates more than U.S. $1 trillion worth of consumer goods, about 25% of consumer expenditures in the United States. This includes $466 billion in food sales, $275 billion in drugs, $60 billion in cosmetics and $18 billion in vitamin supplements. Much of these expenditures are for goods imported into the United States; the FDA is responsible for monitoring imports. [11]

    Scope and Mission

    FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

    FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

    Finally, the FDA plays a significant role in the Nation’s counterterrorism capability. The FDA fulfills this responsibility by ensuring the security of the food supply and by fostering the development of medical products to respond to deliberate and naturally emerging public health threats.

    Most federal laws concerning the FDA are part of the Food, Drug, and Cosmetic Act, (first passed in 1938 and extensively amended since) and are codified in Title 21, Chapter 9 of the United States Code. Other significant laws enforced by the FDA include the Public Health Service Act, parts of the Controlled Substances Act, the Federal Anti-Tampering Act, as well as many others. In many cases, these responsibilities are shared with other federal agencies.

    Regulatory Programs

    The programs for safety regulation vary widely by the type of product, its potential risks, and the regulatory powers granted to the agency. For example, the FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy, and safety—yet FDA regulation of cosmetics focuses primarily on labeling and safety. The FDA regulates most products with a set of published standards enforced by a modest number of facility inspections. Inspection observations are documented on FDA Form 483.

    Regulation of Food and Dietary Supplements by the U.S. Food and Drug Administration

    The regulation of food and dietary supplements by the U.S. Food and Drug Administration is governed by various statutes enacted by the United States Congress and interpreted by the FDA. Pursuant to the Federal Food, Drug, and Cosmetic Act ("the Act") and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States and to monitor claims made in the labeling about both the composition and the health benefits of foods.

    The FDA subdivides substances that it regulates as food into various categories—including foods, food additives, added substances (man-made substances that are not intentionally introduced into food but nevertheless end up in it), and dietary supplements. Specific standards the FDA exercises differ from one category to the next. Furthermore, legislation had granted the FDA a variety of means to address violations of standards for a given substance category.

    Drugs

    The Center for Drug Evaluation and Research uses different requirements for the three main drug product types: new drugs, generic drugs, and over-the-counter drugs. A drug is considered "new" if it is made by a different manufacturer, uses different excipients or inactive ingredients, is used for a different purpose, or undergoes any substantial change. The most rigorous requirements apply to new molecular entities: drugs that are not based on existing medications.

    New Drugs

    New drugs receive extensive scrutiny before FDA approval in a process called a New Drug Application (NDA). New drugs are available only by prescription by default. A change to over-the-counter (OTC) status is a separate process, and the drug must be approved through an NDA first. A drug that is approved is said to be "safe and effective when used as directed."

    Advertising and Promotion

    The FDA's Office of Prescription Drug Promotion reviews and regulates prescription drug advertising and promotion through surveillance activities and issuance of enforcement letters to pharmaceutical manufacturers. Advertising and promotion for over-the-counter drugs are regulated by the Federal Trade Commission.

    The drug advertising regulation contains two broad requirements: (1) a company may advertise or promote a drug only for the specific indication or medical use for which it was approved by the FDA. Also, an advertisement must contain a "fair balance" between the benefits and the risks (side effects) of a drug.

    The term off-label refers to drug usage for indications other than those approved by the FDA.

    Postmarket Safety Surveillance

    After NDA approval, the sponsor must review and report to the FDA every patient adverse drug experience it learns of. They must report unexpected serious and fatal adverse drug events within 15 days, and other events on a quarterly basis. [22] The FDA also receives directly adverse drug event reports through its MedWatch program. [23] These reports are called "spontaneous reports" because reporting by consumers and health professionals is voluntary.

    While this remains the primary tool of postmarket safety surveillance, FDA requirements for postmarketing risk management are increasing. As a condition of approval, a sponsor may be required to conduct additional clinical trials, called Phase IV trials. In some cases, the FDA requires risk management plans for some drugs that may provide for other kinds of studies, restrictions, or safety surveillance activities.

    Generic Drugs

    Generic drugs are chemical equivalents of name-brand drugs whose patents have expired. In general, they are less expensive than their name brand counterparts, are manufactured and marketed by other companies and, in the 1990s, accounted for about a third of all prescriptions written in the United States. For the approval of a generic drug, the U.S. Food and Drug Administration (FDA) requires scientific evidence that the generic drug is interchangeable with or therapeutically equivalent to the originally approved drug. This is called an "ANDA" (Abbreviated New Drug Application). As of 2012 80% of all FDA approved drugs are available in generic form.

    Generic Drug Scandal

    In 1989, a major scandal erupted involving the procedures used by the FDA to approve generic drugs for sale to the public. Charges of corruption in generic drug approval first emerged in 1988, in the course of an extensive congressional investigation into the FDA. The oversight subcommittee of the United States House Energy and Commerce Committee resulted from a complaint brought against the FDA by Mylan Laboratories Inc. of Pittsburgh. When its application to manufacture generics were subjected to repeated delays by the FDA, Mylan, convinced that it was being discriminated against, soon began its own private investigation of the agency in 1987.

    Mylan eventually filed suit against two former FDA employees and four drug-manufacturing companies, charging that corruption within the federal agency resulted in racketeering and in violations of antitrust law. "The order in which new generic drugs were approved was set by the FDA employees even before drug manufacturers submitted applications" and, according to Mylan, this illegal procedure was followed to give preferential treatment to certain companies. During the summer of 1989, three FDA officials (Charles Y. Chang, David J. Brancato, Walter Kletch) pleaded guilty to criminal charges of accepting bribes from generic drugs makers, and two companies (Par Pharmaceutical and its subsidiary Quad Pharmaceuticals) pleaded guilty to giving bribes.

    Furthermore, it was discovered that several manufacturers had falsified data submitted in seeking FDA authorization to market certain generic drugs. Vitarine Pharmaceuticals of New York, which sought approval of a generic version of the drug Dyazide, a medication for high blood pressure, submitted Dyazide, rather than its generic version, for the FDA tests. In April 1989, the FDA investigated 11 manufacturers for irregularities; and later brought that number up to 13. Dozens of drugs were eventually suspended or recalled by manufacturers. In the early 1990s, the U.S. Securities and Exchange Commission filed securities fraud charges against the Bolar Pharmaceutical Company, a major generic manufacturer based in Long Island, New York.

    Over-the-counter drugs

    Over-the-counter (OTC) drugs like aspirin are drugs and combinations that do not require a doctor's prescription. [27] The FDA has a list of approximately 800 approved ingredients that are combined in various ways to create more than 100,000 OTC drug products. Many OTC drug ingredients had been previously approved prescription drugs now deemed safe enough for use without a medical practitioner's supervision like ibuprofen

    Ebola Treatment

    In 2014, the FDA added an Ebola treatment being developed by Canadian pharmaceutical company Tekmira to the Fast Track program but halted the phase 1 trials in July pending the receipt of more information about how the drug works. This is seen as increasingly important in the face of a major outbreak of the disease in West Africa that began in late March 2014 and continued as of August 2014.

    Vaccines, blood and tissue products, and biotechnology

    The Center for Biologics Evaluation and Research is the branch of the FDA responsible for ensuring the safety and efficacy of biological therapeutic agents. [30] These include blood and blood products, vaccines, allergenics, cell, and tissue-based products, and gene therapy products. New biologics are required to go through a premarket approval process called a Biologics License Application (BLA), similar to that for drugs.

    The original authority for government regulation of biological products was established by the 1902 Biologics Control Act, with additional authority established by the 1944 Public Health Service Act. Along with these Acts, the Federal Food, Drug, and Cosmetic Act applies to all biologic products, as well. Originally, the entity responsible for the regulation of biological products resided under the National Institutes of Health; this authority was transferred to the FDA in 1972.

    Medical and radiation-emitting devices

    The Center for Devices and Radiological Health (CDRH) is the branch of the FDA responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance, and safety of these devices. The definition of a medical device is given in the FD&C Act, and it includes products from the simple toothbrush to complex devices such as implantable brain pacemakers. CDRH also oversees the safety performance of non-medical devices that emit certain types of electromagnetic radiation. Examples of CDRH-regulated devices include cellular phones, airport baggage screening equipment, television receivers, microwave ovens, tanning booths, and laser products.

    CDRH regulatory powers include the authority to require certain technical reports from the manufacturers or importers of regulated products, to require that radiation-emitting products meet mandatory safety performance standards, to declare regulated products defective, and to order the recall of defective or noncompliant products. CDRH also conducts limited amounts of direct product testing.

    "FDA-Cleared" vs "FDA-Approved"

    Clearance requests are for medical devices that prove they are "substantially equivalent" to the predicate devices already on the market. Approved requests are for items that are new or substantially different and need to demonstrate "safety and efficacy", for example, it may be inspected for safety in case of new toxic hazards. Both aspects need to be proved or provided by the submitter to ensure proper procedures are followed.

    "FDA-Approved" vs. "FDA-Accepted in Food Processing"

    The FDA does not approve applied coatings used in the food processing industry. There is no review process to approve the composition of nonstick coatings, nor does the FDA inspect or test these materials. Through their governing of processes, however, the FDA does have a set of regulations that cover the formulation, manufacturing, and use of nonstick coatings. Hence, materials like Polytetrafluoroethylene (Teflon) are not, and cannot be, considered as FDA Approved, rather, they are "FDA Compliant" or "FDA Acceptable."

    Cosmetics

    Cosmetics are regulated by the Center for Food Safety and Applied Nutrition, the same branch of the FDA that regulates food. Cosmetic products are not, in general, subject to premarket approval by the FDA unless they make "structure or function claims" that make them into drugs, However, all color additives must be specifically FDA approved before manufacturers can include them in cosmetic products sold in the U.S. The FDA regulates cosmetics labeling, and cosmetics that have not been safety tested must bear a warning to that effect.

    Cosmetic products

    Though the cosmetic industry is predominantly responsible in ensuring the safety of its products, the FDA also has the power to intervene when necessary to protect the public but in general does not require pre-market approval or testing. Companies are required to place a warning note on their products if they have not been tested. Experts in cosmetic ingredient reviews also play a role in monitoring safety through influence on the use of ingredients, but also lack legal authority. Overall the organization has reviewed about 1,200 ingredients and has suggested that several hundred be restricted, but there is no standard or systemic method for reviewing chemicals for safety and a clear definition of what is meant by 'safety' so that all chemicals are tested on the same basis.

    Veterinary products

    The Center for Veterinary Medicine (CVM) is the branch of the FDA that regulates food, food additives, and drugs that are given to animals, including food animals and pets. CVM does not regulate vaccines for animals; these are handled by the United States Department of Agriculture.

    CVM's primary focus is on medications that are used in food animals and ensuring that they do not affect the human food supply. The FDA's requirements to prevent the spread of bovine spongiform encephalopathy are also administered by CVM through inspections of feed manufacturers.

    Tobacco products

    Since the Family Smoking Prevention and Tobacco Control Act became law in 2009, the FDA also has had the authority to regulate tobacco products. [35]

    In 2009, Congress passed a law requiring color warnings on cigarette packages and on printed advertising, in addition to text warnings from the U.S. Surgeon General. However, these new labels were halted because of a court case entitled R.J. Reynolds Tobacco Co. v. U.S. Food and Drug Administration. To date, these new labels have not been put into place.

    QUESTION FOR DISCUSSION: SHOULD THE FDA REGULATE E-CIGARETTES AS TOBACCO PRODUCTS?

    Recently E-Cigarettes have hit the market as "safe" alternatives to the negative effects of tobacco products. Do you think the evidence shows that E-Cigarettes should be regulated in the same way as other tobacco products or do they serve as an alternative to the health risks of tobacco addiction and tobacco products?

    www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm

    archive.org/details/ElectronicCigarettesFdaWarning

    http://www.nytimes.com/2015/01/19/opinion/will-the-fda-kill-off-e-cigs.html?_r=0

    http://healthaffairs.org/blog/2015/02/20/in-regulating-e-cigarettes-no-easy-fix-for-the-fda/

    casaa.org/deeming_regulations.html

    www.reuters.com/article/2015/02/26/us-tobacco-fda-study-idUSKBN0LU02S20150226

    http://time.com/3843214/e-cigarettes-regulation-health-experts/

    http://dailycaller.com/2014/06/25/white-house-deletes-fda-e-cigarette-regulations/

    Regulation of living organisms

    With the acceptance of premarket notification 510(k) k033391 in January 2004, the FDA granted Dr. Ronald Sherman permission to produce and market medical maggots for use in humans or other animals as a prescription medical device. Medical maggots represent the first living organism allowed by the Food and Drug Administration for production and marketing as a prescription medical device.

    In June 2004, the FDA cleared Hirudo medicinalis (medicinal leeches) as the second living organism to be used as medical devices.

    The FDA also requires milk to be pasteurized to remove bacteria and maintains oversight of probiotic products containing living bacterial organisms.

    Figure 4.5.7: The Federal Communications Commission regulates interstate and international communications by radio, television, wire, satellite and cable.

    The FCC is an independent agency of the United States government, created by Congressional statute (see 47 U.S.C. § 151 and 47 U.S.C. § 154) to regulate interstate communications by radio, television, wire, satellite, and cable in all 50 states, the District of Columbia and U.S. territories. The FCC works towards six goals in the areas of broadband, competition, the spectrum, the media, public safety, and homeland security. The Commission is also in the process of modernizing itself.

    The FCC was formed by the Communications Act of 1934 to replace the radio regulation functions of the Federal Radio Commission. The FCC took over wire communication regulation from the Interstate Commerce Commission. The FCC's mandated jurisdiction covers the 50 states, the District of Columbia, and U.S. possessions. The FCC also provides varied degrees of cooperation, oversight, and leadership for similar communications bodies in other countries of North America.

    Mission

    The FCC's mission, specified in Section One of the Communications Act of 1934 and amended by the Telecommunications Act of 1996 (amendment to 47 U.S.C. §151) is to "make available so far as possible, to all the people of the United States, without discrimination on the basis of race, color, religion, national origin, or sex, rapid, efficient, nationwide, and worldwide wire and radio communication services with adequate facilities at reasonable charges." The Act furthermore provides that the FCC was created "for the purpose of the national defense" and "for the purpose of promoting safety of life and property through the use of wire and radio communications."

    Consistent with the objectives of the Act as well as the 1993 Government Performance and Results Act (GPRA), the FCC has identified six goals in its 2006–2011 Strategic Plan. These are:

    Broadband

    "All Americans should have affordable access to robust and reliable broadband products and services. Regulatory policies must promote technological neutrality, competition, investment, and innovation to ensure that broadband service providers have sufficient incentives to develop and offer such products and services."

    Competition

    "Competition in the provision of communication services, both domestically and overseas, supports the Nation's economy. The competitive framework for communications services should foster innovation and offer consumers reliable, meaningful choice in affordable services."

    Spectrum

    "Efficient and effective use of non-federal spectrum domestically and internationally promotes the growth and rapid development of innovative and efficient communication technologies and services."

    Media

    "The Nation's media regulations must promote competition and diversity and facilitate the transition to digital modes of delivery."

    Public Safety and Homeland Security

    "Communications during emergencies and crisis must be available for public safety, health, defense, and emergency personnel, as well as all consumers in need. The Nation's critical communications infrastructure must be reliable, interoperable, redundant, and rapidly restorable."

    Modernize the FCC

    "The Commission shall strive to be highly productive, adaptive, and innovative organization that maximizes the benefits to stakeholders, staff, and management from effective systems, processes, resources, and organizational culture."

    The Federal Communications Commission regulates interstate and international communications by radio, television, wire, satellite, and cable in all 50 states, the District of Columbia and U.S. territories. An independent U.S. government agency overseen by Congress, the commission is the United States' primary authority for communications law, regulation and technological innovation. In its work facing economic opportunities and challenges associated with rapidly evolving advances in global communications, the agency capitalizes on its competencies in:

    What does the FCC do?

    • The FCC has been charged with a number of tasks related to the communications infrastructure of the United States. These include:
    • Promoting competition, innovation, and investment in broadband services and facilities
    • Supporting the nation's economy by ensuring an appropriate competitive framework for the unfolding of the communications revolution
    • Encouraging the highest and best use of spectrum domestically and internationally
    • Revising media regulations so that new technologies flourish alongside diversity and localism
    • Providing leadership in strengthening the defense of the nation's communications infrastructure

    Leadership

    The agency is directed by five commissioners who are appointed by the President of the United States and confirmed by the U.S. Senate. The president also selects one of the commissioners to serve as chairman. Only three commissioners can be of the same political party at any given time and none can have a financial interest in any commission-related business. All commissioners, including the chairman, have five-year terms, except when filling an unexpired term.

    Organization

    The commission is organized into bureaus and offices, based on function (see also Organizational Charts of the FCC). Bureau and office staff members regularly share expertise to cooperatively fulfill responsibilities such as:

    • Developing and implementing regulatory programs
    • Processing applications for licenses and other filings
    • Encouraging the development of innovative services
    • Conducting investigations and analyzing complaints
    • Public safety and homeland security
    • Consumer information and education
    • Rules and Rulemakings

    The FCC's rules and regulations are in Title 47 of the Code of Federal Regulations (CFR), which are published and maintained by the Government Printing Office. Title 47 Rules & Regulations are also available on the web in a searchable format.

    Most FCC rules are adopted by a process known as "notice and comment" rulemaking. Under that process, the FCC gives the public notice that it is considering adopting or modifying rules on a particular subject and seeks the public's comment. The Commission considers the comments received in developing final rules. For more information, check out our online summary of the Rulemaking Process at the FCC.

    Advisory Committees

    In 1972 Congress passed the Federal Advisory Committee Act to ensure that advice by advisory committees is objective and accessible to the public. The Act put in place a process for establishing, operating, overseeing, and terminating these committees that provide valuable input from consumer groups, industry stakeholders, public safety officials and other interested parties.

    The FCC is organized into seven bureaus and ten staff offices. In general, the bureaus handle license applications and related filings, as well as analyzing complaints, developing and enacting regulations, conducting investigations and participating in hearings. The seven bureaus are:

    Consumer & Governmental Affairs (CGB) oversees the FCC’s consumer policies, including disability access. It handles outreach and education through its Consumer Center, which responds to consumer questions and complaints. CGB also collaborates with state, local and tribal governments to ensure emergency preparedness.

    Enforcement Bureau is responsible for enforcing the provisions of the Communications Act of 1934, as well as FCC rules, orders, terms and conditions of station authorizations. This bureau helps to foster local competition and consumer protection, public safety and homeland security.

    International Bureau (IB) helps to develop international telecommunications policy on issues such as allocation of frequencies and minimizing electromagnetic interference. IB is responsible for maintaining FCC compliance with the International Radio Regulations and other international agreements.

    Media Bureau develops and implements policy and licensing programs relating to electronic media, such as cable television, broadcast television, and radio. Post-licensing for direct broadcast satellite services also falls within its purview.

    Wireless Telecommunications Bureau is responsible for all FCC wireless telecommunications programs, policies and outreach programs. These services include amateur radio, cellular networks, pagers, Personal Communications Service (PCS), Part 27 Wireless Communications Services and fixed, mobile and broadcast services in the 700 MHz band.

    Wireline Competition Bureau (WCB) assists in policy development for wireline telecommunications (broadband) to promote growth and investments in infrastructure, development, markets, and services.

    Public Safety and Homeland Security Bureau develops and implements communications for use during emergencies and crises. In the wake of Hurricane Katrina, this bureau was added to make sure public safety, health, defense and emergency personnel, and consumers can communicate during times of greatest need.

    Broadcast Radio and TV

    Specific FCC functions include assigning frequency, power, and call signs for radio; allocating spectrum space for AM and FM radio, as well as VHF and UHF television broadcast services; designating sign-on/sign-off times and operating power for broadcast stations. Although the FCC is prohibited from censoring most programming content, it does, however, regulate material deemed indecent or illegal (which includes, for example, cigarette advertising), some aspects of programming for children, and political campaign advertising.

    The FCC limits the number of broadcasting outlets that may be owned by a single entity and reviews these regulations biennially. The effect of telecommunications reform has been toward loosening such restrictions. In 1996 the FCC removed the upper limit for the number of TV stations that could be owned nationally, provided that the combined viewership does not exceed 35 percent of all U.S. households. Within local markets, restrictions are much tighter to prevent a media monopoly. In general, the same company may not own a TV station along with a newspaper, a second TV station, a cable system, or a radio station. Radio station ownership rules tend to be more liberal, allowing up to eight stations in a single market depending on the total number of stations serving that market. As with television, there is no limit on the number of stations a company can hold nationally.

    Cable TV

    Through its Cable Services Bureau, the commission licenses cable television systems and regulates cable pricing, technical standards, and programming. Pricing is only regulated when local cable competition does not exist according to FCC definitions. The FCC requires that certain local broadcast programming be made available through cable systems and that at least one noncommercial channel be carried on every cable system. The agency also mandates that cable systems have a formal equal employment opportunity program, monitors compliance, and investigates claims of discrimination.

    Telephone Services

    All forms of telephony, including local, long-distance, and wireless, fall under the FCC's purview. This area, in particular, has been subject to considerable reform under the deregulation of the 1990s. The FCC is gradually allowing local service providers, such as the regional Bell operating companies (BOCs), to offer long-distance services once they demonstrate that their respective markets are open to local competition; long-distance companies can also enter local markets. Deregulation has likewise allowed a number of BOCs to merge with other BOCs. The FCC also regulates pricing of telephone network services to prevent local monopolies from charging exorbitant fees to access their networks. Wireless communications like cellular phones and personal communications systems (PCS) are much less regulated, and providers of local and long-distance wire service are permitted to also offer wireless packages.

    New and Emerging Technologies

    The FCC also holds a major stake in the development of emerging communications technologies. Two of the most important currently are the Internet and digital television. The largely unregulated Internet presents a complex regulatory environment because of its diffused technical and competitive structure. The FCC's policy has been decidedly hands-off, but the agency has statutory powers to control many aspects of Internet service, including pricing, competition, and some content. FCC officials have been very cautious, however, not to encourage a monopoly system as was done formerly with telephone service; the commission's leadership continues to favor a largely unrestricted Internet. Significantly, this laissez-faire approach to the Internet was not a new stance for the FCC—one of its commissioners claimed the agency had a 20-year history of shaping the free Internet by choosing not to regulate it as it became commercially viable.

    The FCC played a stronger role in the development of digital television (DTV), but it again deferred many decisions to service providers. It created a timetable for the roll-out of DTV and the eventual elimination of analog television broadcasting. With early digital broadcasts starting in 1998, the FCC created a transition period extending through at least 2006 for broadcasters and consumers to convert to digital equipment. The FCC planned to review the end date periodically to ensure minimal disruption of service. The technical standards for DTV were left up to industry groups and companies to negotiate.

    Agency Controversies

    Indecency: The FCC has the authority to regulate what is said and shown on broadcast television through a series of decency standards that have been in place since the advent of television in the 1950s. Perhaps the most controversial case is that of the “wardrobe malfunction” of the 2004 Super Bowl where Janet Jackson’s top was “accidentally” ripped off by Justin Timberlake. MTV and its parent company CBS were prosecuted and fined by the FCC for violating its decency standards. In another case surrounding radio talk show host Howard Stern in which stations were fined more than $2.5 million between 1990 and 2004 for violating radio decency standards, which refer to obscene language. Eventually Stern left broadcast radio and moved his show to satellite network Sirius where the decency standards and FCC regulation did not apply.

    It is a violation of federal law to air obscene programming at any time or indecent programming or profane language from 6 a.m. to 10 p.m. Congress has given the FCC the responsibility for administratively enforcing these laws. The FCC may revoke a station license, impose a monetary forfeiture or issue a warning if a station airs obscene, indecent or profane material.

    Obscene broadcasts are prohibited at all times

    • Obscene material is not protected by the First Amendment to the Constitution and cannot be broadcast at any time. The Supreme Court has established that to be considered obscene material must meet a three-pronged test:
    • An average person, applying contemporary community standards, must find that the material, as a whole, appeals to the prurient interest.
    • The material must depict or describe, in a patently offensive way, sexual conduct specifically defined by applicable law.
    • The material, taken as a whole, must lack serious literary, artistic, political or scientific value.

    Indecent broadcast restrictions

    The FCC has defined broadcast indecency as "language or material that, in context, depicts or describes, in terms patently offensive as measured by contemporary community standards for the broadcast medium, sexual or excretory organs or activities." Indecent programming contains patently offensive sexual or excretory material that does not rise to the level of obscenity. The courts hold that indecent material is protected by the First Amendment and cannot be banned entirely. FCC rules prohibit indecent speech on broadcast radio and television between 6 a.m. and 10 p.m., when there is a reasonable risk that children may be in the audience.

    Profane broadcast restrictions

    The FCC defines profanity as "including language so grossly offensive to members of the public who actually hear it as to amount to a nuisance." Like indecency, profane speech is prohibited on broadcast radio and television between the hours of 6 a.m. and 10 p.m.

    Cable and satellite services excepted from indecency restrictions

    Congress has charged the Commission with enforcing the statutory prohibition against airing indecent programming "by means of radio communications." The Commission has historically interpreted this restriction to apply to radio and television broadcasters and has never extended it to cover cable or satellite operators. In addition, because cable and satellite services are subscription-based, viewers of these services have greater control over the programming content that comes into their homes, whereas broadcast content traditionally has been available to any member of the public with a radio or television. As noted above, however, obscene material is not protected by the First Amendment to the Constitution and is prohibited with respect to cable and satellite services, as well as radio and television broadcasters.

    Video: CSPAN Discussion on FCC Decency Standards

    Net Neutrality: An Open Internet means consumers can go where they want when they want. This principle is often referred to as Net Neutrality. It means innovators can develop products and services without asking for permission. It means consumers will demand more and better broadband as they enjoy new lawful Internet services, applications, and content, and broadband providers cannot block, throttle, or create special "fast lanes" for that content. The FCC's Open Internet rules protect and maintain open, uninhibited access to legal online content without broadband Internet access providers being allowed to block, impair, or establish fast/slow lanes to lawful content.

    Net Neutrality Rules: Adopted on February 26, 2015, the FCC's Open Internet rules are designed to protect free expression and innovation on the Internet and promote investment in the nation's broadband networks. The Open Internet rules are grounded in the strongest possible legal foundation by relying on multiple sources of authority, including Title II of the Communications Act and Section 706 of the Telecommunications Act of 1996. As part of this decision, the Commission also refrains (or "forbears") from enforcing provisions of Title II that are not relevant to modern broadband service. Together Title II and Section 706 support clear rules of the road, providing the certainty needed for innovators and investors, and the competitive choices and freedom demanded by consumers.

    The new rules apply to both fixed and mobile broadband service. This approach recognizes advances in technology and the growing significance of mobile broadband Internet access in recent years. These rules will protect consumers no matter how they access the Internet, whether on a desktop computer or a mobile device. These “Bright Line” rules include:

    • No Blocking: broadband providers may not block access to legal content, applications, services, or non-harmful devices.
    • No Throttling: broadband providers may not impair or degrade lawful Internet traffic on the basis of content, applications, services, or non-harmful devices.
    • No Paid Prioritization: broadband providers may not favor some lawful Internet traffic over other lawful traffic in exchange for consideration of any kind—in other words, no "fast lanes." This rule also bans ISPs from prioritizing content and services of their affiliates.

    To ensure an open Internet now and in the future, the Open Internet rules also establish a legal standard for other broadband provider practices to ensure that they do not unreasonably interfere with or disadvantage consumers' access to the Internet. The rules build upon existing, strong transparency requirements. They ensure that broadband providers maintain the ability to manage the technical and engineering aspects of their networks. The legal framework used to support these rules also positions the Commission for the first time to be able to address issues that may arise in the exchange of traffic between mass-market broadband providers and other networks and services.

    Video: Net Neutrality Rules Explained

    ISSUE FOR DEBATE: NET NEUTRALITY

    1. How do you use the Internet on a daily basis? Keep a one-day log to see what types of activities you use Internet-connected devices for and how much time you spend on each. What percent of your time is spent on the Internet? What percent of that Internet time is spent on each type of activity?

    2. Many Internet activities that we depend upon on a daily basis demand a more robust Internet infrastructure than other activities (ex: Video takes a lot more bandwidth and infrastructure than sending a text or email). These varied demands on the Internet's infrastructure have triggered a debate about 'Net Neutrality,' an issue rooted in how content should be delivered to consumers. In a nutshell, companies that provide 'high speed' or broadband networks (i.e., phone company DSL or cable Internet services) want to be able to charge higher fees to those who send data-heavy content on the Internet in return for getting that content to consumers faster than the content of individuals or companies who don't pay the higher fees. Broadband network providers say it's only fair that those who place a greater demand on the network should pay more. Critics of this approach believe that such a tiered system would limit the 'openness,' 'freedom' and 'neutrality' of the Internet because not all content providers would be able to reach consumers on a level playing field; those with money would be given an unfair advantage. Some also worry that network providers might block or censor some people's content based on economic or political resources and power. This debate is now being addressed by the FDA with the agency leaning toward the side of ‘net neutrality.’

    3. Watch the video at https://www.youtube.com/watch?v=yxgCWzU_uVM then use internet resources listed below to research the question below.

    4. Prepare arguments (with appropriate evidence) to answer the following question:

    Should the Internet be protected using a “net neutral” policy or should those companies like Netflix be able to get a “fast lane” to deliver their content (based on their ability to pay for it)? What positive and negative characteristics can you identify for both sides of the argument?

    RESOURCE LIST:

    http://www.pbslearningmedia.org/resource/ac6d797b-df87-4aca-93ad-f026e9c280e5/net-neutrality-rules-ensure-equal-access-to-the-internet/

    https://www.eff.org/issues/net-neutrality

    www.savetheinternet.com/resources

    http://www.ala.org/advocacy/telecom/netneutrality

    http://www.pbs.org/moyers/moyersonamerica/net/sites.html

    http://journalistsresource.org/studies/society/internet/net-neutrality-debate-underlying-dynamics-research-perspectives

    http://topics.nytimes.com/top/reference/timestopics/subjects/n/net_neutrality/index.html

    Figure 4.5.8: Copy and Paste Caption here. (Copyright; author via source)

    Study/Discussion Questions

    1. How does the mission of an independent executive agency differ from that of an independent regulatory agency? Give an example of each.
    2. What controversies have the agencies discussed in this section encountered? What issues or problems tend to lead to such controversies?
    3. How does Congress maintain control over independent agencies?
    4. How do these agencies impact your daily life? Give an example from each of the agencies discussed in this section.
    5. What would our lives be like if independent agencies did not exist within our government?
    6. Do you believe these agencies have grown too powerful? Explain.
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    The Wall Street Journal. http://online.wsj.com/article/SB1000142405270230381210457644161
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    10.1039%2FC3LC51235E 
    
    Henderson, Diedtra (September 23, 2006). Panel: FDA needs more power, funds. Boston Globe.
    Webcitation.org http://www.webcitation.org/5NkCrjdpd 
    
    Committee on the Assessment of the US Drug Safety System. (2006). The Future of Drug Safety:
    Promoting and Protecting the Health of the Public. Institute of Medicine. Free full-text. 
    http://www.nap.edu/catalog.php?record_id=11750#toc 
    
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    Further reading 
    
    Givel, Michael (December 2005). "Philip Morris' FDA Gambit: Good for Public Health?" 
    Journal of Public Health Policy (26): pp. 450–468
    
    Henninger, Daniel (2002). "Drug Lag". In David R. Henderson (ed.). Concise Encyclopedia 
    of Economics (1st ed.). Library of Economics and Liberty. OCLC 317650570, 50016270 and 
    163149563. http://www.econlib.org/library/Enc1/DrugLag.html 
    
    Hilts, Philip J. (2003). Protecting America's Health: The FDA, Business, and One Hundred
    Years of Regulation. New York: Alfred E. Knopf. ISBN 0-375-40466-X. http://en.Wikipedia.
    org/wiki/Special:BookSources/037540466X 
    
    Madden, Bartley (2010) Free To Choose Medicine: How Faster Access to New Drugs Would Save
    Countless Lives and End Needless Suffering Chicago: The Heartland Institute. ISBN 978-1-9
    34791-32-5.  en.Wikipedia.org/wiki/Special:BookSources/9781934791325 
    
    Moore, Thomas J. (1998). Prescription for Disaster: The Hidden Dangers in Your Medicine 
    Cabinet. New York: Simon & Schuster. ISBN 0-684-82998-3. http://en.Wikipedia.org/wiki/Sp
    ecial:BookSources/0684829983 
    
    Kevin Fain, Matthew Daubresse, G. Caleb Alexander (2013). "The Food and Drug Administration
    Amendments Act and Postmarketing Commitments." "JAMA" 310(2): 202-204 doi:10.1001/jama.
    2013.7900. 
    
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    e-Broadcasts 
    
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