TOTAL QUALITY MANAGEMENT Manufacturing quality History Taylor system Inspection System Statistical quality control Sampling and

d control charts Total quality management Continuous improvement Definitions of quality Conformance to design If product does not conform to design, then product is defective. Fitness for use serves intended purpose. Quality is defined as meeting or exceeding customers requirements now and in the future, i.e. the product or service is fit for the customers use. Value Ratio of dollar amount willing to pay to price. Higher is the value, better is the quality. Attributes such as Performance miles per gallon, rate of change of acceleration.. Reliability time between breakdowns Maintainability easy to maintain Features Bells & whistles Durability Serviceability

Four dimensions of quality Quality of design Decided before the product is produced. Uses cross functional teams and concurrent engineering. Quality of Conformance Meet specifications. Meets the abilities means high reliability, maintainability and availability. Field Service
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Quality Costs Appraisal costs costs of ensuring quality such as inspection, measuring equipment, training etc. Checking and testing purchased goods and services In-process and final inspection/test Field testing Product, process or service audits Calibration of measuring and test equipment Prevention costs costs of reducing likelihood of defectives. Redesign, training employees etc. Quality planning Supplier evaluation New product review Error proofing Capability evaluations Quality improvement team meetings Quality improvement projects Quality education and training Failure Costs Two types Internal and External Internal failure costs are costs defectives before product leaves the plant. Costs usually include: Rework Delays Re-designing Shortages Failure analysis Re-testing Downgrading Downtime Lack of flexibility and adaptability External failure costs are costs incurred once the product leaves the plant as a result of defective product. External failure costs include litigation costs, lose of goodwill etc.

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Complaints Repairing goods and redoing services Warranties Customers bad will Losses due to sales reductions Environmental costs Quality improves productivity. Higher output. Fixed cost spread over more units. Lower materials and labor costs. Quality Gurus Crosby Quality is free.. Minimum cost at zero defects Conformance to requirements, Zero defects. 14 implementation plan. Problems functional in nature Zero defects is optimal Cost of quality is the only useful measure Fitness for purpose rather than conformance to specifications. Juran Jurans Trilogy Quality planning, quality control, quality improvement Emphasis on management. vital few, trivial many. He noted that 20% of the quality problems caused 80% of the dollar loss. Quality is a predictable degree of uniformity and dependability, at low cost and suited to the market Edwards Deming. Demings 14 points. Use of statistical methods. Continuous imporovement. Plan, Do, Check, Act Plan set objectives Do implement Check determine shortfall between objectives and what is implemented Act take corrective action. Demings 14 points (http://www.ifm.eng.cam.ac.uk/dstools/process/Deming.html) 1. Create constancy of purpose toward improvement of product and service, with the aim to become competitive and to stay in business, and to provide jobs. 2. Adopt the new philosophy. We are in a new economic age. Western management must
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awaken to the challenge, must learn their responsibilities, and take on leadership for change. 3. Cease dependence on inspection to achieve quality. Eliminate the need for inspection on a mass basis by building quality into the product in the first place. 4. End the practice of awarding business on the basis of price tag. Instead, minimize total cost. Move towards a single supplier for any one item, on a long-term relationship of loyalty and trust. 5. Improve constantly and forever the system of production and service, to improve quality and productivity, and thus constantly decrease costs. 6. Institute training on the job. 7. Institute leadership. The aim of supervision should be to help people and machines and gadgets to do a better job. Supervision of management is in need of an overhaul, as well as supervision of production workers. 8. Drive out fear, so that everyone may work effectively for the company. 9. Break down barriers between departments. People in research, design, sales, and production must work as a team, to foresee problems of production and in use that may be encountered with the product or service. 10. Eliminate slogans, exhortations, and targets for the workforce asking for zero defects and new levels of productivity. Such exhortations only create adversarial relationships, as the bulk of the causes of low quality and low productivity belong to the system and thus lie beyond the power of the work force. 11. a. Eliminate work standards (quotas) on the factory floor. Substitute leadership. b. Eliminate management by objective. Eliminate management by numbers, numerical goals. Substitute leadership. 12. a. Remove barriers that rob the hourly paid worker of his right to pride in workmanship. The responsibility of supervisors must be changed from sheer numbers to quality. 13. b. Remove barriers that rob people in management and engineering of their right to pride in workmanship. This means, inter alia, abolishment of the annual or merit rating and management by objective. 14. Institute a vigorous program of education and self-improvement. 15. Put everybody in the company to work to accomplish the transformation. The transformation is everybody's job. Ishikawa Quality circles and cause & effect diagram Taguchi Loss function

Quality Tools Flow chart Pareto Diagram Histogram Cause and Effect Diagram
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Check sheet Scatter diagram Control chart Why-why Force field analysis Brainstorming

Implementing Six Sigma Goal: (3.4 or fewer defective parts per million (ppm)) Identify products Identify customer Identify needs Define process Mistake proof Continuous improvement Instead of PDCA, six sigma can be implemented using the following steps: Define - Measure - Analyze - Improve - Control ISO 9000 Quality standard developed by International Standards Organization. The purpose is to define, establish, and maintain an effective quality system for manufacturing and service industries. The standard follows PDCA cycle. An organization can get ISO 9000 certification by implementing the standard and getting evaluated by an assessor. The assessor interviews staff members and also paperwork prepared to comply with ISO 9000. The assessor then prepares a report identifying deficiencies. If the organization corrects the deficiencies within the time agreed, it gets ISO 9000 certificate. Sampling http://www.itl.nist.gov/div898/handbook/pmc/section2/pmc22.htm A sampling plan is usually denoted as (n,c) plan for a sample size n, where the lot is rejected if there are more than c defectives Acceptable Quality Level (AQL): The AQL is a percent defective that is the base line requirement for the quality of the producer's product. The producer would like to design a sampling plan such that there is a high probability of accepting a lot that has a defect level less than or equal to the AQL. Lot Tolerance Percent Defective (LTPD): The LTPD is a designated high defect level that would be unacceptable to the consumer. The consumer would like the sampling plan to have a low probability of accepting a lot with a defect level as high as the LTPD.
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Type I Error (Producer's Risk): This is the probability, for a given (n,c) sampling plan, of rejecting a lot that has a defect level equal to the AQL. The producer suffers when this occurs, because a lot with acceptable quality was rejected. The symbolis commonly used for the Type I error and typical values for range from 0.2 to 0.01. Type II Error (Consumer's Risk): This is the probability, for a given (n,c) sampling plan, of accepting a lot with a defect level equal to the LTPD. The consumer suffers when this occurs, because a lot with unacceptable quality was accepted. The symbol is commonly used for the Type II error and typical values range from 0.2 to 0.01. These 4 numbers are needed to design a sampling plan. There are programs on the internet which can help you to come up with a sampling plan. One of them I found is: http://www.qualitydigest.com/july99/html/body_samplan.html However, use this program at your own risk. Control Charts Two principles Every process has variations Variations follow normal distribution. The way to calculate control charts is shown on next two pages. We assume process follow normal distribution. We take samples periodically. Calculate the mean and range. Whenever, mean or range or both fall outside lower or upper control limit, stop production and investigate why defective products are being produced and take corrective action. Service quality is measured only in terms of Customer Satisfaction and nothing else. The steps in service quality are as follows: 1. Determine whether customer satisfaction has any effect on profitability. If not, ignore service quality. 2. Estimate the value of a customer. Approximate values of a credit card customer is between $100 and $150. The value of a cable customer is over $6000. Estimate future cash flows from a customer over 6 to 7 years. Calculate net present values of future cash flows. This represents the value of a customer. 3. Find why customers defect. Do survey of customers who defect Do focus group studies Determine what customers expectations are and what they find. For example, use SERVQUAL:
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Then determine what shortfalls are Service quality SERVQUAL is the most popular measure (customer questionnaire based on 5 perpetual measures of service) Tangibles Reliability Responsiveness Assurance Empathy Or Define quality attributes on the basis of customer needs Decide how to measure each attribute Set quality standards Establish appropriate tests for each standard Identify shortfalls 4. Once shortfalls are identified, use quality tools to come up with strategies to reduce defections. 5. Estimate costs of implementation and improved benefits that will be reaped using the value of customers not defected; 6. Select projects based on cost benefit analysis 7. Implement 8. Audit and make corrective actions to achieve planned gains.

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INTELLECTUAL PROPERTY RIGHTS Introduction Businessmen go down with their businesses because they like the old way so well they cannot bring themselves to change. Henry Ford, My Life and Times, 1922

What is Technology? Know-how how to do things The process by which people satisfy their needs and desires Capability of firm to provide goods and services

What is innovation? Brining inventions to commercial use. For example, J. Murray Spengler invented the vacuum cleaner originally called an electric suction sweeper. In other words, JMS developed technology. However, it was W. H. Hoover who did the innovation to bring it to the market. Elias Howe first produced sewing machine. In other words, Howe developed technology. But Singer did the innovation by introducing the product to the market. He stole the patent. So later, Singer was to forced to pay a royalty to Elias Howe for on all machines he sold. In 1830, Joseph Henry showed how a device developed by William Sturgeon could be used to communicate. However, it was Samuel Morse who developed Morse Code and developed telegraph and commercialized it.

Invention involved problem solving and invention Innovation involves invention and implementation. (about 12 to 20 percent of inventions end up with innovation) Economic value is created when innovation is spread out. Management of innovation is developing and creating new ideas.
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Management of technology is managing existing innovations Science involves discoveries that explain natural phenomena without any purpose. Technology helps to transform the knowledge and technique of natural phenomena to satisfy human needs and desires. Engineering is the bridge that links science to technology and deals with knowledge and understanding that transforms scientific knowledge to technology that satisfy human needs and desires. Basic Research deals with activities that explore science for the fundamental principles of nature. Applied Research deals with activities that tries to develop inventions that may satisfy human needs and desires.

Stages of innovation Invention - Create new knowledge. Innovation Find application for new knowledge. Diffusion Exploit knowledge.

Product innovations dominate during introduction and maturity stage Process innovation dominate during maturity and decline stage Product/process innovation during the product life cycle

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High Product Innovation

Rate of Innovation

Process Innovation

Limit of Technology Embryonic Growth Time Mature Aging

Cash flow during product life cycle

First mover advantage

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Clayton Christensens Theory of Disruptive Innovation

Creation of knowledge: To improve existing products and creating new businesses Includes basic research, applied research, and development. Application of knowledge: Applying new knowledge and finding applications for existing knowledge: Includes product (design engineering), process (manufacturing engineering, quality control, fabrication, computer-integrated manufacturing), and market (application engineering, physical distribution, and product service).
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Investments in knowledge can be considered as expenditures on r&d, education, and software. The US spent 6.6% of GDP on knowledge, Japan 5% and EU 3.8% in 2003. Knowledge spending is lowest in southern European countries, highest in the US and South Korea, and Nordic Countries. In many countries, spending on knowledge is more than spending on machines and equipment.

R&D intensity (R&D/GDP) highest in Sweden Finland, Japan, Ireland, Korea, then the US. Sweden spends about 4% of GDP and the US 2.5% in 2003.

Business spending accounts for most R&D spending. In Japan almost of R&D, in the US 63% and EU 55%

China spends on R&D less than the US and Japan (on purchasing power parity basis). Israel has the highest R&D intensity 4.9% of GDP.

Other than developed countries, major spenders are Israel, Russian Federation, Chinese Taipei, China, Singapore

Introduction to IP We will discuss various types of IP, how to take advantage of IP, choose right type of IP and avoiding mistakes. How to commercialize the idea Average gross margins for pharmaceuticals are twice those of semiconductors Integrated circuits costs about $100 million to develop. Copying costs $ 1million So intellectual property rights do have impact on profitability Intellectual property - created in the mind, intangible, and are protected by law. Have high value, attracts customers, partners, and employees; can generate licensing income, can prevent others from practicing IPR, competitive advantage, reduce risk of innovation, branding advantage. Intellectual property is important to someone who wants funding and competitive advantage.
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Types of IP Patents invention, right to exclude others from making, using, selling, importing Copyrights physical expression of ideas, right to duplicate, perform and make derivative works. Trademarks logo, slogan, right for unique identity, distinguishes from competitors product, prevents others from using similar or confusing similar mark Trade Secrets ideas, technical knowhow, right to protect against the misappropriation Semiconductor chip mask work electronic circuit design

You can get multiple protection for the same ip

Coca-Cola Contour bottle Example of a trademark.

Constitution and laws:

The Constitution of the United States gives Congress the power to enact laws relating to patents, in Article I, section 8, which reads "Congress shall have power . . . to promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries." Under this power Congress has from time to time enacted various laws relating to patents. The first patent law was enacted in 1790. The patent laws underwent a general revision which was enacted July 19, 1952, and which came into effect January 1, 1953. It is codified in Title 35, United States Code. Additionally, on November 29, 1999, Congress enacted the American Inventors Protection

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Act of 1999 (AIPA), which further revised the patent laws. See Public Law 106-1 13, 11 3 Stat. 1501 (1 999). The patent law specifies the subject matter for which a patent may be obtained and the conditions for patentability. The law establishes the United States Patent and Trademark Office to administer the law relating to the granting of patents and contains various other provisions relating to patents. Article I, Section 8: The Congress shall have power to promote the progress of science and useful arts by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries." The Patent Bill of 1790 enabled the government to patent "any useful art, manufacture, engine, machine, or device, or any instrument thereon not before known or used." Not discoveries of nature The Copyright Act of 1790 covered books, maps and charts 14-year term of protection, renewable once if the author is still alive (changed later) Notice and deposit requirements

Patents

1) Utility patents may be granted to anyone who invents or discovers any new and useful process, machine, article of manufacture, or composition of matter, or any new and useful improvement thereof Utility patents 20 years - machine, process, article of manufacture, composition of matter

Examples Process (method of making and using) System (cell phone & fuel cell)
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Article of manufacture (fuel cell) Composition of matter (compounds and formulations) metal alloys

Today, any invention can be patented.

2) Design patents may be granted to anyone who invents a new, original, and ornamental design for an article of manufacture; Design patents 14 years, emphasis on aesthetics rather than what it can do

3) Plant patents may be granted to anyone who invents or discovers and asexually reproduces any distinct and new variety of plant. Plant : a new variety of certain kinds of plants

Provisional patents patent place-holder one-year protection defend against disclosures economical Provisional application provides the means to establish an early effective filing date in a patent application and permits the term "Patent Pending" to be applied in connection with the invention. Provisional applications may not be filed for design inventions.

Provisional applications are NOT examined on their merits. A provisional application will become abandoned by the operation of law 12 months from its filing date. The 12-month pendency for a provisional application is not counted toward the 20-year term of a patent granted on a subsequently filed non-provisional application which claims benefit of the filing date of the provisional application. Provisional application will not be examined, cannot become a patent, expires after one year, and does not start 20 year patent term. Usually filed, if you want to sell or publish.

What Can Be Patented

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A patent may be granted for anything under the sun that is made by the hand of man, provided that the invention fulfills the three basic requirements of being novel, useful, and non-obvious The patent law specifies the general field of subject matter that can be patented and the conditions under which a patent may be obtained. In the language of the statute, any person who "invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent," subject to the conditions and requirements of the law. The word "process" is defined by law as a process, act or method, and primarily includes industrial or technical processes. The term "machine" used in the statute needs no explanation. The term "manufacture" refers to articles that are made, and includes all manufactured articles. The term "composition of matter" relates to chemical compositions and may include mixtures of ingredients as well as new chemical compounds. These classes of subject matter taken together include practically everything that is made by man and the processes for making the products. The Atomic Energy Act of 1954 excludes the patenting of inventions useful solely in the utilization of special nuclear material or atomic energy in an atomic weapon. See 42 U.S.C. 2181(a). The patent law specifies that the subject matter must be "useful." The term "useful" in this connection refers to the condition that the subject matter has a useful purpose and also includes operativeness, that is, a machine which will not operate to perform the intended purpose would not be called useful, and therefore would not be granted a patent. Interpretations of the statute by the courts have defined the limits of the field of subject matter that can be patented, thus it has been held that the laws of nature, physical phenomena, and abstract ideas are not patentable subject matter. A patent cannot be obtained upon a mere idea or suggestion. The patent is granted upon the new machine, manufacture, etc., as has been said, and not upon the idea or suggestion of the new machine. A complete description of the actual machine or other subject matter for which a patent is sought is required.

Novelty And Non-Obviousness, Conditions For Obtaining A Patent

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In order for an invention to be patentable it must be new as defined in the patent law, which provides that an invention cannot be patented if: "(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent," or "(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country more than one year prior to the application for patent in the United States . . ." If the invention has been described in a printed publication anywhere in the world, or if it was known or used by others in this country before the date that the applicant made his/her invention, a patent cannot be obtained. If the invention has been described in a printed publication anywhere, or has been in public use or on sale in this country more than one year before the date on which an application for patent is filed in this country, a patent cannot be obtained. In this connection it is immaterial when the invention was made, or whether the printed publication or public use was by the inventor himself/herself or by someone else. If the inventor describes the invention in a printed publication or uses the invention publicly, or places it on sale, he/she must apply for a patent before one year has gone by, otherwise any right to a patent will be lost. The inventor must file on the date of public use or disclosure, however, in order to preserve patent rights in many foreign countries. Even if the subject matter sought to be patented is not exactly shown by the prior art, and involves one or more difference would be obvious. The subject matter sought to be patented must be sufficiently different from what has been used or described before that it may be said to be nonobvious to a person having ordinary skill in the area of technology related to the invention. For example, the substitution of one color for another, or changes in size, are ordinarily not patentable.es over the most nearly similar thing already known, a patent may still be refused if the differences "Whoever invents any new and useful (1) process or method, (2) machine, (3) article of manufacture, (4) composition of matter, or (5) any new and useful improvement thereof, may obtain a patent on their invention." (35 U.S.C. 101)

To obtain a patent, an invention must be "new, useful and non-obvious".

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Novelty not previously known or used by others. Not described in any article or previous patents. Different from existing. Non-obviousness Supreme Court laid out obviousness doctrine in 1851 a patent requires more skill and ingenuity than that of an ordinary mechanic acquainted with business

However, this doctrine was modified in KSR v. Teleflex. Changed rigid application by more expansive and flexible approach Provided more

flexibility to judges. Doctrine modified to: If a person of ordinary skill in the relevant subject area would be able to fit the teaching of multiple patents together like pieces of puzzle then the patent is obvious. Commercial success can confirm nonobviousness.

In the USA patents were awarded to whoever invents first. But recent law has made it whoever files first. Other countries whoever files first. Maintain detailed records of research activities Preserve all papers and documents (memos, email, travel, correspondence, receipts etc) Keep an invention notebook Also corroborate with colleagues not involved in research. Patent application outside US must be filed before public disclosure. Patent application in the US must be filed within one year of: first putting up for sale first nonexperimental commercial use first publication Some events that can require filing within one year include: Publication Distribution of products or samples containing invention Trade shows (offer for sale)
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Dissertation Oral disclosure is not same as the publication. Use of non-disclosure agreements is not the same as publications.

Prior art includes prior publications, presentations, public use.. Nondisclosure of known prior art can invalidate a patent..

Utility - the invention must be useful. Life forms, chemical formulations, manufacturing process, products, computer program, methods of doing business.

Provides owners exclusive rights to the inventions described for a prescribed time within a geographical area. Prevents others from profiting from invention. However, does not give the owner affirmative action to use the knowhow.

In return, owner provides knowhow to the public.

To file outside the US, absolute novelty is a must, should be filed before first disclosure, filing time upto 1 year after filing in US. First to file.

Laws of nature, mathematical formulas, printed matter, and inoperable devices cannot be patented.

Machines, manufactured articles, compositions of matter such as alloys, chemicals, processes, designs, and genetically engineered products can be patented.

Prior agreement/ policy can prevent an inventor from patenting like employment contracts

Strongest means of protecting invention. Patent is like insurance policy against theft.
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Patent can be used to obtain finance. Patent can be sold or transferred. Good for cross-licensing. Patent portfolio may be required in genetics.

R&D involving large sums of money are patented.

To practice your patent, you cannot violate claims from another patent called dominate patent.. you should get license from dominate patent to practice patent

Compensates for time, money and effort put in developing know-how

Encourages further research

Helps to recover R&D costs by providing exclusive use

Limited term forces rapid commercialization

Reduces duplicate research

Drawbacks

Perishable right 20 years from the date of application Enforcement is left to the owner Very expensive to enforce. Patents are bonanza for copy cats and competitors Provides the state-of-the-art knowhow. Protection limited to geographical area.. No international patent yet. Need to file in several countries.
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Need to pay renewal and application fees. Patents are published after 18 months in Japan, Europe and the U.S.A (see exceptions below).

Publication of Patent Applications Publication of patent applications is required by the American Inventors Protection Act of 1999 for most plant and utility patent applications filed on or after November 29, 2000. On filing of a plant or utility application on or after November 29, 2000, an applicant may request that the application not be published, but only if the invention has not been and will not be the subject of an application filed in a foreign country that requires publication 18 months after filing (or earlier claimed priority date) or under the Patent Cooperation Treaty. Publication occurs after the expiration of an 18-month period following the earliest effective filing date or priority date claimed by an application. Following publication, the application for patent is no longer held in confidence by the Office and any member of the public may request access to the entire file history of the application.

As a result of publication, an applicant may assert provisional rights. These rights provide a patentee with the opportunity to obtain a reasonable royalty from a third party that infringes a published application claim provided actual notice is given to the third party by applicant, and patent issues from the application with a substantially identical claim. Thus, damages for prepatent grant infringement by another are now available. Scope of patent is limited in several countries. Life forms cannot be patented in Canada.

Patents are given to one who files patent application first in most countries including the U.S.A.

The Paris Convention allows inventor to file one year patent application in other countries.

Who May Apply For A Patent

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According to the law, only the inventor may apply for a patent, with certain exceptions. If a person who is not the inventor should apply for a patent, the patent, if it were obtained, would be invalid. The person applying in such a case who falsely states that helshe is the inventor would also be subject to criminal penalties. If the inventor is dead, the application may be made by legal representatives, that is, the administrator or executor of the estate. If the inventor is insane, the application for patent may be made by a legal representative (e.g., guardian). If an inventor refuses to apply for a patent or cannot be found, a joint inventor or, if there is no joint inventor available, a person having a proprietary interest in the invention may apply on behalf of the non-signing inventor. In pharmaceutical, patents can be obtained for method of using and method of making Patent should describe prior art, advantages, give examples of use, specify best mode, describe claims, what is and what is not, claims are what is protected.

The following order of arrangement should be observed in framing the patent application: (a) Application transmittal form. (b) Fee transmittal form. (c) Application Data Sheet. (d) Specification. (e) Drawings. (f ) Executed Oath or declaration. The specification should have the following sections, in order: (1) Title of the Invention. (2) Cross Reference to related applications (if any). (Related applications may be listed on an application data sheet, either instead of or together with being listed in the specification.) (3) Statement of federally sponsored research/development (if any). (4) The names of the parties to a joint research agreement if the claimed invention was made as a result of activities within the scope of a joint research agreement.
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(5) Reference to a "Sequence Listing," a table, or a computer program listing appendix submitted on a compact disc and an incorporation by reference of the material on the compact disc. The total number of compact disc including duplicates and the files on each compact disc shall be specified. (6) Background of the Invention. (7) Brief Summary of the Invention. (8) Brief description of the several views of the drawing (if any). (9) Detailed Description of the Invention. (1 0) A claim or claims. (1 1) Abstract of the disclosure. (12) Sequence listing (if any).

The specification must conclude with a claim or claims particularly pointing out and distinctly claiming the subject matter that the applicant regards as the invention. The portion of the application in which the applicant sets forth the claim or claims is an important part of the application, as it is the claims that define the scope of the protection afforded by the patent and which questions of infringement are judged by the courts. This part not included for the exam.(More than one claim may be presented provided they differ substantially from each other and are not unduly multiplied. One or more claims may be presented in dependent form, referring back to and further limiting another claim or claims in the same application. Any dependent claim which refers back to more than one other claim is considered a "multiple dependent claim." Multiple dependent claims shall refer to such other claims in the alternative only. A multiple dependent claim shall not serve as a basis for any other multiple dependent claim. Claims in dependent form shall be construed to include all of the limitations of the claim incorporated by reference into the dependent claim. A multiple dependent claim shall be construed to incorporate all the limitations of each of the particular claims in relation to which it is being considered. The claim or claims must conform to the invention as set forth in the remainder of the specification and the terms and phrases used in the claims must find clear support or
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antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description.)

A patent application consists of introductory page, abstract, brief description, drawings, background, full description, examples, and description of claim. Only claims are protected.

Before patenting consider: How broad, does claims represent values, cover product, cover competitors product, is patent enforceable, does it violate any regulations, is it easy to design around.

Cost of patenting $15000 to 25000.

Others costs: Infringement, interference, and enforcement are some costs of patenting Ideas best for patenting: Knowhows that are easy to express Knowhows that can be expressed in steps or as a process Knowhows that are out of the way Knowhows that can obtain broad patents

Inventions involving narrow claims, hard to express in a few steps, not specific, diffuse, hard to identify what is new are less attractive ideas for patenting.

The patent application must be filed in the name of the Inventor usually is required to assign rights to the employer under employment agreement. Inventor must have contributed to the conception of invention. There can multiple inventors. Inventor-ship is not decided by who implements the inventive concept. Politics has no consideration.

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A patentee who makes or sells patented articles, or a person who does so for or under the patentee is required to mark the articles with the word "Patent" and the number of the patent. The penalty for failure to mark is that the patentee may not recover damages from an infringer unless the infringer was duly notified of the infringement and continued to infringe after the notice.

Why companies patent in the US

Prevent copying Patent blocking Prevent lawsuits Used for negotiation Enhance reputation Licensing revenue

98.9% of companies surveyed 80.3% 72.3% 55.2% 38.8% 29.5%

Measure performance 7.8% Cohen et al. (2002) R&D Spillovers. Research Policy, 31, 1349-1367

Pharmaceutical Industry Uses patents extensively. Drug development goes through several stages. Preclinical testing: show that company can manufacture the product, indicate methodology for clinical trial and show data establishing that drug is reasonably safe. This can be done using existing nonclinical data, using studies done in the US or another country whose population is relevant to the US population, or doing new clinical study. Preclinical testing is typically done on animals at this stage and companies have a lot of flexibility at this stage because there is no human exposure.

Once studies show that drug is safe, a company can file IND (investigational new drug) application with FDA. FDA has 30 days to reject the application. If the company does not hear from FDA, the company can go ahead with clinical trial.
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Phase 1 The drug is tested on 20 to 80 patients or normal human volunteers to obtain safety and pharmacological information. This phase helps to understand optimal way to administer, safe dosage range, side effects etc. Phase 2 Tested on 100-200 patients who suffer from the condition the drug is supposed to treat. The goal is to collect additional safety data and to find whether clinically effective. Phase 2 results provide foundation for phase 3. Phase 3 Tested on a larger group of people (hundreds to thousands) suffering from the condition the drug is supposed to treat. These drugs are rigorous and collect additional data on effectiveness and safety information.

New Drug Application: Drugs are categorized into priority and standard. Priority ones are review quicker.

Pharma companies typically file initial patent application in a European country to take advantage extra year of patent protection they can get in the US. Pharma cannot protect their knowhow as trade secret. They usually go for patent as they will have to reveal chemical composition before they can start clinical trials. Patents are typically filed during IND stage.

Design Patents The patent laws provide for the granting of design patents to any person who has invented any new and nonobvious ornamental design for an article of manufacture. The design patent protects only the appearance of an article, but not its structural or functional features. The proceedings relating to granting of design patents are the same as those relating to other patents with a few differences. A design patent has a term of 14 years from grant, and no fees are necessary to maintain a design patent in force. If on examination it is determined that an applicant is entitled to a design patent under the law, a notice of allowance will be sent to the applicant or applicant's attorney, or agent, calling for the payment of an issue fee. The drawing of the design patent conforms to the same rules as other drawings, but no reference characters are allowed and the
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drawing should clearly depict the appearance, since the drawing defines the scope of patent protection. The specification of a design application is short and ordinarily follows a set form. Only one claim is permitted.

Plant Patents The law also provides for the granting of a patent to anyone who has invented or discovered and asexually reproduced any distinct and new variety of plant, including cultivated sports, mutants, hybrids, and newly found seedlings, other than a tuber-propagated plant or a plant found in an uncultivated state. Asexually propagated plants are those that are reproduced by means other than from seeds, such as by the rooting of cuttings, by layering, budding, grafting, inarching, etc. An application for a plant patent consists of the same parts as other applications. The term of a plant patent shall be 20 years from the date on which the application for the patent was filed in the United States or, if the application contains a specific reference to an earlier filed application under 35 U.S.C. 120, 121 or 365(c), from the date the earliest such application was filed.

Trade secrets

When innovation cannot be protected through patents, trade secrets are a good alternative. Anything that provides competitive advantage is trade secret. Any formula, pattern, device, information, database that gives the owner advantage against competitor

Statutory Definition (********not included for the exam) The version of the UTSA adopted by California defines a trade secret as follows: Trade secret means information, including a formula, pattern, compilation, program, device, method, technique, or process, that: (1) Derives independent economic value, actual or potential, from not being generally known to the public or to other persons who can obtain economic value from its disclosure or use; and
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(2) Is the subject of efforts that are reasonable under the circumstances to maintain its secrecy.

Four Basic Elements Each of four elements must be present in a trade secret: A trade secret must consist of information. The types of information that have been protected by trade secret law are virtually without limit. The most common examples fall under two categories: technical information and business information. In the next section, you will see some examples. The information must derive economic value (actual or potential) from the fact that it is secret. In other words it must have some value flowing from the fact that it is not known, and therefore cannot be put to use, by others. This value is independent of any intrinsic value that the information might have. To look at this element in still another way, information has the requisite independent economic value if a potential competitor or other interested person would have to expend time and money to find or develop it. The information cannot be generally known (either by the public, or, more importantly, by other persons in the industry). To be a trade secret, the information must not be generally known to the public, industry competitors, or others who could realize economic value from its disclosure or use. Knowledge of the information in question by even a very small number of outsiders (say, one key person) can deny or destroy trade secret status. As the Comments to the UTSA state, [i]f the principal person who can obtain economic benefit from information is aware of it, there is no trade secret. Keep in mind, however, that unique combinations of generally known concepts can be a trade secret. The information must be treated as a secret, and be the subject of reasonable efforts to maintain its secrecy. For information to acquire and maintain trade secret status, its owner must exercise reasonable efforts to maintain its secrecy. The owners mere desire or intent to keep information a secret is not enough. Source: trade secrets protection fenwick & west***************

Unlimited life unlike limited life for patents No need to publish

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Company should take actions to prevent disclosure. No need to file any applications. No need to monitor third parties Trade secrets are less expensive than patents.

Competitor can patent a trade secret and prevent owner of trade secret from using it. Competitor can uncover trade secrets through reverse engineering Trade secrets are hard to enforce. They are hard to license. Pharma products are usually protected as patents. Regulatory agencies will not approve a compound protected as a trade secret.

If it costs lot then better to patent it.

If competitive advantage depends on it, then better to patent.

Trademark A trademark is a word, name, symbol, or device that is used in trade with goods to indicate the source of the goods and to distinguish them from the goods of others. A servicemark is the same as a trademark except that it identifies and distinguishes the source of a service rather than a product. The terms "trademark and "mark are commonly used to refer to both trademarks and servicemarks. Trademark rights may be used to prevent others from using a confusingly similar mark, but not to prevent others from making the same goods or from selling the same goods or services under a clearly different mark. Trademarks which are used in interstate or foreign commerce may be registered with the USPTO. The registration procedure for trademarks and general information concerning trademarks is described on a separate page entitled "Basic Facts about Trademarks" (http://www. uspto.gov/trademarks/basics/BasicCFactsC~ademarks.jsp

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Any work, name, or symbol that can be used to distinguish a product or service is trademark. Unlike patents, trademarks never expire (with active use).

Trademark rights can be obtained through actual use. Application for trademark can be filed with the intention of using without actually using. Weakest to strongest Generic hard to protect (Bar for Chocolate bar) Descriptive Bright for a diamond Suggestive Pure for water Arbitrary Apple for computer Fanciful Exxon for oil Fanciful trademarks have the strongest protection and generic weakest. Trademark is for 10 years.. can be renewed.. however lapses with it becoming generic name or non-use. McDonalds, Sony, Google well known trademarks TM can be used anytime but to use federal registration is required. ****** not included->There are two types of drawings: standard character and special form. What is a standard character drawing? A standard character drawing is commonly submitted when the mark you wish to register consists solely of words, letters, or numbers. A standard character mark protects the wording itself, without limiting the mark to a specific font, style, size, or color and therefore gives you broader protection than a special form drawing. A standard character drawing must have the following characteristics: No design element; No stylization of lettering and/or numbers; Any letters and words in Latin characters;

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 Any numbers in Roman or Arabic numerals; Only common punctuation or diacritical marks. The USPTO has created a standard character set that lists letters, numerals, punctuation marks, and diacritical marks that may be used in a standard character drawing. The set is available on the USPTOs website at http://teas.uspto.gov/standardCharacterSet.html. How do I file a standard character drawing? When you file electronically, TEAS generates a standard character drawing for you, based on the information you enter on the form under enter the mark here. When you file on paper, you must use standard letter-size paper and include these elements at the top of the drawing page as part of your application: applicants name; correspondence address; and the following statement: The mark is presented in standard character format without claim to any particular font style, size or color. The representation of the mark must appear in the middle of the page. What is a special form drawing? If your mark includes a design or logo, alone or with wording, or if the particular style of lettering or particular color(s) is important, you must select the special form drawing format. How do I file a special form drawing? When you file electronically, you must upload an image of your mark into the TEAS form. The mark image must be in .jpg format and should have little or no white space appearing around the design of the mark. Mark images should not include the trademark, service mark or registration symbols (TM, SM,). Unless a color image is being submitted for a mark wherein color is claimed as a feature of the mark, the mark image should be pure black-and-white. When you file on paper, you must use standard letter-size paper and include the applicants name and correspondence address at the top of the drawing page as part of your application. The mark must appear in the middle of the page.

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Generally, you may submit a black-and-white drawing even if you use your mark in color, because a black-and-white drawing covers use of your mark in any color. To claim a specific color(s), you must submit a color drawing of your mark. You must submit the following: (1) a color claim naming the color(s) and stating that the color(s) is a feature of the mark; and (2) a separate statement describing the mark and stating where the color(s) appears in the mark. Goods are products, such as bicycles or candles. Services are activities performed for the benefit of someone else, such as bicycle rental services or catering. The difference between goods and services may be confusing. Are your customers paying for a product or paying you to perform a specific activity? If your customer is paying you for a product, such as a candle or bicycle, then you have goods. However, if your customer is paying you to perform an activity, such as catering or bicycle rental, then you have services. You may list both goods and services in an application. You must list the specific goods/services for which you want to register your mark. If you are filing based upon use in commerce, you must be using the mark in commerce on all the goods/services listed. If you are filing based upon a bona fide intent to use the mark, you must have a good faith or bona fide intent to use the mark on all the goods/services listed. <-- **************not included

Copyright Copyright is a form of protection provided to the authors of "original works of authorship" including literary, dramatic, musical, artistic, and certain other intellectual works, both published and unpublished. The 1976 Copyright Act generally gives the owner of copyright the exclusive right to reproduce the copyrighted work, to prepare derivative works, to distribute copies or phonorecords of the copyrighted work, to perform the copyrighted work publicly, or to display the copyrighted work publicly. The copyright protects the form of expression rather than the subject matter of the writing. For example, a description of a machine could be copyrighted, but this would only prevent others from copying the description; it would not prevent others from writing a description of their
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own or from making and using the machine. Copyrights are registered by the Copyright Ofice of the Library of Congress. Term is the author's life plus an additional 70 years after the author's death (50 to 150 years). Work for hire: 95 years from publication or 120 years from creation Provides exclusive right to produce: To reproduce the work in copies or phonorecords; To prepare derivative works based upon the work; To distribute copies or phonorecords of the work to the public by sale or other transfer of ownership, or by rental, lease, or lending; To perform the work publicly, in the case of literary, musical, dramatic, and choreographic works, pantomimes, and motion pictures and other audiovisual works; To display the copyrighted work publicly, in the case of literary, musical, dramatic, and choreographic works, pantomimes, and pictorial, graphic, or sculptural works, including the individual images of a motion picture or other audiovisual work; and In the case of sound recordings, to perform the work publicly by means of a digital audio transmission. Protects expression of idea. but not idea itself Does not protect idea, process, procedure, operation, concept, principle, discovery, Limitations of Copyright: the fair use of a copyrighted work for purposes such as criticism, comment, news reporting, teaching (including multiple copies for classroom use), scholarship, or research, is not an infringement of copyright. In determining whether the use made of a work is a fair use the factors to be considered shall include

1. the purpose and character of the use, including whether such use is of a commercial nature or is for nonprofit educational purposes; 2. the nature of the copyrighted work; 3. the amount and substantiality of the portion used in relation to the copyrighted work as a whole; and 4. The effect of the use upon the potential market for or value of the copyrighted
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work.

The fact that a work is unpublished shall not itself bar a finding of fair use if such finding is made upon consideration of all the above factors You dont have to do anything to get copyright as soon as you put it down on a tangible medium of expression, you have the right In case of work for hire, owner of copyright is employerIn employee/employer case, ownership of employer is presumed.. in other cases, not presumed. Filing for copyright is optional, if someone infringes copyright, you can claim damages and attorney fees.. every new version can be copyrighted. Examples of multiple protections Ornamental design copyrighted as a work of art, also design patent. Copyrighted artistic representation can be also protected as a trademark. Industrial design can be protected as a copyright, patent and trademark.

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Susan Anthony, Attorney-Advisor, Office of International Relations, U.S. Patent and Trademark Office, Patents and Trademarks and Copyrights -- Oh My!, www.stopfakes.gov/smallbusiness. Rolls-Royce The Spirit of Ecstasy protected both as patent, trademark, and copyright ************not included-> The Semiconductor Chip Protection Act provides copyright protection mask works fixed in semiconductor chip products. Administered by the Copyright Office Mask work must be original. It must not have been copied. The mask work may not consist solely of designs that are staple, commonplace or familiar in the semiconductor industry, or variations of such designs, combined in a way that, considered as a whole, are not original. Mask work owner must be living in the US or. Must register within 2 years after mask work is commercially exploited, protection is for 10 years.

Steps to protect IPR Publishing is the easiest way to prevent others from using a knowhow Require all employees prior to hiring to assign ownership of future inventions..
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Noncompete clause prevent employees from joining competitor, and also disclose information to competitor Materials transfer agreement control transfer of materials, also ownership of inventions using the materials Non-disclosure agreements - Prevent disclosure that will bar patentability, bar commercial use of info. Joint invention agreements who will file patents, who will license, sharing expenses and incomes. Patent Licensing Patent licensing helps patent owner (licensor) to allow another party (licensee) to use patented knowhow for a fee exclusively or nonexclusively without transferring the ownership of the patent To licensor Advantages Increased profits Lower risk than foreign direct investment

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Simple no need to give technical advice Allows several licenses at the same time Disadvantages Potential rival Total profits lower than that could have been with full development Profits depend on licensees capability. To licensee Less expensive Reduced risks through payment scheme Shorter product development time Lower risks of commercialization Disadvantage Can violate antitrust laws 5 million patents in force worldwide A survey of technology intensive firms indicate: 12% had more than 1000 unused patents 15% had more than 100 unused patents 30% of Japanese firms had more than 2000 unused patents Cross licensing and patent pools (portfolio patents required for a product) increase access to patents Estimate of patent licensing market $100 billion in 1998. Currently could be $500 billion Licensing is concentrated in few industries Chemical, electronics and electrical industries and industrial machinery Previous connection is important Exclusivity more common in chemical Cross licensing common in electronics Consultants and other intermediaries play a big role in patent licensing Methods of valuation
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Based on strength and breadth of technology patented Based on replacement cost Based on similar transaction Net present value of future cash flows Some contracting issues Field of use Exclusive/nonexclusive Whether sublicensing be allowed What warranties Fees maintenance, royalty, equity..

Good website: http://usinfo.state.gov/products/pubs/intelprp/ http://www.startupjournal.com/runbusiness/survival/200012111008-siegel.html http://otced.umr.edu/files/Integrating%20Patents%20and%20Technology%20Transfer.pdf -not included***********

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Healthcare Operations Management

Health care costs about $ 2 trillion, 15% of gdp, expected to be $3.5 trillion by 2015 and 20 percent of the GDP. Per capita health expenditure $6280 in 2004. Expected to $12357 in 2011 Health Insurance Coverage in 2007 Age Population(mill) Employment Private Medicare Medicaid Military Percent Million Based nongroup Under 19 78.7 60.7% 5.3% 0.7% 27.6% 2.8% 11.3% 8.9 Under 65 262.3 64.4% 6.5% 2.7% 13.8% 3.2% 17.1% 45.0 65+ 36.8 35.0% 25.9% 93.2% 8.9% 7.1% 1.9% 0.7 All ages 299. 60.8% 8.9% 13.8% 13.2% 3.7% 15.3% 45.7 Spending by activity in 2007 Hospital Profession service Dental Nursing Home Prescription Drug Payment Out of pocket Private Health Insurance Federal Medicare Medicaid Other State Medicaid Other state 6.4% 6.2% 19.2% 8.3% 6.1% 12% 34.6% 31% 24% 4.2% 8.5% 10.2

Private usually through employer. Medicare for people over 65. Medicaid for poor people and nursing home for poor over age 65. Health expenses are highly concentrated:
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Top 1% accounts for 22% Top 5% accounts for 49% Top 10% accounts for 64% Top 50% accounts for 97% Bottom 50% accounts for 3% of total health expenditures

Health care accounts for 15 percent of gdp.. but employs only 9.2 percent of employees

Since employee healthcare is paid by employer, every item produced includes health care costs. Higher health care costs higher costs of products.

Health care costs rising at a rate higher than CPI. There was no way to challenge hospital costs. The goal is to come up with a method to pay hospitals and also hospital should not have any incentive to overtreat a patient.

All hospital discharges are categorized by specialty. They are call major medical categories. There were 23 of them. Discharges are categorized based on whether stay involved surgery (operating room) or not. So discharges are classified into medical and surgical groups. So total 46 groups. Then procedures are examined in terms of Length of Stay. (Length of stay is considered as a proxy for cost). Then length of stays are analyzed in terms of age, gender and complications for each procedure. If relationship are seen, then they are grouped into one group. In early 1980s , about 450 groups were identified. These groups were called Diagnosis Related Groups or DRGs and they represented identical consumption of resources.

DRG represent statistically homogenous groups of hospital admissions based on resource consumption. So hospitals cannot claim that they are different. So DRGs can be used one hospital costs with that of another. DRGs can help to reduce costs.
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Since for each DRGs payment is the same, hospital has no incentive to overpay and lot of incentives to innovate to reduce costs.

Easy to negotiate prices.

Everything we learned about operations management can now be applied to hospital by treating DRGs as products. DRGs can also be used to measure resource consumption and outcomes and compare different hospitals in terms of mortality rates, develop internal planning systems etc.

Using DRGs, hospital cost system can be developed. All DRGs can be expressed in unit DRG. So it is possible to calculate sum of unit DRGs treated by a hospital each year. This will represent output. By using various inputs such as nursing hours, hospital productivity can be calculated. In addition, # of unit DRG per patient treated can be calculated. This is called case mix. Higher is the case mix, more resource intensive treatment a hospital is providing.

Source: http://pastirahmat.wordpress.com/2011/02/14/theory-and-application-of-diagnosisrelated-group/ Basic characteristics of the DRG patient classification system Given the limitations of previous patient classification systems and the experience of attempting to develop DRGs with physician panels and statistical analysis, it was concluded that in order for the DRG patient classification system to be practical and meaningful, it should have the following characteristics: The patient characteristics used in the definition of the DRGs should be limited to information routinely collected on hospital abstract systems. There should be a manageable number of DRGs which encompass all patients seen on an inpatient basis. Each DRG should contain patients with a similar pattern of resource intensity.
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 Each DRG should contain patients who are similar from a clinical perspective (i.e., each group should be clinically coherent). Restricting the patient characteristics used in the definition of the DRGs to those readily available insured that the DRGs could be extensively applied. The patient information routinely collected includes age, principal diagnosis, secondary diagnoses and the surgical procedures performed. Creating DRGs based on information that is collected only in a few settings, or on information that is difficult to collect or measure, would have resulted in a patient classification scheme which could not be applied uniformly across hospitals. This is not to say that information beyond that currently collected might not be useful for defining the DRGs. As additional information becomes routinely available, it must be evaluated to determine if it could result in improvements in the ability to classify patients. Additional info for you ,the one site of DRGs list code : ( http://health.utah.gov/opha/IBIShelp/codes/DRGCode.htm) . The IBIS system uses the most recent definition and lists the codes alphabetically. last updated July 2008 and it codes until 579 codes of disease /infection. DRG Payment and the Use of Medical Technology There are two general incentives inherent in any per-case payment system: 1) to reduce the cost to the hospital of each inpatient case stay, and 2) to increase the number of inpatient admissions. Cost per case can be reduced by using fewer technological services, including ancillary services, reducing the number of inpatient days, or both. This incentive may result in specialization among hospitals for services that require a minimum number of patients to maintain profitability. This specialization may imply lower access to care for some Medicare patients. There are built-in constraints of unknown magnitude on the possibility of adverse effects on access and quality. One constraint is the fact that physicians are the decisionmakers, and they continue to have financial, ethical, and legal reasons to practice high-quality medicine. The direction and strength of general incentives for any particular hospital are altered by key features of the DRG payment system, including: 1) the proportion of the hospitals case load covered by DRG payment, 2) the treatment of costs as pass-throughs, * 3) the methods of DRG rate construction, 4) the methods of updating DRG rates, and

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5) the level of risk and reward built into the payment system. Thus, a DRG payment system may include a variety of specific approaches to payment with some predictable effects on medical technology. DRG payment incentives may be expected to affect technology use in the following ways: Overall, the number and intensity of ancillary procedures provided to inpatients can be expected to decrease, but the use of procedures that can be shown to lower the cost per case will increase. The settings of technology use are likely to be influenced by DRG payment, but the incentives work in conflicting directions and are sensitive to the key features of program design. It remains to be seen which incentive will dominate for which procedures. DRG payment will encourage the movement of technologies into the home, particularly those for post-hospital care. DRG payment is likely to influence the specialization of services, but the magnitude and direction of these effects is unknown. The incentives to reduce costs encourage concentration of capital-intensive technologies in fewer institutions. Conversely, the increasing competition among hospitals for physicians and patients will create incentives for the widespread acquisition of some technologies. A change in technology product mix is likely to result from downward pressure on the price and quantity of supplies and, if capital is included in the DRG rate, capital equipment. Greater product standardization can be expected as more expensive models and procedures are eased out of the market through competition. Effects of DRG Payment on Technological Change in Medicine Perhaps even more important than how DRG payment affects the use of presently available medical technologies is how DRG payment will affect technological change in medicinethe adoption of new technologies and discarding of old ones. DRG payment will influence hospitals decisions to adopt new medical technologies and may therefore alter the rate and direction of technological change in medicine. Although no empirical studies on the effect of DRG payment on adoption of technologies are available, studies of other kinds of prospective payment systems suggest that hospitals can and do respond to changes in financial incentives in these decisions. In general, technologies that are cost-reducing to hospitals will be encouraged; cost-raising technologies will be discouraged. However, much depends on the strength and design of the program. In particular, the methods of providing rewards for cost reductions, treating capital costs, and updating DRG prices have important implications for technological change. Though DRG payment does not imply that technological change will approach a standstill, its directions are likely to be altered, and the adoption of technologies that are cost-raising to the hospital is likely to decline by an unknown quantity. The longrun viability of any DRG payment system depends on its ability to both adapt to and encourage appropriate technological change in medicine. The methods and procedures used to adjust the average payment level, relative DRG rates, and the DRG categories themselves are critical to the survival of the system. The objectives of the adjustment process are to maintain equality
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across DRGs in the ratios of price to cost of efficient care and to promote the adoption of appropriate new technologies. There are at least five potential processes of adjustment. They vary according to whether the adjustment is conditional on hospitals actual adoption of new technology, who requests the adjustment, and when in the stage of a new technologys diffusion the adjustment is made. None of these processes alone is sufficient to adjust the system adequately for technological change. Implementation Issues Other considerations for the feasibility of using DRGs as the case-mix measure in the Medicare payment system include two important aspects of implementation of this new system: 1) data and coding issues, and 2) hospital administrative issues. Accurate and timely patient-level data are clearly important to the efficient and effective operation of the DRG system. In the past, evaluations of patient discharge data have found them to be unreliable. However, it is important to note that these abstracts had not been produced for payment purposes. When payment depends on the accuracy and timeliness of discharge abstracts, their importance increases, and data reliability should improve. Monitoring by utilization and quality control peer review organizations as mandated by the new Medicare law, should give hospitals added incentive to improve their data collection and coding. Such improvements in information quality implies a need for several education programs for medical staff, hospital administrators, and medical records personnel. Error detection, feedback, and training would be important parts of data programs. It should be noted that these types of improvements are likely to be more expensive and time-consuming. Some of these costs will vary among the individual hospitals depending on their current practices. For example, some hospitals might need to adopt computer capability for medical records, while others might need to add to their medical records staff. http://www.kaiseredu.org/Issue-Modules/US-Health-Care-Costs/Background-Brief.aspx B AC K GR O UN D Health care costs have been rising for several years. Expenditures in the United States on health care surpassed $2.3 trillion in 2008, more than three times the $714 billion spent in 1990, and over eight times the $253 billion spent in 1980. Stemming this growth has become a major policy priority, as the government, employers, and consumers increasingly struggle to keep up with health care costs. [1] In 2008, U.S. health care spending was about $7,681 per resident and accounted for 16.2% of the nations Gross Domestic Product (GDP); this is among the highest of all industrialized countries. Total health care
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expenditures grew at an annual rate of 4.4 percent in 2008, a slower rate than recent years, yet still outpacing inflation and the growth in national income. Absent reform, there is general agreement that health costs are likely to continue to rise in the foreseeable future. Many analysts have cited controlling health care costs as a key tenet for broader economic stability and growth, and President Obama has made cost control a focus of health reform efforts under way. Although Americans benefit from many of the investments in health care, the recent rapid cost growth, coupled with an overall economic slowdown and rising federal deficit, is placing great strains on the systems used to finance health care, including private employer-sponsored health insurance coverage and public insurance programs such as Medicare and Medicaid. Since 1999, family premiums for employer-sponsored health coverage have increased by 131 percent, placing increasing cost burdens on employers and workers. [2] With workers wages growing at a much slower pace than health care costs, many face difficulty in affording outof-pocket spending. Government programs, such as Medicare and Medicaid, account for a significant share of health care spending, but they have increased at a slower rate than private insurance. Medicare per capita spending has grown at a slightly lower rate, on average, than private health insurance spending, at about 6.8 vs. 7.1% annually respectively between 1998 and 2008. [3] Medicaid expenditures, similarly, have grown at slower rate than private spending, though enrollment in the program has increased during the current economic recession, which may result in increased Medicaid spending figures soon. [4] HOW
IS T H E

U.S.

H E ALT H C AR E D O L L AR SP E N T ?

As shown in the figure below, hospital care and physician/clinical services combined account for half (51%) of the nations health expenditures.

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National Health Expenditures, 2008

Total = $2.3 Trillion Source: Centers for Medicare and Medicaid Services, Office of the Actuary, National Health Statistics Group. W H AT
IS D R IV IN G H E A LT H C AR E C O ST S ?

Controlling health care expenditures requires a solid understanding of the factors that are driving the growth in spending. While there is disagreement on exactly what those are, some of the major factors to consider are: Technology and Prescription drugs For several years, spending on new medical technology and prescription drugs has been cited as a leading contributor to the increase in overall health spending; however, in recent years, the rate of spending on prescription drugs has decelerated. Some analysts state that the availability of more expensive, stateof-the-art technological services and new drugs fuel health care spending not only because the development costs of these products must be recouped by industry but also because they generate consumer demand for more intense, costly services even if they are not necessarily cost-effective. [5] Chronic disease The nature of health care in the U.S. has changed dramatically over the past century with longer life spans and greater prevalence of chronic illnesses. This has
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placed tremendous demands on the health care system, particularly an increased need for treatment of ongoing illnesses and long-term care services such as nursing homes; it is estimated that health care costs for chronic disease treatment account for over 75% of national health expenditures. [6] Aging of the population Health expenses rise with age and as the baby boomers are now in their middle years, some say that caring for this growing population has raised costs. This trend will continue as the baby boomers will begin qualifying for Medicare in 2011 and many of the costs are shifted to the public sector. However, experts agree that aging of the population contributes minimally to the high growth rate of health care spending. [7] Administrative costs It is estimated that at least 7% of health care expenditures are for administrative costs (e.g., marketing, billing) and this portion is much lower in the Medicare program (<2%), which is operated by the federal government. [8] Some argue that the mixed public-private system creates overhead costs and large profits that are fueling health care spending. W H AT
AR E T H E M AJ O R P R O P O SAL S T O C O N T AIN C O ST S ?

The start of a new administration and the economic recession present a new window of opportunity for health care reform and for controlling health costs. However, since the 1960s, the nations efforts to control health care costs have not had much long-term effect, prompting a debate over what proposals are actually able to sustainably reduce costs. [9] One effort, the advent of managed care, which represented a shift towards greater control over utilization of services, did initially seem to generate savings as managed care practices became widespread throughout the late 1980s and 1990s. However, spending has since rebounded sharply as the health sector seems to have exhausted one-time savings and a backlash loosened many managed care policies, particularly restrictions on consumer choice. The different proposals currently in the policy arena are divided broadly by debate over a stronger role for government negotiation or market-based models relying on competitive forces. Investment in information technology (IT) Greater use of technology, such as electronic medical records (EMR), has been promoted and researched for its potential to more efficiently share information and reduce overhead costs. $19 billion in federal funding has already been allocated to uniformly upgrade health IT, a major component of the Obama administrations health reform plan, indicating that the movement to invest in IT has gained significant traction. Improving quality and efficiency There are a number of initiatives in play that aim to help make the health care system more efficient and higher quality, and consequently more cost-effective. Overall, decreasing unwarranted variation in medical practice and unnecessary care is seen as a priority, particularly geographic variation, since higher spending on health care in certain geographical areas does not correspond to better health outcomes. Some experts estimate that up to 30% of health care is unnecessary,
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emphasizing the need to streamline the health system and eliminate this needless spending. Adjusting provider compensation The current system of provider compensation pays physicians a given fee per procedure or test, for example as dictated by the Medicare Physician Fee Schedule guidelines for the value of over 10,000 physician services. Currently, there are proposals to revamp some provider payments to ensure that fees paid to physicians reward value and health outcomes, rather than volume of care. This is meant to eliminate unnecessary care and thereby decrease costs. Comparative effectiveness research (CER) is being increasingly emphasized as a means to determine which treatments are most effective for given conditions, in order to provide doctors with the necessary information to make the best choices for patients care. Government regulation Citing the success of the Medicare program in controlling per capita spending over its history and warning that market-based approaches combined with greater individual financial responsibility can disadvantage those with limited financial resources and create barriers to needed care, some policymakers favor more government involvement in the health care sector. Critics argue that such regulation stifles innovation and that market-based approaches are more cost-effective and will provide consumers with a wider range of choices. Prevention - The burden of chronic diseases, such as diabetes and cardiovascular disease, has risen dramatically; both of these chronic conditions are known to be correlated with obesity, smoking, and diet, and are very expensive to treat over long periods of time. Proposals have been put forward to emphasize prevention by providing financial incentives to workers to engage in wellness and prevention, in order to decrease the prevalence of these conditions and avoid incurring the long-term costs of treatment. However, it is unclear how much prevention programs will decrease costs, since paradoxically healthier people will likely liveand use the health systemlonger. For those already suffering from chronic diseases, disease management strives to improve and streamline the treatment regimen for common, chronic health conditions. Increasing consumer involvement in purchasing Supporters of consumer-driven health care believe that greater price transparency would make consumers more price sensitive and more prudent purchasers and thus save consumers and employers money. One of the major forms currently is tax-favored health reimbursement accounts (HRA), to which employers contribute funds that are managed by the employee to spend on primary health care as she directs. Critics of the consumer-directed approach raise concerns about the potential impacts that the higher cost-sharing would have on lower income people and about the potential for these new arrangements to be disproportionately used by healthy people, shifting sicker groups to more expensive forms of insurance. Altering the tax preference for employer-sponsored insurance Currently, employees do not pay income or payroll tax on money employers spend on their health insurance, regardless of the cost of those benefits. Some current health reform proposals suggest eliminating or changing the tax exclusion for employer-sponsored health care to help finance the costs of expanding coverage as well as reducing incentives for the most generous and therefore expensive health plans. One possibility is that the tax exclusion would be capped at the value of benefits received by Members of Congress, and employees opting for more expensive health plans would be taxed on the difference.
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Those against eliminating the tax exclusion worry doing so could drive up the cost of health insurance to workers and disproportionately affect smaller companies and those with an older workforce, who tend to pay higher premiums. Costs have emerged as a central element of any national health reform effort. As policymakers move forward with plans to enact comprehensive health reform, costs will surely continue to be at the forefront of the surrounding policy debates. D ISC US S IO N Q UE ST IO N S What are the major drivers of the rise in health care spending? How can health care be made more affordable without limiting access to necessary care? What role should government play in controlling increases in the cost of care and the cost of health coverage? What different choices do state and federal policymakers have in containing costs? What is the responsibility of individuals for the cost of their care? Are health savings accounts and high deductible insurance policies an approach that should be expanded? What are the concerns for low-income individuals? How does the rise in costs affect efforts to expand coverage to the nations 47 million uninsured? Acknowledgements: Prepared by Eric Kimbuende, Usha Ranji, Janet Lundy, and Alina Salganicoff of the Kaiser Family Foundation. Updated: March 2010. BACK TO TOP 1 Centers for Medicare and Medicaid Services, Office of the Actuary, National Health Statistics Group, National Health Care Expenditures Data, January 2010. 2 Kaiser Family Foundation and Health Research and Educational Trust. Employer Health Benefits 2009 Annual Survey. September 2009. 3 Altman, D., L. Levitt, and G. Claxton, Kaiser Family Foundation, Pulling it Together: An Actuarial Rorschach Test , 2010. 4
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Kaiser Commission on Medicaid and the Uninsured, The Crunch Continues: Medicaid Spending, Coverage and Policy in the Midst of a Recession, 2009. 5 Congress of the United States, Congressional Budget Office. Technological Change and the Growth of Health Care Spending, January 2008. 6 Centers for Disease Control and Prevention. Chronic Disease Overview. 7 Orszag, P. Congressional Budget Office Testimony: Growth in Health Care Costs. Delivered before the Committee on the Budget, United States Senate, January 31, 2008. 8 Altman, D. and L. Levitt. February 23, 2003. The Sad History of Health Care Cost Containment As Told in One Chart. H E AL T H A F F A I R S Web Exclusive. 9 Partnership to Fight Chronic Disease, 2009 Almanac of Chronic Disease, 2009.

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Environmental Management

Environmental Problems: 30 million computers thrown away each year in US About 14% are recycled Heavy metals pollute water Tackling waste flows can reduce environmental impact and save money

Ecological Footprint = Human pressure on global ecosystems, food, wood, infrastructure, energy, carbon dioxide absorption, expressed in area miles. Go to website www.myfootprint.org

The population time bomb. Stratospheric ozone depletion The word ozone comes from the Greek word ozein to mean to smell pungent blue gas chemically composed of three oxygen atoms O3. Ozone absorbs UV rays. CFCs (Chloroflorocarbons) destroy ozone UV rays cause cancer, disrupts normal weather pattern. Global Warming - The Greenhouse Effect If it were not for naturally occurring greenhouse gases, the Earth would be too cold to support life, as we know it. Without the greenhouse effect, the average temperature of the Earth would be about -2F rather than the 57F we currently experience. Many chemical compounds found in the Earths atmosphere act as "greenhouse gases." These gases allow sunlight to enter the atmosphere freely. When sunlight strikes the Earths surface, some of it is re-radiated back towards space as infrared radiation (heat). Greenhouse gases absorb this infrared radiation and trap its heat in the atmosphere. Many gases exhibit these greenhouse properties. Some occur naturally. Some are also produced by human activities and some are exclusively human made (for example, industrial gases).
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The major greenhouse gases the United States emits as a result of human activity and that are included in U.S. and international emissions estimates are: Carbon dioxide (CO2) Methane (CH4) Nitrous oxide (N2O) Industrial Gases: Hydrofluorocarbons (HFCs) Perfluorocarbons (PFCs) Sulfur hexafluoride (SF6)

There are other greenhouse gases that are not counted in U.S. or international greenhouse gas inventories: Water vapor is the most abundant greenhouse gas, but most scientists believe that water vapor produced directly by human activity contributes very little to the amount of water vapor in the atmosphere, and therefore EIA does not estimate emissions of water vapor. Recent research by NASA suggests a stronger impact from the indirect human effects on water vapor concentrations. Ozone is technically a greenhouse gas because it has an effect on global temperature. However, at higher elevations in the atmosphere (stratosphere), where it occurs naturally, it is needed to block harmful UV light. At lower elevations of the atmosphere (troposphere) it is harmful to human health and is a pollutant regulated independently of its warming effects. In the United States, greenhouse gas (GHG) emissions come primarily from the burning of fossil fuels in energy use. Energy use is largely driven by economic growth with short-term fluctuations in its growth rate created by weather patterns affecting heating and cooling needs. Energy use is also driven by changes in the fuel used in electricity generation. Methane and Other Gases Another greenhouse gas, methane (CH4 ), comes from landfills, coal mines, oil and natural gas operations, and agriculture; it represented about 11% of total U.S. GHG emissions in 2009. Nitrous oxide (N2O) emissions, at about 3% of total GHG emissions, came from the use of
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nitrogen fertilizers, burning fossil fuels, and certain industrial and waste management processes. Several human-made gases, hydrofluorocarbons (HFCs), perfluorocarbons (PFCs), and sulfur hexafluoride (SF6), that are released as byproducts of industrial processes and through leakage, represented about 3% of total emissions. The United States, with 4.5% of the world's population, produced about 19% of global carbon dioxide emissions from burning fossil fuels in 2008, and 18% in 2009, the most recent year for which global data are available. The United States accounts for this share primarily because the U.S. economy is the largest in the world and meets 83% of its energy needs by burning fossil fuels. Caused by Carbon Dioxide preventing the earth from radiating heat out increases temperature melts ice islands disappear, cause floods. Flooding, ocean disruptions, shifting storm patterns, reduced farm output, extinction of animals, droughts. Causes fossil fuel combustion, deforestation, methane from landfills and organic wastes etc. Kyoto conference on December 10, 1997 attended by more than 1500 delegates from 160 countries. Purpose legally binding treaty to reduce impacts of global warming. If nothing is done, developed countries will increase emissions by 20%. Acid Rain caused by burning of coal containing sulfur contaminates lakes, kills fish, damages trees etc.

Vanishing Forests Rising Garbage Hazardous Waste Water quality and so on. Two ways to respond 1) Command Control 2) Incentive Based system

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In command control specify, specific technologies or set standards for products or producers. Policy makers decide where and how to cut pollution. Incentive Based system Cap emissions and require buying emission rights or taxing emissions

Features of U.S. Environmental Laws

Command & Control

Top down, standards based on technology, the goal is to reduce pollutants at the source. Health-based standards to protect humans and the environment from environmental consequences Control through permits Mandates monitoring and self-reporting Large penalties for violations Citizens Suits (may be unconstitutional) States administer federal laws

Liability for violations and damages

Strict liability, retroactive liability, joint and several liabilities, transferable liability, liability for damages to natural resources

Public disclosure

Emergency Planning and community Right-to-know Act of 1986

Ecosystem and Place-Based Programs

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Focuses on land and water uses.

Marketable Permits, Offsets, and Cap & Trade Programs

Set limits on quantities of pollutants and allow trading in pollutants Acid Rain Control Program under the Clean Air Act

Environmental Impact Analysis

Example: National Environmental Policy Act of 1969

Incentives for Compliance Federal assistance to comply Perseveration Encourage preservation of natural, historical, and cultural resources.

Protect wildlife

Restrict fishing, hunting etc, restrict activities harming species, reduction requirements.

P UT T IN G

THE

L AW

TO

WORK

Once a law is official, here's how it is put into practice: Laws often do not include all the details needed to explain how an individual, business, state or local government, or others might follow the law. The U N I TE D S T A T E S C O D E would not tell you, for example, what the speed limit is in front of your house. In order to make the laws work on a day-to-day level, Congress authorizes certain government agencies - including EPA - to create regulations. Regulations set specific requirements about what is legal and what isn't. For example, a regulation issued by EPA to implement the Clean Air Act might explain what levels of a pollutant - such as sulfur dioxide - adequately protect human health and the environment. It would tell industries how much sulfur dioxide they can legally emit into the air, and what the penalty will be if they emit
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too much. Once the regulation is in effect, EPA then works to help Americans comply with the law and to enforce it. C R E AT IN G
A

R E GUL A T IO N

When developing regulations, the first thing we do is ask if a regulation is needed at all. Every regulation is developed under slightly different circumstances, but this is the general process: STEP 1: EPA P R O P O SE S
A

R E G U L A TI O N

The Agency researches the issues and, if necessary, proposes a regulation, also known as a Notice of Proposed Rulemaking (NPRM). The proposal is listed in the F E D E R AL R E G I S T E R (FR) so that members of the public can consider it and send their comments to us. The proposed rule and supporting documents are also filed in EPA's official docket on Regulations.gov STEP 2: EPA C O N SI D E R S Y O U R C O M M E N TS
AN D

I SSU E S

F I N AL R U L E

Generally, once we consider the comments received when the proposed regulation was issued, we revise the regulation accordingly and issue a final rule. This final rule is also published in the FR and in EPA's official docket on Regulations.gov. S TE P 3 : T H E R E G U L A TI O N S
IS

CODIFIED

I N TH E

CODE

OF

FE D E R A L R E G U L A T I O N S

Once a regulation is completed and has been printed in the FR as a final rule, it is codified when it is added to the C O D E O F F E D E R A L R E G U L A TI O N S (CFR). The CFR is the official record of all regulations created by the federal government. It is divided into 50 volumes, called titles, each of which focuses on a particular area. Almost all environmental regulations appear in Title 40. The CFR is revised yearly, with one fourth of the volumes updated every three months. Title 40 is revised every July 1.

The goal is to have uniform standards for all states so that states do not use environmental laws to attract polluters. However, the states can pass more stringent environmental laws. Environmental laws are enforced by the State Environmental Protection Departments. Citizens lawsuit allowing individuals to file suits to enforce environmental laws is an interesting feature of environmental laws.

Three categories of environmental laws:

Media specific regulating emission into the air, water, and land.
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Mandating cradle-to-grave management and cleanup of hazardous waste. Relating to products that generate wastes.

A brief description of various environmental laws are given below:

National Environmental Policy Act of 1969 Established Council of Environmental Quality to advise president, require federal agency to consider environmental consequences in any activity significantly affecting the quality of the human environment. The National Environmental Policy Act (NEPA) was one of the first laws ever written that establishes the broad national framework for protecting our environment. NEPA's basic policy is to assure that all branches of government give proper consideration to the environment prior to undertaking any major federal action that significantly affects the environment. NEPA requirements are invoked when airports, buildings, military complexes, highways, parkland purchases, and other federal activities are proposed. Environmental Assessments (EAs) and Environmental Impact Statements (EISs), which are assessments of the likelihood of impacts from alternative courses of action, are required from all Federal agencies and are the most visible NEPA requirements. Clean Air Act

1)Requires EPA to issue Nationwide Ambient Air Quality Standards (NAAQS) for lead, carbon monoxide, particulate matters, ozone, nitrous oxide, and sulfur dioxide. Primary standard to protect human health and secondary standard to prevent environmental and property damage. 2)Requires states to develop State Environmental Plans (SEPs) to achieve NAAQS and introduce permits. 3)Requirement of reformulated gasoline in the worst ozone non-attainment areas.

4)Requires EPA to come up with technology based emission standards for targeted
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chemicals. For new facilities generating pollution, this act sets performance standards. Divides states into three classes for the attainment of air quality standards. 5)Class I national parks and wilderness areas allow very little deterioration of air quality. For class II areas, only a very little deterioration is allowed. Large increases in air pollution in class III are allowed. 6)Emission trading was established. The Clean Air Act (CAA) is the comprehensive federal law that regulates air emissions from stationary and mobile sources. Among other things, this law authorizes EPA to establish National Ambient Air Quality Standards (NAAQS) to protect public health and public welfare and to regulate emissions of hazardous air pollutants. One of the goals of the Act was to set and achieve NAAQS in every state by 1975 in order to address the public health and welfare risks posed by certain widespread air pollutants. The setting of these pollutant standards was coupled with directing the states to develop state implementation plans (SIPs), applicable to appropriate industrial sources in the state, in order to achieve these standards. The Act was amended in 1977 and 1990 primarily to set new goals (dates) for achieving attainment of NAAQS since many areas of the country had failed to meet the deadlines. Section 112 of the Clean Air Act addresses emissions of hazardous air pollutants. Prior to 1990, CAA established a risk-based program under which only a few standards were developed. The 1990 Clean Air Act Amendments revised Section 112 to first require issuance of technologybased standards for major sources and certain area sources. "Major sources" are defined as a stationary source or group of stationary sources that emit or have the potential to emit 10 tons per year or more of a hazardous air pollutant or 25 tons per year or more of a combination of hazardous air pollutants. An "area source" is any stationary source that is not a major source. For major sources, Section 112 requires that EPA establish emission standards that require the maximum degree of reduction in emissions of hazardous air pollutants. These emission standards are commonly referred to as "maximum achievable control technology" or "MACT" standards. Eight years after the technology-based MACT standards are issued for a source category, EPA is required to review those standards to determine whether any residual risk exists for that source category and, if necessary, revise the standards to address such risk.

Clean Water Act

Requires use of best practicable waste water treatment to clean up wastewater discharges Requires permits to pollute.
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Requires record-keeping The Clean Water Act (CWA) establishes the basic structure for regulating discharges of pollutants into the waters of the United States and regulating quality standards for surface waters. The basis of the CWA was enacted in 1948 and was called the Federal Water Pollution Control Act, but the Act was significantly reorganized and expanded in 1972. "Clean Water Act" became the Act's common name with amendments in 1977. Under the CWA, EPA has implemented pollution control programs such as setting wastewater standards for industry. We have also set water quality standards for all contaminants in surface waters. The CWA made it unlawful to discharge any pollutant from a point source into navigable waters, unless a permit was obtained. EPA's National Pollutant Discharge Elimination System (NPDES) permit program controls discharges. Point sources are discrete conveyances such as pipes or manmade ditches. Individual homes that are connected to a municipal system, use a septic system, or do not have a surface discharge do not need an NPDES permit; however, industrial, municipal, and other facilities must obtain permits if their discharges go directly to surface waters. Safe Drinking Water Act Applicable to systems that serve a minimum of 25 people for at least 60 days in a year. Establishes standards for drinking water and regulates underground injection.

Resource Conservation and Recovery Act Seeks to regulate solid and hazardous waste. Establishes standards for generators and transporters of hazardous waste. A waste is hazardous if it ignitable, corrosive, reactive or toxic. Requires record-keeping. Establishes standards for landfills. The Resource Conservation and Recovery Act (RCRA) gives EPA the authority to control hazardous waste from the "cradle-to-grave." This includes the generation, transportation, treatment, storage, and disposal of hazardous waste. RCRA also set forth a framework for the management of non-hazardous solid wastes. The 1986 amendments to RCRA enabled EPA to address environmental problems that could result from underground tanks storing petroleum and other hazardous substances. HSWA - the Federal Hazardous and Solid Waste Amendments - are the 1984 amendments to RCRA that focused on waste minimization and phasing out land disposal of hazardous waste as well as corrective action for releases. Some of the other mandates of this law include increased
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enforcement authority for EPA, more stringent hazardous waste management standards, and a comprehensive underground storage tank program. Comprehensive Environmental Response, Compensation, and Liability Act Also known as Superfund. Authorizes EPA to take action to control spills and releases of hazardous waste. EPA investigates potential sites, notes most severely contaminated sites into National Priority List sites, and also identifies parties responsible for cleanup. If a responsible party denies responsibility and loses the case, then that party is responsible for treble damages. The Comprehensive Environmental Response, Compensation, and Liability Act -- otherwise known as CERCLA or Superfund -- provides a Federal "Superfund" to clean up uncontrolled or abandoned hazardous-waste sites as well as accidents, spills, and other emergency releases of pollutants and contaminants into the environment. Through CERCLA, EPA was given power to seek out those parties responsible for any release and assure their cooperation in the cleanup. EPA cleans up orphan sites when potentially responsible parties cannot be identified or located, or when they fail to act. Through various enforcement tools, EPA obtains private party cleanup through orders, consent decrees, and other small party settlements. EPA also recovers costs from financially viable individuals and companies once a response action has been completed. EPA is authorized to implement the Act in all 50 states and U.S. territories. Superfund site identification, monitoring, and response activities in states are coordinated through the state environmental protection or waste management agencies. The Superfund Amendments and Reauthorization Act (SARA) of 1986 reauthorized CERCLA to continue cleanup activities around the country. Several site-specific amendments, definitions clarifications, and technical requirements were added to the legislation, including additional enforcement authorities. Also, Title III of SARA authorized the Emergency Planning and Community Right-to-Know Act (EPCRA). Emergency Planning and Community Right to Know Act Requires states to prepare emergency response plans. Requires facilities to report to the EPA annually hazardous chemical inventory and toxic chemical release inventories. Go to RTK.NET for data. Authorized by Title III of the Superfund Amendments and Reauthorization Act (SARA), the Emergency Planning & Community Right-to-Know Act (EPCRA) was enacted by Congress as the national legislation on community safety. This law is designed to help local communities protect public health, safety, and the environment from chemical hazards.

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To implement EPCRA, Congress requires each state to appoint a State Emergency Response Commission (SERC). The SERCs are required to divide their states into Emergency Planning Districts and to name a Local Emergency Planning Committee (LEPC) for each district. Broad representation by fire fighters, health officials, government and media representatives, community groups, industrial facilities, and emergency managers ensures that all necessary elements of the planning process are represented.

Toxic Substances Control Act Requires EPA to collect information about adverse effects of chemical materials. EPA can order tests for health effects of materials for which insufficient or no data exist. 90 days notice is required to introduce or import a new chemical product. The Toxic Substances Control Act of 1976 provides EPA with authority to require reporting, record-keeping and testing requirements, and restrictions relating to chemical substances and/or mixtures. Certain substances are generally excluded from TSCA, including, among others, food, drugs, cosmetics and pesticides. TSCA addresses the production, importation, use, and disposal of specific chemicals including polychlorinated biphenyls (PCBs), asbestos, radon and lead-based paint. Various sections of TSCA provide authority to: Require, under Section 5, pre-manufacture notification for "new chemical substances" before manufacture Require, under Section 4, testing of chemicals by manufacturers, importers, and processors where risks or exposures of concern are found Issue Significant New Use Rules (SNURs), under Section 5, when it identifies a "significant new use" that could result in exposures to, or releases of, a substance of concern. Maintain the TSCA Inventory, under Section 8, which contains more than 83,000 chemicals. As new chemicals are commercially manufactured or imported, they are placed on the list. Require those importing or exporting chemicals, under Sections 12(b) and 13, to comply with certification reporting and/or other requirements. Require, under Section 8, reporting and record-keeping by persons who manufacture, import, process, and/or distribute chemical substances in commerce.
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Require, under Section 8(e), that any person who manufactures (including imports), processes, or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment to immediately inform EPA, except where EPA has been adequately informed of such information. EPA screens all TSCA b8(e) submissions as well as voluntary "For Your Information" (FYI) submissions. The latter are not required by law, but are submitted by industry and public interest groups for a variety of reasons. Federal Insecticide, Fungicide, and Rodenticide Act Regulates pesticides. Mandates registration of a pesticide. Registration for 5 years, can be renewed. Labels must indicate approved uses. Restricted pesticides can only be used by a certified applicator. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) provides for federal regulation of pesticide distribution, sale, and use. All pesticides distributed or sold in the United States must be registered (licensed) by EPA. Before EPA may register a pesticide under FIFRA, the applicant must show, among other things, that using the pesticide according to specifications "will not generally cause unreasonable adverse effects on the environment.'' FIFRA defines the term ''unreasonable adverse effects on the environment'' to mean: ''(1) any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide, or (2) a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under section 408 of the Federal Food, Drug, and Cosmetic Act.'' Source: http://www.epa.gov/lawsregs/laws/#env Some things you should know about environmental management to work effectively in Corporations There are several standards for environmental management system. Almost all of them have Plan, Do, Check, Act, Improve elements. ISO 14000, European Unions Eco Management and Audit Scheme (EMAS), Performance based EMAS (to fit specific organization), and sector specific EMS. Stakeholder Consultation Environmental and Sustainability Reporting, Eco Labels (green labels) green star etc. Life Cycle Assessment useful in new product development. Also useful in comparing various alternatives, Environmental Impact Analysis Design for Environment
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Risk assessment, Risk management and Risk communication Emergency planning Continuous Improvement Environmental training product stewardship According to Shell Chemicals, product stewardship is a key component in our overall commitment to setting and achieving high standards in the management of health, safety and environment (HSE) issues related to our products. Some of the key activities undertaken include: Using Hazard Communication systems to provide product users with consistent hazard information, in their main local languages. In this way we ensure that users have the information they need to manage risks when handling, disposing of or transporting our products. Using assurance processes to verify the quality of all modes of transport. In Europe, for example, we use the Safety and Quality Assessment Scheme (SQAS) developed by the European Chemical Industry Council (CEFIC), to ensure high safety and quality standards among our road hauliers. Globally, we use the Shell Safe C and CEFIC's Chemical Distribution Initiative (CDI) schemes to assess our bulk marine carriers. Implementing appraisal processes for customer and distributor bulk reception facilities to minimise the risk of incidents occurring during the unloading of our products. Providing training to our customers in, for example, the handling and emergency response requirements related to our products. This can take various forms, such as helping to stage an emergency response exercise in conjunction with the local authorities, or providing training videos that can be used as part of a company's own safety programme. http://www.shell.com/home/content/chemicals/responsible_energy/sustainable_development_shel l_chemicals/product_stewardship/

Some relevant websites. Ozone and You Find out what you can do to help protect the ozone layer. http://www.epa.gov/docs/ozone/resource/indiv.html Understanding Global Warming
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The National Oceanic and Atmospheric Administration answers frequently asked questions. http://www.ncdc.noaa.gov/oa/climate/globalwarming.html Ozone Alerts The National Institute of Environmental Health explains acceptable behavior during air quality alerts.

http://www.niehs.nih.gov/oc/factsheets/ozone/ozonevalu.htm

The Deadly Brew New studies link smog to premature deaths. Read a response statement from the president and CEO of the American Lung Association.

http://www.lungusa.org/site/pp.asp?c=dvLUK9O0E&b=22542

Arctic Ozone May Drop to New Low The coming weeks could bring the most severe thinning of the ozone layer over northern Europe since records began, reports BBC News.

http://news.bbc.co.uk/2/hi/science/nature/4217329.stm

Ozone Problems An online version of the Biology textbook describes the situation with the hole in the ozone layer.

http://users.rcn.com/jkimball.ma.ultranet/BiologyPages/O/Ozone.html

Climate Change New Scientist explores the different ways Earth's creatures are affected by global warming. http://www.newscientist.com/channel/earth/climate-change Some things you should know about environmental management to work effectively in
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Corporations There are several standards for environmental management system. Almost all of them have Plan, Do, Check, Act, Improve elements. ISO 14000, European Unions Eco Management and Audit Scheme (EMAS), Performance based EMAS (to fit specific organization), and sector specific EMS. Stakeholder Consultation Environmental and Sustainability Reporting, Eco Labels (green labels) green star etc. Life Cycle Assessment useful in new product development. Also useful in comparing various alternatives, Environmental Impact Analysis Design for Environment Risk assessment, Risk management and Risk communication Emergency planning Continuous Improvement Environmental training product stewardship According to Shell Chemicals, product stewardship is a key component in our overall commitment to setting and achieving high standards in the management of health, safety and environment (HSE) issues related to our products. Some of the key activities undertaken include: Using Hazard Communication systems to provide product users with consistent hazard information, in their main local languages. In this way we ensure that users have the information they need to manage risks when handling, disposing of or transporting our products. Using assurance processes to verify the quality of all modes of transport. In Europe, for example, we use the Safety and Quality Assessment Scheme (SQAS) developed by the European Chemical Industry Council (CEFIC), to ensure high safety and quality standards among our road hauliers. Globally, we use the Shell Safe C and CEFIC's Chemical Distribution Initiative (CDI) schemes to assess our bulk marine carriers. Implementing appraisal processes for customer and distributor bulk reception facilities to minimise the risk of incidents occurring during the unloading of our products. Providing training to our customers in, for example, the handling and emergency response requirements related to our products. This can take various forms, such as helping to stage an emergency response exercise in conjunction with the local authorities, or providing training videos that can be used as part of a company's own safety programme. http://www.shell.com/home/content/chemicals/responsible_energy/sustainable_development_shel l_chemicals/product_stewardship/
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Energy Management Energy Is the Ability To Do Work Energy comes in different forms: Heat (thermal) Light (radiant) Motion (kinetic) Electrical Chemical Nuclear energy Gravitational There are two types of energy: Stored (potential) energy Working (kinetic) energy Energy sources are divided into two groups renewable (an energy source that can be easily replenished) and nonrenewable (an energy source that we are using up and cannot recreate). Renewable and nonrenewable energy sources can be used to produce secondary energy sources including electricity and hydrogen. Renewable energy sources include: Energy source Solar Geothermal Biomass Wind Biofuels Wood Hydropower % of total renewable energy consumed in the U.S. 1% 3% 6% 11 23% 25% 31%

Renewable energy consumed in the U.S. is about 8 percent of all energy consumed. Nonrenewable energy sources include: Energy source Petroleum Coal
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% of total consumed in the U.S. 37% 21%

Natural Gas Nuclear

25% 9%

Petroleum, coal and natural gas are called fossil fuels because they were formed over millions and millions of years by the action of heat from the Earth's core and pressure from rock and soil on the remains (or "fossils") of dead plants and creatures like microscopic diatoms. When these are burned they generate carbon dioxide. Energy Laws or Principles Energy is neither created nor destroyed. "Energy efficiency" is the amount of useful energy you get from any type of system. A perfectly energy-efficient machine would change all the energy put in it into useful work. In reality, converting one form of energy into another form always involves a loss of useable energy. Use of energy: Commercial (19%), Industrial(31%), Residential (23%), Transportation(28%) There are many different uses and a variety of different energy sources used in the industrial sector. One main use is as boiler fuel, which means producing heat that is transferred to the boiler vessel to generate steam or hot water. Another use is as process heating, which is when energy is used directly to raise the temperature of products in the manufacturing process; examples are separating components of crude oil in petroleum refining, drying paint in automobile manufacturing, and cooking packaged foods. Refining, chemical, paper and metal industries use 2/3 rd of total energy inputs of energy used for heat, power, and electricity generation. Please note that when energy sources like coal and petroleum are used as ingredient are called feedstocks. When processes produce (i) hot exhaust gases, (ii) flare gases and (iii) high pressure gases, these are called byproduct energy. Petroleum is the major source energy for transportation. Natural gas, electricity, heating oil and propane gas are used in homes Electricity and natural gas in buildings Difference between Energy conservation reduce use Energy efficiency consume less energy to perform required function Greenhouse gases Carbon dioxide, methane, nitrous oxide, industrial gases (hydroflouro carbon, sulfur hexafluoride) greenhouse gases warm the planetmost of carbon dioxide comes from
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coal and petroleum usecoal is dominant input for energy..recycling saves energy by reducing production of new products Petroleum can be used to produce a variety of products such as ink, plastic etc Exclusive economic zone 200 miles from coastline according to the International Law of the Sea Countries can drill within their economic zone World consumes 85.3 million barrels a dayU.S. 19.8 million, China 8.4 million Environmental laws relating to Oil - no dumping into rivers, reformulated gas Gas price the cost of crude oil, refining costs, distribution costs, taxes and profits Diesel oil produced from crude oil Price of diesel oil was lower than that of gasoline until 2004.After 2004, diesel prices went up because of increased growth in demand, higher federal taxes, need for low sulfur diesel oil, Diesel fuel prices are economically sensitive Natural gas is methane gas It is usually stored in large underground storage systems before delivery.. natural gas can be stored and delivered as liquids. Natural gas transportation network consists of: Gathering systems (small diameter, low pressure pipelines) move gas from wellhead to processing plants. Processing plants separate impurities and liquids from natural gas stream and delivers to mainline transmission system High pressure interstate and intrastate transmission pipelines from producing area to market areas. Compressor stations located strategically keeps natural gas moving Underground storage facilities (gas reservoirs or salt caverns) store gas Liquefied natural gas storage facilities store above ground. Distributors deliver to end users with 1.2 million of local distribution pipelines. There are 200 companies with 306,000 miles of transmission pipelines, 125 natural gas storage operators 200 companies involved in liquefied natural gas storage facilities 1300 distribution companies.
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Liquefied natural gas by cooling to about -260F. Volume is reduced by 600 times. Easy to transport. Natural gas can also be obtained from fine grained sedimentary rock by braking into thin parallel layers. Fracking involves pumping liquids under high pressure into a well to fracture the rock and allow gas to escape gas from tiny pockets in the rock. Proved reserves economically recoverable in future years from known reservoirs Natural gas is clean burning but a strong greenhouse gas Coal by carbon content can be categorized into Anthracite, Bituminous, Subbituminous, and Lignite Surface mining involves mining coal buried less 200 feet underground. Underground mining Surface or strip mining affects large land areasemissions by buring Nuclear fission energy is created by bombarding neutron on uranium splitting into lighter elements, lot of energy and more neutrons.. they in turn bombard others creating chain reaction. Nuclear energy produces no carbon dioxide However produces radioactive waste.. Hydropower Water cycle: Solar energy heat water causing it to evaporate They form into clouds and precipitate in the form of snow and rain Water flows through rivers back into into the sea and evaporates again forming a cycle Hydropower relies on water cycle Hydropower harnesses mechanical energy from moving water Swiftly flowing water and water descending rapidly from a very high point like Niagara Falls are examples for sources for hydropower A dam built to create a reservoir may obstruct migration of fish to their upstream spawning areas. Tidal Power Tides are caused by the gravitational pull of the moon and sun. Water levels can vary upto 40 feet due to tides. A large enough tideal range (10 feet) is required to generate energy economically. Tidal energy more predictable than wind or solar energy. Biomass
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Organic materials from plants and animals. They contain stored energy from sun. Biomass is renewable because we can grow more trees and crops. Biomass include crops, wood, manure and some garbage. Burning biomass is one way to release its energy. They can be converted to other forms such as methane gasThey can fermented to created ethanol. Biodiesel is produced from leftover food products like vegetable oils and animal fats. Burning wood, burning garbage (steam to heat building, generate electricity) are examples getting energy out of biomass. Waste-to-energy plants generate electricity (but more expensive than producing using coal/nuclear/hydropower). Incinerators just burn garbage. Ash from waste-toenergy can contain high concentration of metals such as cadmium and lead. So separating batteries, florescent lamps and other items that contain mercury, lead, and cadmium before burning waste can reduce pollution problems. Ash also needed tested before disposal. We can also get methane gas from landfills. Ethanol and Biodiesel are liquid biofuels. Ethanol is added to petroleum to reduce its imports. Ethanol also reduces co2 emission as plants absorb them while growing. However, they also need fertilizers, land and energy for their growth. Biofuels are more expensive than the fossil fuels. Ethanol is an alcohol made from the sugars found in grains such as corn, sorghum and barley. E10 and E15 have 10 and 15 percent ethanol. Ethanol is nontoxic and biodegradable. Ethanol can reduce pollution. Biodiesel is a fuel made from vegetable oils, fats or greases such as recycled restaurant grease. Biodiesel can used in diesel engines without changing them. Biodiesel is cleaner than diesel, reduce greenhouse gas emissions, Wind Uneven heating of water and land causes wind. Wind cycles Since land heats up more quickly than water in the day, cool air over water moves to land this creates wind. In the night, reverse happens. Similarly, since land near equator heated more by the sun than the land near the north and south pole, the winds circle the earth. Since there are times when there is no wind, there must be other types of power plants to generate energy.
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Geothermal Energy Geothermal energy is heat from within the earth. Geothermal energy is produced to heat homes and to produce electricity by digging deep wells (one or two miles) and pumping the heated underground water or steam to the surface. Geothermal energy sources also include volcanoes, hot springs and geysers. Dry steam plants use steam piped directly from geothermal reservoir, Flash stream plants take high pressure hot water from deep inside the earth and convert to steam to drive the generator turbines. When the steam is cooled and becomes water, they recirculated back into the earth to use again. Solar Energy Used for heating and generating electricity. Photovoltaic devices or solar cells convert sunlight directly into electricity. Solar thermal/electric power plants heat a fluid that is used to power a generator. Advantages include no air pollutants and very little environmental impact. Limitations include uneven sunlight and large surface area is required to collect energy. Photovoltaic cells consists of nonmechanical devices made out of silicon alloy Secondary Energy Sources Electricity and hydrogen are secondary energy sources as they are created from other energy sources. They are also called energy carriers because they move energy in a usable form from one place to another. Electricity is measured in watts and kilowatt (1000 watts). A kilowatt hour is equal to the energy 1000 watts working for one hour. For example, 40 watt light bulb used for 5 hours will consume 40*5/1000=0.2 kilowatt hours of electricity. Hydrogen is much lighter than air. Hydrogen has the highest energy content of any common fuel by weight (about 3 times more than gasoline) but the lowest energy content by volume (about four times less than gasoline). Hydrogen is produced through steam reforming and electrolysis (water splitting). Steam forming separates hydrogen atom from methane gas. Electrolysis splits water into hydrogen and oxygen.

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Hydrogen fuel cells or batteries make electricity. Its byproduct is pure water. Hydrogen fuel cells involve high cost. Hydrogen can be burned to produce electricity. Or they can be used as fuel cell to generate electricity.

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