MPH

Frame work for the Public Health

Reading other people’s work and abstracts will only increase my fascination by the subject of Public Health and how it is developed in the last one hundred years. From every walks of life researchers have contributed to the up running of fair fast delivering robust public health. I went a step further by trying to attend the iug and closely, i did try to gain some work experience
Pondering on other countries’ approaches to implement a fairer public health eg In Preu a research by Carlos F. Cáceres, MD, PhD and Walter Mendoza, MD (October 2009) shows how important to financially support the evaluation and development of the public health framework in the country and limited resources can be a hindrance for the advancement of public health in the country:
“Our findings showed that research policy development and evaluation processes are poor in Peru, most of the country's academic research is published in English only, and researchers' access to funding is limited.” (1)
However, the English public Health Service established 1948, with the intention to provide a standard healthcare service to every citizen in the country never mind the ability to pay the cost as it says :
“to provide healthcare for all, free at the point of use and irrespective of ability to pay. Legislation outlines the broad categories of healthcare service that should or could be provided within the NHS” [10]

This is a very honourable idea and helps the poor as well as the well off, but has some limitations as it says:
“Consequently there are few services that are explicitly unavailable to all NHS patients” [10]

The way that NHS is structured in England through legislative powers to meet the standard requirement of health to everyone in the country this is obvious by:

“However, the legal duties and powers of provision are not absolute, but tempered by powers of discretion as to what is a 'reasonable requirement' and by the right to take into account NHS financial capacity” [10]

A proper framework has to be established and consulted to build such immence National Health service. Professional bodies have to be involved to set such a service as it says:
“National standards, embodied in guidance from National Service Frameworks (NSFs), the National Institute for Health and Clinical Excellence (NICE) and waiting time guarantees, are regulated by the Healthcare Commission, which monitors NHS organisations' compliance. The regulatory framework contributes to what may be considered as 'reasonable requirements' for health care provision and helps to specify entitlement” [10]

The author does numerate the services that can be approved by the regulator for the NHS from curative services to relief symptoms to surgical intervention in injuries to deal with complications. These basic requirements have to be available to the public in full and provisions are made accordingly by the NHS as it says:

“The legal framework Primary legislation addresses the establishment and promotion of' a comprehensive health service, requiring the Secretary of State for Health 'to provide or secure the effective provision of services'” [10]

3 Social values and moral principles are important in running such service. Priority not necessarily means first come first serve rather it is measured by the painful acuteness of the accident or incident . This is supported by Public Health Ethics, doi:10.1093/phe/php018 (© The Author 2009. Published by Oxford University Press. Available online at www.phe.oxfordjournals.org) “I argue that a plausible but under-recognized idea is that the least restrictive alternative might sometimes involve improvement of global health via redistributive taxation—i.e., rather than coercive social distancing measures. I conclude by demonstrating that the proportionality principle leaves open the question of when exactly utility outweighs liberty or vice versa—and I argue that, rather than speaking about the morality of liberty-infringing public health interventions in categorical/binary terms, it would be more fruitful and realistic to think and speak about the degree to which a liberty-infringing public health intervention is morally appropriate. “2 This will take us to the fact that in an emergency some people will wait more than 7 hours while the others will be rushed into the emergency unit. This is determined by the seriousness of the case. therefore implementation of such values are of subjective nature when it comes to the acuteness of the case “Inter alia, such a theory would provide a principled means for striking a balance, or making trade-offs, between these values in cases of conflict. Recent developments in public health ethics have made progress in thinking about how to make trade-offs between liberty and utility in particular. While public health ethicists often claim that the least restrictive alternative should be used to achieve the public health goal in question,” 2 The article concludes that there is no precedence between practicality and moral values “that utility, liberty and equality are legitimate, independent social values and that none should have absolute priority over the others.” 2 Providing guide lines for public health profisionals might give an idea of the relationship and the level of service that requied and giving a refrence point to employers. This is a conclusion has been reached by AJPH First Look, published online ahead of print Dec 4, 2008 “Public health practitioners showed a nuanced understanding of ethical issues and navigated ethical challenges with minimal formal assistance. Decision-making guides that are empirically informed and tailored for practitioners might have some value.”3 6 every person has a theory or framework of value and of power and of the relationship between the two by Public Health Ethics 2008 1(3):196-209; doi:10.1093/phe/phn025 “We propose an ethics framework for public health that builds on the notions of relational personhood (including relational autonomy and social justice) and relational solidarity. In this way, we aim for a public health ethics that, as appropriate, promotes the public interest and the common good.”3 6a. Ethics of public health and the balance between social and economic power which should be incorporated in the national and international plans, as it is said by Public Health Ethics 2008 1(3):196-209; doi:10.1093/phe/phn025)4 “we argue that this framework should reflect the values and insights of feminist relational theory. More specifically, we argue that pandemic planning must be squarely situated in the larger realm of public health and that an ethics framework for public health will be one that recognizes the need to pay particular attention to the vulnerability of subpopulations lacking in social and economic power” 4 4 in defining what is Public Health Approach: In the olden days the definition by Gail Charnley and Bernard D. Goldstein Source: Environmental Health Perspectives, Vol. 106, No. 9 (Sep., 1998), pp. 519-521 Published by: Brogan & Partners Stable “ Over the last 25 years, the traditional command-and-control, risk-by-risk approach to environmental health protection has worked well to greatly improve the quality of our food, air, water, and workplaces.” (5) Due to major changes in the 21 century we should find a new well studied approaches that will ensure a good enough result without the risk to risk approach as Gail Charnley and Bernard D. Goldstein Source: Environmental Health Perspectives, Vol. 106, No. 9 (Sep., 1998), pp. 519-521 Published by: Brogan & Partners Stable say “We need to get beyond the current chemical-by-chemical, medium-by-medium, risk-by-risk approach dictated by current statutes and refocus our priorities by taking a broader view.”5 9 Birth control is essential for the masses of population that increase without control such measures had been advised by Public Health Leader Urges Teaching of Birth Control Source: The Science News-Letter, Vol. 26, No. 700 (Sep. 8, 1934), p. 148 Published by: Society for Science & the Public Prof. Haven Emerson of Columbia University in his presidential address at the meeting of the American Public Health Association. "Let us teach for the sake of women the knowledge which will permit them to choose the time and circumstance of their own childbearing," (6) "Whatever may be one's intuitive, traditional, social, religious or medical preference in the use of contraceptive information as a proper application of knowledge for the protection and integrity of the family and to reduce the evidence of inherited and congenital dis- ease and defect, the almost universal familiarity with half-truths on this sub- ject and the evident effect of their wide application in the falling birthrate makes it incumbent on physicians and health officers to familiarize themselves with organized efforts in this direction at home and abroad." (6) "Both mental hygiene and social hy- giene should benefit by the official in- clusion of a marriage advice service un- der the health department or in con- nection with the outpatient service of a general hospital," (6) 11 Public Health is in danger without taking measures that will ensure the stoppage of epidemic diseases spreading just like it happend in Head of Public Health Service Urges War against Syphilis Source: The Science News-Letter, Vol. 32, No. 852 (Aug. 7, 1937), p. 84 Published by: Society for Science & the Public Public health policy in this case is essential to be comprehensive and well structured: “Surgeon General Thomas H. Parran of the U. S. Public Health Service, in a new book, "Shadow on the Land" (Reynal and Hitchcock), calls upon physicians and laymen alike to insist upon putting into effect a platform of action: i. Locate syphilis. 2. Obtain public funds which assure adequate treatment of all infected per- sons. 3. Educate the private physician and the general public” (7) Syphilis control is important and frequent news letter of suffers indicates the level of control and how it is effective. Also the following can be helpfull in determining the stuation of the spread of infection: “how much syphilis we actually have, month by month and year by year in these states and cities. Where does it come from? How much of it is stopped at the source? Are all cases treated? Is treatment good? Is it considerate? If not, who's responsible ? " (7) 12 In the beginning of the last century public health officials looked into the spread of diseases and they find that if water and sewer and food are all clean and have prescribed standard of hygiene then most transmittable disease by theses means will reduce and can be manageable. Improvement of basic hygienic needs can promote health and reduce contamination which in turn reduces death rates and improve the public health in general eg pror sewers, clean water and healthy clean food as it is expressed in Public Health Measures and Mortality in U.S. Cities in the Late Nineteenth Century (Author(s): Gretchen A. Condran and Eileen Crimmins-Gardner Source: Human Ecology, Vol. 6, No. 1 (Mar., 1978), pp. 27-54 Published by: Springer )“Causes of death are grouped according to their probable relationship to specific public health measures. The reduction which occurred in the death rates from some diseases, e.g., typhoid and diarrheal diseases, can probably be attributed in part to the provision of sewers and waterworks. Large declines also occurred in the death rates from tuberculosis and diphtheria” (8) Although, in this article it says that reducing the mortality rate may not be the full reason: “but that these measures do not provide a complete explanation of the mortality decline” (8) 13 The public health is essential to take in views of professionals as well as a spectrum of the public who would like to voice their demand and the way the public Health Service should be run. This is taking shape in many towns and cities as it is supported by : The Voice of the Public in Public Health Policy and Planning: The Role of Public Judgment Author(s): F. Douglas Scutchfield, Carol Ireson, Laura Hall Source: Journal of Public Health Policy, Vol. 25, No. 2 (2004), pp. 197-205 Published by: Palgrave Macmillan Journals The Role of Public Judgment F. DOUGLAS SCUTCHFIELD, CAROL IRESON, and LAURA HALL say: “COMMUNITY health is the ultimate responsibility of public health agencies and community involvement f C I is an absolute core value of effective public health practice” (9) The voice of public in the public health planning can prove to be difficult and slow response due to numerous comments that need to be addressed in their context: “However, creating public involvement in public health is a cumbersome task” (9) For the maximum benefit of such involvement there should be a specific mechanism : “Public's health demands citizens that feel connected to the decisions being made. How we proceed with that task and the mechanisms used to engage and involve the community in improving its health are evolving” (9)
It is essential that public health officials should give the public a space to express themselves and not to control or rule the community comments rather they should be guiding the motivation: “Through the last several years a number of techniques have been developed to engage the community and obtain its input on how best to improve the community's health. Professionals must be prepared to guide this process, not to dominate it” (9)
The research talks about setting schemes and filing public comments, and working with public terminology, and explaining in laymen terms, and finding a way of filtering results, and arriving to conclusions that will help public health managers Working with government agencies and public to take the right decisions. “Community involvement with public health planning and implementation are vital to improving community health” (9)

As we learnt from above that Public Health Policy and Planning are essential and they should be structured out properly, while deliberation and building the public health with democratic considerations of involvement of the public is essential and proves to be rewarding. This can work for the welfare of the citizen by elevating their awareness of the public health issues and it will save money through minimizing trial and error in making the citizen responds to the health issues and monitoring them. Valuating the community involvement in such a process never was heard of before, but today it is shaping the public health and making the community voice heard.
Harnessing the public health by applying Community Health Assessment Models to help reaching the right conclusion. The assessment models will improve services, reduce cost, revalue the public health service and increase the potential beneficial plans to maximize delivering right health measure to the citizen. 14 Does the English NHS Have a 'Health Benefit Basket'? Author(s): Anne Mason Source: The European Journal of Health Economics, Vol. 6, Supplement (Dec., 2005), pp. S18- S23 Published by: Springer Stable URL: http://www.jstor.org/stable/20069423 Accessed: 29/11/2009 14:51 Your use of the JSTOR archive indicates your acceptance of JSTOR's Terms and Conditions of Use, available at http://www.jstor.org/page/info/about/policies/terms.jsp. JSTOR's Terms and Conditions of Use provides, in part, that unless you have obtained prior permission, you may not download an entire issue of a journal or multiple copies of articles, and you may use content in the JSTOR archive only for your personal, non-commercial use. Please contact the publisher regarding any further use of this work. Publisher contact information may be obtained at http://www.jstor.org/action/showPublisher?publisherCode=springer. Each copy of any part of a JSTOR transmission must contain the same copyright notice that appears on the screen or printed page of such transmission. JSTOR is a not-for-profit service that helps scholars, researchers, and students discover, use, and build upon a wide range of content in a trusted digital archive. We use information technology and tools to increase productivity and facilitate new forms of scholarship. For more information about JSTOR, please contact support@jstor.org. Springer is collaborating with JSTOR to digitize, preserve and extend access to The European Journal of Health Economics. http://www.jstor.org Eur J Health Econ 2005 [Suppl 1] 6:18-23 DO110.1007/sl 0198-005-0314-1 Published online: 5 November 2005 ? Springer Medizin Verlag 2005 Original Papers_ Anne Mason Centre for Health Economics, University of York, Heslington, York, UK Does the English NHS have a 'Health Benefit Basket7? I he
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English National Health Service (NHS) was established in 1948.

***. Strictly speaking, this means that patients have no entitlement to specific services; this partly explains the existence of variation in lo cal provision known as the postcode lottery' [1]. Furthermore, the courts have established that NHS organisations may not operate a 'blanket ban on the provision of particular services [2].***

. Within a health service with no specif ic entitlements but few explicit exclusions, internal quality control mechanisms are important to ensure that citizens' rights to health care, established under international law, are honoured [3].

, S18 I Eur J Health Econom Suppl 1-2005
Fixed charges or payments, whilst in no way guaranteeing provision implicitly brand services with an 'NHS' label and may therefore also serve to signal the service is, or should, be in the health basket. Incentive payments for clinicians may be seen in a similar light. This paper describes the statutory and regulatory frameworks and discusses how these may impact upon patient entitlement to NHS 'services of curative care', 'HO' of the International Classification for Health Accounts (ICHA) taxonomy [4]. An overview of the legal and regulatory framework defining benefits for England is given in O Table 1. England's'Health Benefit Basket7: the case of services of curative care Services of curative care are defined as those where the principal medical intent of care is to relieve symptoms or reduce severity or protect against exacerbation or complication of illness or injury. In addition to in-patient and day care, HCi includes but-patient care, defined as basic medical and diagnostic services, out-patient dental care and other specialist health care pro vided to outpatients by physicians or paramedics, including services provided at home [4].***. However, discretion is at the heart of these duties and politicians are entitled to take into account the resources available to them. Under the 1977 National Health Ser vice Act (chap. 49), the Secretary of State has a duty to provide 'to such extent as he considers necessary to meet all reason able requirements': (a) hospital accommodation [s. 3 (i(a))], including high security psychiatric services (s. 4); (b) other accommodation necessary for the purpose of any other services required by the Act [s. 3 (i(b))]; (c) medical, dental and nursing services [s. 3 (i(c))] (N.B.: 'medical' includes 'surgical'); and (d) such other ser vices as are required for the treatment of illness [s. 3 (i(f))] (N.B.: 'illness' includes a mental disorder and any injury or disability requiring medical or dental treatment or nursing). The Secretary of State for Health also has powers to provide 'as he considers appropriate facilities for the care of persons suffering from illness [s. 3 (i(e))]. The responsibility for providing these services has passed to local health authorities, which in the current organisational structure are known as Primary Care Trusts (PCTs). The 1977 NHS Act also places a duty on PCTs to provide general medical services (s. 29), general dental ser vices (s. 35), pharmaceutical services (s. 41) and general ophthalmic services (s. 38). In the law courts "R v NW Lancashire Health authority, ex p A, D and G" examined the case of three applicants suffering from gender identity dysphoria [2]. The Health Authority had identified this illness as amongst the bottom 10% in terms of need (together with cosmetic surgery, reversal of sterilisation, correction of myopia and most 'alternative' medicines) and Table 1 Documents defining the English Health Basket, 2005 Catalogue: type of document, actors and contents Type of document Legally Positive/nega- Degree of Updating binding tive definition explicitness* of benefits Criteria used for defining benefits N C E CE B Other Acts of Parliament Yes Irregular, amended by further legislation Political judgement 'necessary to meet all reasonable requirements' Statutory instruments Yes (SI) PorN 1-3 Irregular, amended by further legislation + Safety Directions Yes No National Service Frameworks No 2or3 Unclear NICE technology appraisals Yesb PorN Every 4 years + + + NICE clinical guidelines No 2or3 Every 4 to 6 years + + + NICE ?nterventional procedures No PorN Unclear Safety Contracts Yes 1-3 Infrequent-although small amendments more frequent + Waiting time guarantees0 No Irregular HRG tariffs No 2or3 Still evolving Devices tariff No Monthly + + Safety, quality, appropriateness Fee schedules No Annually (at least) N need, C costs, E effectiveness, CE cost-effectiveness, B budget (from [1,2,3], DH website (http://www.dh.gov.uk/home/fs/en), HMSO website (http://www.hmso.gov.uk/), expert advice (see Acknowledgements)) a "Explicit is subdivided as 1: all necessary"; 2: areas of care; 3: items. b The statutory duty is upon PCTs to ensure funding is available to facilitate implementation, not upon doctors to adopt the approved technology. c The dominant instrument for securing these are performance ratings prepared by the Healthcare Commission. therefore transsexual surgery would be provided only in cases of overriding clinical need'. The court acknowledged the need for priority setting in which issues of effectiveness, the seriousness of the condition and cost were taken into account. However, the court found that the Health Authority had in practice adopted a 'blan ket ban and recommended the authorities introduced a fair and consistent policy for decision making that adequately assessed exceptional cases by considering each re quest for treatment on its individual merits. The case therefore made it illegal for health authorities to refuse to provide specific services, with the possible exception of a treatment where 'the clinical evidence of its inefficacy is overwhelming [2]. The case implies that costs and benefits should be evaluated on an individual patient basis, rather basing entitlement on the typical or average case. Primary legislation and case law have therefore not prescribed which services are to be included in or excluded from the English health basket. However, secondary legislation on professional contracts goes some way towards defining entitlement to specific services. For example, the 2004 National Health Service (General Medical Services Contracts) Regulations provide details of the terms of service for general practitioners (GPs) and state that essential services' must be provided, covering emergency treatment and treatment for patients with chronic, terminal and self limiting disease [National Health Service, General Medical Services Contracts, regulation SI 2004/291, reg. 15 (3:5,6:8), 2004; see Q Table 2]. For dental practitioners the Nation al NHS (General Dental Services) Regulations 1992 make provision for the Secretary of State for Health to determine dentists' remuneration, including a 'scale of fees' for providing particular ser vices [reg. 19 (1)]. Updated at least annually, the Statement of Dental Remuneration describes over 400 services covered by the fees, including clinical examinations and treatment planning, diagnostic procedures, such as radiographie examinations, preventative, periodontal, conservation and surgical treatments and the sup Eur J Health Econom Suppl 1-2005 I Si 9 Abstract Eur J Health Econ 2005 [Suppl 1] 6:18-23 DOI 10.1007/S10198-005-0314-1 ? Springer Medizin Verlag 2005 Anne Mason Does the English NHS have a Health Benefit Basket? Abstract A'health benefit basket'is a range of pub licly entitled health-related goods and ser vices. Primary legislation ensures the provi sion of broad categories of healthcare, but this provision is subject to political discre tion. Case law has established that health care organisations may not operate a 'blan ket ban'for particular services. This means that the English health basket currently has very few specific services explicitly includ ed or excluded. Regulation may, however, be important in determining citizens'rights. With reference to'services of curative care', this paper explores whether the NHS is mov ing towards a more explicit definition of a health basket. Keywords Health Services National Health Programmes United Kingdom Health Benefit Plans Public Policy S20 I Eur J Health Econom Suppl 1-2005 ply of prostheses; patients pay 80% of the charge up to a stated maximum, although some exemptions apply (Department of Health, Statement of Dental Remunera tion, amendment no. 93, 2005). The Doc tors' and Dentists' Review Body reviews existing fee scales and makes recommen dations regarding uplift. The Department of Health then considers these recommen dations and the Chief Dental Officer for England notifies Strategic Health author ities, PCTs, NHS Trusts (groups of NHS hospitals, each operating as a single legal entity) and all general dental practitioners of the updated fee scales (ibid.). Similarly, the 1986 NHS (General Oph thalmic Services) Regulations make provi sion for opticians and ophthalmic medical practitioners to charge for sight tests and for optical appliances (National Health Service, General Ophthalmic Services, regulation SI 1986/975,1986). Charges are determined by the Secretary of State in consultation with professional bodies, updated at least annu ally and amended by secondary legislation. For certain patients vouchers are available that reduce or remove the charge incurred by patients. Eligibility for general ophthal mic services, outlined in section 13 of the Health and Medicines Act 1988, is deter mined by age, disease (or risk of disease) or income. Voucher values are updated at least annually by secondary legislation. Quasi-law In addition to legislation, NHS provision is shaped by a considerable amount of 'quasi-law'. Quasi-law is defined as 'ru les which are not usually legally binding, although they may have some legal force, but which will in practice determine the way in which people act' [3]. Amongst the regulation helping to define patient enti tlement to services are NSFs, NICE guid ance, waiting time guarantees, fee sched ules, and incentive schemes. The Health care Commission is the key regulator, as sessing the performance of NHS organisa tions against national standards in its 'an nual health check', a monitoring process that assesses both existing performance (core standards) and capacity to improve ('developmental'standards) [5]. The programme of NSFs, launched by I the Department of Health in April 1998, usually produces one new framework a year. NSFs set national standards, identify key interventions for a defined service or care group that should be available, estab lish strategies to support implementation and outline ways to ensure progress with in an agreed time scale [6]. Frameworks cover some services of curative care (O Ta ble 3). Each NSF is developed with the assistance of an external reference group (ERG), which seeks to engage a range of views from health professionals, service users and carers, health service managers, partner agencies and other advocates. However, the economic input into NSFs is sometimes weak. The Department of Health supports the ERGs and manages the overall process. It is unclear how NSFs are to be updated to reflect changes in the evidence base that underpins them. There is no statutory obligation on health care organisations to implement NSF standards. However, the Health And Social Care (Community Health And Stan dards) Act 2003 [Health and Social Care (Community Health and Standards) Act, Chap. 43, 2003) gave the Secretary of Sta te powers to publish standards for health care [s. 46 (1)] that NHS bodies are bound to take into account [s. 46 (4)]; NSFs could inform these standards. Furthermore, the Healthcare Commission reviews health care organisations' implementation of NS Fs as part of its annual health check [5], reinforcing the quasi-legislative nature of NSF guidance. NICE, the organisation responsible for assessing whether new or existing technologies should be available on the NHS, produces three types of guidance which help define the availability of NHS services of curative care. Firstly, technolo gy appraisals give guidance on the use of new and existing treatments within the NHS. Of the 91 technology appraisals pub lished to date (July 2005) some relate to in-patient care, such as Appraisal No. 11 (the use of implantable cardioverter de fibrillators for arrhythmias); to day ca re, such as Appraisal No. 48 (home com pared with hospital haemodialysis for pa tients with end-stage renal failure); and to out-patient care, such as Appraisal No. 24 (debriding agents for difficult to heal sur gical wounds). Secondly, NICE clinical guidelines offer guidance on the appropri Table 2 Eligibility for primary care'essential services' under the 2004 General Medical Services Contract if rom II9]) Type of essential service Immediate and necessary emergency treatment Eligibility for treatment 'Any person to whom the contractor has been requested to provide treatment... at any place in its practice area' [reg.15 (6)] Management of terminal illness Registered patients and temporary residents Treatment of conditions from which recovery is generally expected Registered patients and temporary residents Treatment of chronic disease Registered patients and temporary residents Advice in connection with the patient's health, including relevant health promotion advice Registered patients and temporary residents Referral of the patient for other services under the 1977 Act Registered patients and temporary residents Home visits Where contractor considers it inappropriate, because of a patient's medical condition, for the patient to attend the practice premises Annual health checks Patients aged over 75 years Patients not seen within 3 years; newly registered patients Table 3 Services of curative care covered by selected National Service Frameworks; ICHA category HC.1 : services of curative Category Children Services Standard 7: Guidance on hospital-based services for children Standard 3: Guidance on community-based care Coronary heart disease Standard 7: NHS Trusts to provide appropriate investigations and treatments for patients with suspected or confirmed coronary heart disease Diabetes Standard 7: NHS to provide rapid and effective treatment for diabetic emergencies Mental health In-patient hospital beds for persons needing a short period of intensive intervention and observation Elderly Standard 4: Need for appropriate specialist care Standard 7: Effective diagnosis, treatment and support for those with mental health problems Renal disease Quality requirement 2: Timely, appropriate and effective investigation, treatment and follow-up for those with chronic kidney disease Standard 5: All likely to benefit from a kidney transplant to receive a high quality service which supports them in managing their transplant (from: DH website, hnp://www.dh.gov.uk/PolicyAnd6uidance/HealthAndSocialCareTopics/HealthAndSod ID=4070951&chk=W3ar/W, accessed 12 July 2005) ate treatment and care of people with spe cific diseases and conditions within the NHS. Clinical guidelines are based on the best available evidence and are intended to help health care professionals in their work but not to replace their knowledge and skills. Services of curative treatment are included amongst the 40 currently pub lished guidelines. For example, the dyspep sia guideline (Clinical Guideline, CG, 18) recommends life-style advice and appro priate medication as secondary preventa tive measures and the guideline on head in jury (CG4) specifies treatment pathways covering emergency, out-patient and in patient care. Thirdly, NICE produces guidance on whether interventional proce dures used for diagnosis or treatment are sufficiently safe and effective for routine use in the NHS. Of the 127 currently pub lished topics most relate to hospital-based care, such as radiotherapy for age-related macular degeneration (Interventional Pro cedure Guidance, IPG, 048) and auditory brainstem implants (IPG108). The three types of NICE guidance are developed and updated using distinct methodologies. Guidance on technology appraisals is formulated by the NICE Ap praisal Committee, an independent advi sory body with individuals from a range of professional backgrounds. Preliminary guidance is based on evidence from an aca demic assessment group and from compa ny submissions. Following consultation, the Final Appraisal Determination is de veloped, approved by the NICE Guidance Executive and put out again for consulta tion. An appeal process may ensue, after which the guidance is published. All guid ance is reviewed at regular intervals [7]. To develop a guideline, NICE commissions one of the National Collaborating Cen tres to establish a Guideline Development Group. The Group appraises clinical and cost-effectiveness evidence from systemat ic reviews of the research evidence. Views of clinicians, consumers and stakeholders Eur J Health Econom Suppl 1-2005 I S21 Original Papers also inform the guideline [8]. To produce guidance on interventional procedures, the Interventional Procedures Advisory Committee, an independent body of 24 members with a range of expertise, consid ers the safety and efficacy of procedures, but does not examine clinical or cost ef fectiveness [9]. The Committee produces a Consultation document and published guidance reflects comments received over the 4-week consultation period. NICE guidance generally acts as qua si-law, but one aspect of guidance on tech nology appraisals is supported by statu te. If NICE guidance is that a new technol ogy should be made available to certain NHS patients, the funding bodies (PCTs) are obliged by law to ensure there are ade quate resources to facilitate the implemen tation of NICE guidance (Secretary of Sta te for Health "National Health Service Act 1977: Directions to Health Authorities, Pri mary Care Trusts and NHS Trusts in Eng land", 2001). However, the guidance is not binding on individual clinicians, who must assess whether the technology is ap propriate for the patients they treat [10]. Another illustration of quality stan dards impacting upon patient rights is Public Service Agreements. Published an nually, these specify national goals within the public sector, including waiting time targets (or guarantees') for the NHS [11]: (a) By the end of 2005, patients will wait a maximum of 6 months for in-patient ad mission and no more than 13 weeks for an out-patient appointment, (b) By the end of 2008 the maximum wait from GP refer ral to hospital treatment will be 18 weeks. Targets that should already be achie ved, and henceforth maintained, include the 4-hour maximum wait for emergency care and the 24/48 target for accessing pri mary care. (The 24/48 target refers to pa tients being able to see a general practitio ner within 2 working days or another pri mary care professional within 1 working day, whilst the 4-hour wait target is that pa tients should spend no more than 4 hours in an accident and emergency hospital de partment from arrival to admission, trans fer or discharge.) Where fee schedules exist for NHS ca re, patient 'entitlement' to services might be inferred. For example, the new national tariff system of payments for hospital ser S22 I Eur J Health Econom Suppl 1 2005 vices, whilst in no way guaranteeing provi sion, 'suggests' services that should be ac cessible on the NHS. The national price schedule for patient services is classified by Health Care Resource Group (HRG) codes. A range of clinical procedures, treat ments and diagnoses is included in the cur rent list of 550 HRG tariffs for elective in patient care [12]. The Quality and Outcomes Frame work, part of the GP contract, is a volun tary mechanism for encouraging primary care provision of some services of curative care, such as antiplatelets for patients with coronary heart disease [13]. With total pay ments amounting to 15-20% of available total practice remuneration [14], there is a clear incentive for GPs to make these ser vices available to NHS patients. Discussion The NHS is a complex and heavily regu lated health care system in which the ro les of actors are in general clearly defined. As the primary emphasis has historically been upon local cost control rather than quality or access issues, geographical vari ations in quality and quantity of provision have emerged [1]. The lack of explicitness in the definition of the health basket has led to a great deal of uncertainty about en titlement. Even if there is a statutory duty gov erning provision, this does not necessari ly guarantee access to NHS services. For example, the 1977 NHS Act obliges PCTs to provide, or to arrange for the provi sion of, general dental services (National Health Service Act, Chap. 49,1977). How ever, a large proportion of the population is unable to access NHS dental services be cause of a shortage of dentists willing to provide these services for the NHS. The rapid growth of private practice since 1992 was apparently precipitated by a 7% cut in NHS fees, which was designed to redress perceived excessive income [15,16]. Access problems to NHS dentistry have triggered an urgent review of the regulations govern ing the dentists' terms of service with a re cent cash injection of over ?350 ( 504) million, aimed at increasing the number of dentists working for the NHS [17]. The British Dental Association in is negotia tions with the Department of Health to develop a new contract which is expect ed in April 2006. This example illustrates the general principle that private practice flourishes where there are access or quali ty problems within the NHS. The use of regulation to address quality and access issues has had mixed results. A national evaluation of compliance by NHS organisations with NICE guidance found variable implementation. Looking at ra tes of prescribing and use of procedures and medical devices, the time-series anal ysis found significantly increased prescrib ing of some taxanes for cancer and orlistat for obesity in line with guidance. However, prescribing practice frequently appeared to have little relation to detailed guidance [18]. NICE guidance specifies entitlement in terms of patient groups and PCTs are obliged to provide funding only for the se patients. Whether this practice is equiv alent to the PCT operating a 'blanket ban for patients whose condition lies outside the specified guidance is debatable and has not been tested in the courts. Over the past decade the growth in qua si-law' suggests that the English system is heading towards a more formal statement of benefits and entitlements. NICE guid ance on new and existing technologies is in effect establishing a 'positive list' of tech nologies that the NHS should fund; NS Fs describe interventions that should be implemented to achieve standards of care. The Payment by Results system will be ex panded to cover non-elective care and the Healthcare Commission will increasing ly encourage NICE and NSF implemen tation, reinforcing standards through the annual health check' [5]. These factors to gether will take the NHS forward in defin ing a more explicit health basket for Eng land. However, variations in local capacity to comply with national standards may re sult in a more explicit rationing of health care services at the local level. Corresponding author Anne Mason Centre for Health Economics, University of York, UK e-mail: arm10@york.ac.uk Acknowledgements The results presented here are based on the pro jecf'Health Benefits and Service Costs in Eu rope-HealthBASKET" which is funded by the Eu ropean Commission within the Sixth Framework Research Programme (grant no. SP21-CT-2004 501588). I thank the following individuals for their helpful and pertinent comments on an ear lier draft: Norman Ballantyne (Public Private Part nerships Programme), Karen Bloor (University of York); Brian Ferguson (Yorkshire and Humber Pub lic Health Observatory); Caroline Glendinning (University of York); Maria Goddard (University of York); Nicky llliott (ABPI); James Mason (University of Durham); Adam Oliver (London School of Eco nomics); Phill O'Neill (ABPI); Mark Sculpher (Uni versity of York); Andrew Street (University of York); and Jon Sussex (Office of Health Economics). Pe ter Smith supervised the work and Mike Drum mond (University of York) provided supportive advice. All remaining inaccuracies and omissions are my own. Nachschlage werk! 2006. Etwa 1180 S. 60 Abb. Brosch. 34,95; sFr 59,50 ISBN 3-540-28368-4 In seiner j?hrlichen Bilanz analysiert der Arzneiverordnungs-Report kritisch und sachlich die kassen?rztlichen Arzneiverord nungen Exklusive Detail-Informationen ?ber Arznei mittel, Verordnungsverhalten, Kosten, neue Therapie-Trends, erfolgreiche Innovationen und Spar-Optionen Brandaktuelle, zuverl?ssige Daten und Fakten Jetzt in Ihrer Buchhandlung. Die -Preise f?r B?cher sind g?ltig in Deutschland und enthalten 7% MwSl Pretsanderungen und Irrt?mer vorbehalten. springer.de 4y Sprini References 1. Department of Health (2000) The NHS plan: a plan for investment, a plan for reform. Stationery Office Limited: London 2. Newdick C (2005) Who should we treat? Rights, ra tioning and resources in the NHS. Oxford Universi ty Press: Oxford 3. Montgomery J (2002) Health care law. Oxford Uni versity Press: Oxford 4. Organisation for Economic Cooperation and Devel opment (2000) A system of health accounts. OECD: Paris 5. Healthcare Commission (2005) Assessment for im provement: the annual health check - measuring what matters. Healthcare Commission: London 6. Department of Health (1997) The new NHS: mod ern, dependable. Cm 3807. HMSO: London 7. National Institute for Clinical Excellence (2004) Guide to the methods of technology appraisal. NICE: London 8. National Institute for Clinical Excellence (2004) The guideline development process: an overview for stakeholders, the public and the NHS. NICE: Lon don 9. National Institute for Clinical Excellence (2004) The interventional procedures programme. NICE: Lon don 10. Newdick C (2005) Evaluating new health technol ogy in the English National Health Service. In: Jost T5 (ed) Health care coverage: an international com parative study. Open University Press: Maidenhead 11. Treasury HM (2004) 2004 spending review: public service agreements 2005-2008. HMSO, London 12. Department of Health (2005) Implementing pay ment by results: technical guidance 2005/06. De partment of Health: London 13. Department of Health (2004) Quality and out comes framework: guidance (updated August 2004). Department of Health: London 14. Anonymous (2005) CCA calls for closer working be tween GPs and pharmacy. Pharm J 274:667 15. Oliver A (2002) Reforming public sector dentistry in the UK. BJHCM 8:212-216 16. Department of Health (2004) NSH dentistry: deliv ering change. Report b y the Chief Dental Officer. Department of Health: London 17. Department of Health (2004) Reforms with bite: 1000 more NHS dentists by October 2005: Reid un veils ?368m funding injection for NHS dentistry. Press release, 2004/0265. Department of Health: London 18. Sheldon TA, Cullum N, Dawson D, Lankshear A, Lowson K, Watt I, West P, Wright D, Wright J (2004) What's the evidence that NICE guidance has been implemented? Results from a national evaluation using time series analysis, audit of patients' notes, and interviews. BMJ 329: doi:10.1136/bmj.329.747 3.9992004;329;999 19. Department of Health (2003) Delivering Invest ment in general practice: implementing the new GMS contract. Department of Health: London (11) 15 Irradiation as a Means to Minimize Public Health Risks from Sludge-Borne Pathogens Author(s): J. Gary Yeager and R. T. O'Brien Source: Journal (Water Pollution Control Federation), Vol. 55, No. 7 (Jul., 1983), pp. 977-983 Published by: Water Environment Federation Stable URL: http://www.jstor.org/stable/25042005 Accessed: 29/11/2009 14:52 Your use of the JSTOR archive indicates your acceptance of JSTOR's Terms and Conditions of Use, available at http://www.jstor.org/page/info/about/policies/terms.jsp. 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Water Environment Federation is collaborating with JSTOR to digitize, preserve and extend access to Journal (Water Pollution Control Federation). http://www.jstor.org Irradiation as a means to minimize public health risks from sludge-borne pathogens J. Gary Yeager, R. T. O'Brien The purpose of the Federal Water Pollution Control Act of 1972 (PL 92-500) and later amendments was to improve the quality of U. S. surface and groundwater supplies, which had been seriously degraded through the years by the disposal of wastes into this convenient me dium. Industry is a major source of toxic chemicals that are waste products of many commercial processes. An other major source of surface water contamination is the discharge of toxic chemicals and nutrients from the wastewater treatment plants that serve growing popu lations often concentrated in metropolitan areas. The implementation of the Clean Water act has forced industry and municipalities to provide additional purifying treatments so that the effluents discharged to receiving waters would have much lower levels of un desirable contaminants. These additional treatments have dramatically helped to clean up municipal and in dustrial effluents. However, this success has proved a mixed blessing. As effluents have become cleaner, the volume of treatment by-products has increased in direct proportion. These by-products, known as sludge, are made up of the particulate material removed from liquid waste as it progresses through various treatment pro cesses. About 8.1 M dry metric tons of sludge annually, and greatly increased amounts by the end of the decade, create special disposal problems. The same (and similar) environmental legislation has limited the options for managing the increasing volume of sludge. Ocean dumping has been severely curtailed, and its ultimate fate is under review. The energy costs and air pollution associated with the incineration of sludge generally make this disposal option undesirable. Increasing population pressures on land area and soaring transportation costs have decreased the attractiveness of landfilling. The Resource Conservation and Recovery Act (PL 94-580) and a general national interest in resource re cycling and conservation have prompted a new per spective toward sludge management options. Sludge has been shown to be an excellent source of macronutrients and trace minerals for soils as well as of organic matter that can improve the physical characteristics of soil.1 The use of nutrients in undigested sludge as a source of animal feed has also been demonstrated in forward looking research at New Mexico State University in Las Cruces.2 Using municipal wastewater sludge as a resource for the beneficial purposes described above may be limited by the presence of heavy metals and toxic organic chem icals. These substances are often concentrated in sludges that result from wastewater with a heavy industrial in put. An additional limitation on the use of sludge in agriculture or in areas of unrestricted public access is the potential presence of pathogenic enteric microor ganisms. Toxic chemicals are subject to removal or re duction by strict source control, a tactic that forms the basis for the current U.S. Environmental Protection Agency (EPA) Industrial Pretreatment Program. How ever, pathogenic microorganisms originating in the in testinal tracts of infected individuals are normal con stituents of sludge and cannot be removed in the same way. Bacterial, parasitic, and fungal pathogens are effectively eliminated by 1 Mrad of gamma radiation, but viruses are somewhat more resistant. Pathogenic microorganisms in sludge can be removed or inactivated only by the various unit processes in sludge treatment. If toxic chemical species are at ac ceptably low levels, the resource potential of wastewater sludge can be realized if the indigenous pathogens are greatly reduced or eliminated before using sludge on foodchain crops or in areas of high public use and un limited access. EPA has issued regulations (40 CFR 257) that specify acceptable sludge treatments and associated public access restrictions that not only protect public health but also allow the large resource potential of sludge to be realized. EPA is currently drafting addi July 1983 977 Yeager & O'Brien tional regulations concerning the sale and giveaway of municipal sludge destined for the "home gardener" market. As defined in the Appendix of 40 CFR 257, there are two categories of pathogen-reducing sludge treatments that have different restrictions for use and public access. In the first category are Processes to Significantly Reduce Pathogens (PSRP), which include aerobic digestion, air drying, anaerobic digestion, low-temperature compost ing, lime stabilization, or other techniques giving equiv alent pathogen reduction. If PSRP-treated sludge is ap plied to land, food crops that would likely contact the sludge cannot be grown for 18 months. Also, animals whose products are to be consumed by humans cannot graze for 1 month, and public access is restricted for at least 12 months. These restrictions are eliminated if the sludge is treated by the second category of treatments known as Processes to Further Reduce Pathogens (PFRP). These include gamma or beta irradiation to an absorbed dose of 1 Mrad, pasteurization, or methods giving equivalent pathogen reduction given after a PSRP treatment. A PSRP is required first because these treat ments do not stabilize sludge by reducing volatile solids. Other PFRPs that do not require a prior PSRP are high temperature composting, heat drying, or thermophilic aerobic digestion. The mission of the U. S. Department of Energy (DOE) Beneficial Uses Program is to identify and develop ways in which radioactive by-products of U. S. defense nu clear programs can be used to provide alternative so lutions to major national problems. About 7 years ago, after PL 92-500 was passed, scientists began work on a biological research and engineering program to deter mine the feasibility of using the isotope cesium-137, a nuclear fuel-cycle by-product, to disinfect municipal wastewater sludge. The researchers realized that vastly increased amounts of sludge, a resource too valuable to justify disposal, would be generated on implementation of the act. This project has resulted in numerous sci entific publications on the efficacy of pathogen reduction by gamma irradiation and the development of a sludge irradiation technology. A 7.3-metric tons/d (8-ton/day) sludge irradiator has been operated since 1979 at a site within SNL. This effort was an integral part of the de cision by EPA to make irradiation to a 1-Mrad dose an approved PFRP. PATHOGEN DESTRUCTION BY GAMMA IRRADIATION Research derived from radiation treatment of foods and from sterilization of heat labile medical materials has shown that the penetrating gamma radiation emitted by cesium-137 and certain other gamma emitting ra dioisotopes (primarily cobalt-60) is effective in destroy ing pathogenic and saprophytic microorganisms in a wide range of media from plastics and food to municipal wastewater sludge. Radiation destroys pathogen in sev eral ways. First, the energy in the photon of gamma radiation may interact directly with a sensitive site in the organ ism. This site is usually the deoxyribonucleic acid (DNA) that directs cellular reproduction and synthesis of cell components, rather than relatively radiation-resistant constituents such as protein and lipids. This type of ra diation damage is termed a "direct effect" of ionizing radiation.3 In addition, the energy in the gamma photon can be deposited in molecules in the medium causing the for mation of toxic products that subsequently damage the microorganism. This damage is termed an "indirect ef fect" of radiation. In dilute aqueous environments most radiation dam age is thought to be caused by "indirect effects." In the presence of high concentrations of organic substances, microbe damage is mainly attributed to "direct effects." In sludge, an extremely complex, concentrated organic environment, radiation inactivation of microorganisms by ionizing radiation is probably almost exclusively caused by direct effects. Recent research by Ward4 dem onstrated that in a complex, organic environment fa voring direct radiation effects, two-thirds of poliovirus inactivation with gamma radiation was caused by dam age to the ribonucleic acid (RNA) genome of the virus. One-third of the damage was caused by alterations of the protein coat of the virus. Under conditions pro moting indirect effects, about one-fourth of the virus inactivation was caused by RNA damage. Three-fourths was attributed to alterations in the protein coat. The sensitivity of a microorganism to ionizing radia tion is described by its Di0 value (the absorbed radiation dose required to reduce a population of microbes by one order of magnitude or 90%). An organism with a high D10 value is resistant to radiation. A low D10 value in dicates sensitivity to radiation. PATHOGENS IN MUNICIPAL SLUDGE AND THEIR INACTIVATION BY IONIZING RADIATION Enteric pathogens are discharged to municipal waste water in the feces of infected individuals who may or may not exhibit signs of disease. These pathogens be come associated with sludge during wastewater treat ment because they remain in their original solids-bound state, or because suspended pathogens have an affinity for the particulate fraction of wastewater. The concen tration of a given enteric pathogen in sludge varies with the disease morbidity in the area served by the treatment plant. Some pathogens are found in sludge at fairly con stant levels throughout the year. Others vary on a sea sonal basis. 978 Journal WPCF, Volume 55, Number 7 _Process Research Table 1?Typical bacterial pathogens found in waste water sludge. Organism Disease Salmonella sp. Gastroenteritis, enteric fever Shi gel la sp. Gastroenteritis Escherichia coli Gastroenteritis Mycobacterium sp. Tuberculosis and enteritis Leptospira sp. Leptospirosis Bacterial pathogens. Bacterial pathogens, including the most extensively studied Salmonella sp., enter a wastewater treatment plant and become associated with sludge during primary clarification. During this sedi mentation process about 80 to 90% of salmonellae (and presumably other bacterial pathogens) become asso ciated with the settled sludge.5 A recent study detected 2400 salmonellae/kg of raw sludge.6 A concentration of 5000 colony-forming units (cfu)/L of raw wastewater is a commonly used average.7 Table 1 lists some typical enteric bacterial pathogens that may be found in sludge depending on local morbidity. Because irradiation of sludge must be preceded by a PSRP treatment, pathogen populations will be reduced by the combined effects of irradiation and the PSRP process. Two commonly used PSRPs that would prob ably precede gamma irradiation in a typical sludge-treat ment train are anaerobic digestion and sand-bed drying. Anaerobic digestion generally reduces bacterial patho gens by one to two orders of magnitude.7 Bacterial reduction during evaporative drying has not been studied widely, but recent studies (Figure 1) dem onstrated that evaporative drying to about 95% solids reduced seeded populations of Salmonella typhimurium more than one order of magnitude.8 Figure 1 shows that the reduction in Salmonella typhimurium and other en teric organisms studied was generally proportional to the reduction in the water content of the sludge. In sludge dried to over 95% solids (a level achievable in the arid Southwest), reductions ranged from one-half order of magnitude to about four logs with Proteus mirabilis. Figure 2 shows that similar results were obtained when various classes of indigenous microflora were observed during drying.8 Mechanical sludge dewatering (for ex ample, centrifugation, belt press) generally gives a solids content of about 20% and would not be expected to reduce significantly bacterial pathogens. After an anaerobically digested sludge is dewatered, the population of the gram-negative enteric pathogens of greatest concern (Salmonella sp., Shigella sp., and enterotoxigenic Escherichia coli) would be reduced by two to three orders of magnitude. The asporogenic, gram-negative bacterial pathogens are generally very sensitive to inactivation by ionizing radiation. When the radiation sensitivities of the gram 10' ,0L 10 Iff1 Iff2' Iff3' S.FAECALIS ?LCOU oKLEBSEUASP. a BfTBW?ACTBISP 20 40 60 % Solids 100 Figure 1 ?Reduction of Salmonella typhimurium and other enteric microorganisms as a result of drying of sludge. negative enteric bacteria used in the previous study were determined, the D10 values in 50% solids sludge averaged 50 krad.8 Table 2 summarizes the observed D10 values % solids Figure 2?Reduction of indigenous microflora as a result of drying of sludge. July 1983 979 Yeager & O'Brien Table 2?Inactivation of seeded enteric bacteria in raw sludge by gamma radiation.8 D10 value (krad) Sludge moisture Salmonella Proteus Streptococcus (% Solids) E. co// Klebsiella sp. Enterobacter sp. typhimurium mirabilis faecalis Liquid (5%) 22 48 36 <54 <24 130 Dewatered (42 to 57%) 22 76 42 <60 <22 130 Dried (94 to 95%) 22 41 50 120 <50 160 a Pure cultures of bacteria were grown to saturation density in sterilized sludge. The sludge was dried by evaporation, and samples taken at the indicated moisture levels were irradiated. for the six enteric bacteria in liquid sludge (5% solids), moderately dry sludge (about 50% solids), and air-dried sludge (about 95% solids). Table 2 shows that the radiation resistance of the E. coli used in this study was not altered by evaporative dewatering. The Klebsiella sp. was protected in partially dewatered but not fully dewatered sludge, and the En tewbacter sp. was slightly protected against radiation by dewatering. The protective effect of drying noted with Enterobac ter sp. was more pronounced with S. typhimurium, where the D10 value observed in liquid sludge more than doubled in dried sludge. P. mirabilis, the other hydrogen sulfide (H2S) producer studied, was extremely sensitive to ionizing radiation at all moisture levels. Finally, S. faecalis, a nonpathogenic indicator bacterium, was found to be the most radiation resistant of the six enteric bacteria studied at all moisture levels, and was slightly protected in dewatered sludge. S. faecalis and other fecal streptococci have been consistently shown to be more resistant to radiation than most bacteria associated with wastewater.9 Similar results were seen when the classes of indige nous sludge organisms described in Figure 2 were irra Table 3?Inactivation of several classes of indigenous sludge bacteria by gamma radiation.8 D10 value (krad) Sludge - moisture Lactose H2S Non-lactose (% Solids) S. faecalis fermenters producers fermenters Liquid (3.5) 177 30 60 <40 Dewatered (44) 160 30 40 <30 Dried (95) 95 50 <85 <60 a Raw sludge was dried by evaporation. Samples taken at the indicated moisture levels were irradiated and assayed for the various classes of organisms. diated under the same conditions. The results in Table 3 indicate that the lactose-fermenting bacteria recovered on Hektoen enteric agar had D10 values of less than 50 krad at the three moisture levels. This category of or ganisms includes E. coli, Klebsiella sp., and Enterobacter sp., which were used in the previous experiment with seeded organisms. H2S producers, a category that usually includes the salmonellae, were present at low initial numbers, and the D10 values were similar to those noted for seeded S. typhimurium. The indigenous S. faecalis also had radiation sensitivities similar to those observed in the seeded experiments. However, no protective effect was noted in the 95% solids samples. These data generally agree with earlier studies.10,11 Extrapolation of these results to full-scale operations suggests that bacterial pathogens in sludge would be re duced to less than detectable levels by the combination of a PSRP and the 1-Mrad PFRP dose of gamma ra diation. Parasite pathogens. The ova and cysts of protozoan and helminthic parasites sometimes found in wastewater are generally resistant to inactivation by physical and chemical processes.12 These parasites are not common to all U.S. sludges, but they may be found where local morbidity is sufficient to provide a source to the waste water treatment system. The resistant ova and cysts are far heavier than bacteria or viruses, and almost all will settle into sludge during primary clarification. These ova and cysts must be removed or killed by later sludge treat ments if sludge is to be used without risk to individuals exposed to it. Some human and animal parasites that might be found in wastewater sludge are shown in Table 4. The cysts of the protozoan parasites Giardia lamblia and Entamoeba histolytica are destroyed by anaerobic digestion, but the resistant stages of the other parasites in Table 4 are not and must be eliminated by a PFRP treatment before unrestricted use of sludge. The highly resistant ova of Ascaris have been used in most studies of parasite inactivation in sludge. These ova are resistant to chemicals such as chlorine, and are 980 Journal WPCF, Volume 55, Number 7 _ Process Research Table 4?Parasites of medical or veterinary importance that may be found in wastewater sludge. Parasite Disease Ascaris sp. Ascariasis Trichuris sp. Whipworm infestation Toxocara sp. Roundworm infestation Taenia sp. Taeniasis Echinococcus sp. Hydatid disease Entamoeba histolytica Amoebic dysentery Giardia lamblia Dysentery undamaged by physical stresses such as pH extremes and moderate temperatures. Ascaris ova are generally found in higher concentrations in sludge than are the resistant stages of other parasites.12 Ascaris ova are un touched by anaerobic digestion, but recent research in dicates that the ova may be inactivated when sludge is dewatered to moisture levels around 20%.12 Research indicated that Ascaris ova are sensitive to gamma radiation with D10 values in liquid and com posted sludge of about 50 krad.13 Because of recent con cern that ova removed from the uterus of adult ascarids may be more sensitive to irradiation than are ova hard ened by transit through the intestines, a double-blind study was initiated in which three types of Ascaris ova were seeded into liquid sludge: Ova recovered from pig feces; Ova recovered from pig feces with the outer layer removed by chemical treatment; and Ova recovered from adult female Ascaris and treated to remove the outer layer. The sludge containing the added ova was irradiated to several dose levels determined for ovum viability. Results of these experiments (Table 5) show that the D10 values for the three types of ova are identical and agree with earlier results.13 These and previous studies indicate that the 1-Mrad PFRP dose will eliminate the parasite hazard from mu nicipal sludges. Virus pathogens. Up to 1 X 106 enteric viruses/g are reportedly excreted in the feces of infected individuals, and over 1 X 105/L have been recovered from raw waste water.14 The actual number of indigenous, and poten tially pathogenic, viruses in wastewater sludge is difficult to determine because not all enteric viruses are recov ered or detected by any given procedure. This can occur because the viruses are incompletely recovered from their sludge-associated state, or because the selected tis sue-culture assay system does not support visible repli cation of the recovered viruses. A series of indigenous virus recovery experiments was recently done to help provide a standard method for virus monitoring at sites where full-scale irradiators will be constructed. A modification of a common virus Table 5?Inactivation of Ascaris Ova in sludge by gamma irradiation.8 D10 value Ovum source/treatment (krad) Pig feces/untreated 62 Pig feces/decoated 45 Ascaris uterus/decoated 45 a Intact ova from pig feces, decoated ova from pig feces, and decoated ova from female, adult ascarids were added to liquid sludge and irradi ated. Viability of ova was determined by observing the ova for embry onation. purification procedure was used. A sample of chilled, liquid raw sludge (generally 100 mL) was mixed in equal proportions with chilled Genetron {trichloro trifluoro ethane) and 10% (V/V) calf serum. The mixture was blended and centrifuged to separate the Genetron and aqueous phases. The aqueous phase containing viruses was saved, and the Genetron phase was re-extracted as before with phosphate buffered saline. The aqueous phases were pooled and ultracentrifuged to pellet the extracted viruses. The pellet was resuspended and treated with ether to reduce bacterial contamination. The final concentrate was then applied to monolayers of five different tissue culture cell lines commonly used to assay enteric viruses. Vero, HeLa, and RD (rhabdo sarcoma) cells are commonly used to recover entero viruses (for example, poliovirus) while L and MDBK cells are used to detect reoviruses. The results of these experiments are shown in Table 6. Under these exper imental conditions, HeLa and MDBK cells provided the greatest recovery of indigenous viruses from raw sludge. If it is assumed that the HeLa and MDBK detected dif ferent viral populations, the sludge used in these studies contained about 1.7 X 104 pfu of recoverable enteric viruses/L. This figure is consistent with results cited ear lier. Table 7 lists some enteric viruses that may be found in wastewater and sludge. Hepatitis A virus (the caus ative agent of infectious hepatitis) and rota viruses (which are responsible for high infant mortality and adult gas Table 6?Recovery of indigenous viruses from raw sludge with selected tissue culture lines.8 Enteric virus recovery Cell line (pfu/L) MDBK 1.3X 104 L 5 X 102 RD 7 X 102 HeLa 4.2 X 103 Vero 4 X 102 a Raw sludge from the Albuquerque Wastewater Treatment Plant was extracted with Genetron as described in the text. Duplicate monolayers of the various cell lines were infected, overlaid with soft agar, and in cubated at 37?C until stained and counted. July 1983 981 Yeager & O'Brien_ Table 7?Representative enteric viruses that may be found in wastewater sludge. Virus Disease Enteroviruses Gastroenteritis.meningitis, cardiac conditions, Poliovirus central-nervous-system involvement Coxsackievirus Rotavirus Gastroenteritis; infant diarrhea Hepatitis A virus Infectious hepatitis Adenovirus Conjunctivitis; respiratory infections Reovirus Respiratory infections troenteritis around the world) are of major concern. Because these viruses cannot be cultured in the labo ratory, most experiments with sludge use enteric viruses such as reovirus and poliovirus that are easily assayed in the laboratory. Because of the affinity of viruses for solids in waste water, it is expected that most will be associated with sludge during primary clarification. About 60% of waste water solids settle into primary sludge, and a corre sponding percentage of viruses are probably partitioned into the sludge. These enteric viruses have largely been physically re moved with the sludge rather than inactivated, and sub sequent sludge treatment processes must be relied on to reduce these pathogens to acceptable levels. Experiments with indigenous and seeded viruses in sludge have shown that anaerobic digestion removes about 90% of the de tectable viruses from sludge.15 Studies by Ward and Ashley16 have shown that polioviruses are irreversibly inactivated by the process, largely because of the am monia produced during anaerobic digestion. Other stud ies by Ward and Ashley17,18 have shown that detergents, which are normal constituents of sludge, can alter the sensitivity of viruses in sludge. Additional studies indi cated that air drying effectively reduces the population of enteric viruses in sludge.19 Recent studies using the indigenous virus extraction technique already described, confirmed that reduction Table 8?Recovery of indigenous viruses from liquid raw and digested sludge and from dried digested sludge.8 Enteric virus recovery (pfu/L) Sludge - (% solids) MDBK HeLa Liquid, raw (5) 8.7 X 104 8.2 X 103 Liquid, digested (5) 2.2 X 103 1.1 X 103 Dried, digested (95) 6 X 102 6 X 102 a Sludges from the Albuquerque Wastewater Treatment Plant were extracted and concentrated as described in the text. Dried sludges were adjusted to 5% solids before extraction. Samples were assayed as de scribed in the legend for Table 6. of viruses occurs during anaerobic digestion and evap orative drying to about 95% solids. Although the sludge samples were not temporally matched, Table 8 shows that anaerobic digestion reduced the indigenous virus content by about one order of magnitude for viruses detected on HeLa cells, and more than one order of magnitude for viruses detected on MDBK cells. In both cases, drying the digested sludge to 95% solids reduced the indigenous viruses below detectable limits. Because of their small size and relatively simple chem ical structure, viruses are more resistant to radiation than bacteria or parasites. Considerable research has been done on the inactivation of viruses in aqueous media, sludges, and food by ionizing radiation. Studies at Sandia have shown D10 values of 330 krad for enteroviruses in sludge.20 Studies on beta-ray inac tivation of enteric viruses in liquid sludge gave D10 val ues of from 300 to 400 krad.21,22 Experiments on the reduction of viruses in other materials have generally yielded D10 values of 150 to 500 krad. These combined results indicate that viruses in sludge would be reduced about three orders of magnitude by the 1-Mrad PFRP dose. Although this in itself is a sub stantial reduction, the radiation treatment coupled with a PSRP should ensure that viruses in sludge are reduced to below detectable limits and that any potential virus hazard in sludge is eliminated. Fungal pathogens. Little is known about the numbers and fate of pathogenic fungi during sludge treatment. One opportunistic fungal pathogen, Aspergillus fumi gatus, has been shown to be present in composting sludge. The airborne spores of this fungus, if inhaled, can cause respiratory disease in individuals whose health is already compromised. Earlier studies demonstrated that the D10 value for A. fumigatus spores in dried sludge ranged from 50 to 60 krad.23 This value is comparable to the Djo values for enteric bacteria and parasites. Thus, any fungal spores of A. fumigatus and other spores of similar radiation sensitivity would be effectively elimi nated by the EPA-prescribed 1-Mrad dose. SUMMARY Table 9 summarizes the previous discussions on path ogen inactivation by gamma irradiation. Bacterial, par Table 9?Summary of pathogen reduction in sludge with PFRP gamma irradiation. Pathogen type Radiation effectiveness Bacteria 1 -Mrad effective Parasites 1 -Mrad effective Viruses 1 -Mrad effective in conjunction with other virucidal effects in wastewater treatment Fungi 1 -Mrad effective for those studied 982 Journal WPCF, Volume 55, Number 7 _ Process Research asitic, and fungal pathogens should be eliminated from sludge by the 1-Mrad PFRP dose required by EPA reg ulations. While viruses are much more radiation resis tant than the other pathogen types, the 1-Mrad PFRP dose of gamma radiation given in conjunction with a required PSRP should effectively eliminate the health hazard posed by viral pathogens in sludge. ACKNOWLEDGMENTS Credits. This work was supported by the Division of Advanced Nuclear Systems and Projects, U. S. Depart ment of Energy, Washington, D. C, and Municipal Environmental Research Laboratory, U.S. Environ mental Protection Agency, Cincinnati, Ohio, Inter agency Agreement E (29-2)-3536/EPA-IAG-D6-0675. This paper was presented at the 54th Annual Conference of the Water Pollution Control Federation, Detroit, Mich. Authors. J. Gary Yeager is a member of technical staff, Environmental Research Division, Sandia Na tional Laboratories, Albuquerque, N. M. R. T. O'Brien is a professor, and chairman of the Department of Bi ology, New Mexico State University, Las Cruces. Our Correspondence should be addressed to J. Gary Yeager, Environmental Research Division 4774, Sandia Na tional Laboratories, Albuquerque, NM 87185. REFERENCES 1. McCaslin, B. D., et al, "Aspects of Land Application of Sewage Solids and Gamma-Irradiated Dried Sewage Solids on Calcareous Soils." 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