APHA 2006 The Administrative Law Basis for Public Health Practice

1. APHA 2006The Administrative Law Basis for Public Health Practice Edward P. Richards Director, Program in Law, Science, and Public Health Louisiana State University Law Center richards@lsu.edu Slides and other info: http://biotech.law.lsu.edu/cphl/lessons/index.htm

2. Objectives • Understand how the history of public health law shapes current practice • Understand how administrative law principles govern public health practice • Understand that the government's public health powers are very broad, and have not been limited by modern constitutional law decisions • Understand that government power must be used wisely or the public will not support public health initiatives

3. Historical Perspective Everyone condemns unnecessary legislation and equally abhors ill considered and badly framed laws, but the relations of human beings are becoming more complex every day. . . . There is no doubt, too, that those who “on general principles” condemn “meddling legislation,” when it comes to specific problems affecting themselves, are in favor of rat proofing plague infected cities, of stamping out virulent smallpox by drastic measures, of compelling one city to cease discharging its sewage into its neighbor’s drinking water and of dealing summarily with him who peddles tuberculosis with his milk. Charles V. Chapin, 1925

4. Law’s Paramount Role:10 Great Public Health Achievements, United States, 1900-1999* Do you know how law contributed to these achievements? • Vaccination • Motor-vehicle safety • Safer workplaces • Control of infectious diseases • Decline in deaths from coronary heart disease and stroke • Safer and healthier foods • Healthier mothers and babies • Family planning • Fluoridation of drinking water • Recognition of tobacco use as a health hazard

5. Impact of Specific Laws onPublic Health Problems

6. What is Administrative Law? • Administrative law is the law of government. • Public health includes many personal behaviors • Public health law deals with the powers of the government to protect the public health • Based on expert analysis and decisionmaking, not jury decisions • Understanding administrative law principles is critical to effective public health practice

7. Misunderstanding Public Health • Quotes from today • "Public health law is bringing human good and health to as many persons as possible" • "Public health is social justice" • This views captured public health in the 1970s and were later fueled by AIDS • The result has been catastrophic • HIV in minority communities • Failure of emergency preparedness - Katrina

8. What Public Health Law Isn't • Public Health Law is Not: • Civil liberties law • Discrimination law • Not poverty law • Not tort law • Not even health care administration law

9. Why Does Seeing Public Health Law as Administrative Law Matter? • If you do not understand how government works, you cannot be an effective public health practitioner or advocate • If you see public health as a mishmash of everything that is warm and friendly, you have not a workable model for policy in a world of limited resources and dangerous threats • People die as we chase our angels around the pin head

10. History of Public Health Law

11. The Roots of Public Health Law • Leviticus • Roman water and sewer works • Early renaissance Venice • Quadraginta • Blackstone • Death for breaking quarantine

12. Public Health in the Colonies • Most of the population lived in poorly drained coastal areas • Cholera • Yellow Fever • Urban Diseases • Smallpox • Tuberculosis • Average Life Expectancy in cities was 25 years

13. Public Health Law Actions in Colonial America • Quarantines, areas of non-intercourse • Inspection of ships and sailors • Nuisance abatement • Colonial governments had and used Draconian powers • The Police Powers

14. Police Power • Police departments came later • Power to protect the public health and safety • Communicable disease control • Quarantine • Sanitation • Nuisance • Drinking water

15. Articles of Confederation • In effect between independence and the ratification of the Constitution in 1789 • Left all powers to the states • The states provided what support they wanted to the federal effort • Did not work during the Revolutionary War • Remember the stories about Washington's troops not having shoes?

16. Public Health in the Constitution • Federal Powers • Interstate commerce • International trade and travel • War powers • State Powers • Powers not given to the federal government • Police Powers

17. Actions in the 1798 Yellow Fever Epidemic For ten years prior, the yellow fever had raged almost annually in the city, and annual laws were passed to resist it. The wit of man was exhausted, but in vain. Never did the pestilence rage more violently than in the summer of 1798. The State was in despair. The rising hopes of the metropolis began to fade. The opinion was gaining ground, that the cause of this annual disease was indigenous, and that all precautions against its importation were useless. But the leading spirits of that day were unwilling to give up the city without a final desperate effort. The havoc in the summer of 1798 is represented as terrific. The whole country was roused. A cordon sanitaire was thrown around the city. Governor Mifflin of Pennsylvania proclaimed a non-intercourse between New York and Philadelphia. (Argument of counsel in Smith v. Turner, 48 U.S. (7 How.) 283, 340-41 (1849))

18. Original Intent and Public Health • The founders saw communicable diseases as the same type of threat as the threat of invasion by foreign troops • The drafters of the Constitution clearly intended to give broad powers to the states to protect the public health • The United States Supreme Court has not limited these powers • Few state courts have limited public health power • Political support has declined as successful public health has reduced the fear of communicable diseases

19. Is there a Federal Police Power? • Constitutional Debate • US Supreme Court says no, but ... • New legislation gives the president the power to use federal troops and national guard in public health emergencies • Do the Feds do local disease control? • CDC only comes in at the state's invitation • Public Health is state and local

20. Public Health as National Security Law • Can the Feds require smallpox vaccinations? • Invasion Clause? • Using national security powers? • Do national security powers depend on an external threat or an insurrection? • Can they be used for disasters and diseases? • The founders saw this as the role of the states

21. Golden Age of Public Health: 1850 - 1970 • Sanitation • Drinking water • Waste water • Environmental Health • Food inspection • Housing codes • Working conditions • Communicable Diseases • Vaccinations • Investigation and control

22. The Results: 1850 - 1970 • Urban life expectancy almost tripled between 1850 and 1970 • Tuberculosis and polio are under control • Food and water borne diseases are rare • Yellow fever, malaria, and smallpox are eradicated in the US • Vaccinations and disease control are routine and not controversial

23. Administrative Law Basics

24. Administrative Law • Administrative law governs: • Powers that legislatures can delegate to government agencies • Formation and organization of government agencies • Functioning and oversight of government agencies • How courts review the actions of government agencies

25. Constitutional Basis of Administrative Law • The US Constitution does not mention agencies • The founders did not anticipate that there would be much federal government • Administrative law doctrines have been shaped by Congress and the courts, within the constraints of the Constitution

26. Separation of Powers • Agencies are part of the executive branch of government • Created by legislatures • Reviewed by courts • Federal agencies are under the President • Independent agencies have appointed commissions • States can have multiple executives • AG, Insurance Commissioner, etc.

27. Legal Justification for Agencies • Expertise • Agencies are meant to have expert staff who manage complex problems • Efficiency • Agencies have more efficient enforcement powers because they are not limited by criminal law protections • Flexibility • Agencies can act without new legislation • Agencies can tap new expertise as needed

28. What is an Administrative Agency? • All parts of the government are agencies for the purpose of administrative law, except: • The legislature • The courts • The executive (President or governor) • The military

29. Public Health as the First Administrative Law • The colonial governments provided public health services that were taken over by the states after independence. • Public health service hospitals and quarantine stations were established by the first U.S. Congress. • City and state Boards of Health were among the first government agencies.

30. Types of Agencies • Agencies are divided into three types, based on their authority and organization: • Enforcement agencies • Independent enforcement agencies • Non-enforcement agencies • Agencies in each category protect the public’s health

31. Enforcement Agencies • Have the power to enforce laws through civil actions and/or criminal penalties • Examples: • Food and Drug Administration (FDA) • State health departments • Federal enforcement agencies must be directly or indirectly controlled by the executive branch (President) • State enforcement agencies are controlled by the governor or other elected officials

32. Independent Enforcement Agencies • Independent enforcement agencies are organized to limit the day-to-day control of the executive branch: • Overseen by commissioners who are appointed by the executive for fixed terms • Head can only be replaced for cause or when their term expires • Examples: • Consumer Products Safety Commission • Some state and local health departments • State commissioners may be appointed by the governor or other officials or the legislature

33. Non-Enforcement Agencies • Non-enforcement agencies may: • Do research and publish reports • Propose voluntary guidelines and standards • Disburse grant funds • Examples: • Congressional budget office • Most parts of the Centers for Disease Control and Prevention

34. Non-Enforcement Agencies:Public Education • Public education is a major vehicle for carrying out public health policy • Not legally binding • May be directed to public, professionals, or regulated parties • Can be provided by both enforcement and non-enforcement agencies • May be developed by agency or private groups • Examples • CDC: “Parents’ Guide to Childhood Immunization” • CDC: Recommendations of the Advisory Committee on Immunization Practices • North Carolina Division of Environmental Health: “Fleas...Some Facts”

35. Legislative Control:Establishing an Agency • Federal agencies: established by acts of Congress • Most state agencies: established by acts of the state legislature • Some states have agencies specified in the state constitution • Such agencies still depend on the legislature for their specific powers • Local agencies: may be established by the state legislature or local governing body

36. The Enabling Act:Establishes an Agency • The enabling act for an agency specifies the agency’s: • Reason for being created • Powers • Organization • Funding sources • The agency budget is established through appropriations bills • The legislature can establish agency priorities through the money it allocates for different agency functions

37. Legislative Delegation ofBroad Powers to the Agency • General grants of power • Delegation of broad powers with limited specific direction • Allows flexible response to new problems • Allows executive branch to set the direction of the agency • Example • State health departments were established with broad grants of power

38. Legislative Grants of Specified Powers to the Agency • Specified grants of power • Delegation of specific and limited powers • Allows legislature to control the direction of agency to achieve specific goals • Limits changes in policy based on changing circumstances • Example • National Childhood Vaccination Injury Compensation Fund • Specifies compensation process and leaves the agency limited discretion

39. Legislative Grants ofContingent Powers • Contingent powers • Delegation of either broad or limited powers • Powers are available only when triggered by a specific event • Powers may be trigged by: • Declaration by the President or governor • Fiscal event (e.g., budget shortfall) • External event (e.g., disease outbreak)

40. Legislative Control of Agencies:Summary • Enabling Act • Organization and type of agency • Nature of the delegated powers • Method of funding the agency • Legislature can amend the enabling act with future legislation or even abolish agency • Appropriations • Legislature can increase or decrease funding for agency functions to change agency priorities

41. Executive Control of Agencies • Appointment of agency director • The executive's (e.g., President, governor, mayor) main control over an agency is through selection or replacement of the director • Independent agency commissioners can be replaced only at the end of their terms, limiting executive control • Executive orders • Orders from the executive to change agency policy • Must be within legislated limits • Especially important in emergencies

42. Separation of Powers in State Government • Most states have multiple executive departments • Health agencies are usually under the governor • Legal services are often controlled by the attorney general's office • In some states the AG is co-equal with the governor and this can complicate public health enforcement

43. Separation of Powers inLocal Government Agencies • Most large municipalities have three branches of government • Agencies are part of the executive branch, headed by the mayor • Smaller cities and counties may consolidate their government into two branches or even one branch • The separation of powers blurs

44. Political Control of Agencies • Agencies’ directions and priorities may be key issues in elections • The voters control agencies through the ballot box • Interested parties contact legislators and the executive to change policy – examples: • Mothers Against Drunk Driving • American Public Health Association • Examples of in public health practice • State and local tobacco use limitations • Seatbelt laws • Exceptions to mandatory childhood immunization laws

45. Intergovernmental Control of Agencies • Federal control of state and local government • Congress can preempt state and local laws to assure uniform national policy • In public health, most federal control is exercised through funding desirable projects • Examples of federal preemption • FDA regulations on medical devices • National Childhood Vaccine Injury Compensation Act • States approaches vary to local public health oversight • Some state health departments control the local departments • In many states, local health departments are controlled by local government authority

46. Administrative Law Process:Rules and Regulations • The terms "rule" and "regulation" mean the same thing and are used interchangeably in administrative law • Legislature must delegate this power to the agency • Regulations are legally binding: they have the same effect as a statute passed by the legislature • Examples • Occupational Safety & Health Administration: Bloodborne pathogens regulations (29 CFR 1910.1030) • Regulations promulgated under the New York City Smoke-Free Air Act

47. Why Make Rules? • Rules provide detail to implement broad grants of authority • Giving an agency rule-making authority allows the legislature to defer to the agency's expertise in the regulated area • Rules help the public understand the law • Rules can incorporate voluntary standards, giving them the force of law – examples: • National building codes • Agency guidelines on food sanitation • Recommendations of the Advisory Committee on Immunization • Courts defer to standards that are incorporated into rules

48. Public Participation in Rulemaking • Rule-making requires public participation • Allows the public to directly affect policy • Proposed rules and any information they are based on must be published for public comment • Public comments • Agency must receive written comments from all interested parties • Legislature also may allow oral comments through public hearings for certain rules • Agency must review and consider the comments • Agency must explain why it did or did not modify proposed rule as suggested by comments

49. Administrative Law Tools:Permits and Licenses • Permits and licenses: key tools in assuring compliance with public health standards • Applicants must meet regulatory standards before being issued permit or license • Applicants must agree to cooperate in quality assurance through inspections and/or re-certification • Must be issued fairly • Requirements must be clear • All qualifying applicants must be treated equally • Examples: • Restaurant license • Dog license • Permit to ship seafood interstate

50. Public Health Inspections • Inspections are examinations of residences and businesses • Random inspections are used to assure that permit and license holders are complying with regulatory standards • Inspections may be made in response to citizen complaints • Inspections may be done on periodic basis to assess health risks • Examples: • Restaurant sanitation inspections • Rodent inspections in warehouses • Investigations of complaints about dangerous dogs