Better Living through Chemistry?

1. Better Living through Chemistry? • The course has two objectives • to understand federal public policy regarding chemical use in the United States • to find and effectively use electronic data for research purposes • Deconstruct law into statutory, administrative and case law

3. Public Policy • The legislature defines and establishes broad social goals, outlines what behavior is needed to achieve those goals, delegates authority necessary to change behavior, appropriates revenue • The executive creates (promulgates) rules that are designed to implement legislation and change behavior • The judiciary examines claims by individuals, organizations, even governments, that specific legislation or specific regulation violates their constitutional rights and cause some harm

4. Regulations and the Rule-making Process Action by the Executive Branch of the Federal Government

6. Assignment 4. Due March 26 • Find the appropriate rule authorized by the statute you analyzed in Project 2 A. Describe what the regulation is intended to do and how B. Trace the history of the regulation, through the Federal Register, from when the rule was first published to its publication in the Code of Federal Regulations C. Describe changes in the rule since it was first promulgated D.  What were the consequences of the rule? E.  What were the predicted consequences of the rule?

7. Safe Drinking Water Act • What is the chemical composition of safe drinking water? • What is the chemical composition of unsafe drinking water? • How can safety be compromised? • What activities change the chemical composition of water to make • safe drinking water unsafe? • unsafe drinking water safe? • Who is responsible for providing it? – Federal government has assumed responsibility • How should it be provided? • Who should pay for it? How?

8. Administrative Law - Structure • The US Government Manual • Official US Executive Branch Web Sites (Library of Congress) • Federal Executive Branch (FirstGov) • Executive Office of the President • Executive Branch (NP Action) • Legal Information Institute (Cornell University) • Uncle Sam (Google)

9. Administrative Law • Federal Register (GPO) • Federal Register (National Archives) • Code of Federal Regulations (GPO) • Regulations.gov • Unofficial • LexisNexis Congressional (Reed Elsevier) • HeinOnline

10. Agency for Toxic Substances and Disease Registry (HHS) Food and Drug Administration (HHS) Arthritis and Musculoskeletal Interagency Coordinating Committee (NIH-HHS) Agricultural Research Service (USDA) Food and Nutrition Service (USDA Food Safety and Inspection Service (USDA) Food, Nutrition and Consumer Services (USDA) Foreign Agricultural Service (USDA) Forest Service (USDA) Alcohol, Tobacco, Firearms, and Explosives Bureau (DoJ) Federal Trade Commission (FTC) Fish and Wildlife Service (DoI) Environmental Protection Agency Federal Policy Regarding Chemicals – Manufacture, Use, and Disposal (Executive action)

12. The Nature of Regulations • Legislation enacted by the legislative branch and signed by the President • establishes national goals, • delegates authority, and • appropriates funds • Regulations promulgated by the executive branch, operating under a legislative mandate, defines what changes in behavior necessary to achieve those goals

13. Legislation ----------- Outcome Legislative History -- Process Codification ---------- Amendments Consequences Regulation ----------- Outcome Regulation History -- Process Codification ---------- Final Rule Consequences Similarities – Legislation and Regulation

14. The Outcome of the Federal Regulatory Process

15. The Outcome of the Federal Regulatory Process

17. Parallel Table • The Toxic Substances Control Act (Pub. L. 94-469, Oct. 11, 1976, 90 Stat. 2003; 15 U.S.C. 2601 et seq.) • Short Title of 1992 Amendment. Pub. L. 102–550, title X, § 1021(c), Oct. 28, 1992, 106 Stat. 3924 “Lead-Based Paint Exposure Reduction Act” • Short Title of 1986 Amendment. Pub. L. 99–519 sec. 1 “Asbestos Hazard Emergency Response Act of 1986” • CFR parts for which 15 USC 2603 provides authority • 40 CFR 76640 CFR 79240 CFR 795 • 40 CFR 79640 CFR 79740 CFR 798

18. All Agencies Possess a Legislative Mandate • Groundwater and Drinking Water (EPA) • Water Quality (USDA) • Food Safety (www.FoodSafety.gov) • Indoor Air Quality (EPA) • USGS Guide to Federal Environmental Laws and Regulations • Summaries of Environmental Laws Administered by the EPA (CRS)

19. Lead • Lead-Based Paint Poisoning Prevention Act (Pub. L. 91-695, Jan. 13, 1971, 84 Stat. 2078; 42 U.S.C. 4801 et seq.) • Lead Contamination Control Act of 1988 (Pub. L. 100-572, Oct. 31, 1988, 102 Stat. 2884; 42 U.S.C. 300j–21 et seq.) • Lead-Based Paint Exposure Reduction Act (Pub. L. 102–550, title X, subtitle B (§1021), Oct. 28, 1992, 106 Stat. 3912 (15 U.S.C. 2681 et seq.) • 24 CFR 965 • Lead (EPA) • Rules and regulations (EPA)

20. The Outcome of the Regulatory Process • Federal Register, daily publication • Federal Register (GPO) • Federal Register (National Archives) • LexisNexis Congressional (Reed Elsevier) • HeinOnline • Code of Federal Regulations, annual publication • Code of Federal Regulations (GPO) • Code of Federal Regulations (Legal Information Institute) • LexisNexis Congressional (Reed Elsevier) • HeinOnline

21. The Outcome of the Regulatory Process • Agency actions implementing the published rules/regulations • EPA • FDA • USDA

23. Rule-Making • Who has Rule-Making Power? • Whomever has been given the power to do so by legislation • Executive departments comprising the Cabinet • Most Independent Agencies and Government Corporations • Some Boards, Commissions, and Committees • The Rule-making Process (Federal Communications Commission) • FAA Rule-making • FDA Rule-making • Recent Reports on Federal Agency Major Rules (GAO)

24. The Rule-making Process

25. Federal Register • The Federal Register is a centralized means of publishing regulations, presidential documents and notices Before it started in 1935 such materials were published without any formal organization As a consequence individuals, organizations and even the federal agencies operated in ignorance of applicable law

27. The Federal Register Act of 1935 (49 Stat. 501) created the daily publication known as the Federal Register • Today the Federal Register Act as amended comprises 44 U.S.C.  §1501 et seq

28. The Administrative Procedures Act (APA) • Enacted on June 11, 1946 (Public Law 79-404,  60 Stat. 237) outlined the administrative procedures federal agencies must follow to • Identify information to be made public • Publish material in the Federal Register • Maintain records, including those involving certain meetings and hearings • Fulfill attendance and notification requirements for specific meetings and hearings • Issue licenses • Review agency actions • 5 U.S.C. § 551 et seq

29. Administrative Procedures Act • Requires most rules be published in the Federal Register with a period for public comment • Most agency rule-making, governed by section 553 of the APA, requires • a notice of proposed rule making published in the Federal Register • a reference to the legal authority under which the rule is proposed • the terms or a description of the subjects and issues to be addressed by the proposed rule • interested persons must be given an opportunity to submit written data, views, or arguments on the proposal, with or without opportunity for oral presentation • a concise general statement of the basis and purpose must accompany the final rule • publication of the final rule must take place not less than 30 days before its effective date

31. Safe Drinking Water Legislation  • Administrative Procedures • Environmental Protection Agency • Proposed Safe Drinking Water Regulations -Federal Register • Final Safe Drinking Water Regulations - Federal Register • Code of Federal Regulations

32. Federal Register (FR) • The Federal Register is published by the National Archives and Records Administration (NARA) • Since Saturday, March 14, 1936, each daily issue of the Federal Register has contained similar information • The Federal Register: What it is and How to Use it (Food & Drug Administration) • Final Rule • Proposed Rule • Presidential Documents – Executive orders, Proclamations, Reorganization Plans • All compiled annually in title 3 of the Code of Federal Regulations

33. Final Rules • Final Rules and Regulations contains final rules, regulatory documents having general applicability and legal effect • Most rules are keyed to and codified in the Code of Federal Regulations (CFR) • Interim rules, designed to respond to an emergency situation, issued without prior notice and are effective immediately. Such rules are usually followed by a final rule document which confirms that the interim rule is final, addresses comments received, and includes any further amendments • Section may include documents that have no regulatory text and do not amend the CFR, for example • general policy statements • interpretations of agency regulations

34. Proposed Rules • Proposed Rules contains notices that an agency intends to issue a rule • The purpose of these notices is to give interested persons an opportunity to participate in the rule making prior to the agency adopting and publishing the final rule • Many such proposals involve changes to agency regulations that have been already published in the Code of Federal Regulations (CFR) and request public comment on those suggested changes • Documents relating to previously published proposed rules, extending the comment period, announcing a public hearing, making  supplemental information available, correcting a previously published proposed rule, or even withdrawing a proposed rule

35. Proposed Rules • Advanced notices of proposed rulemaking, which describe a problem or situation and the anticipated regulatory action of the agency, seeking seek public response concerning the necessity for regulation and the adequacy of the agency's anticipated regulatory action • Many agencies voluntarily publish proposed changes to procedural rules, interpretative rules, and agency policies in order to gather public comments to those changes

36. Notices • Documents, other than rules or proposed rules, that are generally applicable •     Notices of hearings and investigations •     Committee meetings •     Agency decisions and rulings •     Delegations of authority •     Issuances or revocation of licenses •     Grant application deadlines •     Availability of environmental impact statements •     Filing of petitions and applications •     Agency statements of organization and functions

37. Presidential Documents • Documents signed by the President and submitted to the Office of the Federal Register for publication • Include Proclamations and Executive Orders as well as other documents such as determinations, letters, memoranda, and reorganization plans • All compiled annually in title 3 of the Code of Federal Regulations

38. Sunshine Act Meetings • Notices of meetings published under the "Government in the Sunshine Act" (Pub. L. 94-409; 5 U.S.C. 552b(e)(3)) that requires meetings of Government agencies be open to the public, with certain specified exceptions • Includes the time, place, and subject matter of the meeting, the name and telephone number of the agency official to contact for more information, and whether the meeting is open or closed to the public

39. Code of Federal Regulations (CFR) • The CFR is a compilation and codification of the general and permanent rules published in the Federal Register • Divided into 50 titles representing broad areas of behavior subject to federal regulation • Each titledivided into chapters usually bearing the name of the issuing agency • Each chapter is further subdivided into parts covering specific regulatory areas - parts thus become the “rule“ • Each part is keyed to • the legislative authority under which the agency promulgated the rule • the issue of the Federal Register in which the final rule was published • Rules are cited to the section level • Each volume of the CFR is revised once each calendar year

40. Electronic Code of Federal Regulations • LexisNexis Congressional • Hein Online

41. Consumer Product Safety Regulations • U.S. Consumer Product Safety Commission • Rules Promulgated by the Commission • Requirements for Full Size Baby Cribs (Explanatory Notice) • 16 CFR 1508 • 16 CFR 1632 (Standards for the Flammability of Mattresses and Mattress Pads)

42. Other Resources • EPA Federal Register Site • Arsenic in Drinking Water (EPA) • Regulation Magazine (Cato Institute) • Recent Regulatory History of Air Bags (Motorvista.com) • Regulatory History of Mixed Waste (EPA) • Mercury Emissions and Utilities (EPA) • Regulatory Reform in the Power Industry (Cato Institute) • Federal Regulatory Reform an Overview (Congressional Research Service)

43. To Find a Regulation • Check the Parallel Table of Authorities and Rules • Check the web site of the Agency given legislative authority • A Keyword search in the CFR in GPO Access • A Keyword Search in LexisNexis Congressional • For those who chose an early statute look at earlier version of CFR • Search the CFR Index and Finding Aids or the Index to the Code of Federal Regulations • Look for your regulation by subject (e.g., campaign funds) or by agency (e.g., Federal Election Commission)

44. To trace a current CFR section back to its origins • Look for a source note in the CFR at the beginning of the part (after the table of contents), or at the end of a particular section • Look in the appropriate Federal Register describing the Final Rule for a reference to the Proposed Rule published earlier

45. To find the authority for a regulation • At the beginning of the CFR part you are using (after the table of contents), look for an authority note citing the United States Code section(s), or Statute, or Public Law, which authorized the regulations • In the Federal Register an authority note for a proposed or final rule appears at the beginning of the text of the rule (not the preamble)