Guide to US Food Laws and Regulations E-Book
77,99 €
Mehr erfahren.
- Herausgeber: John Wiley & Sons
- Kategorie: Fachliteratur
- Sprache: Englisch
For both student food scientists and experienced professionals, a knowledge of U.S. food law is the foundation that supports an understanding of all industry regulation. Based on a popular internet course, Guide to Food Laws and Regulations, 2nd Edition informs students on the significance, range, and background of food laws and gives tools for finding current regulations.
This compact resource outlines major U.S. food laws, factors that led to their passage, and explains the role of key agencies like the FDA and FSIS in regulation and enforcement. Students are directed to internet sites as well as to indexes and resources available from the Federal government. Other topics include religious dietary law, Occupational Safety and Health Administration regulations, environmental regulations, HACCP and GMPs, laws governing health claims, and the regulation of biotechnology.
New to this edition are six chapters on subjects that have risen to prominence during the last few years:
- Poultry Processing Regulations
- Federal Trade Commission
- Animal Welfare Regulations and Food Production
- Egg Laws and Regulations
- Catfish Regulations
- Locating Laws and Regulations
Guide to Food Laws and Regulations, 2nd Edition is an ideal sourcebook for students and professionals in food science and technology, chemistry, biosystems engineering, food animal production and medicine, agribusiness, and other closely related fields.
Sie lesen das E-Book in den Legimi-Apps auf:
Seitenzahl: 567
Veröffentlichungsjahr: 2013
Ähnliche
Contents
Cover
Title Page
Copyright
List of Contributors
About the Companion Website
Chapter 1: Introduction to Laws and Regulations
Introduction
Sources of American Law
Public and Private Law
Legislative Branch
Judicial Branch
Federal Court System
Executive Branch
Sources of Legislation
How a Bill Becomes a Law
Where to Find Legal Information
Conventional Search Method
How Regulations are Made
Code of Federal Regulations
Using the Code of Federal Regulations
References
Additional Resources
Chapter 2: How Did We Get Where We Are Today?
Introduction
Reasons for Food Laws
American Food Laws
The “Poison Squad”
The Jungle
The Need for a New Food and Drug Law
Elixir of Sulfanilamide: Raspberry Flavored Death
Food Drug and Cosmetic Act of 1938
Silent Spring and the Environmental Protection Agency
First Amendment to the Food, Drug and Cosmetic Act
Public Health Service Act
Milestones in US Food and Drug History (FDA 2010)
A Brief History of Agricultural-Related Agencies
Current Consumer and Regulatory Concerns
Summary of Major Food Laws
References
Further Reading
Chapter 3: Federal, State, and Local Laws
Introduction
National versus State Government
National Government
State Government
Powers of the National Government and State Governments
Food-related Laws and Regulations
Local Government
Tribal Governments
Summary
References
Chapter 4: Major Food Laws and Regulations
Introduction
Pure Food and Drug Act (1906) and Federal Meat Inspection Act (1906)
Amendments to the Federal Meat Inspection Act (1906)
Food, Drug and Cosmetic Act (FDCA), 1938
Amendments to the Food, Drug and Cosmetic Act, 1938
Conclusion
References
Chapter 5: US Federal Laws affecting Food Labeling
Introduction
History of food labeling
Construction of a food label
NLEA of 1990
The FDA Modernization Act of 1997
Labeling exemptions
Results of over 70 years of food labeling regulation
Conclusion
References
Chapter 6: Environmental Regulations and the Food Industry
Introduction
Discharges to surface and ground waters
Solid waste
Hazardous waste
Use of water
Discharges to air
Chemical use, storage, release, and transport
Siting and operation of facilities
Environmental risk management
References
Legal authorities
Chapter 7: OSHA Regulations and the Food Industry
Introduction
Mission
OSHA statistics
Rights and responsibilities under OSHA law
Selected OSHA Standards and Guidelines
Filing a complaint with OSHA
Summary
References
Further Reading
Chapter 8: Federal Trade Commission Regulations and the Food Industry
Introduction
Mission
Authorizing Acts
Bureau of Consumer Protection
Bureau of Competition
Bureau of Economics
Sample enforcement actions
References
Chapter 9: An Introduction to Kosher and Halal Food Laws
Introduction1
The kosher and halal laws
The kosher and halal market
Kosher
Halal
Both kosher and halal
Acknowledgment
References
Further Reading
Additional Resources
Chapter 10: Biotechnology and Genetically Modified Agricultural Crops and Food
Introduction
Biotechnology, genetically modified, and genetic engineering
Regulation of GM foods in the United States
Biotechnology versus organic agriculture
Common examples of GM products
Biotechnology-related court cases
Conclusion
References
Chapter 11: Animal Welfare Regulations and Food Production
Introduction
Participants in the welfare debate
Impact on public perception
Economics
What needs to be done
References
Further Reading
Chapter 12: Egg Laws and Regulations
Introduction
History
Egg Safety Final Rule Implementation
References
Additional Resources
Chapter 13: Regulations Governing Poultry Processing
Introduction
Poultry Products Inspection Act (21 USC 451)
Poultry Products Inspection Regulations (9 CFR 381)
Poultry Processing Operations
HACCP Systems (9 CFR 417)
New Inspection System Proposal
Proposed Changes Affecting All Poultry Slaughter Establishments
HACCP
Poultry Products Inspection Regulations (9 CFR 381)
Definitions of Nonconformances
References
Chapter 14: What Are They Doing Up There? Contacting Your Congressional (House) Member
Writing to your Congressman/Congresswoman
Calling your Congressman/Congresswoman
Visiting your Congressman/Congresswoman
Jobs on the Hill (House of Representatives)
When traveling to Washington DC
Index
This edition first published 2013 © 2013 by John Wiley & Sons, Ltd
Wiley Blackwell is an imprint of John Wiley & Sons, formed by the merger of Wiley's global Scientific, Technical and Medical business with Blackwell Publishing.
Registered office:John Wiley & Sons, Ltd, The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UKEditorial offices:9600 Garsington Road, Oxford, OX4 2DQ, UK The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UK 111 River Street, Hoboken, NJ 07030-5774, USAFor details of our global editorial offices, for customer services and for information about how to apply for permission to reuse the copyright material in this book please see our website at www.wiley.com/wiley-blackwell.
The right of the author to be identified as the author of this work has been asserted in accordance with the UK Copyright, Designs and Patents Act 1988.
All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, except as permitted by the UK Copyright, Designs and Patents Act 1988, without the prior permission of the publisher.
Designations used by companies to distinguish their products are often claimed as trademarks. All brand names and product names used in this book are trade names, service marks, trademarks or registered trademarks of their respective owners. The publisher is not associated with any product or vendor mentioned in this book.
Limit of Liability/Disclaimer of Warranty: While the publisher and author(s) have used their best efforts in preparing this book, they make no representations or warranties with respect to the accuracy or completeness of the contents of this book and specifically disclaim any implied warranties of merchantability or fitness for a particular purpose. It is sold on the understanding that the publisher is not engaged in rendering professional services and neither the publisher nor the author shall be liable for damages arising herefrom. If professional advice or other expert assistance is required, the services of a competent professional should be sought.
Library of Congress Cataloging-in-Publication Data
Guide to US food laws and regulations / Edited by Patricia A. Curtis. – Second edition. pages cm Includes index. ISBN 978-1-118-22778-7 (pbk.) 1. Food law and legislation–United States. I. Curtis, Patricia A., editor. KF3870.C87 2013 344.7304'232–dc23 2013013062
A catalogue record for this book is available from the British Library.
Wiley also publishes its books in a variety of electronic formats. Some content that appears in print may not be available in electronic books.
Cover image © Shutterstock/leedsn Cover design by Meaden Creative
LIST OF CONTRIBUTORS
Kenneth E. AndersonProfessor and Poultry Extension Specialist Department of Poultry Science North Carolina State University Raleigh, North Carolina USA
Jessica ButlerPolicy Advisor and PhD Candidate Washington, DC USA
Brooke CaudillConsultant Flowery Branch, Georgia USA
Muhammad M. ChaudryPresident, Islamic Food and Nutrition Council of America Park Ridge, Illinois USA
Patricia A. CurtisDirector of Auburn University Food Systems Institute Auburn University Auburn, Alabama USA
Theodore A. FeitshansExtension Associate Professor Department of Agricultural and Resource Economics North Carolina State University Raleigh, North Carolina USA
Julie K. NorthcuttProfessor Department of Food, Nutrition and Packaging Sciences Clemson University Clemson, South Carolina USA
Michelle A. ParisiAssistant Professor Department of Human Nutrition Winthrop University Rock Hill, South Carolina USA
Carrie E. RegensteinAssociate Vice Provost for Computer Services, Retired Carnegie Mellon University Pittsburgh, Pennsylvania USA
Joe M. RegensteinProfessor of Food Science Head: Cornell Kosher and Halal Food Initiative Department of Food Science Cornell University Ithaca, New York USA
Emily L. SteinbergGraduate Research Assistant and PhD Candidate Department of Food, Nutrition and Packaging Sciences Clemson University Clemson, South Carolina USA
ABOUT THE COMPANION WEBSITE
This book is accompanied by a companion website:
www.wiley.com/go/curtis/usfoodlaws
The website includes:
Links to additional resourcesPowerpoints of all figures from the book for downloadingPDFs of all tables from the book for downloadingChapter 1
INTRODUCTION TO LAWS AND REGULATIONS
Patricia A. Curtis
Auburn University Food Systems Institute, Auburn, AL, USA
Introduction
American democracy is based on six essential principles. They are:
The majority rulesProtection of political rights of minoritiesCitizens agree to be ruled by a system of lawFree exchange of ideas and opinionsEquality of all citizensGovernment exists to serve the people.In the United States, the combination of federal, state, and local laws, bodies, and agencies are responsible for carrying out operations. This combined group ensures that the people are the source of the government's authority by electing representatives to serve in the government in all levels and provides for checks and balances by sharing power between different levels of government. The President and Vice President are the only public officials elected by all the citizens of the United States. Each serve a 4-year term and are eligible for an additional 4-year term. Each President adds his personal touches to the Oval Office during his occupancy. More information about the president and vice president can be found on the white house website (http://www.whitehouse.gov). A brief biography of each of the previous presidents can be found at http://www.whitehouse.gov/about/presidents.
Sources of American Law
There are four sources of American law: the Constitution, statutory law, common law, and equity.
The Constitution
The Constitution is the supreme law of the United States. It describes what powers the government has, as well as what rights US citizens have. All other laws must comply with the Constitution. It has six basic principles.
Statutory Law
Statutory law is written law that is passed by legislatures. Congress, state legislatures, and local governments all enact statutes. While constitutional law is broad and leaves room for interpretation, statutory law is generally more detailed and precise. Regulations passed by agencies are even more specific than statutes.
Common Law
The laws based on previous court ruling are called common, or case, law. This system dates back to 11th century England where judges contemplating a case would refer to previous case rulings. After seeing what was “common”, he would then make his decision. When common law is in conflict with statutory law, the statutory law is upheld.
Equity
Equity cases deal with the ‘fairness’ or ‘justice’ of a situation. Judges decide the issues, and a jury is not present. The judge often orders injunctions to prevent the unfair act from happening again.
Public and Private Law
There are two branches of law in America (not to be confused with the three branches of government).
Private Law
This branch mainly deals with disputes between individuals, businesses, or other organizations. The outcome of these disputes is usually a fine or award of money as opposed to a jail sentence. Private law encompasses: property, contracts, family relations, and torts.
Public Law
Public laws deal with the relationship between the government and its citizens. The four categories of public law are Constitutional law, international law, criminal law, and administrative law. Administrative law encompasses the rules and regulations that governmental agencies make. The majority of the rules and regulations that control food quality and safety fall into this category.
Legislative Branch
The legislative branch is a bicameral system, which means that it is composed of two houses, the Senate and the House of Representatives, as outlined in the United States Constitution. The US Senate is made up of 100 Members, two elected from each state. The US House of Representatives is composed of 435 Members elected every 2 years from among the 50 States, apportioned to their total populations. These two houses together form the U.S. Congress and are mainly responsible for passing statutory, also known as legislative, laws.
The Constitution gives specific powers to Congress. These are:
To levy and collect taxesTo borrow money for the public treasuryTo make rules and regulations governing commerce among the states and with foreign countriesTo make uniform rules for the naturalization of foreign citizensTo coin money, state its value, and provide for punishment of counterfeitersTo set the standards for weights and measuresTo establish bankruptcy laws for the country as a wholeTo establish post offices and post roadsTo issue patents and copyrightsTo set up a system of federal courtsTo punish piracyTo declare warTo raise and support armiesTo provide for a navyTo call the militia to enforce federal laws, suppress lawlessness or repel invasions by foreign powersTo make all laws for the District of Columbia andTo make all laws necessary to enforce the Constitution.The Vice President is the president of the Senate. He or she only has a vote in the case of a tie. A president pro tempore is chosen by the Senate to preside when the Vice President is absent. The House of Representatives chooses its speaker of the House.
Congress also has the power to investigate. This includes investigating the need for new legislation and the effectiveness of existing legislation, and evaluating the qualifications and performance of members of the executive and judicial branches. The House of Representatives is responsible for conducting impeachment proceedings, and the Senate is responsible for impeachment trials. More information about the legislative branch can be found at http://www.whitehouse.gov/our-government/legislative-branch.
Judicial Branch
The Judicial Branch consists of the federal court system, with the Supreme Court being the top entity. It is its responsibility to interpret the ‘intent’ of laws, and to settle disputes. Its jurisdiction includes cases involving the Constitution, controversies when the US government is a party, and controversies between states or their citizens. In food law, this often includes disputes between an enforcing agency and a food company.
The US Congress has the power to create and abolish federal courts. It cannot abolish the Supreme Court, however. The President appoints US judges, who must then be confirmed by Congress. More information about the judicial branch can be found at http://www.whitehouse.gov/our-government/judicial-branch.
Federal Court System
The Supreme Court
The Supreme Court is the highest court in the federal court system and was created by the Constitution. Its decisions cannot be overturned. About 10% of its cases get there by appeals. The rest of the cases get there through writs of certiorari (sir-shee-uh-RARE-ee). This is an order telling a lower court to send its records of a case to the Supreme Court for review. Writs of certiorari are issued for cases involving a serious constitutional issue or an error in the lower court. The Supreme Court consists of one chief justice and eight associates. More information about the Supreme Court can be found at http://www.supremecourt.gov.
Courts of Appeals
If someone feels that they did not get a fair trial, they can appeal their case to the courts of appeals. Here, a panel of judges who determine if the district court decision was correct reviews the case. If they need clarification on a point, they can ask to hear oral statements. These courts are also known as circuit courts, and they are arranged according to geography, with 12 circuits in all. In addition, the Court of Appeals for the Federal Circuit has nationwide jurisdiction to hear appeals in specialized cases, such as those involving patent laws and cases decided by the Court of International Trade and the Court of Federal Claims.
US District Courts
There are 89 districts in the 50 states, and district courts also exist in Puerto Rico, the Virgin Islands, the District of Columbia, Guam, and the North Mariana Islands. In total there are 94 federal district courts. These courts have original jurisdiction over both criminal and civil federal laws. In criminal cases, a grand jury decides if there is enough evidence to try the case. Then a trial jury determines if the person is guilty. In civil cases, a trial jury can be used, or can be waived if both parties agree. In these cases, a federal judge makes the final decision. More information about the district courts can be found at http://www.uscourts.gov/FederalCourts/UnderstandingtheFederalCourts/DistrictCourts.aspx.
Special Courts
Congress has set up ‘special’ courts to deal with specific problems. One of these courts is the Court of Customs and Patent Appeals. This court handles issues involving the US Patent Office.
Executive Branch
The Executive Branch includes the President, the Cabinet, the Cabinet Departments, and independent agencies. The president has many powers. These include the power to:
Introduce legislation to CongressVeto legislationAppoint federal judgesGrant full and conditional pardonsCall the National Guard into serviceAppoint ambassadors, ministers and consuls to aid in foreign relationsAppoint heads of the executive departments and independent agencies.The heads of the executive departments make up the President's ‘Cabinet’. These Cabinet departments, along with independent agencies also in the executive branch, are responsible for enforcing laws passed by the legislative branch. The responsibility of food safety and quality is spread out among four Cabinet level departments and two independent agencies. More information about the Executive Branch can be found at http://www.whitehouse.gov/our-government/executive-branch.
Sources of Legislation
For the purpose of this discussion, the word “law” refers to statutory law, or laws passed by Congress. As mentioned earlier, the US Congress is responsible for passing laws. The ideas for these laws can come from a variety of places:
A member of CongressConstituentsCitizen's groupsA member of the President's CabinetThe PresidentThe executive agencies.The idea is then drafted into a bill. A bill should contain three things:
Congressional bills are legislative proposals from the House of Representatives and Senate. There are six different types of bills. They are:
House and Senate bills Require the approval of both chambers (House and Senate) and the signature of the President to become law.Joint Resolutions Require the approval of both chambers and the signature of the President.Used for limited matters such as a single appropriation for a specific purpose or to propose an amendment to the Constitution.Concurrent Resolutions Require the approval of both chambers but do not require the signature of the President and do not have the force of lawGenerally used to make or amend rules that apply to both chambers.House and Senate Simple Resolutions Address matters entirely within the prerogative of one chamberDo not require the approval of the other chamber or the signature of the PresidentDo not have the force of law.For more information about Congressional bills click on “About the Congressional Bills” at http://www.gpo.gov/fdsys/browse/collection.action?collectionCode=BILLS.
How a Bill Becomes a Law
There are six main steps a bill goes through on its way to becoming a law:
Introduction
The introduction of the bill can take place in either the House or the Senate. The process is as follows:
‘First Reading’. In the Senate, the bill is usually introduced by presenting it to the clerk at the Presiding Officer's desk. The Senator with a brief statement can introduce it from the floor. In the House of Representatives the bill is simply dropped in a hopper and printed in the Congressional Record.The bill is then numbered. Bills originating from the Senate are numbered S. #, while bills from the House of Representatives are numbered H.R. #.Assigned to a standing committee for consideration,And printed by the Government Printing Office.Considered in Committee
Once in the standing committee, bills are often sent to a subcommittee. If it is a controversial or important topic, the subcommittee may hold a public hearing to get more information. They will then prepare a report for the standing committee with their recommendations and amendments.
The committee will then consider the subcommittee's report and take one of the following actions:
Pigeonhole the bill (“kill” the bill).“Report the bill out of committee favorably” (recommend to the house of origination that it be passed).“Mark up” the bill (amend the bill).Throw out the old bill and write a new one, called a “clean bill.”“Report the bill out unfavorably.” This happens in rare cases when a committee has political reasons for not killing a bill.Once the bill is ‘reported out’ of the committee, it must then be placed on the calendar of the originating house. The Rules Committee decides exactly when and how the bill will be discussed.
Reintroduction
When it is the bill's turn on the calendar, it is reintroduced or “called up” by the standing committee to the full Senate or House. The bill is then considered “Reported out of Committee.”
Debate in Congress
Once the bill is reintroduced, it has its “second reading.” At this time, the Congress members can take one of several “actions” on it.
Pass it as written.Table the bill. This removes the bill from further discussion, or “kills” it.Send the bill back to committee. This often results in the bill being killed in committee.Amend the bill. All amendments are debated and voted on.All actions on the bill are published daily in the Congressional Record. The bill then has its third reading and is voted on in its final form. If it gets a YES vote, it undergoes “engrossment” and graduates from being a bill to being an “act”. The act is then passed on to the other house, where it undergoes the same process, starting again with the introduction of the act.
If the Senate and House of Representatives end up with different versions of the same act due to amendments, members are sent from each house to form a conference committee to resolve the differences. A report of the committee's results is sent to each house, and the act is voted on again.
Presidential Action
The President has three options when he is presented an act. He can:
Approve and sign the act. It then becomes a law.Not act on it within 10 days, excluding Sundays. In that case it will automatically become a law unless Congress is out of session. In that case, it will be considered vetoed. This is called a “pocket veto.”Veto the act by not signing it or sending it back to the House of origin for recommendations. The veto can be overridden if each house approves it by 2/3 vote.Once the act becomes a law, it is printed as a Slip Law and is distributed to the public. If the law is a Public Law, then it is numbered consecutively with the Congress session number and the number of the law. Example: Pub. L. 113-4 is the 4th law passed by the 113th Congress.
Enrollment
The act is enrolled, or reprinted and submitted to the President after being signed by the Speaker of the House and the President of Senate. During every step of the legislative process, information about the bill or act is printed. A list of where the documentation for each step can be found is shown below.
The Legislative Process: Publications
Once the act becomes a law, it is then up to the regulatory agency to enforce it through the use of rules, regulations, policies, and guidelines.
It is possible to find much of the legal information you need on the internet. This is very convenient and allows you to get up to date information quicker. With the improvement of the online search at the Government Printing Office website, online searching has become much easier. At the time of publication, there was a three-part series of YouTube videos published by the John Marshall Law School's Louis L Biro Library. This three-part series provides easy to follow instructions on how to conduct research on the FDsys website (http://www.gpo.gov/fdsys/search/home.action). The three instructional videos are:
Both the electronic means of finding legal information as well as the method of using indexes in the library will be discussed.
Where to Find Legal Information
The Federal government makes legal information available at Federal depository libraries and on the web. There are approximately 1200 Federal depository libraries throughout the United States and its territories. All provide free public access to a wide variety of Federal government information in both print and electronic formats, and have expert staff available to assist users. To locate a Federal Depository Library near you visit http://catalog.gpo.gov/fdlpdir/FDLPdir.jsp.
All of the government information available from the U.S. Government Printing Office's is available on their website (http://www.gpo.gov/fdsys/search/home.action).
Each of the individual federal agency website also contain information regarding agency related laws and regulations.
Information about US laws is printed in many different publications. It is important to know what each one contains and how often it is updated when looking for current information. Some governmental publications of interest are described below.
Law-making Process
Consult the following resources when looking for information about the actually passing of a law. For example, what took place during debate about the law or when will the law be introduced to the House of Representatives or the Senate.
Congressional Record
The Congressional Record is the official record of the proceedings and debates of the United States Congress. It is published daily when Congress is session. It began publication in 1873 and is still in publication today. The Congressional Record consists of four sections:
Daily digest Summarizes the day's floor and committee activities and serves as a table of contents for each issue.House section Contain proceedings for the House chambers.Senate section Contain proceedings for the Senate chambers.Extension of remarks Includes tributes, statements and other information that supplements statements made on the Congressional floor.The FDsys contains Congressional Record volumes from 140 (1994) to present. The current year's Congressional Record is usually updated daily. The date of the publication refers to the date the proceedings were recorded. To browse the Congressional Record go to http://www.gpo.gov/fdsys/browse/collection.action?collectionCode=CREC.
Congressional Calendar
The Congressional Calendars collection includes the Calendars of the US House of Representatives and History of Legislation and the Senate Calendar of Business. The House Calendar contains a history of both House and Senate bills and resolutions that have been reported or considered by either house. The issue for the first legislative day of each week that the House is in session includes legislative history of bills through conference, and index of short titles, and index of major subject headings, and an alphabetical index. The Senate Calendar of Business identifies bills and resolutions awaiting Senate floor actions. It is updated each day the Senate is in session. To browse the Congressional Calendars visit http://www.gpo.gov/fdsys/browse/collection.action?collectionCode=CCAL.
The Laws
Once the laws have been passed, they can be found in the following forms.
Slip Laws
Public Laws are first printed as a slip laws. They can be found loose at Federal Reserve Libraries until the end of the year, when they are reprinted together as the Statutes at Large. They are referred to by their Public Law number (Pub. L. 113-4). GPO has the full text of Public Laws passed since the last Congress.
The Statutes at Large
The Statutes at Large (Stat.) is the official compilation of Federal Laws. It is published annually. It contains all laws, both public and private, passed in the United States. At the end of each congressional session, acts are printed into the Statutes at Large in the order in which they are printed in the statutes. The Statutes at Large present a chronological arrangement of the laws in the exact order that they have been enacted.
At the beginning of each volume there is a list of bills enacted into public laws, a list of public laws by number, a list of proclamations, a popular names index, and a subject index. Because the text of laws published as public laws and Statutes at Large are the same, there is not a Statutes at Large database on GPO. However, users may perform a search by Statutes at Large citation in both the public laws and US Code databases. The Statutes at Large can be found in Federal deposit libraries.
US Code
Every 6 years, public laws are incorporated into the United States Code. The United States Code is the codification by subject matter of the general and permanent laws of the United States based on what is printed in the Statutes at Large. It is divided by broad subjects into 50 titles and published by the Office of the Law Revision Counsel of the US House of Representatives. Of the 50 titles, only 23 have been enacted into positive (statutory) law. These titles are 1, 3, 4, 5, 9, 10, 11, 13, 14, 17, 18, 23, 28, 31, 32, 35, 36, 37, 38, 39, 44, 46, and 49. When a title of the Code was enacted into positive law, the text of the title became legal evidence of the law. Titles that have not been enacted into positive law are only prima facie evidence of the law. In that case, the Statutes at Large still govern.
The US Code also contains helpful indexes and tables. The General Index contains an alphabetical listing of useful subject headings. Entries are also listed under agency names. The US Code citation is given for each entry.
The US Code has nine tables found at the end of its volumes. A couple of particular interest is:
Table 1 – Revised Titles – This table lists all the sections of the titles that have been revised since the last printing.Table 3 – Statutes at Large – Here all the public laws currently in effect and there corresponding US Code citation is listed. Statutes are cited in the US Code as, Title U.S.C. section (subsection). For example, 21 U.S.C. Sec. 301 (a)A US Code Supplement is issued during each of the years between printings of the US Code. This contains additions to and changes in the general and permanent laws of the United States enacted during that Congress and session.
The US Code does not include regulations issued by executive branch agencies, decisions of the Federal courts, treaties, or laws enacted by State or local governments. Regulations issued by executive branch agencies are available in the Code of Federal Regulations (CFR). Proposed and recently adopted regulations may be found in the Federal Register (FR).
Since 1926, the US Code has been published every 6 years. In between editions, annual cumulative supplements are published in order to present the most current information.
When a section is affected by a law passed after a supplement's revision date, the header for that section includes a note that identifies the public law affecting it. In order to find the updated information, you must search the public laws databases for the referenced public law number. You may browse the US Code at http://www.gpo.gov/fdsys/browse/collectionUScode.action?collectionCode=USCODE.
You can search the US Code by subject or by citation. The GPO website contains the 1996–current year editions of the US Code. The List of CFR Sections Affected lists proposed, new, and amended Federal regulations that have been published in the Federal Register since the most recent revision date of a CFR title. Each LSA issue is cumulative and contains the CFR part and section numbers, a description of its status (e.g. amended, confirmed, revised), and the Federal Register page number where the change(s) may be found. The US Code on GPO website is the official version of the Code, however, two unofficial editions are available. These are the USCA (US Code Annotated) and the USCS (US Code Service). The USCA and USCS contain everything that is printed in the official US Code but also include annotations to case law relevant to the particular statute. While these unofficial versions may include annotations, they are not official and not available from the US Government Printing Office.
Code of Federal Regulations (CFR)
The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation. Each title is divided into chapters, which usually bear the name of the issuing agency. Each chapter is further subdivided into parts that cover specific regulatory areas. Large parts may be subdivided into subparts. All parts are organized in sections, and most citations in the CFR are provided at the section level. Titles 7 (Agriculture) and 21 (Food and Drug) contain most laws concerning food. Each volume of the Code of Federal Regulations is updated once each calendar year and is issued on a quarterly basis:
Titles 1–16 (includes Title 7, Agriculture) – 1 January Titles 17–27 (includes Title 21, Food and Drug) – 1 AprilTitles 28–41 – 1 JulyTitles 42–50 – 1 October.CFR volumes are added to FDsys concurrent with the release of the paper editions. When revised CFR volumes are added, the prior editions remain on FDsys as a historical set. FDsys currently titles from 1996 to present.
Due to the update schedule of the CFR, the List of Sections Affected (LSA) provides a cumulative list of CFR sections that have been changed at any time since each CFR title was last updated.
Code of Federal Regulations Citations
The FDsys provides the following description of how information is contained in a CFR citation.
Title: Is the numeric value to the left of “CFR”.Part: Is the numeric value to the right of “CFR” and preceding the period (“.”).Section/Subpart: Is the numeric value to the right of the period (“.”). A subpart is a letter of the alphabet (A-Z) that is used to retrieve an entire subpart of the CFR rather than many individual sections. For example: Subpart E.Revision Year: The four-digit year from the “Revised as of” text represents the year being cited. The revision year is not always available when the CFR is cited.The following example illustrates information contained in a CFR citation.
21 CFR 310.502 Revised as of April 1, 1997
Title: 21Part: 310Section: 502Year: 1997.Conventional Search Method
In order to find a specific law using printed copies:
Example Search
Online Search
You can search the United States Code, Federal Register, etc., using a similar process. Simply select your search choice in the “Available Collections” box. Many searches can be done by simply typing in keywords in the FDsys search box without having to do an advance search.
You can also browse through the different collections (US Code, Federal Register, Congressional Record, etc.) by selecting the specific reference from the ‘Featured Collections’ listing on the FDsys home page and then continuing to select the year and then other selections as needed until you reach the specific publication you desire to browse.
How Regulations are Made
After the bill becomes a law, the agency or department listed in the administrative provisions is responsible for enforcing the statute. In order to do this, the agency must make rules and regulations. Rules are typically administrative in nature, while regulations deal more with scientific and technical issues. They both carry the force of the law, which means that if a rule or regulation is broken, then the statute is broken. For the purpose of this discussion, the terms “rule” and “regulation” will be used interchangeably.
Regulations are made in the following manner:
A list of where in the Federal Register each step in this process is published can be found below.
The Rule-making Process and Publication
Example
An example of this process is the “Pathogen Reduction; Hazard Analysis Critical Control Point Systems Final Rule” published by the USDA. The public was first notified that the USDA was planning a new inspection system when the Advanced Notice for Proposed Rulemaking (ANPR) was published in the Federal Register of December 29, 1995 (60 FR 67469). This ANPR explained the regulation and requested comments from the public. There was an initial comment period of 120 days. The comment period was ultimately extended for 30 days, then reopened for another 95 days. During this time, seven informational briefings were held in seven cities around the United States to help interested parties prepare comments on the proposal. A panel of FSIS officials and scientists provided information on the proposed regulations and answered questions. All of this input assisted USDA in writing the final rule.
Anyone can comment on a proposal and your comments do make a difference. At regulations.gov (http://www.regulations.gov/#!home;tab=search) you can submit comments on proposed regulations and related documents published by the US Federal government. The website provides easy to follow instructions. The site also has links to regulations with comments due soon and newly posted regulations.
Code of Federal Regulations
All the final and interim regulations of the United States are compiled (or codified) into the Code of Federal Regulations (CFR). The CFR is updated yearly. The regulations are categorized into 50 titles. (Note: these are not the same titles as those in the US Code – that would be too easy!) These titles are subdivided into chapters, parts, sections and paragraphs. Regulations are referred to using those parts. An example citation for a regulation in the CFR is:
Titles of particular interest to Food Scientists are Title 9 – Animals and Animal Products and Title 21 – Food & Drugs. The CFR can be found on the internet at the FDsys website. The best way to become familiar with how these regulations are printed is to jump right in and look at them. Published along with the Code of Federal Regulations are the CFR Index and Finding Aids. These resources are available to help people find information located in the CFR. The CFR Index has appropriate CFR citations under subject headings and agency names.
Parallel Table of Authorities and Rules lists rulemaking authority for regulations codified in the CFR. It contains a section for US Code citations, US Statutes at Large citations, Public Law citations, and Presidential document citations. Within each segment the citations are arranged in numerical order.
A list of CFR Titles, Chapters, Subchapters, and Parts outlines what can be found in each section of the CFR. Each agency is listed alphabetically along with the CFR Title, Subtitle, or Chapter in which it is found.
The CFR also publishes a monthly publication, The List of CFR Sections Affected (LSA), which lists the sections of the CFR that have been changed by actions published in the Federal Register. This includes any new or proposed rules. Entries are by CFR title, chapter, part and section. The LSA should be consulted whenever looking for up-to-date regulations to ensure the CFR has not been changed. The Federal Register contains a cumulative List of Parts Affected. The page numbers to the right indicate where the specific amendments begin in the Federal Register. A table of Federal Register Issue Pages and Dates can be found at the back of the LSA.
Using the Code of Federal Regulations
In order to find a regulation in the Code of Federal Regulations:
Example
Searching the Code of Federal Regulations Using the Internet
The Code of Federal Regulations can be searched via the internet from the GPO FDsys website. Selected books and titles of the CFR, keywords, or citations can be used to search the record.
You can also do a simple search at the FDsys website by typing HACCP into the search box on the home page of FDsys. You will probably need to refine your results by choosing “Code of Federal Regulations” from the “Narrow your Search” tool in the left column of your results.
References
Auburn University Library (2011) What's the difference between Google and Library Databases? Video. [Online] Available: http://www.lib.auburn.edu/aubieasks/ [December 12, 2012]
Ferguson, J.H. & McHenry, D.E. (1969) The American System of Government. New York: McGraw-Hill Book Company.
Friedman, L.M. (1984) American Law. New York: W.W. Norton and Company.
Hardy, R.J. (1994) Government in America. Boston: Houghton Mifflin Company.
Hill, R. (2011) Locating the Law. Public Access to Legal Information Committee. [Online] http://www.aallnet.org/chapter/scall/locating.htm (accessed December 12, 2012).
‘The Constitution of the United States of America.’ [Online] http://www.whitehouse.gov/our-government/the-constitution (accessed December 12, 2012).
US Courts (2012) US Courts website. [Online] http://www.uscourts.gov/Home.aspx (accessed December 12, 2012).
US Department of State (2008) ‘The Legislative Branch: The Reach of Congress,’ Outline of Government, [Online], Available: http://www.america.gov/st/usg-english/2008/May/20080624220626eaifas0.5616876.html (accessed December 12, 2012).
US House of Representatives (2012) US House of Representatives website. [Online] http://www.house.gov (accessed December 12, 2012).
US Senate (2012) US Senate website. [Online] http://www.senate.gov (accessed December 12, 2012).
White House (2012) The White House website. [Online] http://www.whitehouse.gov (accessed December 12, 2012).
Additional Resources
Federal Register. 2012. Innovation Gallery, Creating Federal Register 2.0. Video. Last viewed December 12, 2012 http://www.youtube.com/watch?v=U5k50B5KXmc&playnext=1&list=PLEC0942EDC79CC321&feature=results_main
Government Printing Office. 2009. US Government Printing Office: The Congressional Record on 100% Recycled Paper. Video. Last viewed December 12, 2012 http://www.youtube.com/watch?v=Ib754Rp4i8k
Government Printing Office. 2010. US Government Printing Office: Federal Register 2.0. Video. Last viewed December 12, 2012 http://www.youtube.com/watch?v=ADhP0KSmjkQ&list=UUR4mVtuCP3AJWgSofFCydag&index=18&feature=plcp
Government Printing Office. 2012. US Government Printing Office: Official. Digital. Secure. Video. Last viewed December 12, 2012 http://www.youtube.com/watch?v=oPekAxvEnhY
Government Printing Office 2008. History of the Government Printing Office. Video. Last viewed December 12, 2012 http://www.youtube.com/watch?v=aarQl3xAysw
Government Printing Office. 2008. US Government Printing Office: Working with Libraries. Video. Last viewed December 12, 2012 http://www.youtube.com/watch?v=KRSalwvVSnA
Hayes, David. 2012. Laws Aplenty: Code of Federal Regulations. Video. Last viewed December 12, 2012 http://www.youtube.com/watch?v=5AcVbO4I7Bo
John Marshall Law School. 2012. How to Use US Government Websites to Research Federal Regulations. Video. Last viewed December 12, 2012 http://www.youtube.com/watch?v=PKW_19KxKcc
John Marshall Law School. 2012. How to Use the FDSys to Research Federal Regulations. Video. Last viewed December 12, 2012 http://www.youtube.com/watch?v=YGGEBeSlaLQ
John Marshall Law School. 2012. How to Use the Online Code of Federal Regulations (eCFR) to Research Federal Regulations. Video. Last viewed December 12, 2012 http://www.youtube.com/watch?v=GOheBZaWiec
McClanahan, B. 2012. The Founding Fathers Guide to the Constitution. Video overviewing the book. Last viewed December 12, 2012 http://www.c-spanclassroom.org/Video/1292/The+Founding+Fathers+Guide+to+the+Constitution.aspx
US Courts. Impartial Judiciary. Video. Last viewed December 12, 2012 http://www.uscourts.gov/Multimedia/Videos.aspx?video_url=http://www.uscourts.gov/video/source/EducationalResources/outreach_cs-impartial-judiciary_low.f4v&video_image=/uscourts/video/EducationalResources/CS_Impartial_Judiciary_preview.jpg&video_id=cs_ij
US Courts. Jury Service. Video. Last viewed December 12, 2012 http://www.uscourts.gov/Multimedia/Videos.aspx?video_url=http://www.uscourts.gov/video/source/EducationalResources/outreach_cs-jury-service_low.f4v&video_image=/uscourts/video/EducationalResources/CS_Jury_Service_preview.jpg&video_id=cs_js
US House of Representatives. Watch Live House Floor Proceedings. Streaming video. Last viewed December 12, 2012 http://houselive.gov/MediaPlayer.php?view_id=23&event_id=2
US Senate. US Capitol Virtual Tour: A ‘Capitol’ Experience. Photographs and text. Last viewed December 12, 2012 http://www.senate.gov/vtour/index.html
US Senate. Virtual Reference Desk. Last viewed December 12, 2012 http://www.senate.gov/pagelayout/reference/b_three_sections_with_teasers/virtual.htm
White House. The Cabinet. Video. Last viewed December 12, 2012 http://www.whitehouse.gov/videos/2009/December/121109_ITWH_Cabinet.mp4
White House. The Situation Room. Video. Last viewed December 12, 2012 http://www.whitehouse.gov/videos/2009/December/121809_SitRoom.mp4
1http://www.youtube.com/watch?v=PKW_19KxKcc&list=UUX9qoSvd_ePtVDuC60ot7jQ&index=7
2http://www.youtube.com/watch?v=YGGEBeSlaLQ&list=UUX9qoSvd_ePtVDuC60ot7jQ&index=6
3http://www.youtube.com/watch?v=GOheBZaWiec&list=UUX9qoSvd_ePtVDuC60ot7jQ&index=5
Chapter 2
HOW DID WE GET WHERE WE ARE TODAY?
Patricia A. Curtis,a Emily L. Steinberg,b Michelle A. Parisi,c and Julie K. Northcuttb
a Auburn University Food Systems Institute, Auburn, AL, USA
b Department of Food, Nutrition and Packaging Sciences, Clemson University, Clemson, SC, USA
c Department of Human Nutrition, Winthrop University, Rock Hill, SC, USA
Introduction
Throughout history there have been food laws. For example, ancient Samarians had a statute that required innkeepers to give their customers the proper amount of beer or ‘her’ hand would be cut off. The Bible contains many references to food and food laws. The majority of these laws were passed down from Moses and are the basis for kosher foods in the Jewish faith. These laws dealt with clean versus unclean animals, and prohibited practices. They also addressed the use of just balances and weights in the marketplace.
The adulteration of food was also addressed in many treatises in ancient times. For example, Theophrastus (370–285 BCE) wrote the botanical treatise Enquiry Into Plants. This work discussed the use of artificial preservatives and flavors such as balsam gum that were added to many foods for economic reasons. Caveat emptor or “the buyer beware” was the idea behind Roman civil law. The penalty for selling adulterated food in Rome in 400 CE was banishment from Rome or slavery. In the 1600s, London had laws in place against food adulterations and local guilds enforced their own rules regarding unfair practices. In more recent European history, there were many treatises written about food adulteration. One German treatise written in 1820 taught housewives how to test their food for adulteration and became a best seller.
Reasons for Food Laws
Food laws have evolved for a variety of reasons, including:
Ensuring that consumers get what they pay forEnsuring that the food is safeFor religious beliefs.The first two reasons listed above deal with the concepts of “adulteration” and “misbranding.” Adulteration and misbranding are strictly defined in American food laws. According to TheBlack's Law Dictionary (1979, p. 47), adulteration is:
The act of corrupting or debasing. The act of mixing something impure or spurious with something pure or genuine, or an inferior article with a superior one of the same kind. The term is generally applied to the act of mixing up with food or drink intended to be sold other matters of an inferior quality, and usually a more or less deleterious quality. The act, process or omission to act whereby food becomes impure and unfit for consumption. Such is prohibited and regulated by federal and state statutes and agencies.
In the spring of 2007 there were reports of companion animal illness and death linked to pet foods with ingredients imported from China and melamine. The Food Emergency Response Network labs identified melamine and cyanuric acid as the hazardous adulterants. The melamine and cyanuric acid adulterations are examples of intentional adulteration. The Food Safety and Inspection Service (FSIS) will consider ground beef adulterated if it contains Escherichia coli O157:H7. The adulteration would be unintentional, but it is still adulterated.
When the adulterant does not actually physically harm someone, but cheats him or her out of his or her money, this is called ‘economic adulteration.’ Examples include adding water to wine or milk, ash to pepper, and chalk to bread. Adding dyes to conceal inferior ingredients is also considered adulteration. A more recent example of economic adulteration would be the addition of corn sweetener to honey.
Misbranding is the use of false or misleading labeling. All of the American food laws are based on prohibiting these two activities – adulteration and misbranding.
American Food Laws
Food laws were very slow to be developed in the United States. The earliest ‘type’ of food laws to be established in the colonies were actually food standards set by trade guilds (bakers, fruiterers, butchers, etc.). These guilds set up quality standards to ensure they had a strong market with returning customers (it is hard to generate repeat business if you poison your customers). People in the trade guild who were caught adding adulterants to foods and selling them cheap were quickly removed from the trade guild and forced out of business by the “community”. Some were even exiled for “misleading” customers. After the United States gained its independence from the United Kingdom, Congress was very protective of states' rights and was resistant to passing any federal food laws that infringed upon individual state commerce. Thus, the first food laws to be established in the United States were primarily enacted by individual states and did not cover goods shipped from one state to another.
The first food laws and regulations in the United States were loosely based on regulations in England. The first general law against food adulteration in the United States was enacted by Massachusetts in 1784, but Wallace F. Janssen (1975), the noted historian of the FDA, records that as far back as 1630 the Massachusetts Bay Colony sentenced one Nicholas Knopf to pay a fine or be whipped for selling “a water of no worth nor value” as a cure for scurvy. Gradually, other states passed a variety of food and drug statutes, but as the country expanded it became clear that a national law was needed (Burkholz 1994, p. 7). The Massachusetts Bay Colony passed a food adulteration law in 1641 that established inspection of beef, pork and fish (Hull 2011, p. 2). The first colonial Assize of Bread enacted in 1646 (Berneking 1997, p. 40). This assize was almost identical to the English Assize, and required bakers to label their bread and set required weights for three qualities of bread. In addition, each town was required to have two bread inspectors to ensure that the bakers were obeying the law.
In 1820, the US Pharmacopeia was founded and was established as a scientific organization for improving the health of people around the world through public health standards. At the first convention in 1820, all the state societies of medicine were invited to send delegates to the meeting; however, only 11 states sent representatives. At this meeting, medical experts created a set of standards, a system of quality control and a national formulary. This organization has grown into a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. Their drug standards are enforceable in the US by the FDA, and these standards are developed and trusted in over 130 countries. (USP 2012).
From 1846 to 1848, the United States was at war with Mexico. Nearly 85% of the 13 000 casualties during this war were due to disease. This sizeable death rate was attributed to the poor quality of food and medicines within the Army. Many of the medicines were imported from other countries and/or included items banned by other countries. Thus, the quality issues were not just occurring in the Army. In fact, Dr. M.J. Bailey, the New York port inspector, stated that a medicine known as Peruvian Bark was so contaminated that it needed to be dispensed at a much higher dose than normal. This, among several other issues dealing with adulterated medicine, led President James K. Polk to sign the Drug Importation Act of 1848. This law only affected imported drugs and there was no stipulation for substandard domestic drugs. This law stated that drugs needed to be inspected prior to admission into the United States (Worthen 2006).
President Abraham Lincoln established the USDA in 1862 and appointed Charles M. Wetherill to be the Chief Chemist in the USDA's Division of Chemistry (later the Bureau of Chemistry and much later the FDA). The Division of Chemistry began investigating food adulterants in 1867. As the United States became increasingly more urban and industrialized, fewer people grew their own food. Therefore, marketplaces were developed where they could purchase the food they needed. As more food was produced to meet demand, adulteration became a greater problem. Increases in technological knowledge led to many new ingredients and products, many of which were unsafe. Thus, not only was economic adulteration a problem, but adulteration leading to unsafe products increased as well. While most states had regulations in place to deal with adulteration, they did not apply to products going through interstate commerce. According to TheBlack's Law Dictionary (1979, p. 735), interstate commerce is defined as:
Traffic, intercourse, commercial trading, or the transportation of persons or property between or among the several states of the Union, or from or between points in another state; commerce between two states; or between places lying in different states.
In 1880 the chief chemist of the USDA, Peter Collier, recommended the enactment of a national food and drug law. Congress was reluctant to comply, however, because many Americans felt that food regulation was a state issue and the federal government did not have the right to legislate this type of law (FDA 2010). The federal agencies (executive branch) such as USDA can do nothing to directly regulate the food industry until Congress (legislative branch) authorizes the agency to do so. And this is still true today because this is the type of government our ancestors established when they adopted the US Constitution in the late 1700s. Without Congressional authorization, the only step government agency personnel can take is to recommend that Congress address the problem (Saxowsky 2012).
Food legislation in the United States was to some extent anticipated in 1848 by an Act of Congress to secure the purity of imported drugs. In 1877, several State Boards of Health (New York, Massachusetts, Michigan, and New Jersey) formulated laws against adulteration. These State Boards of Health then begin to publish statistics about adulteration in the food supply. The New York State Board of Health statistics can be seen in Tables 2.1 and 2.2. The data was from studies conducted in 1882 to determine the level of adulteration in New York. There were some problems with enforcement of the laws due to the lack of explicit detail in the law. It was far easier to substantiate the fact of the adulteration than it was to produce the offender in court and secure his conviction (Battershall 1887, p. 7). The problem with state enacted laws is the variation in laws between states.
Table 2.1 Level of adulteration in New York in 1882
Table 2.2 Common food adulterants in 1887
Food articleCommon adulterantsBaker's chemicalsStarch, alumBread and flourOther meals, alumButterWater, coloring matter, oleomargarine, and other fatsCanned foodsMetallic poisonsCheeseLard, oleomargarine, cottonseed oil, metallic salts (in rind)Cocoa and chocolateSugar, starch, flourCoffeeChicory, peas, rye, corn, colouring mattersConfectioneryStarch-sugar, starch, artificial essences, poisonous pigments, terra alba, plaster of ParisHoneyGlucose syrup, cane sugarMalt liquor
