To make best use of this unit, please read the information in all boxes, referring to the definitions box as necessary.
Complete the activities in orange type in the Activity box below, and then come back to this box and answer the questions below.
At the end of this lesson, you should be able to:
Administrative Procedures Act (APA)
Federal statute governing the process agencies must follow to make regulations. Pub.L. 79–404, 60 Stat. 237, enacted June 11, 1946.
Code of Federal Regulations (CFR)
Official publication and source of Federal regulations that are general/permanent. Divided into 50 numbered "Titles," each of which represents a subject of regulation.
Enabling Legislation, or Organic Statute
The Federal (Congressional) statute that gives an agency authority to promulgate regulations. An authority statement accompanies every regulation or group of regulations. Look to the beginning of the Suppart, Part, or Subchapter, if you don't find one listed at the end of the regulation itself.
Abbreviation for Federal Digital System, the online access to the U.S. government's publications. Run by the Government Publishing Office (GPO), FDsys is the system used both by Government offices to produce documents, and by the public to gain access to these documents. More information here.
Federal Register (FR or Fed. Reg.)
Official publication of the executive branch of the Federal government. Official source for Federal rulemaking, including notices of proposed rulemaking and final rules, and Executive Orders. Published by GPO, under the direction of the Office of the Federal Register at NARA.
Notice of Proposed Rulemaking (NPR)
Required by the APA, this notifies the public and other governmental bodies that the agency intends to promulgate a new regulation.
To promote or put into effect, this is the verb applied to the action of creating a new rule or regulation (laws are enacted or passed; rules are promulgated).
These are equivalent terms for a body of law created by the Federal agencies, to comply with Congressional directives (i.e., the enabling legislation).
Regulations.gov - Source for tracking rules through the regulatory process, including digital files of public comments.
FDsys - Code of Federal Regulations (2014) - Browse and view or download by Part or Chapter. Food and Drug regulations are in Title 21.
e-CFR - GPO-produced but not official version of the CFR that incorporates changes into the text on an ongoing basis.
FDsys - Federal Register - Browse and view or download by day or page range. Published every business day, reporting on proposed and final rules from Federal agencies, as well as Executive Orders from the office of POTUS.
To cite regulations, use the Name of the regulation, and the title and Part or section.
In any regulatory problem, a host of additional resources may be available to you in the form of:
Legal Research in a Nutshell, Ch. 6, pp. 161-185.
On LexisNexis or Westlaw, retrieve section 101.9 in Title 21 of the Code of Federal Regulations (CFR).
On FDsys, browse to section 101.9.
Regulations, also known as rules, are made by agencies (FCC, EPA, etc.) in accordance with an enabling statute passed by Congress. Congress passes a law outlining an area broadly, and the agency is charged with implementing the legislation by making specific rules and enforcing any violations.
Regulations are published in the Federal Register when they're at the draft "proposed" stage, and again when they're final. The Administrative Procedure Act requires that agencies publicize a proposed rule and allow time for the public to comment before making it final. Publication in the Federal Register satisfies this "notice and comment" requirement.
Final regulations are assembled into a subject-based code, which is used to see what the current regulations are on a given industry or topic. This is the Code of Federal Regulations, and the subject divisions are called Titles (like the U.S. Code).
21 U.S.C. § 321. Definitions.
For the purposes of this chapter--
...(c) The term “Department” means Department of Health and Human Services.
(d) The term “Secretary” means the Secretary of Health and Human Services....
21 U.S.C. § 341. Definitions and standards for food
Whenever in the judgment of the Secretary such action will promote honesty and fair dealing in the interest of consumers, he shall promulgate regulations fixing and establishing for any food, under its common or usual name so far as practicable, a reasonable definition and standard of identity, a reasonable standard of quality, or reasonable standards of fill of container....
21 U.S.C. § 371. Regulations and hearings
(a) Authority to promulgate regulations.
The authority to promulgate regulations for the efficient enforcement of this chapter, except as otherwise provided in this section, is vested in the Secretary....
21 CFR Part 101 - Food Labeling
§ 101.9 Nutrition labeling of food
...(d)(1) Nutrient information specified in paragraph (c) of this section shall be presented on foods in the following format, as shown in paragraph (d)(12) of this section, except on foods on which dual columns of nutrition information are declared as provided for in paragraph (e) of this section, on those food products on which the simplified format is required to be used as provided for in paragraph (f) of this section, on foods for infants and children less than 4 years of age as provided for in paragraph (j)(5) of this section, and on foods in small or intermediate-sized packages as provided for in paragraph (j)(13) of this section. In the interest of uniformity of presentation, FDA urges that the nutrition information be presented using the graphic specifications set forth in Appendix B to part 101.
(i) The nutrition information shall be set off in a box by use of hairlines and shall be all black or one color type, printed on a white or other neutral contrasting background whenever practical.
(ii) All information within the nutrition label shall utilize:
(A) Except as provided for in paragraph (c)(2)(ii) of this section, a single easy-to-read type style,
(B) Upper and lower case letters,
(C) At least one point leading (i.e. space between two lines of text), except that at least four points leading shall be utilized for the information required by paragraphs (d)(7) and (d)(8) of this section as shown in paragraph (d)(12), and,
(D) Letters should never touch.
(iii) Information required in paragraphs (d)(3), (d)(5), (d)(7) and (d)(8) of this section shall be in type size no smaller than 8 point. Except for the heading "Nutrition Facts," the information required in paragraphs (d)(4), (d)(6), and (d)(9) of this section and all other information contained within the nutrition label shall be in type size no smaller than 6 point. When provided, the information described in paragraph (d)(10) of this section shall also be in type no smaller than 6 point....