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Interaction between Statute and Regulation

Regulations promulgated by agencies of the executive branch of government must align with the underlying statute. This page provides an example of a statute enacted in 2002 and the subsequent steps taken by the Food and Drug Administration in promulgating regulations over the next several years.

 

This page illustrates the interaction between a Congressional statute and an agency regulation by providing an example of Congress enacting a statute that sets a policy direction and instructs an agency to implement/execute the new law. The agency subsequently responded by promulgating a regulation that details how the Congressional objective will be achieved. The example describes the interaction as a series of steps.

 

Step 1. Congress enacts legislation that sets a policy direction and instructs FDA to devise procedures in a regulation. This example is an excerpt from the Public Health Security and  Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-188). (This is a large site that may take a few moments to download.)

Example: SEC. 303. ADMINISTRATIVE DETENTION.

(a) EXPANDED AUTHORITY.-Section 304 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334) is amended by adding at the end the following subsection:

''(h) ADMINISTRATIVE DETENTION OF FOODS.-

''(1) DETENTION AUTHORITY.-

''(A) IN GENERAL.-An officer or qualified employee of the Food and Drug Administration may order the detention, in accordance with this subsection, of any article of food that is found during an inspection, examination, or investigation under this Act conducted by such officer or qualified employee, if the officer or qualified employee has credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals.

''(B) SECRETARY'S APPROVAL.-An article of food may be ordered detained under subparagraph (A) only if the Secretary or an official designated by the Secretary approves the order. An official may not be so designated unless the official is the director of the district under this Act in which the article involved is located, or is an official senior to such director.

''(2) PERIOD OF DETENTION.-An article of food may be detained under paragraph (1) for a reasonable period, not to exceed 20 days, unless a greater period, not to exceed 30 days, is necessary, to enable the Secretary to institute an action under subsection (a) or section 302. The Secretary shall by regulation provide for procedures [emphasis added] for instituting such action on an expedited basis with respect to perishable foods.

Found on pages 71-72 of Act

Source:   http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=107_cong_public_laws&docid=f:publ188.107.pdf

 

Step 2. This statute was codified in the U.S. Code at 21 U.S.C. §334(h).

Source: http://www4.law.cornell.edu/uscode/html/uscode21/usc_sec_21_00000334----000-.html

 

Optional Step.  The agency may decide to provide "Advance notice of proposed rulemaking; invitation to comment."

Example: July 17, 2002

"The purpose of this letter is: (1) to give you an overview of the four provisions in Title III, Subtitle A (Protection of the Food Supply), which require the Food and Drug Administration (FDA) to issue regulations in an expedited time period; (2) to inform you how the Department and FDA will be proceeding; and (3) to solicit comment on areas of concern to you and suggestions for how best to communicate those concerns to us.

"We also are committed to receiving and considering the input from stakeholders as we develop the proposed and final regulations. Before issuing these proposed rules, FDA will seek to identify stakeholders' concerns and potential options for addressing them."

 

Step 3. FDA proposes a regulation by publishing it in the Federal Register and announcing a comment period.

Example: May 9, 2003 (68 FR 25242)

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1 and 16

Administrative Detention of Food for Human or Animal Consumption Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of proposed rulemaking.

SUMMARY: The Food and Drug Administration (FDA) is proposing a regulation that provides procedures for the detention of an article of food, if an officer or qualified employee of FDA has credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals (''administrative detention''). The proposed regulation implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which authorizes the use of administrative detentions and requires regulations establishing procedures for instituting on an expedited basis certain enforcement actions against perishable food subject to a detention order.

DATES: Submit written or electronic comments by July 8, 2003.

Source:  http://frwebgate.access.gpo.gov/cgi-bin/getpage.cgi?position=all&page=25242&dbname=2003_register

 

Step 3A.  Opportunity for Public Comment.  Any interested person can review the proposed regulation and submit comments to the agency; the comment submitting process is described in the proposed regulation.  There also is opportunity to provide public comment by participating in a hearing held by the agency for the purpose of receiving comments on the proposed regulation.  This step is an opportunity for the public to influence the executive branch of government as it creates its laws, that is, as the agency promulgates regulations.

 

Step 4. FDA reviews the public comments and revises the proposed regulation.  The agency then promulgates the regulation in its final form by publishing the revised regulation and specifying the date the regulation will take effect.

Example: June 4, 2004 (69 FR 31660)

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 10, and 16

Administrative Detention of Food for Human or Animal Consumption Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Final Rule

ACTION: Final rule.

SUMMARY: The Food and Drug Administration (FDA) is issuing a final regulation that provides procedures for the detention of an article of food , if an officer or qualified employee of FDA has credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals (``administrative detention''). The final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which authorizes the use of administrative detention and requires regulations establishing procedures for instituting on an expedited basis certain enforcement actions against perishable food subject to a detention order.

DATES: This rule is effective July 6, 2004.

Source:   http://frwebgate.access.gpo.gov/cgi-bin/getpage.cgi?position=all&page=31660&dbname=2004_register

  • Note the 160 comments from the public and responses from FDA that appear on pages 31660 to 31700 of the Federal Register.  The final regulation begins on page 31701.

 

Step 5. This final regulation was then codified in the Code of Federal Regulations in 21 CFR parts 1, 10 and 16. For example, a new Subpart K was added to part 1 of Title 21 of the CFR; see 21 CFR 1.377 to 1.406

 

Summary

The purpose of this web page was to illustrate the interaction between a Congressional act (i.e., a statute) and the promulgation of regulations by an agency of the Executive branch as a step in implementing the Congressional act.

The key concepts include 1) the Executive branch can do no more than the Congress authorizes it to do and the Executive branch must do what the Congress mandates, and 2) the public is provided an opportunity to comment on regulations proposed by an agency of the Executive branch.

 

Email David.Saxowsky@ndsu.edu

This material is intended for educational purposes only. It is not a substitute for competent legal counsel. Seek appropriate professional advice for answers to your specific questions.

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