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Interaction Between a Statute and a Regulation

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 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 US 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 4. FDA promulgates the final regulation 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.

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