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“FDA is not and, by the construction of this government, cannot be authorized to determine its own jurisdiction. It must operate within the bounds of the administrative structure authorized by the legislative power harmonious with the limited, delegated powers identified in our constitutional system.”


June 7, 2010
RE: FDA-2010-N-0085
To Whom it may concern:
This document is submitted by:

National Organization for Raw Materials (NORM, http://www.normeconomics.org)

and:  See list below for names of those submitting)


This comment seeks to inform the development of an FDA regulation establishing “safety standards for fresh produce at the farm and packing house” and sanctions for non-compliance. In doing so, it rebuts the jurisdictional presumption through which, under the guise of “food safety,” FDA seeks to vastly exceed the reach of its federal regulatory sphere of action.

Federal executive regulatory power is seated in and restricted to the delegations specified within the Constitution. As stated in Art. I, §8, cl. 18, “Congress shall have power to make all laws which shall be necessary and proper for carrying into execution the foregoing powers, and all other powers vested by this Constitution in the government of the United States, or in any department or officer thereof.” Regulatory jurisdiction statutorily delegated to any agency cannot exceed the jurisdiction of the legislative authority as constitutionally specified.

Regulatory powers or authorities are exercised according to the rules or orders issued by federal agencies according to jurisdiction delegated to that agency through authorizing legislation. 5 U.S.C. § 58(b),

“A sanction may not be imposed or a substantive rule or order issued except within jurisdiction delegated to the agency and as authorized by law.”

The Federal Food, Drug and Cosmetic Act (FFDCA) provides administrative authority for prohibiting “[t]he introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded.” 21 U.S.C. §331(a).

The Public Health Services Act (PHSA) provides administrative authority to “prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession.” 42 U.S.C. §264(a).

Both of the above statutes, FFDCA and PHSA, delegated authority specifying the proper scope of regulatory action as concerning the relations between and among the States, not within any State unless a federal enclave exists such as a “port of entry” over which federal jurisdiction would fall (Art. I, §8, cl. 17).

For example, 21 C.F.R., §1.83, provides as follows: “The term ‘district director’ means the director of the district of the Food and Drug Administration having jurisdiction over the port of entry through which an article is imported or offered for import.”

From 1976 until 1997 the FFDCA jurisdictional presumption of a connection with interstate commerce (21 U.S.C. §379a) applied to “a device,” not “a device, food, drug, or cosmetic.” The 1997 amending language could not have expanded the fundamental delegated legislative jurisdictional authority. It could only have expanded the items to which such regulations may apply, not the situs for regulatory application. The jurisdictional presumption of §379a is thus rebutted and the burden rests upon the regulating agency to prove intent to engage in interstate commerce in order to apply any regulatory sanction within a State.

The PHSA statement authorizing “necessary” agency created rules and regulations for protection against “communicable diseases” moving “from one state…into any other state” explicitly recognizes the existence of governing bodies called “States.” It also implies geographical areas within which those States have their own authority and sphere of action. Otherwise there would be no “from one…into another” relationship.

If it be claimed by a federal entity that constitutionally harmonious acts taken pursuant to the federally delegated power to regulate commerce among the States can, with impunity, operate within rather than among those States, then by that claim those States are made internally incompetent and obsolete on that point of authority, negating their existence by usurpation to the federal regime, contrary to the 10th Amendment guarantee.

This would shred the historical construction of the federal level, again negating the initial competency required for establishing federal power. The created would become greater than its creator, an impossibility according to God’s lessons. Either the States are competent agents of their own populations, each with their own original and exclusive jurisdiction, while the federal level may needfully regulate the commercial relations among them, or the States are superfluous and redundant hurdles to federal hegemony. Asserting a “middle ground” on this point would only illuminate the wellspring of the truths written into our Independence


FDA is not and, by the construction of this government, cannot be authorized to determine its own jurisdiction. It must operate within the bounds of the administrative structure authorized by the legislative power harmonious with the limited, delegated powers identified in our constitutional system. Belief and possibility may rationalize the desire of the usurper to “do good,” but knowledge of and healthy regard for the principles of our self-government must eventually increase our respect for mutual human dignity and illuminate the goals of our endeavor in liberty.

Declaration of, the genesis of our own revolution.


Signatures of those submitting rebuttal to FDA presumptions:

Randy Cook, Michigan,

Paul Griepentrog, Wisconsin,

Randy Yarbrough, Colorado,

Derald Hafner, North Carolina,

Thayne Cozart, Kansas,

Joe McCray, Oklahoma,

Tom Asbridge, North Dakota,

Zane Reese, Texas,

Michael Barosso, California,

David Garton, Tennessee,

Wendel Lutz, Illinois,

Eric Witte, et al., interested parties.