Our Thanks to Ben Garrison for this view of the Swamp.
By Larry Becraft JD and Ralph Fucetola JD
The “Swamp” – the convoluted corridors and moss-hung byways of the Federal Bureaucracy – holds our freedoms in its clawed grasp through impossibly complex rules and regulations. While at one time the idea that “Ignorance of the law is no excuse.” may have had some validity, when the rules become too voluminous for any human mind to comprehend, such old legal concepts can only serve tyranny.
The Swamp wants to know everything about each of us. Does the law allow that?
Congress in its sometimes wisdom seeks, in fits and starts, to rein-in the powers of the bureaucracy. One such act was the Paperwork Reduction Act (PRA) of 1980. [1] This law restricts the Swamp’s capacity to demand information from us. It says that Americans are free to ignore Federal Government “Collection of Information” unless the request has an Office of Management and Budget (OMB) control number on it.
What is a “Collection of Information” request? The Code of Federal Regulations (CFR) tells us, in 5 C.F.R. §1320.3(c)
(c) Collection of information means, except as provided in § 1320.4, the obtaining, causing to be obtained, soliciting, or requiring the disclosure to an agency, third parties or the public of information by or for an agency by means of identical questions posed to, or identical reporting, recordkeeping, or disclosure requirements imposed on, ten or more persons, whether such collection of information is mandatory, voluntary, or required to obtain or retain a benefit.
In the past when the authors have studied FDA Regulations in 21 CFR, we were impressed by the lack of compliance with the PRA which requires those OMB control numbers. Most lawyers who think about these matters believe that such numbers apply only to formal information collection forms, but all the FDA’s Regulations themselves are also subject to the PRA. For example, the FDA shows the assignment of OMB numbers for Regulations by this method:
(Information collection requirements contained
in paragraphs (e) and (f) were approved
by the Office of Management and
Budget under control number 0910–0257)
The problem the FDA bureaucracy has is that there are lots of Regulations that are clearly subject to the PRA for which the FDA – and other Swamp Agencies — do not bother to get OMB numbers.
There are also many FDA Regulations that plainly mandate information be submitted to the FDA, and thus these Regulations are subject to the PRA and must “display” OMB control numbers. Any form or Regulation that lacks an OMB control number can be “ignored with impunity.”
Let’s repeat that: the law clearly lets Americans “ignore with impunity” any Federal Government request for information that lacks an OMB control number.
FDA knows that. Below is a list of all FDA Regulations that do have OMB control numbers (21 CFR).
§ 100.1 Petitions requesting exemption from preemption for State or local requirements.
§ 100.2 State enforcement of Federal regulations.
§ 101.108 Temporary exemptions for purposes of conducting authorized food labeling experiments.
§ 170.35 Affirmation of generally recognized as safe (GRAS) status.
§ 201.21 Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use.
§ 205.5 Minimum required information for licensure.
§ 205.50 Minimum requirements for the storage and handling of prescription drugs and for the establishment and maintenance of prescription drug distribution records
§ 211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.
§ 211.194 Laboratory records.
§ 225.202 Formula, production, and distribution records.
§ 314.81 Other post-marketing reports.
§ 341.76 Labeling of bronchodilator drug products.
§ 357.152 Package inserts for anthelmintic drug products.
§ 500.86 Marker residue and target tissue.
§ 500.88 Regulatory method.
§ 500.90 Waiver of requirements.
§ 700.25 Tamper-resistant packaging requirements for cosmetic products.
§ 720.4 Information requested about cosmetic products.
§ 800.12 Contact lens solutions and tablets; tamper-resistant packaging.
§ 801.430 User labeling for menstrual tampons.
§ 807.87 Information required in a premarket notification submission.
§ 814.15 Research conducted outside the United States.
§ 814.82 Post-approval requirements.
§ 1040.10 Laser products.
That’s a couple dozen Information Collection requests. There are however, thousands of FDA (and other agency) Regulations that do not have OMB control numbers.
The Courts understand this problem, which the politicians and the bureaucrats hope to ignore. These two cases show how the Courts respond to the lack of OMB control numbers.
In United States vs Smith [2] the issue was Government collection of information about a mining claim. Here is a summary of what the Court said:
Appellants argue that the Paperwork Reduction Act of 1980 (“PRA”) prohibits their prosecutions because the Plan of Operations filing requirement lacks a current control number, and appear to raise an issue of first impression in this circuit.
The PRA was enacted “to reduce and minimize the burden Government paperwork imposes on the public.” S.Rep. No. 930, 96th Cong., 2d Sess. 2 (1980), reprinted in 1980 U.S.Code Cong. & Admin.News 6241, 6242. The PRA requires all agencies to submit all “information collection requests” to the Director (the “Director”) of the Office of Management and Budget (“OMB”) for review and approval. See 44 U.S.C. Sec. 3507. If the Director approves the information collection request he must ensure that it contains a control number. See 44 U.S.C. Sec. 3504.
An agency “shall not conduct or sponsor the collection of information unless” the information collection request has been submitted to and approved by the Director, see 44 U.S.C. Sec. 3507(a), and “shall not engage in a collection of information without obtaining from the Director a control number to be displayed upon the information collection request,” see 44 U.S.C. Sec. 3507(f).
“Information collection requests which do not display a current control number or, if not, indicate why not are to be considered ‘bootleg’ requests and [under PRA section 3512] may be ignored by the public.” S.Rep. No. 96-930 at 52, reprinted in 1980 U.S. Code Cong & Admin. News 6292; see 44 U.S.C. Sec. 3512 (penalties may not be imposed for noncompliance with information collection requests that do not display a current control number). [Emphasis added.]
In United States vs Hatch [3] another mining claim was at stake. The summary of the case states:
The purposes of the PRA include minimizing the federal paperwork burden on individuals, minimizing the cost to the federal government of collecting and using information, and maximizing the usefulness of information collected. 44 U.S.C. Sec. 3501.
To these ends, the PRA mandates that an agency shall obtain approval from the Director of the Office of Management and Budget before making an information collection request. 44 U.S.C. Sec. 3507(a). “An agency shall not engage in a collection of information without obtaining from the Director a control number to be displayed upon the information collection request.” 44 U.S.C. Sec. 3507(f).
In its “Public protection” provision, the Act provides that
‘[n]otwithstanding any other provision of law, no person shall be subject to any penalty for failing to maintain or provide information to any agency if the information collection request involved was made after December 31, 1981, and does not display a current control number assigned by the Director, or fails to state that such request is not subject to this chapter.’ [Emphasis added.]
This is powerful language that tells us the Government’s power to collect information is limited.
We know of a number of Constitutional limits on that power. They are set forth in several Amendments to that fundamental law, namely the First, Fourth, Fifth and Fourteenth Amendments among other sections.
But in addition to those Constitutional limits, the governing procedures of the bureaucracy itself imposes a clear limit: unless there is an OMB control number, Americans can refuse to provide information to their Government. Pretended ignorance of that Rule is no excuse for bureaucracy!
While such limits may not, of themselves, Drain the Swamp, the least we can expect from our Government is that it obey its own procedural rules when attempting to micromanage our lives, property and liberty.
Larry Becraft, Esq., who practices law from his home state of Alabama, joined Ralph Fucetola JD in writing this Open Source Truth post.
[1] “The Paperwork Reduction Act of 1980 (Pub. L. No. 96-511, 94 Stat. 2812, codified at 44 U.S.C. §§ 3501–3521) is a United States federal law enacted in 1980 designed to reduce the total amount of paperwork burden the federal government imposes on private businesses and citizens. The Act imposes procedural requirements on agencies that wish to collect information from the public. It also established the Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget (OMB), and authorized this new agency to oversee federal agencies’ collection of information from the public and to establish information policies. A substantial amendment, the Paperwork Reduction Act of 1995,[4] confirmed that OIRA’s authority extended over not only agency orders to provide information to the government, but also agency orders to provide information to the public.” – https://en.wikipedia.org/wiki/Paperwork_Reduction_Act
[2] United States v. Smith, 866 F.2d 1092 (9th Cir. 1989) – https://openjurist.org/866/f2d/1092/united-states-v-smith
[3] United States v. Hatch, 919 F.2d 1394 (9th Cir. 1990) – https://openjurist.org/919/f2d/1394/united-states-v-k-hatch