Browse regulations

This regulation implements the Freedom of Information Act (FOIA) for the National Endowment for Democracy (NED), a private nonprofit corporation created by Congress. It establishes procedures for processing FOIA requests, fee structures, appeals, and annual reporting to Congress.

Imposes costly FOIA compliance on a private entity, diverting resources from its core mission. Treats NED as a federal agency, expanding the regulatory state and creating opportunities for harassment via broad requests. The chilling effect on internal communications and administrative overhead outweigh transparency benefits, which could be achieved through simpler reporting requirements.

FDA classification system for ear, nose, and throat medical devices, establishing three regulatory classes (I, II, III) with varying premarket review requirements, special controls, and exemptions. The regulation determines which devices need FDA approval before marketing and sets specific performance, labeling, and safety standards for numerous device types including audiometers, hearing aids, surgical instruments, and implantable prostheses.

The regulation imposes massive compliance costs that inflate healthcare prices, create regulatory capture favoring large incumbent manufacturers, and violate Tenth Amendment federalism by federalizing what states and private markets could handle. Unseen effects include: stifled innovation from lengthy approval processes, reduced competition from high barriers to entry, misallocation of capital toward compliance instead of R&D, and delayed patient access to new treatments. Patient safety can be adequately protected through tort liability, professional standards, and private certification without the heavy hand of federal bureaucracy.

Establishes premarket approval process for class III medical devices, requiring extensive safety and effectiveness data before market entry, with public disclosure requirements and ongoing monitoring obligations.

Creates excessive regulatory burden that delays life-saving medical innovations, increases costs for patients, and protects established manufacturers from competition through prohibitive compliance costs that disproportionately harm smaller innovators.

This regulation establishes safety, effectiveness, and labeling requirements for over-the-counter anthelmintic drugs (pinworm treatments), cholecystokinetic drugs (gallbladder diagnostic agents), and internal deodorants. It specifies active ingredients, dosage limits, warning statements, and usage directions for these drug categories.

This regulation represents federal overreach into drug safety standards that should be handled by state authorities and private certification bodies. The FDA's involvement in micromanaging labeling requirements, dosage schedules, and warning statements for common medications creates unnecessary compliance costs that are passed to consumers. The market and tort liability already provide strong incentives for drug safety without federal micromanagement.

FDA monograph setting standards for over-the-counter earwax removal aids (carbamide peroxide 6.5% in anhydrous glycerin) and ear drying aids (isopropyl alcohol 95% in anhydrous glycerin). Mandates specific active ingredients, labeling (identity, indications, warnings, directions), and compliance with FDCA to ensure safety and prevent misbranding.

This federal regulation imposes heavy compliance costs, stifles innovation by mandating specific formulations, and creates anti-competitive barriers that disproportionately harm small businesses. The same consumer protection goals could be achieved through state-level oversight, tort law, and market mechanisms, avoiding the unseen consequences of higher prices, reduced choices, and constitutional overreach into purely local economic activity.

FDA's Current Good Manufacturing Practice regulations for food manufacturing, establishing detailed prescriptive requirements for personnel hygiene, facility construction, equipment design, sanitation, water systems, manufacturing processes, and testing to prevent food adulteration. Covers plant grounds, building design, maintenance, pest control, washrooms, equipment materials, raw material handling, temperature controls, and contamination prevention.

$2 trillion annual regulatory burden with disproportionate impact on small businesses (30% higher compliance costs per employee). Federal overreach into local manufacturing - Tenth Amendment police power. One-size-fits-all mandates stifle innovation and protect incumbents via regulatory capture. Market mechanisms (private certifications, brand reputation, insurance, tort liability) and state-level oversight would achieve food safety more efficiently while preserving competition and liberty. Prescriptive rules ignore local conditions and create barriers to entry.

This regulation implements federal statutes requiring the Railroad Retirement Board to honor court orders that divide railroad retirement benefits as property in divorce, annulment, or legal separation proceedings. It establishes procedures for accepting, reviewing, and complying with court decrees or property settlements that award portions of an employee's tier II benefits, vested dual benefits, increases, or supplemental annuities to a spouse or former spouse, including rules for determining amounts, notification, withholding, payment cycles, and liability protections.

The federal government has no constitutional business enforcing state family law property settlements through a federal administrative agency. This violatesTenth Amendment federalism by federalizing divorce ancillary proceedings and imposes significant compliance costs on the Railroad Retirement Board to act as a collection agency for state courts. The proper remedy would be for state courts to award the spouse a contractual right against the employee, who would then be responsible for paying from whatever source; the federal government should not be in the business of directly executing state court judgments. The regulation creates an entire bureaucratic apparatus—review procedures, priority rules, erroneous payment recoveries, information disclosure mandates—that exists only because Congress improperly commandeered a federal agency to circumvent ordinary state-law enforcement mechanisms.

Complex regulatory scheme governing lump-sum death and other benefit payments under the Railroad Retirement Act, with extensive eligibility criteria, priority rules, and calculation formulas for distributing government benefits to railroad workers' survivors and other claimants.

Creates significant compliance costs and bureaucratic overhead for the Railroad Retirement Board, imposes complex burdens on grieving families during bereavement, distorts family behavior and private arrangements through arbitrary eligibility rules (e.g., 'living with' requirements), and perpetuates unconstitutional federal intervention in what should be private provisioning for death. The regulation's complexity makes it unknowable, invites gaming of the system, and overrides private contractual relations like wills, all to administer a benefits program that itself exceeds enumerated federal powers under the Commerce Clause.

This regulation establishes the framework for foreign trade zones in the United States, allowing merchandise to be admitted to zones with special customs status (nonprivileged foreign, privileged foreign, zone-restricted, or domestic) for storage, manipulation, manufacturing, or exhibition without immediate customs duties. It defines operational procedures, inventory control requirements, and Customs supervision mechanisms for zone operators and users.

Foreign trade zones represent a costly and unnecessary federal intervention that distorts market signals and creates regulatory complexity. The $2 trillion annual compliance burden from federal regulations includes such specialized programs that benefit specific industries at the expense of broader economic efficiency. States could establish their own trade facilitation programs if desired, making this federal program an unconstitutional overreach that protects incumbent businesses from competition while imposing significant administrative costs on all participants.

This regulation establishes voluntary certification procedures for containers and road vehicles used in international transport under customs seal, implementing the TIR Convention and Container Conventions. It designates three private nonprofit organizations as the only Certifying Authorities in the U.S., requires manufacturers to submit detailed plans and specifications, obtain certificates of approval, affix approval plates, and maintain records. The Certifying Authorities charge fees (subject to government approval), report all certificates to Customs, and are subject to government oversight.

This regulation creates a government-approved cartel of certifying authorities, stifling competition and raising costs for international shippers. The voluntary framework could be entirely privatized—market forces would discipline certification quality without government gatekeeping. The U.S. could still fulfill treaty obligations by accepting certifications from any competent international body, eliminating the need for designating specific entities, fee approvals, and burdensome reporting requirements. Government's role should be recognizing foreign certifications, not protecting incumbent certifiers from competition.

Section 504 regulation for federal agencies prohibits discrimination based on disability in all agency programs and activities, requiring accessibility, reasonable accommodations, auxiliary aids, and establishing detailed self-evaluation, complaint, and enforcement procedures.

Imposes multi-billion dollar compliance costs on federal agencies and contractors, with small businesses bearing disproportionate burden; extends regulatory reach into private contracting relationships; creates bureaucratic inertia through mandatory self-evaluations and transition plans; and relies on expansive federal authority to micromanage agency operations, violating principles of federalism and limited government.

This regulation establishes annual charges for hydropower licensees and exemptees to reimburse the US for administration costs of the Commission's hydropower regulatory program, with complex formulas based on project capacity, energy output, and use of government lands or dams.

This regulatory framework creates excessive compliance costs ($2 trillion annually industry-wide) through complex formulas and reporting requirements that disproportionately burden small businesses, while the original purpose of cost recovery could be achieved through simpler, more transparent mechanisms without creating bureaucratic overhead.

Prohibits discrimination against handicapped persons in federal agency programs and activities, requiring accessibility, auxiliary aids, and reasonable accommodations. Establishes complaint procedures and implementation deadlines.

Federal regulation exceeds constitutional authority by mandating accessibility standards and accommodations that should be determined by states/localities. Creates $2+ trillion in compliance costs as hidden tax, distorts market incentives, and protects incumbents through regulatory barriers. Unconstitutional federal overreach into areas properly belonging to states under Tenth Amendment.

This regulation implements Section 504 of the Rehabilitation Act, prohibiting discrimination against handicapped persons in federal agency programs and requiring accessibility accommodations, auxiliary aids, and complaint procedures.

Americans would be worse off if deleted because it ensures equal access to federal programs for disabled citizens, preventing systemic exclusion and providing legal recourse for discrimination in government services.

Implements Federal Advisory Committee Act for FTC. Establishes procedures for creating, managing, and overseeing advisory committees, including charter requirements, public meeting notices, balanced membership, and annual reviews.

Deletion would allow FTC advisory committees to operate without transparency, balanced membership, and regular review, enabling regulatory capture and opaque decision-making. These procedural safeguards are essential to ensure these committees remain truly advisory, don't become decision-making bodies, and serve the public interest rather than concentrated industry interests. The modest administrative costs are far outweighed by the accountability and anti-corruption benefits.