Browse regulations

Requires manufacturers, dealers, and distributors of radiation-emitting electronic products to submit product reports, annual reports, accidental radiation occurrence reports, and maintain records for FDA tracking and safety oversight.

Deletion would eliminate critical tracking of radiation-emitting products, preventing timely identification of safety defects and increasing risk of widespread public exposure to harmful radiation. The reporting burden is justified given the catastrophic, often latent health effects of uncontrolled radiation, which create externalities that market mechanisms alone cannot adequately address.

This regulation defines terms for electronic product radiation safety standards, establishing terminology for accidental radiation occurrences, electromagnetic radiation types, electronic products, and regulatory entities under the Federal Food, Drug, and Cosmetic Act.

Americans would be worse off if deleted because this foundational definitional framework enables critical safety standards for electronic products that emit harmful radiation, protecting public health from accidental radiation exposure in manufacturing, testing, and use of electronic devices.

FDA regulation establishing comprehensive manufacturing standards for allergenic products including source material requirements, sterility testing, potency testing, and record-keeping procedures

Creates costly compliance burden that increases drug prices and restricts market entry, while providing minimal safety benefits that could be achieved through voluntary certification and tort liability

Federal regulations establishing comprehensive standards for the collection, processing, testing, storage, and distribution of human blood and blood components including Whole Blood, Red Blood Cells, Platelets, Plasma, Fresh Frozen Plasma, Liquid Plasma, Platelet Rich Plasma, and Cryoprecipitated AHF to ensure safety, purity, and potency for transfusion use.

Blood safety regulations prevent transfusion-transmitted infections, ensure proper blood typing and compatibility, and establish critical quality control standards that protect public health. The unseen costs of relaxing these standards would include increased disease transmission, hemolytic reactions, and preventable deaths from contaminated blood products.

Regulation sets comprehensive testing, manufacturing, and release standards for biologics (vaccines, blood products, therapeutics) to ensure safety, purity, potency, and effectiveness. Mandates lot-by-lot sterility, pyrogen, identity, and residual moisture testing; requires FDA lot release for certain products; regulates process modifications; controls ingredients and cell lines; and mandates infectious disease screening of blood donations, all enforced by CBER and CDER.

The regulation imposes massive compliance costs that disproportionately burden small businesses, stifles innovation through prescriptive mandates, and creates inefficiencies via the knowledge problem. Unseen consequences include delayed access to life-saving biologics, entrenched regulatory capture favoring incumbents, and distorted market incentives that reduce supply and raise prices—harms that outweigh any marginal safety gains, as product integrity could be better assured through liability, private certification, and market discipline.

This regulation establishes the biologics license application (BLA) process for biological products, requiring manufacturers to submit extensive data on safety, purity, potency, manufacturing methods, and clinical studies. It covers approval procedures, labeling requirements, manufacturing changes, and post-market reporting obligations for therapeutic DNA plasmids, synthetic peptides, monoclonal antibodies, and recombinant DNA products.

This regulatory framework creates massive compliance costs and barriers to entry that protect incumbent pharmaceutical companies while delaying life-saving treatments. The extensive pre-market approval requirements, post-market reporting obligations, and manufacturing change restrictions distort market incentives and prevent rapid innovation in biologics development.

Administrative regulations implementing extensions of the Longshoremen's and Harbor Workers' Compensation Act to four specialized jurisdictions: Defense Base Act (overseas federal projects), DC Workmen's Compensation Act, Outer Continental Shelf Lands Act, and Nonappropriated Fund Instrumentalities Act. These rules assign geographic compensation districts, mandate specific insurance policy endorsement language, and incorporate LHWCA regulations with minor variations.

These regulations enforce a mandatory, one-size-fits-all workers' compensation scheme through federal overreach, violating Tenth Amendment federalism and freedom of contract. They impose compliance burdens on insurers and employers in specialized jurisdictions, creating hidden costs that ultimately fall on taxpayers and consumers. The federal government should not be in the business of dictating insurance terms for private parties, even those working on federal projects; states or private markets can provide these arrangements more efficiently without bureaucratic prescription.

Part 703 regulates insurance carrier authorizations, security deposits, and compliance for workers' compensation coverage under the Longshore and Harbor Workers' Compensation Act (LHWCA). It establishes authorization requirements, security deposit obligations, and administrative procedures for carriers providing insurance to employers in maritime and related industries.

This regulation creates unnecessary bureaucratic barriers that increase costs for employers and workers. Security deposit requirements and extensive authorization processes are redundant with state-level regulation and private market mechanisms. The administrative burden falls disproportionately on small businesses while providing questionable benefits to workers. Free market insurance competition would better serve workers' interests than federal micromanagement of carrier operations.

Federal regulations governing workers' compensation procedures for Longshore and Harbor Workers, including claims processing, compensation calculations, fee approvals, and special fund administration.

Americans would be worse off without these regulations as they provide essential protections for injured maritime workers, ensure timely compensation payments, and prevent employer exploitation of vulnerable workers who have no other recourse for workplace injuries.

This regulation governs the Longshore and Harbor Workers' Compensation Act and its extensions, defining covered employees, benefits, and administrative procedures for maritime workers injured on navigable waters and adjoining areas.

This creates a special federal workers' compensation system that duplicates state programs, distorts labor markets by creating different compensation rules for maritime workers, and represents federal overreach into what should be state jurisdiction under the Tenth Amendment.

This regulation (19 CFR Part 159) establishes procedures for the liquidation (final computation) of customs duties on imported merchandise. It covers rounding rules for values and quantities, special treatment for alcoholic beverages and tobacco, a $20 de minimis threshold for billing/refunds, warehouse entry rules, notice requirements (electronic posting), time limits (1 year with extensions up to 4 years), tare weight determination methods, and complex currency conversion procedures based on Federal Reserve-certified exchange rates.

Deletion would cause chaos in international trade operations. This regulatory framework provides essential administrative structure that makes tariff laws predictable and administrable. The de minimis rules and rounding conventions actually reduce compliance burden by eliminating insignificant transactions. Without standardized liquidation procedures, importers would face arbitrary treatment, revenue collection would collapse, and trade flows would be disrupted. While the rules add some administrative overhead, they implement Congress's tariff authority in a way that maintains the rule of law and commercial certainty—prerequisites for a functioning economy. The unseen costs of repeal far exceed the compliance costs of maintaining this necessary administrative infrastructure.

This regulation establishes procedures for tariff classification, appraisement, and valuation of imported merchandise under U.S. Customs law, including definitions, transaction value methods, and valuation standards based on the Harmonized Tariff Schedule and Trade Agreements Act of 1979.

This constitutes an unnecessary federal regulatory burden on international trade that increases compliance costs for businesses, distorts market prices through complex valuation rules, and exceeds constitutional limits on federal commerce power - all functions properly handled through voluntary contracts and state-level oversight.

This regulation establishes procedures for CBP examination and sampling of imported merchandise, including minimum examination rates (1 in 10 packages), exceptions for uniform merchandise, and rules for examinations at various locations. It also governs accreditation of commercial laboratories for testing commodities, setting standards for facility capabilities, methods, fees, and oversight to ensure accurate analysis for classification and admissibility.

This regulation implements legitimate constitutional federal authority over foreign commerce and tariff collection. Proper examination of imports is essential for revenue protection, enforcement of trade laws, and preventing unsafe/illegal goods from entering the country. The laboratory accreditation program ensures reliable third-party testing for complex commodities, which supports accurate classification and admissibility determinations. Without these procedures, border enforcement would be arbitrary, tariff evasion would proliferate, and product safety standards would be unenforceable—directly harming American consumers and businesses that rely on lawful trade. The costs are borne by those who voluntarily engage in importing, not by the general public as hidden domestic compliance burdens.

Regulations governing declaration, examination, duty collection, and exemptions for personal baggage entering the United States, including procedures for distinguishing residents from nonresidents, registering foreign-made items, determining dutiable value, handling violations, and processing preclearance passengers.

Deletion would eliminate the administrative framework necessary to implement legitimate customs laws, causing border chaos, revenue loss, and traveler uncertainty. The uniform procedures are irreplaceable for efficient customs enforcement and cannot be replicated by ad-hoc arrangements, making Americans worse off through delays, corruption, and ineffective duty collection.

Regulation 19 CFR Part 145 establishes comprehensive customs procedures for merchandise imported through international mail, including examination authority, documentation requirements, duty collection, and various exemptions and prohibitions. It covers formal vs informal entry procedures based on $2,500 value threshold, seizure and forfeiture mechanisms, marking requirements, and special rules for gifts, returning goods, diplomatic mail, and prohibited items. The regulation also mandates advance electronic data transmission from USPS to CBP and includes fees for customs documentation services.

This regulation imposes massive compliance costs through an invasive examination regime that treats all international mail as suspect, invades privacy of correspondence with weak protections, creates complex documentation burdens (customs declarations, invoices, multiple form types), and mandates expensive electronic data transmission. The $2,500 threshold creates arbitrary distinctions, and the fee structure adds regressive taxation to international communication. While preventing dangerous contraband is legitimate, this framework sweeps too broadly—transforming a necessary border function into a bureaucratic dragnet that violates rule of law principles through sheer complexity (185,000+ pages of regulations). The unseen costs include stifled international commerce, particularly harming small businesses and individuals who cannot navigate the labyrinth, all while doing little to improve upon what could be achieved through targeted, risk-based enforcement that respects privacy and minimizes burdens.