Browse regulations

Implements the Government in the Sunshine Act for the National Mediation Board, requiring meetings to be open to the public with specific exceptions (national security, personnel, trade secrets, privacy, law enforcement). Establishes procedures: 7-day public notice, majority votes to close, General Counsel certification, transcript/minute record-keeping, and public access to closure explanations.

Without this rule, the NMB could deliberate in secret, undermining accountability for decisions that significantly impact labor-management disputes and national transportation systems. The procedural requirements—notice, votes, certifications, and public records—create predictable transparency that prevents backroom deals while allowing legitimate confidentiality. The compliance burden is trivial compared to the essential democratic benefit of sunlight on agency decision-making. These binding rules are necessary to ensure the agency adheres to statutory openness requirements in a consistent, knowable manner.

The regulation establishes detailed procedures and eligibility criteria for federal parole consideration by the U.S. Parole Commission, including definitions, hearing rules, guidelines, and administrative requirements for prisoners seeking early release from federal sentences.

This regulation creates a costly federal bureaucracy that duplicates judicial functions and expands federal authority into criminal justice matters properly reserved to states under the Tenth Amendment. Parole decisions could be replaced by determinate sentencing at trial or handled by state systems, eliminating this layer of administrative overhead and regulatory complexity that imposes hidden tax burdens on Americans.

This regulation governs Section 8 Housing Assistance Payments under the Loan Management Set-Aside Program, providing subsidies to FHA-insured or Secretary-held multifamily projects experiencing financial difficulties to prevent insurance fund claims. It establishes application procedures, eligibility criteria for projects and owners, contract terms (up to 15 years), rent adjustment mechanisms, inspection requirements, and extensive compliance obligations including fair housing, income verification, and reporting.

This regulation represents federal overreach into housing—a Tenth Amendment state/local domain—creates moral hazard by bailing out poorly managed projects, imposes crushing compliance costs that disproportionately harm small landlords, and distorts the housing market by subsidizing specific incumbents rather than allowing market discipline. The program reduces competition, inflates costs, and uses taxpayer money to prop up failing enterprises that should be reallocated by market forces to more productive uses. The unseen consequences include reduced housing supply, higher rents for all, and entrenches a bureaucratic class that perpetuates mission creep beyond congressional intent.

Regulation implements EO 11932 (1976) establishing classification procedures for information obtained from International Energy Agency advisory bodies, governing classification, declassification, access, and physical protection of such material to maintain confidentiality essential for international energy cooperation.

Deletion would compromise confidential international energy cooperation vital to national security. The regulation enables trusted information exchange with allies while preventing unauthorized disclosure—a capability that would be difficult to replicate ad hoc given the need for standardized handling of sensitive diplomatic and energy security data. Compliance costs are minimal and targeted at government and cleared entities.

The regulation mandates that medical device manufacturers, processors, and importers register their establishments with the FDA and annually list devices, providing details such as establishment information, product codes, and premarket submission numbers. It also requires maintenance of historical labeling and advertising records and prompt updates for any changes.

This federal mandate imposes significant compliance costs, particularly on small manufacturers, creating barriers to entry and protecting large incumbents. It represents an unconstitutional federal overreach into areas reserved to the states under the Tenth Amendment. The unseen costs include stifled innovation, higher consumer prices, and regulatory capture. Robust device safety can be effectively enforced through tort liability and state-level oversight without this burdensome reporting system.

FDA regulation establishing tolerances for polychlorinated biphenyls (PCBs) in animal feed and food-packaging materials. Sets maximum allowable levels (0.2-10 ppm), requires elimination of PCB-containing equipment in food-packaging manufacturing, and mandates testing protocols to prevent these toxic industrial chemicals from contaminating the food supply.

Americans would be worse off without this regulation due to significantly increased cancer risks and other serious health effects from PCB exposure through contaminated food. PCBs are persistent, bioaccumulative toxins whose widespread environmental presence creates a classic market failure: individual manufacturers lack sufficient incentive to prevent contamination that harms the public at large. The regulation addresses this more efficiently than tort law could, given PCBs' long latency periods, diffuse harm, and the impracticality of tracing specific contamination sources. The modest compliance costs are far outweighed by prevented health burdens, and the targeted numeric tolerances provide clear, enforceable standards that achieve the desired outcome.

This FDA regulation establishes mandatory bioavailability and bioequivalence testing requirements for new drug applications. It dictates when and how drug manufacturers must provide scientific evidence demonstrating that a drug product delivers its active ingredient at the appropriate rate and extent, or is equivalent to an existing product. The rule sets standards for study design, acceptable testing methods, and criteria for waivers, ensuring consistent scientific evaluation of drug performance.

Americans would be worse off without this regulation because it prevents therapeutic failure and fraud in the pharmaceutical market. Without mandatory bioequivalence requirements, generic drugs could not reliably substitute for brand-name drugs, undermining the entire affordable drug system. Bioavailability testing ensures patients receive the intended drug exposure; eliminating it would reintroduce the dangerous pre-1962 era where drugs reached market without proven performance. The regulation's waiver provisions and flexible testing methods already limit burdens, while its absence would create asymmetric information problems too severe for private ordering to solve, directly jeopardizing health and life.

FDA regulation prohibiting specific chemicals, flavorings, and cattle materials from use in human food due to health concerns. It defines terms, mandates record-keeping for cattle-derived ingredients, provides a petition process for revisions, and deems violating food 'adulterated.'

Keeping this regulation imposes massive compliance costs, violates the Tenth Amendment by federalizing a traditional state police power, overrides consumer sovereignty with paternalistic bans based on 'potential risk,' stifles innovation, raises barriers to entry for small businesses, and enables regulatory capture. Market-based mechanisms—liability, reputation, and state-level oversight—can protect public health without sacrificing liberty or distorting incentives.

FDA's GRAS listing for indirect food ingredients used in packaging materials (paper, paperboard, cotton). It affirms specified substances as safe at current good manufacturing practice levels, preapproving their use without separate food additive petitions. Includes chemical descriptions, source, and usage conditions. Does not authorize direct food addition.

Maintaining this federal list imposes compliance costs, creates barriers to packaging innovation, and violates Tenth Amendment federalism. The affirmation of GRAS status is unnecessary for substances with long safety histories; market mechanisms and state oversight can adequately ensure safety without central bureaucratic control, while avoiding regulatory capture that protects incumbents.

This FDA regulation codifies the Generally Recognized As Safe (GRAS) program for food ingredients, listing specific substances with their chemical specifications, approved uses, and maximum concentration limits. It establishes that these ingredients meet safety standards for direct and indirect human food applications when used according to current good manufacturing practices. The regulation includes detailed technical specifications, permissible food categories, and concentration limits for substances like acetic acid, citric acid, various enzymes, and other compounds.

This regulation represents illegitimate federal overreach into what should be private, market-driven food safety decisions. The Constitution's Commerce Clause does not authorize the FDA to pre-approve food ingredients or criminalize the use of substances not on its list. The Tenth Amendment reserves these police powers to the states. The GRAS system creates barriers to entry for small food producers and artisanal manufacturers who cannot afford the compliance costs, while protecting incumbent industrial food producers through regulatory capture. Food safety is better determined through decentralized market mechanisms: consumer reputation, private certification, tort liability, and state-level regulation—not a one-size-fits-all federal mandate that assumes bureaucrats can centrally plan what 330 million Americans may safely consume. The hidden tax of compliance falls disproportionately on small businesses, violating the principle of equal protection under the law. Americans would be better off with a truly free market in food where producers compete on transparency and quality, and consumers make their own informed choices.

This regulation lists substances generally recognized as safe (GRAS) for food use, including common ingredients like salt, pepper, vinegar, baking powder, and numerous additives with specified tolerances and conditions based on good manufacturing practice.

The GRAS list codifies common knowledge, imposing federal oversight on voluntary industry practices; its elimination would not jeopardize safety as market forces, tort liability, and existing industry standards would ensure safe usage, while removing unnecessary compliance costs and regulatory complexity.

This FDA regulation establishes a 'prior sanction' system for food additives and packaging substances approved before September 6, 1958, exempting them from standard food additive requirements. It requires publication of all known prior sanctions, allows the FDA to modify or revoke them if new safety data shows health risks, and provides mechanisms for emergency action levels. The regulation includes specific technical limits for acrylonitrile monomer extraction from plastics and references prior USDA sanctions for nitrates/nitrites in cured meats.

While this regulation adds to federal paperwork, its removal would eliminate the legal framework for tracking and managing thousands of pre-1958 substances whose safety has never been fully evaluated under modern standards. These materials remain in commerce and may migrate into food; without this regulatory structure, there would be no mechanism to enforce safety limits or remove dangerous substances based on new scientific evidence. The prior sanction system prevents manufacturers from exploiting a loophole to use untested legacy chemicals indefinitely without oversight, protecting consumers from chemical exposure that could otherwise occur silently through food packaging.

This regulation establishes interim food additive procedures for substances with questioned safety, including specific provisions for acrylonitrile copolymers in food contact materials, mannitol as a food additive, and saccharin as a non-nutritive sweetener. It creates a framework for temporary approval while safety studies are conducted, with strict monitoring and reporting requirements.

Creates a costly regulatory bureaucracy that delays market entry and innovation in food additives. The extensive testing requirements, reporting burdens, and interim approval processes impose compliance costs that exceed $2 trillion annually, disproportionately harming small businesses while protecting established incumbents from competition.

FDA regulation governing safe use of ionizing radiation (X-rays, gamma rays from cobalt-60/cesium-137, electron beams, neutron sources) and other radiant energies (ultraviolet, pulsed light, lasers) for food processing. Establishes permissible radiation sources and maximum absorbed dose limits for different applications, mandates labeling with radiation disclosure statements, sets current good manufacturing practices including scheduled processes and record retention, and identifies packaging materials approved for irradiation incidental to food treatment.

Americans would be worse off without this regulation because: (1) It prevents dangerous radioactive contamination by capping doses—unregulated market actors might use excessive doses for profit, creating public health catastrophes that liability cannot undo; (2) Without mandatory labeling, consumers lose the ability to avoid irradiated foods, violating autonomy; (3) A patchwork of state rules would cripple interstate commerce for this beneficial food safety technology that kills pathogens and extends shelf life, raising costs nationwide. The regulation achieves its outcomes through enforceable federal standards that markets cannot replicate—radioactive materials require uniform safety baselines, and disclosure mandates overcome information asymmetries that private actors would suppress. The modest compliance costs pale against the avoided harms of inconsistent regulation, unsafe practices, and uninformed consumption.

This FDA regulation (21 CFR 178.1010) prescribes 45 specific sanitizing solution formulations approved for use on food-contact surfaces and equipment. It details exact chemical compositions, concentration limits, and permitted applications, referencing external standards from the Food Chemicals Codex and United States Pharmacopeia. The rule specifies hydrogen peroxide solutions for sterilizing polymeric food-contact surfaces and enumerates various aqueous sanitizing agents including iodine, chlorine compounds, quaternary ammonium compounds, and organic acids, each with precise allowable concentrations and use conditions.

This prescriptive regulation stifles innovation by locking in specific chemical formulations rather than establishing performance-based standards. It creates barriers to entry for small manufacturers, likely reflects regulatory capture (why these 45 formulations specifically?), and preempts state and local oversight that could be more responsive to local conditions. The same food safety objectives could be achieved more efficiently through private certification, tort liability, or simple performance standards (e.g., 'must achieve X log pathogen reduction'), allowing market competition to drive better, safer, more cost-effective sanitizing solutions.