Food Safety Regulation

The U.S. food safety system is a divided responsibility between two agencies: the FDA regulates roughly 80% of the food supply — virtually everything except meat, poultry, and processed eggs — while the USDA's Food Safety and Inspection Service (FSIS) handles the remaining 20%. This split means a frozen cheese pizza is FDA-regulated, while a frozen pepperoni pizza is a split jurisdiction depending on the topping. The FDA Food Safety Modernization Act (FSMA, 2011) was the most significant overhaul of FDA food authority since 1938, shifting the agency's approach from responding to outbreaks to requiring preventive controls before contamination occurs. Despite the regulatory framework, foodborne illness remains common: about 48 million Americans get sick, 128,000 are hospitalized, and 3,000 die each year from contaminated food — making food safety one of the most consequential public health policy areas most people never think about until they're affected.

Current Law (2026)

Legal Authority

• 21 U.S.C. § 331 — Prohibited acts (introduction of adulterated or misbranded food into interstate commerce; adulteration or misbranding during manufacture; receiving adulterated/misbranded food)
• 21 U.S.C. § 341 — Standards for food (Secretary prescribes definitions and standards of identity, quality, and fill of container for food)
• 21 U.S.C. § 342 — Adulterated food (food is adulterated if: it contains any poisonous or deleterious substance injurious to health, contains unsafe food additives or pesticide residues, contains filthy/decomposed/unsanitary matter, is prepared in insanitary conditions, is the product of a diseased animal, or its container is unsafe)
• 21 U.S.C. § 343 — Misbranded food (food is misbranded if: labeling is false or misleading, sold under another name, fails to identify manufacturer/packer/distributor, fails to declare net quantity, fails to include nutrition labeling, or makes unauthorized health claims)
• 21 U.S.C. § 346 — Tolerances for poisonous or deleterious substances (Secretary may set tolerances for unavoidable poisonous or deleterious substances in food when required for public health protection; food containing such substances above tolerance levels is adulterated)
• 21 U.S.C. § 346a — Pesticide tolerances (EPA sets tolerances for pesticide chemical residues in food; FDA enforces; food exceeding tolerances is adulterated)
• 21 U.S.C. § 348 — Food additives (no food additive may be used unless it conforms to a regulation prescribing conditions of safe use, or is generally recognized as safe — GRAS; color additives require separate certification)
• 21 U.S.C. § 350f — Reportable food registry (facilities must report to FDA when there is reasonable probability that a food will cause serious adverse health consequences; FDA maintains a searchable registry of reported foods to enable rapid identification and response)
• 21 U.S.C. § 350g — FSMA Preventive Controls (food facilities must implement Hazard Analysis and Risk-Based Preventive Controls — written food safety plan, hazard analysis, preventive controls, monitoring, corrective actions, verification, recall plan)
• 21 U.S.C. § 350h — FSMA Produce Safety Rule (standards for growing, harvesting, packing, and holding of produce — agricultural water quality, biological soil amendments, worker health/hygiene, domesticated/wild animals, equipment/buildings)
• 21 U.S.C. § 350j — FSMA Foreign Supplier Verification (importers must verify that foreign suppliers use processes providing the same level of public health protection as U.S. standards)

Implementing Regulations (21 CFR; 9 CFR)

FDA (21 CFR):

• 21 CFR Part 108 — Emergency Permit Control: FDA's authority to require food manufacturers to obtain permits before distributing food when their processing practices create a risk of introducing harmful microorganisms into interstate commerce. The rule targets two categories where standard post-market detection cannot protect the public — by the time contamination is discovered, the food has been distributed and consumed:

  • § 108.25 — Acidified foods permit: "acidified foods" are low-acid foods (vegetables, meats, seafood, eggs) to which acid or acidic foods are added to achieve a finished pH of 4.6 or below (pickles, salsa, hot sauce, kimchi, pickled beets, chow-chow, peppers in vinegar). Improper acidification — failure to achieve pH ≤ 4.6 throughout the product — creates conditions where Clostridium botulinum spores can survive and produce botulinum toxin; because sealed jars of acidified food are anaerobic environments, the contamination cannot be detected without lab testing. FDA requires all acidified food manufacturers to file scheduled processes with FDA, register their establishments, and follow CGMP; a manufacturer found non-compliant with acidified food processing standards must obtain an emergency permit before distributing
  • § 108.35 — Low-acid canned foods (LACF) permit: "thermally processed low-acid foods packaged in hermetically sealed containers" (canned vegetables, soups, stews, beans, meats — anything with a finished equilibrium pH above 4.6 in a sealed can or jar) must be processed at temperatures sufficient to destroy botulinum spores (typically 250°F/121°C for 3+ minutes — the F0 process); inadequate thermal processing is the primary cause of botulism outbreaks from commercial canned goods; LACF manufacturers must register with FDA, file scheduled processes for each product/container/process combination, and follow CGMP; failure triggers the permit requirement
  • §§ 108.5–108.10 — Permit mechanics: when FDA determines a manufacturer has not met the mandatory requirements, it issues an order requiring a permit; from that point, the manufacturer cannot distribute covered food without a valid permit; FDA must act on permit applications within 10 working days; permits can be suspended immediately for non-compliance and reinstated when compliance is demonstrated; food produced during a period without a required permit must be retained and may not be distributed

  Part 108 predates FSMA by decades — it was codified in the 1970s after the Great Lakes Mushroom outbreak (1973), which killed several people and prompted FDA to establish mandatory processing controls for LACF. The acidified foods and LACF regulations (21 CFR Parts 113 and 114) prescribe the mandatory processing standards whose failure triggers the Part 108 permit requirement. Commercial canners in the U.S. universally treat LACF compliance as mission-critical; home canning is not regulated under 21 CFR 108 (only commercial interstate distribution), which is why the CDC's guidance on pressure canning home vegetables is public health guidance rather than enforceable regulation. Recent rulemakings: 51 FR 24475 (1986) and 44 FR 16235 (1979) established the current framework; no major amendments since.

• 21 CFR Part 117 — Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (FSMA Preventive Controls rule — the cornerstone of modern food safety for manufacturers; 61 sections organized around five operational requirements):

  • § 117.126 — Written food safety plan: every registered food facility must prepare and implement a written food safety plan; the plan must be prepared by or under the oversight of a Preventive Controls Qualified Individual (PCQI) — a person who has successfully completed FDA-recognized training or has equivalent job experience; the PCQI requirement is the most important practical compliance change FSMA introduced for food manufacturers, as it creates a named, trained accountable individual for every facility's food safety program
  • § 117.130 — Hazard analysis: the food safety plan must include a written hazard analysis identifying and evaluating biological (pathogens — Listeria, Salmonella, E. coli O157:H7), chemical (allergens, food-grade chemicals, environmental contaminants, natural toxins), and physical (glass, metal, bone, plastic) hazards that are reasonably likely to occur in each type of food produced; the analysis must consider both the probability of a hazard occurring and the severity of illness or injury that would result — the same risk-based framework used in HACCP systems for decades, now applied across the full FDA-regulated food supply
  • § 117.135 — Preventive controls: for each significant hazard identified in the hazard analysis, the facility must implement one or more preventive controls: process controls (temperature, time, pH — killing pathogens at a critical control point); allergen controls (label review, production scheduling, sanitation procedures to prevent cross-contact); sanitation controls (food contact surface cleaning and sanitizing schedules, hand-washing facilities, pest control); supply-chain controls (approved supplier programs for ingredients that present hazards); the selection and implementation of these controls is the technical heart of the FSMA system
  • § 117.139 — Recall plan: every facility must have a written recall plan to retrieve and dispose of potentially unsafe food that has been distributed; the plan must identify who is responsible for initiating a recall, how affected product will be identified and traced, and how the effectiveness of the recall will be verified
  • §§ 117.140–117.165 — Monitoring, corrective actions, and verification: preventive controls must be monitored at a frequency adequate to ensure they are consistently applied; when monitoring reveals a control was not performed correctly, corrective actions must be taken and documented; verification activities (calibration records, end-product testing, environmental monitoring for Listeria) confirm the system is working as intended — the three-part triad of monitor/correct/verify that distinguishes a functioning FSMA program from paper compliance

• 21 CFR Part 112 — Standards for the Growing, Harvesting, Packing, and Holding of Produce (FSMA Produce Safety Rule): agricultural water standards, biological soil amendments, worker training, equipment/tool sanitation, wild and domesticated animals

• 21 CFR Part 1 — General Enforcement and FSMA Administrative Requirements (251 sections across 13 subparts — the foundational FDA supply chain rules enacted through FSMA, covering facility registration, prior notice, recordkeeping, foreign supplier verification, traceability, and third-party auditor accreditation):

  Subpart H — Food Facility Registration (§§ 1.225–1.245): Any owner, operator, or agent of a domestic or foreign facility that manufactures, processes, packs, or holds food for U.S. consumption must register with FDA before beginning operations. "Facility" means any establishment or group of contiguous structures under one ownership at one physical location. Exemptions (§ 1.226): farms; retail food establishments (restaurants, grocery stores that sell to end consumers); restaurants; nonprofit food facilities; fishing vessels (harvest-only); and foreign facilities where a subsequent non-U.S. facility performs substantial further processing. Registration requirements (§ 1.232): facility name, address, phone; Unique Facility Identifier (UFI, required since October 2020); parent company; all trade names; owner/operator/agent info including email; food product categories and activity types; all submitted electronically at fda.gov/furls (electronic submission mandatory since January 4, 2020). Renewal: biennial renewal required during October 1 – December 31 of each even-numbered year. Updates: any change in required registration information must be updated within 60 calendar days; ownership changes require cancellation of the old registration and a new registration by the new owner. Consequences: failure to register, renew, update, or cancel is a prohibited act under FD&C Act § 301(dd), triggering civil injunction and criminal prosecution authority. Registration records are exempt from FOIA disclosure (§ 1.243) — FDA does not publish the list of registered facilities.

  Subpart L — Foreign Supplier Verification Programs (FSVP) (§§ 1.500–1.510): importers must verify that their foreign suppliers produce food using processes that provide the same level of safety as the FSMA preventive controls or produce safety requirements — or that the food is not reasonably likely to be adulterated or mislabeled; hazard analysis, supplier evaluation, and corrective actions required; a qualified individual at the importing firm must oversee and document compliance.

  Subpart S — Additional Traceability Records for Certain Foods (§§ 1.1300–1.1455, compliance date extended to July 20, 2028): the FSMA Section 204 "Food Traceability Rule" — the most operationally significant FSMA rule enacted after the 2011 statute. Applies to persons who manufacture, process, pack, or hold foods on the Food Traceability List (FTL), published by FDA. FTL foods include: fresh-cut fruits and vegetables (any fruit or vegetable that has been cut); leafy greens (including basil, cabbage, endive, fresh herbs, head lettuce, iceberg, leafy herbs, romaine, spinach); tomatoes (including cherry tomatoes, grape tomatoes, roma); peppers (hot and sweet); cucumbers; tropical tree fruits (including mangoes, papayas, guavas); finfish (including fresh/frozen); sprouts; shell eggs; melons; Cucurbit vegetables (squash, zucchini). Core traceability requirements: covered facilities must keep Key Data Elements (KDEs) at each Critical Tracking Event (CTE) — growing, receiving, transforming, creating, and shipping. KDEs include lot codes, source/recipient info, dates, and quantities. Traceability Lot Codes (TLCs) must be assigned at the first point a food enters the supply chain and must follow the food at each step. Farms must record growing, harvesting, and cooling CTEs; shippers must record CTEs at shipping. FDA can require records within 24 hours of a request — the "24-hour rule" is the practical test of the system's outbreak-response utility. Exemptions: produce farms under the Part 112 (a) size threshold; farms with average annual sales ≤$25,000 (adjusted for inflation from 2020 baseline); shell egg producers with <3,000 laying hens. After FDA proposed an extension in early 2025, Congress in the November 2025 continuing appropriations directed FDA not to enforce the Food Traceability Rule prior to July 20, 2028 — pushing the compliance deadline 30 months past the original January 20, 2026 date for all covered entities.

• 21 CFR Part 507 — Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (FSMA's Preventive Controls for Animal Food rule — the animal food parallel to Part 117 for human food; covers pet food, livestock and poultry feed, equine feed, zoo animal diets, and human food by-products redistributed as animal food; 57 sections with the same HARPC architecture as Part 117):

  • § 507.31 — Food safety plan: every registered animal food facility must prepare and implement a written food safety plan prepared or overseen by a Preventive Controls Qualified Individual (PCQI) — the same named-accountable-individual requirement as human food Part 117, applied to feed mills, pet food manufacturers, rendering facilities, and distributors of human food by-products
  • § 507.33 — Hazard analysis: a written analysis identifying all known or reasonably foreseeable biological, chemical, and physical hazards in each animal food manufactured; for animal food, key hazards include Salmonella (common in poultry feed ingredients), mycotoxins (aflatoxin in corn, fumonisin), heavy metals, drug residues in by-products from pharmaceutical manufacturing, and physical hazards introduced during processing
  • § 507.34 — Preventive controls: for each significant hazard, the facility must implement process controls (heat treatment killing Salmonella; moisture limits preventing mold), sanitation controls, supply-chain controls (approved supplier programs for ingredients whose hazards the receiving facility can't control), and recall plans (§ 507.38)
  • §§ 507.39–507.49 — Monitor/correct/verify triad: monitoring at a frequency appropriate to the control; corrective actions when monitoring reveals failure; verification including calibration records, end-product testing, and environmental monitoring — the same operational architecture as human food FSMA compliance
  • §§ 507.14–507.28 — cGMP baseline: personnel hygiene, plant and grounds maintenance, equipment sanitation, and holding conditions — these cGMP requirements apply even to facilities too small to be required to implement full preventive controls

  Part 507 covers roughly $50 billion in annual U.S. animal food production — including the largest pet food manufacturers (Purina, Hill's, Blue Buffalo), major feed mills, and the rendering industry. FDA compliance timelines were staggered, with large businesses (500+ employees) required first. Pet food Salmonella recalls have both animal and human health implications because humans handling contaminated products can become infected — making animal food safety an integrated public health issue.

• 21 CFR Part 573 — Food Additives Permitted in Feed and Drinking Water of Animals (69 sections — the FDA-approved list of additives that may be added to animal feed, the animal-feed counterpart to Part 172 for human food; each section specifies a substance, its permitted uses, the species it may be fed to, and concentration limits): common approved additives include xanthan gum (§ 573.1010 — as a stabilizer in calf milk replacers up to 0.1% and liquid ruminant supplements up to 0.25%), yellow prussiate of soda (§ 573.1020 — sodium ferrocyanide as an anticaking agent in salt for animals at ≤13 ppm), ammoniated cottonseed meal (§ 573.140 — a high-protein ruminant feed supplement not exceeding 20% of the total ration, with warning label requirements). The most scientifically notable entry is § 573.130 (aminoglycoside 3'-phosphotransferase II — APT II): this section approves a bacterial enzyme encoded by the kanr gene from E. coli Tn5 (an antibiotic-resistance gene product) for use "in the development of genetically modified cotton, oilseed rape, and tomatoes" — FDA approved the marker gene's protein product as a safe animal feed additive because transgenic crops developed using this selection marker will contain trace amounts of APTII when the crops enter the feed supply. The approval framework for new animal feed additives follows the same food additive petition process as Part 172: a manufacturer petitions FDA showing that the substance is safe at proposed use levels; FDA publishes the approved substance and its conditions of use in Part 573. Unlike human food additives (where GRAS self-determination is widely used), animal feed additive petitions often require more explicit FDA action before use

• 21 CFR Part 121 — Intentional Adulteration Rule (FSMA Food Defense): the fourth major FSMA rule, specifically designed to guard against deliberate contamination of food with the intent to cause large-scale public harm. Unlike Parts 117 and 112 (which address accidental contamination), Part 121 addresses intentional adulteration — terrorism or criminally-motivated attacks on the food supply:

  • § 121.1 — Applicability: the rule applies to domestic and foreign facilities required to register with FDA under 21 U.S.C. § 350d that are not otherwise exempt; exemptions include farms, facilities covered by the USDA/FSIS inspection, food for personal consumption, and small/very small businesses (phased compliance timelines applied through 2020); the rule does NOT apply to holding or packing/holding activities
  • § 121.126 — Food defense plan: every covered facility must prepare and implement a written food defense plan — the intentional adulteration counterpart to the food safety plan under § 117.126; the plan must document the facility's vulnerability assessment, mitigation strategies, monitoring, corrective action, and verification procedures; the plan must be prepared by or under the oversight of a Food Defense Qualified Individual (FDQI), who may (but need not) be the same as the FSMA Preventive Controls Qualified Individual
  • § 121.130 — Vulnerability assessment: the plan must include a written vulnerability assessment for each type of food manufactured; the assessment identifies actionable process steps — points where the food is most susceptible to intentional adulteration that could affect large numbers of people; the rule focuses on four key activity types that historically represent the highest vulnerability across all food processes: (1) bulk liquid receiving and loading, (2) liquid storage and handling, (3) secondary ingredient handling, and (4) mixing and similar activities; a facility may alternatively conduct a full vulnerability assessment using the three-element approach — evaluating (a) the potential for an attack at each step (accessibility, deterrability), (b) the likelihood that contamination would be detected before causing harm (detectability), and (c) the severity of the impact (number of people exposed, severity of illness)
  • §§ 121.135–121.138 — Mitigation strategies: for each actionable process step identified in the vulnerability assessment, the facility must implement one or more mitigation strategies sufficient to significantly minimize or prevent the vulnerability; mitigation strategies may include physical security measures (locked access to bulk liquid storage), personnel security (visitor sign-in, restricted areas, background checks), process controls (physical barriers, tamper-evident seals), or other approaches appropriate to the specific vulnerability; the strategies must be recorded in the food defense plan, must be specific to the actual process step, and must be implemented and monitored
  • §§ 121.140–121.150 — Monitoring, corrective actions, verification: the monitoring/correct/verify triad that runs through all FSMA rules is replicated for food defense: monitoring procedures must be implemented to verify each mitigation strategy is being applied consistently; corrective actions must be taken when monitoring reveals a strategy was not performed; verification activities must confirm the mitigation strategy is working as intended; all records must be retained for at least 2 years

  The Intentional Adulteration rule covers an estimated 3,400+ facilities that handle the bulk liquid and similar high-impact food processes most vulnerable to large-scale attack scenarios. FDA has acknowledged the rule's classified context: the full vulnerability analysis on which the key activity types were based is not publicly disclosed for security reasons. This is the only FSMA rule with a national security dimension — FDA coordinates with USDA, DHS, and intelligence community partners on food defense threats.

• 21 CFR Part 101 — Food labeling: Nutrition Facts panel, ingredient lists, allergen declarations (Big 9: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, sesame), health claims, nutrient content claims, serving size standards

• 21 CFR Parts 170-189 — Food additives framework and approved substance lists: Part 170 (general provisions, GRAS petition process, threshold of regulation), Part 172 (food additives permitted for direct addition to food — the codified list of approved additives with their conditions of use), Part 173 (secondary direct additives — processing aids), Parts 174-178 (indirect additives — food packaging, adhesives, paper and paperboard).

• 21 CFR Part 178 — Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers (47 sections — the FDA-approved list of chemical substances used in food processing as production aids, sanitizers, and polymer adjuvants that contact food but are not intended as direct food additives). Part 178 governs the residual chemicals that come into contact with food through manufacturing processes and packaging materials:

  • § 178.1005 — Hydrogen peroxide solution: hydrogen peroxide at specified concentrations may be safely used to sterilize food packaging materials; used widely in aseptic packaging lines (the process that sterilizes packaging before filling with sterile product in an aseptic environment); the section specifies concentration limits and the requirement that residual peroxide contact surfaces be treated to remove excess before food contact
  • § 178.1010 — Sanitizing solutions: lists specific chemical sanitizing agents that may be safely used on food-processing equipment and utensils without subsequent rinse, and on food-contact surfaces: (a) chlorine-based solutions (sodium hypochlorite, chlorine dioxide — up to 200 ppm available chlorine for non-rinse applications, up to 25 ppm for no-rinse applications); (b) iodine solutions (iodine plus an acid — used in dairy processing); (c) quaternary ammonium compounds (quats — effective against a broad spectrum including Listeria, used in ready-to-eat meat processing); (d) acid-anionic surfactant mixtures; (e) peroxyacetic acid (PAA) solutions — increasingly used as an alternative to chlorine in fresh produce processing because PAA does not form chlorinated byproducts. The no-rinse allowance for listed formulations is the operational permission that allows high-throughput food processing lines to sanitize equipment between production runs without rinse cycles that would slow throughput
  • § 178.2010 — Antioxidants and/or stabilizers for polymers: specific antioxidants and stabilizers (including hindered phenols like BHT and phosphite compounds) may be incorporated into food-contact polymers at specified maximum concentrations to prevent polymer degradation during manufacturing; because these stabilizers may migrate from the polymer into food, FDA evaluated their safety at expected migration levels before listing them
  • § 178.2650 — Organotin stabilizers in vinyl chloride plastics: tributyltin oxide, dibutyltin dilaurate, and related organotin compounds may be used as heat stabilizers in rigid PVC used for packaging non-alcoholic beverages and dry foods; concentration limits are specified to keep migration into food below FDA's threshold of regulation

  Part 178 is one of the CFR's largest food contact lists — not because each section is complex, but because the approved substance list covers hundreds of distinct chemicals and formulations. The food processor's compliance framework for Part 178 is simple in structure: if a sanitizing solution or production chemical is not listed in Part 178 (or otherwise GRAS), it cannot be used in food processing. Compliance is monitored through FSMA cGMP inspections and through supplier documentation of the specific chemical formulations used in the production facility. 21 CFR Part 177 (88 sections) is the heart of this group — the codified approval list for polymers and resins used in food contact materials: acrylic and modacrylic resins, acrylonitrile-butadiene-styrene (ABS) copolymers, cellophane, closures with sealing gaskets, ethylene-vinyl acetate copolymers, polyethylene, polycarbonate resins (§ 177.1580 — the polycarbonate/BPA provision), polystyrene, nylon resins, and dozens of others. Each section specifies the polymer's permitted uses (e.g., repeated-use food contact articles, single-use packaging), any extractive limits ("not to exceed X mg/in²"), and conditions that must be met (maximum temperature, food types, contact duration). § 177.1580 (Polycarbonate resins) — the BPA provision — became the subject of intense regulatory and litigation activity after the FDA concluded in 2012 that BPA is safe at current exposure levels from food contact use, while simultaneously banning BPA in baby bottles and sippy cups (at the industry's own request after voluntary phase-out); FDA's BPA position remains contested in academic literature. The framework for adding a new polymer to the Part 177 list uses a food contact substance (FCS) notification process (21 U.S.C. § 348(h)): a manufacturer submits a notification with identity, intended use, and a safety assessment showing dietary exposure below 0.5 ppb (1/1500th of the no-observed-adverse-effect level); FDA has 120 days to object or the notification becomes effective. Migration testing — measuring how much of a contact material transfers into a food simulant (e.g., 3% acetic acid for acidic foods, 8% ethanol for alcoholic foods, corn oil for fatty foods) under time and temperature conditions representing worst-case use — is the core safety assessment tool; labs must follow FDA's validated extraction protocols, Part 181 (prior-sanctioned ingredients), Parts 182-186 (GRAS substances). 21 CFR Part 172 is the core approved-additive list (153 sections): preservatives (§§ 172.105–172.177 — BHA, BHT, EDTA, propionic acid); coatings and films (§§ 172.210–172.280); special dietary/nutritional additives (§§ 172.310–172.395 — ferrous gluconate, potassium iodide for iodized salt, vitamins); anticaking agents (§§ 172.410–172.480); flavoring agents (§§ 172.510–172.580); gums and gum bases (§§ 172.610–172.695); multipurpose additives (§§ 172.710–172.892 — the largest subpart, including polysorbates, xanthan gum, carrageenan, modified food starch). Each section states the chemical identity, permitted uses, and quantitative limits ("not to exceed X parts per million") — the food manufacturer's legal authorization to use that substance

USDA/FSIS (9 CFR):

• 9 CFR Parts 301-392 — Meat inspection regulations: ante-mortem and post-mortem inspection, Hazard Analysis Critical Control Point (HACCP) systems, labeling, sanitation, food safety assessments

• 9 CFR Parts 381-393 — Poultry products inspection: inspection requirements, HACCP, performance standards for Salmonella and Campylobacter

• 21 CFR Part 117 — Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (FSMA implementation — the cornerstone of modern food safety regulation; requires written food safety plans, hazard analysis, preventive controls, monitoring, corrective actions, and verification; 61 sections)

• 21 CFR Part 110 — Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (baseline cGMP requirements for food facilities: personnel, buildings, equipment, processes; 11 sections)

• 21 CFR Part 113 — Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers: FDA's regulations for the canning industry — specifically the thermal processing (retorting) requirements that prevent botulism (Clostridium botulinum toxin), the most deadly food safety hazard in commercially canned goods:

  • § 113.3 — Definitions: "low-acid food" means any food with a finished equilibrium pH greater than 4.6 and a water activity greater than 0.85 — this covers most canned vegetables, meats, fish, and soups; foods with pH ≤4.6 (high-acid foods like tomatoes and most fruits) are covered by Part 114; "hermetically sealed container" means a container designed to be secure against the entry of microorganisms — conventional metal cans, glass jars with vacuum-sealed lids, retort pouches, and aseptic packages
  • § 113.5 — Good manufacturing practice requirements: the criteria in §§ 113.10, 113.40, 113.60, 113.81, 113.83, 113.87, 113.89, and 113.100 constitute the cGMP standards for thermal processing of low-acid canned foods
  • § 113.10 — Personnel: operators of retorts (the pressure cookers that sterilize canned foods) and container closure inspectors must be supervised by trained and experienced individuals; a Better Process Control School certificate (or equivalent training) is typically required for retort operators; untrained operators managing critical thermal processes is a major FDA enforcement concern
  • § 113.40 — Equipment and procedures: each retort must have a calibrated temperature-indicating device (accurate to 0.5°F or 0.25°C), a timing device, temperature recorder, vent and drain configurations, and procedures documented and posted in the thermal processing room; steam still retorts, water immersion retorts, and aseptic processing systems all have specific equipment requirements reflecting their different heat transfer mechanisms
  • § 113.83 — Establishing scheduled processes: the thermal process (time-temperature combination sufficient to achieve commercial sterility) for each product and container size must be established by a qualified process authority — a person or organization with expert knowledge of thermal processing for low-acid canned foods; process authorities use validated mathematical models and often experimental validation to establish the scheduled process; a canning company cannot self-certify its own processes without a qualified process authority's involvement
  • § 113.87 — Operations in the thermal processing room: posted instructions, real-time recording, and required operating parameters must be followed precisely; deviations from the scheduled process trigger mandatory hold-and-evaluate procedures
  • § 113.89 — Processing deviations: whenever any canned lot has received less than the scheduled process (due to retort malfunction, temperature drop, or other cause), the affected lot must be held and evaluated by a process authority or placed under FDA supervision before any distribution; undistributed lots may be re-processed or destroyed; this provision is why botulism outbreaks from commercial canning are rare — the mandated response to processing deviations catches potentially unsafe product before it reaches consumers
  • § 113.100 — Production records: retort operators must complete production records for each retort run documenting product code, container size, retort number, initial and final product temperatures, venting time, processing temperature, processing time, and critical factors; these records must be retained for the shelf life of the product plus 1 year and must be available to FDA inspectors on request; accurate record-keeping is one of the most consistently cited violations in FDA canning inspections

  Part 113 reflects the historical lesson of early canning disasters — before FDA regulated thermal processing, botulism outbreaks from commercially canned goods occasionally killed dozens of people at once (most notably the 1971 Bon Vivant vichyssoise outbreak that killed two people and led to a nationwide recall of 6 million cans). The regulation's key innovation is the process authority requirement: unlike most food safety rules where companies self-certify their processes, Part 113 requires that each scheduled process be established by an independent expert. FDA registers all commercial processors of low-acid canned foods and requires filing of scheduled processes — allowing FDA to audit whether actual processing matches the filed process.

• 21 CFR Part 114 — Acidified Foods: the FDA regulations for shelf-stable foods produced by adding acid or acidic foods to low-acid ingredients to achieve a finished equilibrium pH of 4.6 or below — pickles, salsa, hot sauce, kimchi, pickled vegetables, vinegar-packed peppers, and similar products. Part 114 is the acidified-food complement to Part 113's thermal processing requirements; where Part 113 uses heat to achieve safety, Part 114 uses acidification (pH ≤ 4.6 inhibits Clostridium botulinum growth):

  • § 114.3 — Definitions: "acidified foods" are low-acid foods (water activity > 0.85, equilibrium pH ≤ 4.6 after acidification) to which acid or acid foods are added; excludes carbonated beverages, jams/jellies/preserves, acid foods where low-acid content doesn't significantly affect pH, and refrigerated products; "low-acid foods" have pH > 4.6 and water activity > 0.85 before acidification
  • § 114.10 — Personnel: all operators of acidified food processing and packaging systems must be supervised by a person who has attended a CGMP-approved school covering food-handling, food-protection principles, personal hygiene, plant sanitation, pH controls, and critical factors in acidification — the same trained-supervisor requirement as Part 113
  • § 114.80 — Processes and controls: acidified food processors must use scheduled processes established by a process authority to ensure the finished equilibrium pH is ≤ 4.6 throughout the product; continuous in-line measurements or end-point pH testing of every batch/lot is required; critical factors (acid concentration, contact time, temperature, product formulation) must be monitored and recorded; deviations require hold-and-evaluate procedures
  • § 114.89 — Deviations from scheduled processes: if any lot fails to receive the scheduled acidification process (pH too high, incorrect acid addition, process interruption), the lot must be held and either re-processed or destroyed; if distributed, an emergency permit under Part 108 is required before future distribution
  • § 114.100 — Records: production records must document pH measurements, critical factor monitoring, and scheduling adherence for each batch; records must be retained for the shelf life of the product plus 1 year; all departures from scheduled processes must be separately logged with the remedial action taken

  Part 114 covers an estimated 5,000+ acidified food manufacturers in the U.S., including both large commercial producers and small specialty food businesses — the artisan pickle and hot sauce sector is the most compliance-challenged segment. FDA registration (under 21 U.S.C. § 415) and filing of scheduled processes with FDA is required before distributing acidified foods. Improper acidification (elevated pH) has caused botulism outbreaks in home-canned goods and, historically, in commercial products; the regulatory framework for acidified foods was established in response to a series of botulism incidents in the 1970s. No major rulemakings since 2000.

• 21 CFR Part 120 — Hazard Analysis and Critical Control Point (HACCP) Systems for Juice (15 sections — FDA's mandatory HACCP regulation for juice processors, the agency's first across-the-board HACCP mandate for a food category and a precursor to FSMA's broader preventive controls framework; finalized 2001 (66 FR 6197) in response to outbreak-driven pathogen concerns; updated 2015 (80 FR 56167) to align with FSMA; authority: 21 U.S.C. §§ 321, 342, 371):

  • § 120.1 — Applicability: any juice sold commercially or used as a beverage ingredient must be processed in compliance with Part 120; "juice" means the aqueous liquid expressed or extracted from one or more fruits or vegetables; applies to domestic processors and to foreign processors who export juice to the United States; the broad definition means Part 120 covers apple cider, orange juice, carrot juice, grapefruit juice, blend products, and any shelf-stable or refrigerated beverage that is juice or contains juice as an ingredient
  • § 120.6 — Sanitation standard operating procedures (SSOPs): each juice processor must have and implement written sanitation SOPs that address sanitation conditions and practices before, during, and after processing; the SSOP must include cleaning and sanitizing procedures for all food-contact surfaces, prevention of cross-contamination, control of employee health and hygiene, and proper labeling and storage of toxic compounds; the SSOP documentation requirement — records of daily sanitation monitoring — is one of Part 120's most frequently cited compliance elements in FDA inspections
  • § 120.7 — Written hazard analysis: each processor must develop a written hazard analysis identifying biological, chemical, and physical hazards that are reasonably likely to occur in each type of juice produced; the hazard analysis must consider both the likelihood of occurrence and the severity of the hazard; identified hazards feed directly into the HACCP plan; the required hazard analysis for juice is more specific than the general hazard analysis under Part 117 (FSMA) because FDA established juice-specific pathogen concerns (E. coli O157:H7 in apple juice, Salmonella in citrus juice, Cryptosporidium in fresh juices) when designing Part 120
  • § 120.8 — Written HACCP plan: whenever the hazard analysis identifies hazards reasonably likely to occur, the processor must develop and implement a written HACCP plan specifying: critical control points; critical limits at each CCP; monitoring procedures and frequencies; recordkeeping requirements; corrective action procedures; and the processor or employee responsible for each function; the HACCP plan must be signed and dated by a senior on-site official; the plan must be reassessed whenever any changes in the process or new information about hazards emerge
  • § 120.9 — Legal basis: failure to have and implement a HACCP system that meets §§ 120.6, 120.7, and 120.8 makes the juice adulterated under FDCA § 402(a)(4) (prepared, packed, or held under conditions that may render it injurious to health) and potentially misbranded under FDCA § 403; the adulteration classification means HACCP non-compliance is a per se food safety violation — FDA does not need to prove a specific health hazard occurred, only that the processor lacked a required HACCP system
  • § 120.10 — Corrective actions: when a deviation from a critical limit occurs, the processor must take corrective action by either: (a) following pre-established written corrective action procedures that ensure the finished product is safe before release; or (b) segregating and holding the affected product, contacting a process authority, and reprocessing or destroying the product as appropriate; all corrective actions must be documented in HACCP records
  • § 120.11 — Verification and validation: each processor must verify that the HACCP system is being implemented as designed; verification activities include reviewing HACCP records, reviewing SSOP monitoring records, calibrating monitoring equipment, and conducting periodic finished product or in-process testing; annual reassessment of the HACCP plan is required; the distinction between verification (is the system being followed?) and validation (does the system actually control the hazard?) is the heart of the scientific rigor requirement
  • § 120.14 — Imported juice: every importer of juice must either (1) obtain juice from a country whose food safety system FDA has determined to be equivalent to the U.S. system, OR (2) annually verify through on-site audits, lot-by-lot certificates, or finished product testing that the juice was produced under a HACCP system equivalent to Part 120; the importer verification requirement was strengthened to address a gap where domestic processors bore the HACCP burden while imported juice faced lighter scrutiny
  • § 120.24 — Process controls — 5-log pathogen reduction: the most consequential technical requirement; juice processors must include in their HACCP plans control measures that will consistently produce, at minimum, a 5-log (100,000-fold) reduction of the "pertinent microorganism" — the pathogen most resistant to the control measure that is most likely to occur in the juice; for apple juice, the pertinent organism is E. coli O157:H7 (or a surrogate organism in validation testing); the 5-log standard effectively requires pasteurization or an equivalent validated alternative treatment; raw (unpasteurized) juice may only be sold if it bears a consumer warning label stating that it has not been pasteurized and may harm certain individuals

  Part 120 was FDA's direct regulatory response to the 1996 Odwalla outbreak — fresh apple juice contaminated with E. coli O157:H7 sickened at least 70 people across multiple states and killed a 16-month-old child. Before Part 120, FDA had only voluntary HACCP guidance for juice processors and had relied primarily on warning labels for unpasteurized juice (which began in 1998 under 21 CFR § 101.17(g)). The 5-log reduction standard in § 120.24 drove widespread adoption of pasteurization in the apple juice and cider industries and ended the large-scale commercial distribution of untreated fresh-pressed juice without a consumer warning. The 2015 update (80 FR 56167) harmonized Part 120 with FSMA's Part 117 preventive controls framework — processors subject to Part 120 must still maintain separate Part 120 HACCP plans even if they also have FSMA food safety plans, though some provisions may be satisfied by the FSMA plan if the hazard analysis and CCPs cover juice-specific pathogens.

• 21 CFR Part 179 — Irradiation in the Production, Processing and Handling of Food: the FDA regulations governing the use of ionizing radiation, radiofrequency radiation, and ultraviolet light in food production — both for treating food to kill pathogens and insects, and for using radiation-based inspection and heating technology:

  • § 179.21 — Inspection sources: X-ray tubes (≤500 kVp), sealed radioisotope units (americium-241, cesium-137, cobalt-60, iodine-125, krypton-85, radium-226, strontium-90 at ≤2.2 MeV), californium-252 neutron sources for moisture measurement, and machine X-ray sources (≤10 MeV) may be used for food inspection and process control
  • § 179.25 — General provisions for food irradiation: any firm treating food with ionizing radiation must comply with Parts 110 and 117 (cGMP and FSMA Preventive Controls); food must receive the minimum dose required to accomplish its technical effect, not to exceed the applicable maximum; each irradiation application must follow a scheduled process documenting that the selected dose range is adequate and does not exceed the approved maximum; dose mapping (measuring actual dose distribution throughout the food product) must be conducted
  • § 179.26 — Ionizing radiation for treatment of food: the core approved-use table — energy sources limited to cobalt-60 or cesium-137 gamma rays, electron beams (≤10 MeV), and X-rays (≤5 MeV, or ≤7.5 MeV with tantalum/gold target). Approved applications with dose limits: Trichinella spiralis in pork (0.3–1 kGy); growth inhibition of fresh produce (≤1 kGy); arthropod pest disinfestation (≤1 kGy); microbial disinfection of dried enzyme preparations (≤10 kGy); mold control in dry spices/seasonings (≤30 kGy); pathogen reduction in fresh/frozen uncooked poultry (1.5–3 kGy); pathogen reduction in refrigerated/frozen red meat (1.5–4.5 kGy); Salmonella control in frozen molluscan shellfish (≤5.5 kGy); fresh iceberg lettuce and fresh spinach (≤4 kGy)
  • § 179.30 — Radiofrequency/microwave heating: electronic equipment producing FCC-authorized radio waves may be used wherever heat is necessary and effective for processing food — this is the FDA authorization for commercial microwave heating in food processing
  • § 179.39 — Ultraviolet radiation: UV radiation at 253.7 nanometers may be used for treating the surface of food, equipment, and packaging materials, and for treating water that is used in contact with food; UV is used for surface pasteurization of fresh produce, sanitizing food contact surfaces, and treating process water

  Food irradiation is one of FDA's most science-validated but consumer-controversial food safety technologies. Irradiated food must be labeled with the international radura symbol and the statement "treated with radiation" or "treated by irradiation." Despite strong food safety evidence — irradiation eliminates E. coli O157:H7, Salmonella, Listeria, and Campylobacter at approved doses — consumer acceptance has been slow, limiting commercial adoption primarily to ground beef, fresh spinach/iceberg lettuce, and spices. The spice irradiation market is the largest commercial application: roughly 90% of spices sold in the U.S. are irradiated. No major rulemakings since 2001.

• 21 CFR Part 109 — Unavoidable Contaminants in Food for Human Consumption and Food-Packaging Material: the FDA's regulatory framework for managing "added" poisonous or deleterious substances that cannot be entirely eliminated from the food supply — pesticide residues from environmental deposition, industrial chemicals that contaminate crops or fish, heavy metals that accumulate in soil and water, and industrial byproducts that migrate from food packaging. Part 109 establishes the three-tier system (tolerances, regulatory limits, and action levels) FDA uses to address unavoidable contamination. Key provisions:

  • § 109.3 — Definitions: an "added" poisonous or deleterious substance is one that is not an inherent natural constituent of the food, including naturally occurring substances increased to abnormal levels through mishandling; a "tolerance" is a legally binding maximum set by regulation; a "regulatory limit" is also binding; an "action level" is an enforcement guidance level — not binding as a legal standard but used by FDA to decide when to take action against shipments
  • § 109.4 — Framework for setting tolerances, regulatory limits, and action levels: FDA may set tolerances under section 406 of the FDCA for substances that cannot be entirely avoided; regulatory limits may be set under section 402(a)(1) for adulterated food; action levels (§ 109.4(c)) are established where formal rulemaking is not yet complete — action levels give industry and FDA guidance on the level at which FDA will routinely initiate enforcement while the formal tolerance rulemaking proceeds; action levels can be changed by FDA without rulemaking
  • § 109.6 — Unavoidability standard: tolerances and action levels reflect what is unavoidable given current agricultural practices and food processing technology — they do not establish a safe level of contamination; compliance with an action level does not excuse violations of cGMP requirements; manufacturers must reduce contamination to the lowest level currently feasible regardless of action levels
  • § 109.15 — PCB tolerances in food-packaging materials: polychlorinated biphenyls (PCBs) are persistent organic pollutants banned from new production under TSCA but still present in recycled paper used for food packaging; the rule established tolerances for PCB migration from packaging into food — PCB residues in recycled paper food-contact materials cannot exceed specified limits
  • § 109.16 — Lead in ornamental and decorative ceramicware: ceramicware with leaded glazes or decorative decals must bear conspicuous labels ("Not for Food Use. May Poison Food") if it is not certified to meet FDA lead leaching standards; this provision addresses a persistent source of lead exposure from imported decorative pottery

  Part 109 operates in tandem with FDA's separately published action levels for poisonous or deleterious substances — guidance documents that specify the contamination levels at which FDA will exercise jurisdiction over food. Current FDA action levels include: aflatoxins (20 ppb in human food), lead in fruit juices (10-50 ppb depending on product), arsenic in apple juice (10 ppb), and mercury in commercial fish (1 ppm methyl mercury). Recent rulemakings: 88 FR 45065 (July 2023) addressed lead action levels for processed food for babies and young children, implementing the FDA's Closer to Zero action plan for lead, arsenic, cadmium, and mercury in infant and toddler foods.

• 21 CFR Part 589 — Substances Prohibited from Use in Animal Food or Feed: the FDA's list of ingredients banned from animal feed because they present a risk to public health or have not been demonstrated safe. The most consequential provisions implement the U.S. firewall against bovine spongiform encephalopathy (BSE, or "mad cow disease"):

  • § 589.1 — General framework: any animal food or feed containing a substance listed in Part 589 is adulterated under the Federal Food, Drug, and Cosmetic Act; selling or distributing adulterated animal feed is a federal violation regardless of whether any animal disease or human illness results; Part 589 is a partial list — other substances may be adulterated under general FDCA standards even if not specifically named
  • § 589.1000 — Gentian violet: banned from all animal feed; FDA determined it has not been shown safe by adequate scientific data; use causes the feed to be adulterated per FDCA § 409 unless covered by an active investigational food additive exemption
  • § 589.1001 — Propylene glycol in or on cat food: specifically banned from cat food (propylene glycol is permitted in dog food and some human food applications); cats metabolize propylene glycol differently than dogs and humans, and FDA determined the exposure in cat food creates Heinz body anemia risk; the ban is species-specific — propylene glycol in dog food or livestock feed is not prohibited by this section
  • § 589.2000 — Animal proteins prohibited in ruminant feed (the BSE ruminant feed ban): prohibits feeding mammalian-derived protein to ruminants (cattle, sheep, goats, deer, elk, and other ruminant species); implemented in August 1997 in response to the UK BSE epidemic; the ban blocks the prion disease amplification cycle — BSE spreads when cattle are fed meat-and-bone meal made from infected cattle carcasses; key exemptions from the protein definition: blood and blood products, pure gelatin, tallow with ≤0.15% insoluble impurities, inspected meat already heat-processed for human food then further heat-processed for feed (plate waste), milk products, and single-source non-mammalian protein; the ban applies throughout the feed distribution chain — feed mills that produce ruminant feed must follow strict equipment cleaning and labeling protocols if they also handle non-ruminant feeds that contain mammalian protein
  • § 589.2001 — Cattle materials prohibited in all animal food or feed (the BSE enhanced feed ban, effective 2009): expands beyond the ruminant-to-ruminant prohibition to ban specific specified risk materials (SRMs) from the food or feed of all animals — not just ruminants — including companion animals and poultry; banned cattle-origin materials: (i) entire carcasses of BSE-positive cattle; (ii) brains and spinal cords of cattle 30 months of age or older (highest prion concentration in older cattle); (iii) entire carcasses of cattle not inspected and passed for human consumption; (iv) mechanically separated beef from the skull and vertebral column; (v) tallow that does not meet the insoluble impurities standard; the 30-month age threshold for brain/spinal cord is critical — most beef cattle are slaughtered before 30 months, so the practical impact falls primarily on dairy cattle carcasses and older animals

  The BSE feed bans represent one of the most consequential U.S. food safety regulatory actions of the past 30 years. The 1997 ruminant feed ban was implemented proactively, before any domestic BSE cases were confirmed, based on the UK epidemic's lessons — a rare instance of preventive rather than reactive U.S. food safety regulation. When the first U.S. BSE case was detected in December 2003 (a Canadian-born dairy cow in Washington State), the existing feed ban was credited with limiting the risk of amplification. The 2009 enhanced ban closed additional pathways by removing high-risk cattle materials from the entire animal food chain, not just ruminant feed. The U.S. has had only 6 confirmed BSE cases total (all atypical or imported), a significantly lower rate than the UK's epidemic of 180,000+ cases. Recent rulemakings: 74 FR 756 (January 2009) — the 2009 enhanced BSE feed ban (§ 589.2001).

• 21 CFR Part 106 — Infant Formula CGMP, Quality Control, and Notification Requirements. The FDA regulations implementing 21 U.S.C. § 350a, which established heightened infant formula oversight after the 1980 Syntex recall (low-chloride formula causing metabolic alkalosis in infants). Key provisions:

  • § 106.5 — CGMP framework: minimum current good manufacturing practice standards for all infant formula manufacturing; CGMP violations deem a formula adulterated under FD&C Act § 412(a)(3)
  • § 106.10 — Worker controls: sufficient qualified personnel for all manufacturing operations; good personal hygiene and health screening to prevent contamination; workers with illness or open lesions excluded from direct formula contact
  • § 106.55 — Microorganism controls: manufacturers must establish a system of process controls at all stages designed to prevent microbial contamination — the regulatory hook triggered by Cronobacter sakazakii contamination at Abbott's Sturgis, Michigan plant in 2021–2022
  • § 106.70 — Production aggregate quarantine: each production aggregate must be held under a quarantine system until testing confirms compliance with all specifications — no finished formula may be distributed until cleared; the quarantine requirement is the mechanism by which a lot recall is triggered when testing fails
  • § 106.80 — Traceability: each production aggregate receives a sequential code enabling full trace-back through all manufacturing stages; the traceability requirement makes lot-specific recalls possible
  • § 106.91 — Nutrient testing: each production aggregate must be tested for nutrients both during manufacture (for each nutrient premix) and at end of shelf life (to confirm nutrient stability); testing failures can trigger hold or recall
  • § 106.96 — Quality factors: infant formula must meet the quality factor of supporting "normal physical growth" in infants; manufacturers must provide clinical data establishing the formula's adequacy for this purpose
  • § 106.110 — Pre-market registration: before any new infant formula may be introduced into commerce — including exports — the manufacturer must register with FDA's Center for Food Safety and Applied Nutrition; registration is a threshold requirement, not an approval
  • § 106.120 — 90-day pre-market submission: at least 90 days before introducing a new infant formula, the manufacturer must submit a notice with a full ingredient listing, nutrient content, quality control procedures, and a description of manufacturing steps; FDA reviews (but does not formally approve) the submission and may object if it raises adulteration concerns
  • § 106.140 — Change notification: any formulation or processing change that may affect whether the formula is adulterated requires a submission before the changed formula enters commerce; changes that are unlikely to affect adulteration must still be reported at the next required submission
  • § 106.150 — Adulteration/misbranding notification: a manufacturer that has actual knowledge that its formula is adulterated or misbranded must promptly notify FDA — typically triggering a recall

  The 2021–2022 Abbott Nutrition crisis illustrates Part 106's enforcement significance. Abbott's Sturgis plant manufactured approximately 40% of U.S. powdered infant formula; FDA's 2022 inspection found Cronobacter sakazakii in the environment, inadequate sanitation procedures, and standing water near formula-processing equipment — each a violation of §§ 106.20 and 106.55. The plant shutdown following the February 2022 recall (covering Similac, Alimentum, and EleCare brands) produced a nationwide shortage that required emergency imports and Defense Production Act activation. Congress subsequently passed legislation requiring FDA to adopt enhanced CGMP standards specific to infant formula and created new recall authority for formula safety events. Recent rulemakings: 79 FR 8059 (February 2014) — the final CGMP rule implementing the 2011 FSMA requirements for infant formula; 88 FR 17718 (March 2023) — post-Abbott amendments addressing Cronobacter-specific testing and environmental monitoring.

How It Works

Food safety regulation in the United States is split between two agencies — FDA and USDA — using frameworks that evolved from crisis responses over more than a century, modernized most recently by the FDA Food Safety Modernization Act (2011).

Food safety regulation is split between two agencies along product lines. FDA regulates approximately 80% of the food supply — all foods except meat, poultry, and certain egg products, including produce, dairy, seafood, packaged foods, dietary supplements, infant formula, food additives, and food contact materials. USDA's Food Safety and Inspection Service (FSIS) regulates meat, poultry, catfish, and processed egg products with continuous facility inspection — an inspector must be present whenever a slaughter plant operates. The split creates jurisdictional oddities: an open-faced meat sandwich is USDA; a closed-face meat sandwich is FDA; pepperoni pizza is FDA unless it exceeds a meat threshold. The 2011 Food Safety Modernization Act (FSMA) — the most significant food safety legislation in 70 years — fundamentally shifted FDA from reacting to outbreaks to preventing them. Its core rules: Preventive Controls for Human Food requires written food safety plans with hazard analysis, process and allergen controls, monitoring, corrective action, and verification; Produce Safety sets science-based standards for growing, harvesting, and handling fruits and vegetables; Foreign Supplier Verification requires importers to confirm foreign suppliers meet U.S. standards; and Intentional Adulteration addresses food defense against deliberate contamination.

FDA requires extensive labeling on packaged foods — the Nutrition Facts panel, ingredient list (in descending order of predominance), allergen declarations covering the 9 major allergens (milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame, added by the FASTER Act of 2021), net quantity, manufacturer identification, and authorized health or nutrient content claims. When contaminated food reaches consumers, recalls are the primary corrective tool. Most are voluntary — FDA requests and companies comply — but FSMA gave FDA mandatory recall authority if a company refuses (previously only USDA had that power for meat/poultry). Recalls are classified by severity: Class I (reasonable probability of serious health consequences or death), Class II (temporary or reversible effects), and Class III (unlikely to cause adverse effects). Recent high-profile recalls have involved romaine lettuce (E. coli), peanut products (Salmonella), and infant formula (Cronobacter).

How It Affects You

If you're a consumer who buys food and wants to know about recalls: The most important tool is signing up for FDA and USDA recall alerts before there's a problem. At fda.gov/food/recalls-outbreaks-emergencies, you can sign up for RSS, email, or text alerts for food recalls and safety warnings. USDA/FSIS recall notices are at fsis.usda.gov/recalls. When a Class I recall is announced (the most serious — where there is a reasonable probability that eating the food will cause serious health consequences or death), stop eating the recalled product immediately. Class I recalls include contamination with E. coli O157:H7, Listeria monocytogenes, Salmonella, or undeclared allergens — the pathogens responsible for the most hospitalizations. Photographing the product and UPC code helps with matching against the recall description.

For outbreak tracking: CDC's Foodborne Outbreak Online Database (FOOD) at cdc.gov/foodsafety/fdoss is updated regularly. If you get sick after eating a specific food and believe it caused illness, report it to your state health department and file a MedWatch report with FDA at fda.gov/medwatch or by calling 1-800-FDA-1088. Your report contributes to outbreak detection — the CDC's surveillance systems depend on individual reports to identify clusters. You may also contact the food manufacturer directly and document your illness if you're considering legal action; however, proving foodborne illness causation requires a physician's diagnosis and, ideally, a matching laboratory test or identified outbreak. For significant illness, consult a personal injury attorney — contaminated food cases against large manufacturers are frequently class actions.

If you or a family member has a serious food allergy: The 9 major allergens required to be declared on all packaged food labels (added to products on or after January 1, 2023 for sesame) are: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame (the newest, added under the FASTER Act of 2021). These declarations must appear in plain English in the ingredient list or a "Contains: [allergen]" statement. The key practical point: the law requires a declaration — it does not require separation. A product may contain traces of your allergen through shared manufacturing equipment without being recalled, as long as the facility voluntarily discloses through "may contain" or "manufactured in a facility that also processes" advisory statements. These advisory statements are completely voluntary — there is no FDA standardization of their wording and no legal threshold for when they must be used. The practical consequence: two products with identical levels of cross-contamination risk may have very different advisory labels based entirely on the manufacturer's disclosure policy. For those with anaphylaxis risk, review both the ingredient list and any advisory statements, and when in doubt, contact the manufacturer.

To report an undeclared allergen — a product that doesn't list an allergen that's actually in it — file a complaint with FDA at fda.gov/food/report-problem or call 1-800-FDA-1088. Undeclared allergens are a frequent cause of Class I recalls (the most serious level) because of the direct risk to allergic consumers.

If you run a food manufacturing facility or farm subject to FSMA: FSMA compliance is the law for virtually all food facilities and produce farms above specified size thresholds. The core FSMA obligation for manufacturing is the Hazard Analysis and Risk-Based Preventive Controls (HARPC) plan under 21 CFR Part 117 — a written food safety plan that must include: (1) hazard analysis identifying biological, chemical, physical, and radiological hazards; (2) preventive controls for each significant hazard (process controls, allergen controls, sanitation controls, supply chain controls); (3) monitoring procedures; (4) corrective actions; and (5) verification activities. FDA inspects registered food facilities on a risk-based schedule — higher-risk facilities approximately every 3 years, lower-risk every 5. If FDA inspection results in an FDA-483 observation letter (a list of inspectional observations), respond in writing within 15 business days with your corrective action plan. Failure to respond promptly and meaningfully invites escalation to a Warning Letter (publicly posted on FDA's website and a significant business risk) or to enforcement action.

Produce farms face the Produce Safety Rule (21 CFR Part 112), which covers agricultural water quality testing, biological soil amendments (no raw manure within 9 months of harvest), worker health and hygiene, and domesticated and wild animal intrusion. FDA has modified implementation timelines for agricultural water standards — verify your applicable compliance date at fda.gov/food/food-safety-modernization-act-fsma. The FDA's Food Safety Preventive Controls Alliance (FSPCA, at iit.edu/fspca) provides industry-recognized preventive controls training required for your Preventive Controls Qualified Individual (PCQI) — every facility must have one.

If you import food into the United States: The Foreign Supplier Verification Program (FSVP) requires you, as the importer of record, to develop and implement a documented FSVP for each imported food product from each foreign supplier. At minimum: conduct a hazard analysis for each food, determine what supplier verification activities are needed (supplier audit, certificate of analysis, food safety records, product testing), verify that the foreign supplier meets process and product standards equivalent to U.S. requirements, and maintain documentation for FDA review. FSVP records must be maintained for at least 2 years and produced to FDA within 24 hours of a request.

At the border: FDA uses a risk-based algorithm (PREDICT) to assess import entries and decide which shipments to examine. If your supplier or product is flagged as high-risk, FDA may detain the shipment for sampling and testing. A Detention Without Physical Examination (DWPE) — colloquially an "import alert" — means FDA will automatically detain all future shipments from that supplier without individual examination until you demonstrate the problem is corrected (typically by submitting 5 consecutive clean private lab results showing the problem no longer exists). Check whether your suppliers are already on import alert at fda.gov/consumers/import-alerts before completing purchase orders — import alerts are publicly searchable by product, country, and firm.

State Variations

• State departments of agriculture and health inspect retail food establishments (restaurants, grocery stores) — about 3 million establishments
• State food safety laws supplement federal requirements and may be more stringent
• Some states have cottage food laws allowing home-based food production with limited regulation
• State laboratory networks test food samples and investigate outbreaks
• State Departments of Agriculture handle some food labeling enforcement

Pending Legislation

• S 376 / HR 852 — Expanded Food Safety Investigation Act. Grants FDA authority to conduct food safety sampling at concentrated animal feeding operations (CAFOs). Status: Introduced.
• HR 512 — Imported Seafood Safety Standards Act. Strengthens safety standards and inspection requirements for imported seafood products. Status: Introduced.

Recent Developments

• FDA has proposed a unified "Human Foods Program" reorganization to consolidate its food safety, nutrition, and food labeling functions under a single deputy commissioner
• PFAS contamination in food and food packaging has emerged as a safety concern, with FDA and states investigating levels in produce, dairy, meat, and food contact materials
• Lab-grown/cell-cultivated meat received FDA and USDA regulatory framework approval (2023), with initial products reaching limited markets
• AI and technology-enabled food safety monitoring (predictive outbreak detection, blockchain traceability) is being deployed across the supply chain
• FSIS published a Federal Register notice in March 2026 establishing a uniform compliance date for food labeling regulations, streamlining the transition timeline for industry compliance with updated labeling requirements.
• In February 2026, FDA published final regulations on laboratory accreditation for food analyses under Section 422 of the FD&C Act, establishing requirements for laboratories participating in federal food testing programs to ensure analytical reliability and consistency.