FDA Interstate Food Safety Controls — Raw Milk Ban, Turtle Sale Prohibition, and Parrot Psittacosis Rules

21 CFR Part 1240 — Control of Communicable Diseases — is the FDA's authority to prevent specific foods, animals, and products from becoming vectors for disease transmission across state lines. Three provisions define the practical scope of the rule:

1. § 1240.61 prohibits delivery of unpasteurized milk into interstate commerce — the federal legal basis for the prohibition on selling raw milk across state lines that has defined the raw milk debate in the United States since 1987.
2. § 1240.62 bans the sale or distribution of live turtles with a shell length less than 4 inches — a prohibition in place since 1975, prompted by Salmonella outbreaks linked to small pet turtles that killed children.
3. § 1240.65 requires psittacine birds (parrots, parakeets, macaws, cockatoos, and related species) transported in interstate commerce to be certified disease-free for psittacosis — a bacterial infection (Chlamydia psittaci) that can be transmitted to humans.

Together, these provisions use the federal commerce power to enforce public health standards that individual states have been unwilling or unable to maintain uniformly.

Legal Authority

• 21 U.S.C. § 264 — Public Health Service Act § 264: authorizes the Secretary of HHS to make regulations to prevent the spread of communicable disease through interstate commerce and into foreign countries; the foundational authority for FDA's communicable disease controls on food and animals
• 21 U.S.C. § 331 — FDCA § 301: prohibits introduction of adulterated food into interstate commerce; the basis for FDA's authority to ban raw milk and other food products presenting communicable disease risks
• 21 CFR Part 1240 — FDA regulations implementing interstate communicable disease controls; covers raw milk pasteurization requirements, turtle sale prohibitions, parrot psittacosis rules, and shellfish controls

Key Mechanics

Part 1240 operates through categorical bans and permit requirements on specified products and animals that present communicable disease risks. The raw milk ban (§ 1240.61) is absolute for interstate commerce — no raw milk may be shipped across state lines regardless of state law, labels, or consumer preference. The turtle ban (§ 1240.62) prohibits live turtles with shells less than 4 inches (the size small children can put in their mouths) in interstate commerce. These rules are enforced through customs interceptions, FDA inspections, and warning letters or criminal referrals for violations; the FDA does not issue permits that would authorize sale of covered prohibited products.

Current Rule (2026)

What This Rule Does

Part 1240 is organized around the Public Health Service Act's grant of authority to prevent the interstate transmission of communicable disease. Unlike CDC's quarantine regulations (42 CFR Parts 70 and 71), which address individual travelers and carriers, Part 1240 addresses specific products and animals that have been identified as recurring vehicles for disease spread in interstate commerce.

The Raw Milk Pasteurization Mandate (§ 1240.61)

The centerpiece of the rule: no person may deliver into interstate commerce, sell, distribute, or hold for sale any milk or milk product in final package form for direct human consumption unless the product has been pasteurized. This means that raw (unpasteurized) milk cannot legally be sold across state lines, shipped by mail, or moved in any commercial transaction that constitutes interstate commerce — regardless of whether the source state permits its own intrastate raw milk sales.

The prohibition applies to all milk and milk products in final package form — fluid milk, cream, half-and-half, butter, soft cheeses made from raw milk, and similar products. Hard cheeses aged 60 days or more are subject to FDA enforcement discretion under a separate policy; the raw milk cheese exemption reflects the historical practice and the theory that 60-day aging reduces pathogen loads, though this is contested.

The legal history: FDA proposed the interstate raw milk ban in 1984 following litigation brought by Public Citizen, Inc., which argued that FDA had an obligation to use its authority to prevent raw milk-associated disease outbreaks. The final rule took effect August 10, 1987 (52 FR 29509). States have responded in a range of ways: some permit intrastate sale of raw milk through retail stores (California, Arizona, New Mexico, New Hampshire, and about 20 others), some allow only farm-direct sales or herd shares, and some prohibit raw milk sales entirely. The federal rule leaves those intrastate arrangements intact — it only bars interstate movement.

Raw milk advocacy groups (including the Farm-to-Consumer Legal Defense Fund) have repeatedly challenged the interstate ban in federal court, arguing that FDA exceeded its authority and that the science does not support the prohibition. These challenges have been uniformly rejected by federal courts on the grounds that FDA acted within its delegated statutory authority. Raw milk is associated with outbreaks of E. coli O157:H7, Campylobacter, Salmonella, Listeria, and Brucella — pathogens that cause serious illness and are more common in raw milk than in pasteurized products because pasteurization eliminates them reliably. CDC estimates that raw milk causes 840 times more illnesses and 45 times more hospitalizations than pasteurized milk.

The Small Turtle Ban (§ 1240.62)

The turtle provision bans the sale, distribution, or offer for transportation in interstate commerce of any viable turtle (including tortoises, terrapins, and all members of the order Testudinata except marine species) with a shell length less than 4 inches (10.2 cm), unless the turtle is sold for bona fide scientific, educational, or exhibitional purposes.

The 4-inch threshold is not arbitrary: small turtles are particularly likely to be handled by children, who then touch their mouths before washing their hands. Turtles commonly carry Salmonella enterica asymptomatically on their shells and in their feces — the bacteria cannot be eliminated from the animal, and even clean-appearing turtles harbor it. Between 1970 and 1975, FDA estimated that pet turtles were responsible for 14% of all human Salmonella infections in the United States — approximately 280,000 cases annually. Children under 5, who are most likely to handle small animals and least likely to wash their hands consistently, bear a disproportionate share of the illness and death.

The 4-inch rule was established in 1975. It has been consistently enforced, though the pet trade has continued to sell small turtles in violation of the rule; FDA and CDC have periodically issued enforcement actions and public warnings when turtle-associated Salmonella outbreaks are linked to small turtles sold at flea markets, carnivals, and online. Interstate shipments of small turtles are subject to seizure. The ban on intrastate sales is also authorized under § 1240.62(b), giving it broader effect than most FDA food safety rules, which rely solely on the interstate commerce nexus.

The Psittacine Bird Requirement (§ 1240.65)

No person may transport psittacine birds in interstate commerce unless the shipment is accompanied by documentation certifying that the birds have been examined and are free of evidence of psittacosis (ornithosis), or have been treated for psittacosis. Psittacosis is caused by Chlamydia psittaci — a bacterial pathogen that can be transmitted from psittacine birds (parrots, parakeets, macaws, cockatoos, lovebirds, lorikeets, and related species) to humans through inhalation of aerosolized bird feces or respiratory secretions. In humans, psittacosis causes fever, headache, and pneumonia; before antibiotic treatment was available, it was sometimes fatal.

The psittacosis rule requires either: (1) a licensed veterinarian's examination certificate stating the birds show no signs of psittacosis; or (2) documentation that the birds have been treated with tetracycline or doxycycline at therapeutic doses for the duration required to suppress Chlamydia psittaci carriage. This creates a pre-movement health clearance system for the psittacine bird trade — requiring veterinary certification before birds change hands across state lines.

Key Provisions

• § 1240.10 — Effective bactericidal treatment: whenever Part 1240 requires bactericidal treatment (of equipment, utensils, or conveyance surfaces), it must be accomplished by: immersion in hot water at ≥170°F for at least 2 minutes; immersion in boiling water for at least 30 seconds; or application of a chemical germicide approved by FDA; this establishes the baseline sanitation standard against which compliance is measured

• § 1240.30 — Federal override of inadequate state control: when FDA's Commissioner determines that state or local health authority measures are insufficient to prevent the spread of communicable disease interstate, FDA may take additional measures — including federal inspection, condemnation, and quarantine of products; this provision creates FDA's authority to act unilaterally when state public health systems fail; it was the legal basis for early FDA enforcement of the raw milk ban in states that resisted implementing it

• § 1240.45 — Report of disease on conveyances: the master of any vessel or person in charge of any conveyance engaged in interstate traffic must notify local health authorities at the next port of call if a case or suspected case of communicable disease develops aboard; this reporting requirement complements CDC's airline and vessel illness reporting requirements under 42 CFR Parts 70–71

• § 1240.60 — Molluscan shellfish: no person may transport in interstate commerce any molluscan shellfish (oysters, clams, mussels, scallops) handled or stored in insanitary conditions, or grown in contaminated areas, that are likely to become vehicles for communicable disease; this provision is implemented through the National Shellfish Sanitation Program (NSSP), under which FDA certifies state shellfish programs and publishes the Interstate Certified Shellfish Shippers List — commercial buyers can verify that shellfish comes from certified sources

• § 1240.61 — Interstate raw milk ban: no person shall deliver into interstate commerce or sell any milk or milk product in final package form for direct human consumption unless pasteurized; covers all milk and milk products (including cream, half-and-half, and milk-based beverages) in consumer-retail packaging intended for direct consumption; does not cover industrial bulk milk shipped for further processing (though that milk is subject to other FDA requirements)

• § 1240.62(b) — Small turtle sales prohibition: no person shall sell or distribute, in intrastate or interstate commerce, any live turtle with a shell length less than 4 inches, except for bona fide scientific, educational, or exhibitional purposes; FDA may exempt specific research institutions, zoos, and educational programs from the prohibition

• § 1240.65 — Psittacine bird transportation requirements: psittacine birds moving in interstate commerce must be accompanied by: (a) a certificate from a licensed veterinarian that the birds were examined and showed no evidence of psittacosis; or (b) a certificate from a licensed veterinarian or state/federal official that the birds have been treated with an approved regimen (typically 45 days of tetracycline-impregnated feed) effective against Chlamydia psittaci

• § 1240.75 — Swine garbage feeding prohibition: no person may transport garbage in interstate commerce and feed it to swine unless the garbage has received minimum heat treatment (steam processing at 212°F for 30 minutes, or equivalent) before feeding; this is a foreign animal disease prevention measure — foot-and-mouth disease, swine vesicular disease, and African swine fever can be transmitted to pigs through improperly treated food waste containing meat scraps from infected animals; many states have parallel state laws covering intrastate garbage feeding (called "swill cooking" laws)

• §§ 1240.80–1240.95 — Potable water on conveyances: operators of interstate conveyances (trains, vessels, aircraft, buses) must provide only potable water for drinking and culinary purposes; water must come from FDA-approved watering points or be treated aboard the conveyance under FDA-approved methods; backflow prevention between nonpotable vessel water systems and pier potable water systems is required; this overlaps with the FDA's Interstate Conveyance Sanitation rules at 21 CFR Part 1250

How It Affects You

If you produce or sell milk: the interstate raw milk ban is absolute for consumer-packaged milk. If you make and sell raw milk or raw milk cheese within a single state and do not ship across state lines, FDA's § 1240.61 does not directly apply — your state law governs. But if you ship raw milk products to another state (including via mail order, online sales, or delivery services that cross state lines), you are violating § 1240.61. Raw milk advocacy groups that have advised producers on mail-order raw milk sales have seen FDA warning letters and enforcement actions follow. The growing raw milk market — particularly driven by the farm-to-consumer movement — has created pressure to revisit this rule; advocates argue that FDA's 1987 science is outdated and that informed adults should have the right to purchase raw dairy. FDA's position, supported by CDC epidemiology, remains that the disease burden from raw milk cannot be adequately managed by consumer choice alone given the severity of E. coli O157:H7 and Listeria monocytogenes infections.

If you sell or distribute turtles: the small turtle rule is among the oldest consistently enforced FDA prohibitions still generating active enforcement. Flea markets, boardwalk vendors, pet stores, and online sellers that sell small turtles face FDA seizure authority and state attorney general enforcement (since many states have adopted parallel provisions). The prohibition applies to the turtles themselves, not just to Salmonella-positive turtles — the rule is categorical (size-based) because Salmonella carriage cannot be reliably detected or eliminated in individual animals. Turtles sold for scientific or educational purposes must be accompanied by documentation establishing the purpose and go to institutions with appropriate biosafety protocols.

If you import or ship psittacine birds: veterinary certification is required before interstate transport. The 45-day tetracycline treatment protocol (for birds that cannot be cleared as free of psittacosis) is operationally significant for bird breeders shipping birds between facilities in different states; the treatment protocol must be documented, and the documentation must travel with the birds. USDA/APHIS has separate authority over psittacine bird imports from foreign countries; the FDA Part 1240 requirements apply to domestic interstate movement.

Statutory Authority

This rule implements:

• 42 U.S.C. § 264 — Surgeon General's (delegated to FDA for food and product-specific measures) authority to make and enforce regulations necessary to prevent the introduction, transmission, or spread of communicable diseases from one state to another; the commerce-based disease prevention authority is what gives FDA jurisdiction over raw milk, turtles, and psittacine birds moving in interstate commerce
• 42 U.S.C. § 216 — FDA rulemaking authority under the Public Health Service Act; provides the general authority for FDA to promulgate regulations necessary to carry out its public health functions

Recent Rulemakings

• 57 FR 57344 (December 4, 1992) — Administrative amendments updating references and clarifying definitions; no substantive policy changes to the core prohibitions
• 52 FR 29509 (August 10, 1987) — The original raw milk interstate ban final rule; the most consequential Part 1240 rulemaking; FDA responded to Public Citizen, Inc. v. Heckler (D.D.C. 1985), which found FDA's failure to act on the raw milk hazard arbitrary; the 1987 rule has not been substantively amended despite ongoing advocacy for its revision

The core provisions — raw milk ban (§ 1240.61), small turtle ban (§ 1240.62), and psittacosis certification (§ 1240.65) — have been stable for decades. The turtle rule in particular has not been modified since 1975. Courts have repeatedly upheld all three provisions against constitutional and statutory challenges.

Pending Action