21 C.F.R. § 1240.61

Mandatory pasteurization for all milk and milk products in final package form intended for direct human consumption

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(a) No person shall cause to be delivered into interstate commerce or shall sell, otherwise distribute, or hold for sale or other distribution after shipment in interstate commerce any milk or milk product in final package form for direct human consumption unless the product has been pasteurized or is made from dairy ingredients (milk or milk products) that have all been pasteurized, except where alternative procedures to pasteurization are provided for by regulation, such as in part 133 of this chapter for curing of certain cheese varieties.

(b) Except as provided in paragraphs (c) and (d) of this section, the terms “pasteurization,” “pasteurized,” and similar terms shall mean the process of heating every particle of milk and milk product in properly designed and operated equipment to one of the temperatures given in the following table and held continuously at or above that temperature for at least the corresponding specified time:

Temperature	Time
145 °F (63 °C) ¹	30 minutes.
161 °F (72 °C) ¹	15 seconds.
191 °F (89 °C)	1 second.
¹ If the fat content of the milk product is 10 percent or more, or if it contains added sweeteners, the specified temperature shall be increased by 5 °F (3 °C).

Temperature	Time
194 °F (90 °C)	0.5 second.
201 °F (94 °C)	0.1 second.
204 °F (96 °C)	0.05 second.
212 °F (100 °C)	0.01 second.

Temperature	Time
155 °F (69 °C)	30 minutes.
175 °F (80 °C)	25 seconds.
180 °F (83 °C)	15 seconds.

(d) Neither paragraph (b) nor (c) of this section shall be construed as barring any other pasteurization process that has been recognized by the Food and Drug Administration to be equally efficient in the destruction of microbial organisms of public health significance.

[52 FR 29514, Aug. 10, 1987, as amended at 57 FR 57344, Dec. 4, 1992]

Notes of Decisions

Cited in 4 cases (2 in the last 5 years), 2009–2022 · leading case: Farm-To-Consum. Legal Def. Fund v. Sebelius, 734 F. Supp. 2d 668 (N.D. Iowa 2010).

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Farm-To-Consum. Legal Def. Fund v. Sebelius, 734 F. Supp. 2d 668 (N.D. Iowa 2010). · cites it 11× “All of the plaintiffs also allege that they are, have been, and will be damaged and have suffered, are suffering, and will suffer an injury in fact by the prohibitions contained in regulations promulgated by the FDA, 21 C.F.R. §§ 1240.61 and 131.110, pursuant to the Food, Drug,…”

Oyarzo v. Maryland Dep't of Health & Mental Hygiene, 978 A.2d 804 (Md. Ct. Spec. App. 2009). · cites it 2× “In 1‘esponse to the order issued in the Public Citizen case, the FDA promulgated the regulation that appears at 21 C.F.R. § 1240.61 , providing, in pertinent part: No person shall cause to be delivered into interstate commerce or shall sell, otherwise distribute, or hold for…”

Mark McAfee v. FDA, 36 F.4th 272 (D.C. Cir. 2022). “21 C.F.R. § 1240.61 . It did so following a district court ruling that the FDA had unreasonably delayed responding to a national consumer group’s petition for such a ban, which emphasized that the “overwhelming evidence of the risks associated with” consuming raw milk products…”

McAfee v. U.S. Food & Drug Admin. (D.D.C. 2021). · cites it 2× “10, 1987) (to be codified at 21 C.F.R. § 1240.61 (a)). A few years later, the FDA issued a “technical amendment” to clarify that the pasteurization rule “applie[d] to the dairy ingredients of certain dairy products, such as .”

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