§ 59a.411. Label content review by the Department.
(a) Raw milk in containers owned by the raw milk permitholder.
(1) General label statements. If raw milk for human consumption is prepackaged for sale in containers that are owned by the raw milk permitholder, the labeling on these containers and caps shall be submitted to the Department and approved by the Department prior to use in commerce. The container must be labeled as raw milk, and include the fluid volume as well as the name and address of the distributor or producer and the words ‘‘Keep Refrigerated.’’ It may not be misbranded or contain any false or misleading statements. The Department will, within 10 business days of receiving a complete application for label approval, mail the applicant its written approval or denial of the label.
(i) If the application is denied, the written denial will set forth the basis for denial and afford the applicant notice and opportunity for an administrative hearing on the denial.
(ii) If the application is granted, the written approval will contain a copy of the label and assign a unique serial number to each label approved under the application. The Department will retain copies of these approvals.
(2) Consumer advisory for raw animal-derived foods that have not been processed to remove pathogens. In addition to the information in paragraph (1), the label must contain a consumer advisory statement to notify consumers of the increased risks (particularly to certain highly susceptible populations) associated with the consumption of raw animal-derived foods that have not been processed to remove pathogens. An acceptable notice would be as follows:
Raw milk has not been processed to remove pathogens that can cause illness. The consumption of raw milk may significantly increase the risk of foodborne illness in persons who consume it—particularly with respect to certain highly-susceptible populations such as preschool-age children, older adults, pregnant women, persons experiencing illness, and other people with weakened immune systems.
(3) Label requirement: milk dating.
(i) Requirement. The cap of the raw milk container, or the container itself, must be conspicuously and legibly marked in a contrasting color with the designation of the ‘‘sell-by’’ date—the month and day of the month after which the raw milk may not be sold or offered for sale. The designation may be numerical—such as ‘‘8-15’’—or with the use of an abbreviation for the month, such as ‘‘AUG 15’’ or ‘‘AU 15.’’ The words ‘‘Sell by’’ or ‘‘Not to be sold after’’ must precede the designation of the date, or the statement ‘‘Not to be sold after the date stamped above’’ must appear legibly on the container. This designation of the date may not exceed 17 days beginning after midnight on the day on which the raw milk was produced.
(ii) Prominence of sell-by date on label. The sell-by date must be separate and distinct from any other number, letter or intervening material on the cap or container.
(iii) Prohibition. Raw milk may not be sold or offered for sale for human consumption if the raw milk is sold or offered for sale after the sell-by date designated on the container.
(iv) Monitoring by the Department.
(A) The Department will periodically sample containers of raw milk for human consumption in the possession of the raw milk permitholder or a distributor. This sampling may occur at any time before the raw milk is delivered to the customer. The Department will take at least one sample of raw milk from each raw milk permitholder each calendar year.
(B) The samples described in clause (A) shall be analyzed by the Department or a Pennsylvania-approved dairy laboratory, to determine whether bacterial test results exceed the bacterial limits for raw milk described in the Raw Milk Testing Schedule and Standards in § 59a.408 (relating to regular testing of raw milk for human consumption) prior to the expiration of the sell-by date designated on the raw milk container.
(C) When two or more samples demonstrate a raw milk permitholder cannot produce raw milk for human consumption that remains consistently within the bacterial limits referenced in clause (B) through the sell-by date marked on the container, the Department will require a raw milk permitholder to use a shorter sell-by date specified by the Department. The Department will calculate this revised sell-by date so that bacterial growth in the raw milk will not exceed the referenced bacterial limits within that sell-by period if the raw milk is maintained in accordance with the temperature requirements for raw milk in the Raw Milk Testing Schedule and Standards in § 59a.408.
(D) A raw milk permitholder may submit samples to the Department for analysis to obtain approval to resume a specific sell-by period for the raw milk sampled. The Department will approve resumption of a specific sell-by period when analysis of a sample demonstrates that bacterial growth in the raw milk will not exceed the referenced bacterial limits within that sell-by period if the raw milk is maintained in accordance with the temperature requirements for raw milk in the Raw Milk Testing Schedule and Standards in § 59a.408.
(b) Raw milk in customer-owned containers.
(1) Container labeling and caps. If raw milk for human consumption is packed for sale in containers that are owned by the consumer, Departmental review of the labeling on the container or caps is not required. The Department recommends, but does not require, that customer owned containers be clean, food-grade containers of 1 gallon or smaller capacity.
(2) Consumer advisory. If raw milk for human consumption is packed for sale in containers that are owned by the consumer, the raw milk permitholder shall post a consumer advisory at the location where the customer owned containers are filled, or in close proximity to that location, to provide consumers notice of increased risks associated with the consumption of raw animal-derived foods that have not been processed to remove pathogens by certain highly susceptible populations. An acceptable notice would be as described in subsection (a)(2).
Cross References This section cited in 7 Pa. Code § 59a.14 (relating to labeling: bottles, containers and packages of milk, milk products or manufactured dairy products).
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