PSR.28 Why does the final rule contain additional requirements for sprout production?

Sprouts present a special concern with respect to human pathogens compared to other covered produce because of the warm, moist and nutrient-rich conditions in which they grow. They have frequently been associated with outbreaks of foodborne illness. (See 80 FR 74353 at 74367 (Comment/Response 19)). The Produce Safety Rule includes specific requirements in Subpart M for most sprouts, which are in addition to the other applicable provisions of the Produce Safety Rule. Subpart M does not cover sprouts that are soil- or substrate-grown and are harvested without their roots (see 21 CFR 112.141); however, such sprouts are still “covered produce” and, unless exempt or excluded under the provisions of subpart A, are subject to all other applicable requirements of the Produce Safety Rule (see 80 FR 74353 at 74497 (Comment/Response 364)).