Page:United States Statutes at Large Volume 124.djvu/3958

 124 STAT. 3932 PUBLIC LAW 111–353—JAN. 4, 2011 (F) minimize the number of different recordkeeping requirements for facilities that handle more than 1 type of food; (G) to the extent practicable, not require a facility to change business systems to comply with such require- ments; (H) allow any person subject to this subsection to main- tain records required under this subsection at a central or reasonably accessible location provided that such records can be made available to the Secretary not later than 24 hours after the Secretary requests such records; and (I) include a process by which the Secretary may issue a waiver of the requirements under this subsection if the Secretary determines that such requirements would result in an economic hardship for an individual facility or a type of facility; (J) be commensurate with the known safety risks of the designated food; (K) take into account international trade obligations; (L) not require— (i) a full pedigree, or a record of the complete previous distribution history of the food from the point of origin of such food; (ii) records of recipients of a food beyond the imme- diate subsequent recipient of such food; or (iii) product tracking to the case level by persons subject to such requirements; and (M) include a process by which the Secretary may remove a high-risk food designation developed under para- graph (2) for a food or type of food. (2) DESIGNATION OF HIGH-RISK FOODS.— (A) IN GENERAL.—Not later than 1 year after the date of enactment of this Act, and thereafter as the Secretary determines necessary, the Secretary shall designate high- risk foods for which the additional recordkeeping require- ments described in paragraph (1) are appropriate and nec- essary to protect the public health. Each such designation shall be based on— (i) the known safety risks of a particular food, including the history and severity of foodborne illness outbreaks attributed to such food, taking into consider- ation foodborne illness data collected by the Centers for Disease Control and Prevention; (ii) the likelihood that a particular food has a high potential risk for microbiological or chemical contamination or would support the growth of patho- genic microorganisms due to the nature of the food or the processes used to produce such food; (iii) the point in the manufacturing process of the food where contamination is most likely to occur; (iv) the likelihood of contamination and steps taken during the manufacturing process to reduce the possi- bility of contamination; (v) the likelihood that consuming a particular food will result in a foodborne illness due to contamination of the food; and Deadline.