INSPECTIONS OF RECORDS.

SEC. 101. INSPECTIONS OF RECORDS.(a) In General.—Section 414(a) (21 U.S.C. 350c(a)) is amended—(1) by striking the heading and all that follows through “of food is” and inserting the following: “Records Inspection.—“(1) Adulterated food.—If the Secretary has a reasonable belief that an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, is”;(2) by inserting “, and to any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner,” after “relating to such article”;(3) by striking the last sentence; and(4) by inserting at the end the following:“(2) Use of or exposure to food of concern.—If the Secretary believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such article and to any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether there is a reasonable probability that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals.“(3) Application.—The requirement under paragraphs (1) and (2) applies to all records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of such article maintained by or on behalf of such person 124 STAT. 3887 in any format (including paper and electronic formats) and at any location.”.(b) Conforming Amendment.—Section 704(a)(1)(B) (21 U.S.C. 374(a)(1)(B)) is amended by striking “section 414 when” and all that follows through “subject to” and inserting “section 414, when the standard for records inspection under paragraph (1) or (2) of section 414(a) applies, subject to”.