Page:United States Statutes at Large Volume 124.djvu/3969

124 STAT. 3943 PUBLIC LAW 111–353—JAN. 4, 2011 Cosmetic Act and the status of such recall (such as whether a recall is ongoing or has been completed). (c) CIVIL PENALTY.—Section 303(f)(2)(A) (21 U.S.C. 333(f)(2)(A)) is amended by inserting ‘‘or any person who does not comply with a recall order under section 423’’ after ‘‘section 402(a)(2)(B)’’. (d) PROHIBITED ACTS.—Section 301 (21 U.S.C. 331 et seq.), as amended by section 106, is amended by adding at the end the following: ‘‘(xx) The refusal or failure to follow an order under section 423.’’. (e) GAO REVIEW.— (1) IN GENERAL.—Not later than 90 days after the date of enactment of this Act, the Comptroller General of the United States shall submit to Congress a report that— (A) identifies State and local agencies with the authority to require the mandatory recall of food, and evaluates use of such authority with regard to frequency, effectiveness, and appropriateness, including consideration of any new or existing mechanisms available to compensate persons for general and specific recall-related costs when a recall is subsequently determined by the relevant authority to have been an error; (B) identifies Federal agencies, other than the Depart- ment of Health and Human Services, with mandatory recall authority and examines use of that authority with regard to frequency, effectiveness, and appropriateness, including any new or existing mechanisms available to compensate persons for general and specific recall-related costs when a recall is subsequently determined by the relevant agency to have been an error; (C) considers models for farmer restitution imple- mented in other nations in cases of erroneous recalls; and (D) makes recommendations to the Secretary regarding use of the authority under section 423 of the Federal Food, Drug, and Cosmetic Act (as added by this section) to protect the public health while seeking to minimize unnecessary economic costs. (2) EFFECT OF REVIEW.—If the Comptroller General of the United States finds, after the review conducted under para- graph (1), that the mechanisms described in such paragraph do not exist or are inadequate, then, not later than 90 days after the conclusion of such review, the Secretary of Agriculture shall conduct a study of the feasibility of implementing a farmer indemnification program to provide restitution to agricultural producers for losses sustained as a result of a mandatory recall of an agricultural commodity by a Federal or State regulatory agency that is subsequently determined to be in error. The Secretary of Agriculture shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report that describes the results of the study, including any rec- ommendations. (f) ANNUAL REPORT TO CONGRESS.— (1) IN GENERAL.—Not later than 2 years after the date of enactment of this Act and annually thereafter, the Secretary of Health and Human Services (referred to in this subsection as the ‘‘Secretary’’) shall submit a report to the Committee 21 USC 350l–1. Reports. Deadline. Study. Deadline. Reports.