including whether performance management is being used by those agencies to improve the efficiency and effectiveness of agency programs. (ii) REPORTS.-The Comptroller General shall submit to Congress (I) an initial report on the evaluation under clause (i), not later than September 30, 2015; and (II) a subsequent report on the evaluation under clause (i), not later than September 30, 2017. (C) FEDERAL GOVERNMENT PLANNING AND REPORTING IMPLEMENTATION. (i) EVALUATIONS.-The Comptroller General shall evaluate the implementation of the Federal Government priority goals, Federal Government performance plans and related reporting required by this Act. (ii) REPORTS.-The Comptroller General shall submit to Congress (I) an initial report on the evaluation under clause (i), not later than September 30, 2015; and (II) subsequent reports on the evaluation under clause (i), not later than September 30, 2017 and every 4 years thereafter. (D) RECOMMENDATIONS.-The Comptroller General shall include in the reports required by subparagraphs (B) and (C) any recommendations for improving implementation of this Act and for streamlining the planning and reporting requirements of the Government Performance and Results Act of 1993. Approved January 4, 2011. LEGISLATIVE HISTORY-H.R. 2142: HOUSE REPORTS: No. 111-504 (Comm. on Oversight and Government Reform). SENATE REPORTS: No. 111-372 (Comm. on Homeland Security and Governmental Affairs). CONGRESSIONAL RECORD, Vol. 156 (2010): June 16, considered and passed House. Dec. 16, considered and passed Senate, amended. Dec. 17, House failed to concur in Senate amendment. Public Law 111-353 111th Congress An Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of the food supply. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE; REFERENCES; TABLE OF CONTENTS. Jan. 4, 2011 [H.R. 2751] FDA Food Safety Act. (a) SHORT TITLE.-This Act may be cited as the "FDA Food 21 USC 2201 Safety Modernization Act". (b) REFERENCES.-Except as otherwise specified, whenever in this Act an amendment is expressed in terms of an amendment to a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). (c) TABLE OF CONTENTS.-The table of contents for this Act is as follows: Sec. 1. Short title; references; table of contents. TITLE I-IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS Sec. 101. Inspections of records. Sec. 102. Registration of food facilities. Sec. 103. Hazard analysis and risk-based preventive controls. Sec. 104. Performance standards. Sec. 105. Standards for produce safety. Sec. 106. Protection against intentional adulteration. Sec. 107. Authority to collect fees. Sec. 108. National agriculture and food defense strategy. Sec. 109. Food and Agriculture Coordinating Councils. Sec. 110. Building domestic capacity. Sec. 111. Sanitary transportation of food. Sec. 112. Food allergy and anaphylaxis management. Sec. 113. New dietary ingredients. Sec. 114. Requirement for guidance relating to post harvest processing of raw oys ters. Sec. 115. Port shopping. Sec. 116. Alcohol-related facilities. TITLE II-IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY PROBLEMS Sec. 201. Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report. Sec. 202. Laboratory accreditation for analyses of foods. Sec. 203. Integrated consortium of laboratory networks. Sec. 204. Enhancing tracking and tracing of food and recordkeeping. Sec. 205. Surveillance. Sec. 206. Mandatory recall authority. Sec. 207. Administrative detention of food. Sec. 208. Decontamination and disposal standards and plans. Sec. 209. Improving the training of State, local, territorial, and tribal food safety officials. Sec. 210. Enhancing food safety. note. Notice. Sec. 211. Improving the reportable food registry. TITLE III-IMPROVING THE SAFETY OF IMPORTED FOOD Sec. 301. Foreign supplier verification program. Sec. 302. Voluntary qualified importer program. Sec. 303. Authority to require import certifications for food. Sec. 304. Prior notice of imported food shipments. Sec. 305. Building capacity of foreign governments with respect to food safety. Sec. 306. Inspection of foreign food facilities. Sec. 307. Accreditation of third-party auditors. Sec. 308. Foreign offices of the Food and Drug Administration. Sec. 309. Smuggled food. TITLE IV-MISCELLANEOUS PROVISIONS Sec. 401. Funding for food safety. Sec. 402. Employee protections. Sec. 403. Jurisdiction; authorities. Sec. 404. Compliance with international agreements. TITLE I-IMPROVING CAPACITY TO 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 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". SEC. 102. REGISTRATION OF FOOD FACILITIES. (a) UPDATING OF FOOD CATEGORY REGULATIONS; BIENNIAL REGISTRATION RENEWAL.-Section 415(a) (21 U.S.C. 350d(a)) is amended (1) in paragraph (2), by— (A) striking "conducts business and" and inserting "conducts business, the e-mail address for the contact person of the facility or, in the case of a foreign facility, the United States agent for the facility, and"; and 66 (B) inserting “, or any other food categories as determined appropriate by the Secretary, including by guidance" after "Code of Federal Regulations"; (2) by redesignating paragraphs (3) and (4) as paragraphs (4) and (5), respectively; and (3) by inserting after paragraph (2) the following: “(3) BIENNIAL REGISTRATION RENEWAL.-During the period Time period. beginning on October 1 and ending on December 31 of each even-numbered year, a registrant that has submitted a registration under paragraph (1) shall submit to the Secretary a renewal registration containing the information described in paragraph (2). The Secretary shall provide for an abbreviated registration renewal process for any registrant that has not had any changes to such information since the registrant submitted the preceding registration or registration renewal for the facility involved.". (b) SUSPENSION OF REGISTRATION.— (1) IN GENERAL.-Section 415 (21 U.S.C. 350d) is amended (A) in subsection (a)(2), by inserting after the first sentence the following: "The registration shall contain an assurance that the Secretary will be permitted to inspect such facility at the times and in the manner permitted by this Act."; (B) by redesignating subsections (b) and (c) as subsections (c) and (d), respectively; and (C) by inserting after subsection (a) the following: "(b) SUSPENSION OF REGISTRATION. “(1) IN GENERAL.-If the Secretary determines that food manufactured, processed, packed, received, or held by a facility registered under this section has a reasonable probability of causing serious adverse health consequences or death to humans or animals, the Secretary may by order suspend the registration of a facility "(A) that created, caused, or was otherwise responsible for such reasonable probability; or "(B)(i) that knew of, or had reason to know of, such reasonable probability; and "(ii) packed, received, or held such food. Deadline. Deadline. Effective dates. Deadline. "(2) HEARING ON SUSPENSION.-The Secretary shall provide the registrant subject to an order under paragraph (1) with an opportunity for an informal hearing, to be held as soon as possible but not later than 2 business days after the issuance of the order or such other time period, as agreed upon by the Secretary and the registrant, on the actions required for reinstatement of registration and why the registration that is subject to suspension should be reinstated. The Secretary shall reinstate a registration if the Secretary determines, based on evidence presented, that adequate grounds do not exist to continue the suspension of the registration. "(3) POST-HEARING CORRECTIVE ACTION PLAN; VACATING OF ORDER. "(A) CORRECTIVE ACTION PLAN.-If, after providing opportunity for an informal hearing under paragraph (2), the Secretary determines that the suspension of registration remains necessary, the Secretary shall require the registrant to submit a corrective action plan to demonstrate how the registrant plans to correct the conditions found by the Secretary. The Secretary shall review such plan not later than 14 days after the submission of the corrective action plan or such other time period as determined by the Secretary. "(B) VACATING OF ORDER.-Upon a determination by the Secretary that adequate grounds do not exist to continue the suspension actions required by the order, or that such actions should be modified, the Secretary shall promptly vacate the order and reinstate the registration of the facility subject to the order or modify the order, as appropriate. "(4) EFFECT OF SUSPENSION.-If the registration of a facility is suspended under this subsection, no person shall import or export food into the United States from such facility, offer to import or export food into the United States from such facility, or otherwise introduce food from such facility into interstate or intrastate commerce in the United States. "(5) REGULATIONS. "(A) IN GENERAL.-The Secretary shall promulgate regulations to implement this subsection. The Secretary may promulgate such regulations on an interim final basis. "(B) REGISTRATION REQUIREMENT.-The Secretary may require that registration under this section be submitted in an electronic format. Such requirement may not take effect before the date that is 5 years after the date of enactment of the FDA Food Safety Modernization Act. "(6) APPLICATION DATE.-Facilities shall be subject to the requirements of this subsection beginning on the earlier of"(A) the date on which the Secretary issues regulations under paragraph (5); or "(B) 180 days after the date of enactment of the FDA Food Safety Modernization Act. "(7) NO DELEGATION.-The authority conferred by this subsection to issue an order to suspend a registration or vacate an order of suspension shall not be delegated to any officer or employee other than the Commissioner.". (2) SMALL ENTITY COMPLIANCE POLICY GUIDE.-Not later than 180 days after the issuance of the regulations promulgated |