301. (D) Strategies to reduce the risk of exposure to anaphylactic causative agents in classrooms and common school or early childhood education program areas such as cafeterias. "(A) the Secretary does not assess fees under subsection (a) for a portion of a fiscal year because paragraph (1) applies; and 241 et seq. "(d) Enforcement. "(C) Limitation.--The requirement under subparagraph (B) shall not include any report or other documents resulting from a consultative audit by the accredited third-party auditor, except that the Secretary may access the results of a consultative audit in accordance with section 414. "(iii) to provide compensatory damages to the complainant. "(1) intends to participate in voluntary qualified importer program under section 806; or (III) how school nurses, teachers, administrators, and other school-based staff will be made aware of, and given training on, when applicable, the guidelines in place; and. > --The Secretary of Homeland Security shall, on a biennial basis, submit to the relevant committees of Congress, and make publicly available on the Internet Web site of the Department of Homeland Security, a report on the progress of the integrated consortium of laboratory networks, as established under subsection (a), in carrying out this section. Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report.Sec. (1) striking "credible evidence or information indicating" and inserting "reason to believe"; and > --Not later than 60 days after the date of receipt of a complaint filed under paragraph (1) and after affording the complainant and the person named in the complaint an opportunity to submit to the Secretary a written response to the complaint and an opportunity to meet with a representative of the Secretary to present statements from witnesses, the Secretary shall initiate an investigation and determine whether there is reasonable cause to believe that the complaint has merit and notify, in writing, the complainant and the person alleged to have [Page 124 STAT. "(i) not own or operate an eligible entity to be audited by such agent; "(ii) in carrying out audits of eligible entities under this section, have procedures to ensure that such agent does not have a financial conflict of interest regarding an eligible entity to be audited by such agent; and 308. "(4) Action in court.-- (A) In general.--To be eligible to receive a grant under this subsection, a local educational agency shall submit an application to the Secretary at such time, in such manner, and including such information as the Secretary may reasonably require. "(h) Written Plan and Documentation.--The owner, operator, or agent in charge of a facility shall prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of this section, including analyzing the hazards under subsection (b) and identifying the preventive controls adopted under subsection (c) to address those hazards. (A) the National Incident Management System; (b) Reporting Requirement. > -- The Secretary shall publish and maintain on the Internet Web site of the Food and Drug Administration a current list that includes the name of, location of, and other information deemed necessary by the Secretary about, importers participating under this section.". "(C) provide to the Secretary such information, at such time, and in such manner, as the Secretary may require. > HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS. Food and Agriculture Coordinating Councils.Sec. > LABORATORY ACCREDITATION FOR ANALYSES OF FOODS. "(i) Standard for complainant.--The Secretary shall dismiss a complaint filed under this subsection and shall not conduct an investigation otherwise required under subparagraph (A) unless the complainant makes a prima facie showing that any behavior described in paragraphs (1) through (4) of subsection (a) was a contributing factor in the unfavorable personnel action alleged in the complaint. (b) Suspension of Registration.-- (B) include examples of mitigation strategies or measures described in subsection (b)(2) of such section; and "(2) Requirements.--The regulations promulgated under paragraph (1)-- La FSMA favorise la prestation adéquate de services financiers et oeuvre pour des marchés financiers transparents. 350b) is amended-- (C) improvement in the timeliness and depth of access by regulatory and health agencies, the food industry, academic researchers, and consumers to foodborne illness aggregated, de-identified surveillance data collected by government agencies at all levels, including data compiled by the Centers for Disease Control and Prevention; 350c(a)) is amended-- The language of FSMA is consistent with the Hazard Analysis Critical Control Points (HACCP) approach. "(e) Authorization of Appropriations.--There is authorized to be appropriated such sums as may be necessary to carry out this section. (I) integrating foodborne illness surveillance systems and data with other biosurveillance and public health situational awareness capabilities at the Federal, State, and local levels, including by sharing foodborne illness surveillance data with the National Biosurveillance Integration Center; and Sec. Foreign offices of the Food and Drug Administration.Sec. 301 et seq.) "(4) take any other measures deemed necessary by the Secretary. SEC. "(b) Accreditation System.-- (v) an agreement by the local educational agency to report information required by the Secretary to conduct evaluations under this subsection. (B) by redesignating subsections (b) and (c) as subsections (c) and (d), respectively; and "(A) provide sufficient flexibility to be practicable for all sizes and types of facilities, including small businesses such as a small food processing facility co-located on a farm; and Compliance with international agreements. (3) School.--The term "school" includes public-- (1) Request for information.--Notwithstanding subsection (F) Food allergy management training of school or early childhood education program personnel who regularly come into contact with children with life-threatening food allergies. Prior notice of imported food shipments.Sec. 421. "(ii) a description of the risk associated with such article; and (iii) an itemization of how grant funds received under this subsection will be expended; (A) Analysis of the need for further regulations or guidance to industry. (C) Systems to ensure the prompt distribution to the food industry of information and technical assistance concerning preventive strategies. "(C) Submission of report.--Not later than 18 months after the date of enactment the FDA Food Safety Modernization Act, the Secretary shall submit to Congress a report that describes the results of the study conducted under subparagraph (A). "(1) In general.--The Secretary shall measure the status and success of each grant program authorized under the FDA Food Safety Modernization Act (and any amendment made by such Act), including the grant program under this section. "(i) not be owned, managed, or controlled by any person that owns or operates an eligible entity to be certified by such auditor; 3907] for each foreign facility subject to a reinspection in such fiscal year, to cover reinspection-related costs for such year; 115. "(i) arranging, conducting, and evaluating the results of reinspections; and "(1) The known safety risks of the food to be imported. (B) Accelerate foodborne illness surveillance and outbreak investigation, including rapid shipment of clinical isolates from clinical laboratories to appropriate State laboratories, and conducting more standardized illness outbreak interviews. "(6) strengthening capacity to participate in existing or new foodborne illness surveillance and environmental assessment information systems; and At any time before issuance of a final order, a proceeding under this subsection may be terminated on the basis of a settlement agreement entered into by the Secretary, the complainant, and the person alleged to have committed the violation. 405. (i) activities that constitute on-farm packing or holding of food that is not grown, raised, or "(D) A food allergen control program. "(1) Critical control point.--The term `critical control point' means a point, step, or procedure in a food process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level. "(1) The known safety risks of the food imported. "(b) Effect of Inability To Inspect.--Notwithstanding any other provision of law, food shall be refused admission into the United States if it is from a foreign factory, warehouse, or other establishment of which the owner, operator, or agent in charge, or the government of the foreign country, refuses to permit entry of United States inspectors or other individuals duly designated by the Secretary, upon request, to inspect such factory, warehouse, or other establishment. "(B) the term `reinspection-related costs' means ll expenses, including administrative expenses, incurred in connection with-- Alcohol-related facilities. TITLE III--IMPROVING THE SAFETY OF IMPORTED FOODSec. Such reanalysis shall be completed and additional preventive controls needed to address the hazard identified, if any, shall be implemented before the change in activities at the facility is operative. "(E) such other appropriate entity, as determined by the Secretary. (ii) records of recipients of a food beyond the immediate subsequent recipient of such food; or "(ii) determine whether a facility is eligible to be a facility from which food may be offered for import under the voluntary qualified importer program under section 806. The Secretary shall make operating this program revenue-neutral and shall not generate surplus revenue from such a reimbursement mechanism. "(3) Considerations.--In promulgating regulations under this subsection, the Secretary shall, as appropriate, take into account differences among importers and types of imported foods, including based on the level of risk posed by the imported food. Training team: The course is instructed by a PSA Lead Trainer. 305. "(D) Modification or revocation of a variance.--The Secretary, after notice and an opportunity for a hearing, may modify or revoke a variance if the Secretary determines that such variance is not reasonably likely to ensure that the food is not adulterated under section 402 and is not reasonably likely to provide the same level of public health protection as the requirements of the regulations adopted under subsection (b). (II) how the local educational agency will inform parents and students of the guidelines in place; (2) identify means by which laboratory network members could work cooperatively-- (C) Strengthen the capacity of State and local agencies to carry out inspections and enforce safety standards. The individual providing such notice shall present to such owner, operator, or agent appropriate credentials and shall deliver such notice at reasonable times and within reasonable limits and in a reasonable manner. To view the latest version of this document and thousands of others like it, sign-in to LexisPSL or register for a free trial. 3973] Congressional Record by the Chairman of the Senate Budget Committee, provided that such statement has been submitted prior to the vote on passage. "(j) Authorization of Appropriations.--For the purposes of making grants under this section, there are authorized to be appropriated such sums as may be necessary for fiscal years 2011 through 2015.". FACILITIES, AND PORTS OF ENTRY; ANNUAL REPORT. (4) Limitation.--A request made under paragraph (1) shall not include a request for information relating to the finances, pricing of commodities produced, personnel, research, sales (other than information relating to shipping), or other disclosures that may reveal trade secrets or confidential information from the farm to which the article of food has been traced, other than information necessary to identify potential immediate recipients of such food. (b) Regulations. In defining such terms, the Secretary shall include consideration of harvestable acres, income, the number of employees, and the volume of food harvested. 214), from the requirements of this Act (including the amendments made by this Act). "(1) In general. 103. Decontamination and disposal standards and plans.Sec. Frequently Asked Questions on FSMA PRODUCE FOOD SAFETY RULE. (c) > Effective Date.--The amendment made by this section shall take effect 180 days after the date of enactment of this Act. (7) No impact on non-high-risk foods.--The recordkeeping requirements established under paragraph (1) shall have no effect on foods that are not designated by the Secretary under paragraph (2) as high-risk foods. (B) facilitating sharing of surveillance information on a more timely basis among governmental agencies, including the Food and Drug Administration, the Department of Agriculture, the Department of Homeland Security, and State and local agencies, and with the public; (C) developing improved epidemiological tools for obtaining quality exposure data and microbiological methods for classifying cases; > --Records of an importer related to a foreign supplier verification program shall be maintained for a period of not less than 2 years and shall be made available promptly to a duly authorized representative of the Secretary upon request. TITLE IV--MISCELLANEOUS PROVISIONSSec. An Act to make provision about the regulation of financial services and markets; to provide for the transfer of certain statutory functions relating to building societies, friendly societies, industrial and provident societies and certain other mutual societies; and for connected purposes. Sanitary transportation of food.Sec. (2) to very small businesses (as defined by the Secretary in section 103, not later thn 90 days after the date of enactment of this Act) beginning on the date that is 2 years after the effective date of the final regulations promulgated under subsection (d). > 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. "(3) The Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards of the Food and Drug Administration (or any successor standards). "(6) False statements.--Any statement or representation made by an entity described in paragraph (2) to the Secretary shall be subject to section 1001 of title 18, United States Code. "(i) Voluntary qualified importer program.--In establishing the fee amounts under subparagraph (A)(iii) for a fiscal year, the Secretary shall provide for the number of importers who have submitted to the Secretary a notice under section 806(c) informing the Secretary of the intent of such importer to participate in the program under section 806 in such fiscal year. 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. (B) be science-based; "(1) In general.--The Secretary shall-- (F) Outreach, education, and training provided to States and local governments to build State and local food safety and food defense capabilities, including progress implementing strategies developed under sections 108 and 205. FSMA Full Text (Official) Liên hệ ; Địa chỉ: Tòa nhà IBC, số 01A - Công trường Mê Linh, Bến Nghé, quận 1, Tp. (B) consider international efforts, including an assessment of whether product tracing requirements developed under this section are compatible with global tracing systems, as appropriate; and (J) Maintenance of information for each administration of epinephrine to a child at risk for anaphylaxis and prompt notification to parents. (g) > Dietary Supplements.--Nothing in the amendments made by this section shall apply to any facility with regard to the manufacturing, processing, packing, or holding of a dietary supplement that is in compliance with the requirements of sections 402(g)(2) and 761 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. (1) highest-risk biological, chemical, and radiological threat agents; "(i) under subparagraph (A) of subsection (a)(1) for a fiscal year shall be based on the Secretary's estimate of 100 percent of the costs of the reinspection-related activities (including by type or level of reinspection activity, as the Secretary determines applicable) described in such subparagraph (A) for such year; "(ii) under subparagraph (B) of subsection (a)(1) for a fiscal year shall be based on the Secretary's estimate of 100 percent of the costs of the activities described in such subparagraph (B) for such year; (2) Final regulations.--Not later than 9 months after the close of the comment period for the proposed rulemaking under paragraph (1), the Secretary shall adopt final rules with respect to--. Such written or electronic certification may be included with other documentation regarding such food shipment. 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