3921] the submission of information regarding the article to the Secretary under this section, and any contact information for such person or persons that the Secretary has. Food allergy and anaphylaxis management. "(1) a description of the article of food as provided in subsection (e)(3); (a) Targeting of Inspection Resources for Domestic Facilities, Foreign Facilities, and Ports of Entry.--Chapter IV (21 U.S.C. "(B) a recall of food under this Act. (i) specific types of on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership, as such packing and holding relates to specific foods; and "(B) comply with chapter 35 of title 44, United States Code (commonly known as the `Paperwork Reduction Any such hearing shall be conducted expeditiously. 3916] of such a system, and make recommendations about what new authorities, if any, would be necessary to develop and implement such a system. (5) Limitation on grant funding.--The Secretary may not provide grant funding to a local educational agency under this subsection after such local educational agency has received 2 years of grant funding under this subsection. 103. "(4) Prioritization.--The Secretary shall prioritize the implementation of the regulations under this section for specific fruits and vegetables that are raw agricultural commodities [Page 124 STAT. "(i) requiring that audits performed under this section be unannounced; "(B) that submits an application to the Secretary at such time, in such manner, and including such information as the Secretary may reasonably require. (4) Training of foreign governments and food producers on United States requirements for safe food. "(C) Revocation of recognition as an accreditation body.--The Secretary shall promptly revoke the recognition of any accreditation body found not to be in compliance with the requirements of this section. > --Not later than 180 days after the date of enactment of this Act, the Secretary shall publish guidance that clarifies when a dietary supplement ingredient is a new dietary ingredient, when the manufacturer or distributor of a dietary ingredient or dietary supplement should provide the Secretary with information as described in section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act, the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing the identify of a new dietary ingredient. The final rule went into effect on April, 2016. (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. "(C) Denial of variances.--The Secretary may deny a variance request 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 regulation adopted under subsection (b). 381(a)) is amended by adding "or the importer (as defined in section 805) is in violation of such section 805" after "or in violation of section 505". The FSMA aims to shift the focus of federal regulators from responding to contamination to preventing it to ensure the safety of the U.S. food supply. Examples of preventive controls include sanitation procedures for food contact surfaces; employee hygiene training; environmental monitoring to verify pathogen controls; a recall plan; supplier verification activities; and a food allergen control program. The act ensures workers can disclose food safety concerns without fear of reprisal by their employers. Those procedures, practices, and processes may include the following: "(i) with respect to a food for which a food packaging label is required by the Secretary under any other provision of this Act, include prominently and conspicuously on such label the name and business address of the facility where the food was manufactured or processed; or The Secretary shall consider certifications under section 801(q) and participation in the voluntary qualified importer program described in section 806 when targeting inspection resources under section 421. "(a) Training.--The Secretary shall set standards and administer training and education programs for the employees of State, local, territorial, and tribal food safety officials relating to the regulatory responsibilities and policies established by this Act, including programs for-- (b) Addition of Certification Requirement.--Section 801 (21 U.S.C. (C) specify situations in which the examples of mitigation strategies or measures described in subsection (b)(2) of such section are appropriate. > --At the time the Secretary promulgates the final rules under paragraph (1), the Secretary shall publish the list of the foods designated under subparagraph (A) as high-risk foods on the Internet website of the Food and Drug Administration. "(A) In general.--A facility is a qualified facility for purposes of this subsection if the facility meets the conditions under subparagraph (B) or (C). > --The Secretary, by notice published in the Federal Register, shall establish an exemption from the requirements of this section for articles of food imported in small quantities for research and evaluation purposes or for personal consumption, provided that such foods are not intended for retail sale and are not sold or distributed to the public. "(4) Limited distribution.--In the interest of national security, the Secretary, in coordination with the Secretary of Homeland Security, may determine the time, manner, and form in which the registry established under paragraph (1)(B) is made publicly available. (4) alter or limit the authority of the Secretary of Agriculture under the laws administered by such Secretary, including-- "(B) coordination of inspections of foreign facilities to increase the percentage of imported seafood and seafood facilities inspected; (d) Additional Recordkeeping Requirements for High Risk Foods.-- such governmental entity. or the Public Health Service Act (42 U.S.C. "(i) with respect to a food for which a food packaging label is required by the Secretary under any other provision of this Act, include prominently and conspicuously on such label the name and business address of the farm where the produce was grown; or Inspection of foreign food facilities.Sec. "(C) comply with chapter 35 of title 44, United States Code (commonly known as the `Paperwork Reduction Act'), with special attention to minimizing the burden (as defined in section 3502(2) of such Act) on the business, and collection of information (as defined in section 3502(3) of such Act), associated with such regulations; "(D) acknowledge differences in risk and minimize, as appropriate, the number of separate standards that apply to separate foods; and Protection against intentional adulteration.Sec. "(B) that includes, at a minimum-- "(iii) procedures exist to evaluate and respond promptly to complaints regarding analyses and other activities for which the laboratory is accredited; and "(1) establish a program, in consultation with the Secretary of Homeland Security-- AUTHORITY TO REQUIRE IMPORT CERTIFICATIONS FOR FOOD. [10] The new (FSMA) law broadens that authority, allowing for administrative detention based on ‘reason to believe’ that the food item has been misbranded or adulterated’ and thus violates a legal standard for the product. "(1) In general.--If the Secretary determines that the information in a new dietary ingredient notification submitted under this section for an article purported to be a new dietary ingredient is inadequate to establish that a dietary supplement containing such article will reasonably be expected to be safe because the article may be, or may contain, an anabolic steroid or an analogue of an anabolic steroid, the Secretary shall notify the Drug Enforcement Administration of such determination. "(c) Notification.-- Sec. > 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 recommendations. In reviewing the applications and making determinations on such applications, the Secretary shall consider the risk of the food to be imported based on factors, such as the following: "(B) at a later date in such fiscal year, such paragraph (1) ceases to apply, the Secretary may assess and collect such fees under subsection (a), without any modification to the rate of such fees, notwithstanding the provisions of subsection (a) relating to the date fees are to be paid. (a) Pilot Projects.-- (c) Development of Model Plans.--In carrying out subsection (a), the Administrator, the Secretary of Health and Human Services, and the Secretary of Agriculture shall jointly develop and disseminate model plans for-- "(C) Requirements for issuing certification.-- Q&As have been issued. "(A) the number of foreign offices established; and (ii) Limitation. 342) or misbranded under section 403(w) of such Act (21 U.S.C. > --Not later than 90 days after the date of enactment of this Act, the Secretary shall modify the Internet Web site of the Food and Drug Administration to include a search engine that-- "(1) In general.--The Secretary shall-- "(1) Requirements for accreditation as a third-party auditor.-- "(ii) > documentation, as specified by the Secretary in a guidance document issued not later than 1 year after the date of enactment of this section, that the facility is a qualified facility under paragraph (1)(B) or (1)(C). "(2) Limited distribution.--In the interest of national security, the Secretary, in consultation with the Secretary of Homeland Security, may determine the time, manner, and form in which determinations made under paragraph (1) are made publicly available. New dietary ingredients.Sec. (b) Small Entity Compliance Policy Guide. (4) the impact post harvest processing is expected to have on the sales, cost, and availability of raw oysters; > --If, at any time during an audit, an accredited third-party auditor or audit agent of such auditor discovers a condition that could cause or contribute to a serious risk to the public health, such auditor shall immediately notify the Secretary of-- (i) > Effective Dates.-- "(b) Accreditation System.-- "(A) during the previous 3-year period, the average annual monetary value of the food sold by such farm directly to qualified end-users during such period exceeded the average annual monetary value of the food sold by such farm to all other buyers during such period; and (H) Farm sales to consumers.--The Secretary shall not require a farm to maintain any distribution records under this subsection with respect to a sale of a food described in subparagraph (I) (including a sale of a food that is produced and packaged on such farm), if such sale is made by the farm directly to a consumer. "(D) coordinate with Federal, State, local, and tribal authorities, as appropriate, that have responsibilities related to the recall of a food or a foodborne illness outbreak associated with a food that is subject to the recall, including notification of the Secretary of Agriculture and the Secretary of Education in the event such recalled food is a commodity intended for use in a child nutrition program (as identified in section 25(b) of the Richard B. Russell National School Lunch Act (42 U.S.C. "(D) take into consideration, consistent with ensuring enforceable public health protection, conservation and environmental practice standards and policies established by Federal natural resource conservation, wildlife conservation, and environmental agencies; [2], The Center for Disease Control and Prevention (CDC) estimated in 2011 that each year 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases. (d) Small Entity Compliance Policy Guide. "(c) Limitations.-- (B) Contents.--Each application submitted under subparagraph (A) shall include-- ", "S. 510 Food Safety Modernization Act Healthy Local Foods Amendment", "The Tester – Hagen Amendment to S. 510 protects food safety and small farmers", "The Food Safety Modernization Act: A New Paradigm for Importers and Global Partnerships", "Three things to expect during unannounced FDA inspections", "Food-safety measure passes Senate in Sunday surprise", "H.R. "(1) hazards identified in the hazard analysis conducted under subsection (b)(1) will be significantly minimized or prevented; as in effect on the day before the date of enactment of this Act; 305. (B) food contamination; and "(i) not less often than once in the 7-year period following the date of enactment of the FDA Food Safety Modernization Act; and 805. "(f) Annual Report to Congress.--Not later than 120 days after each fiscal year for which fees are assessed under this section, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to include a description of fees assessed and collected for each such year and a summary description of the entities paying such fees and the types of business in which such entities engage. (c) > Periodic Review.--The Secretary of Health and Human Services shall periodically review and, as appropriate, update the regulations under section 420(b) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), and the guidance documents under subsection (b). (C) information systems to support data management and sharing of food safety and defense information among State and local agencies and with counterparts at the Federal level; and "(b) Prehearing Order To Cease Distribution and Give Notice.-- (3) by striking the last sentence; and Sec. "(A) In general.--The adjustment factor described in paragraph (1) shall be the total percentage change that occurred in the Consumer Price Index for all urban consumers (all items; United States city average) for the 12-month period ending June 30 preceding the fiscal year, but in no case shall such adjustment factor be negative. The USA brewing industry is legally obliged to provide a safe for consumption product and to ensure safety throughout the supply and manufacturing chain. The act, signed into law in 2011, seeks to protect public health more effectively by strengthening the food safety system. Only those parties described in 801(q)(3) or the Secretary may provide a food certification under 301(g). (ii) such administration is not prohibited by State law. "(2) Multistate partnerships.--Grants under this section may be made for projects involving more than 1 State. "(B) Domestic high-risk facilities. (a) In General.--Section 413 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Linkedin. "(B) partner with 1 or more institutions of higher education that have demonstrated knowledge, expertise, and meaningful experience with regional or national food production, processing, and distribution, as well as leadership in the laboratory, epidemiological, and environmental detection and investigation of foodborne illness; and. "(A) the date on which the Secretary issues regulations under paragraph (5); or (ii) provide the report to the country or exporter that is the subject of the report; and > --Not later than 18 months after the date of enactment of the FDA Food Safety Modernization Act, the Secretary, in coordination with the Secretary of Homeland Security and in consultation with the Secretary of Agriculture, shall promulgate regulations to protect against the intentional adulteration of food subject to this Act. (1) facilitating partnerships between public and private entities to help coordinate and enhance the protection of the agriculture and food system of the United States; "(3) Audit report submission requirements.-- 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. 201. (D) Outreach to parents. "(E) such other appropriate entity, as determined by the Secretary. Laboratory accreditation for analyses of foods. (b) Limitation.--Subsection (a) shall not apply to the guidance described in section 103(h). Sec. (ii) conducting surveillance to prevent the spread of diseases. 510. (B) Detection goal.--Improve agriculture and food system detection capabilities by-- Food Safety Modernization Act (FSMA) Produce Safety Rule. (b) Establishment of Voluntary Food Allergy and Anaphylaxis Management Guidelines.-- (b) Export Certification Fees for Foods and Animal Feed.-- Since October 22, 2012, the updated food facility registration system by the US FDA is available. 3955] a foreign supplier verification program in compliance with such section 805.". Such findings and recommendations shall address communication and coordination with the public, industry, and State and local governments, as such communication and coordination relates to outbreak identification and traceback. (i) the food is produced on a farm; and This ground breaking piece of food … "(A) of the recall to consumers and retailers to whom such article was, or may have been, distributed; and > 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. "(d) Record Maintenance and Access. "(1) Verification requirement.--Except as provided under subsections (e) and (f), each importer shall perform risk-based foreign supplier verification activities for the purpose of verifying that the food imported by the importer or agent of an importer is-- (2) Content.--The report under paragraph (1) shall include, with respect to the report year-- "(3) providing training for epidemiological and environmental investigation of foodborne illness, including suggestions for streamlining and standardizing the investigation process; "(iii) the number and types of food facilities co-located on farms, including the number and proportion by commodity and by manufacturing or processing activity; "(4) Renewal and refusal of certifications.--The Secretary may-- "(d) Program Coordination.-- Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. 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