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Richard Durbin Sponsor. Senator for Illinois. Mar 3, th Congress — The Secretary shall prioritize the implementation of the regulations under this section for specific fruits and vegetables that are raw agricultural commodities based on known risks which may include a history and severity of foodborne illness outbreaks.

Not later than 1 year after the close of the comment period for the proposed rulemaking under subsection a , the Secretary shall adopt a final regulation to provide for minimum science-based standards for those types of fruits and vegetables, including specific mixes or categories of fruits or vegetables, that are raw agricultural commodities, based on known safety risks, which may include a history of foodborne illness outbreaks.

The final regulation shall—. The regulations adopted under subsection b shall—. A State or foreign country from which food is imported into the United States may in writing request a variance from the Secretary.

Such request shall describe the variance requested and present information demonstrating that the variance does not increase the likelihood that the food for which the variance is requested will be adulterated under section , and that the variance provides the same level of public health protection as the requirements of the regulations adopted under subsection b.

The Secretary shall review such requests in a reasonable timeframe. The Secretary may approve a variance in whole or in part, as appropriate, and may specify the scope of applicability of a variance to other similarly situated persons.

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 and is not reasonably likely to provide the same level of public health protection as the requirements of the regulation adopted under subsection b.

The Secretary shall notify the person requesting such variance of the reasons for the denial. 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 and is not reasonably likely to provide the same level of public health protection as the requirements of the regulations adopted under subsection b.

The Secretary may coordinate with the Secretary of Agriculture and, as appropriate, shall contract and coordinate with the agency or department designated by the Governor of each State to perform activities to ensure compliance with this section.

Not later than 1 year after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall publish, after consultation with the Secretary of Agriculture, representatives of State departments of agriculture, farmer representatives, and various types of entities engaged in the production and harvesting or importing of fruits and vegetables that are raw agricultural commodities, including small businesses, updated good agricultural practices and guidance for the safe production and harvesting of specific types of fresh produce under this section.

The Secretary shall conduct not fewer than 3 public meetings in diverse geographical areas of the United States as part of an effort to conduct education and outreach regarding the guidance described in paragraph 1 for persons in different regions who are involved in the production and harvesting of fruits and vegetables that are raw agricultural commodities, including persons that sell directly to consumers and farmer representatives, and for importers of fruits and vegetables that are raw agricultural commodities.

The Secretary shall ensure that any updated guidance under this section will—. A farm shall be exempt from the requirements under this section in a calendar year if—.

A farm that is exempt from the requirements under this section shall—. In the event of an active investigation of a foodborne illness outbreak that is directly linked to a farm subject to an exemption under this subsection, or if the Secretary determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with a farm that are material to the safety of the food produced or harvested at such farm, the Secretary may withdraw the exemption provided to such farm under this subsection.

In this subsection, the term qualified end-user , with respect to a food means—. For purposes of subparagraph A , the term consumer does not include a business.

Nothing in this subsection preempts State, local, county, or other non-Federal law regarding the safe production, harvesting, holding, transportation, and sale of fresh fruits and vegetables.

Nothing in this subsection shall prevent the Secretary from exercising any authority granted in the other sections of this Act. This section shall not apply to produce that is produced by an individual for personal consumption.

Not later than days after the issuance of regulations under section of the Federal Food, Drug, and Cosmetic Act as added by subsection a , the Secretary of Health and Human Services shall issue a small entity compliance policy guide setting forth in plain language the requirements of such section and to assist small entities in complying with standards for safe production and harvesting and other activities required under such section.

The failure to comply with the requirements under section The Secretary shall—. 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.

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.

Such regulations shall—. Regulations promulgated under subsection b shall apply only to food for which there is a high risk of intentional contamination, as determined by the Secretary, in consultation with the Secretary of Homeland Security, under subsection a , that could cause serious adverse health consequences or death to humans or animals and shall include those foods—.

This section shall not apply to farms, except for those that produce milk. For purposes of this section, the term farm has the meaning given that term in section 1.

Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with the Secretary of Homeland Security and the Secretary of Agriculture, shall issue guidance documents related to protection against the intentional adulteration of food, including mitigation strategies or measures to guard against such adulteration as required under section of the Federal Food, Drug, and Cosmetic Act, as added by subsection a.

The guidance documents issued under paragraph 1 shall—. In the interest of national security, the Secretary of Health and Human Services, in consultation with the Secretary of Homeland Security, may determine the time, manner, and form in which the guidance documents issued under paragraph 1 are made public, including by releasing such documents to targeted audiences.

The Secretary of Health and Human Services shall periodically review and, as appropriate, update the regulations under section b of the Federal Food, Drug, and Cosmetic Act, as added by subsection a , and the guidance documents under subsection b.

The failure to comply with section Fees for reinspection, recall, and importation activities. For fiscal year and each subsequent fiscal year, the Secretary shall, in accordance with this section, assess and collect fees from—.

For purposes of this section—. Subject to subsections c and d , the Secretary shall establish the fees to be collected under this section for each fiscal year specified in subsection a 1 , based on the methodology described under paragraph 2 , and shall publish such fees in a Federal Register notice not later than 60 days before the start of each such year.

Fees amounts established for collection—. 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 c informing the Secretary of the intent of such importer to participate in the program under section in such fiscal year.

In establishing the fee amounts under subparagraph A iii for the first 5 fiscal years after the date of enactment of this section, the Secretary shall include in such fee a reasonable surcharge that provides a recoupment of the costs expended by the Secretary to establish and implement the first year of the program under section In establishing the fee amounts under subparagraph A for a fiscal year, the Secretary shall provide for the crediting of fees from the previous year to the next year if the Secretary overestimated the amount of fees needed to carry out such activities, and consider the need to account for any adjustment of fees and such other factors as the Secretary determines appropriate.

Not later than days after the date of enactment of the FDA Food Safety Modernization Act , the Secretary shall publish in the Federal Register a proposed set of guidelines in consideration of the burden of fee amounts on small business.

Such consideration may include reduced fee amounts for small businesses. The Secretary shall provide for a period of public comment on such guidelines.

The Secretary shall adjust the fee schedule for small businesses subject to such fees only through notice and comment rulemaking. The Secretary shall make all of the fees collected pursuant to clause i , ii , iii , and iv of paragraph 2 A available solely to pay for the costs referred to in such clause i , ii , iii , and iv of paragraph 2 A , respectively.

Fees under subsection a shall be refunded for a fiscal year beginning after fiscal year unless the amount of the total appropriations for food safety activities at the Food and Drug Administration for such fiscal year excluding the amount of fees appropriated for such fiscal year is equal to or greater than the amount of appropriations for food safety activities at the Food and Drug Administration for fiscal year excluding the amount of fees appropriated for such fiscal year , multiplied by the adjustment factor under paragraph 3.

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 month period ending June 30 preceding the fiscal year, but in no case shall such adjustment factor be negative.

The adjustment under subparagraph A made each fiscal year shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year Notwithstanding any other provision of this section and subject to subparagraph B , the Secretary may not collect fees in a fiscal year such that the amount collected—.

If a domestic facility as defined in section b or an importer becomes subject to a fee described in subparagraph A , B , or D of subsection a 1 after the maximum amount of fees has been collected by the Secretary under subparagraph A , the Secretary may collect a fee from such facility or importer.

Fees authorized under subsection a shall be collected and available for obligation only to the extent and in the amount provided in appropriations Acts.

Such fees are authorized to remain available until expended. 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.

The sums transferred shall be available solely for the purpose of paying the operating expenses of the Food and Drug Administration employees and contractors performing activities associated with these food safety fees.

The Secretary shall specify in the Federal Register notice described in subsection b 1 the time and manner in which fees assessed under this section shall be collected.

In any case where the Secretary does not receive payment of a fee assessed under this section within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to provisions of subchapter II of chapter 37 of title 31, United States Code.

Not later than 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.

For fiscal year and each fiscal year thereafter, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection b for the fiscal year, as adjusted or otherwise affected under the other provisions of this section.

Export certification fees for foods and animal feed. Authority for export certifications for food, including animal feed.

Section e 4 A 21 U. Section e 4 21 U. For purposes of this paragraph, a certification by the Secretary shall be made on such basis, and in such form including a publicly available listing as the Secretary determines appropriate.

Development and submission of strategy. Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services and the Secretary of Agriculture, in coordination with the Secretary of Homeland Security, shall prepare and transmit to the relevant committees of Congress, and make publicly available on the Internet Web sites of the Department of Health and Human Services and the Department of Agriculture, the National Agriculture and Food Defense Strategy.

The strategy shall include an implementation plan for use by the Secretaries described under paragraph 1 in carrying out the strategy.

The strategy shall include a coordinated research agenda for use by the Secretaries described under paragraph 1 in conducting research to support the goals and activities described in paragraphs 1 and 2 of subsection b.

Not later than 4 years after the date on which the strategy is submitted to the relevant committees of Congress under paragraph 1 , and not less frequently than every 4 years thereafter, the Secretary of Health and Human Services and the Secretary of Agriculture, in coordination with the Secretary of Homeland Security, shall revise and submit to the relevant committees of Congress the strategy.

The strategy described in paragraph 1 shall be consistent with—. The strategy shall include a description of the process to be used by the Department of Health and Human Services, the Department of Agriculture, and the Department of Homeland Security—.

The strategy shall include a description of the process to be used by the Department of Health and Human Services, the Department of Agriculture, and the Department of Homeland Security to achieve the following goals:.

Enhance the preparedness of the agriculture and food system by—. Improve agriculture and food system detection capabilities by—. Ensure an efficient response to agriculture and food emergencies by—.

State, local, and tribal governments;. State, local, and tribal governments; and. Secure agriculture and food production after an agriculture or food emergency by—.

In the interest of national security, the Secretary of Health and Human Services and the Secretary of Agriculture, in coordination with the Secretary of Homeland Security, may determine the manner and format in which the National Agriculture and Food Defense strategy established under this section is made publicly available on the Internet Web sites of the Department of Health and Human Services, the Department of Homeland Security, and the Department of Agriculture, as described in subsection a 1.

The Secretary of Homeland Security, in coordination with the Secretary of Health and Human Services and the Secretary of Agriculture, shall within days of enactment of this Act, and annually thereafter, 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 activities of the Food and Agriculture Government Coordinating Council and the Food and Agriculture Sector Coordinating Council, including the progress of such Councils on—.

The Secretary, in coordination with the Secretary of Agriculture and the Secretary of Homeland Security, shall, not later than 2 years after the date of enactment of this Act, submit to Congress a comprehensive report that identifies programs and practices that are intended to promote the safety and supply chain security of food and to prevent outbreaks of foodborne illness and other food-related hazards that can be addressed through preventive activities.

Such report shall include a description of the following:. Analysis of the need for further regulations or guidance to industry. Outreach to food industry sectors, including through the Food and Agriculture Coordinating Councils referred to in section , to identify potential sources of emerging threats to the safety and security of the food supply and preventive strategies to address those threats.

Systems to ensure the prompt distribution to the food industry of information and technical assistance concerning preventive strategies.

Communication systems to ensure that information about specific threats to the safety and security of the food supply are rapidly and effectively disseminated.

Surveillance systems and laboratory networks to rapidly detect and respond to foodborne illness outbreaks and other food-related hazards, including how such systems and networks are integrated.

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 and The estimated resources needed to effectively implement the programs and practices identified in the report developed in this section over a 5-year period.

The impact of requirements under this Act including amendments made by this Act on certified organic farms and facilities as defined in section 21 U.

Specific efforts taken pursuant to the agreements authorized under section c of the Federal Food, Drug, and Cosmetic Act as added by section , together with, as necessary, a description of any additional authorities necessary to improve seafood safety.

On a biennial basis following the submission of the report under paragraph 1 , the Secretary shall submit to Congress a report that—.

The report developed under subsection a 1 shall describe methods that seek to ensure that resources available to the Secretary for food safety-related activities are directed at those actions most likely to reduce risks from food, including the use of preventive strategies and allocation of inspection resources.

The Secretary shall promptly undertake those risk-based actions that are identified during the development of the report as likely to contribute to the safety and security of the food supply.

Capability for laboratory analyses; research. The report developed under subsection a 1 shall provide a description of methods to increase capacity to undertake analyses of food samples promptly after collection, to identify new and rapid analytical techniques, including commercially-available techniques that can be employed at ports of entry and by Food Emergency Response Network laboratories, and to provide for well-equipped and staffed laboratory facilities and progress toward laboratory accreditation under section of the Federal Food, Drug, and Cosmetic Act as added by section The report developed under subsection a 1 shall include a description of such information technology systems as may be needed to identify risks and receive data from multiple sources, including foreign governments, State, local, and tribal governments, other Federal agencies, the food industry, laboratories, laboratory networks, and consumers.

The information technology systems that the Secretary describes shall also provide for the integration of the facility registration system under section of the Federal Food, Drug, and Cosmetic Act 21 U.

The report developed under subsection a 1 shall include a description of progress toward developing and improving an automated risk assessment system for food safety surveillance and allocation of resources.

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.

Biennial food safety and food defense research plan. The Secretary, the Secretary of Agriculture, and the Secretary of Homeland Security shall, on a biennial basis, submit to Congress a joint food safety and food defense research plan which may include studying the long-term health effects of foodborne illness.

Such biennial plan shall include a list and description of projects conducted during the previous 2-year period and the plan for projects to be conducted during the subsequent 2-year period.

Effectiveness of programs administered by the Department of Health and Human Services. To determine whether existing Federal programs administered by the Department of Health and Human Services are effective in achieving the stated goals of such programs, the Secretary shall, beginning not later than 1 year after the date of enactment of this Act—.

The report described under paragraph 1 B shall—. Department of Health and Human Services Programs. Not later than 1 year after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall conduct a study regarding the need for, and challenges associated with, development and implementation of a program that requires a unique identification number for each food facility registered with the Secretary and, as appropriate, each broker that imports food into the United States.

Such study shall include an evaluation of the costs associated with development and implementation of such a system, and make recommendations about what new authorities, if any, would be necessary to develop and implement such a system.

Not later than 15 months after the date of enactment of this Act, the Secretary shall submit to Congress a report that describes the findings of the study conducted under paragraph 1 and that includes any recommendations determined appropriate by the Secretary.

Not later than 18 months after the date of enactment of this Act, the Secretary shall promulgate regulations described in section b of the Federal Food, Drug, and Cosmetic Act 21 U.

The Secretary, acting through the Commissioner of Food and Drugs, shall conduct a study of the transportation of food for consumption in the United States, including transportation by air, that includes an examination of the unique needs of rural and frontier areas with regard to the delivery of safe food.

In this section:. The term early childhood education program means—. The terms local educational agency , secondary school , elementary school , and parent have the meanings given the terms in section of the Elementary and Secondary Education Act of 20 U.

The term school includes public—. Establishment of voluntary food allergy and anaphylaxis management guidelines. Not later than 1 year after the date of enactment of this Act, the Secretary, in consultation with the Secretary of Education, shall—.

Each plan described in subparagraph A that is developed for an individual shall be considered an education record for the purpose of section of the General Education Provisions Act commonly referred to as the Family Educational Rights and Privacy Act of 20 U.

The voluntary guidelines developed by the Secretary under paragraph 1 shall address each of the following and may be updated as the Secretary determines necessary:.

Parental obligation to provide the school or early childhood education program, prior to the start of every school year, with—.

The creation and maintenance of an individual plan for food allergy management, in consultation with the parent, tailored to the needs of each child with a documented risk for anaphylaxis, including any procedures for the self-administration of medication by such children in instances where—.

Communication strategies between individual schools or early childhood education programs and providers of emergency medical services, including appropriate instructions for emergency medical response.

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.

The dissemination of general information on life-threatening food allergies to school or early childhood education program staff, parents, and children.

Food allergy management training of school or early childhood education program personnel who regularly come into contact with children with life-threatening food allergies.

The authorization and training of school or early childhood education program personnel to administer epinephrine when the nurse is not immediately available.

The timely accessibility of epinephrine by school or early childhood education program personnel when the nurse is not immediately available. The creation of a plan contained in each individual plan for food allergy management that addresses the appropriate response to an incident of anaphylaxis of a child while such child is engaged in extracurricular programs of a school or early childhood education program, such as non-academic outings and field trips, before- and after-school programs or before- and after-early child education program programs, and school-sponsored or early childhood education program-sponsored programs held on weekends.

Maintenance of information for each administration of epinephrine to a child at risk for anaphylaxis and prompt notification to parents. Other elements the Secretary determines necessary for the management of food allergies and anaphylaxis in schools and early childhood education programs.

Nothing in this section or the guidelines developed by the Secretary under paragraph 1 shall be construed to preempt State law, including any State law regarding whether students at risk for anaphylaxis may self-administer medication.

School-based food allergy management grants. The Secretary may award grants to local educational agencies to assist such agencies with implementing voluntary food allergy and anaphylaxis management guidelines described in subsection b.

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.

Each application submitted under subparagraph A shall include—. Each local educational agency that receives a grant under this subsection may use the grant funds for the following:.

Purchase of materials and supplies, including limited medical supplies such as epinephrine and disposable wet wipes, to support carrying out the food allergy and anaphylaxis management guidelines described in subsection b.

In partnership with local health departments, school nurse, teacher, and personnel training for food allergy management.

Programs that educate students as to the presence of, and policies and procedures in place related to, food allergies and anaphylactic shock. Outreach to parents.

Any other activities consistent with the guidelines described in subsection b. The Secretary may award grants under this subsection for a period of not more than 2 years.

In the event the Secretary conducts a program evaluation under this subsection, funding in the second year of the grant, where applicable, shall be contingent on a successful program evaluation by the Secretary after the first year.

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.

In awarding grants under this subsection, the Secretary shall give priority to local educational agencies with the highest percentages of children who are counted under section c of the Elementary and Secondary Education Act of 20 U.

The Secretary may not award a grant under this subsection unless the local educational agency agrees that, with respect to the costs to be incurred by such local educational agency in carrying out the grant activities, the local educational agency shall make available directly or through donations from public or private entities non-Federal funds toward such costs in an amount equal to not less than 25 percent of the amount of the grant.

Determination of amount of non-Federal contribution. Non-Federal funds required under subparagraph A may be cash or in kind, including plant, equipment, or services.

Amounts provided by the Federal Government, and any portion of any service subsidized by the Federal Government, may not be included in determining the amount of such non-Federal funds.

A local educational agency that receives a grant under this subsection may use not more than 2 percent of the grant amount for administrative costs related to carrying out this subsection.

At the completion of the grant period referred to in paragraph 4 , a local educational agency shall provide the Secretary with information on how grant funds were spent and the status of implementation of the food allergy and anaphylaxis management guidelines described in subsection b.

Grant funds received under this subsection shall be used to supplement, and not supplant, non-Federal funds and any other Federal funds available to carry out the activities described in this subsection.

The food allergy and anaphylaxis management guidelines developed by the Secretary under subsection b are voluntary.

Nothing in this section or the guidelines developed by the Secretary under subsection b shall be construed to require a local educational agency to implement such guidelines.

Notwithstanding paragraph 1 , the Secretary may enforce an agreement by a local educational agency to implement food allergy and anaphylaxis management guidelines as a condition of the receipt of a grant under subsection c.

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.

Such notification by the Secretary shall include, at a minimum, the name of the dietary supplement or article, the name of the person or persons who marketed the product or made 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.

For purposes of this subsection—. Not later than 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 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.

Subsection a shall not apply to the guidance described in section h. Not later than 30 days after the Secretary issues a proposed regulation or guidance described in subsection a , the Comptroller General of the United States shall—.

The requirement of preparing a report under subsection a shall be waived if the Secretary issues a guidance that is adopted as a consensus agreement between Federal and State regulators and the oyster industry, acting through the Interstate Shellfish Sanitation Conference.

Any report prepared under this section shall be made available to the public. Until the date on which the Secretary promulgates a final rule that implements the amendments made by section of the Public Health Security and Bioterrorism Preparedness and Response Act of , Public Law — , the Secretary shall notify the Secretary of Homeland Security of all instances in which the Secretary refuses to admit a food into the United States under section a of the Federal Food, Drug, and Cosmetic Act 21 U.

Except as provided by sections , , , , , , , and of this Act, and the amendments made by such sections, nothing in this Act, or the amendments made by this Act, shall be construed to apply to a facility that—.

Limited receipt and distribution of non-alcohol food. Subsection a shall not apply to a facility engaged in the receipt and distribution of any non-alcohol food, except that such paragraph shall apply to a facility described in such paragraph that receives and distributes non-alcohol food, provided such food is received and distributed—.

Except as provided in subsections a and b , this section shall not be construed to exempt any food, other than alcoholic beverages, as defined in section of the Federal Alcohol Administration Act 27 U.

Improving capacity to detect and respond to food safety problems. Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry.

Identification and inspection of facilities. The Secretary shall identify high-risk facilities and shall allocate resources to inspect facilities according to the known safety risks of the facilities, which shall be based on the following factors:.

The known safety risks of the food manufactured, processed, packed, or held at the facility. The compliance history of a facility, including with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards.

The rigor and effectiveness of the facility's hazard analysis and risk-based preventive controls. Whether the food manufactured, processed, packed, or held at the facility meets the criteria for priority under section h 1.

Whether the food or the facility that manufactured, processed, packed, or held such food has received a certification as described in section q or , as appropriate.

Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources. Beginning on the date of enactment of the FDA Food Safety Modernization Act , the Secretary shall increase the frequency of inspection of all facilities.

The Secretary shall increase the frequency of inspection of domestic facilities identified under paragraph 1 as high-risk facilities such that each such facility is inspected—.

The Secretary shall ensure that each domestic facility that is not identified under paragraph 1 as a high-risk facility is inspected—. In the 1-year period following the date of enactment of the FDA Food Safety Modernization Act , the Secretary shall inspect not fewer than foreign facilities.

In each of the 5 years following the 1-year period described in clause i , the Secretary shall inspect not fewer than twice the number of foreign facilities inspected by the Secretary during the previous year.

Reliance on Federal, State, or local inspections. In meeting the inspection requirements under this subsection for domestic facilities, the Secretary may rely on inspections conducted by other Federal, State, or local agencies under interagency agreement, contract, memoranda of understanding, or other obligation.

Identification and inspection at ports of entry. The Secretary, in consultation with the Secretary of Homeland Security, shall allocate resources to inspect any article of food imported into the United States according to the known safety risks of the article of food, which shall be based on the following factors:.

The known safety risks of the food imported. The known safety risks of the countries or regions of origin and countries through which such article of food is transported.

The compliance history of the importer, including with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards.

The rigor and effectiveness of the activities conducted by the importer of such article of food to satisfy the requirements of the foreign supplier verification program under section Whether the food importer participates in the voluntary qualified importer program under section Whether the food meets the criteria for priority under section h 1.

Whether the food or the facility that manufactured, processed, packed, or held such food received a certification as described in section q or Interagency agreements with respect to seafood.

The Secretary of Health and Human Services, the Secretary of Commerce, the Secretary of Homeland Security, the Chairman of the Federal Trade Commission, and the heads of other appropriate agencies may enter into such agreements as may be necessary or appropriate to improve seafood safety.

The agreements under paragraph 1 may include—. The Secretary shall improve coordination and cooperation with the Secretary of Agriculture and the Secretary of Homeland Security to target food inspection resources.

For purposes of this section, the term facility means a domestic facility or a foreign facility that is required to register under section Not later than February 1 of each year, the Secretary shall submit to Congress a report, including efforts to coordinate and cooperate with other Federal agencies with responsibilities for food inspections, regarding—.

Public availability of annual food reports. The Secretary shall make the reports required under subsection h available to the public on the Internet Web site of the Food and Drug Administration.

In allocating inspection resources as described in section of the Federal Food, Drug, and Cosmetic Act as added by subsection a , the Secretary may, as appropriate, consult with any relevant advisory committee within the Department of Health and Human Services.

Recognition of laboratory accreditation. The program established under paragraph 1 A shall provide for the recognition of laboratory accreditation bodies that meet criteria established by the Secretary for accreditation of laboratories, including independent private laboratories and laboratories run and operated by a Federal agency including the Department of Commerce , State, or locality with a demonstrated capability to conduct 1 or more sampling and analytical testing methodologies for food.

Increasing the number of qualified laboratories. The Secretary shall work with the laboratory accreditation bodies recognized under paragraph 1 , as appropriate, to increase the number of qualified laboratories that are eligible to perform testing under subparagraph b beyond the number so qualified on the date of enactment of the FDA Food Safety Modernization Act.

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.

Accreditation bodies recognized by the Secretary under paragraph 1 may accredit laboratories that operate outside the United States, so long as such laboratories meet the accreditation standards applicable to domestic laboratories accredited under this section.

The Secretary shall develop model standards that a laboratory shall meet to be accredited by a recognized accreditation body for a specified sampling or analytical testing methodology and included in the registry provided for under paragraph 1.

In developing the model standards, the Secretary shall consult existing standards for guidance. The model standards shall include—.

To ensure compliance with the requirements of this section, the Secretary—. Not later than 30 months after the date of enactment of the FDA Food Safety Modernization Act , food testing shall be conducted by Federal laboratories or non-Federal laboratories that have been accredited for the appropriate sampling or analytical testing methodology or methodologies by a recognized accreditation body on the registry established by the Secretary under subsection a 1 B whenever such testing is conducted—.

The results of any such testing shall be sent directly to the Food and Drug Administration, except the Secretary may by regulation exempt test results from such submission requirement if the Secretary determines that such results do not contribute to the protection of public health.

Test results required to be submitted may be submitted to the Food and Drug Administration through electronic means.

The Secretary may waive requirements under this subsection if—. If food sampling and testing performed by a laboratory run and operated by a State or locality that is accredited by a recognized accreditation body on the registry established by the Secretary under subsection a result in a State recalling a food, the Secretary shall review the sampling and testing results for the purpose of determining the need for a national recall or other compliance and enforcement activities.

Nothing in this section shall be construed to limit the ability of the Secretary to review and act upon information from food testing, including determining the sufficiency of such information and testing.

The Secretary, in coordination with the Secretary of Agriculture, the Secretary of Homeland Security, and State, local, and tribal governments shall, not later than days after the date of enactment of this Act, and biennially thereafter, submit to the relevant committees of Congress, and make publicly available on the Internet Web site of the Department of Health and Human Services, a report on the progress in implementing a national food emergency response laboratory network that—.

The Secretary of Homeland Security, in coordination with the Secretary of Health and Human Services, the Secretary of Agriculture, the Secretary of Commerce, and the Administrator of the Environmental Protection Agency, shall maintain an agreement through which relevant laboratory network members, as determined by the Secretary of Homeland Security, shall—.

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.

Not later than days after the date of enactment of this Act, the Secretary of Health and Human Services referred to in this section as the Secretary , taking into account recommendations from the Secretary of Agriculture and representatives of State departments of health and agriculture, shall establish pilot projects in coordination with the food industry to explore and evaluate methods to rapidly and effectively identify recipients of food to prevent or mitigate a foodborne illness outbreak and to address credible threats of serious adverse health consequences or death to humans or animals as a result of such food being adulterated under section of the Federal Food, Drug, and Cosmetic Act 21 U.

The Secretary shall conduct 1 or more pilot projects under paragraph 1 in coordination with the processed food sector and 1 or more such pilot projects in coordination with processors or distributors of fruits and vegetables that are raw agricultural commodities.

The Secretary shall ensure that the pilot projects under paragraph 1 reflect the diversity of the food supply and include at least 3 different types of foods that have been the subject of significant outbreaks during the 5-year period preceding the date of enactment of this Act, and are selected in order to—.

Not later than 18 months after the date of enactment of this Act, the Secretary shall report to Congress on the findings of the pilot projects under this subsection together with recommendations for improving the tracking and tracing of food.

The Secretary, in coordination with the Secretary of Agriculture and multiple representatives of State departments of health and agriculture, shall assess—.

To the extent practicable, in carrying out paragraph 1 , the Secretary shall—. The Secretary, in consultation with the Secretary of Agriculture, shall, as appropriate, establish within the Food and Drug Administration a product tracing system to receive information that improves the capacity of the Secretary to effectively and rapidly track and trace food that is in the United States or offered for import into the United States.

Prior to the establishment of such product tracing system, the Secretary shall examine the results of applicable pilot projects and shall ensure that the activities of such system are adequately supported by the results of such pilot projects.

Additional recordkeeping requirements for high risk foods. In order to rapidly and effectively identify recipients of a food to prevent or mitigate a foodborne illness outbreak and to address credible threats of serious adverse health consequences or death to humans or animals as a result of such food being adulterated under section of the Federal Food, Drug, and Cosmetic Act or misbranded under section w of such Act, not later than 2 years after the date of enactment of this Act, the Secretary shall publish a notice of proposed rulemaking to establish recordkeeping requirements, in addition to the requirements under section of the Federal Food, Drug, and Cosmetic Act 21 U.

The Secretary shall set an appropriate effective date of such additional requirements for foods designated as high risk that takes into account the length of time necessary to comply with such requirements.

Such requirements shall—. Not later than 1 year after the date of enactment of this Act, and thereafter as the Secretary determines necessary, the Secretary shall designate high-risk foods for which the additional recordkeeping requirements described in paragraph 1 are appropriate and necessary to protect the public health.

Each such designation shall be based on—. 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.

The Secretary may update the list to designate new high-risk foods and to remove foods that are no longer deemed to be high-risk foods, provided that each such update to the list is consistent with the requirements of this subsection and notice of such update is published in the Federal Register.

In promulgating regulations under this subsection, the Secretary shall take appropriate measures to ensure that there are effective procedures to prevent the unauthorized disclosure of any trade secret or confidential information that is obtained by the Secretary pursuant to this section, including periodic risk assessment and planning to prevent unauthorized release and controls to—.

During the comment period in the notice of proposed rulemaking under paragraph 1 , the Secretary shall conduct not less than 3 public meetings in diverse geographical areas of the United States to provide persons in different regions an opportunity to comment.

Except as otherwise provided in this subsection, the Secretary may require that a facility retain records under this subsection for not more than 2 years, taking into consideration the risk of spoilage, loss of value, or loss of palatability of the applicable food when determining the appropriate timeframes.

In establishing requirements under this subsection, the Secretary shall, in consultation with the Secretary of Agriculture, consider the impact of requirements on farm to school or farm to institution programs of the Department of Agriculture and other farm to school and farm to institution programs outside such agency, and shall modify the requirements under this subsection, as appropriate, with respect to such programs so that the requirements do not place undue burdens on farm to school or farm to institution programs.

Identity-preserved labels with respect to farm sales of food that is produced and packaged on a farm. The requirements under this subsection shall not apply to a food that is produced and packaged on a farm if—.

The requirements under this subsection with respect to a food that is produced through the use of a fishing vessel as defined in section 3 18 of the Magnuson-Stevens Fishery Conservation and Management Act 16 U.

Commingled raw agricultural commodities. Recordkeeping requirements under this subsection with regard to any commingled raw agricultural commodity shall be limited to the requirements under subparagraph F.

For the purposes of this subparagraph—. The Secretary may, by notice in the Federal Register, modify the requirements under this subsection with respect to, or exempt a food or a type of facility from, the requirements of this subsection other than the requirements under subparagraph F , if applicable if the Secretary determines that product tracing requirements for such food such as bulk or commingled ingredients that are intended to be processed to destroy pathogens or type of facility is not necessary to protect the public health.

Recordkeeping regarding previous sources and subsequent recipients. In the case of a person or food to which a limitation or exemption under subparagraph C , D , or E applies, if such person, or a person who manufactures, processes, packs, or holds such food, is required to register with the Secretary under section of the Federal Food, Drug, and Cosmetic Act 21 U.

With respect to a sale of a food described in subparagraph H to a grocery store, the Secretary shall not require such grocery store to maintain records under this subsection other than records documenting the farm that was the source of such food.

The Secretary shall not require that such records be kept for more than days. 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.

A sale of a food described in this subparagraph is a sale of a food in which—. 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.

Foods described in the preceding sentence shall be subject solely to the recordkeeping requirements under section of the Federal Food, Drug, and Cosmetic Act 21 U.

Not later than 1 year after the effective date of the final rule promulgated under subsection d 1 , the Comptroller General of the United States shall submit to Congress a report, taking into consideration the costs of compliance and other regulatory burdens on small businesses and Federal, State, and local food safety practices and requirements, that evaluates the public health benefits and risks, if any, of limiting—.

In conducting the evaluation and report under paragraph 1 , if the Comptroller General of the United States determines that the limitations described in such paragraph do not adequately protect the public health, the Comptroller General shall submit to Congress recommendations, if appropriate, regarding recordkeeping requirements for restaurants and additional foods, in order to protect the public health.

Notwithstanding subsection d , during an active investigation of a foodborne illness outbreak, or if the Secretary determines it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak, the Secretary, in consultation and coordination with State and local agencies responsible for food safety, as appropriate, may request that the owner, operator, or agent of a farm identify potential immediate recipients, other than consumers, of an article of the food that is the subject of such investigation if the Secretary reasonably believes such article of food—.

In making a request under paragraph 1 , the Secretary, in consultation and coordination with State and local agencies responsible for food safety, as appropriate, shall issue a written notice to the owner, operator, or agent of the farm to which the article of food has been traced.

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.

The owner, operator, or agent of a farm shall deliver the information requested under paragraph 1 in a prompt and reasonable manner.

Such information may consist of records kept in the normal course of business, and may be in electronic or non-electronic format. 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.

Section j of the Federal Food, Drug, and Cosmetic Act and the Freedom of Information Act shall apply with respect to any confidential commercial information that is disclosed to the Food and Drug Administration in the course of responding to a request under paragraph 1.

Except with respect to identifying potential immediate recipients in response to a request under this subsection, nothing in this subsection shall require the establishment or maintenance by farms of new records.

Nothing in this section shall be construed to authorize the Secretary to impose any limitation on the commingling of food.

Not later than days after promulgation of a final rule under subsection d , the Secretary shall issue a small entity compliance guide setting forth in plain language the requirements of the regulations under such subsection in order to assist small entities, including farms and small businesses, in complying with the recordkeeping requirements under such subsection.

Notwithstanding any other provision of law, the regulations promulgated under subsection d shall apply—.

Bill s510

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Senate Bill S510

Bill S510 Video

Senate - Bill # S510 ~ *Start Storiing Your Food Now* - Wake Up USA - 760-625-1509

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