114 S287 IS: Safe Food Act of 2015
U.S. Senate
2015-01-28
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II114th CONGRESS1st SessionS. 287IN THE SENATE OF THE UNITED STATESJanuary 28, 2015Mr. Durbin (for himself, Mrs. Feinstein, Mrs. Gillibrand, and Mr. Blumenthal) introduced the following bill; which was read twice and referred to the Committee on Agriculture, Nutrition, and ForestryA BILLTo establish the Food Safety Administration to protect the public health by preventing foodborne
			 illness, ensuring the safety of food, improving research on contaminants
			 leading to foodborne illness, and improving security of food from
 intentional contamination, and for other purposes.1.Short title; table of contents(a)Short titleThis Act may be cited as the Safe Food Act of 2015.(b)Table of contentsThe table of contents of this Act is as follows:Sec. 1. Short title; table of contents.Sec. 2. Findings; purposes.Sec. 3. Definitions.Title I—Establishment of Food Safety AdministrationSec. 101. Establishment of food safety administration.Sec. 102. Consolidation of separate food safety and inspection services and agencies.Sec. 103. Additional duties of the administration.Title II—Administration of food safety programSec. 201. Administration of national program.Sec. 202. Registration of food facilities.Sec. 203. Preventive process controls to reduce adulteration of food.Sec. 204. Performance standards for contaminants in food.Sec. 205. Inspections of food facilities.Sec. 206. Food production establishments.Sec. 207. Federal and State cooperation.Sec. 208. Foreign supplier verification program.Sec. 209. Imports.Sec. 210. Traceback.Sec. 211. Food safety technology.Title III—Research and educationSec. 301. Public health assessment system.Sec. 302. Public education and advisory system.Sec. 303. Research.Title IV—EnforcementSec. 401. Prohibited acts.Sec. 402. Mandatory recall authority.Sec. 403. Injunction proceedings.Sec. 404. Civil and criminal penalties.Sec. 405. Presumption.Sec. 406. Whistleblower protection.Sec. 407. Administration and enforcement.Sec. 408. Citizen civil actions.Title V—ImplementationSec. 501. Definition.Sec. 502. Reorganization plan.Sec. 503. Transitional authorities.Sec. 504. Savings provisions.Sec. 505. Conforming amendments.Sec. 506. Additional technical and conforming amendments.Sec. 507. Regulations.Sec. 508. Authorization of appropriations.Sec. 509. Limitation on authorization of appropriations.Sec. 510. Effective date.2.Findings; purposes(a)FindingsCongress finds that—(1)the safety of the food supply of the United States is vital to the public health, to public confidence in the food supply, and to the success of the food sector of the Nation’s economy;(2)lapses in the protection of the food supply and loss of public confidence in food safety are damaging to consumers and the food industry, and place a burden on interstate commerce;(3)the safety and security of the food supply requires an integrated, systemwide approach to preventing foodborne illness, a thorough and broad-based approach to basic and applied research, and intensive, effective, and efficient management of the Nation’s food safety program;(4)the task of preserving the safety of the food supply of the United States faces tremendous pressures with regard to—(A)emerging pathogens and other contaminants and the ability to detect all forms of contamination;(B)an aging and immune-compromised population, with a growing number of people at high risk for foodborne illnesses, including infants and children;(C)a concern regarding food fraud for economic gain, especially with mislabeling and intentionally misleading claims;(D)an increasing volume of imported food, without adequate monitoring and inspection; and(E)maintenance of rigorous inspection of the domestic food processing and food service industries;(5)Federal food safety standard setting, inspection, enforcement, and research efforts should be based on the best available science and public health considerations and food safety resources should be systematically deployed in ways that most effectively prevent foodborne illness;(6)the Federal food safety system is fragmented, with at least 15 Federal agencies sharing responsibility for food safety, and operates under laws that do not reflect current conditions in the food system or current scientific knowledge about the cause and prevention of foodborne illness;(7)the fragmented Federal food safety system and outdated laws preclude an integrated, systemwide approach to preventing foodborne illness, to the effective and efficient operation of the Nation’s food safety program, and to the most beneficial deployment of food safety resources;(8)the National Academy of Sciences recommended in the report Ensuring Safe Food from Production to Consumption that Congress establish by statute a unified and central framework for managing Federal food safety programs, and recommended modifying Federal statutes so that inspection, enforcement, and research efforts are based on scientifically supportable assessments of risks to public health; and(9)the lack of a single focal point for food safety leadership in the United States undercuts the ability of the United States to exert food safety leadership internationally, which is detrimental to the public health and the international trade interests of the United States.(b)PurposesThe purposes of this Act are—(1)to establish a single agency to be known as the Food Safety Administration to—(A)regulate food safety and related labeling to strengthen the protection of the public health;(B)ensure that food facilities fulfill their responsibility to produce food in a manner that protects the public health of all people in the United States;(C)lead an integrated, systemwide approach to food safety and to make more effective and efficient use of resources to prevent foodborne illness;(D)provide a single focal point for food safety leadership, both nationally and internationally; and(E)provide an integrated food safety research capability, utilizing internally generated, scientifically and statistically valid studies, in cooperation with academic institutions and other scientific entities of the Federal and State governments, to achieve the continuous improvement of research on foodborne illness and contaminants;(2)to transfer to the Food Safety Administration the food safety, labeling, inspection, and enforcement functions that, as of the day before the effective date of this Act, are performed by other Federal agencies; and(3)to modernize and strengthen the Federal food safety laws to achieve more effective application and efficient management of the laws for the protection and improvement of public health.3.DefinitionsIn this Act:(1)AdministrationThe term Administration means the Food Safety Administration established under section 101(a)(1).(2)AdministratorThe term Administrator means the Administrator of Food Safety appointed under section 101(a)(3).(3)Adulterated(A)In generalThe term adulterated has the meaning given such term in—(i)section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342) for food regulated under such Act;(ii)section 1(m) of the Federal Meat Inspection Act (21 U.S.C. 601(m)) for food regulated under such Act;(iii)section 4(g) of the Poultry Products Inspection Act (21 U.S.C. 453(g)) for food regulated under such Act; and(iv)section 4(a) of the Egg Products Inspection Act (21 U.S.C. 1033(a)) for food regulated under such Act.(B)InclusionIn applying the definitions cited in subparagraph (A), poisonous or deleterious substances in food shall be treated as an added substance if the poisonous or deleterious substances are known to cause serious illness or death in persons, including in sensitive populations.(4)AgencyThe term agency has the meaning given that term in section 551 of title 5, United States Code.(5)Category 1 food facilityThe term category 1 food facility means a facility that slaughters animals for food.(6)Category 2 food facilityThe term category 2 food facility means a facility that processes—(A)raw meat, poultry, or seafood in a manner that may reduce but is not validated to destroy contaminants; or(B)other products that the Administrator determines by regulation to be at high risk of contamination.(7)Category 3 food facilityThe term category 3 food facility means a facility—(A)that processes meat, poultry, or seafood, or other products that the Administrator determines by regulation to be at high risk of contamination; and(B)whose processes include one or more steps validated to destroy contaminants.(8)Category 4 food facilityThe term category 4 food facility means a facility that processes food but is not a category 1, 2, or 3 food facility.(9)Category 5 food facilityThe term category 5 food facility means a facility that stores, holds, or transports food prior to delivery for retail sale.(10)ContaminantThe term contaminant includes biological, chemical, physical, or radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food or color additives.(11)ContaminationThe term contamination refers to a presence of a contaminant in food, which may occur naturally or be introduced into a food.(12)Feed facilityThe term feed facility means a domestic or foreign feed manufacturer, processor, packer, warehouse, or other facility that—(A)if operating in the United States, manufactures, slaughters, processes, or holds animal feed or feed ingredients; or(B)if operating elsewhere, manufactures, slaughters, processes, or holds animal feed or feed ingredients intended for consumption in the United States.(13)Food(A)In generalThe term food means a product intended to be used for food or drink for a human or an animal.(B)InclusionsThe term food includes any product (including a meat food product, as defined in section 1(j) of the Federal Meat Inspection Act (21 U.S.C. 601(j))), capable for use as human and animal food that is made in whole or in part from any animal, including cattle, sheep, swine, goat, or poultry (as defined in section 4 of the Poultry Products Inspection Act (21 U.S.C. 453)), and animal feed.(14)Food facility(A)In generalThe term food facility means a domestic or foreign food manufacturer, slaughterhouse, processor, packer, warehouse, or other facility that—(i)if operating in the United States, manufactures, slaughters, processes, or holds food or food ingredients; or(ii)if operating outside the United States, manufactures, slaughters, processes, or holds food intended for consumption in the United States.(B)ExclusionsFor the purposes of registration, the term food facility does not include—(i)a farm, restaurant, other retail food establishment, nonprofit food establishment in which food is prepared for or served directly to the consumer; or(ii)a fishing vessel (other than a fishing vessel engaged in processing, as that term is defined in section 123.3(k) of title 21, Code of Federal Regulations).(15)Food production establishmentThe term food production establishment means any farm, ranch, orchard, vineyard, aquaculture facility, or confined animal-feeding operation.(16)Food safety lawThe term food safety law means—(A)the provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) related to and requiring the safety, labeling, and inspection of food, infant formulas, food additives, pesticide residues, and other substances present in food under that Act;(B)the provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and of any other Act that are administered by the Center for Veterinary Medicine of the Food and Drug Administration;(C)the Poultry Products Inspection Act (21 U.S.C. 451 et seq.);(D)the Federal Meat Inspection Act (21 U.S.C. 601 et seq.);(E)the FDA Food Safety Modernization Act (Public Law 111–353);(F)the Egg Products Inspection Act (21 U.S.C. 1031 et seq.);(G)the Sanitary Food Transportation Act of 1990 (49 U.S.C. App. 2801 et seq.);(H)chapter 57 of title 49, United States Code;(I)Public Law 85–765 (commonly known as the Humane Methods of Slaughter Act of 1958) (7 U.S.C. 1901 et seq.);(J)the provisions of this Act; and(K)such other provisions of law related to and requiring food safety, labeling, inspection, and enforcement as the President designates by Executive order as appropriate to include within the jurisdiction of the Administration.(17)Interstate commerceThe term interstate commerce has the meaning given that term in section 201(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(b)).(18)MisbrandedThe term misbranded has the meaning given to it in—(A)section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343) for food regulated under such Act;(B)section 1(n) of the Federal Meat Inspection Act (21 U.S.C. 601(n)) for food regulated under such Act;(C)section 4(h) of the Poultry Products Inspection Act (21 U.S.C. 453(h)) for food regulated under such Act; and(D)section 4(l) of the Egg Products Inspection Act (21 U.S.C. 1033(l)) for food regulated under such Act.(19)ProcessThe term process or processing means the commercial slaughter, packing, preparation, or manufacture of food.(20)SafeThe term safe refers to human and animal health.(21)StateThe term State means—(A)a State;(B)the District of Columbia;(C)the Commonwealth of Puerto Rico; and(D)any other territory or possession of the United States.(22)ValidationThe term validation means the act of obtaining evidence that the process control measure or measures selected to control a contaminant in food is capable of effectively and consistently controlling the contaminant.(23)Statistically validThe term statistically valid means evaluated and conducted under standards set by the National Institute of Standards and Technology.IEstablishment of Food Safety Administration101.Establishment of food safety administration(a)Establishment(1)In generalThere is established in the executive branch an agency to be known as the Food Safety Administration.(2)StatusThe Administration shall be an independent establishment (as defined in section 104 of title 5, United States Code).(3)Head of administrationThe Administration shall be headed by the Administrator of Food Safety, who shall be appointed by the President, by and with the advice and consent of the Senate.(b)Duties of administratorThe Administrator shall—(1)administer and enforce the food safety law;(2)serve as a representative to international food safety bodies and discussions;(3)promulgate regulations to ensure the security of the food supply from all forms of contamination, including intentional contamination; and(4)oversee—(A)implementation of Federal food safety inspection, labeling, enforcement, and research efforts to protect the public health;(B)development of consistent and science-based standards for safe food;(C)coordination and prioritization of food safety research and education programs with other Federal agencies;(D)prioritization of Federal food safety efforts and deployment of Federal food safety resources to achieve the greatest benefit in reducing foodborne illness;(E)coordination of the Federal response to foodborne illness outbreaks with other Federal and State agencies; and(F)integration of Federal food safety activities with State and local agencies.102.Consolidation of separate food safety and inspection services and agencies(a)Transfer of functionsFor each Federal agency specified in subsection (b), there are transferred to the Administration all functions that the head of the Federal agency exercised on the day before the effective date of this Act (including all related functions of any officer or employee of the Federal agency) that relate to administration or enforcement of the food safety law, as determined by the President.(b)Transferred agenciesThe Federal agencies referred to in subsection (a) are—(1)the Food Safety and Inspection Service of the Department of Agriculture;(2)the Center for Food Safety and Applied Nutrition of the Food and Drug Administration;(3)the part of the Agriculture Marketing Service that administers shell egg surveillance services established under the Egg Products Inspection Act (21 U.S.C. 1031 et seq.);(4)the resources and facilities of the Office of Regulatory Affairs of the Food and Drug Administration that administer and conduct inspections of food and feed facilities and imports;(5)the Center for Veterinary Medicine of the Food and Drug Administration;(6)the resources and facilities of the Office of the Commissioner of the Food and Drug Administration, known as the Office of Food and Veterinary Medicine, that support—(A)the Center for Food Safety and Applied Nutrition;(B)the Center for Veterinary Medicine; and(C)the Office of Regulatory Affairs facilities and resources described in paragraph (4);(7)the part of the Research, Education, and Economics mission area of the Department of Agriculture related to food and feed safety;(8)the part of the National Marine Fisheries Service of the National Oceanic and Atmospheric Administration of the Department of Commerce that administers the seafood inspection program;(9)the part of the Animal and Plant Inspection Health Service of the Department of Agriculture related to the management of animals going into the food supply; and(10)such other offices, services, or agencies as the President designates by Executive order to carry out this Act.103.Additional duties of the administration(a)Officers and employeesThe Administrator may—(1)appoint officers and employees for the Administration in accordance with the provisions of title 5, United States Code, relating to appointment in the competitive service; and(2)fix the compensation of those officers and employees in accordance with chapter 51 and with subchapter III of chapter 53 of that title, relating to classification and General Schedule pay rates.(b)Experts and consultantsThe Administrator may—(1)procure the services of temporary or intermittent experts and consultants as authorized by section 3109 of title 5, United States Code; and(2)pay in connection with those services the travel expenses of the experts and consultants, including transportation and per diem in lieu of subsistence while away from the homes or regular places of business of the individuals, as authorized by section 5703 of that title.(c)Bureaus, offices, and divisionsThe Administrator may establish within the Administration such bureaus, offices, and divisions as the Administrator determines are necessary to perform the duties of the Administrator.(d)Advisory committees(1)In generalThe Administrator shall establish advisory committees that consist of representatives of scientific expert bodies, academics, industry specialists, and consumers.(2)DutiesThe duties of an advisory committee established under paragraph (1) may include developing recommendations with respect to the development of regulatory science and processes, research, communications, performance standards, and inspection.IIAdministration of food safety program201.Administration of national program(a)In generalThe Administrator shall—(1)administer a national food safety program (referred to in this section as the program) to protect public health; and(2)ensure that persons who produce or process food meet their responsibility to prevent or minimize food safety hazards related to their products.(b)Comprehensive analysisThe program shall be based on a comprehensive analysis of the hazards associated with different food and with the processing of different food, including the identification and evaluation of—(1)the severity of the health risks;(2)the sources and specific points of potential contamination extending from the farm or ranch to the consumer that may render food unsafe;(3)the potential for persistence, multiplication, or concentration of naturally occurring or added contaminants in food;(4)opportunities across the food production, processing, distribution, and retail system to manage and reduce potential health risks; and(5)opportunities for intentional contamination.(c)Program elementsIn carrying out the program, the Administrator shall—(1)adopt and implement a national system for the registration of food facilities and regular unannounced inspection of food facilities;(2)verify and enforce the adoption of preventive process controls in food facilities, based on the best available scientific and public health considerations and best available technologies;(3)establish and enforce science-based standards for—(A)substances that may contaminate food; and(B)safety and sanitation in the processing and handling of food;(4)implement a statistically valid sampling program to ensure that industry programs and procedures that prevent food contamination are effective on an ongoing basis and that food meets the performance standards established under this Act;(5)implement procedures and requirements to ensure the safety and security of imported food;(6)coordinate with other agencies and State or local governments in carrying out inspection, enforcement, research, and monitoring;(7)access the surveillance data of the Centers for Disease Control and Prevention, and other Federal Government agencies, in order to develop and implement a national surveillance system to assess the health risks associated with the human consumption of food or to create surveillance data and studies;(8)partner with relevant agencies to identify and prevent terrorist threats to food;(9)establish a process for providing a single point of contact to assist impacted consumers in navigating Federal, State, and local agencies involved in responding to or monitoring a foodborne outbreak;(10)develop public education risk communication and advisory programs;(11)implement a basic and applied research program to further the purposes of this Act; and(12)coordinate and prioritize food safety research and educational programs with other agencies, including State or local agencies.202.Registration of food facilities(a)In generalThe Administrator shall require that all food and feed facilities register before the facility can operate in the United States or import food, feed, or ingredients into the United States.(b)Registration requirements(1)In generalTo be registered under subsection (a)—(A)all food facilities covered under this Act shall comply with registration requirements in section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d);(B)for food facilities that have not registered under such section 415 prior to the date of enactment of this Act, the requirement in subparagraph (A) applies beginning on the day that is 180 days after the date of enactment of this Act; and(C)for food facilities that have registered under such section 415 prior to the date of enactment of this Act, such facilities shall file an amended registration within 180 days of such date of enactment to deliver the information required by paragraph (2).(2)CategoriesIn addition to the information required under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) to be included in registration, a food facility shall—(A)list the facility’s primary purpose and business activity, including the dates of operation if the food facility is operating seasonally; and(B)list the types of food handled at the facility and identify the activities conducted in the facility, that are relevant to determining whether the facility is a category 1, 2, 3, 4, or 5 facility.(3)ProcedureUpon receipt of a completed or amended registration described in paragraph (1), the Administrator shall notify the registrant of the receipt of the registration, review the activities identified in the registration, designate the facility as a category 1, 2, 3, 4, or 5 food facility for the purposes of inspection, and assign a registration number to each food facility.(4)ListThe Administrator—(A)shall compile and maintain an up-to-date list of food facilities that are registered under this section, in accordance with section 415(a)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d(a)(5)); and(B)may establish regulations on how the list may be shared with other governmental authorities.203.Preventive process controls to reduce adulteration of food(a)In generalThe Administrator shall review existing regulations on hazard analysis and process controls and amend existing regulations as appropriate, upon the basis of best available public health, scientific, and technological information, to ensure that those regulations are working effectively to—(1)ensure food facilities operate in a sanitary manner so that food is not adulterated;(2)limit the presence of contaminants in food;(3)meet the performance standards established under section 204;(4)ensure fully processed or ready-to-eat foods are processed using reasonably available techniques and technologies to eliminate contaminants;(5)label food intended for final processing outside commercial food facilities with instructions for handling and preparation for consumption that will destroy contaminants;(6)require sampling and testing at a frequency and in a manner sufficient to ensure that process controls are effective on an ongoing basis and that performance standards are being met; and(7)provide for agency access to records kept by food facilities and submission of copies of the records to the Administrator, as the Administrator determines appropriate.(b)Processing controlsThe Administrator may require any person with responsibility for or control over food or food ingredients to adopt process controls, if the process controls are needed to ensure the protection of the public health.204.Performance standards for contaminants in food(a)Performance standardsWhenever the Administrator determines that a foodborne contaminant presents the risk of serious adverse health consequences or death to consumers, causes food to be adulterated, or could promote the spread of communicable disease described in section 361 of the Public Health Service Act (42 U.S.C. 264), the Administrator shall issue a performance standard (in the form of guidance, action levels, or regulations) to prevent or control the contaminant.(b)Enforcement(1)In generalNot later than 1 year after the promulgation of a performance standard under this section, the Administrator shall implement a statistically significant sampling program to determine whether food facilities are complying with the standards promulgated under this section.(2)ActionsIf the Administrator determines that a food facility fails to meet a standard promulgated under this section, and such facility fails to take appropriate corrective action as determined by the Administrator, the Administrator shall, as appropriate—(A)detain, seize, or condemn food from the food facility under section 209(i);(B)order a recall of food from the food facility under section 402;(C)increase the inspection frequency for the food facility;(D)withdraw the mark of inspection from the food facility, if in use; or(E)take other appropriate enforcement action concerning the food facility, including suspension of registration.(c)Newly identified contaminantsNotwithstanding any other provision of this section, the Administrator shall promulgate interim performance standards for newly identified contaminants as necessary to protect the public health.(d)Revocation by administratorAll performance standards, tolerances, action levels, or other similar standards with respect to food in effect on the date of enactment of this Act shall remain in effect until revised or revoked by the Administrator.205.Inspections of food facilities(a)In generalThe Administrator shall establish an inspection program, which shall include sampling and testing of food and food facilities, to determine if each food facility—(1)is operating in a sanitary manner;(2)has continuous systems, interventions, and processes in place to minimize or eliminate contaminants in food;(3)uses validated process controls and ongoing verification;(4)is in compliance with applicable performance standards established under section 204, process control regulations, and other requirements;(5)is processing food that is safe and not adulterated or misbranded;(6)maintains records of process control plans under section 203, and other records related to the processing, sampling, and handling of food; and(7)is in compliance with the requirements of the applicable food safety law.(b)Facility categories and inspection frequenciesInspections of food facilities under this Act shall be based on the following categories and inspection frequencies, subject to subsections (c), (d), and (e):(1)Category 1 food facilitiesA category 1 food facility shall be subject to antemortem, postmortem, and continuous inspection of each slaughter line during all operating hours, and other inspection on a daily basis, sufficient to verify that—(A)diseased animals are not offered for slaughter;(B)the food facility has successfully identified and removed from the slaughter line visibly defective or contaminated carcasses, has avoided cross-contamination, and destroyed or reprocessed contaminated carcasses in a manner acceptable to the Administrator; and(C)that applicable performance standards and other provisions of the food safety law, including those intended to eliminate or reduce pathogens, have been satisfied.(2)Category 2 food facilitiesA category 2 food facility shall be randomly inspected at least daily.(3)Category 3 food facilitiesA category 3 food facility shall—(A)provide documentation to the Administrator on request that ongoing verification shows that its processes are controlled; and(B)be randomly inspected at least monthly.(4)Category 4 food facilitiesA category 4 food facility shall be randomly inspected at least quarterly.(5)Category 5 food facilitiesA category 5 food facility shall be randomly inspected at least annually.(c)Establishment of inspection proceduresThe Administrator shall establish procedures under which inspectors or safety officers inspect food facilities, which shall allow the taking of random samples, photographs, and copies of records in food facilities.(d)Alternative inspection frequenciesWith respect to a category 2, 3, 4, or 5 food facility, the Administrator may establish alternative increased or decreased inspection frequencies for subcategories of food facilities or for individual facilities, to foster risk-based allocation of resources, subject to the following criteria and procedures:(1)Subcategories of food facilities and their alternative inspection frequencies shall be defined by regulation, subject to paragraphs (2) and (3).(2)Alternative inspection frequencies for subcategories of food facilities under paragraph (1) and for a specific food facility under paragraph (4) shall provide that—(A)category 2 food facilities shall be inspected at least monthly; and(B)category 3 and 4 food facilities shall be inspected at least annually.(3)In defining subcategories of food facilities and their alternative inspection frequencies under paragraphs (1) and (2), the Administrator shall consider—(A)the nature of the foods being processed, stored, or transported;(B)the manner in which foods are processed, stored, or transported;(C)the inherent likelihood that the foods will contribute to the risk of foodborne illness;(D)the best available evidence concerning reported illnesses associated with the foods produced in the proposed subcategory of facilities; and(E)the overall record of compliance with the food safety law among facilities in the proposed subcategory, including compliance with applicable performance standards and the frequency of recalls.(4)The Administrator may adopt alternative inspection frequencies for increased or decreased inspection for a specific facility, subject to paragraphs (2) and (5), and shall annually publish a list of facilities subject to alternative inspections.(5)In adopting alternative inspection frequencies for a specific facility, the Administrator shall consider—(A)the supporting evidence that an individual food facility shall submit related to whether an alternative inspection frequency should be established for such facility by the Administrator;(B)whether products from the specific facility have been associated with a case or an outbreak of foodborne illness;(C)the record of the facility of compliance with the food safety law, including compliance with applicable performance standards and the frequency of recalls; and(D)the criteria in paragraph (3).(6)Before establishing decreased alternative inspection frequencies for subcategories of facilities or individual facilities, the Administrator shall—(A)describe the alternative uses of resources in general terms when issuing the regulation or order that establishes the alternative inspection frequency; and(B)determine, based on the best available evidence, that the alternative uses of the resources required to carry out the inspection activity would make a greater contribution to protecting the public health and reducing the risk of foodborne illness.(e)Inspection transitionThe Administrator shall manage the transition to the inspection system described in this Act as follows:(1)RegulationsThe Administrator shall promulgate regulations to implement this section no later than 24 months after the date of enactment of this Act.(2)Limit on reduction in inspection frequencyFor any food facility, the Administrator shall not reduce the inspection frequency from the frequency required pursuant to the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) until the food facility has demonstrated that sufficient changes in facilities, procedures, personnel, or other aspects of the process control system have been made such that the Administrator determines that compliance with the food safety law is achieved.(f)Official mark(1)In general(A)EstablishmentBefore the completion of the transition process under subsection (e), the Administrator shall by regulation establish an official mark that can be affixed to a food produced in a category 1, 2, or 3 food facility if—(i)the facility is in compliance with the food safety law; and(ii)has been inspected in accordance with the inspection frequencies under this section.(B)Removal of official markThe Administrator shall promulgate regulations that provide for the removal of the official mark under this subsection if—(i)the Administrator makes a finding that the facility is not in compliance with the food safety law; or(ii)the Administrator suspends the registration of the facility.(2)Category 1, 2, or 3 food facilitiesIn the case of products manufactured, slaughtered, processed, or held in a category 1, 2, or 3 food facility—(A)products subject to Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), and the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) as of the date of enactment of this Act, shall remain subject to the requirement under those Acts that they bear the mark of inspection pending completion of the transition process under subsection (e);(B)the Administrator shall publicly certify on a monthly basis that the inspection frequencies required under this section have been achieved; and(C)a product from a facility that has not been inspected in accordance with the required frequencies under this section shall not bear the official mark and shall not be shipped in interstate commerce.(3)Category 4 and 5 food facilitiesIn the case of a product manufactured, slaughtered, processed, or held in a category 4 or 5 food facility, the Administrator shall provide by regulation for the voluntary use of the official mark established under paragraph (1), subject to—(A)such minimum inspection frequencies as determined appropriate by the Administrator;(B)compliance with applicable performance standards and other provisions of the food safety law; and(C)such other requirements as the Administrator considers appropriate.(g)Maintenance and inspection of records(1)In general(A)RecordsA food facility shall—(i)maintain such records as the Administrator requires by regulation, including all records relating to the processing, distributing, receipt, or importation of any food; and(ii)permit the Administrator, in addition to any authority of the food safety agencies in effect on the day before the date of enactment of this Act, upon presentation of appropriate credentials and at reasonable times and in a reasonable manner, to have access to and copy all records maintained by or on behalf of such food facility representative in any format (including paper or electronic) and at any location, that are necessary to assist the Administrator to determine whether the food is contaminated or not in compliance with the food safety law.(B)Required disclosureA food facility shall have an affirmative obligation to disclose to the Administrator the results of testing or sampling of food, equipment, or material in contact with food, that is positive for any contaminant.(2)Maintenance of recordsThe records required by paragraph (1) shall be maintained for a reasonable period of time, as determined by the Administrator.(3)RequirementsThe records required by paragraph (1) shall include records describing—(A)the origin, receipt, delivery, sale, movement, holding, and disposition of food or ingredients;(B)the identity and quantity of ingredients used in the food;(C)the processing of the food;(D)the results of laboratory, sanitation, or other tests performed on the food or in the food facility;(E)consumer complaints concerning the food or packaging of the food;(F)the production codes, open date codes, and locations of food production; and(G)other matters reasonably related to whether food is unsafe, is adulterated or misbranded, or otherwise fails to meet the requirements of this Act.(h)Protection of sensitive information(1)In generalThe Administrator shall develop and maintain procedures to prevent the unauthorized disclosure of any trade secret or confidential information obtained by the Administrator.(2)LimitationThe requirement under this subsection does not—(A)limit the authority of the Administrator to inspect or copy records or to require the facility or maintenance of records under this Act;(B)have any legal effect on section 1905 of title 18, United States Code;(C)extend to any food recipe, financial data, pricing data, personnel data, or sales data (other than shipment dates relating to sales);(D)limit the public disclosure of distribution records or other records related to food subject to a voluntary or mandatory recall under section 402; or(E)limit the authority of the Administrator to promulgate regulations to permit the sharing of data with other governmental authorities.(i)Bribery of or gifts to inspector or other officers and acceptance of giftsSection 22 of the Federal Meat Inspection Act (21 U.S.C. 622) shall apply under this Act.206.Food production establishmentsIn carrying out the duties of the Administrator and the purposes of this Act, the Administrator shall have the authority, with respect to food production establishments, to—(1)visit and inspect food production establishments in the United States and in foreign countries for food safety purposes;(2)review food safety records as needed to carry out traceback and for other food safety purposes;(3)set good practice standards to protect the public and promote food safety;(4)partner with appropriate agencies to monitor animals, plants, products, or the environment, as appropriate; and(5)collect and maintain information relevant to public health and farm practices.207.Federal and State cooperation(a)In generalThe Administrator shall work with the States to carry out activities and programs that create a national food safety program so that Federal and State programs function in a coordinated and cost-effective manner.(b)State actionThe Administrator shall work with States to—(1)continue, strengthen, or establish State food safety programs, especially with respect to the regulation of retail commercial food establishments, transportation, harvesting, and fresh markets;(2)continue, strengthen, or establish inspection programs and requirements to ensure that food under the jurisdiction of the State is safe; and(3)support recall authorities at the State and local levels.(c)AssistanceTo assist in planning, developing, and implementing a food safety program, the Administrator may provide to a State—(1)advisory assistance;(2)technical and laboratory assistance and training (including necessary materials and equipment); and(3)financial assistance, in kind, and other aid.(d)Service agreements(1)In generalThe Administrator may, under agreements entered into with Federal, State, or local agencies, use on a reimbursable basis or otherwise, the personnel and services of those agencies in carrying out this Act.(2)TrainingAgreements with a State under this subsection may provide for training of State employees.(3)Maintenance of agreementsThe Administrator shall maintain any agreement that is in effect on the day before the date of enactment of this Act until the Administrator evaluates such agreement and determines whether to maintain or substitute such agreement.(e)Audits(1)In generalThe Administrator shall annually conduct a comprehensive review of each State program that provides services to the Administrator in carrying out the responsibilities under this Act, including mandated inspections under section 205.(2)RequirementsThe review shall—(A)include a determination of the effectiveness of the State program; and(B)identify any changes necessary to ensure enforcement of Federal requirements under this Act.(f)No Federal preemptionNothing in this Act shall be construed to preempt the enforcement of State food safety laws and standards that are at least as stringent as those under this Act.208.Foreign supplier verification program(a)In generalThe Administrator shall require that each importer of products from a feed facility, food facility, or food producer establishment be in compliance with the foreign supplier verification program requirements under section 805 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384a).(b)Rule of constructionIn applying subsection (a) with respect to products subject to the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), references in section 805 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384a) to sections 402, 403(w), 418, and 419 of such Act (21 U.S.C. 342, 343(w), 350g, and 350h) shall be construed to be references to the corresponding provisions of the food safety law, if any, that apply to such products, as determined by the Administrator.(c)Repeal of exemptionsSubsection (e) of section 805 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384a) is hereby repealed.209.Imports(a)In generalNot later than 2 years after the effective date of this Act, the Administrator shall establish a system under which a foreign government seeking to certify food for importation into the United States shall submit a request for accreditation to the Administrator.(b)Accreditation standardA foreign government requesting to be accredited to certify food for importation into the United States shall demonstrate, in a manner determined appropriate by the Administrator, that the foreign government (or an agency thereof) is capable of adequately ensuring that eligible entities or foods certified by such government (or agency) meet the requirements of the food safety law.(c)Request by foreign governmentPrior to granting accreditation to a foreign government under this section, the Administrator shall review and audit the food safety program of the requesting foreign government and certify that such program (including all statutes, regulations, and inspection authority) meets the standard specified in subsection (b).(d)LimitationsAny accreditation of a foreign government under this section shall—(1)specify the foods covered by the accreditation; and(2)be limited to a period not to exceed 5 years.(e)Withdrawal of accreditationThe Administrator may withdraw accreditation fully or partially from a foreign government if the Administrator finds that—(1)food covered by the accreditation is linked to an outbreak of human illness;(2)the programs or procedures of the foreign government no longer meet the standards of the food safety programs and procedures of the United States; or(3)the foreign government refuses to allow United States officials to conduct such audits and investigations as may be necessary to fulfill the requirements under this section.(f)Renewal of accreditationThe Administrator shall audit foreign governments accredited under this section at least every 5 years to ensure the continued compliance by such governments with the standard set forth in subsection (b).(g)Required routine inspectionThe Administrator shall routinely inspect food or food animals by physical examination before the food or food animals enter the United States to ensure that the food or food animals—(1)are safe;(2)are labeled as required for food produced in the United States; and(3)otherwise meet the requirements of the food safety law.(h)EnforcementThe Administrator may—(1)deny importation of food from any country if the country’s government does not permit United States officials to enter the country to conduct such audits and inspections as may be necessary to fulfill the requirements under this section;(2)deny importation of food from any country or foreign facility that does not consent to an investigation by the Administrator when food from that country or foreign facility is linked to a foodborne illness outbreak or is otherwise found to be adulterated or mislabeled; and(3)promulgate regulations to carry out the purposes of this section, including setting terms and conditions for the destruction of products that fail to meet the standards of the food safety law.(i)Detention and seizureAny food imported for consumption in the United States that fails to meet the standards of the food safety law may be detained, seized, or condemned.210.Traceback(a)In generalThe Administrator, in order to protect the public health, shall establish requirements for a national system for tracing food, animals, or ingredients from point of origin to retail sale, subject to subsection (b).(b)ApplicabilityTraceability requirements shall—(1)be established in accordance with regulations and guidelines issued by the Administrator; and(2)apply to food production establishments and food facilities.211.Food safety technology(a)In generalThe Administrator shall establish and implement a program, to be known as the Food Safety Technology Program, to foster innovation in food technologies and foods that have the potential to improve food safety at the point of production, processing, transport, storage, or final preparation.(b)Program describedThe program under this section shall consist of technical guidance to and consultation with technology developers to assist them in meeting requirements for approval of technologies and products described in subsection (a).IIIResearch and education301.Public health assessment system(a)In generalThe Administrator, acting in coordination with the Director of the Centers for Disease Control and Prevention and with the Research Education and Economics mission area of the Department of Agriculture, shall—(1)have access to the applicable data systems of the Centers for Disease Control and Prevention and to the databases made available by a State;(2)partner with relevant agencies to maintain or access an active surveillance system of food and epidemiological evidence submitted by States to the Centers for Disease Control and Prevention based on a representative proportion of the population of the United States;(3)assess the frequency and sources of human illness in the United States associated with the consumption of food;(4)partner with relevant agencies to maintain or access a state-of-the-art partial or full genome sequencing system and epidemiological system dedicated to foodborne illness identification, outbreaks, and containment; and(5)have access to the surveillance data created via monitoring and statistical studies conducted as part of its own inspection.(b)Public health sampling(1)In generalNot later than 1 year after the effective date of this Act, the Administrator shall establish guidelines for a sampling system under which the Administrator shall take and analyze samples of food—(A)to assist the Administrator in carrying out this Act; and(B)to assess the nature, frequency of occurrence, and quantities of contaminants in food.(2)RequirementsThe sampling system described in paragraph (1) shall provide—(A)statistically valid monitoring, including market-based studies, on the nature, frequency of occurrence, and quantities of contaminants in food available to consumers; and(B)at the request of the Administrator, such other information, including analysis of monitoring and verification samples, as the Administrator determines may be useful in assessing the occurrence of contaminants in food.(c)Assessment of health hazardsThrough the surveillance system referred to in subsection (a), the sampling system described in subsection (b), and other available data, the Administrator shall—(1)rank food categories based on the hazard to human health presented by the food category;(2)identify appropriate industry and regulatory approaches to minimize hazards in the food supply; and(3)assess the public health environment for emerging diseases, including zoonosis, for their risk of appearance in the United States food supply.302.Public education and advisory system(a)Public educationThe Administrator shall—(1)in cooperation with private and public organizations, including the cooperative extension services and building on the efforts of appropriate State and local entities, establish a national public education program on food safety; and(2)coordinate with other Federal departments and agencies to integrate food safety messaging into all food-related agricultural, nutrition, and health promotion programs.(b)Health advisoriesThe Administrator, in consultation with such other Federal departments and agencies as the Administrator determines necessary, shall work with the States and other appropriate entities—(1)to develop and distribute regional and national advisories concerning food safety;(2)to develop standardized formats for written and broadcast advisories;(3)to incorporate State and local advisories into the national public education program established under subsection (a); and(4)to present prompt, specific information regarding foods found to pose a threat to the public health.303.Research(a)In generalThe Administrator shall conduct research to carry out this Act, including studies to—(1)improve sanitation and food safety practices in the processing of food;(2)develop improved techniques to monitor and inspect food;(3)develop efficient, rapid, and sensitive methods to detect contaminants in food;(4)determine the sources of contamination of contaminated food;(5)develop food consumption data;(6)identify ways that animal production techniques could improve the safety of the food supply;(7)draw upon research and educational programs that exist at the State and local level;(8)determine the food safety education needs of vulnerable populations, including children less than 10 years of age, pregnant women, adults 65 years of age and older, and individuals with compromised immune systems;(9)utilize the partial or full genome sequencing system and other processes to identify and control pathogens;(10)address common and emerging zoonotic diseases;(11)develop methods to reduce or destroy harmful pathogens before, during, and after processing;(12)analyze the incidence of antibiotic resistance as it pertains to the food supply and develop new methods to reduce infection by antibiotic resistant bacteria in humans and animals; and(13)conduct other research that supports the purposes of this Act.(b)Contract authorityThe Administrator may enter into contracts and agreements with any State, university, Federal Government agency, or person to carry out this section.IVEnforcement401.Prohibited actsIt is prohibited—(1)to manufacture, introduce, deliver for introduction, or receive into interstate commerce any food that is adulterated, misbranded, or otherwise unsafe;(2)to adulterate or misbrand any food in interstate commerce;(3)for a food facility or foreign food facility to fail to register under section 202, or to operate without a valid registration;(4)to refuse to permit access to a food facility for the inspection and copying of a record as required under section 205(g);(5)to fail to establish or maintain any record or to make any report as required under section 205(g);(6)to refuse to permit entry to or inspection of a food facility as required under section 205;(7)to fail to provide to the Administrator the results of a testing or sampling of a food, equipment, or material in contact with contaminated food under section 205(g)(1)(B);(8)to fail to comply with an applicable provision of, or a regulation or order of the Administrator under, section 202, 204, or 208;(9)to slaughter an animal that is capable for use in whole or in part as human food at a food facility processing any such food for commerce, except in compliance with the food safety law;(10)to fail to comply with a recall or other order under section 402; or(11)to otherwise violate the food safety law.402.Mandatory recall authority(a)Voluntary proceduresIf the Administrator determines that there is a reasonable probability that an article of food (other than infant formula) is adulterated or misbranded and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals, the Administrator shall provide the owner, operator, or agent in charge of the facility that created, caused, or was otherwise responsible for such food with an opportunity to cease distribution and recall such article.(b)Prehearing Order To Cease Distribution and Give Notice(1)In generalIf the owner, operator, or agent in charge of the facility refuses to or does not voluntarily cease distribution or recall such article within the time and in the manner prescribed by the Administrator (if so prescribed), the Administrator may by order require, as the Administrator deems necessary, such person to—(A)immediately cease distribution of such article;(B)as applicable, immediately notify all persons manufacturing, processing, packing, transporting, distributing, receiving, holding, or importing and selling such article; and(C)to which such article has been distributed, transported, or sold, immediately cease distribution of such article.(2)Required additional information(A)In generalIf an article of food covered by a recall order issued under paragraph (1)(B) has been distributed to a warehouse-based, third-party logistics provider without providing such provider sufficient information to know or reasonably determine the precise identity of the article of food covered by a recall order that is in its possession, the notice provided by the responsible party subject to the order issued under paragraph (1)(B) shall include such information as is necessary for the warehouse-based, third-party logistics provider to identify the food.(B)Rules of constructionNothing in this paragraph shall be construed—(i)to exempt a warehouse-based, third-party logistics provider from the requirements of food safety law; or(ii)to exempt a warehouse-based, third-party logistics provider from being the subject of a mandatory recall order.(3)Determination to limit areas affectedIf the Administrator requires an owner, operator, or agent in charge of the facility to cease distribution under paragraph (1)(A) of an article of food identified in subsection (a), the Administrator may limit the size of the geographic area and the markets affected by such cessation if such limitation would not compromise the public health.(c)Hearing on orderThe Administrator shall provide the owner, operator, or agent in charge of the facility subject to an order under subsection (b) with an opportunity for an informal hearing, to be held as soon as possible, but not later than 2 days after the issuance of the order, on the actions required by the order and on why the article that is the subject of the order should not be recalled.(d)Post-Hearing Recall Order and Modification of Order(1)Amendment of orderIf, after providing opportunity for an informal hearing under subsection (c), the Administrator determines that removal of the article from commerce is necessary, the Administrator shall, as appropriate—(A)amend the order to require recall of such article or other appropriate action;(B)specify a timetable in which the recall shall occur;(C)require periodic reports to the Administrator describing the progress of the recall; and(D)provide notice to consumers to whom such article was, or may have been, distributed.(2)Vacating of orderIf, after such hearing, the Administrator determines that adequate grounds do not exist to continue the actions required by the order, or that such actions should be modified, the Administrator shall vacate the order or modify the order.(e)Rule regarding alcoholic beveragesThe Administrator shall not initiate a mandatory recall or take any other action under this section with respect to any alcohol beverage until the Administrator has provided the Alcohol and Tobacco Tax and Trade Bureau with a reasonable opportunity to cease distribution and recall such article under the Alcohol and Tobacco Tax and Trade Bureau’s authority.(f)Cooperation and consultationThe Administrator shall work with State and local public health officials in carrying out this section, as appropriate.(g)Public notificationIn conducting a recall under this section, the Administrator shall—(1)ensure that a press release is published regarding the recall, as well as alerts and public notices, as appropriate, in order to provide notification—(A)of the recall to consumers and retailers to whom such article was, or may have been, distributed; and(B)that includes, at a minimum—(i)the name of the article of food subject to the recall;(ii)a description of the risk associated with such article; and(iii)to the extent practicable, information for consumers about similar articles of food that are not affected by the recall;(2)provide to the public a list of retail consignees receiving products for which there is determined to be a reasonable probability that eating the food will cause serious adverse health consequences or death to humans or animals; and(3)if available, publish on the Internet website of the Administration an image of the article that is the subject of the press release described in paragraph (1).(h)No delegationThe authority conferred by this section to order a recall or vacate a recall order shall not be delegated to any officer or employee other than the Administrator.(i)EffectNothing in this section shall affect the authority of the Administrator to request or participate in a voluntary recall, or to issue an order to cease distribution or to recall under any other provision of the food safety law or under the Public Health Service Act (42 U.S.C. 201 et seq.).(j)Coordinated communication(1)In generalTo assist in carrying out the requirements of this subsection, the Administrator shall establish an incident command operation or a similar operation that will operate not later than 24 hours after the initiation of a mandatory recall or the recall of an article of food for which the use of, or exposure to, such article will cause serious adverse health consequences or death to humans or animals.(2)RequirementsTo reduce the potential for miscommunication during recalls or regarding investigations of a foodborne illness outbreak associated with a food that is subject to a recall, each incident command operation or similar operation under paragraph (1) shall use regular staff and resources of the Administration to—(A)ensure timely and coordinated communication within the Administration, including enhanced communication and coordination between different agencies and organizations within the Administration;(B)ensure timely and coordinated communication from the Administration, including public statements, throughout the duration of the investigation and related foodborne illness outbreak;(C)identify a single point of contact within the Administration for public inquiries regarding any actions by the Administrator related to a recall;(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 defined in section 25(b) of the Richard B. Russell National School Lunch Act (42 U.S.C. 1769f(b))); and(E)conclude operations at such time as the Administrator determines appropriate.(3)Multiple recallsThe Administrator may establish multiple or concurrent incident command operations or similar operations in the event of multiple recalls or foodborne illness outbreaks.(4)Fees applicable to all facilitiesFees described in section 743 of Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–31) for not complying with a recall order are applicable to all food facilities under this Act as if—(A)the term responsible party means owner, operator, or agent in charge of the facility; and(B)references to section 423 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350l) are references to section 402 of this Act.403.Injunction proceedings(a)JurisdictionThe district courts of the United States, and the United States courts of the territories and possessions of the United States, shall have jurisdiction, for cause shown, to restrain a violation of section 202, 203, 204, 207, or 401 (or a regulation promulgated under that section).(b)TrialIn a case in which violation of an injunction or restraining order issued under this section also constitutes a violation of the food safety law, trial shall be by the court or, upon demand of the accused, by a jury.404.Civil and criminal penalties(a)Civil sanctions(1)Civil penalty(A)In generalAny person that commits an act that violates the food safety law may be assessed a civil penalty by the Administrator of not more than $10,000 for each such act.(B)Separate offenseEach act described in subparagraph (A) and each day during which that act continues shall be considered a separate offense.(2)Other requirements(A)Written orderThe civil penalty described in paragraph (1) shall be assessed by the Administrator by a written order, which shall specify the amount of the penalty and the basis for the penalty under subparagraph (B) considered by the Administrator.(B)Amount of penaltySubject to paragraph (1)(A), the amount of the civil penalty shall be determined by the Administrator, after considering—(i)the gravity of the violation;(ii)the degree of culpability of the person;(iii)the size and type of the business of the person; and(iv)any history of prior offenses by the person under the food safety law.(C)Review of orderThe order may be reviewed only in accordance with subsection (c).(b)Criminal sanctions(1)In generalExcept as provided in paragraphs (2) and (3), a person that knowingly produces or introduces into commerce food that is unsafe or otherwise adulterated or misbranded shall be imprisoned for not more than 1 year or fined not more than $10,000, or both.(2)Severe violationsA person that commits a violation described in paragraph (1) after a conviction of that person under this section has become final, or commits such a violation with the intent to defraud or mislead, shall be imprisoned for not more than 3 years or fined not more than $100,000, or both.(3)ExceptionNo person shall be subject to the penalties of this subsection—(A)for having received, proffered, or delivered in interstate commerce any food, if the receipt, proffer, or delivery was made in good faith, unless that person refuses to furnish (on request of an officer or employee designated by the Administrator)—(i)the name, address, and contact information of the person from whom that person purchased or received the food;(ii)copies of all documents relating to the person from whom that person purchased or received the food; and(iii)copies of all documents pertaining to the delivery of the food to that person; or(B)if that person establishes a guaranty signed by, and containing the name and address of, the person from whom that person received in good faith the food, stating that the food is not adulterated or misbranded within the meaning of this Act.(c)Judicial review(1)In generalAn order assessing a civil penalty under subsection (a) shall be a final order unless the person—(A)not later than 30 days after the effective date of the order, files a petition for judicial review of the order in the United States court of appeals for the circuit in which that person resides or has its principal place of business or the United States Court of Appeals for the District of Columbia; and(B)simultaneously serves a copy of the petition by certified mail to the Administrator.(2)Filing of recordNot later than 45 days after the service of a copy of the petition under paragraph (1)(B), the Administrator shall file in the court a certified copy of the administrative record upon which the order was issued.(3)Standard of reviewThe findings of the Administrator relating to the order shall be set aside only if found to be unsupported by substantial evidence on the record as a whole.(d)Collection Actions for Failure To Pay(1)In generalIf any person fails to pay a civil penalty assessed under subsection (a) after the order assessing the penalty has become a final order, or after the court of appeals described in subsection (b) has entered final judgment in favor of the Administrator, the Administrator shall refer the matter to the Attorney General, who shall institute in a United States district court of competent jurisdiction a civil action to recover the amount assessed.(2)Limitation on reviewIn a civil action under paragraph (1), the validity and appropriateness of the order of the Administrator assessing the civil penalty shall not be subject to judicial review.(e)Penalties paid into accountThe Administrator—(1)shall deposit penalties collected under this section in an account in the Treasury; and(2)may use the funds in the account, without further appropriation or fiscal year limitation—(A)to carry out enforcement activities under food safety law; or(B)to provide assistance to States to inspect retail commercial food establishments or other food or firms under the jurisdiction of State food safety programs.(f)Discretion of the Administrator To ProsecuteNothing in this Act requires the Administrator to report for prosecution, or for the commencement of an action, the violation of the food safety law in a case in which the Administrator finds that the public interest will be adequately served by the assessment of a civil penalty under this section.(g)Remedies not exclusiveThe remedies provided in this section may be in addition to, and not exclusive of, other remedies that may be available.405.PresumptionIn any action to enforce the requirements of the food safety law, the connection with interstate commerce required for jurisdiction shall be presumed to exist.406.Whistleblower protectionSection 1012 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 399d) shall apply with respect to any violation of, or any act or omission an employee reasonably believes to be a violation of, any provision of this Act to the same extent and in the same manner as such section 1012 applies with respect to a violation of, or any act or omission an employee reasonably believes to be a violation of, any provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).407.Administration and enforcement(a)In generalFor the efficient administration and enforcement of the food safety law, the provisions (including provisions relating to penalties) of sections 6, 8, 9, and 10 of the Federal Trade Commission Act (15 U.S.C. 46, 48, 49, and 50) (except subsections (c) through (h) of section 6 of that Act (15 U.S.C. 46)), relating to the jurisdiction, powers, and duties of the Federal Trade Commission and the Attorney General to administer and enforce that Act, and to the rights and duties of persons with respect to whom the powers are exercised, shall apply to the jurisdiction, powers, and duties of the Administrator and the Attorney General in administering and enforcing the provisions of the food safety law and to the rights and duties of persons with respect to whom the powers are exercised, respectively.(b)Inquiries and actions(1)In generalThe Administrator, in person or by such agents as the Administrator may designate, may prosecute any inquiry necessary to carry out the duties of the Administrator under the food safety law in any part of the United States.(2)PowersThe powers conferred by sections 9 and 10 of the Federal Trade Commission Act (15 U.S.C. 49, 50) on the United States district courts may be exercised for the purposes of this chapter by any United States district court of competent jurisdiction.408.Citizen civil actions(a)Civil actionsA person may commence a civil action against—(1)a person that violates a regulation (including a regulation establishing a performance standard), order, or other action of the Administrator to ensure the safety of food; or(2)the Administrator (in his or her capacity as the Administrator), if the Administrator fails to perform an act or duty to ensure the safety of food that is not discretionary under the food safety law.(b)Court(1)In generalThe action shall be commenced in the United States district court for the district in which the defendant resides, is found, or has an agent.(2)JurisdictionThe court shall have jurisdiction, without regard to the amount in controversy or the citizenship of the parties, to enforce a regulation (including a regulation establishing a performance standard), order, or other action of the Administrator, or to order the Administrator to perform the act or duty.(3)DamagesThe court may—(A)award damages, in the amount of damages actually sustained; and(B)if the court determines it to be in the interest of justice, award the plaintiff the costs of suit, including reasonable attorney’s fees, reasonable expert witness fees, and penalties.(c)Remedies not exclusiveThe remedies provided for in this section shall be in addition to, and not exclusive of, other remedies that may be available.VImplementation501.DefinitionFor purposes of this title, the term transition period means the 12-month period beginning on the effective date of this Act.502.Reorganization plan(a)Submission of planNot later than 180 days after the effective date of this Act, the President shall transmit to the appropriate congressional committees a reorganization plan regarding the following:(1)The transfer of agencies, personnel, assets, and obligations to the Administration pursuant to this Act.(2)Any consolidation, reorganization, or streamlining of agencies transferred to the Administration pursuant to this Act.(b)Plan elementsThe plan transmitted under subsection (a) shall contain, consistent with this Act, such elements as the President determines appropriate, including the following:(1)Identification of any functions of agencies designated to be transferred to the Administration pursuant to this Act that will not be transferred to the Administration under the plan.(2)Specification of the steps to be taken by the Administrator to organize the Administration, including the delegation or assignment of functions transferred to the Administration among the officers of the Administration in order to permit the Administration to carry out the functions transferred under the plan.(3)Specification of the funds available to each agency that will be transferred to the Administration as a result of transfers under the plan.(4)Specification of the proposed allocations within the Administration of unexpended funds transferred in connection with transfers under the plan.(5)Specification of any proposed disposition of property, facilities, contracts, records, and other assets and obligations of agencies transferred under the plan.(6)Specification of the proposed allocations within the Administration of the functions of the agencies and subdivisions that are not related directly to ensuring the safety of food.(c)Modification of planThe President may, on the basis of consultations with the appropriate congressional committees, modify or revise any part of the plan until that part of the plan becomes effective in accordance with subsection (d).(d)Effective date(1)In generalThe reorganization plan described in this section, including any modifications or revisions of the plan under subsection (c), shall become effective for an agency on the earlier of—(A)the date specified in the plan (or the plan as modified pursuant to subsection (c)), except that such date may not be earlier than 90 days after the date the President has transmitted the reorganization plan to the appropriate congressional committees pursuant to subsection (a); or(B)the end of the transition period.(2)Statutory constructionNothing in this subsection may be construed to require the transfer of functions, personnel, records, balances of appropriations, or other assets of an agency on a single date.(3)Supercedes existing lawParagraph (1) shall apply notwithstanding section 905(b) of title 5, United States Code.503.Transitional authorities(a)Provision of assistance by officialsUntil the transfer of an agency to the Administration, any official having authority over or function relating to the agency immediately before the effective date of this Act shall provide the Administrator such assistance, including the use of personnel and assets, as the Administrator may request in preparing for the transfer and integration of the agency to the Administration.(b)Services and personnelDuring the transition period, upon the request of the Administrator, the head of any Executive agency may, on a reimbursable basis, provide services or detail personnel to assist with the transition.(c)Acting officials(1)In generalDuring the transition period, pending the advice and consent of the Senate to the appointment of an officer required by this Act to be appointed by and with such advice and consent, the President may designate any officer whose appointment was required to be made by and with such advice and consent and who was such an officer immediately before the effective date of this Act (and who continues to be in office) or immediately before such designation, to act in such office until the same is filled as provided in this Act.(2)CompensationWhile acting pursuant to paragraph (1), such officers shall receive compensation at the higher of—(A)the rates provided by this Act for the respective offices in which they act; or(B)the rates provided for the offices held at the time of designation.(3)LimitationNothing in this Act shall be construed to require the advice and consent of the Senate to the appointment by the President to a position in the Administration of any officer whose agency is transferred to the Administration pursuant to this Act and whose duties following such transfer are germane to those performed before such transfer.(d)Transfer of personnel, assets, obligations, and function(1)In generalConsistent with section 1531 of title 31, United States Code, the personnel, assets, liabilities, contracts, property, records, and unexpended balances of appropriations, authorizations, allocations, and other funds that relate to the functions transferred under subsection (a) from a Federal agency shall be transferred to the Administration.(2)Unexpended fundsUnexpended funds transferred under this subsection shall be used by the Administration only for the purposes for which the funds were originally authorized and appropriated.504.Savings provisions(a)Completed administrative actionsThe enactment of this Act or the transfer of functions under this Act shall not affect any order, determination, rule, regulation, permit, personnel action, agreement, grant, contract, certificate, license, registration, privilege, or other administrative action issued, made, granted, or otherwise in effect or final with respect to that agency on the day before the transfer date with respect to the transferred functions.(b)Pending proceedingsSubject to the authority of the Administrator under this Act—(1)pending proceedings in an agency, including notices of proposed rulemaking, and applications for licenses, permits, certificates, grants, and financial assistance, shall continue notwithstanding the enactment of this Act or the transfer of the agency to the Administration, unless discontinued or modified under the same terms and conditions and to the same extent that such discontinuance could have occurred if such enactment or transfer had not occurred; and(2)orders issued in such proceedings, and appeals from those orders, and payments made pursuant to such orders, shall be issued in the same manner on the same terms as if this Act had not been enacted or the agency had not been transferred, and any such order shall continue in effect until amended, modified, superceded, terminated, set aside, or revoked by an officer of the United States or a court of competent jurisdiction, or by operation of law.(c)Pending civil actionsSubject to the authority of the Administrator under this Act, any civil action commenced with regard to that agency pending before that agency on the day before the transfer date with respect to the transferred functions shall continue notwithstanding the enactment of this Act or the transfer of an agency to the Administration.(d)References(1)In generalAfter the transfer of functions from a Federal agency under this Act, any reference in any other Federal law, Executive order, rule, regulation, directive, document, or other material to that Federal agency or the head of that agency in connection with the administration or enforcement of the food safety laws shall be deemed to be a reference to the Administration or the Administrator, respectively.(2)Statutory reporting requirementsStatutory reporting requirements that applied in relation to such an agency immediately before the effective date of this Act shall continue to apply following such transfer if the reporting requirements refer to the agency by name.505.Conforming amendmentsSection 5313 of title 5, United States Code, is amended by adding at the end the following new item:Administrator of Food Safety..506.Additional technical and conforming amendmentsNot later than 60 days after the submission of the reorganization plan under section 502, the President shall prepare and submit proposed legislation to Congress containing necessary and appropriate technical and conforming amendments to any food safety law to reflect the changes made by this Act.507.RegulationsThe Administrator may promulgate such regulations as the Administrator determines are necessary or appropriate to perform the duties of the Administrator.508.Authorization of appropriationsThere are authorized to be appropriated such sums as are necessary to carry out this Act.509.Limitation on authorization of appropriationsFor the fiscal year that includes the effective date of this Act, the amount authorized to be appropriated to carry out this Act shall not exceed—(1)the amount appropriated for that fiscal year for the Federal agencies identified in section 102(b) for the purpose of administering or enforcing the food safety law; or(2)the amount appropriated for those agencies for that purpose for the preceding fiscal year, if, as of the effective date of this Act, appropriations for those agencies for the fiscal year that includes the effective date have not yet been made.510.Effective dateThis Act and the amendments made by this Act take effect on the date of enactment of this Act.


109 HR 5861 : National Historic Preservation Act

U.S. House of Representatives
2006-11-13
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

		IIB
		109th CONGRESS
		2d Session
		H. R. 5861
		IN THE SENATE OF THE UNITED
		  STATES

			September 26, 2006
			Received

			November 13, 2006
			 Read twice and referred to the
			 Committee on Energy and Natural
			 Resources

		AN ACT
		To amend the National Historic Preservation
		  Act, and for other purposes.

		1.Short titleThis Act may be cited as the
			 National Historic Preservation Act
			 Amendments of 2006.
		2.Historic
			 Preservation Officer responsibilitiesSection 101(b) of the National Historic
			 Preservation Act (16
			 U.S.C. 470a(b)) is amended by adding at the end the
			 following:

				(7)The State Historic Preservation Officer
				shall have no authority to require an applicant for Federal assistance, permit,
				or license to identify historic properties outside the undertaking’s area of
				potential effects as determined by the Federal agency in accordance with the
				regulations implementing section 106.
				(8)If the State Historic Preservation Officer,
				Tribal representative, or Tribal Historic Preservation Officer fails to respond
				within 30 days after an adequately documented finding of no historic
				properties affected or no adverse effect as provided in
				the regulations implementing section 106, the Federal agency may assume that
				the State Historic Preservation Officer or Tribal Historic Preservation Officer
				has no objection to the
				finding.
				.
		3.Additional
			 criteria for certification of local governments to carry out national historic
			 preservation actSection
			 101(c)(1) of the National Historic Preservation Act (16 U.S.C.
			 470a(c)(1)) is amended—
			(1)by striking
			 and at the end of subparagraph (D);
			(2)by redesignating
			 subparagraph (E) as subparagraph (F);
			(3)by inserting after
			 subparagraph (D) the following new subparagraph:

					(E)agrees that it
				shall not use any eligibility determination regarding the inclusion of any
				property or District on the National Register to initiate local regulatory
				requirements unless the entity provides full due process protection to the
				owner or owners of the property or District through a hearing process;
				and
					;
				and
			(4)in the matter
			 below the subparagraphs, by striking through (E) and inserting
			 through (F).
			4.Historic
			 preservation fundSection 108
			 of the National Historic Preservation Act (16 U.S.C. 470h) is amended by
			 striking 2005 and inserting 2015.
		5.Advisory council
			 on historic preservation
			(a)MembershipSection
			 201 of the national historic preservation act (16 U.S.C. 470i) is amended—
				(1)in
			 subsection (a)(4), by striking four and inserting
			 seven;
				(2)in subsection (b),
			 by striking (5) and (6) and inserting paragraph
			 (6); and
				(3)in subsection (f),
			 by striking Nine and inserting Eleven.
				(b)Financial and
			 administrative servicesSection 205(f) of such Act
			 (16 U.S.C.
			 470m(f)) is amended to read as follows:

					(f)Financial and
				administrative services (including those related to budgeting, accounting,
				financial reporting, personnel and procurement) shall be provided the Council
				by the Department of the Interior or, at the discretion of the Council, such
				other agency or private entity that reaches an agreement with the Council, for
				which payments shall be made in advance or by reimbursement from funds of the
				Council in such amounts as may be agreed upon by the Chairman of the Council
				and the head of the agency or, in the case of a private entity, the authorized
				representative of the private entity that will provide the services. When a
				Federal agency affords such services, the regulations of that agency for the
				collection of indebtedness of personnel resulting from erroneous payments,
				prescribed under section 5514(b) of title 5, United
				States Code, shall apply to the collection of erroneous payments made to or on
				behalf of a Council employee, and regulations of that agency for the
				administrative control of funds under sections
				1513(d) and
				1514
				of title 31, United States Code, shall apply to appropriations of the Council.
				The Council shall not be required to prescribe such
				regulations.
					.
			(c)Authorization of
			 appropriationsSection 212(a) of the Act (16 U.S.C. 470t(a))
			 is amended by striking for purposes of this title not to exceed
			 $4,000,000 for each fiscal year 1997 through 2005 and inserting
			 such amounts as may be necessary to carry out this title.
			6.Effectiveness of
			 federal grant and assistance programs in meeting purposes and policies of the
			 national historic preservation actThe National Historic Preservation Act is
			 amended by inserting after section 215 (16 U.S.C. 470v–1) the following
			 new section:

				216.Effectiveness
				of federal grant and assistance programs
					(a)Cooperative
				agreementsThe Council may enter into a cooperative agreement
				with any Federal agency that administers a grant or assistance program for the
				purpose of improving the effectiveness of the administration of such program in
				meeting the purposes and policies of this Act. Such cooperative agreements may
				include provisions that modify the selection criteria for a grant or assistance
				program to further the purposes of this Act or that allow the Council to
				participate in the selection of recipients, if such provisions are not
				inconsistent with the statutory authorization and purpose of the grant or
				assistance program.
					(b)Review of grant
				and assistance programsThe council may—
						(1)review the
				operation of any Federal grant or assistance program to evaluate the
				effectiveness of such program in meeting the purposes and policies of this
				Act;
						(2)make
				recommendations to the head of the Federal agency that administers such program
				to further the consistency of the program with the purposes and policies of
				this Act and to improve its effectiveness in carrying out those purposes and
				policies; and
						(3)make
				recommendations to the President and the Congress regarding the effectiveness
				of Federal grant and assistance programs in meeting the purposes and policies
				of this Act, including recommendations with regard to appropriate funding
				levels.
						.

			Passed the House of
			 Representatives September 25, 2006.
			Karen L. Haas,
			Clerk.


		I
		112th CONGRESS
		1st Session
		H. R. 2750
		IN THE HOUSE OF REPRESENTATIVES

			August 1, 2011
			Mr. Inslee (for
			 himself, Mr. Bartlett,
			 Mr. Tonko,
			 Ms. Berkley,
			 Mr. Blumenauer,
			 Ms. Baldwin,
			 Mr. Israel,
			 Mr. Pascrell,
			 Mr. Quigley, and
			 Ms. Sutton) introduced the following
			 bill; which was referred to the Committee
			 on Ways and Means

		A BILL
		To amend the Internal Revenue Code of 1986 to modify the
		  investment tax credit for combined heat and power system
		  property.

		1.PurposeThe purposes of this Act are—
			(1)to promote energy
			 efficiency through the use of combined heat and power systems by increasing
			 limits on the size of systems qualifying for tax credits under section 48(c) of
			 the Internal Revenue Code of 1986, and
			(2)to allow systems
			 using waste energy from industrial processes to produce electricity or
			 mechanical energy to qualify for the tax credits.
			2.Modifications in
			 credit for combined heat and power system property
			(a)Modification of
			 certain capacity limitationsSubparagraph (B) of section 48(c)(3)
			 of the Internal Revenue Code of 1986 is amended—
				(1)in clause
			 (ii)—
					(A)by striking
			 15 megawatts and inserting 25 megawatts,
			 and
					(B)by striking
			 20,000 horsepower and inserting 34,000
			 horsepower, and
					(2)by striking clause
			 (iii).
				(b)Inclusion of
			 waste energy recovery and related technologies
				(1)In
			 generalSubparagraph (A) of section 48(c)(3) of such Code is
			 amended to read as follows:

						(A)Combined heat
				and power system propertyThe
				term combined heat and power system property means property
				comprising a system which is placed in service before January 1, 2017,
				and—
							(i)which uses the same energy source for the
				simultaneous or sequential generation of electrical power, mechanical shaft
				power, or both, in combination with the generation of steam or other forms of
				useful thermal energy (including heating and cooling applications), and—
								(I)produces at least
				20 percent of its total useful energy in the form of thermal energy which is
				not used to produce electrical or mechanical power (or combination
				thereof),
								(II)produces at least
				20 percent of its total useful energy in the form of electrical or mechanical
				power (or combination thereof), and
								(III)has an energy
				efficiency percentage exceeding 60 percent, or
								(ii)which produces electrical or mechanical
				power or usable thermal energy (in the form of steam, hot water, or other
				heated thermal working fluid) from recovered waste energy, including systems
				using—
								(I)back-pressure
				turbines in place of pressure-reducing valves,
								(II)rankine,
				sterling, kalina, or other heat engines, or
								(III)waste energy to
				heat a thermal working fluid to displace the need for combustion of a
				fuel.
								.
				(2)Conforming
			 amendmentSection
			 48(c)(3)(D)(i) of such Code is amended by striking subparagraph
			 (A)(iii) and inserting subparagraph (A)(i)(III).
				(c)Effective
			 dateThe amendments made by this section shall apply to periods
			 after the date of the enactment of this Act, under rules similar to the rules
			 of section 48(m) of the Internal Revenue Code of 1986 (as in effect on the day
			 before the date of the enactment of the Revenue Reconciliation Act of
			 1990).


113 SRES 57 ATS: Designating February 28, 2013, as “Rare Disease Day”.
U.S. Senate
2013-02-26
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

		III
		113th CONGRESS
		1st Session
		S. RES. 57
		IN THE SENATE OF THE UNITED STATES

			February 26, 2013
			Mr. Brown (for himself,
			 Mr. Barrasso, Mr. Whitehouse, Mr.
			 Pryor, and Mrs. Hagan)
			 submitted the following resolution; which was considered and agreed
			 to

		RESOLUTION
		Designating February 28, 2013, as
		  Rare Disease Day.

		Whereas rare diseases and disorders are those that affect
			 a small number of patients, typically less than 200,000 people in the United
			 States;
		Whereas, as of the date of approval of this resolution,
			 nearly 7,000 rare diseases affect approximately 30,000,000 people in the United
			 States and their families;
		Whereas children with rare genetic diseases account for
			 more than half of the population affected by rare diseases in the United
			 States;
		Whereas many rare diseases are serious, life-threatening,
			 and lack an effective treatment;
		Whereas rare diseases and conditions include epidermolysis
			 bullosa, progeria, sickle cell anemia, Tay-Sachs, cystic fibrosis, many
			 childhood cancers, and fibrodysplasia ossificans progressiva;
		Whereas people with rare diseases experience challenges
			 that include difficulty in obtaining an accurate diagnosis, limited treatment
			 options, and difficulty finding physicians or treatment centers with expertise
			 in their diseases;
		Whereas great strides have been made in research and
			 treatment for rare diseases as a result of the Orphan Drug Act (Public Law
			 97–414; 96 Stat. 2049) and amendments made by that Act;
		Whereas 2013 marks the 30th anniversary of the Orphan Drug
			 Act and therefore a time to reflect upon the successes of that Act and the
			 challenges to be addressed in the future;
		Whereas both the Food and Drug Administration and the
			 National Institutes of Health have established special offices to advocate for
			 rare disease research and treatments;
		Whereas the National Organization for Rare Disorders, an
			 organization established in 1983 to provide services to, and advocate on behalf
			 of, patients with rare diseases, was a primary force behind the enactment of
			 the Orphan Drug Act and remains a critical public voice for people with rare
			 diseases;
		Whereas the National Organization for Rare Disorders
			 sponsors Rare Disease Day in the United States to increase public awareness of
			 rare diseases;
		Whereas Rare Disease Day has become a global event
			 occurring annually on the last day of February and was observed in more than 60
			 countries in 2012;
		Whereas Rare Disease Day was observed in the United States
			 for the first time on February 28, 2009; and
		Whereas Rare Disease Day is anticipated to be observed
			 globally for years to come, providing hope and information for rare disease
			 patients around the world; Now, therefore, be it

		That the Senate—
			(1)designates
			 February 28, 2013, as Rare Disease Day;
			(2)recognizes the
			 importance of improving awareness and encouraging accurate and early diagnosis
			 of rare diseases and disorders; and
			(3)supports a
			 national and global commitment to improving access to, and developing new
			 treatments, diagnostics, and cures for, rare diseases and disorders.


		III
		110th CONGRESS
		1st Session
		S. RES. 305
		IN THE SENATE OF THE UNITED STATES

			August 3, 2007
			Mr. Specter (for himself
			 and Mr. Lautenberg) submitted the
			 following resolution; which was referred to the
			 Committee on
			 Finance

			September 4, 2007
			Committee discharged; considered and agreed
			 to

		RESOLUTION
		To express the sense of the Senate regarding the Medicare
		  national coverage determination on the treatment of anemia in cancer
		  patients.

		Whereas the Centers for Medicare & Medicaid Services
			 issued a final Medicare National Coverage Determination on the Use of
			 Erythropoiesis Stimulating Agents in Cancer and Related Neoplastic Conditions
			 (CAG–000383N) on July 30, 2007;
		Whereas 52 United States Senators and 235 Members of the
			 House of Representatives, representing bipartisan majorities in both chambers,
			 have written to the Centers for Medicare & Medicaid Services expressing
			 significant concerns with the proposed National Coverage Determination on the
			 Use of Erythropoiesis Stimulating Agents in Cancer and Related Neoplastic
			 Conditions, issued on May 14, 2007, regarding the use of erythropoiesis
			 stimulating agent therapy for Medicare cancer patients;
		Whereas, although some improvements have been incorporated
			 into such final National Coverage Determination, the policy continues to raise
			 significant concerns among physicians and patients about the potential impact
			 on the treatment of cancer patients in the United States;
		Whereas the American Society of Clinical Oncology, the
			 national organization representing physicians who treat patients with cancer,
			 is specifically concerned about a provision in such final National Coverage
			 Determination that restricts coverage whenever a patient’s hemoglobin goes
			 above 10 g/dL;
		Whereas the American Society of Clinical Oncology has
			 written to the Centers for Medicare & Medicaid Services to note that such a
			 restriction is inconsistent with both the FDA-approved labeling and
			 national guidelines, to express deep concerns about such final National
			 Coverage Determination, and to urge that the Centers for Medicare &
			 Medicaid Services reconsider such restriction;
		Whereas such restriction could increase blood transfusions
			 and severely compromise the high quality of cancer care delivered by physicians
			 in United States; and
		Whereas the Centers for Medicare & Medicaid Services
			 has noted that the agency did not address the impact on the blood supply in
			 such final National Coverage Determination and has specifically stated, “[t]he
			 concern about the adequacy of the nation’s blood supply is not a relevant
			 factor for consideration in this national coverage determination”: Now,
			 therefore, be it

		That it is the sense of the Senate
			 that—
			(1)the Centers for
			 Medicare & Medicaid Services should begin an immediate reconsideration of
			 the final National Coverage Determination on the Use of Erythropoiesis
			 Stimulating Agents in Cancer and Related Neoplastic Conditions
			 (CAG–000383N);
			(2)the Centers for
			 Medicare & Medicaid Services should consult with members of the clinical
			 oncology community to determine appropriate revisions to such final National
			 Coverage Determination; and
			(3)the Centers for
			 Medicare & Medicaid Services should implement appropriate revisions to such
			 final National Coverage Determination as soon as feasible and provide a
			 briefing to Congress in advance of announcing such changes.