FDA Food Safety Modernization Act

Bill: 111-hr-2751
Sponsor: Rep. Sutton, Betty [D-OH-13]
Introduced: 2009-06-08 in the House
Policy area: Transportation and Public Works
Subjects: Administrative law and regulatory procedures
Administrative remedies
Agricultural marketing and promotion
Agricultural practices and innovations
Agricultural research
Agricultural trade
Allergies
Animal and plant health
Business records
Child health
Congressional oversight
Consumer affairs
Department of Health and Human Services
Department of Transportation
Drug, alcohol, tobacco use
Education programs funding
Elementary and secondary education
Emergency communications systems
Emergency medical services and trauma care
Emergency planning and evacuation
Employment discrimination and employee rights
Energy efficiency and conservation
Executive agency funding and structure
Food and Drug Administration (FDA)
Food industry and services
Food supply, safety, and labeling
Foreign aid and international relief
Government buildings, facilities, and property
Government employee pay, benefits, personnel management
Government information and archives
Government liability
Government studies and investigations
Hazardous wastes and toxic substances
Health information and medical records
Health programs administration and funding
Health promotion and preventive care
Homeland security
Licensing and registrations
Livestock
Meat
Motor vehicles
Nutrition and diet
Preschool education
Public-private cooperation
Retail and wholesale trades
Rural conditions and development
Seafood
Small business
Smuggling and trafficking
Terrorism
Trade restrictions
User charges and fees

Summary:
action_date: 2009-06-08
text: 
Consumer Assistance to Recycle and Save Act - Establishes in the National Highway Traffic Safety Administration (NHTSA) a voluntary Consumer Assistance to Recycle and Save Program through which the Secretary of Transportation shall: (1) authorize the issuance of an electronic voucher to offset the purchase or lease price for a new fuel efficient automobile upon the surrender of an eligible trade-in vehicle to a participating dealer; (2) register dealers for Program participation; (3) make electronic payments to them for eligible transactions they accept between specified dates; and (4) establish and provide for the enforcement of measures to prevent and penalize fraud under the Program.
 
Prescribes requirements, including combined fuel economy, for $3,500 and $4,500 vouchers to offset the purchase or lease price for a qualifying passenger automobile or truck.
 
Limits the number of vouchers to one per customer, including joint registered owners of a single eligible trade-in vehicle.
 
Requires a dealer to certify about each eligible trade-in vehicle that the dealer: (1) will arrange for transfer to the United States of the vehicle's title; (2) will accept possession of the vehicle on behalf of the United States; (3) has not and will not sell, lease, exchange, or otherwise dispose of the vehicle for use as an automobile anywhere in the world; and (4) will transfer, on behalf of the United States, the vehicle and its title to an entity that will ensure that the vehicle will be crushed or shredded within the Program period, and has not been, and will not be, sold, leased, exchanged, or otherwise disposed of for use as an automobile anywhere in the world. 
 
Prescribes standards which any regulations issued by the Secretary for the Program must meet.
 
Makes it unlawful for any person to violate this Act or any regulations issued under it, particularly by fraud. Prescribes civil penalties for any such violation.
 
Directs the Secretary to make Program information available on an Internet website and through other means.

action_date: 2009-06-09
text: 

(This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)

 
Consumer Assistance to Recycle and Save Act - (Sec. 2) Establishes in the National Highway Traffic Safety Administration (NHTSA) a voluntary Consumer Assistance to Recycle and Save Program through which the Secretary of Transportation shall: (1) authorize the issuance of an electronic voucher to offset the purchase or lease price for a new fuel efficient automobile upon the surrender of an eligible trade-in vehicle to a participating dealer; (2) register dealers for Program participation; (3) make electronic payments to them for eligible transactions they accept between specified dates; and (4) establish and provide for the enforcement of measures to prevent and penalize fraud under the Program.
 
Prescribes requirements, including combined fuel economy, for $3,500 and $4,500 vouchers to offset the purchase or lease price for a qualifying passenger automobile or truck.
 
Limits the number of vouchers to one per customer, including joint registered owners of a single eligible trade-in vehicle.
 
Requires a dealer to certify about each eligible trade-in vehicle that the dealer: (1) will arrange for transfer to the United States of the vehicle's title; (2) will accept possession of the vehicle on behalf of the United States; (3) has not and will not sell, lease, exchange, or otherwise dispose of the vehicle for use as an automobile anywhere in the world; and (4) will transfer, on behalf of the United States, the vehicle and its title to an entity that will ensure that the vehicle will be crushed or shredded within the Program period, and has not been, and will not be, sold, leased, exchanged, or otherwise disposed of for use as an automobile anywhere in the world. 
 
Requires the Secretary to coordinate with the Attorney General to ensure that the National Motor Vehicle Title Information System and other publicly accessible systems are timely updated to reflect the crushing or shredding of vehicles and appropriate reclassification of vehicle titles under this Act.
 
Prescribes standards which any regulations issued by the Secretary for the Program must meet.
 
Makes it unlawful for any person to violate this Act or any regulations issued under it, particularly by fraud. Prescribes civil penalties for any such violation.
 
Directs the Secretary to: (1) make Program information available on an Internet website and through other means; (2) maintain a database of vehicle identification numbers (VINs) of all new fuel efficient vehicles purchased or leased and eligible trade-in vehicles disposed of under the Program; and (3) report to Congress on Program results.
 
Provides that a voucher issued or payment made for a voucher under this Act shall not be considered as gross income to the recipient or be used to determine the recipient's (or family members') eligibility for benefits or assistance under any federal or state program. 
 
Authorizes appropriations.

action_date: 2010-12-19
text: 

(This summary will be expanded.)

 
FDA Food Safety Modernization Act - 
Title I: Improving Capacity to Prevent Food Safety Problems
 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the food safety activities of the Secretary of Health and Human Services (HHS), including to authorize the Secretary to inspect records related to food. 
 
Exempts certain establishments that sell food directly to consumers, such as roadside stands, farmers markets or participants in a community supported agriculture program, from specified requirements of this Act. 
 
Requires each owner, operator, or agent in charge of a food facility to identify and implement preventive controls to significantly minimize or prevent hazards that could affect food manufactured, processed, packed, or held by such facility. Sets forth provisions governing exemptions from such requirements for certain facilities.
 
Requires the Secretary to: (1) issue guidance documents to reduce the risk from the most significant foodborne contaminants; and (2) establish minimum standards for the safe production and harvesting of fruits and vegetables based on known safety risks. Authorizes the Secretary to issue exemptions and variances from such standards. 
 
Directs the Secretary to assess and collect fees related to: (1) food facility reinspection; (2) food recalls; (3) the voluntary qualified importer program; and (4) importer reinspection.
 
Directs the Secretary to develop voluntary food allergy and anaphylaxis management guidelines for schools and early childhood education programs.
 

Title II: Improving Capacity to Detect and Respond to Food Safety Problems
 - Requires the Secretary to: (1) allocate resources to inspect facilities and imported food according to the known safety risks of the facilities or food; and (2) establish a product tracing system to track and trace food that is in the United States or offered for import into the United States.
 
Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to enhance foodborne illness surveillance systems to improve the collection, analysis, reporting, and usefulness of data on foodborne illnesses.
 
Gives the Secretary the authority to order a recall of an article of food.
 

Title III: Improving the Safety of Imported Food
 - Requires U.S. importers to perform risk-based foreign supplier verification activities to verify that imported food is produced in compliance with applicable requirements related to hazard analysis and standards for produce safety and is not adulterated or misbranded.
 
Requires the Secretary to establish a program to expedite review and importation of food offered for importation by U.S. importers who have voluntarily agreed to participate in such program.
 
Authorizes the Secretary to: (1) require a certification that an article of food imported or offered for import complies with applicable requirements of this Act; and (2) enter into arrangements and agreements with foreign governments to facilitate the inspection of registered foreign facilities. Requires food to be refused admission into the United States if permission to inspect the food facility is denied by the facility owner, operator, or agent or the foreign country. 
 
Sets forth provisions governing the establishment of a system to recognize bodies that accredit third-party auditors and audit agents to certify that foreign entities meet applicable FFDCA requirements for importation of food into the United States.
 

Title IV: Miscellaneous Provisions
 - Authorizes appropriations for FY2011-FY2015 for the activities of the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and related field activities in the Office of Regulatory Affairs of the Food and Drug Administration (FDA). Directs the Secretary to increase the field staff of such Centers and Office.
 
Establishes whistleblower's protections for employees of entities involved in the manufacturing, processing, packing, transporting, distribution, reception, holding, or importation of food who provide information relating to any FFDCA violation.

action_date: 2011-01-04
text: 

(This measure has not been amended since it was passed by the Senate on November 30, 2010. The summary of that version is repeated here.)

 
FDA Food Safety Modernization Act - 
Title I: Improving Capacity to Prevent Food Safety Problems
 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the food safety activities of the Secretary of Health and Human Services (HHS), including to authorize the Secretary to inspect records related to food. 
 
Exempts certain establishments that sell food directly to consumers, such as roadside stands, farmers markets or participants in a community supported agriculture program, from specified requirements of this Act. 
 
Requires each owner, operator, or agent in charge of a food facility to identify and implement preventive controls to significantly minimize or prevent hazards that could affect food manufactured, processed, packed, or held by such facility. Sets forth provisions governing exemptions from such requirements for certain facilities.
 
Requires the Secretary to: (1) issue guidance documents to reduce the risk from the most significant foodborne contaminants; and (2) establish minimum standards for the safe production and harvesting of fruits and vegetables based on known safety risks. Authorizes the Secretary to issue exemptions and variances from such standards. 
 
Directs the Secretary to assess and collect fees related to: (1) food facility reinspection; (2) food recalls; (3) the voluntary qualified importer program; and (4) importer reinspection.
 
Directs the Secretary to develop voluntary food allergy and anaphylaxis management guidelines for schools and early childhood education programs.
 

Title II: Improving Capacity to Detect and Respond to Food Safety Problems
 - Requires the Secretary to: (1) allocate resources to inspect facilities and imported food according to the known safety risks of the facilities or food; and (2) establish a product tracing system to track and trace food that is in the United States or offered for import into the United States.
 
Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to enhance foodborne illness surveillance systems to improve the collection, analysis, reporting, and usefulness of data on foodborne illnesses.
 
Gives the Secretary the authority to order a recall of an article of food.
 

Title III: Improving the Safety of Imported Food
 - Requires U.S. importers to perform risk-based foreign supplier verification activities to verify that imported food is produced in compliance with applicable requirements related to hazard analysis and standards for produce safety and is not adulterated or misbranded.
 
Requires the Secretary to establish a program to expedite review and importation of food offered for importation by U.S. importers who have voluntarily agreed to participate in such program.
 
Authorizes the Secretary to: (1) require a certification that an article of food imported or offered for import complies with applicable requirements of this Act; and (2) enter into arrangements and agreements with foreign governments to facilitate the inspection of registered foreign facilities. Requires food to be refused admission into the United States if permission to inspect the food facility is denied by the facility owner, operator, or agent or the foreign country. 
 
Sets forth provisions governing the establishment of a system to recognize bodies that accredit third-party auditors and audit agents to certify that foreign entities meet applicable FFDCA requirements for importation of food into the United States.
 

Title IV: Miscellaneous Provisions
 - Authorizes appropriations for FY2011-FY2015 for the activities of the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and related field activities in the Office of Regulatory Affairs of the Food and Drug Administration (FDA). Directs the Secretary to increase the field staff of such Centers and Office.
 
Establishes whistleblower's protections for employees of entities involved in the manufacturing, processing, packing, transporting, distribution, reception, holding, or importation of food who provide information relating to any FFDCA violation.


Legislative actions:
action_date: 2011-01-04
text: Became Public Law No: 111-353.
action_date: 2011-01-04
text: Became Public Law No: 111-353.
action_date: 2011-01-04
text: Signed by President.
action_date: 2011-01-04
text: Signed by President.
action_date: 2010-12-29
text: Presented to President.
action_date: 2010-12-29
text: Presented to President.
action_date: 2010-12-21
text: Cleared for White House.
action_date: 2010-12-21
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2010-12-21
text: On motion that the House agree to the Senate amendments Agreed to by the Yeas and Nays: 215 - 144 (Roll no. 661). (text as House agreed to Senate amendment: CR H8861-8884)
action_date: 2010-12-21
text: Resolving differences -- House actions: On motion that the House agree to the Senate amendments Agreed to by the Yeas and Nays: 215 - 144 (Roll no. 661).(text as House agreed to Senate amendment: CR H8861-8884)
action_date: 2010-12-21
text: Considered as unfinished business. (consideration: CR H8892)
action_date: 2010-12-21
text: POSTPONED PROCEEDINGS - At the conclusion of debate on the motion to agree to the Senate amendments to H.R. 2751, the Chair announced that pursuant to the order of the House of December 21, 2010, further proceedings on the motion would be postponed until a time to be announced.
action_date: 2010-12-21
text: The previous question was ordered pursuant to the rule. (consideration: CR H8890)
action_date: 2010-12-21
text: DEBATE - The House proceeded with one hour of debate on motion to agree to the Senate amendments to H.R. 2751.
action_date: 2010-12-21
text: Mr. Dingell moved that the House agree to the Senate amendments. (consideration: CR H8861-8890)
action_date: 2010-12-21
text: Pursuant to the provisions of H.Res. 1781, the Chair recognized Mr. Dingell for a motion.
action_date: 2010-12-21
text: Rules Committee Resolution H. Res. 1781 Reported to House. Rule provides for consideration of H.R. 5116, H.R. 2751 and H.R. 5142. Providing for consideration of the Senate amendment to H.R. 5116, consideration of the Senate amendments to H.R. 2751, and consideration of the Senate amendment H.R. 2142
action_date: 2010-12-20
text: Message on Senate action sent to the House.
action_date: 2010-12-19
text: Passed Senate with an amendment and an amendment to the Title by Voice Vote. (text: CR 12/20/2010 S10824-10847)
action_date: 2010-12-19
text: Passed/agreed to in Senate: Passed Senate with an amendment and an amendment to the Title by Voice Vote.(text: CR 12/20/2010 S10824-10847)
action_date: 2010-12-19
text: Measure laid before Senate by unanimous consent. (consideration: CR S10770)
action_date: 2009-06-11
text: Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 74.
action_date: 2009-06-10
text: Received in the Senate. Read the first time. Placed on Senate Legislative Calendar under Read the First Time.
action_date: 2009-06-09
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2009-06-09
text: On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 298 - 119, 2 Present (Roll no. 314). (text: CR H6345-6347)
action_date: 2009-06-09
text: Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 298 - 119, 2 Present (Roll no. 314).(text: CR H6345-6347)
action_date: 2009-06-09
text: DEBATE - The House proceeded with forty minutes of debate on H.R. 2751.
action_date: 2009-06-09
text: Considered under suspension of the rules. (consideration: CR H6345-6357)
action_date: 2009-06-09
text: Ms. Sutton moved to suspend the rules and pass the bill.
action_date: 2009-06-09
text: Referred to the Subcommittee on Energy and Environment.
action_date: 2009-06-08
text: Referred to House Ways and Means
action_date: 2009-06-08
text: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
action_date: 2009-06-08
text: Referred to House Energy and Commerce
action_date: 2009-06-08
text: Introduced in House
action_date: 2009-06-08
text: Introduced in House

Enacted as: number: 111-353