h 673 4 58220 1244433600 false 1248991320 1249272000 159 2749 21650 This bill would give the FDA greater regulatory powers over the national food supply and food providers with the goal of preventing food-borne illnesses and ensuring food safety. More specifically, it would increase the frequency of FDA inspections of food processing plants, expand the FDA's traceback capabilities for when outbreaks do occur, give the FDA mandatory recall authority, and require food facilities to have safety plans in place in order to mitigate hazards. Concurrently, the bill would impose annual registration fees of $500 on all facilities holding, processing, or manufacturing food and require that such facilities also engaged in the transport or packing of food maintain pedigrees of the origin and previous distribution history of the food. The bill is an enhancement to <a href="http://www.opencongress.org/bill/111-h759/show">H.R.759</a>, and to a lesser extent, <a href="http://www.opencongress.org/bill/111-h875/show">H.R. 857</a>, previously proposed food safety bills in the 111th Congress. 111 400110

7/30/2009--Passed House amended. Food Safety Enhancement Act of 2009 - (Sec. 5) Exempts food and facilities regulated by the Secretary of Agriculture under specified acts from the requirements of this Act. (Sec. 6) Exempts specified alcohol-related facilities from the requirements of this Act. Title I: Food Safety - Subtitle A: Prevention - (Sec. 101) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to deem a food to be misbranded if it was manufactured, processed, packed, or held in a facility that is not registered. Declares that a facility under the FFDCA does not include private residences of individuals. Requires annual registration of food facilities, including food facilities that export food. Authorizes the Secretary of Health and Human Services (HHS) to suspend the registration of any food facility for a violation of the FFDCA that could result in serious adverse health consequences or death to humans or animals. Sets forth procedures for such a registration suspension. Directs the Secretary to collect an annual fee for registration of a food facility to defray the costs of food safety activities. Terminates the authority to collect such fees after FY2014. (Sec. 102) Deems a food to be adulterated if it has been manufactured, processed, packed, transported, or held under conditions that do not meet the requirements for hazard analysis and risk-based preventive controls. Requires the owner, operator, or agent of a food facility to: (1) conduct a hazard analysis; (2) identify and implement effective preventive controls; (3) monitor preventive controls; (4) institute corrective actions as necessary; (5) conduct verification activities; and (6) maintain records of monitoring, corrective action, and verification. Authorizes the Secretary to: (1) identify hazards that are reasonably likely to occur in the absence of preventive controls; and (2) establish preventive controls for specific product types to prevent unintentional contamination throughout the supply chain. Requires the owner, operator, or agent of a food facility to implement a food safety plan before introducing any shipment of food into interstate commerce. Directs the Secretary to establish science-based standards for conducting a hazard analysis, documenting hazards, identifying and implementing preventive controls, and documenting the implementation of the preventive controls. Authorizes the Secretary to require the submission of finished product test results documenting the presence of contaminants in food posing a risk of severe adverse health consequences or death for certain high-risk food facilities after completion of pilot projects and a feasibility study. Requires the owner, operator, or agent of a food facility to implement a food defense plan that includes: (1) an identification of conditions and practices that may permit a hazard to be intentionally introduced; and (2) a description of preventive measures implemented. Authorizes the Secretary to establish by regulation or guidance preventive measures for specific product types to prevent intentional contamination throughout the supply chain. Requires the owner, operator, or agent of a facility to implement any preventive measures identified by the Secretary. (Sec. 103) Deems a food to be adulterated if it has been manufactured, processed, packed, transported, or held under conditions that do not meet performance standards. Requires the Secretary to: (1) issue science-based performance standards applicable to foods or food classes to minimize to an acceptable level, prevent, or eliminate the occurrence of the most significant foodborne contaminants and the most significant resulting hazards; and (2) publish a list of foodborne contaminants that have the greatest adverse impact on public health. Authorizes the Secretary to make recommendations to industry for conducting product sampling. (Sec. 104) Deems a food to be adulterated if it has been grown, harvested, processed, packed, sorted, transported, or held under conditions that do not meet safety standards for raw agricultural commodities. Requires the Secretary to establish scientific and risk-based food safety standards for the growing, harvesting, packing, sorting, transporting, and holding of raw agricultural commodities: (1) that are a fruit, vegetable, nut, or fungus; and (2) for which the Secretary has determined that such standards are reasonably necessary to minimize the risk of serious adverse health consequences or death to humans or animals. Requires the Secretary to provide for effective implementation of education and compliance activities. Requires the Secretary to update existing guidance related to minimizing microbial food safety hazards for fresh fruits and vegetables. (Sec. 105) Requires food facilities to be inspected at a frequency determined pursuant to a risk-based schedule. (Sec. 106) Directs each person who manufactures, processes, packs, transports, distributes, receives, or holds an article of food in the United States or for import into the United States to permit an officer or employee of the Secretary to have access to and copy all records bearing on whether the food may be adulterated, misbranded, or otherwise in violation of the FFDCA. Limits access to such records on farms. (Sec. 107) Requires the Secretary to establish a tracing system for food that is located in the United States or is for import into the United States that enables the Secretary to quickly identify each person who grows, produces, manufactures, processes, packs, transports, holds, or sells such food. Exempts certain food from tracing requirements, including food produced on a farm or produced through the use of a fishing vessel. Limits the tracing requirements for any grain or similarly handled commodity. Authorizes the Secretary to exempt a food or a type of facility, farm, or restaurant from tracing requirements. Prohibits the violation of any requirement of the food tracing system under this section. Requires the refusal of admission of articles that have not complied with the requirements of the food tracing system. (Sec. 108) Requires the Secretary to assess fees on each food facility in a fiscal year that: (1) commits a violation of the FFDCA relating to food and so requires additional inspections by the Food and Drug Administration (FDA); or (2) has been subject to a food recall. (Sec. 109) Deems a food to be misbranded if it is part of a shipment offered for import into the United States and such shipment is in violation of provisions requiring a certification of compliance. Requires imported food to be refused admission if it is not in compliance with such certification requirements. Authorizes the Secretary to require a qualified certifying entity to provide a certification that the imported food article complies with specified requirements of the FFDCA under certain circumstances. Requires qualified certifying entities to be free from conflicts of interest. (Sec. 110) Sets forth requirements for analytical testing of an article of food conducted by an accredited laboratory. Requires the Secretary to establish a program for the recognition of bodies that accredit laboratories to perform analytical testing of food for import or export. Prohibits violation of any requirement relating to testing by accredited laboratories. (Sec. 111) Includes as a prohibited act under the FFDCA the failure to notify the Secretary of adulterated or misbranded food that presents a reasonable probability that the use or consumption of, or exposure to, such food will cause a threat of serious adverse health consequences or death to humans or animals. Requires notification to the Secretary of the identity and location of certain adulterated or misbranded food. Sets forth the circumstances under which the Secretary has the authority to: (1) request an immediate cease of distribution of a food; (2) order an immediate cease of distribution; or (3) issue an immediate recall. Provides for notice of affected persons. (Sec. 112) Expands the definition of &quot;responsible party&quot; for purposes of reporting to the FDA's Reportable Food Registry to include farms, restaurants, retail food establishments, and importers. Requires reporting to include documentation of results from any sampling and testing of such article. Provides for the exchange of information on food exempt from disclosure under the Freedom of Information Act, as appropriate. (Sec. 113) Authorizes the Secretary to establish a program that facilitates the movement of food through the importation process if the importer: (1) verifies that each facility is in compliance with food safety and security guidelines; and (2) ensures that appropriate safety and security controls are in place throughout the supply chain for such food. (Sec. 114) Establishes additional requirements for any new infant formula, including information on prior approval of a new ingredient. Deems a new infant formula to be misbranded if it does not meet the requirements of this section. Subtitle B: Intervention - (Sec. 121) 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. Requires the Secretary to develop and implement strategies to leverage and enhance the food safety and defense capacities of state and local agencies. (Sec. 122) Requires the Secretary to design and implement a national public education program on food safety. (Sec. 123) Requires the Secretary to conduct research to assist in the implementation of this Act, including studies to: (1) improve sanitation and food safety practices in the production, harvesting, and processing of food products; and (2) develop improved techniques for monitoring food and inspecting food products. Subtitle C: Response - (Sec. 131) Revises procedures related to seizure of food, including to deem that exigent circumstances exist for all seizures brought under FFDCA provisions. (Sec. 132) Provides for administrative detention of any food that is adulterated, misbranded, or otherwise in violation of the FFDCA. (Sec. 133) Authorizes the Secretary to prohibit or restrict the movement of an article of food within a state if there is credible evidence that such food presents an imminent threat of serious adverse health consequences or death to humans or animals. Prohibits any action from being taken under this section unless there is no less drastic action that is feasible and that would be adequate to prevent such threat. (Sec. 134) Extends the sentence for prohibited acts relating to adulterated or misbranded food from imprisonment for not more than one year to imprisonment for not more than ten years. (Sec. 135) Expands civil penalties for FFDCA violations related to food. (Sec. 136) Prohibits: (1) the submission of inaccurate or incomplete information relating to food that is required for import; and (2) the failure to submit such required information. Authorizes the Secretary to require the submission of documentation or other information for articles of food that are imported or offered for import into the United States. Title II: Miscellaneous - (Sec. 201) Requires the Secretary to post on the FDA's public website notice of any determination that a substance is a GRAS food substance and the supporting scientific justification. Defines &quot;GRAS food substance&quot; to mean a substance excluded from the term &quot;food additive&quot; because such substance is generally recognized to be safe under the conditions of its intended use. (Sec. 202) Deems a processed food to be misbranded if the labeling fails to identify the country in which the final processing of the food occurs. Deems a nonprocessed food to be misbranded if the labeling fails to identify the country of the origin of the food. (Sec. 203) Extends the export certification program currently applicable to drugs and devices to include food. Sets forth provisions regarding the fee for an export certification for food. (Sec. 204) Directs the Secretary to require an importer of food to be registered with the Secretary and to submit appropriate unique facility identifiers as a condition of registration. Conditions maintenance of registration on compliance with good importer practices. Provides for suspension or cancellation of such registration. Requires the Secretary to establish an exemption for importation for personal use. Requires the Secretary to assess an annual fee for the registration of an importer. Deems a food to be misbranded if it is imported or offered for import by an importer not duly registered. (Sec. 205) Directs the Secretary to require a customs broker, with respect to the importation of food, to be registered with the Secretary and to submit appropriate unique facility identifiers as a condition of registration. Authorizes the Secretary to cancel a registration. Provides for a personal use exemption. (Sec. 206) Requires each registered food facility to submit a unique facility identifier for the facility or establishment. ( Sec. 207) Deems a product to be adulterated if inspection of the food facility is delayed, limited, or refused. (Sec. 208) Requires the Secretary to establish and maintain a corps of inspectors dedicated to inspections of foreign food facilities. (Sec. 209) Requires the Secretary to submit a reorganization plan to the Comptroller General and relevant congressional committees before the Secretary terminates specified laboratories or district offices responsible for analyzing food or with food safety functions. (Sec. 210) Prohibits the submission of any required report related to food that is false or misleading in any material respect. ( Sec. 211) Includes as a prohibited Act under the FFDCA the failure or refusal to obey a subpoena issued under such Act. Authorizes the Commissioner of Food and Drugs to issue subpoenas. (Sec. 212) Prohibits any person required to submit information related to food from discriminating against an employee because of a lawful act done by the employee. (Sec. 213) Prohibits the production, manufacture, processing, preparation, packing, holding, or distribution of an adulterated or misbranded food with the knowledge or intent that such article will be imported into the United States. (Sec. 214) Requires the Secretary, acting through the Commissioner, to provide financial and other assistance to establish and maintain food protection training institutes. (Sec. 215) Requires the Secretary to notify Congress whether the available scientific data supports a determination that there is a reasonable certainty of no harm for approved uses of polycarbonate plastic and epoxy resin made with bisphenol A in food and beverage containers under the conditions of use prescribed in current FDA regulations. Requires the Secretary to notify Congress of the actions the Secretary intends to take if such a determination cannot be made. (Sec. 216) Deems ceramic tableware or cookware that includes a glaze or decorations containing lead and that is for an intended functional purpose to be misbranded unless: (1) the product and its packaging bears a warning that the product is made with lead-based glaze; or (2) the product is in compliance with requirements applicable to ornamental and decorative ceramicware. Requires the Secretary to educate consumers on the safety of ceramicware for food.

1249272000 2009-08-03 Fri Nov 13 20:55:40 -0600 2009 passed house 58220 'act':4 '2009':6 'food':1 'enhanc':3 'safeti':2 80479 false short reported to house 58220 'act':4 '2009':6 'food':1 'enhanc':3 'safeti':2 80478 false short introduced 58220 'act':4 '2009':6 'food':1 'enhanc':3 'safeti':2 74349 false short introduced 58220 'act':4 'food':1 'enhanc':3 'safeti':2 74302 true popular introduced 58220 'act':9 'drug':6 'food':5,15 'amend':2 'feder':4 'cosmet':8 'global':18 'improv':11 'market':19 'purpos':23 'safeti':13 74275 false official action 58220 Tue Aug 04 18:59:42 -0500 2009 1249272000 Mon Aug 03 00:00:00 -0500 2009 206320 Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. D000355 1926-07-08 8525 2328 Rayburn House Office Building https://forms.house.gov/wyr/welcome.shtml 15 202-226-0371 John 'd':4 'mi':5 '-15':6 'rep':1 'john':2,7,9 'dingel':3,8,10 M 400110 Dingell John_D._Dingell D. Rep. John Dingell [D, MI-15] 5283 N00001783 12350 Democrat 202-225-4071 Roman Catholic MI John Dingell 3.06451612903226 http://www.house.gov/dingell/ D000197 1957-07-29 3739 1527 Longworth House Office Building http://www.house.gov/formdegette/zip_auth.htm 1 202-225-5657 Diana 'd':4 '-1':6 'co':5 'rep':1 'diana':2,7,9 'degett':3,8,10 F 400101 DeGette Diana_DeGette L. Rep. Diana DeGette [D, CO-1] 1945 N00006134 7780 Democrat 202-225-4431 Presbyterian CO Diana DeGette 3.47058823529412 http://www.house.gov/degette/index.shtml ddegette P000034 1951-10-30 3983 237 Cannon House Office Building http://www.house.gov/pallone/contact.shtml 6 202-225-9665 Frank 'd':4 '-6':6 'nj':5 'rep':1 'frank':2,7,9 'pallon':3,8,10 M 400308 Pallone Frank_Jr.Pallone J. Rep. Frank Pallone [D, NJ-6] 2273 N00000781 6709 Democrat 202-225-4671 Catholic NJ Frank Pallone 3.41666666666667 http://www.house.gov/pallone/ S001045 1952-02-29 5878 2352 Rayburn House Office Building http://www.house.gov/stupak/IMA/issue2.htm 1 202-225-4744 Bart 'd':4 '-1':6 'mi':5 'rep':1 'bart':2,7,9 'stupak':3,8,10 M 400391 Stupak Bart_Stupak T. Rep. Bart Stupak [D, MI-1] 3112 N00004196 7646 Democrat 202-225-4735 Catholic MI Bart Stupak 3.63636363636364 http://www.house.gov/stupak BartStupak S001174 2519 1721 Longworth House Office Building http://sutton.house.gov/about/emailform.cfm 13 202-225-2266 Betty 'd':4 'oh':5 '-13':6 'rep':1 'betti':2,7,9 'sutton':3,8,10 F 412228 Sutton Betty_Sue_Sutton Rep. Betty Sutton [D, OH-13] 911 N00027901 7179 Democrat 202-225-3401 OH Betty Sutton 3.45454545454545 http://sutton.house.gov/ W000215 1939-09-12 14265 2204 Rayburn House Office Building http://www.house.gov/waxman/contact.htm 30 202-225-4099 Henry 'd':4 'ca':5 '-30':6 'rep':1 'henri':2,7,9 'waxman':3,8,10 M 400425 Waxman Henry_A._Waxman A. Rep. Henry Waxman [D, CA-30] 6541 N00001861 13866 Democrat 202-225-3976 Jewish CA Henry Waxman 1.98823529411765 http://www.house.gov/waxman/ action 58220 Tue Aug 04 18:59:42 -0500 2009 1249272000 Mon Aug 03 00:00:00 -0500 2009 206320 Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. vote 58220 Fri Jul 31 18:58:52 -0500 2009 1248987720 Thu Jul 30 18:02:00 -0500 2009 roll 205738 pass 6039 680 On passage Passed by recorded vote: 283 - 142 (Roll no. 680). vote h action 58220 Fri Jul 31 18:58:52 -0500 2009 1248987240 Thu Jul 30 17:54:00 -0500 2009 205737 On motion to recommit with instructions Failed by the Yeas and Nays: 186 - 240 (Roll no. 679). action 58220 Fri Jul 31 18:58:52 -0500 2009 1248985740 Thu Jul 30 17:29:00 -0500 2009 205736 The previous question on the motion to recommit with instructions was ordered without objection. action 58220 Fri Jul 31 18:58:52 -0500 2009 1248984540 Thu Jul 30 17:09:00 -0500 2009 205735 Mr. Dingell raised a point of order against the motion to recommit with instructions. Mr. Dingell stated that the provisions of the motion to recommit exceeds the scope of the bill. Overruled by the Chair. action 58220 Fri Jul 31 18:58:52 -0500 2009 1248984420 Thu Jul 30 17:07:00 -0500 2009 205733 Mr. Lucas moved to recommit with instructions to Energy and Commerce. action 58220 Fri Jul 31 18:58:52 -0500 2009 1248984420 Thu Jul 30 17:07:00 -0500 2009 205734 DEBATE - The House proceeded with 10 minutes of debate on the Lucas(OK) motion to recommit with instructions. The instructions contained in the motion seek to require the bill to be reported back to the House with amendments, pending the reservation of a point of order. action 58220 Fri Jul 31 18:58:52 -0500 2009 1248984360 Thu Jul 30 17:06:00 -0500 2009 205732 The previous question was ordered pursuant to the rule. action 58220 Fri Jul 31 18:58:52 -0500 2009 1248983040 Thu Jul 30 16:44:00 -0500 2009 205731 DEBATE - The House continued with further debate on H.R. 2749. action 58220 Fri Jul 31 18:58:52 -0500 2009 1248981540 Thu Jul 30 16:19:00 -0500 2009 205730 DEBATE - The House proceeded with one hour of debate on H.R. 2749. action 58220 Fri Jul 31 18:58:52 -0500 2009 1248981480 Thu Jul 30 16:18:00 -0500 2009 205729 Rule provides for consideration of H.R. 2749 with 1 hour of general debate. Previous question shall be considered as ordered without intervening motions except motion to recommit with or without instructions. Measure will be considered read. Bill is closed to amendments. In lieu of the amendment in the nature of a substitute recommended by the Committee on Energy and Commerce now printed in the bill, the amendment in the nature of a substitute printed in the report of the Committee on Rules shall be considered as adopted. All points of order against consideration of the bill are waived except those arising under clause 9 or 10 of rule XXI. action 58220 Fri Jul 31 18:58:52 -0500 2009 1248981480 Thu Jul 30 16:18:00 -0500 2009 205728 Considered under the provisions of rule H. Res. 691. action 58220 Fri Jul 31 18:58:52 -0500 2009 1248980640 Thu Jul 30 16:04:00 -0500 2009 205727 Rule H. Res. 691 passed House. action 58220 Thu Jul 30 18:58:19 -0500 2009 1248902220 Wed Jul 29 18:17:00 -0500 2009 205358 Rules Committee Resolution H. Res. 691 Reported to House. Rule provides for consideration of H.R. 2749 with 1 hour of general debate. Previous question shall be considered as ordered without intervening motions except motion to recommit with or without instructions. Measure will be considered read. Bill is closed to amendments. In lieu of the amendment in the nature of a substitute recommended by the Committee on Energy and Commerce now printed in the bill, the amendment in the nature of a substitute printed in the report of the Committee on Rules shall be considered as adopted. All points of order against consideration of the bill are waived except those arising under clause 9 or 10 of rule XXI. vote 58220 Thu Jul 30 18:58:19 -0500 2009 1248892140 Wed Jul 29 15:29:00 -0500 2009 roll 205357 fail 6017 657 On motion to suspend the rules and pass the bill, as amended Failed by the Yeas and Nays: (2/3 required): 280 - 150 (Roll no. 657). vote h action 58220 Thu Jul 30 18:58:19 -0500 2009 1248887100 Wed Jul 29 14:05:00 -0500 2009 205355 Considered under suspension of the rules. action 58220 Thu Jul 30 18:58:19 -0500 2009 1248887100 Wed Jul 29 14:05:00 -0500 2009 205356 DEBATE - The House proceeded with forty minutes of debate on H.R. 2749. action 58220 Thu Jul 30 18:58:19 -0500 2009 1248887100 Wed Jul 29 14:05:00 -0500 2009 205354 Mr. Dingell moved to suspend the rules and pass the bill, as amended. calendar 58220 Thu Jul 30 18:58:19 -0500 2009 1248886860 Wed Jul 29 14:01:00 -0500 2009 205353 Placed on the Union Calendar, Calendar No. 130. action 58220 Thu Jul 30 18:58:19 -0500 2009 1248886800 Wed Jul 29 14:00:00 -0500 2009 205352 Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 111-234. action 58220 1245211200 Wed Jun 17 00:00:00 -0500 2009 199761 Committee Consideration and Mark-up Session Held. calendar 58220 1245211200 Wed Jun 17 00:00:00 -0500 2009 199762 Ordered to be Reported (Amended) by Voice Vote. action 58220 1244692800 Thu Jun 11 00:00:00 -0500 2009 198960 Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote . action 58220 1244606400 Wed Jun 10 00:00:00 -0500 2009 198672 Subcommittee Consideration and Mark-up Session Held. action 58220 1244520000 Tue Jun 09 00:00:00 -0500 2009 198671 Referred to the Subcommittee on Health. action 58220 1244433600 Mon Jun 08 00:00:00 -0500 2009 198083 Referred to the House Committee on Energy and Commerce. introduced 58220 1244433600 Mon Jun 08 00:00:00 -0500 2009 198082 8 283 58220 Thu Jul 30 17:02:00 -0500 2009 true 6039 false 142 680 1201 0 On Passage: H R 2749 Food Safety Enhancement Act of 2009 false 1/2 Passed On Passage Thu Jul 30 18:05:16 -0500 2009 house 7 186 58220 Thu Jul 30 16:55:00 -0500 2009 false 6034 false 240 679 484 0 On Motion to Recommit with Instructions: H R 2749 Food Safety Enhancement Act of 2009 true 1/2 Failed On Motion to Recommit with Instructions Thu Jul 30 18:05:08 -0500 2009 house 3 280 58220 Wed Jul 29 14:29:00 -0500 2009 true 6017 false 150 657 263 0 On Motion to Suspend the Rules and Pass, as Amended: H R 2749 Food Safety Enhancement Act of 2009 false 2/3 Failed On Motion to Suspend the Rules and Pass, as Amended Wed Jul 29 15:05:57 -0500 2009 house