[Congressional Record (Bound Edition), Volume 155 (2009), Part 15]
[House]
[Pages 19691-19719]
[From the U.S. Government Publishing Office, www.gpo.gov]




                  FOOD SAFETY ENHANCEMENT ACT OF 2009

  Mr. DINGELL. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 2749) to amend the Federal Food, Drug, and Cosmetic Act to 
improve the safety of food in the global market, and for other 
purposes, as amended.

[[Page 19692]]

  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 2749

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Food Safety Enhancement Act 
     of 2009''.

     SEC. 2. TABLE OF CONTENTS.

       The table of contents of this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. References.
Sec. 4. Rules of construction.
Sec. 5. USDA exemptions.
Sec. 6. Alcohol-related facilities.

                          TITLE I--FOOD SAFETY

                         Subtitle A--Prevention

Sec. 101. Changes in registration of food facilities.
Sec. 102. Hazard analysis, risk-based preventive controls, food safety 
              plan, finished product test results from category 1 
              facilities.
Sec. 103. Performance standards.
Sec. 104. Safety standards for produce and certain other raw 
              agricultural commodities.
Sec. 105. Risk-based inspection schedule.
Sec. 106. Access to records.
Sec. 107. Traceability of food.
Sec. 108. Reinspection and food recall fees applicable to facilities.
Sec. 109. Certification and accreditation.
Sec. 110. Testing by accredited laboratories.
Sec. 111. Notification, nondistribution, and recall of adulterated or 
              misbranded food.
Sec. 112. Reportable food registry; exchange of information.
Sec. 113. Safe and secure food importation program.
Sec. 114. Infant formula.

                        Subtitle B--Intervention

Sec. 121. Surveillance.
Sec. 122. Public education and advisory system.
Sec. 123. Research.

                          Subtitle C--Response

Sec. 131. Procedures for seizure.
Sec. 132. Administrative detention.
Sec. 133. Authority to prohibit or restrict the movement of food.
Sec. 134. Criminal penalties.
Sec. 135. Civil penalties for violations relating to food.
Sec. 136. Improper import entry filings.

                        TITLE II--MISCELLANEOUS

Sec. 201. Food substances generally recognized as safe.
Sec. 202. Country of origin labeling.
Sec. 203. Exportation certificate program.
Sec. 204. Registration for commercial importers of food; fee.
Sec. 205. Registration for customs brokers.
Sec. 206. Unique identification number for food facilities, importers, 
              and custom brokers.
Sec. 207. Prohibition against delaying, limiting, or refusing 
              inspection.
Sec. 208. Dedicated foreign inspectorate.
Sec. 209. Plan and review of continued operation of field laboratories.
Sec. 210. False or misleading reporting to FDA.
Sec. 211. Subpoena authority.
Sec. 212. Whistleblower protections.
Sec. 213. Extraterritorial jurisdiction.
Sec. 214. Support for training institutes.
Sec. 215. Bisphenol A in food and beverage containers.
Sec. 216. Lead content labeling requirement for ceramic tableware and 
              cookware.

     SEC. 3. REFERENCES.

       Except as otherwise specified, whenever in this Act an 
     amendment is expressed in terms of an amendment to a section 
     or other provision, the reference shall be considered to be 
     made to a section or other provision of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

     SEC. 4. RULES OF CONSTRUCTION.

       (a) Nothing in this Act or the amendments made by this Act 
     shall be construed to prohibit or limit--
       (1) any cause of action under State law; or
       (2) the introduction of evidence of compliance or 
     noncompliance with the requirements of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
       (b) Nothing in this Act or any amendment made by this Act 
     shall be construed to--
       (1) alter the jurisdiction between the Secretary of 
     Agriculture and the Secretary of Health and Human Services, 
     under applicable statutes and regulations;
       (2) limit the authority of the Secretary of Health and 
     Human Services to issue regulations related to the safety of 
     food under--
       (A) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
     et seq.) as in effect on the day before the date of the 
     enactment of this Act; or
       (B) the Public Health Service Act (42 U.S.C. 301 et seq.) 
     as in effect on the day before the date of the enactment of 
     this Act; or
       (3) impede, minimize, or affect the authority of the 
     Secretary of Agriculture to prevent, control, or mitigate a 
     plant or animal health emergency, or a food emergency 
     involving products regulated under 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.).

     SEC. 5. USDA EXEMPTIONS.

       (a) USDA-Regulated Products.--Food is exempt from the 
     requirements of this Act to the extent that such food is 
     regulated by the Secretary of Agriculture under 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.).
       (b) Livestock and Poultry.--Livestock and poultry that are 
     intended to be presented for slaughter pursuant to the 
     regulations by the Secretary of Agriculture under the Federal 
     Meat Inspection Act or the Poultry Products Inspection Act 
     are exempt from the requirements of this Act. A cow, sheep, 
     or goat that is used for the production of milk is exempt 
     from the requirements of this Act.
       (c) USDA-Regulated Facilities.--A facility is exempt from 
     the requirements of this Act to the extent such facility is 
     regulated as an official establishment by the Secretary of 
     Agriculture under the Federal Meat Inspection Act, the 
     Poultry Products Inspection Act, or the Egg Products 
     Inspection Act or under a program recognized by the Secretary 
     of Agriculture as at least equal to Federal regulation under 
     the Federal Meat Inspection Act, the Poultry Products 
     Inspection Act, or the Egg Products Inspection Act.
       (d) Farms.--A farm is exempt from the requirements of this 
     Act to the extent such farm raises animals from which food is 
     derived that is regulated under the Federal Meat Inspection 
     Act, the Poultry Products Inspection Act, or the Egg Products 
     Inspection Act.

     SEC. 6. ALCOHOL-RELATED FACILITIES.

       (a) In General.--With the exception of the amendments made 
     by section 101(a) and (b) and section 113 of this Act, 
     nothing in this Act, or the amendments made by this Act, 
     shall be construed to apply to a facility that--
       (1) under the Federal Alcohol Administration Act (27 U.S.C. 
     201 et seq.) or chapter 51 of subtitle E of the Internal 
     Revenue Code of 1986 (26 U.S.C. 5291 et seq.) is required to 
     obtain a permit or to register with the Secretary of the 
     Treasury as a condition of doing business in the United 
     States; and
       (2) under section 415 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 350d), as amended by this Act, is 
     required to register as a facility because such facility is 
     engaged in manufacturing, processing, packing, or holding 1 
     or more alcoholic beverages.
       (b) Limited Receipt and Distribution of Non-Alcohol Food.--
     Subsection (a) shall not apply to a facility engaged in the 
     distributing of any non-alcohol food, except that subsection 
     (a) shall apply to a facility described in paragraphs (1) and 
     (2) of subsection (a) that receives and distributes non-
     alcohol food provided such food is received and distributed--
       (1) in a prepackaged form that prevents any direct human 
     contact with such food; and
       (2) in amounts that constitute not more than 5 percent of 
     the overall sales of such facility, as determined by the 
     Secretary of the Treasury.
       (c) Rule of Construction.--This section shall not be 
     construed to exempt any food, apart from distilled spirits, 
     wine, and malt beverages, as defined in section 211 of the 
     Federal Alcohol Administration Act (27 U.S.C. 211), from the 
     requirements of this Act and the amendments made by this Act.

                          TITLE I--FOOD SAFETY

                         Subtitle A--Prevention

     SEC. 101. CHANGES IN REGISTRATION OF FOOD FACILITIES.

       (a) Misbranding.--Section 403 (21 U.S.C. 343) is amended by 
     adding at the end the following:
       ``(z) If it was manufactured, processed, packed, or held in 
     a facility that is not duly registered under section 415, 
     including a facility whose registration is canceled or 
     suspended under such section.''.
       (b) Annual Registration.--
       (1) Definition of facility.--Paragraph (1) of section 
     415(b) (21 U.S.C. 350d(b)) is amended to read as follows:
       ``(1)(A) The term `facility' means any factory, warehouse, 
     or establishment (including a factory, warehouse, or 
     establishment of an importer) that manufactures, processes, 
     packs, or holds food.
       ``(B) Such term does not include farms; private residences 
     of individuals; restaurants; other retail food 
     establishments; nonprofit food establishments in which food 
     is prepared for or served directly to the consumer; or 
     fishing vessels (except such vessels engaged in processing as 
     defined in section 123.3(k) of title 21, Code of Federal 
     Regulations, or any successor regulations).
       ``(C)(i) The term `retail food establishment' means an 
     establishment that, as its primary function, sells food 
     products (including those food products that it manufactures, 
     processes, packs, or holds) directly to consumers (including 
     by Internet or mail order).
       ``(ii) Such term includes--
       ``(I) grocery stores;

[[Page 19693]]

       ``(II) convenience stores;
       ``(III) vending machine locations; and
       ``(IV) stores that sell bagged feed, pet food, and feed 
     ingredients or additives over-the-counter directly to 
     consumers and final purchasers for their own personal 
     animals.
       ``(iii) A retail food establishment's primary function is 
     to sell food directly to consumers if the annual monetary 
     value of sales of food products directly to consumers exceeds 
     the annual monetary value of sales of food products to all 
     other buyers.
       ``(D)(i) The term `farm' means an operation in one general 
     physical location devoted to the growing and harvesting of 
     crops, the raising of animals (including seafood), or both.
       ``(ii) Such term includes--
       ``(I) such an operation that packs or holds food, provided 
     that all food used in such activities is grown, raised, or 
     consumed on such farm or another farm under the same 
     ownership;
       ``(II) such an operation that manufactures or processes 
     food, provided that all food used in such activities is 
     consumed on such farm or another farm under the same 
     ownership;
       ``(III) such an operation that sells food directly to 
     consumers if the annual monetary value of sales of the food 
     products from the farm or by an agent of the farm to 
     consumers exceeds the annual monetary value of sales of the 
     food products to all other buyers;
       ``(IV) such an operation that manufactures grains or other 
     feed stuffs that are grown and harvested on such farm or 
     another farm under the same ownership and are distributed 
     directly to 1 or more farms for consumption as food by humans 
     or animals on such farm; and
       ``(V) a fishery, including a wild fishery, an aquaculture 
     operation or bed, a fresh water fishery, and a saltwater 
     fishery.
       ``(iii) Such term does not include such an operation that 
     receives manufactured feed from another farm as described in 
     clause (ii)(IV) if the receiving farm releases the feed to 
     another farm or facility under different ownership.
       ``(iv) The term `harvesting' includes washing, trimming of 
     outer leaves of, and cooling produce.
       ``(E) The term `consumer' does not include a business.''.
       (2) Registration.--Section 415(a) (21 U.S.C. 350d(a)) is 
     amended--
       (A) in the first sentence of paragraph (1)--
       (i) by striking ``require that'' and inserting ``require 
     that, on or before December 31 of each year,''; and
       (ii) by striking ``food for consumption in the United 
     States'' and inserting ``food for consumption in the United 
     States or for export from the United States'';
       (B) in subparagraphs (A) and (B) of paragraph (1), by 
     inserting ``and pay the registration fee required under 
     section 743'' after ``submit a registration to the 
     Secretary'' each place it appears;
       (C) in the first sentence of paragraph (2), by inserting 
     ``in electronic format'' after ``submit''; and
       (D) in paragraph (4), by inserting after the first sentence 
     the following: ``The Secretary shall remove from such list 
     the name of any facility that fails to reregister in 
     accordance with this section, that fails to pay the 
     registration fee required under section 743, or whose 
     registration is canceled by the registrant, canceled by the 
     Secretary in accordance with this section, or suspended by 
     the Secretary in accordance with this section.''.
       (3) Contents of registration.--Paragraph (2) of section 
     415(a) (21 U.S.C. 350d(a)), as amended by paragraph (1), is 
     amended by striking ``containing information'' and all that 
     follows and inserting the following: ``containing information 
     that identifies the following:
       ``(A) The name, address, and emergency contact information 
     of the facility being registered.
       ``(B) The primary purpose and business activity of the 
     facility, including the dates of operation if the facility is 
     seasonal.
       ``(C) The general food category (as defined by the 
     Secretary by guidance) of each food manufactured, processed, 
     packed, or held at the facility.
       ``(D) All trade names under which the facility conducts 
     business related to food.
       ``(E) The name, address, and 24-hour emergency contact 
     information of the United States distribution agent for the 
     facility, which agent shall have access to the information 
     required to be maintained under section 414(d) for food that 
     is manufactured, processed, packed, or held at the facility.
       ``(F) If the facility is located outside of the United 
     States, the name, address, and emergency contact information 
     for a United States agent.
       ``(G) The unique facility identifier of the facility, as 
     specified under section 1011.
       ``(H) Such additional information pertaining to the 
     facility as the Secretary may require by regulation.
     The registrant shall notify the Secretary of any change in 
     the submitted information not later than 30 days after the 
     date of such change, unless otherwise specified by the 
     Secretary.''.
       (4) Suspension and cancellation authority.--Section 415(a) 
     (21 U.S.C. 350d(a)), as amended by paragraphs (1) and (2), is 
     further amended by adding at the end the following:
       ``(5) Suspension of registration.--
       ``(A) In general.--The Secretary may suspend the 
     registration of any facility registered under this section 
     for a violation of this Act that could result in serious 
     adverse health consequences or death to humans or animals.
       ``(B) Notice of suspension.--Suspension of a registration 
     shall be preceded by--
       ``(i) notice to the facility of the intent to suspend the 
     registration; and
       ``(ii) an opportunity for an informal hearing, as defined 
     in guidance or regulations issued by the Secretary, 
     concerning the suspension of such registration for such 
     facility.
       ``(C) Request.--The owner, operator, or agent in charge of 
     a facility whose registration is suspended may request that 
     the Secretary vacate the suspension of registration when such 
     owner, operator, or agent has corrected the violation that is 
     the basis for such suspension.
       ``(D) Vacating of suspension.--If, based on an inspection 
     of the facility or other information, the Secretary 
     determines that adequate reasons do not exist to continue the 
     suspension of a registration, the Secretary shall vacate such 
     suspension.
       ``(6) Cancellation of registration.--
       ``(A) In general.--Not earlier than 10 days after providing 
     the notice under subparagraph (B), the Secretary may cancel a 
     registration if the Secretary determines that--
       ``(i) the registration was not updated in accordance with 
     this section or otherwise contains false, incomplete, or 
     inaccurate information; or
       ``(ii) the required registration fee has not been paid 
     within 30 days after the date due.
       ``(B) Notice of cancellation.--Cancellation shall be 
     preceded by notice to the facility of the intent to cancel 
     the registration and the basis for such cancellation.
       ``(C) Timely update or correction.--If the registration for 
     the facility is updated or corrected no later than 7 days 
     after notice is provided under subparagraph (B), the 
     Secretary shall not cancel such registration.
       ``(7) Report to congress.--Not later than March 30th of 
     each year, the Secretary shall submit to the Congress a 
     report, based on the registrations on or before December 31 
     of the previous year, on the following:
       ``(A) The number of facilities registered under this 
     section.
       ``(B) The number of such facilities that are domestic.
       ``(C) The number of such facilities that are foreign.
       ``(D) The number of such facilities that are high-risk.
       ``(E) The number of such facilities that are low-risk.
       ``(F) The number of such facilities that hold food.
       ``(8) Limitation on delegation.--The authority conferred by 
     this subsection to issue an order to suspend a registration 
     or cancel a registration shall not be delegated to any 
     officer or employee other than the Commissioner of Food and 
     Drugs, the Principal Deputy Commissioner, the Associate 
     Commissioner for Regulatory Affairs, or the Director for the 
     Center for Food Safety and Applied Nutrition, of the Food and 
     Drug Administration.''.
       (c) Registration Fee.--Chapter VII (21 U.S.C. 371 et seq.) 
     is amended by adding at the end of subchapter C the 
     following:

                    ``PART 6--FEES RELATING TO FOOD

     ``SEC. 743. FACILITY REGISTRATION FEE.

       ``(a) In General.--
       ``(1) Assessment and collection.--Beginning in fiscal year 
     2010, the Secretary shall assess and collect an annual fee 
     for the registration of a facility under section 415.
       ``(2) Payable date.--A fee under this section shall be 
     payable--
       ``(A) for a facility that was not registered under section 
     415 for the preceding fiscal year, on the date of 
     registration; and
       ``(B) for any other facility--
       ``(i) for fiscal year 2010, not later than the sooner of 90 
     days after the date of the enactment of this part or December 
     31, 2009; and
       ``(ii) for a subsequent fiscal year, not later than 
     December 31 of such fiscal year.
       ``(b) Fee Amounts.--
       ``(1) In general.--The registration fee under subsection 
     (a) shall be--
       ``(A) for fiscal year 2010, $500; and
       ``(B) for fiscal year 2011 and each subsequent fiscal year, 
     the fee for fiscal year 2010 as adjusted under subsection 
     (c).
       ``(2) Annual fee setting.--The Secretary shall, not later 
     than 60 days before the start of fiscal year 2011 and each 
     subsequent fiscal year, establish, for the next fiscal year, 
     registration fees under subsection (a), as described in 
     paragraph (1).
       ``(3) Maximum amount.--Notwithstanding paragraph (1), a 
     person who owns or operates multiple facilities for which a 
     fee must be paid under this section for a fiscal year shall 
     be liable for not more than $175,000 in aggregate fees under 
     this section for such fiscal year.
       ``(c) Inflation Adjustment.--For fiscal year 2011 and each 
     subsequent fiscal year, the fee amount under subsection 
     (b)(1) shall be adjusted by the Secretary by notice, 
     published in the Federal Register, to reflect the greater 
     of--
       ``(1) the total percentage change that occurred in the 
     Consumer Price Index for all urban consumers (all items; U.S. 
     city average) for the 12-month period ending June 30

[[Page 19694]]

     preceding the fiscal year for which fees are being 
     established;
       ``(2) the total percentage change for the previous fiscal 
     year in basic pay under the General Schedule in accordance 
     with section 5332 of title 5, United States Code, as adjusted 
     by any locality-based comparability payment pursuant to 
     section 5304 of such title for Federal employees stationed in 
     the District of Columbia; or
       ``(3) the average annual change in the cost, per full-time 
     equivalent position of the Food and Drug Administration, of 
     all personnel compensation and benefits paid with respect to 
     such positions for the first 5 years of the preceding 6 
     fiscal years.

     The adjustment made each fiscal year under this subsection 
     shall be added on a compounded basis to the sum of all 
     adjustments made each fiscal year after fiscal year 2010 
     under this subsection.
       ``(d) Limitations.--
       ``(1) In general.--Fees under subsection (a) shall be 
     refunded for a fiscal year beginning after fiscal year 2010 
     unless appropriations for salaries and expenses of the Food 
     and Drug Administration for such fiscal year (excluding the 
     amount of fees appropriated for such fiscal year) are equal 
     to or greater than the amount of appropriations for the 
     salaries and expenses of the Food and Drug Administration for 
     fiscal year 2010 (excluding the amount of fees appropriated 
     for such fiscal year) multiplied by the adjustment factor 
     applicable to the fiscal year involved.
       ``(2) Authority.--If the Secretary does not assess fees 
     under subsection (a) during any portion of a fiscal year 
     because of paragraph (1) and if at a later date in such 
     fiscal year the Secretary may assess such fees, the Secretary 
     may assess and collect such fees, without any modification in 
     the rate, for registration under section 415 at any time in 
     such fiscal year.
       ``(3) Adjustment factor.--In this subsection, the term 
     `adjustment factor' applicable to a fiscal year is the 
     Consumer Price Index for all urban consumers (all items; 
     United States city average) for October of the preceding 
     fiscal year divided by such Index for October 2009.
       ``(e) Crediting and Availability of Fees.--
       ``(1) In general.--Fees authorized under subsection (a) 
     shall be collected and available for obligation only to the 
     extent and in the amount provided in advance in 
     appropriations Acts. Such fees are authorized to remain 
     available until expended. Such sums as may be necessary may 
     be transferred from the Food and Drug Administration salaries 
     and expenses appropriation account without fiscal year 
     limitation to such appropriation account for salaries and 
     expenses with such fiscal year limitation.
       ``(2) Collections and appropriations acts.--The fees 
     authorized by this section--
       ``(A) shall be retained in each fiscal year in an amount 
     not to exceed the amount specified in appropriation Acts, or 
     otherwise made available for obligation, for such fiscal 
     year; and
       ``(B) shall only be collected and available to defray the 
     costs of food safety activities.
       ``(3) Authorization of appropriations.--For each of fiscal 
     years 2010 through 2014, there are authorized to be 
     appropriated for fees under this section such sums as may be 
     necessary.
       ``(4) Public meetings.--For each fiscal year, the Secretary 
     shall hold a public meeting on how fees collected under this 
     section will be used to defray the costs of food safety 
     activities in order to solicit the views of the regulated 
     industry, consumers, and other interested stakeholders.
       ``(f) Collection of Unpaid Fees.--In any case where the 
     Secretary does not receive payment of a fee assessed under 
     subsection (a) within 30 days after it is due, such fee shall 
     be treated as a claim of the United States Government subject 
     to subchapter II of chapter 37 of title 31, United States 
     Code.
       ``(g) Construction.--This section may not be construed to 
     require that the number of full-time equivalent positions in 
     the Department of Health and Human Services, for officers, 
     employees, and advisory committees not engaged in food safety 
     activities, be reduced to offset the number of officers, 
     employees, and advisory committees so engaged.
       ``(h) Annual Fiscal Reports.--Beginning with fiscal year 
     2011, not later than 120 days after the end of each fiscal 
     year for which fees are collected under this section, the 
     Secretary shall prepare and submit to the Committee on Energy 
     and Commerce of the House of Representatives and the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate a report on the implementation of the authority for 
     such fees during such fiscal year and the use, by the Food 
     and Drug Administration, of the fees collected for such 
     fiscal year.
       ``(i) Definitions.--In this section:
       ``(1) The term `costs of food safety activities' means the 
     expenses incurred in connection with food safety activities 
     for--
       ``(A) officers and employees of the Food and Drug 
     Administration, contractors of the Food and Drug 
     Administration, advisory committees, and costs related to 
     such officers, employees, and committees and to contracts 
     with such contractors;
       ``(B) laboratory capacity;
       ``(C) management of information, and the acquisition, 
     maintenance, and repair of technology resources;
       ``(D) leasing, maintenance, renovation, and repair of 
     facilities and acquisition, maintenance, and repair of 
     fixtures, furniture, scientific equipment, and other 
     necessary materials and supplies; and
       ``(E) collecting fees under this section and accounting for 
     resources allocated for food safety activities.
       ``(2) The term `food safety activities' means activities 
     related to compliance by facilities registered under section 
     415 with the requirements of this Act relating to food 
     (including research related to and the development of 
     standards (such as performance standards and preventive 
     controls), risk assessments, hazard analyses, inspection 
     planning and inspections, third-party inspections, compliance 
     review and enforcement, import review, information technology 
     support, test development, product sampling, risk 
     communication, and administrative detention).''.
       (d) Transitional Provisions.--
       (1) Fees.--The Secretary of Health and Human Services shall 
     first impose the fee established under section 743 of the 
     Federal Food, Drug, and Cosmetic Act, as added by subsection 
     (c), for fiscal years beginning with fiscal year 2010.
       (2) Modification of registration form.--Not later than 180 
     days after the date of the enactment of this Act, the 
     Secretary of Health and Human Services shall modify the 
     registration form under section 415 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 350d) to comply with the 
     amendments made by this section.
       (3) Application.--The amendments made by this section, 
     other than subsections (b)(2) and (c), shall take effect on 
     the date that is 30 days after the date on which such 
     modified registration form takes effect, but not later than 
     210 days after the date of the enactment of this Act.
       (4) Sunset date.--Section 743 of the Federal Food, Drug, 
     and Cosmetic Act, as added by subsection (c), does not 
     authorize the assessment or collection of a fee for 
     registration under section 415 of such Act (21 U.S.C. 360) 
     occurring after fiscal year 2014.

     SEC. 102. HAZARD ANALYSIS, RISK-BASED PREVENTIVE CONTROLS, 
                   FOOD SAFETY PLAN, FINISHED PRODUCT TEST RESULTS 
                   FROM CATEGORY 1 FACILITIES.

       (a) Hazard Analysis, Risk-Based Preventive Controls, Food 
     Safety Plan.--
       (1) Adulterated food.--Section 402 (21 U.S.C. 342) is 
     amended by adding at the end the following:
       ``(j) If it has been manufactured, processed, packed, 
     transported, or held under conditions that do not meet the 
     requirements of sections 418 and 418A.''.
       (2) Requirements.--Chapter IV (21 U.S.C. 341 et seq.) is 
     amended by adding at the end the following:

     ``SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE 
                   CONTROLS.

       ``(a) In General.--The owner, operator, or agent of a 
     facility shall, in accordance with this section--
       ``(1) conduct a hazard analysis (or more than one if 
     appropriate);
       ``(2) identify and implement effective preventive controls;
       ``(3) monitor preventive controls;
       ``(4) institute corrective actions when--
       ``(A) monitoring shows that preventive controls have not 
     been properly implemented; or
       ``(B) monitoring and verification show that such controls 
     were ineffective;
       ``(5) conduct verification activities;
       ``(6) maintain records of monitoring, corrective action, 
     and verification; and
       ``(7) reanalyze for hazards.
       ``(b) Identification of Hazards.--
       ``(1) In general.--The owner, operator, or agent of a 
     facility shall evaluate whether there are any hazards, 
     including hazards due to the source of the ingredients, that 
     are reasonably likely to occur in the absence of preventive 
     controls that may affect the safety, wholesomeness, or 
     sanitation of the food manufactured, processed, packed, 
     transported, or held by the facility, including--
       ``(A) biological, chemical, physical, and radiological 
     hazards, natural toxins, pesticides, drug residues, filth, 
     decomposition, parasites, allergens, and unapproved food and 
     color additives; and
       ``(B) hazards that occur naturally or that may be 
     unintentionally introduced.
       ``(2) Identified by the secretary.--The Secretary may, by 
     regulation or guidance, identify hazards that are reasonably 
     likely to occur in the absence of preventive controls.
       ``(3) Hazard analysis.--The owner, operator, or agent of a 
     facility shall identify and describe the hazards evaluated 
     under paragraph (1) or identified under paragraph (2), to the 
     extent applicable to the facility, in a hazard analysis.
       ``(c) Preventive Controls.--
       ``(1) In general.--The owner, operator, or agent of a 
     facility shall identify and implement effective preventive 
     controls to prevent, eliminate, or reduce to acceptable 
     levels the occurrence of any hazards identified in the hazard 
     analysis under subsection (b)(3).
       ``(2) Identified by the secretary.--

[[Page 19695]]

       ``(A) Establishment.--The Secretary may establish by 
     regulation or guidance preventive controls for specific 
     product types to prevent unintentional contamination 
     throughout the supply chain. The owner, operator, or agent of 
     a facility shall implement any preventive controls identified 
     by the Secretary under this paragraph.
       ``(B) Alternative controls.--Such regulation or guidance 
     shall allow the owner, operator, or agent of a facility to 
     implement an alternative preventive control to one 
     established by the Secretary, provided that, in response to a 
     request by the Secretary, the owner, operator, or agent can 
     present to the Secretary data or other information sufficient 
     to demonstrate that the alternative control effectively 
     addresses the hazard, including meeting any applicable 
     performance standard.
       ``(C) Limitation.--Subparagraph (B) shall not apply to any 
     preventive control described in subparagraph (A), (B), or (E) 
     of subsection (i)(2).
       ``(d) Monitoring.--The owner, operator, or agent of a 
     facility shall monitor the implementation of preventive 
     controls under subsection (c) to identify any circumstances 
     in which the preventive controls are not fully implemented or 
     verification shows that such controls were ineffective.
       ``(e) Corrective Actions.--The owner, operator, or agent of 
     a facility shall establish and implement procedures to ensure 
     that, if the preventive controls under subsection (c) are not 
     fully implemented or are not found effective--
       ``(1) no affected product from such facility enters 
     commerce; and
       ``(2) appropriate action is taken to reduce the likelihood 
     of recurrence of the implementation failure.
       ``(f) Verification.--The owner, operator, or agent of a 
     facility shall ensure that--
       ``(1) the system of preventive controls identified under 
     subsection (c) has been validated as scientifically and 
     technically sound so that, if such system is implemented, the 
     hazards identified in the hazard analysis under subsection 
     (b)(3) will be prevented, eliminated, or reduced to an 
     acceptable level;
       ``(2) the facility is conducting monitoring in accordance 
     with subsection (d);
       ``(3) the facility is taking effective corrective actions 
     under subsection (e); and
       ``(4) the preventive controls are effectively preventing, 
     eliminating, or reducing to an acceptable level the 
     occurrence of identified hazards, including through the use 
     of environmental and product testing programs and other 
     appropriate means.
       ``(g) Requirement to Reanalyze and Revise.--
       ``(1) Requirement.--The owner, operator, or agent of a 
     facility shall--
       ``(A) review the evaluation under subsection (b) for the 
     facility and, as necessary, revise the hazard analysis under 
     subsection (b)(3) for the facility--
       ``(i) not less than every 2 years;
       ``(ii) if there is a change in the process or product that 
     could affect the hazard analysis; and
       ``(iii) if the Secretary determines that it is appropriate 
     to protect public health; and
       ``(B) whenever there is a change in the hazard analysis, 
     revise the preventive controls under subsection (c) for the 
     facility as necessary to ensure that all hazards that are 
     reasonably likely to occur are prevented, eliminated, or 
     reduced to an acceptable level, or document the basis for the 
     conclusion that no such revision is needed.
       ``(2) Nondelegation.--Any revisions ordered by the 
     Secretary under this subsection shall be ordered by the 
     Secretary or an official designated by the Secretary. An 
     official may not be so designated unless the official is the 
     director of the district under this Act in which the facility 
     involved is located, or is an official senior to such 
     director.
       ``(h) Recordkeeping.--The owner, operator, or agent of a 
     facility shall maintain, for not less than 2 years, records 
     documenting the activities described in subsections (a) 
     through (g).
       ``(i) Definitions.--For purposes of this section:
       ``(1) Facility.--The term `facility' means a domestic 
     facility or a foreign facility that is required to be 
     registered under section 415.
       ``(2) Preventive controls.--The term `preventive controls' 
     means those risk-based procedures, practices, and processes 
     that a person knowledgeable about the safe manufacturing, 
     processing, packing, transporting, or holding of food would 
     employ to prevent, eliminate, or reduce to an acceptable 
     level the hazards identified in the hazard analysis under 
     subsection (b)(3) and that are consistent with the current 
     scientific understanding of safe food manufacturing, 
     processing, packing, transporting, or holding at the time of 
     the analysis. Those procedures, practices, and processes 
     shall include the following, as appropriate to the type of 
     facility or food:
       ``(A) Sanitation procedures and practices.
       ``(B) Supervisor, manager, and employee hygiene training.
       ``(C) Process controls.
       ``(D) An allergen control program to minimize potential 
     allergic reactions in humans from ingestion of, or contact 
     with, human and animal food.
       ``(E) Good manufacturing practices.
       ``(F) Verification procedures, practices, and processes for 
     suppliers and incoming ingredients, which may include onsite 
     auditing of suppliers and testing of incoming ingredients.
       ``(G) Other procedures, practices, and processes 
     established by the Secretary under subsection (c)(2).
       ``(3) Hazard that is reasonably likely to occur.--A food 
     safety hazard that is reasonably likely to occur is one for 
     which a prudent person who, as applicable, manufactures, 
     processes, packs, transports, or holds food, would establish 
     controls because experience, illness data, scientific 
     reports, or other information provides a basis to conclude 
     that there is a reasonable possibility that the hazard will 
     occur in the type of food being manufactured, processed, 
     packed, transported, or held in the absence of those 
     controls.

     ``SEC. 418A. FOOD SAFETY PLAN.

       ``(a) In General.--Before a facility (as defined in section 
     418(i)) introduces or delivers for introduction into 
     interstate commerce any shipment of food, the owner, 
     operator, or agent of the facility shall develop and 
     implement a written food safety plan (in this section 
     referred to as a `food safety plan').
       ``(b) Contents.--The food safety plan shall include each of 
     the following elements:
       ``(1) The hazard analysis and any reanalysis conducted 
     under section 418.
       ``(2) A description of the preventive controls being 
     implemented under subsection 418(c), including those to 
     address hazards identified by the Secretary under subsection 
     418(b)(2).
       ``(3) A description of the procedures for monitoring 
     preventive controls.
       ``(4) A description of the procedures for taking corrective 
     actions.
       ``(5) A description of verification activities for the 
     preventive controls, including validation that the system of 
     controls, if implemented, will prevent, eliminate, or reduce 
     to an acceptable level the identified hazards, review of 
     monitoring and corrective action records, and procedures for 
     determining whether the system of controls as implemented is 
     effectively preventing, eliminating, or reducing to an 
     acceptable level the occurrence of identified hazards, 
     including the use of environmental and product testing 
     programs.
       ``(6) A description of the facility's recordkeeping 
     procedures.
       ``(7) A description of the facility's procedures for the 
     recall of articles of food, whether voluntarily or when 
     required under section 422.
       ``(8) A description of the facility's procedures for 
     tracing the distribution history of articles of food, whether 
     voluntarily or when required under section 414.
       ``(9) A description of the facility's procedures to ensure 
     a safe and secure supply chain for the ingredients or 
     components used in making the food manufactured, processed, 
     packed, transported, or held by such facility.
       ``(10) A description of the facility's procedures to 
     implement the science-based performance standards issued 
     under section 419.''.
       (3) Guidance or regulations.--
       (A) In general.--The Secretary of Health and Human Services 
     (referred to in this subsection as the ``Secretary'') shall 
     issue guidance or promulgate regulations 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, including verification and corrective 
     actions under sections 418 and 418A of the Federal Food, 
     Drug, and Cosmetic Act (as added by paragraph (2)).
       (B) International standards.--In issuing guidance or 
     regulations under subparagraph (A), the Secretary shall 
     review international hazard analysis and preventive control 
     standards that are in existence on the date of the enactment 
     of this Act and relevant to such guidelines or regulations to 
     ensure that the programs under sections 418 and 418A of the 
     Federal Food, Drug, and Cosmetic Act (as added by paragraph 
     (2)) are consistent, to the extent the Secretary determines 
     practicable and appropriate, with such standards.
       (C) Authority with respect to certain facilities.--The 
     Secretary may, by regulation, exempt or modify the 
     requirements for compliance under this section and the 
     amendments made by this section with respect to facilities 
     that are solely engaged in--
       (i) the production of food for animals other than man or 
     the storage of packaged foods that are not exposed to the 
     environment; or
       (ii) the storage of raw agricultural commodities for 
     further distribution or processing.
       (D) Small businesses.--The Secretary--
       (i) shall consider the impact of any guidance or 
     regulations under this section on small businesses; and
       (ii) shall issue guidance to assist small businesses in 
     complying with the requirements of this section and the 
     amendments made by this section.
       (4) No effect on existing haccp authorities.--Nothing in 
     this section or the amendments made by this section limits 
     the authority of the Secretary under the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health 
     Service Act (42 U.S.C. 201 et seq.), as in effect on the day 
     before the date of the enactment of this Act, to

[[Page 19696]]

     revise, issue, or enforce product- and category-specific 
     regulations, such as the Seafood Hazard Analysis Critical 
     Controls Points Program, the Juice Hazard Analysis Critical 
     Control Program, and the Thermally Processed Low-Acid Foods 
     Packaged in Hermetically Sealed Containers standards.
       (5) Consideration.--When implementing sections 418 and 418A 
     of the Federal Food, Drug, and Cosmetic Act, as added by 
     paragraph (2), the Secretary may take into account 
     differences between food intended for human consumption and 
     food intended for consumption by animals other than man.
       (6) Effective date.--
       (A) General rule.--The amendments made by subsection (a) 
     and this subsection shall take effect 18 months after the 
     date of the enactment of this Act.
       (B) Exceptions.--Notwithstanding subparagraph (A)--
       (i) the amendments made by subsection (a) and this 
     subsection shall apply to a small business (as defined by the 
     Secretary) after the date that is 2 years after the date of 
     the enactment of this Act; and
       (ii) the amendments made by subsection (a) and this 
     subsection shall apply to a very small business (as defined 
     by the Secretary) after the date that is 3 years after the 
     date of the enactment of this Act.
       (b) Finished Product Test Results From Category 1 
     Facilities.--
       (1) Adulteration.--Section 402 (21 U.S.C. 342), as amended 
     by subsection (a), is amended by adding at the end the 
     following:
       ``(k) If it is manufactured or processed in a facility that 
     is in violation of section 418B.''.
       (2) Requirements.--Chapter IV (21 U.S.C. 341 et seq.), as 
     amended, is further amended by adding at the end the 
     following:

     ``SEC. 418B. FINISHED PRODUCT TEST RESULTS FROM CATEGORY 1 
                   FACILITIES.

       ``(a) Authority.--Beginning on the date specified in 
     subsection (c), the Secretary shall require, after public 
     notice and an opportunity for comment, the submission to the 
     Secretary of finished product test results by the owner, 
     operator, or agent of each category 1 facility subject to 
     good manufacturing practices regulations documenting the 
     presence of contaminants in food in the possession or control 
     of such facility posing a risk of severe adverse health 
     consequences or death.
       ``(b) Considerations.--The Secretary shall require 
     submissions under subsection (a)--
       ``(1) as the Secretary determines feasible and appropriate; 
     and
       ``(2) taking into consideration available data and 
     information on the potential risks posed by the facility.
       ``(c) Beginning Date.--The date specified in this 
     subsection is the sooner of--
       ``(1) the date of completion of the pilot projects and 
     feasibility study under subsections (d) and (e); and
       ``(2) the date that is 2 years after the date of the 
     enactment of this section.
       ``(d) Pilot Projects.--The Secretary shall conduct 2 or 
     more pilot projects to evaluate the feasibility of collecting 
     positive finished product testing results from category 1 
     facilities, including the value and feasibility of reporting 
     corrective actions taken when positive finished product test 
     results are reported to the Secretary.
       ``(e) Feasibility Study.--The Secretary shall assess the 
     feasibility and benefits of the reporting by facilities 
     subject to good manufacturing practices regulations of 
     appropriate finished product testing results from category 1 
     facilities to the Secretary, including the extent to which 
     the collection of such finished product testing results will 
     help the Secretary assess the risk presented by a facility or 
     product category.
       ``(f) Limitations.--Nothing in this section shall be 
     construed--
       ``(1) to require the Secretary to mandate testing or 
     submission of test results that the Secretary determines 
     would not provide useful information in assessing the 
     potential risk presented by a facility or product category; 
     or
       ``(2) to limit the Secretary's authority under any other 
     provisions of law to require any person to provide access, or 
     to submit information or test results, to the Secretary, 
     including the ability of the Secretary to require field or 
     other testing and to obtain test results in the course of an 
     investigation of a potential food-borne illness or 
     contamination incident.
       ``(g) Definition.--In this section, the term `category 1 
     facility' means a category 1 facility within the meaning of 
     section 704(h).''.
       (c) Food Defense.--
       (1) Adulteration.--Section 402(j), as added by subsection 
     (a), is amended by striking ``and 418A'' and inserting ``, 
     418A, or 418C''.
       (2) Requirements.--Chapter IV (21 U.S.C. 341 et seq.), as 
     amended, is further amended by adding at the end the 
     following:

     ``SEC. 418C. FOOD DEFENSE.

       ``(a) In General.--Before a facility (as defined in section 
     418(i)) introduces or delivers for introduction into 
     interstate commerce any shipment of food, the owner, 
     operator, or agent of the facility shall develop and 
     implement a written food defense plan (in this section 
     referred to as a `food defense plan').
       ``(b) Contents.--The food defense plan shall include each 
     of the following elements:
       ``(1) A food defense assessment to identify conditions and 
     practices that may permit a hazard that may be intentionally 
     introduced, including by an act of terrorism. This assessment 
     shall evaluate processing security, cybersecurity, material 
     security (including ingredients, finished product, and 
     packaging), personnel security, storage security, shipping 
     and receiving security, and utility security.
       ``(2) A description of the preventive measures being 
     implemented as a result of such assessment to minimize the 
     risk of intentional contamination.
       ``(3) A description of the procedures to check for and 
     identify any circumstances in which the preventive measures 
     are not fully implemented or were ineffective.
       ``(4) A description of the procedures for taking corrective 
     actions to ensure that when preventive measures have not been 
     properly implemented or have been ineffective, appropriate 
     action is taken--
       ``(A) to reduce the likelihood of recurrence of the 
     failure; and
       ``(B) to assess the consequences of the failure.
       ``(5) A description of evaluation activities for the 
     preventive measures, including a review of records provided 
     for under paragraph (6) and procedures to periodically test 
     the effectiveness of the plan.
       ``(6) A description of the facility's record-keeping 
     procedures, including records documenting implementation of 
     the procedures under paragraphs (3), (4), and (5).
       ``(c) Hazard.--For purposes of this section, the term 
     `hazard that may be intentionally introduced, including by an 
     act of terrorism' means a hazard for which a prudent person 
     who, as applicable, manufactures, processes, packs, 
     transports, or holds food, would establish preventive 
     measures because the hazard has been identified by a food 
     defense assessment by application of--
       ``(1) a targeting assessment tool recommended by the 
     Secretary by guidance; or
       ``(2) a comparable targeting assessment tool.
       ``(d) Food Defense Hazards Identified by the Secretary.--
       ``(1) Establishment.--The Secretary may establish by 
     regulation or guidance preventive measures for specific 
     product types to prevent intentional contamination throughout 
     the supply chain. The owner, operator, or agent of a facility 
     shall implement any preventive measures identified by the 
     Secretary under this paragraph.
       ``(2) Alternative measures.--Such regulation or guidance 
     shall allow the owner, operator, or agent of a facility to 
     implement an alternative preventive measure to one 
     established by the Secretary, provided that, in response to a 
     request by the Secretary, the owner, operator, or agent can 
     present to the Secretary data or other information sufficient 
     to demonstrate that the alternative measure effectively 
     addresses the hazard.
       ``(e) Requirement To Reassess and Revise.--
       ``(1) Requirement.--The owner, operator, or agent of a 
     facility shall--
       ``(A) review the food defense assessment under subsection 
     (b)(1) for the facility and, as necessary, revise the food 
     defense assessment under subsection (b)(1) for the facility--
       ``(i) not less than every 2 years;
       ``(ii) if there is a change in the process or product that 
     could affect the food defense assessment; and
       ``(iii) if the Secretary determines that it is appropriate 
     to protect public health; and
       ``(B) whenever there is a change in the food defense 
     assessment, revise the preventive measures under subsection 
     (b)(2) for the facility as necessary to ensure that for all 
     hazards identified, the risk is minimized, or document the 
     basis for the conclusion that no such revision is needed.
       ``(2) Nondelegation.--Any revisions ordered by the 
     Secretary under this subsection shall be ordered by the 
     Secretary or an official designated by the Secretary. An 
     official may not be so designated unless the official is the 
     director of the district under this Act in which the facility 
     involved is located, or is an official senior to such 
     director.
       ``(f) Recordkeeping.--The owner, operator, or agent of a 
     facility shall maintain, for not less than 2 years, records 
     documenting the activities described in subsections (b) and 
     (e).
       ``(g) Access to Plan.--
       ``(1) On inspection.--An officer or employee of the 
     Secretary shall have access to the food defense plan of a 
     facility under section 414(a) only if the Secretary, through 
     an official who is the director of the district under this 
     Act in which the facility is located or an official who is 
     senior to such a director, provides notice under section 
     414(a)(1)(C).
       ``(2) Nondisclosure.--A food defense plan, and any 
     information derived from such a plan, shall be exempt from 
     disclosure under section 552 of title 5, United States 
     Code.''.
       (3) Prohibition.--Section 301(j) (21 U.S.C. 331(j)) is 
     amended by inserting after ``entitled to protection'' the 
     following: ``or a food defense plan, or any information 
     derived from such a plan, under section 418C''.

     SEC. 103. PERFORMANCE STANDARDS.

       (a) Adulterated Food.--Section 402 (21 U.S.C. 342), as 
     amended by section 102, is amended by adding at the end the 
     following:

[[Page 19697]]

       ``(l) If it has been manufactured, processed, packed, 
     transported, or held under conditions that do not meet the 
     standards issued under section 419.''.
       (b) Requirements.--Chapter IV (21 U.S.C. 341 et seq.), as 
     amended by section 102(b), is further amended by adding at 
     the end the following:

     ``SEC. 419. PERFORMANCE STANDARDS.

       ``(a) Performance Standards.--The Secretary shall, not less 
     frequently than every 2 years, review and evaluate 
     epidemiological data and other appropriate sources of 
     information, including research under section 123 of the Food 
     Safety Enhancement Act of 2009, to identify the most 
     significant food-borne contaminants and the most significant 
     resulting hazards. The Secretary shall issue, as soon as 
     practicable, through guidance or by regulation, science-based 
     performance standards (which may include action levels) 
     applicable to foods or food classes, as appropriate, to 
     minimize to an acceptable level, prevent, or eliminate the 
     occurrence of such hazards. Such standards shall be 
     applicable to foods and food classes. Notwithstanding the 
     timelines set forth in this paragraph, the Secretary shall as 
     appropriate establish such science-based performance 
     standards for identified contaminants as necessary to protect 
     the public health.
       ``(b) List of Contaminants.--Following each review under 
     subsection (a), the Secretary shall publish in the Federal 
     Register a list of food-borne contaminants that have the 
     greatest adverse impact on public health. In determining 
     whether a particular food-borne contaminant should be added 
     to such list, the Secretary shall consider the number and 
     severity of illnesses and the number of deaths associated 
     with the foods associated with such contaminants.
       ``(c) Sampling Program.--In conjunction with the 
     establishment of a performance standard under this section, 
     the Secretary may make recommendations to industry for 
     conducting product sampling.
       ``(d) Revocation by Secretary.--All performance standards 
     of the Food and Drug Administration applicable to foods or 
     food classes in effect on the date of the enactment of this 
     section, or issued under this section, shall remain in effect 
     until revised or revoked by the Secretary.''.
       (c) Report to Congress.--The Secretary of Health and Human 
     Services shall submit to the Congress by March 30th of the 
     year following each review under section 419 of the Federal 
     Food, Drug, and Cosmetic Act, as added by subsection (b), a 
     report on the results of such review and the Secretary's 
     plans to address the significant food-borne hazards 
     identified, or the basis for not addressing any significant 
     food-borne hazards identified, including any resource 
     limitations or limitations in data that preclude further 
     action at that time.

     SEC. 104. SAFETY STANDARDS FOR PRODUCE AND CERTAIN OTHER RAW 
                   AGRICULTURAL COMMODITIES.

       (a) Adulterated Food.--Section 402 (21 U.S.C. 342), as 
     amended by sections 102 and 103(a), is amended by adding at 
     the end the following:
       ``(m) If it has been grown, harvested, processed, packed, 
     sorted, transported, or held under conditions that do not 
     meet the standards established under section 419A.''.
       (b) Standards.--Chapter IV (21 U.S.C. 341 et seq.), as 
     amended by sections 102(b) and 103(b), is amended by adding 
     at the end the following:

     ``SEC. 419A. SAFETY STANDARDS FOR PRODUCE AND CERTAIN OTHER 
                   RAW AGRICULTURAL COMMODITIES.

       ``(a) Standards.--The Secretary, in coordination with the 
     Secretary of Agriculture, shall establish by regulation 
     scientific and risk-based food safety standards for the 
     growing, harvesting, processing, packing, sorting, 
     transporting, and holding of those types 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.
       ``(b) Contents.--The regulations under subsection (a)--
       ``(1) may set forth such procedures, processes, and 
     practices as the Secretary determines to be reasonably 
     necessary--
       ``(A) to prevent the introduction of known or reasonably 
     foreseeable biological, chemical, and physical hazards, 
     including hazards that occur naturally, may be 
     unintentionally introduced, or may be intentionally 
     introduced, including by acts of terrorism, into raw 
     agricultural commodities that are a fruit, vegetable, nut, or 
     fungus; and
       ``(B) to provide reasonable assurances that such commodity 
     is not adulterated under section 402;
       ``(2) may include, with respect to growing, harvesting, 
     processing, packing, sorting, transporting, and storage 
     operations, standards for safety as the Secretary determines 
     to be reasonably necessary;
       ``(3) may include standards addressing manure use, water 
     quality, employee hygiene, sanitation and animal control, and 
     temperature controls, as the Secretary determines to be 
     reasonably necessary;
       ``(4) may include standards for such other elements as the 
     Secretary determines necessary to carry out subsection (a);
       ``(5) shall provide a reasonable period of time for 
     compliance, taking into account the needs of small businesses 
     for additional time to comply;
       ``(6) may provide for coordination of education and 
     enforcement activities;
       ``(7) shall take into consideration, consistent with 
     ensuring enforceable public health protection, the impact on 
     small-scale and diversified farms, and on wildlife habitat, 
     conservation practices, watershed-protection efforts, and 
     organic production methods;
       ``(8) may provide for coordination of education and 
     training with other government agencies, universities, 
     private entities, and others with experience working directly 
     with farmers; and
       ``(9) may provide for recognition through guidance of other 
     existing publicly available procedures, processes, and 
     practices that the Secretary determines to be equivalent to 
     those established under paragraph (1).
       ``(c) Education and Compliance.--The Secretary shall 
     coordinate with the Secretary of Agriculture to provide for 
     effective implementation of education and compliance 
     activities. The Secretary may contract and coordinate with 
     the agency or department designated by the Governor of each 
     State to perform activities to ensure compliance with this 
     section.''.
       (c) Timing.--
       (1) Proposed rule.--Not later than 18 months after the date 
     of enactment of this Act, the Secretary of Health and Human 
     Services shall issue a proposed rule to carry out section 
     419A of the Federal Food, Drug, and Cosmetic Act, as added by 
     subsection (b).
       (2) Final rule.--Not later than 3 years after such date, 
     the Secretary of Health and Human Services shall issue a 
     final rule under such section.
       (d) No Effect on Existing HACCP Authorities.--Nothing in 
     this section or the amendments made by this section limits 
     the authority of the Secretary under the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health 
     Service Act (42 U.S.C. 201 et seq.), as in effect on the day 
     before the date of the enactment of this Act, to revise, 
     issue, or enforce product- and category-specific regulations, 
     such as the Seafood Hazard Analysis Critical Controls Points 
     Program, the Juice Hazard Analysis Critical Control Program, 
     and the Thermally Processed Low-Acid Foods Packaged in 
     Hermetically Sealed Containers standards.
       (e) Update Existing Guidance.--Not later than 1 year after 
     the date of the enactment of this Act, the Secretary of 
     Health and Human Services shall update the guidance document 
     entitled ``Guidance For Industry: Guide To Minimize Microbial 
     Food Safety Hazards For Fresh Fruits And Vegetables'' (issued 
     on October 26, 1998) in accordance with this section and the 
     amendments made by this section.

     SEC. 105. RISK-BASED INSPECTION SCHEDULE.

       (a) In General.--Section 704 (21 U.S.C. 374) is amended by 
     adding at the end the following:
       ``(h)(1) Each facility registered under section 415 shall 
     be inspected--
       ``(A)(i) by one or more officers duly designated under 
     section 702 or other statutory authority by the Secretary;
       ``(ii) for domestic facilities, by a Federal, State, or 
     local official recognized by the Secretary under paragraph 
     (2); or
       ``(iii) for foreign facilities, by an agency or a 
     representative of a country that is recognized by the 
     Secretary under paragraph (2); and
       ``(B) at a frequency determined pursuant to a risk-based 
     schedule.
       ``(2) For purposes of paragraph (1)(A), the Secretary--
       ``(A) may recognize Federal, State, and local officials and 
     agencies and representatives of foreign countries as meeting 
     standards established by the Secretary for conducting 
     inspections under this Act; and
       ``(B) may limit such recognition to inspections of specific 
     commodities or food types.
       ``(3) The risk-based schedule under paragraph (1)(B) shall 
     be implemented beginning not later than 18 months after the 
     date of the enactment of this subsection.
       ``(4) Such risk-based schedule shall provide for a 
     frequency of inspections commensurate with the risk presented 
     by the facility and shall be based on the following 
     categories and inspection frequencies:
       ``(A) Category 1.--A category 1 food facility is a high-
     risk facility that manufactures or processes food. The 
     Secretary shall randomly inspect a category 1 food facility 
     at least every 6 to 12 months.
       ``(B) Category 2.--A category 2 food facility is a low-risk 
     facility that manufactures or processes food or a facility 
     that packs or labels food. The Secretary shall randomly 
     inspect a category 2 facility at least every 18 months to 3 
     years.
       ``(C) Category 3.--A category 3 food facility is a facility 
     that holds food. The Secretary shall randomly inspect a 
     category 3 facility at least every 5 years.
       ``(5) The Secretary--
       ``(A) may, by guidance, modify the types of food facilities 
     within a category under paragraph (4);

[[Page 19698]]

       ``(B) may alter the inspection frequencies specified in 
     paragraph (4) based on the need to respond to food-borne 
     illness outbreaks and food recalls; and
       ``(C) may inspect a facility more frequently than the 
     inspection frequency provided by paragraph (4);
       ``(D) beginning 6 months after submitting the report 
     required by section 105(b)(2) of the Food Safety Enhancement 
     Act of 2009, may--
       ``(i) publish in the Federal Register adjustments to the 
     inspection frequencies specified in subparagraphs (B) and (C) 
     of paragraph (4) for category 2 and category 3 food 
     facilities, which adjustments shall be in accordance with the 
     Secretary's recommendations in such report; and
       ``(ii) after such publication, implement the adjustments; 
     and
       ``(E) except as provided in subparagraphs (B) and (C), may 
     not alter the inspection frequency specified in paragraph 
     (4)(A) for category 1 food facilities.
       ``(6) In determining the appropriate frequency of 
     inspection, the Secretary shall consider--
       ``(A) the type of food manufactured, processed, packed, or 
     held at the facility;
       ``(B) the compliance history of the facility;
       ``(C) whether the facility importing or offering for import 
     into the United States food is certified by a qualified 
     certifying entity in accordance with section 801(q); and
       ``(D) such other factors as the Secretary determines by 
     guidance to be relevant to assessing the risk presented by 
     the facility.
       ``(7) Before establishing or modifying the categorization 
     under paragraph (4) of any food facility or type of food 
     facility, the Secretary shall publish a notice of the 
     proposed categorization in the Federal Register and provide a 
     period of not less than 60 days for public comment on the 
     proposed categorization.''.
       (b) Reports on Risk-Based Inspections of Food Facilities.--
       (1) Annual report.--Not later than December 31 of each 
     year, the Secretary of Health and Human Services shall submit 
     a report to the Committee on Energy and Commerce of the House 
     of Representatives and the Committee on Health, Education, 
     Labor, and Pensions of the Senate describing--
       (A) the number of foreign and domestic facilities, by risk 
     category, inspected under the risk-based inspection schedule 
     established under section 704(h) of the Federal Food, Drug, 
     and Cosmetic Act, as added by subsection (a), in the 
     preceding fiscal year; and
       (B) the costs of implementing the risk-based inspection 
     schedule for the preceding 12 months.
       (2) Third-year report.--Not later than 3 years after the 
     date of the enactment of this Act, the Secretary of Health 
     and Human Services shall submit a report to the Committee on 
     Energy and Commerce of the House of Representatives and the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate describing recommendations on the risk-based 
     inspection schedule under section 704(h) of the Federal Food, 
     Drug, and Cosmetic Act, as added by subsection (a), including 
     recommendations for adjustments to the timing of the schedule 
     and other ways to improve the risk-based allocation of 
     resources by the Food and Drug Administration. In making such 
     recommendations, the Secretary shall consider--
       (A) the nature of the food products being processed, 
     stored, or transported;
       (B) the manner in which food products are processed, 
     stored, or transported;
       (C) the inherent likelihood that the products will 
     contribute to the risk of food-borne illness;
       (D) the best available evidence concerning reported 
     illnesses associated with the foods processed, stored, held, 
     or transported in the category of facilities; and
       (E) the overall record of compliance with food safety law 
     among facilities in the category, including compliance with 
     applicable performance standards and the frequency of 
     recalls.

     SEC. 106. ACCESS TO RECORDS.

       (a) Records Access.--Subsection (a) of section 414 (21 
     U.S.C. 350c) is amended to read as follows:
       ``(a) Records Access.--
       ``(1) Records access during an inspection.--
       ``(A) In general.--Except as provided in paragraph (3), 
     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 shall, at 
     the request of an officer or employee duly designated by the 
     Secretary, permit such officer or employee, upon presentation 
     of appropriate credentials, at reasonable times and within 
     reasonable limits and in a reasonable manner, to have access 
     to and copy all records relating to such article bearing on 
     whether the food may be adulterated, misbranded, or otherwise 
     in violation of this Act, including all records collected or 
     developed to comply with section 418 or 418A.
       ``(B) Scope of records.--The requirement under subparagraph 
     (A) applies to all records relating to the manufacture, 
     processing, packing, transporting, distribution, receipt, 
     holding, or importation of such article maintained by or on 
     behalf of such person in any format (including paper and 
     electronic formats) and at any location.
       ``(C) Immediate availability with notice.--Records not 
     required to be made available immediately on commencement of 
     an inspection under subparagraph (A) shall nonetheless be 
     made available immediately on commencement of such an 
     inspection if, by a reasonable time before such inspection, 
     the Secretary by letter to the person identifies the records 
     to be made available during such inspection. Nothing in this 
     subparagraph shall be construed as permitting a person to 
     refuse to produce records required under and in accordance 
     with subparagraph (A) due to failure of the Secretary to 
     provide notice under this paragraph.
       ``(2) Additional authorities to access records remotely; 
     submission of records to the secretary.--
       ``(A) Remote access in emergencies.--If the Secretary has a 
     reasonable belief that an article of food presents a threat 
     of serious adverse health consequences or death to humans or 
     animals, the Secretary may require each person who 
     manufactures, processes, packs, transports, distributes, 
     receives, holds, or imports such article of food, or any 
     article of food that the Secretary determines may be affected 
     in a similar manner, to submit to the Secretary all records 
     reasonably related to such article of food as soon as is 
     reasonably practicable, after receiving written notice 
     (including by notice served personally and outside normal 
     business hours to an agent identified under subparagraph (E) 
     or (F) of section 415(a)(2)) of such requirement.
       ``(B) Remote access to records related to food safety 
     plans.--With respect to a facility subject to section 418 and 
     418A, the Secretary may require the owner, operator, or agent 
     of such facility to submit to the Secretary, as soon as 
     reasonably practicable after receiving written notice of such 
     requirement, the food safety plan, supporting information 
     relied on by the facility to select the preventive controls 
     to include in its food safety plan, and documentation of 
     corrective actions, if any, taken under section 418(e) within 
     the preceding 2 years.
       ``(C) Electronic submission.--If the records required to be 
     submitted to the Secretary under subparagraph (A) or (B) are 
     available in electronic format, such records shall be 
     submitted electronically unless the Secretary specifies 
     otherwise in the notice under such subparagraph.
       ``(3) Limited records access on farms.--
       ``(A) Application.--Paragraphs (1) and (2) do not apply 
     with respect to farms, except as provided in this paragraph.
       ``(B) In general.--A person who is the owner, operator, or 
     agent of a farm (as defined in section 415) shall, at the 
     request of an officer or employee duly designated by the 
     Secretary, permit such officer or employee, at reasonable 
     times and within reasonable limits and in a reasonable 
     manner, to have access to and copy all records relating to an 
     article of food produced, manufactured, processed, packed, or 
     held on such farm as specified in paragraphs (1) and (2) if--
       ``(i) such article of food is a fruit, vegetable, nut, or 
     fungus that is the subject of a standard issued under section 
     419A; or
       ``(ii) such article of food is the subject of an active 
     investigation by the Secretary of a food borne illness 
     outbreak and is not a grain or similarly handled commodity as 
     defined in subsection (c)(4)(C)(ii).
       ``(C) Records access on farms prior to rulemaking.--
       ``(i) In general.--As soon as practicable after the 
     enactment of this paragraph, the Secretary shall, in 
     coordination with the Secretary of Agriculture, identify 1 or 
     more fruits, vegetables, nuts, or fungi for which the 
     Secretary shall have access to records on farms. Such 
     identification shall be made by guidance, following notice 
     and public comment.
       ``(ii) Identification of raw agricultural commodities.--The 
     Secretary, in coordination with the Secretary of Agriculture, 
     shall make the identification in clause (i), based on any 
     past food borne illness outbreak attributed to the fruit, 
     vegetable, nut, or fungus--

       ``(I) in the United States and the risk that a similar 
     outbreak could occur again in the United States; or
       ``(II) in a foreign country and the risk that a similar 
     outbreak could occur in the United States.

       ``(iii) Duration of authority.--The authority to have 
     access to records for a fruit, vegetable, nut, or fungus 
     under this subparagraph shall begin on the date on which the 
     Secretary identifies such fruit, vegetable, nut, or fungus 
     under clause (i) and shall terminate on the effective date of 
     a final rule issued by the Secretary under section 419A.
       ``(iv) Scope of records access.--In the guidance under 
     clause (i), and for the period specified in clause (iii), the 
     Secretary, in coordination with the Secretary of Agriculture, 
     shall determine the scope of the records to which the 
     Secretary shall have access under this subparagraph.
       ``(D) Rule of construction.--This paragraph shall not be 
     construed as limiting access to any records authorized 
     under--
       ``(i) this Act or the Public Health Service Act, as in 
     effect on the day before the date of the enactment of this 
     paragraph; or

[[Page 19699]]

       ``(ii) regulations issued under such Acts on any date 
     before the date of the enactment of this paragraph.''.
       (b) Regulations Concerning Recordkeeping.--
       (1) Amendment.--Subsection (b) of section 414 (21 U.S.C. 
     350c) is amended to read as follows:
       ``(b) Regulations Concerning Recordkeeping.--The Secretary, 
     in consultation and coordination, as appropriate, with other 
     Federal departments and agencies with responsibilities for 
     regulating food safety, shall by regulation establish 
     requirements regarding the establishment and maintenance, for 
     not longer than 3 years, of records by persons who 
     manufacture, process, pack, transport, distribute, receive, 
     or hold food in the United States or for import into the 
     United States. The Secretary shall take into account the size 
     of a business in promulgating regulations under this 
     subsection. The Secretary shall consult with the Secretary of 
     Agriculture in promulgating regulations with respect to farms 
     under this subsection and shall take into account the nature 
     of and impact on farms in promulgating such regulations. The 
     only distribution records which may be required of 
     restaurants under this subsection are those showing the 
     restaurant's suppliers and subsequent distribution other than 
     to consumers.''.
       (2) Application.--The Secretary of Health and Human 
     Services shall promulgate revised regulations to implement 
     section 414(b) of the Federal Food, Drug, and Cosmetic Act, 
     as amended by this subsection. Section 414(b) of the Federal 
     Food, Drug, and Cosmetic Act and regulations thereunder, as 
     in effect on the day before the date of the enactment of this 
     Act, shall apply to acts and omissions occurring before the 
     effective date of such revised regulations.
       (c) Conforming Amendments.--Section 704(a)(1) (21 U.S.C. 
     374(a)(1)) is amended--
       (1) in the second sentence--
       (A) by striking ``(excluding farms or restaurants)'' and 
     inserting ``(excluding farms, except as provided in section 
     414(a)(3))'';
       (B) by inserting ``receives,'' before ``holds'';
       (C) by striking ``described in section 414'' and inserting 
     ``described in or required under section 414''; and
       (D) by striking ``when the Secretary has a reasonable 
     belief that an article of food is adulterated and presents a 
     threat of serious adverse health consequences or death to 
     humans or animals'' and inserting ``bearing on whether such 
     food is adulterated, misbranded, or otherwise in violation of 
     this Act, including all records collected or developed to 
     comply with section 418 or 418A''; and
       (2) in the fourth sentence--
       (A) by striking ``the preceding sentence'' and inserting 
     ``either of the preceding two sentences''; and
       (B) by inserting ``recipes for food,'' before ``financial 
     data,''.

     SEC. 107. TRACEABILITY OF FOOD.

       (a) Prohibited Act.--Section 301(e) (21 U.S.C. 331(e)) is 
     amended by inserting ``, the violation of any requirement of 
     the food tracing system under section 414(c);'' before ``or 
     the refusal to permit access to or verification or copying of 
     any such required record''.
       (b) Imports.--Section 801(a) (21 U.S.C. 381(a)) is amended 
     by inserting ``or (4) the requirements of section 414 have 
     not been complied with regarding such article,'' before 
     ``then such article shall be refused admission''.
       (c) Product Tracing for Food.--Section 414 (21 U.S.C. 
     350c), as amended by section 106, is amended--
       (1) by redesignating subsections (c) and (d) as subsections 
     (d) and (e), respectively; and
       (2) by inserting after subsection (b) the following:
       ``(c) Tracing System for Food.--
       ``(1) In general.--The Secretary shall by regulation 
     establish a tracing system for food that is located in the 
     United States or is for import into the United States.
       ``(2) Information gathering.--
       ``(A) Tracing technologies.--Before issuing a proposed 
     regulation under this subsection, the Secretary shall--
       ``(i) identify technologies and methodologies for tracing 
     the distribution history of a food that are, or may be, used 
     by members of different sectors of the food industry, 
     including technologies and methodologies to enable each 
     person who produces, manufactures, processes, pack, 
     transports, or holds a food to--

       ``(I) maintain the full pedigree of the origin and previous 
     distribution history of the food;
       ``(II) link that history with the subsequent distribution 
     of the food;
       ``(III) establish and maintain a system for tracing the 
     food that is interoperable with the systems established and 
     maintained by other such persons; and
       ``(IV) use a unique identifier for each facility owned or 
     operated by such person for such purpose, as specified under 
     section 1011; and

       ``(ii) to the extent practicable, assess--

       ``(I) the costs and benefits associated with the adoption 
     and use of such technologies;
       ``(II) the feasibility of such technologies for different 
     sectors of the food industry; and
       ``(III) whether such technologies are compatible with the 
     requirements of this subsection.

       ``(B) Public meetings.--Before issuing a proposed 
     regulation under this subsection, the Secretary shall conduct 
     not less than 2 public meetings in diverse geographical areas 
     of the United States to provide persons in different regions 
     an opportunity to provide input and information to the 
     Secretary.
       ``(C) Pilot projects.--Before issuing a proposed regulation 
     under this subsection, the Secretary shall conduct 1 or more 
     pilot projects in coordination with 1 or more sectors of the 
     food industry to explore and evaluate tracing systems for 
     food. The Secretary shall coordinate with the Secretary of 
     Agriculture in conducting pilot projects with respect to 
     farms under this subsection.
       ``(3) Regulation.--
       ``(A) In general.--Taking into account information obtained 
     through information gathering under paragraph (2), the 
     Secretary shall issue regulations establishing a tracing 
     system that enables the Secretary to identify each person who 
     grows, produces, manufactures, processes, packs, transports, 
     holds, or sells such food in as short a timeframe as 
     practicable but no longer than 2 business days.
       ``(B) Scope of regulation.--The Secretary may include in 
     the regulations establishing a tracing system--
       ``(i) the establishment and maintenance of lot numbers;
       ``(ii) a standardized format for pedigree information; and
       ``(iii) the use of a common nomenclature for food.
       ``(C) Coordination regarding farm impact.--In issuing 
     regulations under this paragraph that will impact farms, the 
     Secretary--
       ``(i) shall coordinate with the Secretary of Agriculture; 
     and
       ``(ii) take into account the nature of the impact of the 
     regulations on farms.
       ``(4) Exemptions and limitations.--
       ``(A) Direct sales by farms.--Food is exempt from the 
     requirements of this subsection if such food is--
       ``(i) produced on a farm; and
       ``(ii) sold by the owner, operator, or agent in charge of 
     such farm directly to a consumer or to a restaurant or 
     grocery store.
       ``(B) Fishing vessels.--Food is exempt from the 
     requirements of this subsection if such food is produced 
     through the use of a fishing vessel as defined in section 
     3(18) of the Magnuson-Stevens Fishery Conservation and 
     Management Act until such time as the food is sold by the 
     owner, operator, or agent in charge of such fishing vessel.
       ``(C) Grains and similarly handled commodities.--
       ``(i) Limitation on extent of tracing.--In addition to the 
     exemption under subparagraph (A), any tracing system 
     established under this subsection with regard to any grain or 
     similarly handled commodity shall be limited to enabling the 
     Secretary to identify persons who received, processed, 
     packed, transported, distributed, held, or sold the grain or 
     similarly handled commodity from the initial warehouse 
     operator that held the grain or similarly handled commodity 
     for any period of time to the ultimate consumer.
       ``(ii) Definitions.--In this subparagraph:

       ``(I) The term `grain or similarly handled commodity' means 
     wheat, corn, grain sorghum, barley, oats, rice, wild rice, 
     rye, soybeans, legumes, sugar cane, sugar beets, sunflower 
     seed, rapeseed, canola, safflower, flaxseed, mustard seed, 
     crambe, sesame seed, camelina, cottonseed, cocoa beans, grass 
     hay, and honey. The term may include any other commodity as 
     determined by the Secretary in coordination with the 
     Secretary of Agriculture.
       ``(II) The term `warehouse operator' has the meaning given 
     that term in section 2 of the United States Warehouse Act (7 
     U.S.C. 241), except that the term also includes any person or 
     entity that handles or stores agricultural products for other 
     persons or entities or, in the case of a cooperative, handles 
     or stores agricultural products for its members, as 
     determined by the Secretary in coordination with the 
     Secretary of Agriculture.

       ``(D) Exemption of other foods.--The Secretary may by 
     notice in the Federal Register exempt a food or a type of 
     facility, farm, or restaurant from, or modify the 
     requirements with respect to, the requirements of this 
     subsection if the Secretary determines that a tracing system 
     for such food or type of facility, farm, or restaurant is not 
     necessary to protect the public health.
       ``(E) Recordkeeping regarding previous sources and 
     subsequent recipients.--For a food or person covered by a 
     limitation or exemption under subparagraph (B), (C), or (D), 
     the Secretary shall require each person who produces, 
     receives, manufactures, processes, packs, transports, 
     distributes, or holds such food to maintain records to 
     identify the immediate previous sources of such food and its 
     ingredients and the immediate subsequent recipients of such 
     food.
       ``(F) Recordkeeping by restaurants and grocery stores.--For 
     a food covered by an exemption under subparagraph (A), 
     restaurants and grocery stores shall keep records documenting 
     the farm that was the source of the food.
       ``(G) Recordkeeping by farms.--For a food covered by an 
     exemption under subparagraph

[[Page 19700]]

     (A), farms shall keep records, in electronic or non-
     electronic format, for at least 6 months documenting the 
     restaurant or grocery store to which the food was sold.''.

     SEC. 108. REINSPECTION AND FOOD RECALL FEES APPLICABLE TO 
                   FACILITIES.

       (a) In General.--Part 6 of subchapter C of chapter VII (21 
     U.S.C. 371 et seq.), as added by section 101(c), is amended 
     by adding at the end the following:

     ``SEC. 743A. REINSPECTION AND FOOD RECALL FEES APPLICABLE TO 
                   FACILITIES.

       ``(a) In General.--The Secretary shall assess and collect 
     fees from each entity in a fiscal year--
       ``(1) that--
       ``(A) during such fiscal year commits a violation of any 
     requirement of this Act relating to food, including any such 
     requirement relating to good manufacturing practices; and
       ``(B) because of such violation, undergoes additional 
     inspection by the Food and Drug Administration; or
       ``(2) during such fiscal year is subject to a food recall.
       ``(b) Amount of Fees.--The Secretary shall set the amount 
     of the fees under this section to fully cover the costs of--
       ``(1) in the case of fees collected under subsection 
     (a)(1), conducting the additional inspections referred to in 
     such subsection; and
       ``(2) in the case of fees collected under subsection 
     (a)(2), conducting food recall activities, including 
     technical assistance, follow-up effectiveness checks, and 
     public notifications, during the fiscal year involved.
       ``(c) Crediting and Availability of Fees.--
       ``(1) In general.--Fees authorized under subsection (a) 
     shall be collected and available for obligation only to the 
     extent and in the amount provided in advance in 
     appropriations Acts. Such fees are authorized to remain 
     available until expended. Such sums as may be necessary may 
     be transferred from the Food and Drug Administration salaries 
     and expenses appropriation account without fiscal year 
     limitation to such appropriation account for salaries and 
     expenses with such fiscal year limitation.
       ``(2) Collections and appropriations acts.--The fees 
     authorized by this section--
       ``(A) shall be retained in each fiscal year in an amount 
     not to exceed the amount specified in appropriation Acts, or 
     otherwise made available for obligation, for such fiscal 
     year; and
       ``(B) shall only be collected and available to defray the 
     costs referred to in subsection (b).
       ``(3) Authorization of appropriations.--For each of fiscal 
     years 2010 through 2014, there are authorized to be 
     appropriated for fees under this section such sums as may be 
     necessary.
       ``(d) Waiver.--The Secretary shall waive and, if 
     applicable, refund the amount of any fee collected under this 
     section from an entity as a result of a food recall that the 
     Secretary determines was inappropriately ordered.''.
       (b) Effective Date.--The amendment made by subsection (a) 
     shall apply to additional inspections and food recall 
     activities occurring after the date of the enactment of this 
     Act.

     SEC. 109. CERTIFICATION AND ACCREDITATION.

       (a) Misbranding.--
       (1) In general.--Section 403 (21 U.S.C. 343), as amended by 
     section 101(a), is amended by adding at the end the 
     following:
       ``(aa) If it is part of a shipment offered for import into 
     the United States and such shipment is in violation of 
     section 801(q) (requiring a certification of compliance for 
     certain food shipments).''.
       (2) Effective date.--The amendment made by paragraph (1) 
     shall apply to shipments offered for import on or after the 
     date that is 3 years after the date of the enactment of this 
     Act.
       (b) Certification of Compliance for Imports.--Chapter VIII 
     (21 U.S.C. 381 et seq.) is amended--
       (1) in section 801(a), as amended by section 107(b), by 
     inserting after the third sentence the following: ``If such 
     article is food being imported or offered for import into the 
     United States and is not in compliance with the requirement 
     of subsection (q) (relating to certifications of compliance 
     with this Act), then such article shall be refused 
     admission.'';
       (2) in the second sentence of section 801(b), by striking 
     ``the fourth sentence'' and inserting ``the fifth sentence''; 
     and
       (3) by adding at the end of section 801 the following:
       ``(q) Certifications Concerning Imported Articles.--
       ``(1) In general.--
       ``(A) Requirement.--The Secretary may require, as an 
     additional condition of granting admission to an article of 
     food being imported or offered for import into the United 
     States, that a qualified certifying entity provide a 
     certification that the article complies with requirements of 
     this Act as specified by the Secretary if--
       ``(i) for food imported from a particular country, 
     territory, or region, the Secretary finds, based on 
     scientific, risk-based evidence, that the government controls 
     in such country, territory, or region are inadequate to 
     ensure that the article is safe and that certification would 
     assist the Secretary in determining whether to refuse to 
     admit such article under subsection (a);
       ``(ii) for a type of food for which there is scientific 
     evidence that there is a particular risk associated with the 
     food that presents a threat of serious adverse health 
     consequences or death, the Secretary finds that certification 
     would assist the Secretary in determining whether to refuse 
     to admit such article under subsection (a); or
       ``(iii) for an article imported from a particular country 
     or territory, there is an agreement between the Secretary and 
     the government of such country or territory providing for 
     such certification.
       ``(B) Form of certification.--A certification under 
     subparagraph (A) may take the form of a statement that the 
     article or the facility or farm that manufactured, processed, 
     packed, held, grew, harvested, sorted, or transported the 
     article, as the case may be, complies with requirements of 
     this Act as specified by the Secretary, or any other form as 
     the Secretary may specify, including a listing of certified 
     facilities or other entities. The Secretary may require that 
     the certification include additional information regarding 
     compliance.
       ``(C) Adequate government controls.--
       ``(i) Process.--Before requiring a certification under 
     clause (ii) of subparagraph (A) with respect to a food, the 
     Secretary shall establish a process by which a country or 
     territory may demonstrate that its government controls are 
     adequate to ensure that such food exported from its territory 
     to the United States is safe.
       ``(ii) Demonstration.--The Secretary shall not require a 
     certification under clause (ii) of subparagraph (A) for a 
     food exported from a country or territory, if that country or 
     territory has demonstrated, pursuant to the process 
     established by the Secretary under clause (i), that its 
     government controls are adequate to ensure that such food 
     exported from its territory to the United States is safe.
       ``(D) Notice of cancellation or suspension of 
     certification.--As a condition on acceptance of 
     certifications from a qualified certifying entity, the 
     Secretary shall require the qualified certifying entity to 
     notify the Secretary whenever the qualified certifying entity 
     cancels or suspends the certification of any facility or 
     other entity included in a listing under subparagraph (B).
       ``(E) Consistency with international obligations.--The 
     Secretary shall apply this paragraph consistently with United 
     States obligations under international agreements.
       ``(2) Qualified certifying entity.--For purposes of this 
     subsection, the term `qualified certifying entity' means--
       ``(A) an agency or a representative of the government of 
     the country from which the article originated, as designated 
     by such government or the Secretary; or
       ``(B) an individual or entity determined by the Secretary 
     or an accredited body recognized by the Secretary to be 
     qualified to provide a certification under paragraph (1).
       ``(3) No conflicts of interest.--
       ``(A) In general.--The Secretary shall issue regulations to 
     ensure that any qualified certifying entity and its auditors 
     are free from conflicts of interest. In issuing these 
     regulations, the Secretary may rely on or incorporate 
     international certification standards.
       ``(B) Regulations.--Such regulations shall require that--
       ``(i) the qualified certifying entity shall have a 
     committee or management structure for safeguarding 
     impartiality;
       ``(ii) conflict of interest policies for a qualified 
     certifying entity and auditors acting for the qualified 
     certifying entity shall be written;
       ``(iii) the qualified certifying entity shall not be owned, 
     operated, or controlled by a producer, manufacturer, 
     processor, packer, holder, supplier, or vendor of any article 
     of the type it certifies;
       ``(iv) the qualified certifying entity shall not have any 
     ownership or financial interest in any product, producer, 
     manufacturer, processor, packer, holder, supplier or vendor 
     of the type it certifies;
       ``(v) no auditor acting for the qualified certifying entity 
     (or spouse or minor children) shall have any significant 
     ownership or other financial interest regarding any product 
     of the type it certifies;
       ``(vi) the qualified certifying entity shall--

       ``(I) obtain and maintain annual declarations from all 
     personnel who may be directly involved in the performance of 
     audits as to whether they do or do not have direct financial 
     interests in any producer, manufacturer, processor, packer, 
     holder, supplier, or vendor of foods, and a list of any such 
     companies in which they do have financial interests or by 
     which they were employed in the past year; and
       ``(II) when an auditor is assigned to audit a facility, 
     require that individual to affirm that he or she has no 
     financial interest in the company that owns or operates that 
     facility and was not employed by that facility in the 
     previous year;

       ``(vii) neither the qualified certifying entity nor any of 
     its auditors acting for the qualified certifying entity shall 
     participate in the production, manufacture, processing, 
     packing, holding, promotion, or sale of any product of the 
     type it certifies;

[[Page 19701]]

       ``(viii) neither the qualified certifying entity nor any of 
     its auditors shall provide consultative services to any 
     facility certified by the qualified certifying entity, or the 
     owner, operator, or agent in charge of such a facility, 
     unless the qualified certifying entity has procedures in 
     place, approved by the Secretary, to ensure separation of 
     functions between auditors providing consultative services 
     and auditors providing certification services under this 
     subsection;
       ``(ix) no auditors acting for the qualified certifying 
     entity shall participate in an audit of a facility they were 
     employed by within the last 12 months;
       ``(x) fees charged or accepted shall not be contingent or 
     based upon the report made by the qualified certifying entity 
     or any personnel involved in the audit process;
       ``(xi) neither the qualified certifying entity nor any of 
     its auditors shall accept anything of value from anyone in 
     connection with the facility being audited other than the 
     audit fee;
       ``(xii) the qualified certifying entity shall not be owned, 
     operated, or controlled by a trade association whose member 
     companies operate facilities that it certifies;
       ``(xiii) the qualified certifying entity and its auditors 
     shall be free from any other conflicts of interest that 
     threaten impartiality;
       ``(xiv) the qualified certifying entity and its auditors 
     shall sign a statement attesting to compliance with the 
     conflict of interests requirements under this paragraph; and
       ``(xv) the qualified certifying entity shall ensure that 
     any subcontractors that might be used (such as laboratories 
     and sampling services) provide similar assurances, except 
     that it shall not be a violation of this subsection to the 
     extent such subcontractors perform additional nutritional 
     testing services unrelated to the testing under this 
     subsection.
       ``(C) Definitions.--In this paragraph:
       ``(i) The term `anything of value' includes gifts, 
     gratuities, reimbursement of non-audit-related expenses, 
     entertainment, loans, or any other form of compensation in 
     cash or in kind.
       ``(ii) The term `direct financial interest' does not 
     include any ownership of mutual funds that have a financial 
     interest in a company.
       ``(4) Renewal and refusal of certifications.--The Secretary 
     shall--
       ``(A) require that, to the extent applicable, any 
     certification provided by a qualified certifying entity be 
     renewed by such entity at such times as the Secretary 
     determines appropriate; and
       ``(B) refuse to accept any certification if the Secretary 
     determines that such certification is no longer valid or 
     reliable.
       ``(5) On-site audits.--In evaluating whether an 
     accreditation body meets, or continues to meet, the standards 
     for recognition under this subsection, or whether to accept 
     certifications from a qualified certifying entity, the 
     Secretary may--
       ``(A) observe on-site audits of qualified certifying 
     entities by such accreditation body; or
       ``(B) for any facility that is certified by a qualified 
     certifying entity, upon request of an officer or employee 
     designated by the Secretary and upon presentation of 
     appropriate credentials, at reasonable times and within 
     reasonable limits and in a reasonable manner, conduct an on-
     site audit of the facility, which shall include access to, 
     and copying and verification of, any related records.
       ``(6) Electronic submission.--The Secretary shall provide, 
     in coordination with the Commissioner responsible for Customs 
     and Border Protection, for the electronic submission of 
     certifications under this subsection.
       ``(7) No limit on authority.--This subsection shall not be 
     construed to limit the authority of the Secretary to conduct 
     random inspections of imported articles or facilities of 
     importers, issue import alerts for detention without physical 
     examination, require submission to the Secretary of 
     documentation or other information about an article imported 
     or offered for import, or to take such other steps as the 
     Secretary deems appropriate to determine the admissibility of 
     imported articles.''.

     SEC. 110. TESTING BY ACCREDITED LABORATORIES.

       (a) Prohibited Act.--Section 301 (21 U.S.C. 331) is amended 
     by adding at the end the following:
       ``(uu) The violation of any requirement of section 714 
     (relating to testing by accredited laboratories).''.
       (b) Laboratory Accreditation.--Subchapter A of chapter VII 
     (21 U.S.C. 371 et seq.) is amended by adding at the end the 
     following:

     ``SEC. 714. TESTING BY ACCREDITED LABORATORIES.

       ``(a) In General.--
       ``(1) Requirement.--Whenever analytical testing of an 
     article of food is conducted as part of testimony for the 
     purposes of section 801(a), or for such other purposes as the 
     Secretary deems appropriate through regulation or guidance, 
     such testing shall be conducted by a laboratory that--
       ``(A) is accredited, for the analytical method used, by a 
     laboratory accreditation body that has been recognized by the 
     Secretary; and
       ``(B) samples such article with adequate controls for 
     ensuring the integrity of the samples analyzed.
       ``(2) Independence of laboratory.--
       ``(A) Certain tests.--Tests required for purposes of 
     section 801(a) or in response to a finding of noncompliance 
     by the Secretary shall be conducted by a laboratory 
     independent of the person on whose behalf such testing is 
     conducted and analyzed.
       ``(B) Certain products.--The Secretary may require that 
     testing for certain products under paragraph (1) be conducted 
     by a laboratory independent of the person on whose behalf 
     such testing is conducted.
       ``(b) Recognition of Laboratory Accreditation Bodies.--The 
     Secretary shall establish and implement a program for the 
     recognition, based on standards the Secretary deems 
     appropriate, of laboratory accreditation bodies that accredit 
     laboratories to perform analytical testing for the purposes 
     of this section. The Secretary shall issue regulations or 
     guidance to implement this program.
       ``(c) Onsite Audits.--In evaluating whether an 
     accreditation body meets, or continues to meet, the standards 
     for recognition under subsection (b), the Secretary may--
       ``(1) observe onsite audits of laboratories by such 
     accreditation bodies; or
       ``(2) for any laboratory that is accredited by such 
     accreditation body under this section, upon request of an 
     officer or employee designated by the Secretary and upon 
     presentation of appropriate credentials, at reasonable times 
     and within reasonable limits and in a reasonable manner, 
     conduct an onsite audit of the laboratory, which shall 
     include access to, and copying and verification of, any 
     related records.
       ``(d) Publication of List of Recognized Accreditation 
     Bodies.--The Secretary shall publish and maintain on the 
     public Web site of the Food and Drug Administration a list of 
     accreditation bodies recognized by the Secretary under 
     subsection (b).
       ``(e) Notification of Accreditation of Laboratory.--An 
     accreditation body that has been recognized pursuant to this 
     section shall promptly notify the Secretary whenever it 
     accredits a laboratory for the purposes of this section and 
     whenever it withdraws or suspends such accreditation.
       ``(f) Advance Notice.--Whenever analytical testing is 
     conducted pursuant to subsection (a), the person on whose 
     behalf the testing is conducted shall notify the Secretary 
     before any sample of the article is collected. Such notice 
     shall contain information the Secretary determines is 
     appropriate to identify the article, the location of the 
     article, and each laboratory that will analyze the sample on 
     the person's behalf.
       ``(g) Contents of Laboratory Packages.--Whenever analytical 
     testing is conducted pursuant to subsection (a), the 
     laboratory conducting such testing shall submit, directly to 
     the Secretary--
       ``(1) the results of all analyses conducted by the 
     laboratory on each sample of such article; and
       ``(2) all information the Secretary deems appropriate to--
       ``(A) determine whether the laboratory is accredited by a 
     recognized laboratory accreditation body;
       ``(B) identify the article tested;
       ``(C) evaluate the analytical results; and
       ``(D) determine whether the requirements of this section 
     have been met.
       ``(h) Exigent Circumstances.--The Secretary may waive the 
     requirement of subsection (a)(1)(A) (relating to analytical 
     methods) on a laboratory or method basis due to exigent or 
     other circumstances.
       ``(i) Federal Laboratory Testing.--If Customs and Border 
     Protection laboratory testing concludes that an article of 
     food is adulterated or misbranded, the Secretary shall 
     consider and utilize as appropriate the testing results 
     issued by the Customs and Border Protection laboratories in 
     making a decision about the admissibility of the product.
       ``(j) No Limit on Authority.--Nothing in this section shall 
     be construed to limit--
       ``(1) the ability of the Secretary to review and act upon 
     information from the analytical testing of food (including 
     under this section), including determining the sufficiency of 
     such information and testing; or
       ``(2) the authority of the Secretary to conduct, require, 
     or consider the results of analytical testing pursuant to any 
     other provision of law.''.

     SEC. 111. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF 
                   ADULTERATED OR MISBRANDED FOOD.

       (a) Prohibited Acts.--Section 301 (21 U.S.C. 331), as 
     amended by section 110, is amended by adding at the end the 
     following:
       ``(vv)(1) The failure to notify the Secretary in violation 
     of section 420(a).
       ``(2) The failure to comply with any order issued under 
     section 420.''.
       (b) Notification, Nondistribution, and Recall of 
     Adulterated or Misbranded Food.--Chapter IV (21 U.S.C. 341 et 
     seq.), as amended by sections 102, 103, and 104, is amended 
     by adding at the end the following:

     ``SEC. 420. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF 
                   ADULTERATED OR MISBRANDED FOOD.

       ``(a) Notification, Nondistribution, and Recall of 
     Adulterated or Misbranded Food.--

[[Page 19702]]

       ``(1) In general.--A responsible party as that term is 
     defined in section 417(a)(1) or a person required to register 
     under section 801(s) that has reason to believe that an 
     article of food when introduced into or while in interstate 
     commerce, or while held for sale (regardless of whether the 
     first sale) after shipment in interstate commerce, is 
     adulterated or misbranded in a manner that presents a 
     reasonable probability that the use or consumption of, or 
     exposure to, the article (or an ingredient or component used 
     in any such article) will cause a threat of serious adverse 
     health consequences or death to humans or animals shall, as 
     soon as practicable, notify the Secretary of the identity and 
     location of the article.
       ``(2) Manner of notification.--Notification under paragraph 
     (1) shall be made in such manner and by such means as the 
     Secretary may require by regulation or guidance.
       ``(b) Voluntary Recall.--The Secretary may request that any 
     person who distributes an article of food that the Secretary 
     has reason to believe is adulterated, misbranded, or 
     otherwise in violation of this Act voluntarily--
       ``(1) recall such article; and
       ``(2) provide for notice, including to individuals as 
     appropriate, to persons who may be affected by the recall.
       ``(c) Order to Cease Distribution.--If the Secretary has 
     reason to believe that the use or consumption of, or exposure 
     to, an article of food may cause serious adverse health 
     consequences or death to humans or animals, the Secretary 
     shall have the authority to issue an order requiring any 
     person who distributes such article to immediately cease 
     distribution of such article.
       ``(d) Action Following Order.--Any person who is subject to 
     an order under subsection (c) shall immediately cease 
     distribution of such article and provide notification as 
     required by such order, and may appeal within 24 hours of 
     issuance such order to the Secretary. Such appeal may include 
     a request for an informal hearing and a description of any 
     efforts to recall such article undertaken voluntarily by the 
     person, including after a request under subsection (b). 
     Except as provided in subsection (f), an informal hearing 
     shall be held as soon as practicable, but not later than 5 
     calendar days, or less as determined by the Secretary, after 
     such an appeal is filed, unless the parties jointly agree to 
     an extension. After affording an opportunity for an informal 
     hearing, the Secretary shall determine whether the order 
     should be amended to require a recall of such article. If, 
     after providing an opportunity for such a hearing, the 
     Secretary determines that inadequate grounds exist to support 
     the actions required by the order, the Secretary shall vacate 
     the order.
       ``(e) Order to Recall.--
       ``(1) Amendment.--Except as provided under subsection (f), 
     if after providing an opportunity for an informal hearing 
     under subsection (d), the Secretary determines that the order 
     should be amended to include a recall of the article with 
     respect to which the order was issued, the Secretary shall 
     amend the order to require a recall.
       ``(2) Contents.--An amended order under paragraph (1) 
     shall--
       ``(A) specify a timetable in which the recall will occur;
       ``(B) require periodic reports to the Secretary describing 
     the progress of the recall; and
       ``(C) provide for notice, including to individuals as 
     appropriate, to persons who may be affected by the recall.
     In providing for such notice, the Secretary may allow for the 
     assistance of health professionals, State or local officials, 
     or other individuals designated by the Secretary.
       ``(3) Nondelegation.--An amended order under this 
     subsection shall be ordered by the Secretary or an official 
     designated by the Secretary. An official may not be so 
     designated unless the official is the director of the 
     district under this Act in which the article involved is 
     located, or is an official senior to such director.
       ``(f) Emergency Recall Order.--
       ``(1) In general.--If the Secretary has credible evidence 
     or information that an article of food subject to an order 
     under subsection (c) presents an imminent threat of serious 
     adverse health consequences or death to humans or animals, 
     the Secretary may issue an order requiring any person who 
     distributes such article--
       ``(A) to immediately recall such article; and
       ``(B) to provide for notice, including to individuals as 
     appropriate, to persons who may be affected by the recall.
       ``(2) Action following order.--Any person who is subject to 
     an emergency recall order under this subsection shall 
     immediately recall such article and provide notification as 
     required by such order, and may appeal within 24 hours after 
     issuance such order to the Secretary. An informal hearing 
     shall be held within as soon as practicable but not later 
     than 5 calendar days, or less as determined by the Secretary, 
     after such an appeal is filed, unless the parties jointly 
     agree to an extension. After affording an opportunity for an 
     informal hearing, the Secretary shall determine whether the 
     order should be amended pursuant to subsection (e)(1). If, 
     after providing an opportunity for such a hearing, the 
     Secretary determines that inadequate grounds exist to support 
     the actions required by the order, the Secretary shall vacate 
     the order.
       ``(3) Nondelegation.--An order under this subsection shall 
     be issued by the Commissioner of Food and Drugs, the 
     Principal Deputy Commissioner, or the Associate Commissioner 
     for Regulatory Affairs of the Food and Drug Administration.
       ``(g) Notice to Consumers and Health Officials.--The 
     Secretary shall, as the Secretary determines to be necessary, 
     provide notice of a recall order under this section to 
     consumers to whom the article was, or may have been, 
     distributed and to appropriate State and local health 
     officials.
       ``(h) Savings Clause.--Nothing contained in this section 
     shall be construed as limiting--
       ``(1) the authority of the Secretary to issue an order to 
     cease distribution of, or to recall, an article under any 
     other provision of this Act or the Public Health Service Act; 
     or
       ``(2) the ability of the Secretary to request any person to 
     perform a voluntary activity related to any article subject 
     to this Act or the Public Health Service Act.''.
       (c) Articles Subject to Refusal.--The third sentence of 
     subsection (a) of section 801 (21 U.S.C. 381), as amended by 
     section 107(b), is amended by inserting ``or (5) such article 
     is subject to an order under section 420 to cease 
     distribution of or recall the article,'' before ``then such 
     article shall be refused admission''.
       (d) Effective Date.--Sections 301(vv)(1) and 420 of the 
     Federal Food, Drug, and Cosmetic Act, as added by subsections 
     (a) and (b), shall apply with respect to articles of food as 
     of such date, not later than 1 year after the date of the 
     enactment of this Act, as the Secretary of Health and Human 
     Services shall specify.

     SEC. 112. REPORTABLE FOOD REGISTRY; EXCHANGE OF INFORMATION.

       (a) Reportable Food Registry.--Section 417 (21 U.S.C. 350f) 
     is amended--
       (1) in subsection (a)(1), by striking ``means a person'' 
     and all that follows through the end of paragraph (1) and 
     inserting the following: ``means--
       ``(A) a person who submits the registration under section 
     415(a) for a food facility that is required to be registered 
     under section 415(a), at which such food is manufactured, 
     processed, packed, or held;
       ``(B) a person who owns, operates, is an agent of, or is 
     otherwise responsible for such food on a farm (as such term 
     is defined in section 1.227(b)(3) of title 21, Code of 
     Federal Regulations, or successor regulations) at which such 
     food is produced for sale or distribution in interstate 
     commerce;
       ``(C) a person who owns, operates, or is an agent of a 
     restaurant or other retail food establishment (as such terms 
     are defined in section 1.227(b)(11) and (12), respectively, 
     of title 21, Code of Federal Regulations, or successor 
     regulations) at which such food is offered for sale; or
       ``(D) a person that is required to register pursuant to 
     section 801(s) with respect to importation of such food.'';
       (2) in subsection (b), by adding at the end the following:
       ``(3) Reporting by farms, restaurants, and retail food 
     establishments.--In addition to the electronic portal 
     described in paragraph (1), the Secretary shall make 
     available alternative means of reporting under this section 
     with respect to farms, restaurants, and other retail food 
     establishments with limited ability for such reporting.'';
       (3) in subsection (d)(1)--
       (A) in the matter preceding subparagraph (A), by inserting 
     ``following a timely review of any reasonably available data 
     and information,'' after ``reportable food,'';
       (B) in subparagraph (A), by striking ``and'' at the end;
       (C) by redesignating subparagraph (B) as subparagraph (C); 
     and
       (D) by inserting after subparagraph (A) the following:
       ``(B) submit, with such report, through the electronic 
     portal, documentation of results from any sampling and 
     testing of such article, including--
       ``(i) analytical results from testing of such article 
     conducted by or on behalf of the responsible party under 
     section 418, 418A, 419, 419A, or 714;
       ``(ii) analytical results from testing conducted by or on 
     behalf of such responsible party of a component of such 
     article;
       ``(iii) analytical results of environmental testing of any 
     facility at which such article, or a component of such 
     article, is manufactured, processed, packed, or held; and
       ``(iv) any other information the Secretary determines is 
     necessary to evaluate the adulteration of such article, any 
     component of such article, any other article of food 
     manufactured, processed, packed or held in the same manner 
     as, or at the same facility as, such article, or any other 
     article containing a component from the same source as a 
     component of such article; and''; and
       (4) in subsection (e)--
       (A) in paragraph (1), by inserting ``if the responsible 
     party is required to register'' after ``415(a)(3)''; and
       (B) by adding at the end the following:
       ``(12) Such additional information as the Secretary deems 
     appropriate.''.

[[Page 19703]]

       (b) Exchange of Information.--Section 708 (21 U.S.C. 379) 
     is amended--
       (1) by striking ``The Secretary'' and inserting ``(a) The 
     Secretary''; and
       (2) by adding at the end the following:
       ``(b)(1)(A) The Secretary may provide to any Federal agency 
     acting within the scope of its jurisdiction any information 
     relating to food that is exempt from disclosure pursuant to 
     subsection (a) of section 552 of title 5, United States Code, 
     by reason of subsection (b)(4) of such section, or that is 
     referred to in section 301(j) or 415(a)(4).
       ``(B) Any such information provided to another Federal 
     agency shall not be disclosed by such agency except in any 
     action or proceeding under the laws of the United States to 
     which the receiving agency or the United States is a party.
       ``(2)(A) In carrying out this Act, the Secretary may 
     provide to a State or local government agency any information 
     relating to food that is exempt from disclosure pursuant to 
     section 552(a) of title 5, United States Code, by reason of 
     subsection (b)(4) of such section, or that is referred to in 
     section 301(j) or 415(a)(4).
       ``(B) Any such information provided to a State or local 
     government agency shall not be disclosed by such agency.
       ``(3) In carrying out this Act, the Secretary may provide 
     to any person any information relating to food that is exempt 
     from disclosure pursuant to section 552(a) of title 5, United 
     States Code, by reason of subsection (b)(4) of such section, 
     if the Secretary determines that providing the information to 
     the person is appropriate under the circumstances and the 
     recipient provides adequate assurances to the Secretary that 
     the recipient will preserve the confidentiality of the 
     information.
       ``(4) In carrying out this Act, the Secretary may provide 
     any information relating to food that is exempt from 
     disclosure pursuant to section 552(a) of title 5, United 
     States Code, by reason of subsection (b)(4) of such section, 
     or that is referred to in section 301(j)--
       ``(A) to any foreign government agency; or
       ``(B) any international organization established by law, 
     treaty, or other governmental action and having 
     responsibility--
       ``(i) to facilitate global or regional harmonization of 
     standards and requirements in an area of responsibility of 
     the Food and Drug Administration; or
       ``(ii) to promote and coordinate public health efforts,
     if the agency or organization provides adequate assurances to 
     the Secretary that the agency or organization will preserve 
     the confidentiality of the information.
       ``(c) Except where specifically prohibited by statute, the 
     Secretary may disclose to the public any information relating 
     to food that is exempt from disclosure pursuant to section 
     552(a) of title 5, United States Code, by reason of 
     subsection (b)(4) of such section, if the Secretary 
     determines that such disclosure is necessary to protect the 
     public health.
       ``(d) Except as provided in subsection (e), the Secretary 
     shall not be required to disclose under section 552 of title 
     5, United States Code, or any other provision of law any 
     information relating to food obtained from a Federal, State, 
     or local government agency, or from a foreign government 
     agency, or from an international organization described in 
     subsection (b)(4), if the agency or organization has 
     requested that the information be kept confidential, or has 
     precluded such disclosure under other use limitations, as a 
     condition of providing the information.
       ``(e) Nothing in subsection (d) authorizes the Secretary to 
     withhold information from the Congress or prevents the 
     Secretary from complying with an order of a court of the 
     United States.
       ``(f) This section shall not affect the authority of the 
     Secretary to provide or disclose information under any other 
     provision of law.''.
       (c) Conforming Amendment.--Section 301(j) (21 U.S.C. 
     331(j)) is amended by striking ``or to the courts when 
     relevant in any judicial proceeding under this Act,'' and 
     inserting ``to the courts when relevant in any judicial 
     proceeding under this Act, or as specified in section 708,''.

     SEC. 113. SAFE AND SECURE FOOD IMPORTATION PROGRAM.

       Chapter VIII (21 U.S.C. 381 et seq.) is amended by adding 
     at the end the following:

     ``SEC. 805. SAFE AND SECURE FOOD IMPORTATION PROGRAM.

       ``(a) In General.--The Secretary may establish by 
     regulation or guidance in coordination with the Commissioner 
     responsible for Customs and Border Protection a program that 
     facilitates the movement of food through the importation 
     process under this Act if the importer of such food--
       ``(1) verifies that each facility involved in the 
     production, manufacture, processing, packaging, and holding 
     of the food is in compliance with the food safety and 
     security guidelines developed under subsection (b) with 
     respect to such food;
       ``(2) ensures that appropriate safety and security controls 
     are in place throughout the supply chain for such food; and
       ``(3) provides supporting information to the Secretary.
       ``(b) Guidelines.--
       ``(1) Development.--For purposes of the program established 
     under subsection (a), the Secretary shall develop in 
     consultation with the Commissioner responsible for Customs 
     and Border Protection safety and security guidelines 
     applicable to the importation of food taking into account, to 
     the extent appropriate, other relevant Federal programs, such 
     as the Customs-Trade Partnership Against Terrorism (C-TPAT) 
     programs under section 211 of the Security and Accountability 
     for Every Port Act of 2006.
       ``(2) Factors.--Such guidelines shall take into account the 
     following factors:
       ``(A) The personnel of the person importing the food.
       ``(B) The physical and procedural safety and security of 
     such person's food supply chain.
       ``(C) The sufficiency of preventive controls for food and 
     ingredients purchased by such person.
       ``(D) Vendor and supplier information.
       ``(E) Other programs for certification or verification by a 
     qualified certifying entity used by the importer.
       ``(F) Such other factors as the Secretary determines 
     necessary.''.

     SEC. 114. INFANT FORMULA.

       (a) Misbranding.--Section 403 (21 U.S.C. 343), as amended 
     by sections 101(a) and 109(a), is amended by adding at the 
     end the following:
       ``(bb) If it is a new infant formula and--
       ``(1) it is not the subject of a registration made pursuant 
     to section 412(c)(1)(A);
       ``(2) it is not the subject of a submission made pursuant 
     to section 412(c)(1)(B), or
       ``(3) at least 90 days have not passed since the making of 
     such registration or of such submission to the Secretary.''.
       (b) Requirements.--Section 412 (21 U.S.C. 350a) is 
     amended--
       (1) in subsection (c)(1)(B), by striking ``(c)(1)'' at the 
     end and inserting ``(d)(1), subject to subsection 
     (d)(2)(B)'';
       (2) in subsection (d)(1)--
       (A) by striking ``and'' at the end of subparagraph (C);
       (B) by striking the period at the end of subparagraph (D) 
     and inserting ``, and''; and
       (C) by adding at the end the following:
       ``(E) information on any new ingredient in accordance with 
     paragraph (2)(A).'';
       (3) in subsection (d), by redesignating paragraphs (2) and 
     (3) as paragraphs (3) and (4), respectively; and
       (4) by inserting after paragraph (1) of subsection (d) the 
     following:
       ``(2)(A) The description of any new infant formula required 
     under paragraph (1) shall include, for any new ingredient for 
     use in the formula--
       ``(i) a citation to a prior approval by the Secretary of 
     the new ingredient for use in infant formula under section 
     409;
       ``(ii) a citation to or information showing a prior 
     consideration of the new ingredient for use in infant formula 
     under any program established by the Secretary for the review 
     of ingredients used in food; or
       ``(iii) for a new ingredient that is not a food additive or 
     a color additive, information equivalent to that provided 
     under any program established by the Secretary for the review 
     of ingredients used in food.
       ``(B) If the information submitted under subparagraph (A) 
     is the information described in clause (iii) of such 
     subparagraph, the 90 day period provided by subsection 
     (c)(1)(B) shall not commence until the Secretary has 
     completed review of the information submitted under such 
     clause and has provided the submitter notice of the results 
     of such review.''.

                        Subtitle B--Intervention

     SEC. 121. SURVEILLANCE.

       (a) Definition of Food-Borne Illness Outbreak.--In this 
     section, the term ``food-borne illness outbreak'' means the 
     occurrence of 2 or more cases of a similar illness resulting 
     from the ingestion of a food.
       (b) Food-Borne Illness Surveillance Systems.--The Secretary 
     of Health and Human Services (in this subtitle referred to as 
     the ``Secretary''), acting through the Director of the 
     Centers for Disease Control and Prevention, shall enhance 
     food-borne illness surveillance systems to improve the 
     collection, analysis, reporting, and usefulness of data on 
     food-borne illnesses by--
       (1) coordinating Federal, State, and local food-borne 
     illness surveillance systems, including complaint systems, 
     and increasing participation in national networks of public 
     health and food regulatory agencies and laboratories;
       (2) facilitating sharing of findings on a more timely basis 
     among governmental agencies, including the Food and Drug 
     Administration, the Department of Agriculture, and State and 
     local agencies, and with the public;
       (3) developing improved epidemiological tools for obtaining 
     quality exposure data, and microbiological methods for 
     classifying cases;
       (4) augmenting such systems to improve attribution of a 
     food-borne illness outbreak to a specific food;
       (5) expanding capacity of such systems, including 
     fingerprinting and other detection strategies for food-borne 
     infectious agents, in order to identify new or rarely 
     documented causes of food-borne illness;
       (6) allowing timely public access to aggregated, de-
     identified surveillance data;

[[Page 19704]]

       (7) at least annually, publishing current reports on 
     findings from such systems;
       (8) establishing a flexible mechanism for rapidly 
     initiating scientific research by academic institutions;
       (9) integrating food-borne illness surveillance systems and 
     data with other biosurveillance and public health situational 
     awareness capabilities at the Federal, State, and local 
     levels; and
       (10) other activities as determined appropriate by the 
     Secretary.
       (c) Improving Food Safety and Defense Capacity at the State 
     and Local Level.--
       (1) In general.--The Secretary shall develop and implement 
     strategies to leverage and enhance the food safety and 
     defense capacities of State and local agencies in order to 
     achieve the following goals:
       (A) Improve food-borne illness outbreak response and 
     containment.
       (B) Accelerate food-borne illness surveillance and outbreak 
     investigation, including rapid shipment of clinical isolates 
     from clinical laboratories to appropriate State laboratories, 
     and conducting more standardized illness outbreak interviews.
       (C) Strengthen the capacity of State and local agencies to 
     carry out inspections and enforce safety standards.
       (D) Improve the effectiveness of Federal, State, and local 
     partnerships to coordinate food safety and defense resources 
     and reduce the incidence of food-borne illness.
       (E) Share information on a timely basis among public health 
     and food regulatory agencies, with the food industry, with 
     health care providers, and with the public.
       (2) Review.--In developing the strategies required by 
     paragraph (1), the Secretary shall, not later than 1 year 
     after the date of enactment of this Act, complete a review of 
     State and local capacities, and needs for enhancement, which 
     may include a survey with respect to--
       (A) staffing levels and expertise available to perform food 
     safety and defense functions;
       (B) laboratory capacity to support surveillance, outbreak 
     response, inspection, and enforcement activities;
       (C) information systems to support data management and 
     sharing of food safety and defense information among State 
     and local agencies and with counterparts at the Federal 
     level; and
       (D) other State and local activities and needs as 
     determined appropriate by the Secretary.

     SEC. 122. PUBLIC EDUCATION AND ADVISORY SYSTEM.

       (a) Public Education.--The Secretary, in cooperation with 
     private and public organizations, including the appropriate 
     State entities, shall design and implement a national public 
     education program on food safety. The program shall provide--
       (1) information to the public so that individuals can 
     understand the potential impact and risk of food-borne 
     illness, take action to reduce their risk of food-borne 
     illness and injury, and make healthy dietary choices;
       (2) information to health professionals so that they may 
     improve diagnosis and treatment of food-related illness and 
     advise individuals whose health conditions place them in 
     particular risk; and
       (3) such other information or advice to consumers and other 
     persons as the Secretary determines will promote the purposes 
     of this Act.
       (b) Health Advisories.--The Secretary shall work with the 
     States and other appropriate entities to--
       (1) develop and distribute regional and national advisories 
     concerning food safety;
       (2) develop standardized formats for written and broadcast 
     advisories; and
       (3) incorporate State and local advisories into the 
     national public education program required under subsection 
     (a).

     SEC. 123. RESEARCH.

       The Secretary shall 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;
       (2) develop improved techniques for the monitoring of food 
     and inspection of food products;
       (3) develop efficient, rapid, and sensitive methods for 
     determining and detecting the presence of contaminants in 
     food products;
       (4) determine the sources of contamination of food and food 
     products, including critical points of risk for fresh produce 
     and other raw agricultural commodities;
       (5) develop consumption data with respect to food products;
       (6) draw upon research and educational programs that exist 
     at the State and local level;
       (7) utilize the DNA matching system and other processes to 
     identify and control pathogens;
       (8) address common and emerging zoonotic diseases;
       (9) develop methods to reduce or destroy pathogens before, 
     during, and after processing;
       (10) analyze the incidence of antibiotic resistance as it 
     pertains to the food supply and evaluate methods to reduce 
     the transfer of antibiotic resistance to humans; and
       (11) conduct other research that supports the purposes of 
     this Act.

                          Subtitle C--Response

     SEC. 131. PROCEDURES FOR SEIZURE.

       Section 304(b) (21 U.S.C. 334(b)) is amended by inserting 
     ``and except that, with respect to proceedings relating to 
     food, Rule G of the Supplemental Rules of Admiralty or 
     Maritime Claims and Asset Forfeiture Actions shall not apply 
     in any such case, exigent circumstances shall be deemed to 
     exist for all seizures brought under this section, and the 
     summons and arrest warrant shall be issued by the clerk of 
     the court without court review in any such case'' after ``in 
     any such case shall be tried by jury''.

     SEC. 132. ADMINISTRATIVE DETENTION.

       (a) Amendments.--Section 304(h) (21 U.S.C. 334(h)) is 
     amended--
       (1) in paragraph (1)(A), by striking ``credible evidence or 
     information indicating'' and inserting ``reason to believe'';
       (2) in paragraph (1)(A), by striking ``presents a threat of 
     serious adverse health consequences or death to humans or 
     animals'' and inserting ``is adulterated, misbranded, or 
     otherwise in violation of this Act'';
       (3) in paragraph (2), by striking ``30'' and inserting 
     ``60'';
       (4) in paragraph (3), by striking the third sentence; and
       (5) in paragraph (4)(A) by striking the terms ``five'' and 
     ``five-day'' and inserting ``fifteen'' and ``fifteen-day'', 
     respectively.
       (b) Regulations.--The Secretary shall issue regulations or 
     guidance to implement the amendments made by this section.
       (c) Effective Date.--The amendments made by this section 
     shall take effect 180 days after the date of the enactment of 
     this Act.

     SEC. 133. AUTHORITY TO PROHIBIT OR RESTRICT THE MOVEMENT OF 
                   FOOD.

       (a) Prohibited Act.--Section 301 (21 U.S.C. 331), as 
     amended by sections 110 and 111, is amended by adding at the 
     end by adding the following:
       ``(ww) The violation of a prohibition or restriction under 
     section 304(i).''.
       (b) In General.--Section 304 (21 U.S.C. 334) is amended by 
     adding at the end the following:
       ``(i) Authority to Prohibit or Restrict the Movement of 
     Food Within a State or Portion of a State.--
       ``(1) Authority to prohibit or restrict the movement of 
     food.--
       ``(A) In general.--
       ``(i) After consultation with the Governor or other 
     appropriate official of an affected State, if the Secretary 
     determines that there is credible evidence that an article of 
     food presents an imminent threat of serious adverse health 
     consequences or death to humans or animals, the Secretary may 
     prohibit or restrict the movement of an article of food 
     within a State or portion of a State for which the Secretary 
     has credible evidence that such food is located within, or 
     originated from, such State or portion thereof.
       ``(ii) In carrying out clause (i), the Secretary may 
     prohibit or restrict the movement within a State or portion 
     of a State of any article of food or means of conveyance of 
     such article of food, if the Secretary determines that the 
     prohibition or restriction is a necessary protection from an 
     imminent threat of serious adverse health consequences or 
     death to humans or animals.
       ``(2) Notification procedures.--Subject to paragraph (3), 
     before any action is taken in a State under this subsection, 
     the Secretary shall--
       ``(A) notify the Governor or other appropriate official of 
     the State affected by the proposed action;
       ``(B) issue a public announcement of the proposed action; 
     and
       ``(C) publish in the Federal Register--
       ``(i) the findings of the Secretary that support the 
     proposed action;
       ``(ii) a statement of the reasons for the proposed action; 
     and
       ``(iii) a description of the proposed action, including--

       ``(I) the area affected; and
       ``(II) an estimate of the anticipated duration of the 
     action.

       ``(3) Notice after action.--If it is not practicable to 
     publish in the Federal Register the information required 
     under paragraph (2)(C) before taking action under paragraph 
     (1), the Secretary shall publish the information as soon as 
     practicable, but not later than 10 business days, after 
     commencement of the action.
       ``(4) Application of least drastic action.--No action shall 
     be taken under paragraph (1) unless, in the opinion of the 
     Secretary, there is no less drastic action that is feasible 
     and that would be adequate to prevent the imminent threat of 
     serious adverse health consequences or death to humans or 
     animals.
       ``(5) Nondelegation.--An action under paragraph (1) may 
     only be ordered by the Secretary or an official designated by 
     the Secretary. An official may not be so designated unless 
     the official is the Commissioner of Food and Drugs or the 
     Principal Deputy Commissioner.
       ``(6) Duration.--Fourteen days after the initiation of an 
     action under paragraph (1), and each 14 days thereafter, if 
     the Secretary determines that it is necessary to continue the 
     action, the Secretary shall--
       ``(A) notify the Governor or other appropriate official of 
     the State affected of the continuation of the action;

[[Page 19705]]

       ``(B) issue a public announcement of the continuation of 
     the action; and
       ``(C) publish in the Federal Register the findings of the 
     Secretary that support the continuation of the action, 
     including an estimate of the anticipated duration of the 
     action.
       ``(7) Rulemaking.--The Secretary shall, consistent with 
     national security interests and as appropriate for known 
     hazards, establish by regulation standards for conducting 
     actions under paragraph (1), including, as appropriate, 
     sanitation standards and procedures to restore any affected 
     equipment or means of conveyance to its status prior to an 
     action under paragraph (1).''.

     SEC. 134. CRIMINAL PENALTIES.

       Section 303(a) (21 U.S.C. 333) is amended--
       (1) in paragraph (1), by striking ``Any'' and inserting 
     ``Except as provided in paragraph (2) or (3), any''; and
       (2) by adding at the end the following:
       ``(3) Notwithstanding paragraph (1), any person who 
     knowingly violates paragraph (a), (b), (c), (k), or (v) of 
     section 301 with respect to any food that is misbranded or 
     adulterated shall be imprisoned for not more than 10 years or 
     fined in accordance with title 18, United States Code, or 
     both.''.

     SEC. 135. CIVIL PENALTIES FOR VIOLATIONS RELATING TO FOOD.

       (a) In General.--Paragraph (2) of section 303(f) (21 U.S.C. 
     331 et seq.) is amended to read as follows:
       ``(2)(A) Any person who violates a provision of section 301 
     relating to food shall be subject to a civil penalty for each 
     such violation of not more than--
       ``(i) $20,000 in the case of an individual, not to exceed 
     $50,000 in a single proceeding; and
       ``(ii) $250,000 in the case of any other person, not to 
     exceed $1,000,000 in a single proceeding.
       ``(B) Any person who knowingly violates a provision of 
     section 301 relating to food shall be subject to a civil 
     penalty for each such violation of not more than--
       ``(i) $50,000 in the case of an individual, not to exceed 
     $100,000 in a single proceeding; and
       ``(ii) $500,000 in the case of any other person, not to 
     exceed $7,500,000 in a single proceeding.
       ``(C) Each violation described in subparagraph (A) or (B) 
     and each day during which the violation continues shall be 
     considered to be a separate offense.''.
       (b) Effective Date.--The amendment made by subsection (a) 
     applies to violations committed on or after the date of the 
     enactment of this Act.

     SEC. 136. IMPROPER IMPORT ENTRY FILINGS.

       (a) Prohibited Acts.--Section 301 (21 U.S.C. 331), as 
     amended by sections 110, 111, and 133, is amended by adding 
     at the end the following:
       ``(xx) The submission of information relating to food that 
     is required by or under section 801 that is inaccurate or 
     incomplete.
       ``(yy) The failure to submit information relating to food 
     that is required by or under section 801.''.
       (b) Documentation for Imports.--Section 801 (21 U.S.C. 
     381), as amended by section 109, is amended by adding at the 
     end the following:
       ``(r) Documentation.--
       ``(1) Submission.--The Secretary may require by regulation 
     or guidance the submission of documentation or other 
     information for articles of food that are imported or offered 
     for import into the United States. When developing any 
     regulation or guidance in accordance with this paragraph, to 
     the extent that the collection of documentation or other 
     information involves Customs and Border Protection efforts or 
     resources, the Secretary shall consult with Customs and 
     Border Protection.
       ``(2) Format.--A regulation or guidance under paragraph (1) 
     may specify the format for submission of the documentation or 
     other information.''.

                        TITLE II--MISCELLANEOUS

     SEC. 201. FOOD SUBSTANCES GENERALLY RECOGNIZED AS SAFE.

       Section 409 (21 U.S.C. 348) is amended by adding at the end 
     the following:

               ``Substances Generally Recognized as Safe

       ``(k)(1) Not later than 60 days after the date of receipt 
     by the Secretary, after the date of the enactment of this 
     subsection, of a determination that a substance is a GRAS 
     food substance, the Secretary shall post notice of such 
     determination and the supporting scientific justifications on 
     the Food and Drug Administration's public Web site.
       ``(2) Not later than 60 days after the date of receipt of a 
     request under paragraph (1), the Secretary shall acknowledge 
     receipt of such request by informing the requester in writing 
     of the date on which the request was received.
       ``(3) In this subsection, the term `GRAS food substance' 
     means a substance excluded from the definition of the term 
     `food additive' in section 201(s) because such substance is 
     generally recognized, among experts qualified by scientific 
     training and experience to evaluate its safety, as having 
     been adequately shown through scientific procedures (or, in 
     the case of a substance used in food prior to January 1, 
     1958, through either scientific procedures or experience 
     based on common use in food) to be safe under the conditions 
     of its intended use.''.

     SEC. 202. COUNTRY OF ORIGIN LABELING.

       (a) Misbranding.--Section 403 (21 U.S.C. 343), as amended 
     by sections 101(a), 109(a), and 114(a), is amended by adding 
     at the end the following:
       ``(cc) In the case of a processed food, if the labeling of 
     the food fails to identify the country in which the final 
     processing of the food occurs.
       ``(dd) In the case of nonprocessed food, if the labeling of 
     the food fails to identify the country of origin of the 
     food.''.
       (b) Regulations.--
       (1) Promulgation.--Not later than 180 days after the date 
     of the enactment of this Act, the Secretary of Health and 
     Human Services shall promulgate final regulations to carry 
     out paragraphs (cc) and (dd) of section 403 of the Federal 
     Food, Drug, and Cosmetic Act, as added by subsection (a).
       (2) Relation to other requirements.--Regulations 
     promulgated under paragraph (1) shall provide that labeling 
     meets the requirements of paragraphs (cc) and (dd) of section 
     403 of the Federal Food, Drug, and Cosmetic Act, as added by 
     subsection (a), if--
       (A) in the case of a processed food, the label of the food 
     informs the consumer of the country where the final 
     processing of the food occurred in accordance with country of 
     origin marking requirements of the United States Customs and 
     Border Protection; or
       (B) in the case of a nonprocessed food, the label of the 
     food informs the consumer of the country of origin of the 
     food in accordance with labeling requirements of the 
     Department of Agriculture.
       (c) Effective Date.--The requirements of paragraphs (cc) 
     and (dd) of section 403 of the Federal Food, Drug, and 
     Cosmetic Act, as added by subsection (a), take effect on the 
     date that is 2 years after the date of the enactment of this 
     Act.

     SEC. 203. EXPORTATION CERTIFICATE PROGRAM.

       Section 801(e)(4) (21 U.S.C. 381) is amended--
       (1) in the matter preceding clause (i) in subparagraph 
     (A)--
       (A) by inserting ``from the United States'' after 
     ``exports''; and
       (B) by striking ``a drug, animal drug, or device'' and 
     inserting ``a food (including animal feed), drug, animal 
     drug, or device'';
       (2) in subparagraph (A)(i)--
       (A) by striking ``in writing''; and
       (B) by striking ``exported drug, animal drug, or device'' 
     and inserting ``exported food, drug, animal drug, or 
     device'';
       (3) in subparagraph (A)(ii)--
       (A) by striking ``in writing'';
       (B) by striking ``the drug, animal drug, or device'' and 
     inserting ``the food, drug, animal drug, or device''; and
       (C) by striking ``the drug or device'' and inserting ``the 
     food, drug, or device'';
       (4) by redesignating subparagraph (B) as subparagraph (C);
       (5) by inserting after subparagraph (A) the following:
       ``(B) For purposes of this paragraph, a certification by 
     the Secretary shall be made on such basis and in such form 
     (such as a publicly available listing) as the Secretary 
     determines appropriate.''; and
       (6) by adding at the end the following:
       ``(D) Notwithstanding subparagraph (C), if the Secretary 
     issues an export certification within the 20 days prescribed 
     by subparagraph (A) with respect to the export of food, a fee 
     for such certification shall not exceed such amount as the 
     Secretary determines is reasonably related to the cost of 
     issuing certificates under subparagraph (A) with respect to 
     the export of food. The Secretary may adjust this fee 
     annually to account for inflation and other cost adjustments. 
     Fees collected for a fiscal year pursuant to this 
     subparagraph shall be credited to the appropriation account 
     for salaries and expenses of the Food and Drug Administration 
     and shall be available in accordance with appropriations Acts 
     until expended, without fiscal year limitation. Such fees 
     shall be collected in each fiscal year in an amount equal to 
     the amount specified in appropriations Acts for such fiscal 
     year and shall only be collected and available for the costs 
     of the Food and Drug Administration to cover the cost of 
     issuing such certifications. Such sums as necessary may be 
     transferred from such appropriation account for salaries and 
     expenses of the Food and Drug Administration without fiscal 
     year limitation to such appropriation account for salaries 
     and expenses with fiscal year limitation.''.

     SEC. 204. REGISTRATION FOR COMMERCIAL IMPORTERS OF FOOD; FEE.

       (a) Registration.--
       (1) Prohibitions.--Section 301 (21 U.S.C. 331), as amended 
     by sections 110, 111, 133, and 136, is amended by adding at 
     the end the following:
       ``(zz) The failure to register in accordance with section 
     801(s).''.
       (2) Misbranding.--Section 403 (21 U.S.C. 343) as amended by 
     sections 101(a), 109(a), 114(a), and 202, is amended by 
     adding at the end the following:
       ``(ee) If it is imported or offered for import by an 
     importer not duly registered under section 801(s).''.
       (3) Registration.--Section 801, as amended by sections 109 
     and 136, is amended by adding at the end the following:
       ``(s) Registration of Importers.--
       ``(1) Registration.--The Secretary shall require an 
     importer of food--

[[Page 19706]]

       ``(A) to be registered with the Secretary in a form and 
     manner specified by the Secretary; and
       ``(B) consistent with section 1011, to submit appropriate 
     unique facility identifiers as a condition of registration.
       ``(2) Good importer practices.--The maintenance of 
     registration under this subsection is conditioned on 
     compliance with good importer practices in accordance with 
     the following:
       ``(A) The Secretary, in consultation with Customs and 
     Border Protection, shall promulgate regulations to establish 
     good importer practices that specify the measures an importer 
     shall take to ensure imported food is in compliance with the 
     requirements of this Act.
       ``(B) The measures under subparagraph (A) shall ensure that 
     the importer of a food--
       ``(i) has adequate information about the food, its hazards, 
     and the requirements of this Act applicable to such food;
       ``(ii) has adequate information or procedures in place to 
     verify that both the food and each person that produced, 
     manufactured, processed, packed, transported, or held the 
     food, including components of the food, are in compliance 
     with the requirements of this Act; and
       ``(iii) has adequate procedures in place to take corrective 
     action, such as the ability to appropriately trace, withhold, 
     and recall articles of food, if a food imported by the 
     importer is not in compliance with the requirements of this 
     Act.
       ``(C) In promulgating good importer practices regulations, 
     the Secretary may, as appropriate--
       ``(i) incorporate certification of compliance under section 
     801(q) and participation in the safe and secure food 
     importation program under section 805; and
       ``(ii) take into account differences among importers and 
     the types of imports, including based on the level of risk 
     posed by the imported food.
       ``(3) Suspension of registration.--
       ``(A) In general.--Registration under this subsection is 
     subject to suspension upon a finding by the Secretary, after 
     notice and an opportunity for an informal hearing, of--
       ``(i) a violation of this Act; or
       ``(ii) the knowing or repeated making of an inaccurate or 
     incomplete statement or submission of information relating to 
     the importation of food.
       ``(B) Request.--The importer whose registration is 
     suspended may request that the Secretary vacate the 
     suspension of registration when such importer has corrected 
     the violation that is the basis for such suspension.
       ``(C) Vacating of suspension.--If the Secretary determines 
     that adequate reasons do not exist to continue the suspension 
     of a registration, the Secretary shall vacate such 
     suspension.
       ``(4) Cancellation of registration.--
       ``(A) In general.--Not earlier than 10 days after providing 
     the notice under subparagraph (B), the Secretary may cancel a 
     registration that the Secretary determines was not updated in 
     accordance with this section or otherwise contains false, 
     incomplete, or inaccurate information.
       ``(B) Notice of cancellation.--Cancellation shall be 
     preceded by notice to the importer of the intent to cancel 
     the registration and the basis for such cancellation.
       ``(C) Timely update or correction.--If the registration for 
     the importer is updated or corrected no later than 7 days 
     after notice is provided under subparagraph (B), the 
     Secretary shall not cancel such registration.
       ``(5) Exemptions.--The Secretary, by notice published in 
     the Federal Register--
       ``(A) shall establish an exemption from the requirements of 
     this subsection for importations for personal use; and
       ``(B) may establish other exemptions from the requirements 
     of this subsection.''.
       (4) Regulations.--Not later than 36 months after the date 
     of the enactment of this Act, the Secretary of Health and 
     Human Services in consultation with the Commissioner 
     responsible for Customs and Border Protection shall 
     promulgate the regulations required to carry out section 
     801(s) of the Federal Food, Drug, and Cosmetic Act, as added 
     by paragraph (3). In establishing the effective date of a 
     regulation promulgated under section 801(s), the Secretary 
     shall, in consultation with the Commissioner responsible for 
     Customs and Border Protection, as appropriate, provide a 
     reasonable period of time for importers of food to comply 
     with good importer practices, taking into account differences 
     among importers and the types of imports, including based on 
     the level of risk posed by the imported food.
       (5) Effective date.--The amendments made by this subsection 
     shall take effect on the date that is 24 months after the 
     date of enactment of this Act.
       (b) Fee.--Subchapter C of chapter VII (21 U.S.C. 379f et 
     seq.) as added and amended by sections 101 and 108, is 
     amended by adding at the end the following:

                      ``PART 7--IMPORTERS OF FOOD

     ``SEC. 744. IMPORTERS OF FOOD.

       ``(a) Importers.--The Secretary shall assess and collect an 
     annual fee for the registration of an importer of food under 
     section 801(s).
       ``(b) Amount of Fee.--
       ``(1) Base amounts.--The registration fee under subsection 
     (a) shall be--
       ``(A) for fiscal year 2010, $500; and
       ``(B) for fiscal year 2011 and each subsequent fiscal year, 
     the fee for fiscal year 2010 as adjusted under paragraph (2).
       ``(2) Adjustment.--For fiscal year 2011 and subsequent 
     fiscal years, the fees established pursuant to paragraph (1) 
     shall be adjusted by the Secretary by notice, published in 
     the Federal Register, for a fiscal year to reflect the 
     greater of--
       ``(A) the total percentage change that occurred in the 
     Consumer Price Index for all urban consumers (all items; 
     United States city average), for the 12-month period ending 
     June 30 preceding the fiscal year for which fees are being 
     established;
       ``(B) the total percentage change for the previous fiscal 
     year in basic pay under the General Schedule in accordance 
     with section 5332 of title 5, United States Code, as adjusted 
     by any locality-based comparability payment pursuant to 
     section 5304 of such title for Federal employees stationed in 
     the District of Columbia; or
       ``(C) the average annual change in the cost, per full-time 
     equivalent position of the Food and Drug Administration, of 
     all personnel compensation and benefits paid with respect to 
     such positions for the first 5 years of the preceding 6 
     fiscal years.
       ``(3) Compounded basis.--The adjustment made each fiscal 
     year pursuant to this subsection shall be added on a 
     compounded basis to the sum of all adjustments made each 
     fiscal year after fiscal year 2010 under this subsection.
       ``(4) Waiver for importers required to pay registration 
     fee.--In the case of a person who is required to pay both a 
     fee under section 743 for registration of one or more 
     facilities under section 415 and a fee under this section for 
     registration as an importer of food under section 801(s), the 
     Secretary shall waive the fees applicable to such person 
     under section 743 or the fee applicable to such person under 
     this section.
       ``(c) Crediting and Availability of Fees.--
       ``(1) In general.--Fees authorized under subsection (a) 
     shall be collected and available for obligation only to the 
     extent and in the amount provided in advance in 
     appropriations Acts. Such fees are authorized to remain 
     available until expended. Such sums as may be necessary may 
     be transferred from the Food and Drug Administration salaries 
     and expenses appropriation account without fiscal year 
     limitation to such appropriation account for salaries and 
     expenses with such fiscal year limitation.
       ``(2) Collections and appropriations acts.--The fees 
     authorized by this section--
       ``(A) shall be retained in each fiscal year in an amount 
     not to exceed the amount specified in appropriation Acts, or 
     otherwise made available for obligation, for such fiscal 
     year; and
       ``(B) shall only be collected and available to cover the 
     costs associated with registering importers under section 
     801(s) and with ensuring compliance with good importer 
     practices respecting food.
       ``(3) Authorization of appropriations.--For each of fiscal 
     years 2010 through 2014, there are authorized to be 
     appropriated for fees under this section such sums as may be 
     necessary.''.
       (c) Inspection.--Section 704 (21 U.S.C. 374), as amended by 
     section 105, is amended by adding at the end the following:
       ``(i) Importers.--Every person engaged in the importing of 
     any food shall, upon request of an officer or employee 
     designated by the Secretary, permit such officer or employee 
     at all reasonable times to inspect the facilities of such 
     person and have access to, and to copy and verify, any 
     related records.''.

     SEC. 205. REGISTRATION FOR CUSTOMS BROKERS.

       (a) Registration.--
       (1) Prohibitions.--Section 301(zz) (21 U.S.C. 331), as 
     added by section 204, is amended by inserting ``or 801(t)'' 
     after ``801(s)''.
       (2) Misbranding.--Section 403(ee) (21 U.S.C. 343), as added 
     by section 204, is amended--
       (A) by inserting ``or a customs broker'' after ``by an 
     importer''; and
       (B) by inserting ``or 801(t)'' after ``801(s)''.
       (3) Registration.--Section 801, as amended by sections 109, 
     136, and 204, is amended by adding at the end the following:
       ``(t) Registration of Customs Broker.--
       ``(1) Registration.--The Secretary shall require a customs 
     broker, with respect to the importation of food--
       ``(A) to be registered with the Secretary in a form and 
     manner specified by the Secretary; and
       ``(B) consistent with section 1011, to submit appropriate 
     unique facility identifiers as a condition of registration.
       ``(2) Cancellation of registration.--
       ``(A) In general.--Not earlier than 10 days after providing 
     the notice under subparagraph (B), the Secretary may cancel a 
     registration that the Secretary determines was not updated in 
     accordance with this section or otherwise contains false, 
     incomplete, or inaccurate information.
       ``(B) Notice of cancellation.--Cancellation shall be 
     preceded by notice to the customs broker of the intent to 
     cancel the registration and the basis for such cancellation.
       ``(C) Timely update or correction.--If the registration for 
     the customs broker is updated or corrected no later than 7 
     days after

[[Page 19707]]

     notice is provided under subparagraph (B), the Secretary 
     shall not cancel such registration.
       ``(3) Notification.--The Secretary shall notify the 
     Commissioner responsible for Customs and Border Protection 
     whenever the Secretary cancels a registration under this 
     subsection.
       ``(4) Exemptions.--In consultation with the Commissioner 
     responsible for Customs and Border Protection, the Secretary, 
     by notice published in the Federal Register--
       ``(A) shall establish an exemption from the requirements of 
     this subsection for importations for personal use; and
       ``(B) may establish other exemptions from the requirements 
     of this subsection.
       ``(5) Civil penalties.--Notwithstanding any other provision 
     in this Act, a customs broker who violates section 301 
     because of a violation of section 403(ee), or who violates 
     section 301(xx), 301(yy), or 301(zz), shall not be subject to 
     a civil penalty under section 303(f)(2).''.
       (4) Regulations.--Not later than 24 months after the date 
     of the enactment of this Act, the Secretary of Health and 
     Human Services, in consultation with the Commissioner 
     responsible for Customs and Border Protection, shall 
     promulgate the regulations required to carry out section 
     801(t) of the Federal Food, Drug, and Cosmetic Act, as added 
     by paragraph (2).
       (5) Effective date.--The amendments made by this subsection 
     shall take effect on the date that is 24 months after the 
     date of enactment of this Act.
       (b) Inspection.--Section 704 (21 U.S.C. 374), as amended by 
     sections 105 and 204, is amended by adding at the end the 
     following:
       ``(j) Brokers.--Every customs broker required to be 
     registered with the Secretary shall, upon request of an 
     officer or employee designated by the Secretary, permit such 
     officer or employee at all reasonable times to inspect the 
     facilities of such person and have access to, and to copy and 
     verify, any related records.''.

     SEC. 206. UNIQUE IDENTIFICATION NUMBER FOR FOOD FACILITIES, 
                   IMPORTERS, AND CUSTOM BROKERS.

       Chapter X (21 U.S.C. 391 et seq.) is amended by adding at 
     the end the following:

     ``SEC. 1011. UNIQUE FACILITY IDENTIFIER.

       ``(a) Registration of Facility or Establishment.--A person 
     required to register a facility pursuant to section 415 shall 
     submit, at the time of registration, a unique facility 
     identifier for the facility or establishment.
       ``(b) Registration of Importers and Custom Brokers.--A 
     person required to register pursuant to section 801(s) or 
     801(t) shall submit, at the time of registration, a unique 
     facility identifier for the principal place of business for 
     which such person is required to register under section 
     801(s) or 801(t).
       ``(c) Guidance.--The Secretary may, by guidance, and, with 
     respect to importers and customs brokers, in consultation 
     with the Commissioner responsible for Customs and Border 
     Protection, specify the unique numerical identifier system to 
     be used to meet the requirements of subsections (a) and (b) 
     and the form, manner, and timing of a submission under such 
     subsections. Development of such guidelines shall take into 
     account the utilization of existing unique identification 
     schemes and compatibility with customs automated systems, 
     such as integration with the Automated Commercial Environment 
     (ACE) and the International Trade Data System (ITDS), and any 
     successor systems.
       ``(d)  Importation.--An article of food imported or offered 
     for import shall be refused admission unless the appropriate 
     unique facility identifiers, as specified by the Secretary, 
     are provided for such article.''.

     SEC. 207. PROHIBITION AGAINST DELAYING, LIMITING, OR REFUSING 
                   INSPECTION.

       (a) Adulteration.--Section 402 (21 U.S.C. 342), as amended 
     by section 102, 103(a), and 104(a), is amended by adding at 
     the end the following:
       ``(n) If it has been produced, manufactured, processed, 
     packed, or held in any farm, factory, warehouse, or 
     establishment and the owner, operator, or agent of such farm, 
     factory, warehouse, or establishment, or any agent of a 
     governmental authority in the foreign country within which 
     such farm, factory, warehouse, or establishment is located, 
     delays or limits an inspection, or refuses to permit entry or 
     inspection, under section 414 or 704.''.
       (b) Foreign Inspections.--Section 704(a)(1) (21 U.S.C. 
     374(a)(1)), as amended by section 106(c), is amended--
       (1) in the first sentence, by inserting ``, including any 
     such food factory, warehouse, or establishment whether 
     foreign or domestic,'' after ``factory, warehouse, or 
     establishment''; and
       (2) in the third sentence, by inserting ``, including any 
     food factory, warehouse, establishment, or consulting 
     laboratory whether foreign or domestic,'' after ``factory, 
     warehouse, establishment, or consulting laboratory''.

     SEC. 208. DEDICATED FOREIGN INSPECTORATE.

       Section 704 (21 U.S.C. 374), as amended by sections 105, 
     204, and 205, is amended by adding at the end the following:
       ``(k) Dedicated Foreign Inspectorate.--The Secretary shall 
     establish and maintain a corps of inspectors dedicated to 
     inspections of foreign food facilities. This corps shall be 
     staffed and funded by the Secretary at a level sufficient to 
     enable it to assist the Secretary in achieving the frequency 
     of inspections for food facilities as described in this 
     Act.''.

     SEC. 209. PLAN AND REVIEW OF CONTINUED OPERATION OF FIELD 
                   LABORATORIES.

       (a) Submission of Plan.--Not later than 90 days before the 
     Secretary terminates or consolidates any laboratory, district 
     office, or the functions (including the inspection and 
     compliance functions) of any such laboratory or district 
     office, specified in subsection (b), the Secretary shall 
     submit a reorganization plan to the Comptroller General of 
     the United States, the Committee on Energy and Commerce of 
     the House of Representatives, and the Committee on Health, 
     Education, Labor, and Pensions of the Senate.
       (b) Specified Laboratories and Offices.--The laboratories 
     and offices specified in this subsection are the following:
       (1) Any of the 13 field laboratories responsible for 
     analyzing food that were operated by the Office of Regulatory 
     Affairs of the Food and Drug Administration as of January 1, 
     2007.
       (2) Any of the 20 district offices of the Food and Drug 
     Administration with responsibility for food safety 
     functioning as of January 1, 2007.
       (c) Congressional Review.--A reorganization plan described 
     in subsection (a) is deemed to be a major rule (as defined in 
     section 804(2) of title 5, United States Code) for purposes 
     of chapter 8 of such title.

     SEC. 210. FALSE OR MISLEADING REPORTING TO FDA.

       (a) In General.--Section 301(q)(2) (21 U.S.C. 331(q)(2)) is 
     amended by inserting after ``device'' the following: ``, 
     food,''.
       (b) Effective Date.--The amendment made by subsection (a) 
     shall apply to submissions made on or after the date of the 
     enactment of this Act.

     SEC. 211. SUBPOENA AUTHORITY.

       (a) Prohibited Act.--Section 301(f) is amended by inserting 
     before the period ``or the failure or refusal to obey a 
     subpoena issued pursuant to section 311''.
       (b) Amendment.--Chapter III (21 U.S.C. 331 et seq.) is 
     amended by adding at the end the following:

     ``SEC. 311. EXERCISE OF SUBPOENA AUTHORITY.

       ``(a) In General.--For the purpose of--
       ``(1) any hearing, investigation, or other proceeding 
     respecting a violation of a provision of this Act, the Public 
     Health Service Act, or the Federal Anti-Tampering Act, 
     relating to food; or
       ``(2) any hearing, investigation, or other proceeding to 
     determine if a person is in violation of a specific provision 
     of this Act, the Public Health Service Act, or the Federal 
     Anti-Tampering Act, relating to food,
     the Commissioner may issue subpoenas requiring the attendance 
     and testimony of witnesses and the production of records and 
     other things.
       ``(b) Timing of Compliance.--When the Commissioner deems 
     that immediate compliance with a subpoena issued under this 
     section is necessary to address a threat of serious adverse 
     health consequences or death, the subpoena may require 
     immediate production.
       ``(c) Service of Subpoena.--
       ``(1) In general.--Subpoenas of the Commissioner shall be 
     served by a person authorized by the Commissioner by 
     delivering a copy thereof to the person named therein or by 
     certified mail addressed to such person at such person's last 
     known dwelling place or principal place of business.
       ``(2) Corporations and other entities.--Service on a 
     domestic or foreign corporation, partnership, unincorporated 
     association, or other entity that is subject to suit under a 
     common name may be made by delivering the subpoena to an 
     officer, a managing or general agent, or any other agent 
     authorized by appointment or by law to receive service of 
     process.
       ``(3) Person outside u.s. jurisdiction.--Service on any 
     person not found within the territorial jurisdiction of any 
     court of the United States may be made in any manner as the 
     Federal Rules of Civil Procedure prescribe for service in a 
     foreign nation.
       ``(4) Proof of service.--A verified return by the person so 
     serving the subpoena setting forth the manner of service, or, 
     in the case of service by certified mail, the return post 
     office receipt therefor signed by the person so served, shall 
     be proof of service.
       ``(d) Payment of Witnesses.--Witnesses subpoenaed under 
     subsection (a) shall be paid the same fees and mileage as are 
     paid witnesses in the district courts of the United States.
       ``(e) Enforcement.--In the case of a refusal to obey a 
     subpoena duly served upon any person under subsection (a), 
     any district court of the United States for the judicial 
     district in which such person charged with refusal to obey is 
     found, resides, or transacts business, upon application by 
     the Commissioner, shall have jurisdiction to issue an order 
     compelling compliance with the subpoena and requiring such 
     person to appear and give testimony or to appear and produce 
     records and other things, or both. The failure to obey such 
     order of the court may be punished by the court as contempt 
     thereof. If the person charged with failure or refusal to 
     obey is not found within the territorial jurisdiction of the 
     United States, the United States District

[[Page 19708]]

     Court for the District of Columbia shall have the same 
     jurisdiction, consistent with due process, to take any action 
     respecting compliance with the subpoena by such person that 
     such district court would have if such person were personally 
     within the jurisdiction of such district court.
       ``(f) Nondisclosure.--A United States district court for 
     the district in which the subpoena is or will be served, upon 
     application of the Commissioner, may issue an ex parte order 
     that no person or entity disclose to any other person or 
     entity (other than to an attorney to obtain legal advice) the 
     existence of such subpoena for a period of up to 90 days. 
     Such order may be issued on a showing that the records or 
     things being sought may be relevant to the hearing, 
     investigation, proceeding, or other matter and that there is 
     reason to believe that such disclosure may result in--
       ``(1) furtherance of a potential violation under 
     investigation;
       ``(2) endangerment to the life or physical safety of any 
     person;
       ``(3) flight or other action to avoid prosecution or other 
     enforcement remedies;
       ``(4) destruction of or tampering with evidence; or
       ``(5) intimidation of potential witnesses.
     An order under this subsection may be renewed for additional 
     periods of up to 90 days upon a showing that any of the 
     circumstances described in paragraphs (1) through (5) 
     continue to exist.
       ``(g) Relation to Other Provisions.--The subpoena authority 
     vested in the Commissioner and the district courts of the 
     United States by this section is in addition to any such 
     authority vested in the Commissioner or such courts by other 
     provisions of  law, or as is otherwise authorized by law.
       ``(h) Nondelegation.--The authority to issue a subpoena 
     under this section is limited to the Secretary or an official 
     designated by the Secretary. An official may not be so 
     designated unless the official is the director of the 
     district under this Act in which the article involved is 
     located, or is an official senior to such director.''.

     SEC. 212. WHISTLEBLOWER PROTECTIONS.

       Chapter X (21 U.S.C. 391 et seq.), as amended by section 
     206, is amended by adding at the end the following:

     ``SEC. 1012 PROTECTIONS FOR EMPLOYEES WHO REFUSE TO VIOLATE, 
                   OR WHO DISCLOSE VIOLATIONS OF, THIS ACT.

       ``(a) In General.--No person who submits or is required 
     under this Act or the Public Health Service Act to submit any 
     information related to a food, or any officer, employee, 
     contractor, subcontractor, or agent of such person may 
     discharge, demote, suspend, threaten, harass, or in any other 
     manner discriminate against an employee in the terms and 
     conditions of employment because of any lawful act done by 
     the employee, including within the ordinary course of the job 
     duties of such employee--
       ``(1) to provide information, cause information to be 
     provided, or otherwise assist in any investigation regarding 
     any conduct which the employee reasonably believes 
     constitutes a violation of this Act, or any other provision 
     of Federal law relating to the safety of a food, if the 
     information or assistance is provided to, or an investigation 
     stemming from the provided information is conducted by--
       ``(A) a Federal regulatory or law enforcement agency;
       ``(B) any Member of Congress or any committee of Congress; 
     or
       ``(C) a person with supervisory authority over the employee 
     (or such other person working for the employer who has the 
     authority to investigate, discover, or terminate the 
     misconduct);
       ``(2) to file, cause to be filed, testify, participate in, 
     or otherwise assist in a proceeding filed, or about to be 
     filed (with any knowledge of the employer), in any court or 
     administrative forum relating to any such alleged violation; 
     or
       ``(3) to refuse to commit or assist in any such violation.
       ``(b) Enforcement Action.--
       ``(1) In general.--An employee who alleges discharge or 
     other discrimination in violation of subsection (a) may seek 
     relief in accordance with the provisions of subsection (c) 
     by--
       ``(A) filing a complaint with the Secretary of Labor; or
       ``(B) if the Secretary of Labor has not issued a final 
     decision within 210 days of the filing of the complaint and 
     there is no showing that such delay is due to the bad faith 
     of the claimant, or within 90 days after receiving a final 
     decision or order from the Secretary, bringing an action at 
     law or equity for de novo review in the appropriate district 
     court of the United States, which court shall have 
     jurisdiction over such action without regard to the amount in 
     controversy, and which action shall, at the request of either 
     party to such action, be tried by the court with a jury.
       ``(2) Procedure.--
       ``(A) In general.--Any action under paragraph (1) shall be 
     governed under the rules and procedures set forth in section 
     42121(b) of title 49, United States Code.
       ``(B) Exception.--Notification in an action under paragraph 
     (1) shall be made in accordance with section 42121(b)(1) of 
     title 49, United States Code, except that such notification 
     shall be made to the person named in the complaint, the 
     employer, and the Commissioner of Food and Drugs.
       ``(C) Burdens of proof.--An action brought under paragraph 
     (1)(A) or (1)(B) shall be governed by the legal burdens of 
     proof set forth in section 42121(b) of title 49, United 
     States Code.
       ``(D) Statute of limitations.--An action under paragraph 
     (1)(A) shall be commenced not later than 180 days after the 
     date on which the violation occurs.
       ``(c) Remedies.--
       ``(1) In general.--An employee prevailing in any action 
     under subsection (b)(1) shall be entitled to all relief 
     necessary to make the employee whole.
       ``(2) Issuance of order.--If, in response to a complaint 
     filed under paragraph (b)(1), the Secretary of Labor or the 
     district court, as applicable, determines that a violation of 
     subsection (a) has occurred, the Secretary or the court shall 
     order the person who committed such violation--
       ``(A) to take affirmative action to abate the violation;
       ``(B) to--
       ``(i) reinstate the complainant to his or her former 
     position together with compensation (including back pay); and
       ``(ii) restore the terms, conditions, and privileges 
     associated with his or her employment; and
       ``(C) to provide compensatory damages to the complainant.
     If such an order is issued under this paragraph, the 
     Secretary or the court, at the request of the complainant, 
     shall assess against the person against whom the order is 
     issued a sum equal to the aggregate amount of all costs and 
     expenses (including attorney and expert witness fees) 
     reasonably incurred, as determined by the Secretary, by the 
     complainant for, or in connection with, the bringing of the 
     complaint upon which the order was issued.
       ``(d) Rights Retained by Employee.--Nothing in this section 
     shall be deemed to diminish the rights, privileges, or 
     remedies of any employee under any Federal or State law or 
     under any collective bargaining agreement. The rights and 
     remedies in this section may not be waived by any agreement, 
     policy, form, or condition of employment.''.

     SEC. 213. EXTRATERRITORIAL JURISDICTION.

       (a) Prohibited Act.--Section 301 (21 U.S.C. 331), as 
     amended by sections 110, 111, 133, 136, and 204, is amended 
     by adding at the end the following:
       ``(aaa) 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.''.
       (b) Jurisdiction.--Chapter III (21 U.S.C. 331 et seq.), as 
     amended by section 211, is amended by adding at the end the 
     following:

     ``SEC. 312. EXTRATERRITORIAL JURISDICTION.

       ``There is extraterritorial Federal jurisdiction over any 
     violation of this Act relating to any article of food if such 
     article was intended for import into the United States or if 
     any act in furtherance of the violation was committed in the 
     United States.''.

     SEC. 214. SUPPORT FOR TRAINING INSTITUTES.

       The Secretary of Health and Human Services, acting through 
     the Commissioner of Food and Drugs, shall provide financial 
     and other assistance to appropriate entities to establish and 
     maintain one or more university-affiliated food protection 
     training institutes that--
       (1) conduct training related to food protection activities 
     for Federal, State, local, territorial, and tribal officials; 
     and
       (2) meet standards developed by the Secretary.

     SEC. 215. BISPHENOL A IN FOOD AND BEVERAGE CONTAINERS.

       (a) Notice of Determination.--No later than December 31, 
     2009, the Secretary of Health and Human Services shall notify 
     the Congress whether the available scientific data support a 
     determination that there is a reasonable certainty of no 
     harm, for infants, young children, pregnant women, and 
     adults, for approved uses of polycarbonate plastic and epoxy 
     resin made with bisphenol A in food and beverage containers, 
     including reusable food and beverage containers, under the 
     conditions of use prescribed in current Food and Drug 
     Administration regulations.
       (b) Notice of Actions to Be Taken.--If the Secretary 
     concludes that such a determination cannot be made for any 
     approved use, the Secretary shall notify the Congress of the 
     actions the Secretary intends to take under the Secretary's 
     authority to regulate food additives to protect the public 
     health, which may include--
       (1) revoking or modifying any of the approved uses of 
     bisphenol A in food and beverage containers, including 
     reusable food and beverage containers; and
       (2) ensuring that the public is sufficiently informed of 
     such determination and the steps the public may take in 
     response to such determination.
       (c) Rule of Construction.--Nothing herein is intended or 
     shall be construed to modify existing Food and Drug 
     Administration authority, procedures, or policies for 
     assessing scientific data, making safety determinations, or 
     regulating the safe use of food additives.

[[Page 19709]]



     SEC. 216. LEAD CONTENT LABELING REQUIREMENT FOR CERAMIC 
                   TABLEWARE AND COOKWARE.

       (a) In General.--Section 403 (21 U.S.C. 343), as amended by 
     sections 101(a), 109(a), 114(a), 202, and 204, is amended by 
     adding at the end the following:
       ``(ff) If it is ceramic tableware or cookware and includes 
     a glaze or decorations containing lead for an intended 
     functional purpose, unless--
       ``(1) the product and its packaging bear the statement: 
     `This product is made with lead-based glaze consistent with 
     Food and Drug Administration guidelines for such lead.'; or
       ``(2) the product is in compliance with the requirements 
     applicable to ornamental and decorative ceramicware in 
     section 109.16 of title 21, Code of Federal Regulations (or 
     any successor regulation).''.
       (b) Effective Date.--Section 403(ff) of the Federal Food, 
     Drug, and Cosmetic Act, as added by subsection (a), shall 
     apply only to ceramic tableware or cookware that is 
     manufactured on or after the date that is 1 year after the 
     date of the enactment of this Act.
       (c) Consumer Education.--Chapter IV (21 U.S.C. 341 et 
     seq.), as amended by sections 102, 103, 104, and 111, is 
     amended by adding at the end the following:

     ``SEC. 421. CONSUMER EDUCATION ON THE CONTENT OF LEAD IN 
                   CERAMICWARE AND APPLICABLE LABELING 
                   REQUIREMENTS.

       ``(a) In General.--The Secretary shall educate consumers on 
     the safety of ceramicware for food use by posting information 
     on the Web site of the Food and Drug Administration with 
     regard to--
       ``(1) the content of lead in ceramicware and its glaze;
       ``(2) existing Federal laws and regulations governing lead 
     in ceramicware;
       ``(3) as appropriate, existing industry practices and 
     guidelines; and
       ``(4) the labeling requirements applicable under this Act.
       ``(b) Topics.--The education under this section shall 
     address--
       ``(1) the broad range of ceramicware types, including 
     traditional pottery, ornamental and decorative ceramicware, 
     cookware, and everyday dinnerware;
       ``(2) the safety of ceramicware that is aged or damaged;
       ``(3) the use of ceramicware in microwave ovens;
       ``(4) the storage of foods in ceramicware;
       ``(5) the use of home lead test kits by consumers;
       ``(6) the use of ceramicware by children and women of 
     childbearing age; and
       ``(7) issues that are especially relevant to subpopulations 
     of consumers who may preferentially use certain types of 
     ceramicware made with lead.''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Michigan (Mr. Dingell) and the gentleman from Texas (Mr. Barton) each 
will control 20 minutes.
  The Chair now recognizes the gentleman from Michigan.
  Mr. BARTON of Texas. Before we recognize Chairman Dingell, I would 
ask unanimous consent that Mr. Lucas, the ranking member of the 
Agriculture Committee, control 10 minutes of my time.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Texas?
  There was no objection.


                             General Leave

  Mr. DINGELL. Mr. Speaker, I ask unanimous consent that all Members 
have 5 legislative days in which to revise and extend their remarks and 
insert extraneous matter into the Record.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Michigan?
  There was no objection.
  Mr. DINGELL. Mr. Speaker, I yield myself 2 minutes.
  Mr. Speaker, this is a remarkable piece of bipartisan work. I want to 
pay tribute to my dear friend Mr. Barton, the ranking minority member 
of the committee; my good friend, the chairman of the committee, for 
his outstanding leadership on this, Mr. Waxman; and also Mr. Pallone, 
as chairman of the subcommittee, for their leadership.
  I want to tell the House how important the labors of my dear friend 
Mr. Stupak have been in the Oversight Investigations Committee in 
creating the basis from which this legislation can move forward. This 
has been a piece of legislation which moved unanimously out of the 
committee. It is something which we would hope this House would always 
be able to emulate.
  I want to congratulate Representatives Sutton, Nathan Deal, and John 
Shimkus for their labors, and the outstanding staff on both sides of 
the Commerce Committee.
  I want to express my appreciation to Collin Peterson and Mr. Cardoza 
of California for their labors, and Representative DeLauro and 
President Obama and the White House food safety group.
  The legislation is supported by the Consumers Union, the Centers for 
Science and Public Interest, the National Consumers League, and a large 
number of other organizations, including the Grocery Manufacturers, 
GMA, and United Fresh Produce. Jeanie Ireland and my good friend Virgil 
Miller have worked very hard at the staff level, and they deserve 
thanks.
  This is a piece of legislation that will stop Americans being killed 
by bad foods. It is a piece of legislation that will see to it that the 
Food and Drug Administration has both the authority and the funds to 
address not only American foods but foods being imported from places 
like China. It will stop harmful seafood, E. coli in spinach, tainted 
peppers from Mexico, and a large number of other things.
  I urge my colleagues to support this legislation.
  I reserve the balance of my time.
  Mr. BARTON of Texas. Mr. Speaker, I want to yield 2 minutes to the 
ranking member of the Health Subcommittee, Mr. Deal of Georgia.
  Mr. DEAL of Georgia. I thank the gentleman for yielding.
  I, too, want to thank the sponsor of this legislation and our 
committee for working in a bipartisan fashion. As many of you will 
recall, earlier this year, our Nation was rocked with a peanut butter 
contamination that involved salmonella, and it became very apparent 
very shortly after the investigation started that a rogue operator, the 
Peanut Corporation of America, had risked the well-being of thousands 
of Americans.
  In addition, it resulted in millions of dollars of loss to an 
industry that is very important to my State of Georgia. Peanut sales 
plummeted. It was in an effort to shore up the company's individual 
bottom line that PCA had recklessly jeopardized both peanut farmers and 
processors and the public in this country.
  Now, this is a piece of legislation that is designed to try to 
correct some of those problems because they are not unique just to the 
peanut industry. We've seen them in the tomato, jalapeno pepper, the 
pistachio nuts, the contamination of spinach and many others. This 
legislation requires the development and implementation of a hazard 
analysis and food safety plan with regular updating, a requirement 
which is already in place for USDA-regulated facilities, such as 
poultry processing that is in my district. These plans have proved to 
be effective in reducing the hazard of food-borne contamination.
  This legislation also implements a risk-based inspection schedule, 
which improves today's unacceptable status quo and targets our most 
vulnerable facilities for greater oversight. I know there's been 
concern about the overlap into USDA activities. There is language in 
the bill that would exclude the inclusion of farms within the bill. 
They are excluded. They are not required to register. They're not 
required to pay a registration fee. Livestock and poultry are also 
exempt. It does not allow the FDA to regulate what are now USDA-
regulated facilities and products.
  I commend this legislation and urge my colleagues to adopt it.
  Mr. DINGELL. Mr. Speaker, I yield 2 minutes to the distinguished 
chairman of the Committee on Energy and Commerce, Mr. Waxman, whose 
leadership in this matter has been appreciated.
  Mr. WAXMAN. Mr. Speaker, a series of food-borne disease outbreaks in 
spinach, peanuts, and peppers, to name a few, have not only just 
sickened and killed American consumers, they've laid bare the 
unacceptable gaps in our food safety laws. And today, the House will 
act to close those gaps, give FDA new authorities, new tools, and a new 
source of funding to carry out this vital mission.
  This legislation contains policy solutions that come from many 
Members on both sides of the aisle. It's largely based on legislation 
introduced by Chairman Emeritus John Dingell,

[[Page 19710]]

Subcommittee Chairmen Pallone and Stupak. These three Members have 
played an instrumental role in this legislation, as have 
Representatives Sutton and DeGette on our committee.
  In addition, I want to single out Chairwoman Rosa DeLauro who 
introduced the landmark legislation which contributed in a substantial 
way to this bill. I want to thank our full committee Ranking Member 
Barton and subcommittee Ranking Members Shimkus and Deal for their 
contributions to the legislation as well, and Chairman Peterson and 
Chairman Rangel who gave suggestions to make the bill a better bill.
  The coalition of food safety groups worked with the Members to 
develop and maintain the strong, public health protections in this 
bill. I think that they deserve an enormous amount of recognition, but 
I want to thank Rachel Sher of my staff for her thoughtful work and 
countless hours on this bill. Other key staff on the effort include 
Eric Flamm, Virgil Miller, Elana Leventhal, and Erika Orloff, as well 
as several individuals from the minority staff, including Ryan Long, 
Clay Alspach, Blake Fulenwider, and Chris Sarley.
  And finally, I want to thank President Obama and his administration 
for their contributions to this legislation. The safety of the food 
supply is a critical issue, and this legislation will give the 
administration the tools they need to keep this food supply safe.
  I urge a ``yes'' vote for the bill.
  Mr. LUCAS. I yield myself 5 minutes.
  Mr. Speaker, I truly regret that I must rise in opposition to this 
legislation, H.R. 2749, the Food Safety Enhancement Act of 2009.
  Let me begin by saying that I believe our Nation has the safest food 
supply in the world. I also believe that we must continually examine 
our food production and regulatory system and look for ways to improve 
food safety. However, the bill before us today does little to 
accomplish the goal of enhancing food safety. One glaring example is 
the fact that the authors of the bill did not require the U.S. Food and 
Drug Administration--``require'' being the operative phrase--to spend 
one additional penny on the inspection of food.

                              {time}  1415

  The bill before us today is the product of a flawed process. This is 
just another example of Federal power without the benefit of careful 
consideration. It is what we have come to expect from the majority 
leadership of the 111th Congress. We could point to the stimulus 
package, cap-and-trade, and soon the health care bill as examples of a 
blatant disregard for the legislative process and for the American 
people, for whom we work. As of last night, no one had seen a copy of 
this bill.
  It is tragic that despite a clear jurisdictional claim, the chairman 
of the House Agriculture Committee did not demand that the bill be 
referred, conduct hearings on its provisions and work at the 
committee's will to make improvements.
  But this is not just a matter of jurisdiction between two committees. 
The real losers today are farmers, ranchers, and, yes, consumers. 
During a recent committee hearing on the general topic of food safety, 
not a single producer witness would support this bill in its current 
form. This is a stunning failure to fulfill our legislative 
responsibility.
  One provision of particular concern would mandate that the Food and 
Drug Administration set on-farm production performance standards. For 
the first time, we would have the Federal Government prescribing how 
our farmers grow crops. Farming, the growing of crops and the raising 
of livestock, is one of the first organized activities pursued by man. 
We have been doing it for a very long time, and we have been doing it 
without the FDA.
  New language to the bill would exclude row crop producers from FDA 
regulatory authority over growing and harvesting crops. Language was 
also approved that would relieve livestock producers from some of the 
burdens of the law. Although these are needed changes, they do not go 
far enough to make the bill acceptable.
  This bill still leaves our Nation's fruit and vegetable producers 
subject to objectionable regulatory burdens.
  There are other problems in the bill as well. New registration 
authorities for food processing facilities create what amounts to a 
Federal license to be in the food business. Hundreds of millions of 
dollars in associated fees represented by a new tax on food production, 
along with regulatory burdens, will increase the cost of food for 
consumers, increasingly forcing food production out of this country, 
unfortunately.
  New quarantine authorities for FDA will undermine animal and plant 
inspection control programs that have been in place at USDA for 
decades.
  The vast majority of these provisions, along with new penalties, 
record-keeping requirements, traceability, labeling, country-of-origin 
labeling, will do absolutely nothing to prevent food-borne disease 
outbreaks, but will do plenty to keep the Federal bureaucracy busy. 
These issues can be worked out through the normal legislative process, 
but only if there is a process.
  Mr. Speaker, let me return to where I started. We have the safest 
food supply in the world. Anyone following current events knows that 
our food production system faces ongoing food safety challenges, and I 
stand ready to work with my colleagues to address these challenges. But 
this is not the way to create law.
  We should not suspend the rules to pass this bill. Our Nation's 
farmers, ranchers and consumers deserve better, Mr. Speaker.
  Mr. Speaker, I reserve the balance of my time.
  Mr. DINGELL. Mr. Speaker, I will have a full rebuttal for the remarks 
of the gentleman who has just spoken.
  I yield 1 minute at this time to my dear friend, the chairman of the 
subcommittee, the gentleman from New Jersey (Mr. Pallone).
  Mr. PALLONE. Mr. Speaker, I thank the chairman.
  I rise in strong support of H.R. 2749, the Food Safety Enhancement 
Act of 2009. It is time that we put in place a stronger and more 
thorough system to prevent food-borne illness rather than continuing to 
simply react to outbreak after outbreak of contaminated products.
  This bill will require that food manufacturers put in place 
preventive controls to monitor the production lines and identify, 
prevent or eliminate hazards, should they arise. It requires them to 
have food safety plans detailing all the food safety activities that 
the company is undertaking to ensure the safety of their products.
  Under the bill, the FDA will have the authority to set performance 
standards that companies must incorporate into their food safety plans; 
it requires the FDA to put in place a traceability system for food 
products. It requires the FDA to inspect facilities according to a 
minimum inspection frequency, and it provides the FDA with enhanced 
enforcement authorities.
  Mr. Speaker, this is the strongest bill it can be. It will catapult 
the FDA into the 21st century, and it will arm the agency with the 
necessary authorities and enforcement power to protect our Nation's 
food supply.
  Mr. BARTON of Texas. Mr. Speaker, I yield 2 minutes to the gentleman 
from Illinois (Mr. Shimkus).
  Mr. SHIMKUS. Mr. Speaker, I want to thank Chairman Emeritus Dingell 
for his work on this bill. I also want to thank Chairman Waxman.
  Mr. DINGELL. If the gentleman will yield, I want to tell the House 
how important the labors of the gentleman have been, and also those of 
Mr. Barton and Mr. Deal. We owe a great debt to the gentleman.
  Mr. SHIMKUS. Thank you very much. I also want to thank Chairman 
Waxman for mentioning Chris Sarley, who did yeoman's work with the 
majority staff, and I appreciate their kindness and work effort.
  This is a model for what we can do on energy and what we can do on 
health if we would move in that direction. We can't defend the current 
system. As a former ranking member on Oversight and Investigations, 
there are fixes that have to be made.

[[Page 19711]]

  This bill provides a risk-based inspection regime and gives the FDA 
flexibility to change the frequency of inspections to lower-risk 
facilities. It allows FDA access to records. It gives companies 
flexibility to use different preventative control systems. And where 
things are working, we let existing authority remain with respect to 
USDA.
  I am an ag Republican, so I understand the concerns of my colleagues 
on the Ag Committee. But this bill does not require farms to register 
with the FDA; and as a result, farms do not have to pay a registration 
fee.
  Access to farm records is significantly restricted. Livestock and 
poultry are exempt from the bill. Grain and related commodities are 
exempt from produce standards. USDA-regulated farms, facilities and 
products are not subject to this bill. It allows farms to be exempt 
from any traceability requirements.
  But I will pledge to continue to work with any ag Republican 
colleagues as this process moves forward to try to address some of the 
remaining concerns. I do appreciate the majority and their work on 
this. Again, I think it is a good method for which we can move on 
energy and health care when we get to a point where we want to do that.
  Mr. DINGELL. Mr. Speaker, I am very delighted at this time to yield 1 
minute to the distinguished gentleman from Michigan (Mr. Stupak), 
chairman of the Subcommittee on Oversight and Investigations, who has 
done so much to make the investigations which have brought us to the 
point where people understand the need for this legislation.
  Mr. STUPAK. Mr. Speaker, I rise in support of H.R. 2749, the Food 
Safety Enhancement Act. As chairman of the Subcommittee on Oversight 
and Investigations, I, along with Ranking Members Whitfield, Shimkus 
and Walden, have held 10 hearings over the past 2 years to examine the 
safety and security of our Nation's food supply.
  This investigation takes important steps towards addressing the 
gaping holes in our Nation's food supply by recognizing that the food 
industry and the FDA must share responsibility for securing our 
Nation's food supply. Provisions granting the FDA additional 
authorities, such as quarantine, recall, subpoena power and access to 
records, are all addressed in H.R. 2749.
  I want to thank my colleagues and friends, Chairman Dingell, Chairman 
Pallone and Chairman Waxman, for all their hard work on this issue. I 
also wish to thank their staffs, who have worked diligently to see this 
bill come before us today. Plus I want to thank the Obama 
administration for working with us.
  All the dedication of all the individuals have paid off with a piece 
of legislation that will help protect and ensure all Americans have 
access to safe food. I am proud to be part of such great legislation. I 
urge all of my colleagues to support its passage.
  Mr. LUCAS. Mr. Speaker, I wish to yield 1\1/4\ minutes to the 
gentleman from Kansas (Mr. Moran).
  Mr. MORAN of Kansas. Mr. Speaker, I thank the gentleman for yielding.
  Do not vote in favor of H.R. 2749 thinking that today's vote is a 
throwaway one to demonstrate one's support for food safety.
  We are all interested in food safety. It matters. Those of us 
involved in agriculture care about food safety. It is a matter of life 
and health for our consumers, and for the farmers and ranchers it is a 
matter of their livelihood. Even the rumor of unsafe food causes 
commodity prices to fall and farm incomes to decline.
  While I am unable to tell my colleagues the exact details of this 
bill, I can say with certainty there are significant adverse 
consequences to farmers, especially our smallest ones, and those 
consequences include on-farm performance standards, record-keeping 
requirements, arbitrary record access requirements and registration 
fees, none of which may actually improve food safety.
  The reason I am unable to describe the details of this bill is that 
those details became available only this morning. The bill before us 
was amended, striking everything after the enacting clause and 
inserting a new text. The entire bill as it existed yesterday was 
deleted and new language put in its place. There have been few hearings 
on this bill, constant redrafting by a few people outside the 
committees, and no referral to the Committee on Agriculture.
  Do not let the Suspension Calendar fool you. This bill is substantive 
legislation with uncertain consequences. Vote ``no.''
  Mr. DINGELL. Mr. Speaker, I yield 1 minute to the distinguished 
gentlewoman from Connecticut (Ms. DeLauro).
  Ms. DeLAURO. Mr. Speaker, I rise in support of this bill and thank 
Chairman Waxman and Chairman Emeritus Dingell for their hard work.
  The bill begins a long task of rectifying decades of neglect by 
updating FDA's ancient tools and outdated mandates. It gives the FDA 
the means to deal with dangers imposed by a global food system and 
enhances the agency's ability to prevent food contamination.
  It incorporates key provisions from legislation I introduced this 
year and moves the FDA to a risk-based inspection system. It requires 
the agency to inspect the highest-risk facilities once every 6 months 
to a year, rather than once a decade.
  It enhances reporting requirements for companies and establishes 
performance standards for fighting food-based pathogens. Performance 
standards form the backbone for monitoring the effectiveness of process 
control systems and identifying the foods at greatest risk.
  I continue to strongly believe that the best way to protect our food 
supply is to streamline the FDA into two separate agencies within 
Health and Human Services so that food and drug safety both get the 
full and comprehensive attention they deserve.
  This bill is a strong, solid first step in creating a comprehensive 
food safety system that can protect American families from the many 
dangers of contaminated food. I urge my colleagues to support this 
bill.
  Mr. BARTON of Texas. I yield 2 minutes to the gentleman from Oregon 
(Mr. Walden), the ranking member of the Oversight Subcommittee of the 
Committee on Energy and Commerce.
  Mr. WALDEN. Mr. Speaker, this really ought to be called Jake's Law, 
after 3-year-old Jake Hurley of Wilsonville, Oregon. In February, 
before the Oversight and Investigations Subcommittee, Jake's father, 
Peter, testified about how Jake contracted salmonella from eating 
peanut butter products from Peanut Corporation of America in Georgia.
  In January, Jake became sick. His doctors asked his parents, what 
does he like to eat? They recommended some food products. As it turned 
out, those very food products in their home were contaminated with 
salmonella that came about because of PCA.
  So when Stewart Parnell, the PCA president, testified before our 
Oversight Committee, I asked him, Would you like to sample some of the 
products that you sent out to little kids like Jake and other Americans 
to eat? His response? He took the Fifth Amendment.
  Thankfully, Jake recovered. But nine people died from the outbreak, 
and at least 691 people, half of them children, were sickened.
  If PCA had to follow a law like this that would require a fully-
functioning food safety plan at food production facilities, 
traceability of the food chain, increased inspection and recall 
authority from FDA, there is a good chance that the salmonella outbreak 
could have been avoided and Jake and hundreds of others never would 
have been poisoned.
  Because of Jake's story and others like it we uncovered in bipartisan 
O&I food safety hearings since 2007, we now have a bipartisan piece of 
legislation here to pass the House of Representatives; and I urge your 
support for it, for the food safety of our country and the citizens 
that live here.
  Mr. DINGELL. If the gentleman will yield, I want to compliment the 
gentleman on his comments and I want to praise him for his valuable and 
important contribution to the legislation. As

[[Page 19712]]

he has said, this is how legislation should be done, bipartisan; and we 
have gone across the aisle. But we have also gone between committees, 
working with the distinguished chairman of the Agriculture Committee. I 
commend the gentleman and thank him.
  Mr. WALDEN. I thank the gentleman for his comments.
  Mr. DINGELL. Mr. Speaker, I yield 1 minute to my distinguished 
friend, the gentlewoman from California (Ms. DeGette), a Member who has 
worked very hard on this legislation for a long time and who was one of 
the original sponsors and has been a valuable contributor to the 
process of bringing it forward.

                              {time}  1430

  Ms. DeGETTE. Mr. Speaker, many of us have been talking about 
comprehensive food safety for years. Our Nation's business community is 
calling for it. Our constituents are begging for it. I am so pleased 
that today, at long last, we are considering this bill on the House 
floor on a bipartisan basis.
  The bill before us will strengthen our food supply in a number of 
areas. It will transform our system into one that focuses on 
prevention, rather than reaction. It will provide the FDA with the 
resources it has lacked; and by giving it mandatory recall authority 
and subpoena authority, it will give the FDA the tools it needs to deal 
with an emergency.
  Mr. Speaker, this bill also will give the FDA the ability to track 
our food products along the supply chain, enabling targeted and 
speedier recalls that will benefit business and consumers alike. This 
traceability provision of the legislation, we know we can't do it 
overnight, but it will require the FDA to write regulations undertaking 
a pilot project, cost-benefit analysis, feasibility studies and public 
meetings to make sure that we can track food from field to fork. This 
will improve consumer safety and we exempt the family farm.
  I urge adoption of this important bill.
  Mr. LUCAS. Mr. Speaker, I yield 1 minute to the gentleman from Ohio 
(Mr. Latta).
  Mr. LATTA. Mr. Speaker, I thank the gentleman for yielding.
  Mr. Speaker, section 101 of the bill requires an annual registration 
for a facility. The term ``facility'' means any factory, warehouse or 
establishment, including a factory, warehouse or establishment of an 
importer that manufactures, processes, packs or holds foods.
  The user fees under this section require registration each year 
starting in 2010 to be $500 and each subsequent year to be adjusted for 
inflation. This will affect small businesses and impose tax increases. 
For companies and individuals that own or operate multiple facilities, 
a maximum level for total fees per year is set at $175,000. These will 
have to be passed on to the consumer and will raise the price of food 
to cover the fees associated under this bill.
  I encourage my colleagues to vote ``no'' on this bill under 
suspension so that Congress may debate food safety and come to an 
agreement on how to protect our Nation's farmers and food facilities in 
order to maintain the United States as having the world's safest, most 
economically viable food source.
  The SPEAKER pro tempore. The Chair will note that the gentleman from 
Texas has 4 minutes remaining, the gentleman from Oklahoma has 3\1/4\ 
minutes remaining, and the gentleman from Michigan has 12 minutes 
remaining.
  Mr. DINGELL. Mr. Speaker, just for administrative purposes, does my 
friend on the Republican side have a sufficiency of time? I speak about 
Mr. Barton.
  Mr. BARTON of Texas. Mr. Chairman, we could use another 2 to 3 
minutes, if you have it.
  Mr. DINGELL. I will try to see if we can share, if it is necessary.
  Mr. Speaker, at this time I yield to one of the original sponsors of 
the legislation, the distinguished gentlelady who has done much work to 
get this legislation to the floor, the distinguished gentlewoman from 
Ohio (Ms. Sutton) 1 minute.
  Ms. SUTTON. Mr. Speaker, I rise today as a proud cosponsor of the 
Food Safety Enhancement Act of 2009, and I commend the distinguished 
Chair Emeritus, John Dingell, for his dedication to formulating and 
passing this bill, which is so sorely needed to protect the safety of 
our food supply.
  This year alone, we have experienced a series of outbreaks of food-
borne illnesses. These outbreaks have taken a disproportionate toll on 
our State of Ohio. The peanut-related salmonella outbreak affected 92 
individuals in Ohio, and, sadly, resulted in three tragic deaths. 
Nellie Napier, a constituent of mine, died from salmonella poisoning 
that she contracted in a nursing facility.
  This bill is an essential step toward lowering these tragic numbers 
and restoring consumer confidence in our food supply. It will increase 
inspections of food facilities, improve traceability, and provide 
needed funding to the FDA for food safety activities. And with the 
increased globalization of our food supply--close to 13 percent of the 
food we eat comes from abroad--and this bill will help protect 
consumers from unsafe imported foods.
  Mr. BARTON of Texas. I yield 2 minutes to the former Republican 
Conference chairman and probably future Governor of Florida (Mr. 
Putnam).
  Mr. PUTNAM. I thank my friend from Texas.
  I rise to support this bill which is built on a bipartisan 
foundation. I thank my friend from California (Mr. Costa) who worked 
with a number of us to put together a strong food safety bill, and many 
of the key principles embedded in that bill have been built into the 
bill that we're debating here today. This is an issue that brings 
together America's farmers, ranchers and the consumers. There is no 
difference or distinction between the interests of those two parties. 
As the FDA's false information about the tomatoes implicated in the 
food-borne illness outbreak illustrates, when there is false 
information out there, the industry suffers; and when there is food-
borne illness out there, consumer confidence is eroded. Both of those 
outcomes are unacceptable. So there is a need for both sides to come 
together on this, and I am proud that this is a bipartisan effort.
  I would highlight some issues, though, that need additional work as 
this moves into the Senate. Most importantly, the quarantine and 
traceability issues need further work as well as the work that is done 
by our State and local Departments of Health and Departments of 
Agriculture. They are delegated 80 percent of FDA's authority to 
implement most of this bill and the other responsibilities of FDA. They 
must have better coordination and cooperation from the FDA in 
implementing this legislation as well as the rest of the food safety 
mandates already in the law. But overall, it is important that this 
Nation move forward with a modernization of the food safety system, 
some of which has not been built upon since the Teddy Roosevelt 
administration. It is important to our farmers and ranchers, and it is 
important to our consumers.
  So for that reason, I am proud to stand in support of this bill and 
urge its passage, recognizing that there are issues that we need to 
continue to work with our friends and colleagues in the Senate on.
  Mr. DINGELL. At this time I yield 1 minute to the distinguished 
chairman of the Agriculture Committee's subcommittee on food safety, 
the gentleman from Georgia (Mr. Scott), with thanks and appreciation 
for his good work.
  Mr. SCOTT of Georgia. Thank you so much, Chairman Dingell. I 
appreciate that so much. I really, quite honestly, can't understand how 
anybody could vote against this bill. We've already had three outbreaks 
that have definitely taken lives of the American people. But I want to 
thank, Chairman Peterson on our Agriculture Committee, as well as 
Chairman Dingell; and I certainly want to congratulate and thank our 
staff on my own subcommittee, Chandler Goule and Gary Woodward, for the 
excellent job that they have done. And to the gentleman

[[Page 19713]]

on the other side, we've had hearings on this; but the greatest hearing 
we've had on this has been the threats to the safety of the American 
people. If we enact these measures in this bill, we will save American 
lives.
  Let me just tell you about one example: Better access to records in 
order to prevent the outbreaks. This bill will give the FDA access to 
the records of food producers and manufacturers during the time that 
they are inspecting the plants. Under current law, the FDA must wait 
for the food-borne illness to occur before they can even access the 
records. Now, ladies and gentlemen, if this had been in place, eight 
people would be alive today from the peanut outbreak in my district of 
Georgia. This is an important bill, it's timely, and I urge its 
passage.
  Mr. LUCAS. Mr. Speaker, I yield 1 minute to the gentleman from Iowa 
(Mr. King).
  Mr. KING of Iowa. I thank the gentleman from Oklahoma for yielding, 
and I rise in opposition to this food safety bill, as it's labeled. It 
will provide some more food safety. I won't dispute that. But the point 
is that it grows government regulation, and it broadens the FDA's 
regulations over what I think, if it's going to be regulated, should be 
USDA.
  We are looking at two, three or four individual food safety problems; 
and instead of looking at that and trying to solve the problem, first, 
we should try to solve it without legislation. Second, it should be 
specific to the food rather than the broad stroke that this bill is. I 
know that there are exemptions for feed grains; but in the end, this is 
a growth of regulation. It's a burden on our farmers and our food 
producers. It's a tax on our food producers. It's going to come out of 
the pockets of the American consumers, and it will diminish the smaller 
operations among us.
  We have here a solution in search of a problem. We can solve this 
problem without new extra regulatory authority for the FDA. I rise in 
opposition to this bill, and I believe it should be Ag Committee 
jurisdiction.
  Mr. DINGELL. Mr. Speaker, at this time I yield 2 minutes to the 
distinguished gentleman from California (Mr. Costa), one of the great 
leaders in food safety, a distinguished member of the Committee on 
Agriculture, a man who has worked very closely with me and with the 
others who have been working on this, including the distinguished 
chairman of the Agriculture Committee.
  Mr. COSTA. I want to start by thanking Chairman Emeritus John Dingell 
for his hard work on this effort, as he does in so many pieces of 
legislation that have been a part of his legacy; Chairman Waxman and 
Chairman Peterson for their support and efforts to ensure that we come 
together in a collective effort; Ranking Member Barton and my colleague 
and friend Congressman Adam Putnam from Florida.
  We introduced this legislation in the last session of Congress, 
working to try to put together a bipartisan effort, understanding that 
food safety is job number one for all American farmers, ranchers and 
dairymen because they are consumers, their families consume their 
products, and they must ensure, as we all must ensure, that America's 
food on our dinner tables is the safest it can possibly be.
  Our farmers are to be commended for their tireless efforts to produce 
the world's safest and most wholesome food, but we can always do 
better. This legislation intends to address that. Our food safety laws 
have not been updated for nearly 50 years. They're in need of 
modernization, both to protect the consumers and to protect our farmers 
from the loss of the markets. When an outbreak occurs, they're the 
first to be impacted; and obviously food safety is job number one for 
all consumers in America. I think it's important for us to note that 
there is not a one-size-fits-all approach to food safety; therefore, 
working together with the United States Department of Agriculture and 
the Food and Drug Administration is critical to making this legislation 
work.
  What does it establish? It establishes science-based, risk-based 
standards for both producers and processors here and abroad; and let me 
underline abroad. Any food products that come into this country ought 
to meet the same standards that we require of our farmers and food 
processors here in America. This legislation attempts to do that. It 
means that ensuring our foreign partners, whether they are growing 
leafy greens or peppers or anything else, that they meet the same 
standards that American farmers must meet to put those products on the 
table.
  Is this a perfect bill? No. It's a work in progress, but I think it's 
a good bipartisan bill. I would urge my colleagues to support this 
measure, and I thank the chairmen for their good work.
  Mr. BARTON of Texas. Mr. Speaker, I'm the last speaker on my side in 
support of the bill, so I'm going to reserve the balance of my time.
  Mr. DINGELL. With a great deal of pleasure and pride, at this time I 
yield 2 minutes to the gentleman from Minnesota (Mr. Peterson), my good 
friend, the distinguished chairman of the Committee on Agriculture who 
has worked so hard not only on food safety but also with us to make 
this bill something which is acceptable to the House, to him and to 
American agriculture.
  Mr. PETERSON. I thank the gentleman from Michigan for recognizing me, 
and I want to thank him for his hard work and his practical way of 
approaching legislation, which is the right way to do things.
  I rise today in support of this legislation. Our committee has had 
hearings regarding food safety, and we had some concerns about the bill 
as it came out of the Energy and Commerce Committee. Mr. Dingell was 
kind enough to sit down and work with us on those concerns; and out of 
that we were able to especially address the concerns of the livestock 
industry and the grain industry who were concerned that there may be 
unintended consequences. So we were able to get exemptions in those 
areas and also make other changes to make sure that the bill didn't 
interfere with the production and harvesting parts of agriculture.

                              {time}  1445

  We had, at the beginning of this, a number of groups that were 
concerned or even opposed to this legislation. And now, because of the 
changes that we have been able to work through with Mr. Dingell and 
others, I am happy to report that these organizations are either now 
neutral or dropped their opposition or are supporting the bill: the 
United Fresh Fruit and Vegetable folks, Western Growers, the American 
Farm Bureau Federation, National Wheat Growers, the National 
Cattlemen's Beef Association, the National Turkey Federation, the 
National Chicken Council, the National Pork Producers Council, National 
Corn Growers, the American Soybean Association, the U.S. Rice 
Federation, American Feed Industry, United Egg Producers, and the 
American Sheep Industry.
  I think this demonstrates that we have been able to move this 
legislation in a direction where we in agriculture are comfortable. I 
agree with Mr. Putnam that there is some additional work that can be 
done on this, and we intend to do that. So I encourage my colleagues to 
support this legislation.
  The SPEAKER pro tempore. The gentleman's time has expired.
  Mr. DINGELL. I yield the gentleman 30 seconds.
  Would the gentleman yield to me?
  Mr. PETERSON. I will yield.
  Mr. DINGELL. I would just observe to my good friend that we have 
talked about this before, and I have assured the gentleman that we will 
continue to work together to address the concerns that he and the very 
able gentleman from Florida (Mr. Putnam) have expressed their concerns 
about. It has been a privilege to work with the gentleman, and I thank 
him.
  Mr. PETERSON. I thank the gentleman. And I know that he will work 
with us as he has through this part of the process.
  Mr. DINGELL. I thank the gentleman.
  Mr. LUCAS. Mr. Speaker, I yield 1 minute to the gentleman from Ohio, 
the minority leader, Mr. Boehner.
  Mr. BOEHNER. Mr. Speaker and my colleagues, here we go again. This is 
a

[[Page 19714]]

major piece of legislation that was introduced last night at the Rules 
Committee about 12:15. Then about 9:36 this morning we saw another 
version of this bill introduced to replace the first version. And then 
at 10:50 this morning we see a third version of this same bill. Now, 
this may be a great bill. I have no idea. But the fact is that 
introducing three different versions of the bill yet this day and then 
bringing it to the floor some 4 hours later begins to ask the question, 
Did anybody read the bill?
  Now, I think the chairman and the ranking member and the chairman of 
the subcommittee probably did read the bill and understand what's in 
it, but how about the other 431 of us who serve in this House who are 
expected to vote on this?
  And my second complaint about this bill is the fact that we are 
considering it here in the House under a procedure where there is a 
whopping 40 minutes of debate, 20 minutes on each side, 40 minutes, and 
no amendments are allowed to be offered. We've got this major food 
safety bill here on the floor, and nobody gets to offer an amendment, 
nobody gets to have a debate about it, and nobody, clearly, has much of 
an idea of what's in the bill.
  Now, as a longtime member of the House Ag Committee, I understand 
that we've got the safest food supply in the world. It's probably not 
perfect, but it is the safest food supply in the world, and we can do 
better. But to legislate in this manner under these conditions without 
Members having a clue about what's in the bill is not, in my view, in 
the best interest of the House.
  Mr. DINGELL. Mr. Speaker, at this time, I am happy to yield 1 minute 
to the distinguished gentlewoman from Illinois (Ms. Schakowsky).
  Ms. SCHAKOWSKY. I thank the chairman emeritus for yielding, and I 
thank him for his leadership in creating this bipartisan bill that 
passed unanimously out of our committee and is so important.
  This is very personal to me. My dear friend, Nancy Donley, lost her 
son, Alex, in 1993, her only child, after he ate ground beef 
contaminated with E. coli. And we heard testimony from people whose 
children have died and whose family members and loved ones have become 
sick and died.
  Finally, we are able to pass, in a bipartisan way, an overhaul of our 
food safety system. And so I am pleased to be able to join in this 
bipartisan agreement to support this legislation. I am also glad that 
it includes some language directing the FDA to examine antibiotic 
resistance as it relates to the food supply. I hope we will continue to 
move forward.
  But I urge all of my colleagues to take this great opportunity so 
never again do we have to look at a victim, a family member of a victim 
or someone who has died because food that they believed was safe 
actually killed them. Let's vote for this.
  The SPEAKER pro tempore. The Chair will note that the gentleman from 
Michigan has 4\1/2\ minutes remaining, the gentleman from Texas has 2 
minutes remaining, and the gentleman from Oklahoma has 1\1/4\ minutes 
remaining.
  The gentleman from Oklahoma is recognized.
  Mr. LUCAS. Mr. Chairman, I rise to yield 1 minute to the gentleman 
from Pennsylvania (Mr. Thompson).
  Mr. THOMPSON of Pennsylvania. Mr. Speaker, as a member of the 
Agriculture Committee, I rise in strong opposition to this bill. We all 
agree that food safety is an extremely important issue, and 
improvements can be clearly made to our system, but this legislation 
concerns me for a number of reasons.
  First of all, it will do little to actually increase food safety, and 
it will add new burdens to many small businesses and farms across the 
country. One provision this bill contains is an expanded registration 
requirement which creates a license to be in the food industry. The 
license is expensive, and the provision will make it unlawful to sell 
food without it. And this bill would have significant impacts on 
agriculture sectors, particularly with fruits and vegetables.
  Fundamentally, I take issue with this legislation because it opens 
our farms to the Food and Drug Administration. Farms and agricultural 
activities are already regulated by the USDA. The FDA does not, and 
should not, have jurisdiction over farms or agricultural practices.
  Good policy makes for good politics, and that can only occur with a 
real, full debate on this issue, which would occur if this bill would 
have stayed within the jurisdiction of the Agriculture Committee.
  I urge my colleagues to vote ``no'' on this misguided legislation.
  Mr. DINGELL. Mr. Speaker, I am the last speaker on this side, so I am 
going to reserve my time, but I want to yield 2 minutes to my dear 
friend, Mr. Barton. And I want to commend him for his courage, his 
decency, and the extraordinary way in which he has worked with the 
distinguished Agriculture Committee and its great chairman, and also 
with me and the Democrats. We are handling this bill the way it should 
be handled, in a proper bipartisan fashion, and I want to commend him.
  Mr. BARTON of Texas. I want to inquire of the Chair, with his 
yielding, I have 4 minutes; is that correct?
  The SPEAKER pro tempore. The gentleman now has 4 minutes, yes.
  Mr. BARTON of Texas. Thank you, Chairman Dingell. 
  First, I want to acknowledge the strong staff work on both sides on 
this legislation. It has been a debate whether we would get the bill to 
the floor or whether Rachel Sher would have her baby first, and I am 
proud to report that we have gotten the bill to the floor. So we are 
birthing the food safety bill before she gives birth to another lovely 
human being.
  What our minority leader said just a minute ago is absolutely true in 
the technical sense about different versions of the bill being 
introduced at different times, but that is not all of the story, as 
Paul Harvey used to say in his radio commentary. Those different 
versions have been introduced in the last day because of changes that I 
have asked for and other Republican Members have asked for to improve 
the bill at the request of Congressman Lucas and his staff on the 
Agriculture Committee. We have been improving the bill to make it more 
supportive of agriculture.
  I want to read part of a letter that we just got today from the Sheep 
Industry, the Cattlemen's Association and the Pork Council. It says: 
``America's livestock and poultry producers support the tightening of 
language recognizing the U.S. Department of Agriculture's authorities 
regarding products, facilities and farms raising animals from which 
meat and eggs are regulated under the Federal Meat Inspection Act, the 
Poultry Products Inspection Act or the Egg Products Inspection Act. 
There have also been great improvements made to the traceability 
language, the recordkeeping provisions, as well as a more targeted 
approach for the new authority granted to the Food and Drug 
Administration to prohibit or restrict the movement of food. We also 
appreciate the strengthening of language that requires the Secretary of 
Health and Human Services to consult with the Secretary of 
Agriculture.''
  All of these changes were made at the suggestion of Congressman Lucas 
and his staff, working through myself and my staff, through Mr. Waxman 
and Mr. Dingell's staff.
  This is a strong food safety bill. This is a necessary improvement to 
food safety. We have had outbreaks in the last several years in the 
peanuts industry, in the pepper industry, and in seafood products that 
have been imported. We need to bring the FDA authority into the 21st 
century.
  I want to specifically go through some of the things that we have 
done with regard to agriculture. This bill does not require farms to 
register with the FDA. Under section 415 of the Food, Drug and Cosmetic 
Act, farms are not considered facilities, therefore, they do not have 
to register with the FDA.
  This bill does not require farms to pay a registration fee. This bill 
does not apply to livestock and poultry. This bill does not apply to 
USDA-regulated farms, facilities and products.

[[Page 19715]]

This bill allows farms to be exempted from traceability requirements 
and greatly limits access to records. This bill exempts specifically 
grains and related commodities from produce standards. This bill does 
not apply to farmers markets.
  So I understand that my friends on the Ag Committee did not have a 
legislative markup of this bill; they should have, I understand that. I 
have been in a situation in the Energy and Commerce Committee this year 
on the climate change bill and the health care bill where we on the 
Republican side have not been allowed to negotiate in the room. But on 
this bill, in this case, Chairman Waxman, Chairman Dingell, Chairman 
Stupak and Chairman Pallone have worked with myself and Mr. Deal and 
Mr. Shimkus and Mr. Walden and others. We have had an open, bipartisan 
process. We've had hearings going back to the prior Congress.
  The process is fair on this bill. The product is fair on this bill. 
We do need an improved food safety bill.
  I strongly recommend a ``yes'' vote on this legislation.
  The SPEAKER pro tempore. The gentleman from Oklahoma has 15 seconds 
remaining.
  Mr. LUCAS. I yield the entire sum to myself, Mr. Speaker.
  I want to thank the chairman emeritus of the Energy and Commerce 
Committee and the ranking member, Mr. Barton. You were kind to help us. 
You were kind to work with us. But the bottom line is the minority 
party of the Ag Committee should not have to go to the Energy and 
Commerce committee to work on an ag-related section of the bill.
  Thank you, gentlemen. I appreciate you. But you shouldn't have had to 
have done it.
  The SPEAKER pro tempore. The gentleman from Michigan has 2\1/2\ 
minutes remaining.
  Mr. DINGELL. Mr. Speaker, I yield myself the balance of the time to 
close.
  Mr. Speaker, this is a bipartisan bill. It has been worked on long 
and hard by three committees, including the Ways and Means. The 
chairman, Mr. Rangel, and subcommittee chairman, Mr. Levin, have been 
extremely cooperative in resolving questions between the two 
committees.
  I would note that staff at all levels of our committee, in the 
minority and on the majority--Rachel Sher and Eric Flamm--have been of 
enormous value in these discussions.
  The complaint made by my colleague about exclusion of Members I can't 
comment on. I can only say we have tried to include everybody in this 
process as much as we could, and we have brought in industry, which 
supports the bill. But more importantly--and I say this to my friend 
with affection and respect--the reason for a lot of the changes that 
they're talking about have been that, right up to the time that we have 
brought this bill to the floor, we have sought to see to it that we 
included everyone and took advantage of the wisdom of all the Members 
that we could possibly take advantage of.
  The legislation will address from the point of origin to the 
consumer's table. It will enable us to get at unsafe foods, not just in 
this country, but in China, in India, and other places where these 
foods are coming in. It will provide Food and Drug with the resources 
they need to address these problems in terms of personnel and money. It 
will also keep their laboratories open. More importantly, it will see 
to it that the public comes first, and for the first time in years, 
know that the foods that we are bringing into this country and that are 
being made available to the American people are in fact safe. No major 
reviews of the food provisions of the Food and Drug Act have been done 
since 1938, and, as was wisely pointed out by my colleagues, some not 
back to 1912.
  This is an important step which will protect the American people, who 
are today being killed, sickened, and hurt by unsafe foods brought in 
by unscrupulous people.

                              {time}  1500

  It will do something more than this. It will protect the American 
food industry, the processors, the manufacturers, and the growers, 
against unfair competition in places like China where they are adding 
melamine to food and delivering patently unsafe food.
  Mr. VAN HOLLEN. Mr. Speaker, I rise in strong support of the Food 
Safety Enhancement Act of 2009. This bipartisan legislation will 
address and reform the shortcomings in our food supply system.
  Serious gaps have been exposed in the Food and Drug Administration's 
ability to protect the American public due to recent outbreaks and 
recalls of food-borne diseases in spinach, peanuts, peppers, and other 
foods that many Americans depend on daily. These outbreaks have not 
only shaken consumer confidence in the industry that produces one of 
our most basic and important commodities, but it has also caused 
sickness and even death.
  We need to ensure that FDA has the necessary tools and resources to 
fulfill its vital mission in protecting the American public from unsafe 
products. The Food Safety Enhancement Act will accomplish this by 
bringing the FDA into the 21st century so that it can address the 
challenges and problems created by a global food system and to prevent 
the causes associated with food-borne illnesses. Currently, FDA is only 
able to inspect approximately one percent of imported food at the 
border. The bill will require the FDA to inspect high-risk facilities 
once every six months to a year and create a system to prevent 
contamination of imported and domestically produced food from 
occurring.
  Mr. Speaker, American consumers should not live in fear of the food 
they eat. I want to thank Chairman Waxman and Chairman Dingell for 
their leadership on this very important issue. I urge my colleagues to 
join me in supporting this much-needed legislation.
  Mr. HOYER. Mr. Speaker, I rise in strong support of the Food Safety 
Enhancement Act of 2009, and I thank Chairman Emeritus Dingell, 
Chairmen Waxman, Pallone, and Stupak, and Representatives DeGette and 
Sutton for their hard work to bring it to the floor today. This bill 
gives the Food and Drug Administration the authority and resources it 
needs to ensure that all Americans can be confident that the food they 
are putting on their family tables is free of contamination.
  A string of recent food safety scares shows that this bill is 
overdue--from the discovery of E. coli in spinach to salmonella in 
peppers and peanut butter. In fact, Time magazine reports that 
contaminated food causes 5,000 deaths and 325,000 hospitalizations each 
year. Unsafe food does not only put health and lives at risk; it 
undermines confidence across the board and poses a real threat to 
Americans' trust in our food industry. And that lack of trust is 
harmful to both families' peace of mind and the food industry's 
economic future. So it is in the interest of consumers and industry 
alike to see safety regulations faithfully enforced.
  This bill speeds up the inspection schedule, ensuring that the FDA 
checks up on high-risk food facilities every six to 12 months, and on 
lower-risk facilities at least once every 18 months to three years. It 
requires all food facilities operating in the U.S. or exporting to the 
U.S. to develop and submit food safety plans. It strengthens safeguards 
against unsafe imported food products. And it provides for a faster, 
more effective FDA response in case we do see a food emergency: with an 
up-to-date registry of food facilities, better traceability of 
contaminated food, and stronger authority to quarantine and recall 
dangerous products, the FDA will be empowered to take quick action that 
can nip outbreaks in the bud and save lives.
  These steps, and more, combine to make this what many have called the 
most sweeping reform of food safety laws in 50 years. One only needs to 
watch the news to see that this reform is highly needed. I urge my 
colleagues to support it.
  Mr. MARKEY of Massachusetts. Mr. Speaker, I rise in support of the 
Food Safety Enhancement Act of 2009, and commend Chairmen Waxman, 
Barton, Pallone, Dingell, Deal and Stupak for all of their bipartisan 
and extensive work on this important legislation.
  The Food Safety Enhancement Act is a critical part of protecting the 
health and wellbeing of our citizens from food-borne illnesses and 
negligent food manufacturers. This bill strengthens the FDA's oversight 
of our nation's food supply by increasing inspections, improving 
traceability, and empowering the agency to order mandatory recalls when 
necessary.
  The FDA is responsible for the safety of 80 percent of our nation's 
food supply, but only has the resources to inspect food-manufacturing 
facilities once every 10 years. Over the past several years we have 
seen an increase in outbreaks of Salmonella, resulting in recalls of 
tainted food, health problems, and sadly,

[[Page 19716]]

deaths. The FDA under the Bush Administration failed to take the steps 
necessary to ensure the safety of our food supply, but this bill, which 
was approved by the Energy and Commerce Committee with bipartisan 
support, will change that.
  I am pleased that the bill we are considering today also includes a 
modified version of my bill, the Ban Poisonous Additives--or BPA Act.
  BPA is a ubiquitous chemical found in most food and beverage cans and 
many reusable plastic containers. It was also found in most baby 
bottles until recently, when major baby bottle manufacturers agreed to 
voluntarily stop using it because of concerns about its effects on 
health, which are many: BPA can be linked to increases in breast and 
prostate cancer risk, heart disease, liver abnormalities and diabetes; 
BPA can result in adverse impacts to reproductive health; BPA can be 
linked to increases in obesity, attention deficit and hyperactivity 
disorder, brain damage, altered immune function and other problems; BPA 
can be found at dramatically higher levels in infants than in the rest 
of the population, and is also found in placental tissue and umbilical 
cord blood; BPA has been found at higher levels in women with a history 
of repeated spontaneous miscarriages; and BPA has been shown to alter 
the effectiveness of chemotherapy in cancer patients.
  The Food Safety Enhancement Act of 2009 calls on FDA to evaluate the 
approved uses of BPA in food and beverage containers and to tell the 
Committee on Energy and Commerce whether each use is safe by the end of 
this year. If FDA finds that BPA isn't safe, it is additionally 
directed to tell Congress how it plans to protect public health--which 
could include banning the chemical as well as efforts such as placing 
warning labels on products that contain it so that the most vulnerable 
populations will be better able to avoid it.
  Not all industries are as receptive to addressing health concerns as 
the baby bottle manufacturers were. In fact, just recently, the food 
and packaging industry convened a meeting in Washington at which they 
devised an expensive public relations claim to combat their consumer 
confidence crisis. They even concluded that their ``holy grail'' 
spokesperson would be a pregnant woman who could publicly extol the 
virtues of BPA, and thought about how to create fears that its removal 
would lead to scarce or unsafe food products.
  Although the baby bottle manufacturers' voluntary action and a 
variety of State laws banning its use are helpful, what we really need 
is federal leadership on this vital public health issue, and I am 
pleased that the FDA has commenced a scientific review of all the data. 
The language in this bill will ensure that the review occurs quickly 
and that appropriate steps will be taken to protect public health.
  I thank my colleagues for working with me to craft this compromise 
provision, and I urge support for the underlying bill.
  Mr. WAXMAN. Mr. Speaker, I submit the following exchange of letters:

                                         House of Representatives,


                                  Committee on Ways and Means,

                                    Washington, DC, July 27, 2009.
     Hon. Henry A. Waxman,
     Chairman, Committee on Energy and Commerce, Rayburn House 
         Office Building, Washington, DC.
       Dear Mr. Chairman: The Committee on Ways and Means applauds 
     your efforts to improve and ensure the security and safety of 
     food offered for consumption and consumed in the United 
     States and appreciates your willingness to work with us to 
     satisfactorily resolve a number of trade-related issues 
     falling within our jurisdiction. Such issues include the 
     regulation of importers and brokers, Customs and Border 
     Protection (CBP) implementation and enforcement of U.S. laws, 
     and compliance with U.S. international trade obligations. In 
     particular, we appreciate your efforts to address our 
     concerns with respect to sections 204 and 205 of your bill, 
     H.R. 2749, the Food Safety Enhancement Act of 2009, regarding 
     the registration of importers and brokers, respectively.
       In light of the agreed upon changes, the Committee will 
     forgo action on this bill and will not oppose its 
     consideration on the Suspension Calendar. These changes 
     ensure that the application of the Food Safety Enhancement 
     Act on the registration of importers is carried out in 
     consultation with CBP, taking into consideration time needed 
     for CBP and importers to make necessary adjustments to comply 
     with the new requirements of the Act, and that the 
     registration of customs brokers is consistent with and does 
     not extend beyond current requirements set forth in current 
     law, including granting new authority to any other agency to 
     regulate customs brokers.
       This is being done with the understanding that it does not 
     in any way prejudice the Committee with respect to the 
     appointment of conferees or the full exercise of its 
     jurisdictional prerogatives on this bill or similar 
     legislation in the future.
       The Committee intends to look for opportunities to improve 
     the safety of imported food and the safety of imported goods 
     overall, in accordance with the existing statutory and 
     regulatory scheme under CBP. We look forward to soliciting 
     your suggestions for reform.
           Sincerely,
                                                Charles B. Rangel,
                                                         Chairman.
                                  ____
                                  
                                         House of Representatives,


                             Committee on Energy and Commerce,

                                    Washington, DC, July 29, 2009.
     Hon. Charles B. Rangel,
     Chairman, Committee on Ways and Means, Longworth House Office 
         Building, Washington, DC.
       Dear Mr. Chairman: Thank you for your letter regarding H.R. 
     2749, the ``Food Safety Enhancement Act of 2009.'' I 
     appreciate your work and thoughtful input on this bill.
       Your letter noted that certain provisions of the bill are 
     within the jurisdiction of the Committee on Ways and Means. 
     The Committee on Energy and Commerce recognizes the 
     jurisdictional interest of the Committee on Ways and Means in 
     this bill. We appreciate your agreement to forgo action on 
     the bill, and I concur that this agreement does not in any 
     way prejudice the Committee on Ways and Means with respect to 
     its jurisdictional prerogatives on this bill or similar 
     legislation in the future.
       As the bill moves through the legislative process, we will 
     continue to work with you to ensure that the concerns raised 
     by the Committee on Ways and Means have been addressed to 
     your satisfaction. I will include our letters in the 
     Congressional Record during consideration of the bill on the 
     House floor.
       Again, I appreciate your cooperation regarding this 
     important legislation and I look forward to working with the 
     Committee on Ways and Means as the bill moves through the 
     legislative process.
           Sincerely,
                                                  Henry A. Waxman,
     Chairman.
                                  ____

                                         House of Representatives,


                                     Committee on Agriculture,

                                    Washington, DC, July 28, 2009.
     Hon. Henry A. Waxman,
     Chairman, Committee on Energy and Commerce, Rayburn HOB, 
         Washington, DC.
       Dear Mr. Chairman: I am writing regarding H.R. 2749, the 
     Food Safety Enhancement Act of 2009, which may be considered 
     this week on the floor, and which contains provisions within 
     the jurisdiction of the Committee on Agriculture.
       I would note that our Committees have had a history of 
     working cooperatively on matters that generally concern food 
     safety. In order to permit floor consideration of this bill, 
     the Committee will forgo action with the understanding that 
     it does not prejudice the Committee with respect to the 
     appointment of conferees or its jurisdictional prerogatives 
     on this bill or similar legislation in the future.
       I would appreciate your response to this letter, confirming 
     this understanding with respect to H.R. 2749, and would ask 
     that a copy of our exchange of letters on this matter be 
     included in the Congressional Record during consideration on 
     the House floor.
           Sincerely.
                                               Collin C. Peterson,
     Chairman.
                                  ____

                                         House of Representatives,


                             Committee on Energy and Commerce,

                                    Washington, DC, July 29, 2009.
     Hon. Collin C. Peterson,
     Chairman, Committee on Agriculture, Longworth HOB, 
         Washington, DC.
       Dear Mr. Chairman: Thank you for your letter of July 28, 
     2009, indicating your jurisdictional interest in H.R. 2749, 
     the Food Safety Enhancement Act of 2009. I acknowledge that 
     the bill contains provisions within the jurisdiction of the 
     Committee on Agriculture, and appreciate your willingness to 
     work with us to permit consideration of this bill, which will 
     enhance food safety for all Americans. I understand that this 
     action will in no way waive your Committee's jurisdiction in 
     the subject matter of the legislation.
       Furthermore, in the event that a conference with the Senate 
     is requested on this matter, I would support naming Committee 
     on Agriculture Members to the conference committee. A copy of 
     our exchange of letters regarding this bill will be inserted 
     into the Congressional Record during floor consideration.
           Sincerely,
                                                  Henry A. Waxman,
                                                         Chairman.

  Mr. GENE GREEN of Texas. Mr. Speaker, I rise today in support of H.R. 
2749, the Food Safety Enhancement Act.
  Over the past year or so there have been several high profile food 
contamination incidents in the U.S. involving: spinach, cantaloupes, 
peanut butter, and tomatoes.

[[Page 19717]]

  Congress has diligently investigated all of these incidents and found 
FDA simply does not have the resources, funding, manpower, or 
technology it needs to protect the American food supply and fulfill its 
mission.
  This bill finally gives the FDA the authority to conduct mandatory 
recall. We should not to rely on the voluntary efforts of food 
manufacturers to ensure the safety of their product.
  H.R. 2749 will also require the FDA to inspect high-risk facilities 
once every six months to a year. FDA now inspects food production 
facilities once a decade on average.
  The one shortcoming of the bill is that funding is not dedicated to 
the creation of additional FDA labs, but it does allow for third party 
inspection by accredited labs.
  The Port of Houston does not have an FDA lab and in fact there is no 
FDA lab in the entire state of Texas even though we share the longest 
border with Mexico.
  Right now, the FDA is only able to inspect approximately 1 percent of 
imported food at the border. With its level of trade and southern 
border with Mexico, it is a glaring hole in the system that Texas does 
not have an FDA lab. In fact, there are over 300 ports of entry in the 
U.S. and only 13 ports actually have FDA labs.
  It is my hope that we will be able to provide additional funds for 
the creation of these labs in the future.
  H.R. 2749 provides some of those funds to get the FDA moving in the 
correct direction, and we will have to appropriate more, but I am happy 
the Food Safety Enhancement Act finally gives the FDA the authority and 
improved systems to protect our food supply.
  I am pleased that after two years of hard work we will finally be 
moving a comprehensive food safety bill out of House.
  I want to commend Chairman Emeritus Dingell, Chairman Waxman, 
Chairman Pallone, and Chairman Stupak for their continued and dedicated 
work on this issue.
  Mr. MATHESON. Mr. Speaker, I would like to thank Chairman Waxman and 
especially Chairman Emeritus Dingell and his staffer, Virgil Miller, 
for their work to include an amendment I authored regarding lead in 
ceramic ware.
   A couple years ago in Utah, a young mother used ceramic plates to 
heat her food in the microwave. Her infant became very sick. Doctors 
discovered that the baby was suffering from lead poisoning because lead 
had leached out of the ceramic plates she used. Most of us are unaware 
of this risk and most people don't know that lead can leach out of 
ceramic ware when the glaze is improperly fired or when the glaze has 
broken down over time. When lead is released into food and drink from 
ceramics, hazardous levels can contaminate food substances and expose 
children and adults to toxic levels.
  FDA regulates the lead levels of ceramic ware and has set acceptable 
levels of lead-allowed ceramic ware used in food preparation and 
currently has a safety warning designating ceramic items not intended 
for food use. However, there is currently no label alerting consumers 
that the ceramic products they purchase for food use/preparation (i.e. 
plates, cups, etc.) contain any lead.
  My language requires labels on plates and packaging for ceramic ware/
cookware containing lead for an intended functional purpose. It focuses 
on the glazing because all ceramic ware has trace amounts of lead in 
clay and those trace amounts do not contribute to lead poisoning. 
Problems arise when ceramicware contains lead-based glaze that is 
either fired incorrectly or contains high amounts of lead (above safe 
levels).
  This language doesn't affect ornamental plates or decorative 
ceramics, which are already regulated by FDA and which are not 
considered safe for food use because of their lead levels.
  Finally, my provision requires FDA to set up an educational program 
on its website to further educate consumers about these issues and 
about safe practices.
  I am hopeful that these measures will enable us to better protect 
children and families from the potential problems caused by incorrectly 
fired ceramic ware and lead leaching from ceramics.
  Ms. SCHAKOWSKY. Mr. Speaker, the use of massive amounts of human 
antibiotics for non-therapeutic purposes in industrial food animal 
production is seriously jeopardizing the health of Americans. This 
practice is contributing to the emergence and spread of antibiotic-
resistant bacteria, often rendering ineffective human life-savings 
drugs.
  I am submitting for the record a letter to the White House, signed by 
twenty reputable organizations such as the Infectious Diseases Society 
of America, American Medical Association, American Academy of 
Pediatrics, and Pew Charitable Trusts, which supports the Food and Drug 
Administration's early steps to phase out the use of antibiotics for 
growth promotion and feed efficiency in food animals, and calls on the 
Administration to go further.

                                                    July 24, 2009.
     Ms. Melody Barnes,
     Assistant to the President for Domestic Policy, The White 
         House, Washington, DC.
       Dear Ms. Barnes: As organizations committed to protecting 
     patients, public health, animal health, and food safety, the 
     undersigned groups are writing to express our grave concern 
     about the misuse of antibiotics in agriculture and our strong 
     support for the Administration's new ``public health approach 
     to antimicrobial use in animals,'' which was articulated by 
     the Food and Drug Administration (FDA) in its July 13th 
     statement before the Rules Committee of the U.S. House of 
     Representatives. The Obama Administration's leadership in 
     providing a clear path forward on this highly politically 
     charged issue is very much welcomed after decades of inertia.
       Our combined memberships include the country's foremost 
     scientific and medical experts and represent more than eleven 
     million concerned Americans and health professionals. Our 
     position is based on objective health interests and concerns 
     that dangerous drug resistant infections are rapidly 
     increasing in hospitals and community settings adding to the 
     economic burden of the U.S. healthcare costs.
       Specifically, we support the FDA's calls for phasing out 
     the use of antimicrobial drugs for growth promotion and feed 
     efficiency, and for requiring that all other uses of these 
     drugs be carried out under the supervision of a veterinarian 
     and within the boundaries of a valid veterinarian-client-
     patient relationship--which we expect will end over-the-
     counter sales of tons of antimicrobial drugs annually. We 
     also support the agency's expressed intent to clearly define 
     the limited instances where antimicrobials may be used 
     judiciously in food animals for purposes of disease 
     prevention and control and are eager to work with FDA to 
     ensure that the policy developed is the most protective of 
     public health. We also urge the agency to make the new 
     antimicrobial policy mandatory, retroactive to already-
     approved drugs, and enforceable, in order to best guarantee a 
     significant reduction in antimicrobial use. The 
     Administration's statement clearly demonstrates a commitment 
     to sound and science-based policies that are backed up by 
     scores of scientific and medical publications and will 
     protect the health of every American.
       The development of antimicrobial agents to treat life-
     threatening infections has been one of the most notable 
     medical achievements of the past century. Physicians, 
     healthcare professionals, and public health and food safety 
     advocates are greatly concerned about the growing body of 
     scientific evidence demonstrating that antimicrobial drug use 
     in livestock and poultry contributes to the spread of drug-
     resistant bacteria to people. Drug-resistant organisms are 
     plaguing Americans, including otherwise healthy individuals, 
     in healthcare settings and communities across the country. We 
     are pleased that these concerns finally are being recognized 
     and addressed by the federal government to forestall 
     epidemics of untreatable infections.
       Fundamental to FDA's new approach--and our support for it--
     are the principles that: ``protecting public health requires 
     the judicious use in animal agriculture of those 
     antimicrobials of importance in human medicine'' and that 
     ``purposes other than for the advancement of animal and human 
     health should not be considered judicious use.''--Dr. Joshua 
     Sharfstein, FDA's Principal Deputy Commissioner, July 13, 
     2009.
       The Administration's vision to eliminate non-judicious uses 
     of antimicrobial drugs, including for purposes of growth 
     promotion and feed efficiency and non-judicious disease 
     prevention which have been practiced in animal agriculture 
     for several decades, demonstrates a critical public policy 
     shift that will better protect the public against resistant 
     infections and preserve the power of existing antibiotics. In 
     addition, we urge FDA to formalize its position on veterinary 
     supervision of all antimicrobial uses and ending the over-
     the-counter sale of antibiotics for animal agricultural uses, 
     which are long-overdue. The sale of antimicrobials for use in 
     human medicine requires a prescription; there is no reason to 
     permit a lower standard for agricultural purposes where 
     considerably more antimicrobial drugs are used annually.
       The Administration's new policy direction appears intended 
     to reflect the concerns of a broad consensus of the 
     scientific, medical, public health and international health 
     communities. Such consensus is buttressed by the actions of 
     expert bodies and governments. For example:
       Since 2002, the World Health Organization (WHO) has called 
     upon all nations to shift from use of antimicrobials in non-
     human medicine.
       In 2003, the Institute of Medicine (IOM) of the National 
     Academies of Science called on the FDA to ban the use of 
     antimicrobials for growth promotion in animals, if those 
     drugs were also used in human medicine.
       In 2006, the European Union banned non-therapeutic use of 
     antimicrobials, because such use was found to raise food 
     safety concerns, and the ban was instituted to protect

[[Page 19718]]

     against further development of antimicrobial resistance.
       We recognize that phasing out of antimicrobials for non-
     judicious uses in animals will require changes in the 
     agricultural industry. But protection of the public's health 
     must come first, and the phase out can be conducted in a way 
     that that minimizes costs to the agriculture industry. 
     Farmers in Europe have adapted to such a policy without undue 
     disruption of production or increased consumer costs; the 
     United States can learn from that experience while also 
     protecting American lives. In addition, the U.S. Department 
     of Agriculture has recognized that various production methods 
     used in the United States today are viable alternatives to 
     non judicious antimicrobial uses and such alternatives are 
     employed with little negative--or even with somewhat 
     positive--economic impact to producers.
       We urge you to maintain the scientifically sound positions 
     the Administration already has taken in support of phasing 
     out growth promotion and feed efficiency uses, and to 
     finalize a policy that will strictly manage a narrow set of 
     prophylactic uses while mandating veterinary-patient 
     relationships and eliminating the over-the-counter sale of 
     antibiotics for use in animals.
       We remain committed to working with the Administration to 
     implement these new approaches in ways that will best protect 
     the lives and health of both humans and animals.
           Sincerely,
       Alliance for the Prudent Use of Antibiotics.
       American Academy of Pediatrics.
       American Association of Critical-Care Nurses.
       American Medical Association.
       American Pharmacists Association.
       American Public Health Association.
       American Society of Health-System Pharmacists.
       Association for Professionals in Infection Control and 
     Epidemiology.
       Food Animal Concerns Trust.
       Humane Society of the United States.
       Infectious Diseases Society of America.
       Institute for Agriculture and Trade Policy.
       Keep Antibiotics Working.
       Michigan Antibiotic Resistance Reduction Coalition.
       National Association of County and City Health Officials.
       Pew Campaign on Human Health and Industrial Farming.
       Premier, a healthcare alliance serving 2,100 nonprofit 
     hospitals and 58,000 healthcare sites.
       Society of Infectious Diseases Pharmacists.
       Trust for America's Health.
       Union of Concerned Scientists.

  Mrs. BACHMANN. Mr. Speaker, I rise today in reluctant support of H.R. 
2749, the Food Safety Enhancement Act of 2009. While I support the 
legislation, it is by no means perfect and it is my sincere hope that 
the concerns I share with my colleagues in the House will be addressed 
as the bill moves through the legislative process.
  Ensuring the safety of America's food supply is a critical issue, 
which warrants our utmost attention. In light of recent outbreaks of 
food-borne illnesses that have caused sickness and death in our 
country, I believe it is imperative the action be taken to restore 
confidence to the American people in the food they eat. This task 
requires careful analysis of our current food supply dynamic, as well 
as thoughtful consideration of implications of any potential solutions. 
Our constituents deserve no less.
  Indeed, every link in the food supply chain from the farm to the 
shelf plays a valuable role in delivering a safe product to consumers, 
and I believe each link requires flexibility in order to continue to 
provide high-quality, competitively priced goods to American consumers. 
A dutiful producer should expect unwarranted government intrusion no 
more than a consumer should expect their next meal will make them sick.
  The detrimental consequences of an overly onerous federal government 
and bureaucratic red-tape must be carefully weighed against the need 
for regulation to ensure safe foods. That being said, H.R. 2749 does 
attempt to find a balance. As a result, the bill has earned the support 
of a wide range of stakeholders from farm groups to distributors.
  Mr. Speaker, while I stress the importance of continued work to 
improve the bill, I support its passage and urge my colleagues to do 
the same.
  Mr. DINGELL. Mr. Speaker, I yield back the balance of my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Michigan (Mr. Dingell) that the House suspend the rules 
and pass the bill, H.R. 2749, as amended.
  The question was taken.
  The SPEAKER pro tempore. In the opinion of the Chair, two-thirds 
being in the affirmative, the ayes have it.
  Mr. BARTON of Texas. Mr. Speaker, I object to the vote on the ground 
that a quorum is not present and make the point of order that a quorum 
is not present.
  The SPEAKER pro tempore. Evidently a quorum is not present.
  The Sergeant at Arms will notify absent Members.
  Pursuant to clause 8 of rule XX, this 15-minute vote will be followed 
by 5-minute votes on suspending the rules and passing:
  H.R. 1665, if ordered; and
  House Resolution 373, if ordered.
  The vote was taken by electronic device, and there were--yeas 280, 
nays 150, not voting 3, as follows:

                             [Roll No. 657]

                               YEAS--280

     Abercrombie
     Ackerman
     Adler (NJ)
     Altmire
     Andrews
     Baca
     Bachmann
     Baird
     Baldwin
     Barrow
     Barton (TX)
     Becerra
     Berkley
     Berman
     Berry
     Biggert
     Bilirakis
     Bishop (GA)
     Bishop (NY)
     Boccieri
     Boren
     Boswell
     Boucher
     Boyd
     Brady (PA)
     Braley (IA)
     Bright
     Brown, Corrine
     Buchanan
     Burgess
     Butterfield
     Buyer
     Camp
     Cao
     Capito
     Capps
     Capuano
     Cardoza
     Carnahan
     Carney
     Carson (IN)
     Castle
     Castor (FL)
     Chandler
     Chu
     Clarke
     Clay
     Cleaver
     Clyburn
     Cohen
     Connolly (VA)
     Conyers
     Cooper
     Costa
     Costello
     Courtney
     Crenshaw
     Crowley
     Cuellar
     Cummings
     Dahlkemper
     Davis (AL)
     Davis (CA)
     Davis (IL)
     Deal (GA)
     DeFazio
     DeGette
     Delahunt
     DeLauro
     Dent
     Diaz-Balart, L.
     Diaz-Balart, M.
     Dicks
     Dingell
     Doggett
     Donnelly (IN)
     Doyle
     Driehaus
     Edwards (MD)
     Edwards (TX)
     Ehlers
     Ellison
     Ellsworth
     Engel
     Eshoo
     Etheridge
     Farr
     Fattah
     Filner
     Fortenberry
     Foster
     Frank (MA)
     Frelinghuysen
     Fudge
     Gerlach
     Giffords
     Gingrey (GA)
     Gonzalez
     Gordon (TN)
     Grayson
     Green, Al
     Green, Gene
     Grijalva
     Guthrie
     Gutierrez
     Hall (NY)
     Halvorson
     Hare
     Harman
     Hastings (FL)
     Herseth Sandlin
     Higgins
     Hill
     Himes
     Hinojosa
     Hirono
     Hodes
     Holden
     Holt
     Honda
     Hoyer
     Inslee
     Israel
     Jackson (IL)
     Jackson-Lee (TX)
     Johnson (GA)
     Johnson, E. B.
     Kanjorski
     Kaptur
     Kennedy
     Kildee
     Kilpatrick (MI)
     Kilroy
     King (NY)
     Kirk
     Kirkpatrick (AZ)
     Kissell
     Klein (FL)
     Kosmas
     Kucinich
     Lance
     Langevin
     Larsen (WA)
     Larson (CT)
     LaTourette
     Lee (CA)
     Lee (NY)
     Levin
     Lewis (GA)
     Lipinski
     LoBiondo
     Loebsack
     Lofgren, Zoe
     Lowey
     Lynch
     Maffei
     Maloney
     Marchant
     Markey (MA)
     Matheson
     Matsui
     McCollum
     McCotter
     McDermott
     McGovern
     McIntyre
     McMahon
     McNerney
     Meek (FL)
     Meeks (NY)
     Melancon
     Michaud
     Miller (MI)
     Miller (NC)
     Miller, George
     Mitchell
     Mollohan
     Moore (KS)
     Moore (WI)
     Moran (VA)
     Murphy (CT)
     Murphy (NY)
     Murphy, Patrick
     Murphy, Tim
     Murtha
     Nadler (NY)
     Napolitano
     Neal (MA)
     Nye
     Oberstar
     Obey
     Olver
     Ortiz
     Pallone
     Pascrell
     Pastor (AZ)
     Paulsen
     Payne
     Perlmutter
     Peters
     Peterson
     Platts
     Polis (CO)
     Pomeroy
     Price (NC)
     Putnam
     Quigley
     Rahall
     Rangel
     Reichert
     Reyes
     Richardson
     Rodriguez
     Rogers (KY)
     Rogers (MI)
     Ros-Lehtinen
     Roskam
     Ross
     Rothman (NJ)
     Roybal-Allard
     Ruppersberger
     Rush
     Ryan (OH)
     Sanchez, Linda T.
     Sanchez, Loretta
     Sarbanes
     Scalise
     Schakowsky
     Schauer
     Schiff
     Schrader
     Schwartz
     Scott (GA)
     Scott (VA)
     Serrano
     Sestak
     Shea-Porter
     Sherman
     Shimkus
     Sires
     Skelton
     Slaughter
     Smith (NJ)
     Smith (WA)
     Snyder
     Space
     Speier
     Spratt
     Stark
     Stupak
     Sutton
     Tanner
     Terry
     Thompson (CA)
     Thompson (MS)
     Tiberi
     Tierney
     Titus
     Tonko
     Towns
     Tsongas
     Turner
     Upton
     Van Hollen
     Velazquez
     Visclosky
     Walden
     Walz
     Wasserman Schultz
     Waters
     Watson
     Watt
     Waxman
     Weiner
     Wexler
     Whitfield
     Wilson (OH)
     Wolf
     Wu
     Yarmuth

                               NAYS--150

     Aderholt
     Akin
     Alexander
     Arcuri
     Austria
     Bachus
     Barrett (SC)
     Bartlett
     Bean
     Bilbray
     Bishop (UT)
     Blackburn
     Blumenauer
     Blunt
     Boehner
     Bonner
     Bono Mack
     Boozman
     Boustany
     Brady (TX)
     Broun (GA)
     Brown (SC)
     Brown-Waite, Ginny
     Burton (IN)
     Calvert
     Campbell
     Cantor
     Carter
     Cassidy
     Chaffetz
     Childers
     Coble
     Coffman (CO)
     Cole
     Conaway
     Culberson
     Davis (KY)
     Dreier
     Duncan
     Emerson
     Fallin
     Flake
     Fleming
     Forbes
     Foxx
     Franks (AZ)
     Gallegly
     Garrett (NJ)
     Gohmert
     Goodlatte
     Granger
     Graves
     Griffith

[[Page 19719]]


     Hall (TX)
     Harper
     Hastings (WA)
     Heinrich
     Heller
     Hensarling
     Herger
     Hinchey
     Hoekstra
     Hunter
     Inglis
     Issa
     Jenkins
     Johnson (IL)
     Johnson, Sam
     Jones
     Jordan (OH)
     Kagen
     Kind
     King (IA)
     Kingston
     Kline (MN)
     Kratovil
     Lamborn
     Latham
     Latta
     Lewis (CA)
     Linder
     Lucas
     Luetkemeyer
     Lujan
     Lummis
     Lungren, Daniel E.
     Mack
     Manzullo
     Markey (CO)
     Marshall
     Massa
     McCarthy (CA)
     McCaul
     McClintock
     McHenry
     McKeon
     McMorris Rodgers
     Mica
     Miller (FL)
     Miller, Gary
     Minnick
     Moran (KS)
     Myrick
     Neugebauer
     Nunes
     Olson
     Paul
     Pence
     Perriello
     Petri
     Pingree (ME)
     Pitts
     Poe (TX)
     Posey
     Price (GA)
     Radanovich
     Rehberg
     Roe (TN)
     Rogers (AL)
     Rohrabacher
     Rooney
     Royce
     Ryan (WI)
     Salazar
     Schmidt
     Schock
     Sensenbrenner
     Sessions
     Shadegg
     Shuler
     Shuster
     Simpson
     Smith (NE)
     Smith (TX)
     Souder
     Stearns
     Sullivan
     Taylor
     Teague
     Thompson (PA)
     Thornberry
     Tiahrt
     Wamp
     Welch
     Westmoreland
     Wilson (SC)
     Wittman
     Woolsey
     Young (AK)
     Young (FL)

                             NOT VOTING--3

     Davis (TN)
     McCarthy (NY)
     McHugh

                              {time}  1529

  Messrs. WAMP, DAVIS of Kentucky, BROWN of South Carolina, WELCH, Ms. 
BEAN and Ms. WOOLSEY changed their vote from ``yea'' to ``nay.''
  Messrs. MARCHANT, TERRY, ROGERS of Kentucky, ROSKAM, BUYER, CAO, 
FRELINGHUYSEN, GINGREY of Georgia and Mrs. BACHMANN changed their vote 
from ``nay'' to ``yea.''
  So (two-thirds not being in the affirmative) the motion was rejected.
  The result of the vote was announced as above recorded.

                          ____________________