[Congressional Record (Bound Edition), Volume 155 (2009), Part 15]
[House]
[Pages 20177-20204]
[From the U.S. Government Publishing Office, www.gpo.gov]




                  FOOD SAFETY ENHANCEMENT ACT OF 2009

  Mr. DINGELL. Mr. Speaker, pursuant to H. Res. 691, I call up the bill 
(H.R. 2749) to amend the Federal Food,

[[Page 20178]]

Drug, and Cosmetic Act to improve the safety of food in the global 
market, and for other purposes, and ask for its immediate consideration 
in the House.
  The Clerk read the title of the bill.
  The SPEAKER pro tempore. Pursuant to House Resolution 691, in lieu of 
the amendment in the nature of a substitute recommended by the 
Committee on Energy and Commerce now printed in the bill, the amendment 
in the nature of a substitute printed in House Report 111-235 is 
adopted, and the bill, as amended, is considered read.
  The text of the bill, as amended, 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;

[[Page 20179]]

     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;
       ``(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).

[[Page 20180]]

       ``(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 
     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

[[Page 20181]]

     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.--
       ``(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

[[Page 20182]]

       (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 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

[[Page 20183]]

     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:
       ``(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.

[[Page 20184]]

       ``(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);
       ``(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,

[[Page 20185]]

     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
       ``(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),

[[Page 20186]]

     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 (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

[[Page 20187]]

     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;
       ``(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.''.

[[Page 20188]]



     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.--
       ``(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;

[[Page 20189]]

       ``(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.''.
       (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;

[[Page 20190]]

       (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;
       (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.

[[Page 20191]]

       ``(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;
       ``(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

[[Page 20192]]

     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--
       ``(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 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)''.

[[Page 20193]]

       (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 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

[[Page 20194]]

     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 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

[[Page 20195]]

     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.

     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. The gentleman from Michigan (Mr. Dingell) 
and the gentleman from Illinois (Mr. Shimkus) each will control 30 
minutes.
  The Chair recognizes the gentleman from Michigan.
  Mr. DINGELL. Mr. Speaker, I yield myself 3 minutes.
  Mr. Speaker, I rise in strong support of H.R. 2749, the Food Safety 
Enhancement Act of 2009.
  I remind my colleagues that this bill was up before us yesterday and 
got 280-something votes in favor of it. It is a good piece of 
legislation. It is bipartisan. It will fundamentally change the way in 
which we ensure the safety of our food supply and protect American 
consumers, farmers and business. I would note it came out of committee 
in a bipartisan fashion, unanimously, by voice vote.
  A series of foodborne disease outbreaks have laid bare unacceptable 
gaps in our food-safety laws, and this will be the first major change 
in our food-safety laws with regard to food and drugs since 1938.
  In the past 2 years alone, we have witnessed issues of melamine in 
infant formula and in milk products, and we have seen tainted peppers 
from Mexico, harmful seafood and shellfish from China, E. coli in 
spinach, and problems with strawberries and raspberries. Each year, in 
spite of the fact that we have the most careful and safe food in the 
world, we find that 76 million people contact a foodborne illness in 
the United States. According to CDC, some 5,000 die.
  This legislation contains significant policy solutions that will 
address this situation. It is largely based upon legislation I 
introduced last year along with Energy and Commerce subcommittee 
Chairmen Pallone and Stupak.
  We have worked for months with our Republican colleagues in a 
bipartisan fashion on the Committee on Energy and Commerce to get this 
bill right. We have worked with our colleagues on the Agriculture and 
the Ways and Means Committees to address their concerns, and I believe 
we have done so.
  In the end, we have a bill that strikes an important balance; it does 
not create unnecessary burdens for farmers and small businesses, but it 
does allow FDA to retain all its existing authority. It takes no 
authority from the Department of Agriculture or the Committee on 
Agriculture, and it gives FDA new authorities that it needs to trace 
and prevent food-safety problems that may originate on the farm or in 
other sectors of the food supply chain. And we have carefully protected 
the farmers against intrusion by the Food and Drug Administration.
  I want to talk about key provisions in the bill. Under the 
legislation, FDA has clear authority to issue and require manufacturers 
to meet strong, enforceable performance standards to ensure the safety 
of different types of food.
  FDA will establish a food trace-back system so that the public health 
officials can easily determine the source of foodborne disease 
outbreaks and protect farmers and producers against unwise and 
inadequate judgments because of lack of personnel and money.
  FDA is going to be required to inspect all food facilities more 
frequently. And the bill requires FDA to inspect the riskiest ones at 
least once per year.
  FDA will be given new authority to ensure that imported foods are 
safe, a source of major concern and hazard to our people.
  FDA will be given new tools--recalls, record access, penalties to 
punish bad actors, and the ability to act quickly when presented with a 
food-safety emergency.
  FDA will get a new dedicated source of funding from a $500 million 
annual registration fee on food facilities to help it conduct its work 
of keeping America safe. And this provision and the rest of the bill 
are supported by American food producers.
  FDA will not be the only cop on the beat. Our food producers will 
focus also on prevention and have a well-deserved and shared 
responsibility between FDA and food manufacturers to keep our food 
supplies safe.
  The bill will require manufacturers to implement preventive systems 
to stop outbreaks before they occur. All food facilities will be 
required to conduct hazard analyses, assess potential food-safety 
risks, and develop plans to keep the food supply safe.
  Mr. Speaker, there is nothing in this bill that is overly burdensome 
for farmers small or big. We have worked hard--and I believe we have 
succeeded--in protecting farms of the family size from burdens that 
could harm their business and their way of life. My own district has 
many small farms and people with whom I work closely on agricultural 
matters, and I believe that they will be satisfied with this 
legislation.
  It is a fact here--and I want to address the concerns that I have 
heard--that farmers who sell a majority of their product direct to the 
consumers are exempt from the fee system in this bill. Farms that sell 
directly to consumers, restaurants, and grocery stores will also be 
exempt from the trace-back system.
  Some have expressed concern that FDA will have access to confidential

[[Page 20196]]

farm records and make them available for distribution. This is not so. 
FDA is already limited in the types of records they can access under 
the law, and they cannot access financial data, pricing data, personnel 
data, research data, or sales data other than shipment data regarding 
sales.
  The SPEAKER pro tempore. The gentleman's time has expired.
  Mr. DINGELL. Mr. Speaker, I yield myself 1 additional minute.
  I have also heard concern that FDA will have the authority to issue 
safety standards that will apply to farms and interfere with organic 
farming practices. I want to make it clear that that is not so. In 
fact, FDA is prohibited from imposing safety standards unless it 
determines those standards are ``reasonably necessary to minimize the 
risk of serious adverse health consequences or death,'' a very, very 
high standard that they have to meet. This will ensure protection of 
the concerns of organic farmers and that they are taken into 
consideration before issuing standards. This is why it has the support 
of the distinguished chairman of the Agriculture Committee and members 
of that committee from both sides of the aisle.
  Mr. Speaker, this is a product of bipartisan cooperation. It is 
supported by industry. It was approved unanimously by a voice vote in 
the Energy and Commerce Committee. It reflects findings of more than 20 
hearings on the failure of our food system safety processes conducted 
by five different committees of the House over 3 years. It addresses 
weaknesses in the food-safety system at FDA that were identified under 
the Bush administration and included in concerns under the current 
administration.
  H.R. 2749 it is a well-vetted, mature piece of legislation. I urge my 
colleagues to support H.R. 2749. It is old enough to vote; it is over 
21 years old.
  I urge my colleagues to support this legislation. It is a good bill. 
It will protect the American people, the American consumers, and it 
will not hurt American industry, which supports this bill.
  Mr. Speaker, I reserve the balance of my time.
  Mr. SHIMKUS. Mr. Speaker, I yield myself such time as I may consume.
  I was a member of the Oversight and Investigation Subcommittee in the 
last Congress, serving 10 or 12 months in that position. And every time 
we had a hearing on some unsafe food product, another outbreak would 
occur. So we knew that we really had to get our heads together and try 
to address food-safety issues, and we think we've done that with this 
bill.
  I want to thank Chairman Emeritus Dingell and I want to thank 
Chairman Waxman, Chairman Pallone and Chairman Stupak for working with 
Ranking Member Barton and Deal and myself to really move the bill 
forward in a way that we could pass it on a voice vote. I just only 
wish--and I think we could do this, we could do this on energy and we 
could do this on health if we really sat down and tried to work out the 
differences.
  This is not an easy bill to pass. And as Chairman Emeritus Dingell 
said, 21 years he has been working on this. And this is not an easy 
thing to do. We did all we could. And I do appreciate the time that we 
spent on the floor and then with staff to work out the difficult 
options. And so we come here today with a pretty united bill, one that 
would have passed had it not been on the suspension calendar, and so we 
bring it up again today.
  We have to have confidence in our food supply, and that's what we're 
trying to do in this bill. And this bill takes the necessary steps to 
move us forward.
  The changes that we have made not just in the original text of the 
bill, but in addressing some of the concerns we think are very, very 
helpful. And I want to pledge to my ag Republican friends--and I'm from 
an agricultural district, and a lot of these groups that support them 
are good friends of mine. And we want to ensure that we continue to 
work forward and move forward as the bill does.
  A couple of issues that Chairman Emeritus Dingell said was, you know, 
the bill does not require farms to register with 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 the 
bill. It allows farms to be exempt from the traceability requirements.
  We, as a committee, both in the Oversight and Investigation and then 
as a full committee, we just couldn't sit on the sidelines anymore as 
we saw case after case of food-borne illnesses. We had to come together 
in a way to address this.

                              {time}  1630

  I think we have done it. I think it's a good product. Can there be 
some fixes as it moves forward? Yes, there can. But I would ask all my 
colleagues to support this bill.
  Mr. Speaker, I reserve the balance of my time.
  Mr. DINGELL. I want to thank the gentleman for his hard work both in 
the Investigations Subcommittee and on the legislation. He and Mr. Deal 
and the ranking Republican member, our good friend Mr. Barton, have 
been enormously valuable in the work that has been done to bring us to 
where we are. I commend him and I thank him.
  Mr. Speaker, I yield at this time 2 minutes to the distinguished 
chairwoman of the Appropriations Subcommittee of jurisdiction on this 
matter, Ms. DeLauro.
  Ms. DeLAURO. Mr. Speaker, what is this bill about? What is it about?
  Food-borne illness in the United States of America kills 5,000 people 
every single year.
  We went to war in Iraq and Afghanistan when 3,000 people, unbeknownst 
that when they went to work that day that they weren't coming home, and 
we went to war in Afghanistan as a result.
  We know that 5,000 people every year die of a food-borne illness and 
an illness, my friends, that can be prevented.
  Stand with the mother and the father of a 2-year-old child, the 
parents who went to the grocery store and brought home spinach or 
lettuce or sprouts or tomatoes and their child died because of E.coli. 
Stand with the son and daughter of an elderly person in a nursing home 
who ate a peanut-based product and wound up dying because of that, 
having survived illness. That's what this bill is all about.
  We can prevent food-borne illness in the United States of America. We 
can prevent 5,000 deaths every year. That's what this bill is focused 
on. It is of critical importance. It is about the health and the safety 
of American families. That health and safety is not only threatened in 
airports and border checkpoints or harbor containers. It's in fridges, 
on kitchen tables.
  And for too long the cornerstone of our food safety system, the FDA, 
has only rudimentary, ancient tools and an outdated mandate at its 
disposal. This bill rectifies that oversight. It gives the FDA the 
means to deal with the dangers that are posed by our global food 
system. It enhances the agency's ability to stem microbial illnesses, 
prevent contamination before it happens.
  It looks at risk-based inspection and says, what are the foods that 
are at highest risk? Let's set up some performance standards to deal 
with that. Let's put mechanisms in place so that we can trace the 
contamination and make sure we find it and find it quickly, protect the 
public health, and, yes, protect industry as well. That was part of 
this effort as well.
  Performance standards are the backbone for monitoring an effective 
process and a control system. I would urge the FDA to develop testing 
protocols for each performance standard that it sets. This would 
include ongoing industry testing programs, supported by periodic 
sampling by the FDA.
  The SPEAKER pro tempore. The time of the gentlewoman has expired.
  Mr. DINGELL. Mr. Speaker, I yield the distinguished gentlewoman an 
additional 30 seconds.
  Ms. DeLAURO. Thank you. We have an opportunity. The laws and the 
statutes at the Food and Drug Administration today are inadequate to 
protect

[[Page 20197]]

the food and the safety of the American people and at the very same 
time they put at risk the industries that deal with these products. The 
industry has come forward and said, Give us standards. That's what this 
bill is all about.
  We have an obligation today to pass this bill and to make sure that 
we say to the American people we are doing everything that we can to 
prevent 5,000 deaths every single year and particularly the most 
vulnerable, our children and the elderly.
  Mr. SHIMKUS. Mr. Speaker, I yield such time as he may consume to the 
gentleman from Michigan (Mr. Upton), who is ranking member on the 
Energy and Air Quality Subcommittee.
  Mr. UPTON. Mr. Speaker, let's face it: the recent events have shown 
us that the current system regarding food safety is not working. And I 
want to compliment those Members that have been actively involved in 
this, those from our Committee on Oversight and Investigations that 
exposed many of the problems, obviously the leadership on both sides, 
Republicans and Democrats, as we moved this bill through our 
subcommittee and then full committee by a voice vote.
  The Oversight and Investigations Subcommittee found severe problems. 
We are very aware of those problems because those problems have been 
exposed nationally. Obviously, we have a number of very bad actors, but 
they have jeopardized the whole food chain. We remember the peanut 
butter issue and spinach and tomatoes. We need to be deliberate to 
tackle the issue and obviously be bipartisan to resolve the issue, and 
that's what this legislation does.
  As Mr. Shimkus indicated, farms are not required to register with the 
FDA. There are no large fees associated with this bill. There is no 
duplication with the USDA, as I understand it.
  My district in southwest Michigan has a whole number of different 
food sources from fruits and vegetables to giant food processors and 
great companies like Kellogg's. Industry is united behind this 
legislation. It needs to happen so that consumers will know for sure 
that there is a mechanism in place to identify when a product, in fact, 
is bad, that needs to be recalled. And this bill, as it has moved 
through committee, has shown that bipartisan support.
  I would urge my colleagues on both sides to support it.
  Mr. DINGELL. Mr. Speaker, I yield at this time 3 minutes to the 
distinguished gentleman from California (Mr. Farr).
  Mr. FARR. I thank the chairman for yielding.
  Mr. Speaker, I rise to engage in a colloquy with my friend, the 
distinguished gentleman from Michigan (Mr. Dingell).
  We are passing an historic food safety measure today, and I truly 
appreciate the effort that you and committee staff have made to move 
this legislation to the floor today. As a Member of Congress who 
represents the Salad Bowl of the World, Salinas Valley, I feel landmark 
legislation is long overdue and look forward to working with my 
colleague as the process moves to the Senate and to the conference 
committee.
  Also as a member of the Agriculture Appropriations Committee, I look 
forward to working with the gentleman to allocate the resources 
necessary to make the safest food in the world even safer.
  I'd be remiss if I didn't mention my concerns with the fee structure 
in this measure, and I appreciate the effort by the chairman and the 
committee, and it's my preference to find a more equitable fee that 
does not inhibit our farm families from taking advantage of new 
markets. As a member of the Organic Caucus, I have concerns about the 
interplay between this bill and the National Organic Program.
  It is my understanding, Mr. Chairman, that this bill would not 
establish any requirements for organically produced or processed 
products which are in conflict with the requirements established in the 
Organic Foods Production Act of 1990 and USDA's National Organic 
Program regulations.
  Mr. DINGELL. If the gentleman would yield, the answer to that 
question is, yes.
  Mr. FARR. Thank you. And would this bill necessarily require small 
farms to participate in the expensive and unworkable electronic 
traceability system that FDA will set up?
  Mr. DINGELL. The answer to that question is, no.
  Mr. FARR. I yield to Mr. Blumenauer from Oregon, who has worked with 
Ms. Kaptur and myself to make sure that the organic and small growers 
and processors' concerns have a voice.
  Mr. BLUMENAUER. I appreciate the gentleman's courtesy, as I 
appreciate the leadership of the chairman. And it's great to see food 
safety receive the full attention that it deserves.
  I am especially concerned about the language regarding interaction 
between wildlife, livestock, and farming practices. Biodiversity is a 
prerequisite for a healthy farm. We should not penalize farmers for 
utilizing techniques such as naturescaping, floodplain restoration, and 
natural hedgerows to encourage crop health, control pests and invasive 
species, and enhance soil quality.
  We should target reform and safety efforts towards practices which 
have been directly linked to food disease outbreaks rather than 
limiting approaches that farmers have used for centuries to reduce 
their dependence on pesticides, herbicides, and other carbon-intensive 
farming techniques.
  I would like the assurance from the chairman that he will work with 
us as Food and Drug Administration develops these criteria so that they 
will consider the needs of small farms and the practices of organic 
farmers.
  Mr. DINGELL. The answer to that question is, yes; and I will have a 
more detailed response.
  Mr. BLUMENAUER. Thank you, Mr. Chairman, for your courtesy.
  Thank you, Mr. Farr, for permitting me to participate in this 
colloquy.
  Mr. DINGELL. If the gentleman from California would yield, I would 
like to give a more exhaustive response to my friends.
  First, we've been hearing complaints that the bill will put unfair, 
inappropriate, and unnecessary burdens on farmers, particularly small, 
diversified, and organic farms. We have worked hard to avoid doing 
that. I want to tell my good friends we would be extremely concerned if 
this bill created a conflict between food safety and other farm 
practices aimed at protecting and sustaining the environment. The bill 
therefore has a number of important provisions designed to prevent such 
conflicts.
  For example, it requires FDA to take into consideration the impacts 
of any produced food safety standards on small-scale and diversified 
farms or on wildlife habitat, on conservation practices, watershed 
protection efforts, and organic production methods. It prohibits FDA 
from setting any such standards unless these standards are necessary to 
minimize the risk of serious adverse health consequences or death.
  The bill also requires FDA to work in coordination with the U.S. 
Department of Agriculture to issue such standards. USDA administers the 
National Organic Program and will be working with FDA to ensure that 
the safety standards are compatible with organic standards.
  Let me speak now to the question about the traceability system in the 
bill. The traceability provisions in the bill are a critically 
important part because they allow FDA to quickly track down the sources 
of food-borne outbreaks. Before FDA can establish any traceability 
requirements, the bill requires FDA to go through an extensive 
information-gathering process with public meetings and a pilot project.
  As a part of the process, it requires FDA to consider the costs and 
the benefits and the feasibility for different sectors of the food 
industry of any traceability technologies under consideration. And for 
any regulation that would have an impact on farms, FDA must coordinate 
with USDA and take into account the nature of the impact on the 
regulation on farms.
  Additionally, FDA will be prohibited from requiring farms selling 
food directly to consumers, restaurants, or

[[Page 20198]]

grocery stores to participate in this system.
  So I believe we can be confident that whatever traceability system is 
developed will appropriately take into account the needs and interests 
of the farmers. And I assure my two good friends that I will work with 
them to see to it that these commitments are kept.
  Mr. FARR. Thank you, Mr. Chairman. I really appreciate that.
  Mr. BLUMENAUER. Thank you, sir.
  Mr. DINGELL. I thank my two colleagues for their valuable assistance 
to the committee.
  Mr. SHIMKUS. Mr. Speaker, before I yield time to my colleague, I 
yield myself 15 seconds.
  Mr. Speaker, I want to recognize my colleagues Mr. Putnam and Mr. 
Costa for their bill, the Safe FEAST Act, which I was an original 
cosponsor on, which got rolled into this bill, and it was of great help 
when they did that.
  Mr. Speaker, I yield such time as he may consume to my colleague from 
Florida (Mr. Putnam).
  Mr. PUTNAM. I thank my friend from Illinois for his leadership on 
this issue and his original cosponsorship of that Safe FEAST Act, which 
has had a number of its key principles incorporated into the bill that 
we're debating today.
  I rise in support of the bill that we are debating today. It is a 
bipartisan bill built on a bipartisan effort and a model that could and 
should be followed for the other big issues facing this Congress. It's 
unfortunate that the process that was taken did not adequately include 
our Agriculture Committee, and I would hope that as we move this issue 
forward that it will continue to improve upon that because it is 
important that our Agriculture Committee and our Representatives from 
rural America have input into this, and the bill will benefit from 
their input.

                              {time}  1645

  The scares that have undermined consumer confidence in our food 
supply over the last several years have as oftentimes been a result of 
international food products, imported food goods, as they have been 
domestic. This bill takes an important step forward in setting the same 
standards on imported food that we place upon domestically produced 
food as well. That is a major step in the right direction.
  One only need look at the controversy over baby formula, at the 
economic devastation that came from the misleading public statements by 
the FDA about tomatoes that were grown in America, which turned out to 
have been food-borne illness resulting from jalapenos imported from 
Mexico, to learn the lesson that this legislation must apply the same 
standards to imported foods as it does to domestic.
  This legislation implements risk-based assessments, something that is 
very important as we look at the breadth and depth of the food industry 
as it has become globalized. As the world has grown smaller, as 
America's tastes and preferences have changed and they desire produce 
from Latin America and spices from Asia, these challenges will continue 
to grow, and this, by placing risk-based science into the bill, will 
allow us to build up and maintain public confidence in our food supply.
  And that is really the crux of the matter between our producers and 
our consumers, that on this issue of food safety, there is no 
distinction between the interests of the farmer and the shopper in the 
grocery store, because the farmer loses out if FDA and USDA cannot 
rapidly and accurately trace back the source of food-borne illness.
  If they paint the industry with a broad brush, economic losses are 
severe, so the interests of the farmer are that we have a modern, 
effective regulatory system. The interests of the consumer are that we 
have a modern, effective regulatory system, so that they have a high 
level of confidence in the items that they purchase to put on their 
family's kitchen table. There must be the highest possible standard and 
the best possible science behind that law.
  As this issue moves forward, improvements can be made as it relates 
to the quarantine, as it relates to traceability, and, most 
importantly, as it relates to the implementation of this bill for State 
and local governments, the State Departments of Agriculture and Health, 
who, by definition, are delegated much of the responsibility by FDA to 
implement this legislation. They must have the resources and the 
authority and the full cooperation of FDA. There have been breakdowns 
in the past where FDA did not share as much as they should. This bill 
does much to address that, and can do a bit more.
  And in an era where organic farming continues to grow in popularity, 
we must be sensitive to these ever-changing forms and trends in 
American agriculture.
  With that, I am proud to support the legislation, and I appreciate 
the leadership of my friend from Illinois and my friend from Michigan.
  Mr. DINGELL. If the gentleman will yield to me just briefly, I want 
to commend the gentleman not just for a fine statement, but also for 
the long and strong support he has given for this kind of legislation 
and protection for industry and for the consumers.
  I would like to observe that the concerns the gentleman has expressed 
are very valuable and are included in the legislation, particularly in 
seeing to it that foreigners now have to meet the same requirement that 
Americans do.
  Americans produce and process safe food. Foreigners do not. This will 
assure our people that they can rely on Food and Drug to protect them 
not just from American producers and from American processors, but also 
from the foreigners, who are slipping in dangerous substances.
  I want to commend the gentleman and thank him.
  Mr. PUTNAM. I thank the chairman emeritus and the dean of the House.
  Mr. DINGELL. Mr. Speaker, I am delighted at this time to yield 1 
minute to the distinguished gentleman from Georgia (Mr. Scott), the 
chairman of the Subcommittee on Livestock, Dairy and Poultry.
  Mr. SCOTT of Georgia. I thank the chairman for yielding.
  I just want to state that under the auspices of my subcommittee, food 
safety is a jurisdiction that we handle. It is very important as we 
move forward on this to understand that we have got to make our food 
supply safe. There is no greater thing we can do for the American 
people and the people of the world than to give absolute assurance that 
our food supply is safe.
  Now, I come from a State, Georgia, where we had an outbreak from 
salmonella in which we lost eight lives, eight persons that would be 
alive today if we had this bill in place, because we would have a 
process of accessing records that we don't have now.
  Before this bill is passed, in order to get records from a 
manufacturer or food processing plant, we can't get it until the food 
outbreak occurs. But under this bill, when we are inspecting the plant, 
we will be able to get access to those records. If this was in place, 
eight Americans would be alive today.
  Mr. Speaker, 76 million Americans suffer from food poisoning from our 
food supply a year; 5,000 are dying.
  The SPEAKER pro tempore. The time of the gentleman from Georgia has 
expired.
  Mr. DINGLE. I yield the gentleman 30 seconds more.
  Mr. SCOTT of Georgia. Five thousand are dying. There is no more plain 
thing we can do.
  And I have heard some comments from those who oppose this bill that 
this bill does nothing, but it does, Mr. Speaker. It provides for us to 
have inspections at food plants every 6 to 12 months. Do you know how 
often we are inspecting them now? Once every 10 years. The American 
people deserve better than that. They deserve for us to have a trace-
back system so that we can trace back and get the origins of the 
outbreak as quickly as possible.
  This is a tremendous bill, a tremendous bipartisan effort, and the 
American people are expecting us to pass it, and pass it 
overwhelmingly.
  Mr. SHIMKUS. Mr. Speaker, I don't have any additional speakers. I 
reserve my time.

[[Page 20199]]


  Mr. DINGELL. Mr. Speaker, I yield to the distinguished gentlewoman 
from New York (Mrs. Maloney) for purposes of making a unanimous consent 
request.
  Mrs. MALONEY. Mr. Speaker, I rise in strong support of this bill.
  In recent years, a series of outbreaks of food-borne illnesses have 
made clear the need to effectively secure our nation's food supply.
  From spinach to cookie dough, foods have become contaminated and have 
threatened the health of the American people, exposing widespread 
problems with the food safety system in this country. H.R. 2749 will 
fundamentally change the way we ensure the safety of the foods we eat.
  This bipartisan bill will provide the FDA with new powers and the 
tools it needs to protect the food supply by providing for more 
frequent inspections of food-processing plants here in the U.S. and by 
ensuring the safety of foods imported from overseas.
  H.R. 2749 will also provide a new focus on the prevention of food-
borne illness by putting systems in place that allow us to better track 
the source of these outbreaks. This legislation is critical to the 
health and safety of the American people, and I urge my colleagues to 
support it.
  Mr. SHIMKUS. Mr. Speaker, I continue to reserve.
  Mr. DINGELL. Mr. Speaker, at this time I yield 2 minutes to my 
distinguished friend, the gentleman from Utah (Mr. Matheson), a superb 
Member of this body and a great friend of mine.
  Mr. MATHESON. Mr. Speaker, I thank the gentleman for yielding.
  Included in this bill was the manager's amendment addressing an issue 
that I raised that Mr. Dingell has worked long and hard on and helped 
me figure out a way to address concerns about, lead glazing on ceramic 
plates on which we eat our food.
  This issue first came to my attention with reports in my home State 
of Utah when a child was sick. After they analyzed the child, they 
determined the child had lead poisoning. They investigated the home 
where this child was living and couldn't find any sources of lead.
  Ultimately it was discovered that the child's mother had been heating 
food in the microwave oven. The ceramic bowl or plate she was using 
wasn't properly glazed or wasn't properly sealed, and lead was leaching 
out of the plate into the food. Then when she would nurse the baby, the 
baby would get lead poisoning.
  I think we all want to take steps to prevent that type of thing from 
happening. What we determined is most people don't even realize lead 
glazing is used on these plates. These plates come in with FDA labels, 
because the Food and Drug Administration has authority over it, so 
people who see a label from the Federal Government probably assume it 
safe.
  Included in the manager's amendment is a requirement that there is 
labeling, just so consumers have the right to know, that it contains a 
lead-glazed product. If it is properly glazed, it is not necessarily 
dangerous. But people have the right to know that.
  I really commend my friend from Michigan, who has been working on 
this issue and has been aware of it for a long time. He worked with my 
office extensively to come up with some way to try to at least make 
some progress on this issue. It is included in this bill. He is a great 
legislator, and I am glad he helped me figure that out.
  I encourage people to support this bill.
  Mr. DINGELL. Mr. Speaker, if the gentleman will yield, I would 
appreciate it if the gentleman didn't praise me, and instead let me say 
good words about him.
  He is a valuable member, a valuable member of our committee. He works 
hard. He is smart and decent and has been great on this issue. We are 
proud of him.
  Mr. SHIMKUS. I continue to reserve, Mr. Speaker.
  Mr. DINGELL. Mr. Speaker, at this time it is my privilege to yield 3 
minutes to the gentleman from Minnesota (Mr. Peterson), a very 
distinguished Member of this body, the chairman of the Agriculture 
Committee in the House and an extremely wise defender of American 
agriculture and American farmers.
  Mr. PETERSON. Mr. Speaker, I thank the gentleman for yielding.
  I first want to commend Chairman Emeritus Dingell for all of his hard 
work on this issue, not only during this session of Congress but in 
many sessions past. We are hopeful that we can move this legislation 
forward and get additional safeguards in place for food safety in this 
country.
  We also want to commend the other members of the Energy and Commerce 
Committee on our side of the aisle and on the Republican side of the 
aisle for their work on this on a bipartisan basis. It is good to see 
some bipartisan effort happening in the House, and there was some good 
work done.
  We did have some concerns in the Agriculture Committee that we 
engaged in some discussions and negotiations with Mr. Dingell and 
others on the staff of the Energy and Commerce Committee on, and we 
think we have further improved the bill in terms of how it relates to 
agriculture. We were able to clarify things in terms of livestock and 
grain farmers that there was some concern about the language, so that 
we cleared up some things in terms of performance standards and record 
keeping.
  As the bill came out of Energy and Commerce, there were concerns 
registered by some of the farm groups. Some of them even indicated they 
might oppose it. But at this point, because of the changes that have 
been made, we now have groups that in the past had some concerns, they 
are now either neutral or supporting this bill. The United Fresh Fruit 
and Vegetable Group, Western Growers, the American Farm Bureau, 
National Association of Wheat Growers, the Cattlemen Beef Association, 
Turkey Federation, Chicken Council, Pork Producers, Corn Growers, 
Soybean Association, Rice Federation, American Food Industry 
Association, United Egg Producers, the American Sheep Industry, the 
Wheat Growers and the Barley Growers, are now either supporting the 
legislation or are neutral on the legislation.
  We believe that we have addressed the concerns of agriculture. We 
believe this is a good bill. I encourage Members to support this bill, 
and again commend my good friend and colleague and the chairman 
emeritus, Mr. Dingell, for the great work he has done, as well as his 
staff.
  Mr. SHIMKUS. I continue to reserve, Mr. Speaker.
  Mr. DINGELL. Mr. Speaker, I am the only speaker remaining on this 
side, so if my good friend from Illinois would like to proceed, I will 
follow him in closing.
  Mr. SHIMKUS. Mr. Speaker, I yield myself such time as I may consume 
and will just close briefly by saying this is good to see on the floor.
  We did take a very difficult issue, one that has been languishing for 
21 years, and worked with young Members and new Members, like Adam 
Putnam, and with the distinguished Chairman Emeritus Dingell, and got 
into a room and moved a bill that has the support of almost everybody 
in the food processing and agriculture community and the marketing of 
this.
  I have sat in numerous hearings, as I said in my opening statement, 
and every time we would have an oversight investigation hearing there 
would be an alert of another food-borne illness, and we just knew we 
couldn't continue down that route.
  As my colleague Mr. Putnam said, it is going to be helpful to the 
farmers. It is going to be helpful to the processors when we bring some 
more security and safety and knowledge that we continue to produce the 
best food supply in the world. It also will help us with the imported 
products, and that was a big issue in our debate.
  So, with that, this has worked well. We should try this bipartisan 
method on things like energy and things like health, and maybe we will 
get there in months to come, I hope, because this is a much better 
process than us fighting altogether.
  With that, again, I thank Chairman Emeritus Dingell, who really led 
the way for us to get to where we are today.
  I yield back the balance of my time.

[[Page 20200]]



                              {time}  1700

  Mr. DINGELL. Mr. Speaker, I yield myself such time as I may consume. 
First, I want to commend my friend and colleague, Mr. Shimkus, and I 
want to express my gratitude to him. I also want to express my 
gratitude to Chairman Waxman, Chairman Stupak and Chairman Pallone, the 
legislative and appropriation and investigative committee chairmen of 
the Commerce Committee for the outstanding work they did in preparing 
this legislation. Also Representative DeGette and Representative 
Sutton.
  My colleagues Mr. Barton, Mr. Deal and Mr. Shimkus on the minority 
side have worked very well, carefully, thoughtfully with us, and I owe 
them a debt of thanks and gratitude. Staff Members like Rachel Sher and 
Eric Flamm have worked hard on this, as has my friend, Virgil Miller. 
Chairman Peterson and Jim Costa of the Agriculture Committee have been 
wise advisers and helpers in coming to a bill that could be agreed on 
by the two committees. Representative Levin, Chair of the Subcommittee 
on Trade of the Ways and Means Committee has been extremely important, 
as has Representative DeLauro, the Chair of the Appropriations 
Subcommittee. And Jeanne Ireland, a former staff member of this 
committee, has been of enormous help in the drafting of the 
legislation.
  We had a long list of supporters. The Obama administration; Grocery 
Manufacturers Association--the people who sell are going to understand 
that they're being charged a participation fee; the Wine Institute; 
Wine America; Distilled Spirits Council of the United States; Center 
for Science in the Public Interest; Consumers Union; Consumers 
Federation of America; Center for Foodborne Illness Research & 
Prevention; Food & Water Watch; Government Accountability Project; 
National Consumers League; Pew Charitable Trusts; and Safe Tables Our 
Priority are all active supporters of this legislation.
  And these agencies which previously had concerns about the 
legislation have either lifted their opposition, become neutral or 
actively support H.R. 2749: United Fresh Fruit and Vegetable; Western 
Growers; American Farm Bureau Federation; National Association of Wheat 
Growers; National Cattlemen's Beef Association; National Turkey 
Federation; National Chicken Council; National Pork Producers Council; 
National Corn Growers Association; American Soybean Association; U.S. 
Rice Federation; American Feed Industry Association; United Egg 
Producers; and the American Sheep Industry.
  We have seen that in the long time since legislation was passed to 
bring food and drug up to national needs back in 1938, that many 
changes have occurred that have required significant changes, both in 
the authority of FDA, in its moneys and its abilities to deal, not just 
with domestic producing problems, but with problems overseas, from 
which we are receiving lots of dangerous and unsafe food commodities 
and food products.
  This legislation gives food and drug the authority that it needs, the 
ability to trace, the ability to hold producers abroad accountable, and 
it sets up a system where foreigners have to participate in the same 
responsibilities American producers, manufacturers and growers have to, 
and it enables Food and Drug, for the first time, to have real 
authorities to enforce the laws of the United States on food safety to 
protect Americans against unsafe foods coming in from abroad.
  And I would remind my colleagues that Food and Drug has neither the 
resources at the points of entry, nor do they have the personnel at 
those places to inspect foods coming in. This changes that situation. 
It is also true that the legislation does something else of importance 
to our people, and that is, it sees to it that where misbehavior occurs 
abroad, those same penalties that would be assessed against Americans 
are assessed against foreigners. This is an important matter of 
competition to American producers and manufacturers. It sees to it that 
they are fairly treated, and that there is no more unfair competition 
by people who could market unsafe commodities to the detriment of 
American consumers and American growers, producers and processors.
  So the legislation is good. A system of assuring responsibility and 
traceability is available for the first time. And Food and Drug has the 
authority to terminate the ability of foreigners to sell in this 
country for the first time in a way which is consistent with American 
trade laws and the obligations of American people with regard to the 
safety of food. So, it is a good piece of legislation, and I would urge 
my colleagues to support it. I would have them know that this is 
bipartisan, this is a good piece of legislation. It is legislation 
which protects American people, which sees to it that Americans will no 
longer be dying of dangerous foods imported into the United States, and 
it will see to it that American producers are treated fairly in the 
world marketplace without jeopardy of violation of our law.
  It also will see that Food and Drug has the personnel, the resources 
that it needs to protect the American people, and it is kind to the 
budget of the American taxpayers.
  Mr. HASTINGS of Washington. Mr. Speaker, I rise today in opposition 
to H.R. 2749, the Food Safety Enhancement Act. This bill makes drastic 
changes to our nation's food safety laws that will affect every farmer 
and rancher in the United States. However, Mr. Speaker, the extent of 
these changes is unknown, because the full text of this bill was not 
yet available to Members until the day before the vote.
  Our Nation has the safest food supply in the world, Mr. Speaker, and 
that is because our growers and processors work hard to provide quality 
products to consumers. While the circumstances surrounding recent food 
safety violations must be addressed, in nearly every case, these were 
violations of existing laws and standards. It is imperative that 
Congress does not rush to use these incidents as an excuse to 
unnecessarily and dramatically expand federal regulation of our 
producers and processors.
  This is a better bill than the one that came out of the Energy and 
Commerce Committee. Yet, I am still concerned about the broad authority 
this legislation gives to the Food and Drug Administration to regulate 
on-farm practices for our fruit and vegetable growers. If this bill is 
signed into law, the FDA will for the first time have the explicit 
authority to regulate the way produce is grown and harvested.
  I am also concerned, Mr. Speaker, with the significant financial 
burden that the new traceability and record-keeping requirement will 
have on America's small farmers and agriculture processors. This bill 
would allow FDA to charge huge fines for even minor paperwork 
violations that could put smaller operations out of business.
  Also of note, is the broad quarantine authority that this bill gives 
to FDA. While I recognize the need to quarantine the source of food-
borne illnesses, this bill would allow the FDA to quarantine wide 
geographic areas where the source may exist. We know that the FDA can 
make mistakes over the origin of an outbreak, and this provision could 
cause devastating economic impacts to growers and processors who have 
done absolutely nothing wrong.
  Agriculture is the number one industry in Washington State. Creating 
jobs and growing our economy is dependent upon supporting our farmers 
and ranchers--not passing legislation that could put them out of 
business.
  I have heard some of my colleagues say that we can rely on the Senate 
to address the flaws in this bill. I believe that the House of 
Representatives owes it to our growers and processors to take the time 
to do this right, and not rely on the Senate to fix our mistakes.
  Mr. HOLT. Mr. Speaker, I rise today in support of the Food Safety 
Enhancement Act (H.R. 2749), and to commend the Committees on 
Agriculture and Energy and Commerce for their hard work in crafting the 
bill.
  According to a 2005 study by the Centers for Disease Control, each 
year 76 million people (25 percent of the population) become sick, 
325,000 are hospitalized and 5,000 die from foodborne illnesses in the 
United States. In recent years, the United States has experienced many 
incidents of food contamination, caused by biological and man-made 
toxins. For example, in 2000, various brands of taco shells were found 
to be contaminated with genetically modified corn meant only for animal 
feed. In the fall of 2006, spinach contaminated with E. coli bacteria 
resulted in more than 200 confirmed illnesses and at least three 
deaths. In 2007, various products imported from China

[[Page 20201]]

were found to contain wheat gluten contaminated with the industrial 
chemical melamine, which killed more than a dozen house pets. And 
recently, people across the country were infected with Salmonella 
bacteria from eating peanut products from a processing plant in 
Georgia. Even contaminated cookie dough has ended up in the food 
supply.
  Therefore I commend my colleagues Chairman Emeritus Dingell, Chairman 
Waxman, Mr. Pallone and Mr. Stupak for their firm and comprehensive 
response to this torrent of food contamination incidents, and for 
crafting the bill before us today. In addition, I want to acknowledge 
my colleague Ms. DeLauro for her own substantial efforts to improve 
food safety, and her contributions to this bill. It would make many 
important improvements to our food safety regulations, including 
creating an up-to-date registry of all food facilities serving American 
consumers, requiring foreign and domestic food facilities to have 
safety plans in place to identify and mitigate hazards, and require 
high-risk food facilities to be inspected every 12 months, and low-risk 
facilities to be inspected every 18 months. It also requires the Food 
and Drug Administration, FDA, to develop a system which would expedite 
import processing for importers who agree to adhere to enhanced safety 
and security guidelines, and expands FDA trace-back capabilities in the 
event of a foodborne illness.
  In particular, I want to thank the Committees for responding to many 
of the concerns raised by the National Sustainable Agriculture 
Coalition and constituents from my district that the bill would 
negatively impact small, family-owned, and organic farms. For example, 
the bill before us today provides an exemption from traceability and 
registration for direct farmer-to-consumer marketing, an exemption for 
food, facilities and farms that are already regulated by the U.S. 
Department of Agriculture, and an exemption for grain and hay farmers 
from full-scale electronic traceability requirements. In all these 
cases the regulations would be unnecessary and wasteful.
  However, a number of the concerns they raised have not been 
addressed, and I look forward to working with my colleagues in both 
Chambers to ensure that those matters are addressed as the bill moves 
through the process. Most importantly, it will be critical to assure 
that none of the new safety standards weaken the standards under the 
National Organic Program. In addition, it will be important that we 
facilitate and enhance the role of conservation and sustainability 
practices to address food safety issues. And we must ensure that the 
fee structure in the bill does not disproportionately impact small 
agricultural producers.
  I thank my colleagues again for their leadership and prompt action on 
this matter, and I urge my colleagues to support this bill, and to work 
to fine-tune it as it moves through the legislative process.
  Mr. DINGELL. I yield back the balance of my time.
  The SPEAKER pro tempore. All time for debate has expired.
  Pursuant to House Resolution 691, the previous question is ordered on 
the bill, as amended.
  The question is on the engrossment and third reading of the bill.
  The bill was ordered to be engrossed and read a third time, and was 
read the third time.


                           Motion to Recommit

  Mr. LUCAS. Mr. Speaker, I have a motion to recommit at the desk.
  The SPEAKER pro tempore. Is the gentleman opposed to the bill?
  Mr. LUCAS. I am opposed to the bill in its current form.
  The SPEAKER pro tempore. The Clerk will report the motion to 
recommit.
  The Clerk read as follows:

       Mr. Lucas moves to recommit the bill H.R. 2749 to the 
     Committee on Energy and Commerce with instructions to report 
     the bill back to the House forthwith with the following 
     amendments:
       Page 21, lines 3 and 4, strike subparagraph (B) and insert 
     the following:
       ``(B) shall only be collected and available as follows:
       ``(i) Fifty percent shall be available to defray the costs 
     of additional safety inspection of food in the United States.
       ``(ii) Fifty percent shall be available for use under 
     section 137 of the Food Safety Enhancement Act of 2009.
       Page 23, line 8, strike ``and''.
       Page 23, line 11, strike the period and insert ``; and''.
       Page 23, after line 11, insert the following:
       ``(F) preemptive purchase of product from facilities as 
     defined in section 415.''.
       At the end of subtitle C of title I add the following (and 
     revise the table of contents in section 2 accordingly):

     SEC. 137. PREEMPTIVE PURCHASE.

       (a) In General.--From the fees collected under section 743 
     of the Federal Food, Drug, and Cosmetic Act, as added by 
     section 102, the Secretary of Health and Human Services may 
     make a preemptive purchase related to activities by the 
     Government in carrying out any provision of this Act or an 
     amendment made by this Act.
       (b) Limitation.--Notwithstanding subsection (a), the 
     Secretary shall not make any payment under such subsection in 
     excess of the amount of fees available under section 
     743(e)(2)(B)(ii) of the Federal Food, Drug, and Cosmetic Act, 
     as added by section 102.

  Mr. DINGELL. I reserve a point of order, Mr. Speaker.
  The SPEAKER pro tempore. The point of order is reserved.
  Pursuant to the rule, the gentleman from Oklahoma is recognized for 5 
minutes in support of the motion.


                             Point of Order

  Mr. DINGELL. Mr. Speaker, I raise a point of order against the motion 
to recommit.
  The SPEAKER pro tempore. The gentleman will state his point of order.
  Mr. DINGELL. Under rule XVI, clause 7, and the language of the rule, 
it says no motion or proposition on a subject different from that under 
consideration shall be admitted under color of amendment. And I'd point 
out that that is applicable to the questions before us. I would note 
that the language of the motion does take and separates the receipts 
that will be gotten from the registration fees, so that 50 percent are 
available to defray the costs of additional safety inspection of food; 
but 50 percent shall be available for use under section 137. But the 
purpose of that is, rather, for the preemptive purchase of product from 
facilities as defined in section 415. This allows the broadest kind of 
purchase of food.
  The legislation itself allows certain specific actions, none of which 
involve purchase of food, particularly under such broad circumstances 
as the motion allows. The bill only allows expenditure of these 
registration fees for the following purpose: records access, 
traceability, recall authority, authority to detain, subpoena 
authority, prohibition or restriction on the movement of bad food. No 
further authorities for purchase or expenditure of this money are 
permitted.
  This goes well beyond the fundamental purpose of the legislation and, 
as such, it constitutes a violation of the rules, going beyond that 
which is the fundamental purpose of the legislation and so constituting 
a violation of rule XVI, clause 7 of being not germane.
  The SPEAKER pro tempore. Does any other Member wish to be heard on 
the point of order?
  Mr. LUCAS. Mr. Speaker, the nature of this bill contemplates a number 
of different things that try to address and protect the supply of 
domestic food in this country, food in general, I should say. The bill, 
the language offered, the motion, refers to using 50 percent of these 
fees collected under section 137 of the motion, which is referenced on 
the second page. This is just an additional item to all of the things 
already outlined in the bill in its present form.
  The SPEAKER pro tempore. The Chair recognizes the gentleman from 
Michigan.
  Mr. DINGELL. Mr. Speaker, I would observe that the language of the 
legislation nowhere authorizes purchase of food. Under the number of 
the legislation appears the language, to amend the Food, Drug and 
Cosmetic Act to improve the safety of food in the global market and for 
other purposes. And then, down there where you follow, following the 
words, a bill, and it says, to amend the Federal Food, Drug and 
Cosmetic Act to improve the safety of food in the global market and for 
other purposes. Nowhere in the legislation, in my reading, have I been 
able to find the authorization for the purchase of food or the purchase 
of food to achieve safety.
  I would observe that the language of the motion to recommit permits 
the purchase of the food without restriction, without restraint or 
limit. It is some of the grandest authority that is given and well 
beyond any authority which Food and Drug now has or seeks. Food and 
Drug has no authority in this area whatsoever for the purchase of food. 
And the purchasing of food is not for the purpose of protecting the 
American people, of seeing to it that Food

[[Page 20202]]

and Drug can properly assure the safety of the food or the protection 
of the American consumers. And the language that is, I think, most 
particularly descriptive of what the proposal does, it follows line 3 
at page 2. It says, the Secretary of Health--and this is, I'm reading 
at line 6--the Secretary of Health and Human Services may make a 
preemptive purchase related to activities by the government in carrying 
out any provisions of this act or amendment made by this act.

                              {time}  1715

  That might be good language for the Committee on Agriculture to 
present to the House, but it is not language that you will find in Food 
and Drug and none that would be suggested by the commerce committee.
  The SPEAKER pro tempore. If no other Member wishes to be heard, the 
Chair is prepared to rule.
  The gentleman from Michigan makes a point of order that the amendment 
proposed in the motion to recommit offered by the gentleman from 
Oklahoma is not germane. The test of germaneness in this situation is 
the relationship of the amendment proposed in the motion to recommit to 
the provisions of the bill as a whole.
  The bill, as perfected, amends the Federal Food, Drug, and Cosmetic 
Act to improve the safety of food. It grants the Secretary of Health 
and Human Services authority to issue mandatory performance standards 
for reducing hazards and requires the Secretary to conduct risk-based 
inspections. It also expands the Secretary's access to food safety 
records and increases the Secretary's ability to oversee the safety of 
imported food, requiring safety-related documentation for potentially 
unsafe imported food as a condition of import.
  In most pertinent part to the question at hand, the bill provides the 
Secretary with sundry tools to address an outbreak of food-borne 
illness. These include a system for the rapid tracing of the origin of 
food, authority to mandate recalls of contaminated food, and authority 
to quarantine geographic areas of the United States from which the 
Secretary reasonably believes contaminated food has originated.
  The amendment proposed in the motion to recommit contemplates 
allowing the Secretary to preemptively purchase food as a matter of 
food safety, as in the context of section 415 of the Act. The amendment 
also would make a portion of the proceeds of certain fees contemplated 
by the bill available only for such preemptive purchases.
  The Chair finds that the amendment pursues the same fundamental 
purpose of the bill by a method that dwells within the range of methods 
employed by the bill. The Chair therefore holds that the amendment is 
germane.
  Accordingly, the point of order is overruled. The motion is in order.
  The gentleman from Michigan may be recognized for 5 minutes in 
opposition.
  Mr. DINGELL. Mr. Speaker, we have before us a bad motion to recommit. 
With all due respect for its author, we know that the FDA has been 
chronically starved of resources, particularly in the food area and 
particularly in its ability to protect the American people.
  The amendment offered before us would raid that money and would use 
it for the purpose of purchasing food. The food is not designated as to 
how or why it might be purchased. I would point out that this breaks an 
agreement and an understanding that the committee had in this 
legislation with regard to the support by the food production industry, 
especially the parts of the industry that will pay the tax.
  The bill only authorizes a modest $500 registration fee for food 
facilities. The motion to recommit asserts the bill does not require 
the FDA to spend one additional penny on the inspection of food. This 
is a serious untruth.
  On Page 23, the bill directs the FDA to spend its registration fees 
on food safety activities. The bill explicitly provides that food 
safety activities include conducting inspections. This money will be 
diverted from the inspection and the protection of the American people, 
and it will not be available for the activities of Food and Drug. It 
might give relief to somebody, and it might even be somebody who needs 
relief, but there's no standards whatsoever given as to who will get 
the money, how it will be spent, on what, and for what purposes.
  The bill requires the FDA to adhere to a rigorous mandatory 
inspection schedule based on risk. This bill does nothing to enhance 
that, but it takes money away from the protection of the American 
consumer by having proper inspections at points of entry or inspections 
in other countries. That is a bad situation and one which is going to 
seriously hurt the safety of the American public.
  The bill is carefully crafted to ensure that the American Food and 
Drug Administration will protect American consumers and American 
manufacturers, processors, growers, and the farmers of this Nation. It 
enables them to focus on where there is danger, and it enables them to 
provide the kind of protection that all of those entities need, 
especially the farmers, the processors and the producers, because today 
the broad authority that Food and Drug has is no longer sufficiently 
focused to enable the correct and direct focus on the dangers to the 
American public.
  The bill gives Food and Drug modern authorities to safeguard the food 
supply, but it gives them the money to do the things that they have to 
do to protect the American industry and the American-consuming public.
  This legislation diverts 50 percent of the receipts that we would get 
under the legislation from the protection both of producers and from 
the protection of the American-consuming public.
  The bill has provisions that ensure that FDA cannot use its ability 
to stop distribution recall or to detain or to prohibit or to restrict 
the movement of food. The Food and Drug Administration will have to use 
modern authorities in a very careful way, in a way which has the 
support of the consuming public and of the people whose names and whose 
organizational structures I mentioned earlier.
  We have found out what an inadequately funded FDA does. This 
legislation will ensure that those evils will persist. The amendment 
reduces funds to FDA. It thereby increases the likelihood of outbreaks 
and of danger to the health of the American people and of hurt to the 
American producers, growers, and farmers.
  This is a bad amendment. It is an amendment which threatens the 
support of industry for this legislation by diverting the money into 
unwise, unnecessary and undue expenditures which threaten the basic 
purposes of the legislation. It is bad legislation, and it will worsen 
what is a carefully thought-out bipartisan bill, which has been 
produced in consultation, not just with the industry but with the 
Agriculture Committee, with the administration and with both the 
Department of Agriculture and the Food and Drug Administration.
  I urge my colleagues to reject this amendment, which wastes money and 
which jeopardizes the life, safety and the well being of American 
consumers and the well being of American farmers, agriculture, and 
producers. It's a bad, bad motion to recommit.
  I urge the House to reject it.
  The SPEAKER pro tempore. The Chair was mis-advised that the gentleman 
from Oklahoma had already explained the motion.
  The proponent of the motion is entitled to 5 minutes and is 
recognized.
  Mr. LUCAS. Mr. Speaker, once again, let me express my gratitude to 
the chairman emeritus and to the ranking member of the Energy and 
Commerce Committee. They have both put a great deal of effort into 
developing this very important piece of legislation, and they are to be 
commended for their attempts to accommodate the concerns raised by 
members of the minority party of the Agriculture Committee.
  During the past few days, I have discussed many of the more 
objectionable provisions of this legislation. Today, I am hopeful and 
optimistic, in offering this motion to recommit, that we can at the 
very least address two of the bill's most glaring omissions.
  Specifically, I would like to focus on what I believe to be a lack of 
accountability on the part of the Food and

[[Page 20203]]

Drug Administration. The legislation before us provides the agency with 
numerous punitive authorities as well as a new source of revenue 
charged to people wishing to be in the food business, but it does not 
require the FDA to spend one additional penny on the inspection of 
food.
  I am hopeful that my colleagues will agree that this is something 
that we can and should address in this bill as it leaves the House. 
Therefore, I propose that FDA spend a portion of the funds collected as 
registration fees for additional food inspections in the United States 
of America. Let's face it, if we are going to call this bill the Food 
Safety Enhancement Act, we should probably have something in here that 
actually enhances food safety.
  Now, another issue that is very troubling and the one we hear 
repeatedly from farm groups is the issue of indemnification. I would 
point out that the chairman emeritus and the ranking member explained 
that concern in a Dear Colleague that was sent out last night. The 
issue of indemnification can be illustrated with the example of what 
happened to tomato crops in 2008.
  The FDA mistakenly attributed an outbreak of salmonella to tomatoes. 
It was later discovered that contaminated peppers were the actual 
source of the illness. However, the discovery came after a large part 
of the 2008 tomato crop was destroyed, and the industry suffered, 
perhaps, $100 million in losses as a result.
  I appreciate that Mr. Dingell and Mr. Barton feel that the passage of 
this bill will reduce the number and the severity of these mistakes in 
the future. I truly hope they are right. We must not kid ourselves into 
believing that the FDA will not make such mistakes in the future. 
Wrongly implicating agriculture products to food-borne disease 
outbreaks can cause severe economic losses to farmers and ranchers, who 
can ill afford them. Unfortunately, this legislation does not address 
this real concern.
  We attempt to address this omission in our motion to recommit. We 
propose that some of the money coming from the registration fees be set 
aside for preemptive purchase products from producers. Remember, these 
purchases only result from direct government action. These changes will 
not fix everything that we feel to be wrong with the legislation, but 
they will address some of the more significant problems.
  Nothing in this motion adds to the cost of the bill, but it does 
strengthen FDA accountability, and it guarantees enhanced food safety 
inspection.
  Once again, let's direct that half the money goes to food inspection. 
Let's make sure the other half of this registration money is available 
to correct the mistakes that the FDA may make.
  I urge all of my colleagues to support this motion. Let's clean up 
two of the biggest problems, and let's move forward. I urge all of my 
colleagues to support this motion once again.
  Mr. Speaker, I yield back the balance of my time.
  Mr. DINGELL. Mr. Speaker, I understand that the majority on the 
committee that handles the bill is entitled to close; is that correct?
  The SPEAKER pro tempore. That is ordinarily correct.
  Mr. DINGELL. Then I ask unanimous consent that I be permitted to 
proceed.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Michigan?
  Mr. LUCAS. I reserve the right to object, Mr. Speaker.
  Mr. Speaker, could I note for the record: Has the gentleman not used 
his 5 minutes?
  The SPEAKER pro tempore. Because recognitions to explain and oppose 
the motion were conferred out of sequence, if there is no objection, 
the gentleman from Michigan will be recognized for 1 minute to close 
the debate.
  There was no objection.
  Mr. DINGELL. Mr. Speaker, I will simply observe as follows: the 
motion to recommit asserts that the bill does not require FDA to spend 
one additional penny on the inspection of food. That is totally false.
  On page 23 of the bill, it directs FDA to spend its registration fees 
on food safety activities. On line 18, the bill explicitly provides 
that food safety activities include conducting inspections. The bill 
also requires FDA to adhere to a rigorous mandatory inspection schedule 
based on risk.
  I yield now to the distinguished gentleman from Georgia (Mr. Scott).
  Mr. SCOTT of Georgia. Mr. Speaker, for the remaining seconds, the 
bill on two points:
  It violates the rule, and it will weaken the FDA program. This bill 
inspects the food processing plants at an increased rate, far more than 
it is doing now. Again, it violates the rule, and it weakens the FDA's 
program. On those grounds, we reject this motion to recommit.
  The SPEAKER pro tempore. Without objection, the previous question is 
ordered on the motion to recommit.
  There was no objection.
  The SPEAKER pro tempore. The question is on the motion to recommit.
  The question was taken; and the Speaker pro tempore announced that 
the noes appeared to have it.
  Mr. LUCAS. 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 and clause 9 of rule XX, this 15-minute vote on 
the motion to recommit will be followed by 5-minute votes on passage of 
H.R. 2749, if ordered, and motions to suspend the rules with regard to:
  H.R. 1752, if ordered;
  H. Res. 535, if ordered;
  H. Res. 550, if ordered.
  The vote was taken by electronic device, and there were--yeas 186, 
nays 240, not voting 7, as follows:

                             [Roll No. 679]

                               YEAS--186

     Aderholt
     Akin
     Alexander
     Altmire
     Arcuri
     Austria
     Bachmann
     Bachus
     Barrett (SC)
     Bartlett
     Barton (TX)
     Biggert
     Bilbray
     Bilirakis
     Bishop (UT)
     Blackburn
     Blunt
     Boehner
     Bonner
     Bono Mack
     Boozman
     Boren
     Boustany
     Brady (TX)
     Bright
     Broun (GA)
     Brown (SC)
     Brown-Waite, Ginny
     Buchanan
     Burgess
     Burton (IN)
     Buyer
     Calvert
     Camp
     Campbell
     Cantor
     Cao
     Capito
     Carter
     Cassidy
     Castle
     Chaffetz
     Coble
     Coffman (CO)
     Cole
     Conaway
     Crenshaw
     Culberson
     Davis (KY)
     Deal (GA)
     Dent
     Diaz-Balart, L.
     Diaz-Balart, M.
     Dreier
     Duncan
     Ehlers
     Emerson
     Fallin
     Flake
     Fleming
     Forbes
     Fortenberry
     Foxx
     Franks (AZ)
     Frelinghuysen
     Gallegly
     Garrett (NJ)
     Gerlach
     Gingrey (GA)
     Gohmert
     Goodlatte
     Granger
     Graves
     Guthrie
     Hall (TX)
     Harper
     Hastings (WA)
     Heller
     Hensarling
     Herger
     Hoekstra
     Hunter
     Inglis
     Issa
     Jenkins
     Johnson (IL)
     Johnson, Sam
     Jones
     Jordan (OH)
     King (IA)
     King (NY)
     Kingston
     Kirk
     Kline (MN)
     Lamborn
     Lance
     Latham
     LaTourette
     Latta
     Lee (NY)
     Lewis (CA)
     LoBiondo
     Lucas
     Luetkemeyer
     Lummis
     Lungren, Daniel E.
     Mack
     Manzullo
     Marchant
     Marshall
     McCarthy (CA)
     McCaul
     McClintock
     McCotter
     McHenry
     McHugh
     McIntyre
     McKeon
     McMorris Rodgers
     McNerney
     Mica
     Miller (FL)
     Miller (MI)
     Miller, Gary
     Moran (KS)
     Murphy (NY)
     Murphy, Tim
     Myrick
     Neugebauer
     Nunes
     Olson
     Paul
     Paulsen
     Pence
     Perriello
     Petri
     Pitts
     Platts
     Poe (TX)
     Posey
     Price (GA)
     Putnam
     Radanovich
     Rehberg
     Reichert
     Roe (TN)
     Rogers (AL)
     Rogers (KY)
     Rogers (MI)
     Rohrabacher
     Rooney
     Ros-Lehtinen
     Roskam
     Royce
     Ryan (WI)
     Scalise
     Schmidt
     Schock
     Sensenbrenner
     Sessions
     Shadegg
     Shimkus
     Shuster
     Simpson
     Smith (NE)
     Smith (NJ)
     Smith (TX)
     Souder
     Stearns
     Sullivan
     Terry
     Thompson (PA)
     Thornberry
     Tiahrt
     Tiberi
     Turner
     Upton
     Walden
     Wamp
     Westmoreland
     Whitfield
     Wilson (SC)
     Wittman
     Wolf
     Young (AK)
     Young (FL)

                               NAYS--240

     Abercrombie
     Ackerman
     Andrews
     Baca
     Baird
     Baldwin
     Barrow
     Bean
     Becerra
     Berkley
     Berman
     Berry
     Bishop (GA)
     Bishop (NY)
     Blumenauer
     Boccieri
     Boswell
     Boucher
     Boyd
     Brady (PA)
     Braley (IA)
     Brown, Corrine
     Butterfield
     Capps
     Capuano
     Cardoza
     Carnahan
     Carney
     Carson (IN)
     Castor (FL)
     Chandler
     Childers
     Chu
     Clarke
     Clay
     Cleaver
     Clyburn
     Cohen
     Connolly (VA)
     Conyers
     Cooper
     Costa
     Costello
     Courtney
     Crowley
     Cuellar
     Cummings
     Dahlkemper

[[Page 20204]]


     Davis (AL)
     Davis (CA)
     Davis (IL)
     Davis (TN)
     DeFazio
     DeGette
     Delahunt
     DeLauro
     Dicks
     Dingell
     Doggett
     Donnelly (IN)
     Doyle
     Driehaus
     Edwards (MD)
     Edwards (TX)
     Ellison
     Ellsworth
     Engel
     Eshoo
     Etheridge
     Farr
     Fattah
     Filner
     Foster
     Frank (MA)
     Fudge
     Giffords
     Gonzalez
     Gordon (TN)
     Green, Al
     Green, Gene
     Griffith
     Grijalva
     Gutierrez
     Hall (NY)
     Halvorson
     Hare
     Harman
     Hastings (FL)
     Heinrich
     Herseth Sandlin
     Higgins
     Hill
     Himes
     Hinchey
     Hinojosa
     Hirono
     Hodes
     Holden
     Holt
     Honda
     Hoyer
     Inslee
     Israel
     Jackson (IL)
     Jackson-Lee (TX)
     Johnson (GA)
     Johnson, E. B.
     Kagen
     Kanjorski
     Kaptur
     Kennedy
     Kildee
     Kilpatrick (MI)
     Kilroy
     Kind
     Kirkpatrick (AZ)
     Kissell
     Klein (FL)
     Kosmas
     Kratovil
     Kucinich
     Langevin
     Larsen (WA)
     Larson (CT)
     Lee (CA)
     Levin
     Lewis (GA)
     Lipinski
     Loebsack
     Lofgren, Zoe
     Lowey
     Lujan
     Lynch
     Maffei
     Maloney
     Markey (CO)
     Markey (MA)
     Massa
     Matheson
     Matsui
     McCollum
     McDermott
     McGovern
     McMahon
     Meek (FL)
     Meeks (NY)
     Melancon
     Michaud
     Miller (NC)
     Miller, George
     Minnick
     Mitchell
     Mollohan
     Moore (KS)
     Moore (WI)
     Moran (VA)
     Murphy (CT)
     Murphy, Patrick
     Nadler (NY)
     Napolitano
     Neal (MA)
     Nye
     Oberstar
     Obey
     Olver
     Ortiz
     Pallone
     Pascrell
     Pastor (AZ)
     Payne
     Perlmutter
     Peters
     Peterson
     Pingree (ME)
     Polis (CO)
     Pomeroy
     Price (NC)
     Quigley
     Rahall
     Rangel
     Reyes
     Richardson
     Rodriguez
     Ross
     Rothman (NJ)
     Roybal-Allard
     Ruppersberger
     Rush
     Ryan (OH)
     Sanchez, Linda T.
     Sarbanes
     Schakowsky
     Schauer
     Schiff
     Schrader
     Schwartz
     Scott (GA)
     Scott (VA)
     Serrano
     Sestak
     Shea-Porter
     Sherman
     Shuler
     Sires
     Skelton
     Slaughter
     Smith (WA)
     Snyder
     Space
     Speier
     Spratt
     Stark
     Stupak
     Sutton
     Tanner
     Taylor
     Teague
     Thompson (CA)
     Thompson (MS)
     Tierney
     Titus
     Tonko
     Towns
     Tsongas
     Van Hollen
     Velazquez
     Visclosky
     Walz
     Wasserman Schultz
     Waters
     Watson
     Watt
     Waxman
     Weiner
     Welch
     Wexler
     Wilson (OH)
     Woolsey
     Wu
     Yarmuth

                             NOT VOTING--7

     Adler (NJ)
     Grayson
     Linder
     McCarthy (NY)
     Murtha
     Salazar
     Sanchez, Loretta

                              {time}  1755

  Messrs. MOLLOHAN, CARNEY, YARMUTH, Ms. SCHWARTZ, Messrs. BISHOP of 
Georgia and OBERSTAR changed their vote from ``yea'' to ``nay.''
  Mr. GARY G. MILLER of California changed his vote from ``nay'' to 
``yea.''
  So the motion to recommit was rejected.
  The result of the vote was announced as above recorded.
  The SPEAKER pro tempore. The question is on the passage of the bill.
  The question was taken; and the Speaker pro tempore announced that 
the ayes appeared to have it.


                             Recorded Vote

  Mr. SHIMKUS. Mr. Speaker, I demand a recorded vote.
  A recorded vote was ordered.
  The SPEAKER pro tempore. This is a 5-minute vote.
  The vote was taken by electronic device, and there were--ayes 283, 
noes 142, not voting 8, as follows:

                             [Roll No. 680]

                               AYES--283

     Abercrombie
     Ackerman
     Altmire
     Andrews
     Baca
     Bachmann
     Baird
     Baldwin
     Barrow
     Barton (TX)
     Bean
     Becerra
     Berkley
     Berman
     Berry
     Biggert
     Bilirakis
     Bishop (GA)
     Bishop (NY)
     Blumenauer
     Boccieri
     Boren
     Boswell
     Boucher
     Boyd
     Brady (PA)
     Braley (IA)
     Brown, Corrine
     Brown-Waite, Ginny
     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)
     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.
     Kagen
     Kanjorski
     Kaptur
     Kennedy
     Kildee
     Kilpatrick (MI)
     Kilroy
     King (NY)
     Kirk
     Kirkpatrick (AZ)
     Kissell
     Klein (FL)
     Kline (MN)
     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
     Markey (MA)
     Matheson
     Matsui
     McCollum
     McCotter
     McDermott
     McGovern
     McHugh
     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
     Myrick
     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.
     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
     Taylor
     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
     Young (FL)

                               NOES--142

     Aderholt
     Alexander
     Arcuri
     Austria
     Bachus
     Barrett (SC)
     Bartlett
     Bilbray
     Bishop (UT)
     Blackburn
     Blunt
     Boehner
     Bonner
     Bono Mack
     Boozman
     Boustany
     Brady (TX)
     Bright
     Broun (GA)
     Brown (SC)
     Burton (IN)
     Calvert
     Campbell
     Cantor
     Carter
     Cassidy
     Chaffetz
     Childers
     Coble
     Coffman (CO)
     Cole
     Conaway
     Culberson
     Davis (KY)
     Davis (TN)
     Dreier
     Duncan
     Emerson
     Fallin
     Flake
     Fleming
     Forbes
     Foxx
     Franks (AZ)
     Gallegly
     Garrett (NJ)
     Gohmert
     Goodlatte
     Granger
     Graves
     Griffith
     Hall (TX)
     Harper
     Hastings (WA)
     Heinrich
     Heller
     Hensarling
     Herger
     Hinchey
     Hoekstra
     Hunter
     Inglis
     Issa
     Jenkins
     Johnson (IL)
     Johnson, Sam
     Jones
     Jordan (OH)
     Kind
     King (IA)
     Kingston
     Kratovil
     Lamborn
     Latham
     Latta
     Lewis (CA)
     Lucas
     Luetkemeyer
     Lujan
     Lummis
     Lungren, Daniel E.
     Mack
     Manzullo
     Marchant
     Markey (CO)
     Marshall
     Massa
     McCarthy (CA)
     McCaul
     McClintock
     McHenry
     McKeon
     McMorris Rodgers
     Mica
     Miller (FL)
     Miller, Gary
     Minnick
     Moran (KS)
     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)
     Schmidt
     Schock
     Sensenbrenner
     Sessions
     Shadegg
     Shuler
     Shuster
     Simpson
     Smith (NE)
     Smith (TX)
     Souder
     Stearns
     Sullivan
     Teague
     Thompson (PA)
     Thornberry
     Tiahrt
     Wamp
     Welch
     Westmoreland
     Wilson (SC)
     Wittman
     Woolsey
     Young (AK)

                             NOT VOTING--8

     Adler (NJ)
     Akin
     Grayson
     Linder
     McCarthy (NY)
     Murtha
     Salazar
     Sanchez, Loretta


                Announcement by the Speaker Pro Tempore

  The SPEAKER pro tempore (during the vote). There are 2 minutes 
remaining on this vote.

                              {time}  1802

  So the bill was passed.
  The result of the vote was announced as above recorded.
  A motion to reconsider was laid on the table.
  Stated against:
  Mr. AKIN. Mr. Speaker, on rollcall No. 680, had I been present, I 
would have voted ``no.''

                          ____________________