[House Report 111-235]
[From the U.S. Government Publishing Office]


111th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 1st Session                                                    111-235

======================================================================

 
   PROVIDING FOR CONSIDERATION OF THE BILL (H.R. 2749) TO AMEND THE 
 FEDERAL FOOD, DRUG, AND COSMETIC ACT TO IMPROVE THE SAFETY OF FOOD IN 
               THE GLOBAL MARKET, AND FOR OTHER PURPOSES

                                _______
                                

   July 29, 2009.--Referred to the House Calendar and ordered to be 
                                printed

                                _______
                                

  Ms. Slaughter, from the Committee on Rules, submitted the following

                              R E P O R T

                       [To accompany H. Res. 691]

    The Committee on Rules, having had under consideration 
House Resolution 691, by a nonrecord vote, report the same to 
the House with the recommendation that the resolution be 
adopted.

                SUMMARY OF PROVISIONS OF THE RESOLUTION

    The resolution provides for consideration of H.R. 2749, the 
``Food Safety Enhancement Act of 2009,'' under a closed rule. 
The resolution provides one hour of debate equally divided and 
controlled by the chair and ranking minority member of the 
Committee on Energy and Commerce.
    The resolution waives all points of order against 
consideration of the bill except those arising under clause 9 
or 10 of rule XXI. It provides that in lieu of the amendment in 
the nature of a substitute recommended by the Committee on 
Energy and Commerce, the amendment in the nature of a 
substitute printed in this report shall be considered as 
adopted and the bill, as amended, shall be considered as read. 
The resolution waives all points of order against provisions in 
the bill, as amended. This waiver does not affect the point of 
order available under clause 9 of rule XXI (regarding earmark 
disclosure). Finally, the resolution provides one motion to 
recommit with or without instructions.

                         EXPLANATION OF WAIVERS

    The waiver of all points of order against consideration of 
the bill (except those arising under clause 9 or 10 of rule 
XXI) includes a waiver of clause 4(a) of rule XIII (regarding 
availability of committee report). Although the resolution 
waives all points of order against the bill, as amended, the 
Committee is not aware of any points of order. The waiver of 
all points of order against the bill is prophylactic.

                            COMMITTEE VOTES

    The results of each record vote on an amendment or motion 
to report, together with the names of those voting for and 
against, are printed below:

Rules Committee record vote No. 239

    Date: July 29, 2009.
    Measure: H.R. 2749.
    Motion by: Mr. Dreier.
    Summary of motion: To report an open rule.
    Results: Defeated 3-7.
    Vote by Members: McGovern--Nay; Hastings--Nay; Cardoza--
Nay; Arcuri--Nay; Perlmutter--Nay; Polis--Nay; Dreier--Yea; 
Diaz-Balart--Yea; Foxx--Yea; Slaughter--Nay.

Rules Committee record vote No. 240

    Date: July 29, 2009.
    Measure: H.R. 2749.
    Motion by: Mr. Dreier.
    Summary of motion: To make in order an amendment in the 
nature of a substitute by Rep. Lucas, Frank (OK), #4, which 
would strike all after the enacting clause and insert the text 
of the Safe Food Enforcement, Assessment, Standards, and 
Targeting Act of 2009.
    Results: Defeated 3-7.
    Vote by Members: McGovern--Nay; Hastings--Nay; Cardoza--
Nay; Arcuri--Nay; Perlmutter--Nay; Polis--Nay; Dreier--Yea; 
Diaz-Balart--Yea; Foxx--Yea; Slaughter--Nay.

Rules Committee record vote No. 241

    Date: July 29, 2009.
    Measure: H.R. 2749.
    Motion by: Dr. Foxx.
    Summary of motion: To make in order an amendment by Rep. 
Lucas, Frank (OK), #3, which would except farmers from section 
419 performance standards. It also would strike section 104, 
relating to safety standards for produce and certain other raw 
agricultural commodities.
    Results: Defeated 3-7.
    Vote by Members: McGovern--Nay; Hastings--Nay; Cardoza--
Nay; Arcuri--Nay; Perlmutter--Nay; Polis--Nay; Dreier--Yea; 
Diaz-Balart--Yea; Foxx--Yea; Slaughter--Nay.

SUMMARY OF AMENDMENT IN THE NATURE OF A SUBSTITUTE TO BE CONSIDERED AS 
                                ADOPTED

    The amendment in the nature of a substitute retains the 
provisions of the bill as reported by the Committee on Energy 
and Commerce and would provide for increased coordination 
between FDA and Customs and Border Patrol and between FDA and 
USDA. It harmonizes FDA's authority to prohibit or restrict the 
movement of tainted foods with that of USDA. It clarifies who 
exactly does--and does not--have to register with FDA and pay 
the annual registration fee. For instance, the substitute 
amendment provides that farms, including those that process 
food and feed that they sell to other farms or primarily 
directly to consumers, do not have to register or pay. In 
addition, retail food establishments that sell products 
directly to consumers also do not have to register or pay. In 
the section of the bill that deals with FDA's ability to trace 
the supply chain of food, limits are imposed on how far back 
that traceback system needs to go. In the fresh produce section 
of the bill, it is clarified that the FDA should issue 
standards only for the riskiest types of products.

  TEXT OF AMENDMENT IN THE NATURE OF A SUBSITUTE TO BE CONSIDERED AS 
                                ADOPTED

    Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

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

SEC. 2. TABLE OF CONTENTS.

  The table of contents of this Act is as follows:

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

                          TITLE I--FOOD SAFETY

                         Subtitle A--Prevention

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

                        Subtitle B--Intervention

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

                          Subtitle C--Response

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

                         TITLE II--MISCELLANEOUS

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

SEC. 3. REFERENCES.

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

SEC. 4. RULES OF CONSTRUCTION.

  (a) Nothing in this Act or the amendments made by this Act 
shall be construed to prohibit or limit--
          (1) any cause of action under State law; or
          (2) the introduction of evidence of compliance or 
        noncompliance with the requirements of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
  (b) Nothing in this Act or any amendment made by this Act 
shall be construed to--
          (1) alter the jurisdiction between the Secretary of 
        Agriculture and the Secretary of Health and Human 
        Services, under applicable statutes and regulations;
          (2) limit the authority of the Secretary of Health 
        and Human Services to issue regulations related to the 
        safety of food under--
                  (A) the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 301 et seq.) as in effect on the day 
                before the date of the enactment of this Act; 
                or
                  (B) the Public Health Service Act (42 U.S.C. 
                301 et seq.) as in effect on the day before the 
                date of the enactment of this Act; or
          (3) impede, minimize, or affect the authority of the 
        Secretary of Agriculture to prevent, control, or 
        mitigate a plant or animal health emergency, or a food 
        emergency involving products regulated under the 
        Federal Meat Inspection Act (21 U.S.C. 601 et seq.), 
        the Poultry Products Inspection Act (21 U.S.C. 451 et 
        seq.), or the Egg Products Inspection Act (21 U.S.C. 
        1031 et seq.).

SEC. 5. USDA EXEMPTIONS.

  (a) USDA-Regulated Products.--Food is exempt from the 
requirements of this Act to the extent that such food is 
regulated by the Secretary of Agriculture under the Federal 
Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry 
Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg 
Products Inspection Act (21 U.S.C. 1031 et seq.).
  (b) Livestock and Poultry.--Livestock and poultry that are 
intended to be presented for slaughter pursuant to the 
regulations by the Secretary of Agriculture under the Federal 
Meat Inspection Act or the Poultry Products Inspection Act are 
exempt from the requirements of this Act. A cow, sheep, or goat 
that is used for the production of milk is exempt from the 
requirements of this Act.
  (c) USDA-Regulated Facilities.--A facility is exempt from the 
requirements of this Act to the extent such facility is 
regulated as an official establishment by the Secretary of 
Agriculture under the Federal Meat Inspection Act, the Poultry 
Products Inspection Act, or the Egg Products Inspection Act or 
under a program recognized by the Secretary of Agriculture as 
at least equal to Federal regulation under the Federal Meat 
Inspection Act, the Poultry Products Inspection Act, or the Egg 
Products Inspection Act.
  (d) Farms.--A farm is exempt from the requirements of this 
Act to the extent such farm raises animals from which food is 
derived that is regulated under the Federal Meat Inspection 
Act, the Poultry Products Inspection Act, or the Egg Products 
Inspection Act.

SEC. 6. ALCOHOL-RELATED FACILITIES.

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

                          TITLE I--FOOD SAFETY

                         Subtitle A--Prevention

SEC. 101. CHANGES IN REGISTRATION OF FOOD FACILITIES.

  (a) Misbranding.--Section 403 (21 U.S.C. 343) is amended by 
adding at the end the following:
  ``(z) If it was manufactured, processed, packed, or held in a 
facility that is not duly registered under section 415, 
including a facility whose registration is canceled or 
suspended under such section.''.
  (b) Annual Registration.--
          (1) Definition of facility.--Paragraph (1) of section 
        415(b) (21 U.S.C. 350d(b)) is amended to read as 
        follows:
          ``(1)(A) The term `facility' means any factory, 
        warehouse, or establishment (including a factory, 
        warehouse, or establishment of an importer) that 
        manufactures, processes, packs, or holds food.
          ``(B) Such term does not include farms; private 
        residences of individuals; restaurants; other retail 
        food establishments; nonprofit food establishments in 
        which food is prepared for or served directly to the 
        consumer; or fishing vessels (except such vessels 
        engaged in processing as defined in section 123.3(k) of 
        title 21, Code of Federal Regulations, or any successor 
        regulations).
          ``(C)(i) The term `retail food establishment' means 
        an establishment that, as its primary function, sells 
        food products (including those food products that it 
        manufactures, processes, packs, or holds) directly to 
        consumers (including by Internet or mail order).
                  ``(ii) Such term includes--
                          ``(I) grocery stores;
                          ``(II) convenience stores;
                          ``(III) vending machine locations; 
                        and
                          ``(IV) stores that sell bagged feed, 
                        pet food, and feed ingredients or 
                        additives over-the-counter directly to 
                        consumers and final purchasers for 
                        their own personal animals.
                  ``(iii) A retail food establishment's primary 
                function is to sell food directly to consumers 
                if the annual monetary value of sales of food 
                products directly to consumers exceeds the 
                annual monetary value of sales of food products 
                to all other buyers.
          ``(D)(i) The term `farm' means an operation in one 
        general physical location devoted to the growing and 
        harvesting of crops, the raising of animals (including 
        seafood), or both.
          ``(ii) Such term includes--
                  ``(I) such an operation that packs or holds 
                food, provided that all food used in such 
                activities is grown, raised, or consumed on 
                such farm or another farm under the same 
                ownership;
                  ``(II) such an operation that manufactures or 
                processes food, provided that all food used in 
                such activities is consumed on such farm or 
                another farm under the same ownership;
                  ``(III) such an operation that sells food 
                directly to consumers if the annual monetary 
                value of sales of the food products from the 
                farm or by an agent of the farm to consumers 
                exceeds the annual monetary value of sales of 
                the food products to all other buyers;
                  ``(IV) such an operation that manufactures 
                grains or other feed stuffs that are grown and 
                harvested on such farm or another farm under 
                the same ownership and are distributed directly 
                to 1 or more farms for consumption as food by 
                humans or animals on such farm; and
                  ``(V) a fishery, including a wild fishery, an 
                aquaculture operation or bed, a fresh water 
                fishery, and a saltwater fishery.
          ``(iii) Such term does not include such an operation 
        that receives manufactured feed from another farm as 
        described in clause (ii)(IV) if the receiving farm 
        releases the feed to another farm or facility under 
        different ownership.
          ``(iv) The term `harvesting' includes washing, 
        trimming of outer leaves of, and cooling produce.
          ``(E) The term `consumer' does not include a 
        business.''.
          (2) Registration.--Section 415(a) (21 U.S.C. 350d(a)) 
        is amended--
                  (A) in the first sentence of paragraph (1)--
                          (i) by striking ``require that'' and 
                        inserting ``require that, on or before 
                        December 31 of each year,''; and
                          (ii) by striking ``food for 
                        consumption in the United States'' and 
                        inserting ``food for consumption in the 
                        United States or for export from the 
                        United States'';
                  (B) in subparagraphs (A) and (B) of paragraph 
                (1), by inserting ``and pay the registration 
                fee required under section 743'' after ``submit 
                a registration to the Secretary'' each place it 
                appears;
                  (C) in the first sentence of paragraph (2), 
                by inserting ``in electronic format'' after 
                ``submit''; and
                  (D) in paragraph (4), by inserting after the 
                first sentence the following: ``The Secretary 
                shall remove from such list the name of any 
                facility that fails to reregister in accordance 
                with this section, that fails to pay the 
                registration fee required under section 743, or 
                whose registration is canceled by the 
                registrant, canceled by the Secretary in 
                accordance with this section, or suspended by 
                the Secretary in accordance with this 
                section.''.
          (3) Contents of registration.--Paragraph (2) of 
        section 415(a) (21 U.S.C. 350d(a)), as amended by 
        paragraph (1), is amended by striking ``containing 
        information'' and all that follows and inserting the 
        following: ``containing information that identifies the 
        following:
                  ``(A) The name, address, and emergency 
                contact information of the facility being 
                registered.
                  ``(B) The primary purpose and business 
                activity of the facility, including the dates 
                of operation if the facility is seasonal.
                  ``(C) The general food category (as defined 
                by the Secretary by guidance) of each food 
                manufactured, processed, packed, or held at the 
                facility.
                  ``(D) All trade names under which the 
                facility conducts business related to food.
                  ``(E) The name, address, and 24-hour 
                emergency contact information of the United 
                States distribution agent for the facility, 
                which agent shall have access to the 
                information required to be maintained under 
                section 414(d) for food that is manufactured, 
                processed, packed, or held at the facility.
                  ``(F) If the facility is located outside of 
                the United States, the name, address, and 
                emergency contact information for a United 
                States agent.
                  ``(G) The unique facility identifier of the 
                facility, as specified under section 1011.
                  ``(H) Such additional information pertaining 
                to the facility as the Secretary may require by 
                regulation.
        The registrant shall notify the Secretary of any change 
        in the submitted information not later than 30 days 
        after the date of such change, unless otherwise 
        specified by the Secretary.''.
          (4) Suspension and cancellation authority.--Section 
        415(a) (21 U.S.C. 350d(a)), as amended by paragraphs 
        (1) and (2), is further amended by adding at the end 
        the following:
          ``(5) Suspension of registration.--
                  ``(A) In general.--The Secretary may suspend 
                the registration of any facility registered 
                under this section for a violation of this Act 
                that could result in serious adverse health 
                consequences or death to humans or animals.
                  ``(B) Notice of suspension.--Suspension of a 
                registration shall be preceded by--
                          ``(i) notice to the facility of the 
                        intent to suspend the registration; and
                          ``(ii) an opportunity for an informal 
                        hearing, as defined in guidance or 
                        regulations issued by the Secretary, 
                        concerning the suspension of such 
                        registration for such facility.
                  ``(C) Request.--The owner, operator, or agent 
                in charge of a facility whose registration is 
                suspended may request that the Secretary vacate 
                the suspension of registration when such owner, 
                operator, or agent has corrected the violation 
                that is the basis for such suspension.
                  ``(D) Vacating of suspension.--If, based on 
                an inspection of the facility or other 
                information, the Secretary determines that 
                adequate reasons do not exist to continue the 
                suspension of a registration, the Secretary 
                shall vacate such suspension.
          ``(6) Cancellation of registration.--
                  ``(A) In general.--Not earlier than 10 days 
                after providing the notice under subparagraph 
                (B), the Secretary may cancel a registration if 
                the Secretary determines that--
                          ``(i) the registration was not 
                        updated in accordance with this section 
                        or otherwise contains false, 
                        incomplete, or inaccurate information; 
                        or
                          ``(ii) the required registration fee 
                        has not been paid within 30 days after 
                        the date due.
                  ``(B) Notice of cancellation.--Cancellation 
                shall be preceded by notice to the facility of 
                the intent to cancel the registration and the 
                basis for such cancellation.
                  ``(C) Timely update or correction.--If the 
                registration for the facility is updated or 
                corrected no later than 7 days after notice is 
                provided under subparagraph (B), the Secretary 
                shall not cancel such registration.
          ``(7) Report to congress.--Not later than March 30th 
        of each year, the Secretary shall submit to the 
        Congress a report, based on the registrations on or 
        before December 31 of the previous year, on the 
        following:
                  ``(A) The number of facilities registered 
                under this section.
                  ``(B) The number of such facilities that are 
                domestic.
                  ``(C) The number of such facilities that are 
                foreign.
                  ``(D) The number of such facilities that are 
                high-risk.
                  ``(E) The number of such facilities that are 
                low-risk.
                  ``(F) The number of such facilities that hold 
                food.
          ``(8) Limitation on delegation.--The authority 
        conferred by this subsection to issue an order to 
        suspend a registration or cancel a registration shall 
        not be delegated to any officer or employee other than 
        the Commissioner of Food and Drugs, the Principal 
        Deputy Commissioner, the Associate Commissioner for 
        Regulatory Affairs, or the Director for the Center for 
        Food Safety and Applied Nutrition, of the Food and Drug 
        Administration.''.
  (c) Registration Fee.--Chapter VII (21 U.S.C. 371 et seq.) is 
amended by adding at the end of subchapter C the following:

                    ``PART 6--FEES RELATING TO FOOD

``SEC. 743. FACILITY REGISTRATION FEE.

  ``(a) In General.--
          ``(1) Assessment and collection.--Beginning in fiscal 
        year 2010, the Secretary shall assess and collect an 
        annual fee for the registration of a facility under 
        section 415.
          ``(2) Payable date.--A fee under this section shall 
        be payable--
                  ``(A) for a facility that was not registered 
                under section 415 for the preceding fiscal 
                year, on the date of registration; and
                  ``(B) for any other facility--
                          ``(i) for fiscal year 2010, not later 
                        than the sooner of 90 days after the 
                        date of the enactment of this part or 
                        December 31, 2009; and
                          ``(ii) for a subsequent fiscal year, 
                        not later than December 31 of such 
                        fiscal year.
  ``(b) Fee Amounts.--
          ``(1) In general.--The registration fee under 
        subsection (a) shall be--
                  ``(A) for fiscal year 2010, $500; and
                  ``(B) for fiscal year 2011 and each 
                subsequent fiscal year, the fee for fiscal year 
                2010 as adjusted under subsection (c).
          ``(2) Annual fee setting.--The Secretary shall, not 
        later than 60 days before the start of fiscal year 2011 
        and each subsequent fiscal year, establish, for the 
        next fiscal year, registration fees under subsection 
        (a), as described in paragraph (1).
          ``(3) Maximum amount.--Notwithstanding paragraph (1), 
        a person who owns or operates multiple facilities for 
        which a fee must be paid under this section for a 
        fiscal year shall be liable for not more than $175,000 
        in aggregate fees under this section for such fiscal 
        year.
  ``(c) Inflation Adjustment.--For fiscal year 2011 and each 
subsequent fiscal year, the fee amount under subsection (b)(1) 
shall be adjusted by the Secretary by notice, published in the 
Federal Register, to reflect the greater of--
          ``(1) the total percentage change that occurred in 
        the Consumer Price Index for all urban consumers (all 
        items; U.S. city average) for the 12-month period 
        ending June 30 preceding the fiscal year for which fees 
        are being established;
          ``(2) the total percentage change for the previous 
        fiscal year in basic pay under the General Schedule in 
        accordance with section 5332 of title 5, United States 
        Code, as adjusted by any locality-based comparability 
        payment pursuant to section 5304 of such title for 
        Federal employees stationed in the District of 
        Columbia; or
          ``(3) the average annual change in the cost, per 
        full-time equivalent position of the Food and Drug 
        Administration, of all personnel compensation and 
        benefits paid with respect to such positions for the 
        first 5 years of the preceding 6 fiscal years.
The adjustment made each fiscal year under this subsection 
shall be added on a compounded basis to the sum of all 
adjustments made each fiscal year after fiscal year 2010 under 
this subsection.
  ``(d) Limitations.--
          ``(1) In general.--Fees under subsection (a) shall be 
        refunded for a fiscal year beginning after fiscal year 
        2010 unless appropriations for salaries and expenses of 
        the Food and Drug Administration for such fiscal year 
        (excluding the amount of fees appropriated for such 
        fiscal year) are equal to or greater than the amount of 
        appropriations for the salaries and expenses of the 
        Food and Drug Administration for fiscal year 2010 
        (excluding the amount of fees appropriated for such 
        fiscal year) multiplied by the adjustment factor 
        applicable to the fiscal year involved.
          ``(2) Authority.--If the Secretary does not assess 
        fees under subsection (a) during any portion of a 
        fiscal year because of paragraph (1) and if at a later 
        date in such fiscal year the Secretary may assess such 
        fees, the Secretary may assess and collect such fees, 
        without any modification in the rate, for registration 
        under section 415 at any time in such fiscal year.
          ``(3) Adjustment factor.--In this subsection, the 
        term `adjustment factor' applicable to a fiscal year is 
        the Consumer Price Index for all urban consumers (all 
        items; United States city average) for October of the 
        preceding fiscal year divided by such Index for October 
        2009.
  ``(e) Crediting and Availability of Fees.--
          ``(1) In general.--Fees authorized under subsection 
        (a) shall be collected and available for obligation 
        only to the extent and in the amount provided in 
        advance in appropriations Acts. Such fees are 
        authorized to remain available until expended. Such 
        sums as may be necessary may be transferred from the 
        Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to 
        such appropriation account for salaries and expenses 
        with such fiscal year limitation.
          ``(2) Collections and appropriations acts.--The fees 
        authorized by this section--
                  ``(A) shall be retained in each fiscal year 
                in an amount not to exceed the amount specified 
                in appropriation Acts, or otherwise made 
                available for obligation, for such fiscal year; 
                and
                  ``(B) shall only be collected and available 
                to defray the costs of food safety activities.
          ``(3) Authorization of appropriations.--For each of 
        fiscal years 2010 through 2014, there are authorized to 
        be appropriated for fees under this section such sums 
        as may be necessary.
          ``(4) Public meetings.--For each fiscal year, the 
        Secretary shall hold a public meeting on how fees 
        collected under this section will be used to defray the 
        costs of food safety activities in order to solicit the 
        views of the regulated industry, consumers, and other 
        interested stakeholders.
  ``(f) Collection of Unpaid Fees.--In any case where the 
Secretary does not receive payment of a fee assessed under 
subsection (a) within 30 days after it is due, such fee shall 
be treated as a claim of the United States Government subject 
to subchapter II of chapter 37 of title 31, United States Code.
  ``(g) Construction.--This section may not be construed to 
require that the number of full-time equivalent positions in 
the Department of Health and Human Services, for officers, 
employees, and advisory committees not engaged in food safety 
activities, be reduced to offset the number of officers, 
employees, and advisory committees so engaged.
  ``(h) Annual Fiscal Reports.--Beginning with fiscal year 
2011, not later than 120 days after the end of each fiscal year 
for which fees are collected under this section, the Secretary 
shall prepare and submit to the Committee on Energy and 
Commerce of the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Senate a report 
on the implementation of the authority for such fees during 
such fiscal year and the use, by the Food and Drug 
Administration, of the fees collected for such fiscal year.
  ``(i) Definitions.--In this section:
          ``(1) The term `costs of food safety activities' 
        means the expenses incurred in connection with food 
        safety activities for--
                  ``(A) officers and employees of the Food and 
                Drug Administration, contractors of the Food 
                and Drug Administration, advisory committees, 
                and costs related to such officers, employees, 
                and committees and to contracts with such 
                contractors;
                  ``(B) laboratory capacity;
                  ``(C) management of information, and the 
                acquisition, maintenance, and repair of 
                technology resources;
                  ``(D) leasing, maintenance, renovation, and 
                repair of facilities and acquisition, 
                maintenance, and repair of fixtures, furniture, 
                scientific equipment, and other necessary 
                materials and supplies; and
                  ``(E) collecting fees under this section and 
                accounting for resources allocated for food 
                safety activities.
          ``(2) The term `food safety activities' means 
        activities related to compliance by facilities 
        registered under section 415 with the requirements of 
        this Act relating to food (including research related 
        to and the development of standards (such as 
        performance standards and preventive controls), risk 
        assessments, hazard analyses, inspection planning and 
        inspections, third-party inspections, compliance review 
        and enforcement, import review, information technology 
        support, test development, product sampling, risk 
        communication, and administrative detention).''.
  (d) Transitional Provisions.--
          (1) Fees.--The Secretary of Health and Human Services 
        shall first impose the fee established under section 
        743 of the Federal Food, Drug, and Cosmetic Act, as 
        added by subsection (c), for fiscal years beginning 
        with fiscal year 2010.
          (2) Modification of registration form.--Not later 
        than 180 days after the date of the enactment of this 
        Act, the Secretary of Health and Human Services shall 
        modify the registration form under section 415 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) 
        to comply with the amendments made by this section.
          (3) Application.--The amendments made by this 
        section, other than subsections (b)(2) and (c), shall 
        take effect on the date that is 30 days after the date 
        on which such modified registration form takes effect, 
        but not later than 210 days after the date of the 
        enactment of this Act.
          (4) Sunset date.--Section 743 of the Federal Food, 
        Drug, and Cosmetic Act, as added by subsection (c), 
        does not authorize the assessment or collection of a 
        fee for registration under section 415 of such Act (21 
        U.S.C. 360) occurring after fiscal year 2014.

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

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

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

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

``SEC. 418A. FOOD SAFETY PLAN.

  ``(a) In General.--Before a facility (as defined in section 
418(i)) introduces or delivers for introduction into interstate 
commerce any shipment of food, the owner, operator, or agent of 
the facility shall develop and implement a written food safety 
plan (in this section referred to as a `food safety plan').
  ``(b) Contents.--The food safety plan shall include each of 
the following elements:
          ``(1) The hazard analysis and any reanalysis 
        conducted under section 418.
          ``(2) A description of the preventive controls being 
        implemented under subsection 418(c), including those to 
        address hazards identified by the Secretary under 
        subsection 418(b)(2).
          ``(3) A description of the procedures for monitoring 
        preventive controls.
          ``(4) A description of the procedures for taking 
        corrective actions.
          ``(5) A description of verification activities for 
        the preventive controls, including validation that the 
        system of controls, if implemented, will prevent, 
        eliminate, or reduce to an acceptable level the 
        identified hazards, review of monitoring and corrective 
        action records, and procedures for determining whether 
        the system of controls as implemented is effectively 
        preventing, eliminating, or reducing to an acceptable 
        level the occurrence of identified hazards, including 
        the use of environmental and product testing programs.
          ``(6) A description of the facility's recordkeeping 
        procedures.
          ``(7) A description of the facility's procedures for 
        the recall of articles of food, whether voluntarily or 
        when required under section 422.
          ``(8) A description of the facility's procedures for 
        tracing the distribution history of articles of food, 
        whether voluntarily or when required under section 414.
          ``(9) A description of the facility's procedures to 
        ensure a safe and secure supply chain for the 
        ingredients or components used in making the food 
        manufactured, processed, packed, transported, or held 
        by such facility.
          ``(10) A description of the facility's procedures to 
        implement the science-based performance standards 
        issued under section 419.''.
          (3) Guidance or regulations.--
                  (A) In general.--The Secretary of Health and 
                Human Services (referred to in this subsection 
                as the ``Secretary'') shall issue guidance or 
                promulgate regulations to establish science-
                based standards for conducting a hazard 
                analysis, documenting hazards, identifying and 
                implementing preventive controls, and 
                documenting the implementation of the 
                preventive controls, including verification and 
                corrective actions under sections 418 and 418A 
                of the Federal Food, Drug, and Cosmetic Act (as 
                added by paragraph (2)).
                  (B) International standards.--In issuing 
                guidance or regulations under subparagraph (A), 
                the Secretary shall review international hazard 
                analysis and preventive control standards that 
                are in existence on the date of the enactment 
                of this Act and relevant to such guidelines or 
                regulations to ensure that the programs under 
                sections 418 and 418A of the Federal Food, 
                Drug, and Cosmetic Act (as added by paragraph 
                (2) are consistent, to the extent the Secretary 
                determines practicable and appropriate, with 
                such standards.
                  (C) Authority with respect to certain 
                facilities.--The Secretary may, by regulation, 
                exempt or modify the requirements for 
                compliance under this section and the 
                amendments made by this section with respect to 
                facilities that are solely engaged in--
                          (i) the production of food for 
                        animals other than man or the storage 
                        of packaged foods that are not exposed 
                        to the environment; or
                          (ii) the storage of raw agricultural 
                        commodities for further distribution or 
                        processing.
                  (D) Small businesses.--The Secretary--
                          (i) shall consider the impact of any 
                        guidance or regulations under this 
                        section on small businesses; and
                          (ii) shall issue guidance to assist 
                        small businesses in complying with the 
                        requirements of this section and the 
                        amendments made by this section.
          (4) No effect on existing haccp authorities.--Nothing 
        in this section or the amendments made by this section 
        limits the authority of the Secretary under the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or 
        the Public Health Service Act (42 U.S.C. 201 et seq.), 
        as in effect on the day before the date of the 
        enactment of this Act, to revise, issue, or enforce 
        product- and category-specific regulations, such as the 
        Seafood Hazard Analysis Critical Controls Points 
        Program, the Juice Hazard Analysis Critical Control 
        Program, and the Thermally Processed Low-Acid Foods 
        Packaged in Hermetically Sealed Containers standards.
          (5) Consideration.--When implementing sections 418 
        and 418A of the Federal Food, Drug, and Cosmetic Act, 
        as added by paragraph (2), the Secretary may take into 
        account differences between food intended for human 
        consumption and food intended for consumption by 
        animals other than man.
          (6) Effective date.--
                  (A) General rule.--The amendments made by 
                subsection (a) and this subsection shall take 
                effect 18 months after the date of the 
                enactment of this Act.
                  (B) Exceptions.--Notwithstanding subparagraph 
                (A)--
                          (i) the amendments made by subsection 
                        (a) and this subsection shall apply to 
                        a small business (as defined by the 
                        Secretary) after the date that is 2 
                        years after the date of the enactment 
                        of this Act; and
                          (ii) the amendments made by 
                        subsection (a) and this subsection 
                        shall apply to a very small business 
                        (as defined by the Secretary) after the 
                        date that is 3 years after the date of 
                        the enactment of this Act.
  (b) Finished Product Test Results From Category 1 
Facilities.--
          (1) Adulteration.--Section 402 (21 U.S.C. 342), as 
        amended by subsection (a), is amended by adding at the 
        end the following:
  ``(k) If it is manufactured or processed in a facility that 
is in violation of section 418B.''.
          (2) Requirements.--Chapter IV (21 U.S.C. 341 et 
        seq.), as amended, is further amended by adding at the 
        end the following:

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

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

``SEC. 418C. FOOD DEFENSE.

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

SEC. 103. PERFORMANCE STANDARDS.

  (a) Adulterated Food.--Section 402 (21 U.S.C. 342), as 
amended by section 102, is amended by adding at the end the 
following:
  ``(l) If it has been manufactured, processed, packed, 
transported, or held under conditions that do not meet the 
standards issued under section 419.''.
  (b) Requirements.--Chapter IV (21 U.S.C. 341 et seq.), as 
amended by section 102(b), is further amended by adding at the 
end the following:

``SEC. 419. PERFORMANCE STANDARDS.

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

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

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

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

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

SEC. 105. RISK-BASED INSPECTION SCHEDULE.

  (a) In General.--Section 704 (21 U.S.C. 374) is amended by 
adding at the end the following:
  ``(h)(1) Each facility registered under section 415 shall be 
inspected--
          ``(A)(i) by one or more officers duly designated 
        under section 702 or other statutory authority by the 
        Secretary;
          ``(ii) for domestic facilities, by a Federal, State, 
        or local official recognized by the Secretary under 
        paragraph (2); or
          ``(iii) for foreign facilities, by an agency or a 
        representative of a country that is recognized by the 
        Secretary under paragraph (2); and
          ``(B) at a frequency determined pursuant to a risk-
        based schedule.
  ``(2) For purposes of paragraph (1)(A), the Secretary--
          ``(A) may recognize Federal, State, and local 
        officials and agencies and representatives of foreign 
        countries as meeting standards established by the 
        Secretary for conducting inspections under this Act; 
        and
          ``(B) may limit such recognition to inspections of 
        specific commodities or food types.
  ``(3) The risk-based schedule under paragraph (1)(B) shall be 
implemented beginning not later than 18 months after the date 
of the enactment of this subsection.
  ``(4) Such risk-based schedule shall provide for a frequency 
of inspections commensurate with the risk presented by the 
facility and shall be based on the following categories and 
inspection frequencies:
          ``(A) Category 1.--A category 1 food facility is a 
        high-risk facility that manufactures or processes food. 
        The Secretary shall randomly inspect a category 1 food 
        facility at least every 6 to 12 months.
          ``(B) Category 2.--A category 2 food facility is a 
        low-risk facility that manufactures or processes food 
        or a facility that packs or labels food. The Secretary 
        shall randomly inspect a category 2 facility at least 
        every 18 months to 3 years.
          ``(C) Category 3.--A category 3 food facility is a 
        facility that holds food. The Secretary shall randomly 
        inspect a category 3 facility at least every 5 years.
  ``(5) The Secretary--
          ``(A) may, by guidance, modify the types of food 
        facilities within a category under paragraph (4);
          ``(B) may alter the inspection frequencies specified 
        in paragraph (4) based on the need to respond to food-
        borne illness outbreaks and food recalls; and
          ``(C) may inspect a facility more frequently than the 
        inspection frequency provided by paragraph (4);
          ``(D) beginning 6 months after submitting the report 
        required by section 105(b)(2) of the Food Safety 
        Enhancement Act of 2009, may--
                  ``(i) publish in the Federal Register 
                adjustments to the inspection frequencies 
                specified in subparagraphs (B) and (C) of 
                paragraph (4) for category 2 and category 3 
                food facilities, which adjustments shall be in 
                accordance with the Secretary's recommendations 
                in such report; and
                  ``(ii) after such publication, implement the 
                adjustments; and
          ``(E) except as provided in subparagraphs (B) and 
        (C), may not alter the inspection frequency specified 
        in paragraph (4)(A) for category 1 food facilities.
  ``(6) In determining the appropriate frequency of inspection, 
the Secretary shall consider--
          ``(A) the type of food manufactured, processed, 
        packed, or held at the facility;
          ``(B) the compliance history of the facility;
          ``(C) whether the facility importing or offering for 
        import into the United States food is certified by a 
        qualified certifying entity in accordance with section 
        801(q); and
          ``(D) such other factors as the Secretary determines 
        by guidance to be relevant to assessing the risk 
        presented by the facility.
  ``(7) Before establishing or modifying the categorization 
under paragraph (4) of any food facility or type of food 
facility, the Secretary shall publish a notice of the proposed 
categorization in the Federal Register and provide a period of 
not less than 60 days for public comment on the proposed 
categorization.''.
  (b) Reports on Risk-Based Inspections of Food Facilities.--
          (1) Annual report.--Not later than December 31 of 
        each year, the Secretary of Health and Human Services 
        shall submit a report to the Committee on Energy and 
        Commerce of the House of Representatives and the 
        Committee on Health, Education, Labor, and Pensions of 
        the Senate describing--
                  (A) the number of foreign and domestic 
                facilities, by risk category, inspected under 
                the risk-based inspection schedule established 
                under section 704(h) of the Federal Food, Drug, 
                and Cosmetic Act, as added by subsection (a), 
                in the preceding fiscal year; and
                  (B) the costs of implementing the risk-based 
                inspection schedule for the preceding 12 
                months.
          (2) Third-year report.--Not later than 3 years after 
        the date of the enactment of this Act, the Secretary of 
        Health and Human Services shall submit a report to the 
        Committee on Energy and Commerce of the House of 
        Representatives and the Committee on Health, Education, 
        Labor, and Pensions of the Senate describing 
        recommendations on the risk-based inspection schedule 
        under section 704(h) of the Federal Food, Drug, and 
        Cosmetic Act, as added by subsection (a), including 
        recommendations for adjustments to the timing of the 
        schedule and other ways to improve the risk-based 
        allocation of resources by the Food and Drug 
        Administration. In making such recommendations, the 
        Secretary shall consider--
                  (A) the nature of the food products being 
                processed, stored, or transported;
                  (B) the manner in which food products are 
                processed, stored, or transported;
                  (C) the inherent likelihood that the products 
                will contribute to the risk of food-borne 
                illness;
                  (D) the best available evidence concerning 
                reported illnesses associated with the foods 
                processed, stored, held, or transported in the 
                category of facilities; and
                  (E) the overall record of compliance with 
                food safety law among facilities in the 
                category, including compliance with applicable 
                performance standards and the frequency of 
                recalls.

SEC. 106. ACCESS TO RECORDS.

  (a) Records Access.--Subsection (a) of section 414 (21 U.S.C. 
350c) is amended to read as follows:
  ``(a) Records Access.--
          ``(1) Records access during an inspection.--
                  ``(A) In general.--Except as provided in 
                paragraph (3), each person who manufactures, 
                processes, packs, transports, distributes, 
                receives, or holds an article of food in the 
                United States or for import into the United 
                States shall, at the request of an officer or 
                employee duly designated by the Secretary, 
                permit such officer or employee, upon 
                presentation of appropriate credentials, at 
                reasonable times and within reasonable limits 
                and in a reasonable manner, to have access to 
                and copy all records relating to such article 
                bearing on whether the food may be adulterated, 
                misbranded, or otherwise in violation of this 
                Act, including all records collected or 
                developed to comply with section 418 or 418A.
                  ``(B) Scope of records.--The requirement 
                under subparagraph (A) applies to all records 
                relating to the manufacture, processing, 
                packing, transporting, distribution, receipt, 
                holding, or importation of such article 
                maintained by or on behalf of such person in 
                any format (including paper and electronic 
                formats) and at any location.
                  ``(C) Immediate availability with notice.--
                Records not required to be made available 
                immediately on commencement of an inspection 
                under subparagraph (A) shall nonetheless be 
                made available immediately on commencement of 
                such an inspection if, by a reasonable time 
                before such inspection, the Secretary by letter 
                to the person identifies the records to be made 
                available during such inspection. Nothing in 
                this  subparagraph shall be construed as 
                permitting a person to refuse to produce 
                records required under and in accordance with 
                subparagraph (A) due to failure of the 
                Secretary to provide  notice under this 
                paragraph.
          ``(2) Additional authorities to access records 
        remotely; submission of records to the secretary.--
                  ``(A) Remote access in emergencies.--If the 
                Secretary has a reasonable belief that an 
                article of food presents a threat of serious 
                adverse health consequences or death to humans 
                or animals, the Secretary may require each 
                person who manufactures, processes, packs, 
                transports, distributes, receives, holds, or 
                imports such article of food, or any article of 
                food that the Secretary determines may be 
                affected in a similar manner, to submit to the 
                Secretary all records reasonably related to 
                such article of food as soon as is reasonably 
                practicable, after receiving written notice 
                (including by notice served personally and 
                outside normal business hours to an agent 
                identified under subparagraph (E) or (F) of 
                section 415(a)(2)) of such requirement.
                  ``(B) Remote access to records related to 
                food safety plans.--With respect to a facility 
                subject to section 418 and 418A, the Secretary 
                may require the owner, operator, or agent of 
                such facility to submit to the Secretary, as 
                soon as reasonably practicable after receiving 
                written notice of such requirement, the food 
                safety plan, supporting information relied on 
                by the facility to select the preventive 
                controls to include in its food safety plan, 
                and documentation of corrective actions, if 
                any, taken under section 418(e) within the 
                preceding 2 years
                  ``(C) Electronic submission.--If the records 
                required to be submitted to the Secretary under 
                subparagraph (A) or (B) are available in 
                electronic format, such records shall be 
                submitted electronically unless the Secretary 
                specifies otherwise in the notice under such 
                subparagraph.
          ``(3) Limited records access on farms.--
                  ``(A) Application.--Paragraphs (1) and (2) do 
                not apply with respect to farms, except as 
                provided in this paragraph.
                  ``(B) In general.--A person who is the owner, 
                operator, or agent of a farm (as defined in 
                section 415) shall, at the request of an 
                officer or employee duly designated by the 
                Secretary, permit such officer or employee, at 
                reasonable times and within reasonable limits 
                and in a reasonable manner, to have access to 
                and copy all records relating to an article of 
                food produced, manufactured, processed, packed, 
                or held on such farm as specified in paragraphs 
                (1) and (2) if--
                          ``(i) such article of food is a 
                        fruit, vegetable, nut, or fungus that 
                        is the subject of a standard issued 
                        under section 419A; or
                          ``(ii) such article of food is the 
                        subject of an active investigation by 
                        the Secretary of a food borne illness 
                        outbreak and is not a grain or 
                        similarly handled commodity as defined 
                        in subsection (c)(4)(C)(ii).
                  ``(C) Records access on farms prior to 
                rulemaking.--
                          ``(i) In general.--As soon as 
                        practicable after the enactment of this 
                        paragraph, the Secretary shall, in 
                        coordination with the Secretary of 
                        Agriculture, identify 1 or more fruits, 
                        vegetables, nuts, or fungi for which 
                        the Secretary shall have access to 
                        records on farms. Such identification 
                        shall be made by guidance, following 
                        notice and public comment.
                          ``(ii) Identification of raw 
                        agricultural commodities.--The 
                        Secretary, in coordination with the 
                        Secretary of Agriculture, shall make 
                        the identification in clause (i), based 
                        on any past food borne illness outbreak 
                        attributed to the fruit, vegetable, 
                        nut, or fungus--
                                  ``(I) in the United States 
                                and the risk that a similar 
                                outbreak could occur again in 
                                the United States; or
                                  ``(II) in a foreign country 
                                and the risk that a similar 
                                outbreak could occur in the 
                                United States.
                          ``(iii) Duration of authority.--The 
                        authority to have access to records for 
                        a fruit, vegetable, nut, or fungus 
                        under this subparagraph shall begin on 
                        the date on which the Secretary 
                        identifies such fruit, vegetable, nut, 
                        or fungus under clause (i) and shall 
                        terminate on the effective date of a 
                        final rule issued by the Secretary 
                        under section 419A.
                          ``(iv) Scope of records access.--In 
                        the guidance under clause (i), and for 
                        the period specified in clause (iii), 
                        the Secretary, in coordination with the 
                        Secretary of Agriculture, shall 
                        determine the scope of the records to 
                        which the Secretary shall have access 
                        under this subparagraph.
                  ``(D) Rule of construction.--This paragraph 
                shall not be construed as limiting access to 
                any records authorized under--
                          ``(i) this Act or the Public Health 
                        Service Act, as in effect on the day 
                        before the date of the enactment of 
                        this paragraph; or
                          ``(ii) regulations issued under such 
                        Acts on any date before the date of the 
                        enactment of this paragraph.''.
  (b) Regulations Concerning Recordkeeping.--
          (1) Amendment.--Subsection (b) of section 414 (21 
        U.S.C. 350c) is amended to read as follows:
  ``(b) Regulations Concerning Recordkeeping.--The Secretary, 
in consultation and coordination, as appropriate, with other 
Federal departments and agencies with responsibilities for 
regulating food safety, shall by regulation establish 
requirements regarding the establishment and maintenance, for 
not longer than 3 years, of records by persons who manufacture, 
process, pack, transport, distribute, receive, or hold food in 
the United States or for import into the United States. The 
Secretary shall take into account the size of a business in 
promulgating regulations under this subsection. The Secretary 
shall consult with the Secretary of Agriculture in promulgating 
regulations with respect to farms under this subsection and 
shall take into account the nature of and impact on farms in 
promulgating such regulations. The only distribution records 
which may be required of restaurants under this subsection are 
those showing the restaurant's suppliers and subsequent 
distribution other than to consumers.''.
          (2) Application.--The Secretary of Health and Human 
        Services shall promulgate revised regulations to 
        implement section 414(b) of the Federal Food, Drug, and 
        Cosmetic Act, as amended by this subsection. Section 
        414(b) of the Federal Food, Drug, and Cosmetic Act and 
        regulations thereunder, as in effect on the day before 
        the date of the enactment of this Act, shall apply to 
        acts and omissions occurring before the effective date 
        of such revised regulations.
  (c) Conforming Amendments.--Section 704(a)(1) (21 U.S.C. 
374(a)(1)) is amended--
          (1) in the second sentence--
                  (A) by striking ``(excluding farms or 
                restaurants)'' and inserting ``(excluding 
                farms, except as provided in section 
                414(a)(3))'';
                  (B) by inserting ``receives,'' before 
                ``holds'';
                  (C) by striking ``described in section 414'' 
                and inserting ``described in or required under 
                section 414''; and
                  (D) by striking ``when the Secretary has a 
                reasonable belief that an article of food is 
                adulterated and presents a threat of serious 
                adverse health consequences or death to humans 
                or animals'' and inserting ``bearing on whether 
                such food is adulterated, misbranded, or 
                otherwise in violation of this Act, including 
                all records collected or developed to comply 
                with section 418 or 418A''; and
          (2) in the fourth sentence--
                  (A) by striking ``the preceding sentence'' 
                and inserting ``either of the preceding two 
                sentences''; and
                  (B) by inserting ``recipes for food,'' before 
                ``financial data,''.

SEC. 107. TRACEABILITY OF FOOD.

  (a) Prohibited Act.--Section 301(e) (21 U.S.C. 331(e)) is 
amended by inserting ``, the violation of any requirement of 
the food tracing system under section 414(c);'' before ``or the 
refusal to permit access to or verification or copying of any 
such required record''.
  (b) Imports.--Section 801(a) (21 U.S.C. 381(a)) is amended by 
inserting ``or (4) the requirements of section 414 have not 
been complied with regarding such article,'' before ``then such 
article shall be refused admission''.
  (c) Product Tracing for Food.--Section 414 (21 U.S.C. 350c), 
as amended by section 106, is amended--
          (1) by redesignating subsections (c) and (d) as 
        subsections (d) and (e), respectively; and
          (2) by inserting after subsection (b) the following:
  ``(c) Tracing System for Food.--
          ``(1) In general.--The Secretary shall by regulation 
        establish a tracing system for food that is located in 
        the United States or is for import into the United 
        States.
          ``(2) Information gathering.--
                  ``(A) Tracing technologies.--Before issuing a 
                proposed regulation under this subsection, the 
                Secretary shall--
                          ``(i) identify technologies and 
                        methodologies for tracing the 
                        distribution history of a food that 
                        are, or may be, used by members of 
                        different sectors of the food industry, 
                        including technologies and 
                        methodologies to enable each person who 
                        produces, manufactures, processes, 
                        pack, transports, or holds a food to--
                                  ``(I) maintain the full 
                                pedigree of the origin and 
                                previous distribution history 
                                of the food;
                                  ``(II) link that history with 
                                the subsequent distribution of 
                                the food;
                                  ``(III) establish and 
                                maintain a system for tracing 
                                the food that is interoperable 
                                with the systems established 
                                and maintained by other such 
                                persons; and
                                  ``(IV) use a unique 
                                identifier for each facility 
                                owned or operated by such 
                                person for such purpose, as 
                                specified under section 1011; 
                                and
                          ``(ii) to the extent practicable, 
                        assess--
                                  ``(I) the costs and benefits 
                                associated with the adoption 
                                and use of such technologies;
                                  ``(II) the feasibility of 
                                such technologies for different 
                                sectors of the food industry; 
                                and
                                  ``(III) whether such 
                                technologies are compatible 
                                with the requirements of this 
                                subsection.
                  ``(B) Public meetings.--Before issuing a 
                proposed regulation under this subsection, the 
                Secretary shall conduct not less than 2 public 
                meetings in diverse geographical areas of the 
                United States to provide persons in different 
                regions an opportunity to provide input and 
                information to the Secretary.
                  ``(C) Pilot projects.--Before issuing a 
                proposed regulation under this subsection, the 
                Secretary shall conduct 1 or more pilot 
                projects in coordination with 1 or more sectors 
                of the food industry to explore and evaluate 
                tracing systems for food. The Secretary shall 
                coordinate with the Secretary of Agriculture in 
                conducting pilot projects with respect to farms 
                under this subsection.
          ``(3) Regulation.--
                  ``(A) In general.--Taking into account 
                information obtained through information 
                gathering under paragraph (2), the Secretary 
                shall issue regulations establishing a tracing 
                system that enables the Secretary to identify 
                each person who grows, produces, manufactures, 
                processes, packs, transports, holds, or sells 
                such food in as short a timeframe as 
                practicable but no longer than 2 business days.
                  ``(B) Scope of regulation.--The Secretary may 
                include in the regulations establishing a 
                tracing system--
                          ``(i) the establishment and 
                        maintenance of lot numbers;
                          ``(ii) a standardized format for 
                        pedigree information; and
                          ``(iii) the use of a common 
                        nomenclature for food.
                  ``(C) Coordination regarding farm impact.--In 
                issuing regulations under this paragraph that 
                will impact farms, the Secretary--
                          ``(i) shall coordinate with the 
                        Secretary of Agriculture; and
                          ``(ii) take into account the nature 
                        of the impact of the regulations on 
                        farms.
          ``(4) Exemptions and limitations.--
                  ``(A) Direct sales by farms.--Food is exempt 
                from the requirements of this subsection if 
                such food is--
                          ``(i) produced on a farm; and
                          ``(ii) sold by the owner, operator, 
                        or agent in charge of such farm 
                        directly to a consumer or to a 
                        restaurant or grocery store.
                  ``(B) Fishing vessels.--Food is exempt from 
                the requirements of this subsection if such 
                food is produced through the use of a fishing 
                vessel as defined in section 3(18) of the 
                Magnuson-Stevens Fishery Conservation and 
                Management Act until such time as the food is 
                sold by the owner, operator, or agent in charge 
                of such fishing vessel.
                  ``(C) Grains and similarly handled 
                commodities.--
                          ``(i) Limitation on extent of 
                        tracing.--In addition to the exemption 
                        under subparagraph (A), any tracing 
                        system established under this 
                        subsection with regard to any grain or 
                        similarly handled commodity shall be 
                        limited to enabling the Secretary to 
                        identify persons who received, 
                        processed, packed, transported, 
                        distributed, held, or sold the grain or 
                        similarly handled commodity from the 
                        initial warehouse operator that held 
                        the grain or similarly handled 
                        commodity for any period of time to the 
                        ultimate consumer.
                          ``(ii) Definitions.--In this 
                        subparagraph:
                                  ``(I) The term `grain or 
                                similarly handled commodity' 
                                means wheat, corn, grain 
                                sorghum, barley, oats, rice, 
                                wild rice, rye, soybeans, 
                                legumes, sugar cane, sugar 
                                beets, sunflower seed, 
                                rapeseed, canola, safflower, 
                                flaxseed, mustard seed, crambe, 
                                sesame seed, camelina, 
                                cottonseed, cocoa beans, grass 
                                hay, and honey. The term may 
                                include any other commodity as 
                                determined by the Secretary in 
                                coordination with the Secretary 
                                of Agriculture.
                                  ``(II) The term `warehouse 
                                operator' has the meaning given 
                                that term in section 2 of the 
                                United States Warehouse Act (7 
                                U.S.C. 241), except that the 
                                term also includes any person 
                                or entity that handles or 
                                stores agricultural products 
                                for other persons or entities 
                                or, in the case of a 
                                cooperative, handles or stores 
                                agricultural products for its 
                                members, as determined by the 
                                Secretary in coordination with 
                                the Secretary of Agriculture.
                  ``(D) Exemption of other foods.--The 
                Secretary may by notice in the Federal Register 
                exempt a food or a type of facility, farm, or 
                restaurant from, or modify the requirements 
                with respect to, the requirements of this 
                subsection if the Secretary determines that a 
                tracing system for such food or type of 
                facility, farm, or restaurant is not necessary 
                to protect the public health.
                  ``(E) Recordkeeping regarding previous 
                sources and subsequent recipients.--For a food 
                or person covered by a limitation or exemption 
                under subparagraph (B), (C), or (D), the 
                Secretary shall require each person who 
                produces, receives, manufactures, processes, 
                packs, transports, distributes, or holds such 
                food to maintain records to identify the 
                immediate previous sources of such food and its 
                ingredients and the immediate subsequent 
                recipients of such food.
                  ``(F) Recordkeeping by restaurants and 
                grocery stores.--For a food covered by an 
                exemption under subparagraph (A), restaurants 
                and grocery stores shall keep records 
                documenting the farm that was the source of the 
                food.
                  ``(G) Recordkeeping by farms.--For a food 
                covered by an exemption under subparagraph (A), 
                farms shall keep records, in electronic or non-
                electronic format, for at least 6 months 
                documenting the restaurant or grocery store to 
                which the food was sold.''.

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

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

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

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

SEC. 109. CERTIFICATION AND ACCREDITATION.

  (a) Misbranding.--
          (1) In general.--Section 403 (21 U.S.C. 343), as 
        amended by section 101(a), is amended by adding at the 
        end the following:
  ``(aa) If it is part of a shipment offered for import into 
the United States and such shipment is in violation of section 
801(q) (requiring a certification of compliance for certain 
food shipments).''.
          (2) Effective date.--The amendment made by paragraph 
        (1) shall apply to shipments offered for import on or 
        after the date that is 3 years after the date of the 
        enactment of this Act.
  (b) Certification of Compliance for Imports.--Chapter VIII 
(21 U.S.C. 381 et seq.) is amended--
          (1) in section 801(a), as amended by section 107(b), 
        by inserting after the third sentence the following: 
        ``If such article is food being imported or offered for 
        import into the United States and is not in compliance 
        with the requirement of subsection (q) (relating to 
        certifications of compliance with this Act), then such 
        article shall be refused admission.'';
          (2) in the second sentence of section 801(b), by 
        striking ``the fourth sentence'' and inserting ``the 
        fifth sentence''; and
          (3) by adding at the end of section 801 the 
        following:
  ``(q) Certifications Concerning Imported Articles.--
          ``(1) In general.--
                  ``(A) Requirement.--The Secretary may 
                require, as an additional condition of granting 
                admission to an article of food being imported 
                or offered for import into the United States, 
                that a qualified certifying entity provide a 
                certification that the article complies with 
                requirements of this Act as specified by the 
                Secretary if--
                          ``(i) for food imported from a 
                        particular country, territory, or 
                        region, the Secretary finds, based on 
                        scientific, risk-based evidence, that 
                        the government controls in such 
                        country, territory, or region are 
                        inadequate to ensure that the article 
                        is safe and that certification would 
                        assist the Secretary in determining 
                        whether to refuse to admit such article 
                        under subsection (a);
                          ``(ii) for a type of food for which 
                        there is scientific evidence that there 
                        is a particular risk associated with 
                        the food that presents a threat of 
                        serious adverse health consequences or 
                        death, the Secretary finds that 
                        certification would assist the 
                        Secretary in determining whether to 
                        refuse to admit such article under 
                        subsection (a); or
                          ``(iii) for an article imported from 
                        a particular country or territory, 
                        there is an agreement between the 
                        Secretary and the government of such 
                        country or territory providing for such 
                        certification.
                  ``(B) Form of certification.--A certification 
                under subparagraph (A) may take the form of a 
                statement that the article or the facility or 
                farm that manufactured, processed, packed, 
                held, grew, harvested, sorted, or transported 
                the article, as the case may be, complies with 
                requirements of this Act as specified by the 
                Secretary, or any other form as the Secretary 
                may specify, including a listing of certified 
                facilities or other entities. The Secretary may 
                require that the certification include 
                additional information regarding compliance.
                  ``(C) Adequate government controls.--
                          ``(i) Process.--Before requiring a 
                        certification under clause (ii) of 
                        subparagraph (A) with respect to a 
                        food, the Secretary shall establish a 
                        process by which a country or territory 
                        may demonstrate that its government 
                        controls are adequate to ensure that 
                        such food exported from its territory 
                        to the United States is safe.
                          ``(ii) Demonstration.--The Secretary 
                        shall not require a certification under 
                        clause (ii) of subparagraph (A) for a 
                        food exported from a country or 
                        territory, if that country or territory 
                        has demonstrated, pursuant to the 
                        process established by the Secretary 
                        under clause (i), that its government 
                        controls are adequate to ensure that 
                        such food exported from its territory 
                        to the United States is safe.
                  ``(D) Notice of cancellation or suspension of 
                certification.--As a condition on acceptance of 
                certifications from a qualified certifying 
                entity, the Secretary shall require the 
                qualified certifying entity to notify the 
                Secretary whenever the qualified certifying 
                entity cancels or suspends the certification of 
                any facility or other entity included in a 
                listing under subparagraph (B).
                  ``(E) Consistency with international 
                obligations.--The Secretary shall apply this 
                paragraph consistently with United States 
                obligations under international agreements.
          ``(2) Qualified certifying entity.--For purposes of 
        this subsection, the term `qualified certifying entity' 
        means--
                  ``(A) an agency or a representative of the 
                government of the country from which the 
                article originated, as designated by such 
                government or the Secretary; or
                  ``(B) an individual or entity determined by 
                the Secretary or an accredited body recognized 
                by the Secretary to be qualified to provide a 
                certification under paragraph (1).
          ``(3) No conflicts of interest.--
                  ``(A) In general.--The Secretary shall issue 
                regulations to ensure that any qualified 
                certifying entity and its auditors are free 
                from conflicts of interest. In issuing these 
                regulations, the Secretary may rely on or 
                incorporate international certification 
                standards.
                  ``(B) Regulations.--Such regulations shall 
                require that--
                          ``(i) the qualified certifying entity 
                        shall have a committee or management 
                        structure for safeguarding 
                        impartiality;
                          ``(ii) conflict of interest policies 
                        for a qualified certifying entity and 
                        auditors acting for the qualified 
                        certifying entity shall be written;
                          ``(iii) the qualified certifying 
                        entity shall not be owned, operated, or 
                        controlled by a producer, manufacturer, 
                        processor, packer, holder, supplier, or 
                        vendor of any article of the type it 
                        certifies;
                          ``(iv) the qualified certifying 
                        entity shall not have any ownership or 
                        financial interest in any product, 
                        producer, manufacturer, processor, 
                        packer, holder, supplier or vendor of 
                        the type it certifies;
                          ``(v) no auditor acting for the 
                        qualified certifying entity (or spouse 
                        or minor children) shall have any 
                        significant ownership or other 
                        financial interest regarding any 
                        product of the type it certifies;
                          ``(vi) the qualified certifying 
                        entity shall--
                                  ``(I) obtain and maintain 
                                annual declarations from all 
                                personnel who may be directly 
                                involved in the performance of 
                                audits as to whether they do or 
                                do not have direct financial 
                                interests in any producer, 
                                manufacturer, processor, 
                                packer, holder, supplier, or 
                                vendor of foods, and a list of 
                                any such companies in which 
                                they do have financial 
                                interests or by which they were 
                                employed in the past year; and
                                  ``(II) when an auditor is 
                                assigned to audit a facility, 
                                require that individual to 
                                affirm that he or she has no 
                                financial interest in the 
                                company that owns or operates 
                                that facility and was not 
                                employed by that facility in 
                                the previous year;
                          ``(vii) neither the qualified 
                        certifying entity nor any of its 
                        auditors acting for the qualified 
                        certifying entity shall participate in 
                        the production, manufacture, 
                        processing, packing, holding, 
                        promotion, or sale of any product of 
                        the type it certifies;
                          ``(viii) neither the qualified 
                        certifying entity nor any of its 
                        auditors shall provide consultative 
                        services to any facility certified by 
                        the qualified certifying entity, or the 
                        owner, operator, or agent in charge of 
                        such a facility, unless the qualified 
                        certifying entity has procedures in 
                        place, approved by the Secretary, to 
                        ensure separation of functions between 
                        auditors providing consultative 
                        services and auditors providing 
                        certification services under this 
                        subsection;
                          ``(ix) no auditors acting for the 
                        qualified certifying entity shall 
                        participate in an audit of a facility 
                        they were employed by within the last 
                        12 months;
                          ``(x) fees charged or accepted shall 
                        not be contingent or based upon the 
                        report made by the qualified certifying 
                        entity or any personnel involved in the 
                        audit process;
                          ``(xi) neither the qualified 
                        certifying entity nor any of its 
                        auditors shall accept anything of value 
                        from anyone in connection with the 
                        facility being audited other than the 
                        audit fee;
                          ``(xii) the qualified certifying 
                        entity shall not be owned, operated, or 
                        controlled by a trade association whose 
                        member companies operate facilities 
                        that it certifies;
                          ``(xiii) the qualified certifying 
                        entity and its auditors shall be free 
                        from any other conflicts of interest 
                        that threaten impartiality;
                          ``(xiv) the qualified certifying 
                        entity and its auditors shall sign a 
                        statement attesting to compliance with 
                        the conflict of interests requirements 
                        under this paragraph; and
                          ``(xv) the qualified certifying 
                        entity shall ensure that any 
                        subcontractors that might be used (such 
                        as laboratories and sampling services) 
                        provide similar assurances, except that 
                        it shall not be a violation of this 
                        subsection to the extent such 
                        subcontractors perform additional 
                        nutritional testing services unrelated 
                        to the testing under this subsection.
                  ``(C) Definitions.--In this paragraph:
                          ``(i) The term `anything of value' 
                        includes gifts, gratuities, 
                        reimbursement of non-audit-related 
                        expenses, entertainment, loans, or any 
                        other form of compensation in cash or 
                        in kind.
                          ``(ii) The term `direct financial 
                        interest' does not include any 
                        ownership of mutual funds that have a 
                        financial interest in a company.
          ``(4) Renewal and refusal of certifications.--The 
        Secretary shall--
                  ``(A) require that, to the extent applicable, 
                any certification provided by a qualified 
                certifying entity be renewed by such entity at 
                such times as the Secretary determines 
                appropriate; and
                  ``(B) refuse to accept any certification if 
                the Secretary determines that such 
                certification is no longer valid or reliable.
          ``(5) On-site audits.--In evaluating whether an 
        accreditation body meets, or continues to meet, the 
        standards for recognition under this subsection, or 
        whether to accept certifications from a qualified 
        certifying entity, the Secretary may--
                  ``(A) observe on-site audits of qualified 
                certifying entities by such accreditation body; 
                or
                  ``(B) for any facility that is certified by a 
                qualified certifying entity, upon request of an 
                officer or employee designated by the Secretary 
                and upon presentation of appropriate 
                credentials, at reasonable times and within 
                reasonable limits and in a reasonable manner, 
                conduct an on-site audit of the facility, which 
                shall include access to, and copying and 
                verification of, any related records.
          ``(6) Electronic submission.--The Secretary shall 
        provide, in coordination with the Commissioner 
        responsible for Customs and Border Protection, for the 
        electronic submission of certifications under this 
        subsection.
          ``(7) No limit on authority.--This subsection shall 
        not be construed to limit the authority of the 
        Secretary to conduct random inspections of imported 
        articles or facilities of importers, issue import 
        alerts for detention without physical examination, 
        require submission to the Secretary of documentation or 
        other information about an article imported or offered 
        for import, or to take such other steps as the 
        Secretary deems appropriate to determine the 
        admissibility of imported articles.''.

SEC. 110. TESTING BY ACCREDITED LABORATORIES.

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

``SEC. 714. TESTING BY ACCREDITED LABORATORIES.

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

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

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

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

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

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

  (a) Reportable Food Registry.--Section 417 (21 U.S.C. 350f) 
is amended--
          (1) in subsection (a)(1), by striking ``means a 
        person'' and all that follows through the end of 
        paragraph (1) and inserting the following: ``means--
                  ``(A) a person who submits the registration 
                under section 415(a) for a food facility that 
                is required to be registered under section 
                415(a), at which such food is manufactured, 
                processed, packed, or held;
                  ``(B) a person who owns, operates, is an 
                agent of, or is otherwise responsible for such 
                food on a farm (as such term is defined in 
                section 1.227(b)(3) of title 21, Code of 
                Federal Regulations, or successor regulations) 
                at which such food is produced for sale or 
                distribution in interstate commerce;
                  ``(C) a person who owns, operates, or is an 
                agent of a restaurant or other retail food 
                establishment (as such terms are defined in 
                section 1.227(b)(11) and (12), respectively, of 
                title 21, Code of Federal Regulations, or 
                successor regulations) at which such food is 
                offered for sale; or
                  ``(D) a person that is required to register 
                pursuant to section 801(s) with respect to 
                importation of such food.'';
          (2) in subsection (b), by adding at the end the 
        following:
          ``(3) Reporting by farms, restaurants, and retail 
        food establishments.--In addition to the electronic 
        portal described in paragraph (1), the Secretary shall 
        make available alternative means of reporting under 
        this section with respect to farms, restaurants, and 
        other retail food establishments with limited ability 
        for such reporting.'';
          (3) in subsection (d)(1)--
                  (A) in the matter preceding subparagraph (A), 
                by inserting ``following a timely review of any 
                reasonably available data and information,'' 
                after ``reportable food,'';
                  (B) in subparagraph (A), by striking ``and'' 
                at the end;
                  (C) by redesignating subparagraph (B) as 
                subparagraph (C); and
                  (D) by inserting after subparagraph (A) the 
                following:
                  ``(B) submit, with such report, through the 
                electronic portal, documentation of results 
                from any sampling and testing of such article, 
                including--
                          ``(i) analytical results from testing 
                        of such article conducted by or on 
                        behalf of the responsible party under 
                        section 418, 418A, 419, 419A, or 714;
                          ``(ii) analytical results from 
                        testing conducted by or on behalf of 
                        such responsible party of a component 
                        of such article;
                          ``(iii) analytical results of 
                        environmental testing of any facility 
                        at which such article, or a component 
                        of such article, is manufactured, 
                        processed, packed, or held; and
                          ``(iv) any other information the 
                        Secretary determines is necessary to 
                        evaluate the adulteration of such 
                        article, any component of such article, 
                        any other article of food manufactured, 
                        processed, packed or held in the same 
                        manner as, or at the same facility as, 
                        such article, or any other article 
                        containing a component from the same 
                        source as a component of such article; 
                        and''; and
          (4) in subsection (e)--
                  (A) in paragraph (1), by inserting ``if the 
                responsible party is required to register'' 
                after ``415(a)(3)''; and
                  (B) by adding at the end the following:
          ``(12) Such additional information as the Secretary 
        deems appropriate.''.
  (b) Exchange of Information.--Section 708 (21 U.S.C. 379) is 
amended--
          (1) by striking ``The Secretary'' and inserting ``(a) 
        The Secretary''; and
          (2) by adding at the end the following:
  ``(b)(1)(A) The Secretary may provide to any Federal agency 
acting within the scope of its jurisdiction any information 
relating to food that is exempt from disclosure pursuant to 
subsection (a) of section 552 of title 5, United States Code, 
by reason of subsection (b)(4) of such section, or that is 
referred to in section 301(j) or 415(a)(4).
  ``(B) Any such information provided to another Federal agency 
shall not be disclosed by such agency except in any action or 
proceeding under the laws of the United States to which the 
receiving agency or the United States is a party.
  ``(2)(A) In carrying out this Act, the Secretary may provide 
to a State or local government agency any information relating 
to food that is exempt from disclosure pursuant to section 
552(a) of title 5, United States Code, by reason of subsection 
(b)(4) of such section, or that is referred to in section 
301(j) or 415(a)(4).
  ``(B) Any such information provided to a State or local 
government agency shall not be disclosed by such agency.
  ``(3) In carrying out this Act, the Secretary may provide to 
any person any information relating to food that is exempt from 
disclosure pursuant to section 552(a) of title 5, United States 
Code, by reason of subsection (b)(4) of such section, if the 
Secretary determines that providing the information to the 
person is appropriate under the circumstances and the recipient 
provides adequate assurances to the Secretary that the 
recipient will preserve the confidentiality of the information.
  ``(4) In carrying out this Act, the Secretary may provide any 
information relating to food that is exempt from disclosure 
pursuant to section 552(a) of title 5, United States Code, by 
reason of subsection (b)(4) of such section, or that is 
referred to in section 301(j)--
          ``(A) to any foreign government agency; or
          ``(B) any international organization established by 
        law, treaty, or other governmental action and having 
        responsibility--
                  ``(i) to facilitate global or regional 
                harmonization of standards and requirements in 
                an area of responsibility of the Food and Drug 
                Administration; or
                  ``(ii) to promote and coordinate public 
                health efforts,
        if the agency or organization provides adequate 
        assurances to the Secretary that the agency or 
        organization will preserve the confidentiality of the 
        information.
  ``(c) Except where specifically prohibited by statute, the 
Secretary may disclose to the public any information relating 
to food that is exempt from disclosure pursuant to section 
552(a) of title 5, United States Code, by reason of subsection 
(b)(4) of such section, if the Secretary determines that such 
disclosure is necessary to protect the public health.
  ``(d) Except as provided in subsection (e), the Secretary 
shall not be required to disclose under section 552 of title 5, 
United States Code, or any other provision of law any 
information relating to food obtained from a Federal, State, or 
local government agency, or from a foreign government agency, 
or from an international organization described in subsection 
(b)(4), if the agency or organization has requested that the 
information be kept confidential, or has precluded such 
disclosure under other use limitations, as a condition of 
providing the information.
  ``(e) Nothing in subsection (d) authorizes the Secretary to 
withhold information from the Congress or prevents the 
Secretary from complying with an order of a court of the United 
States.
  ``(f) This section shall not affect the authority of the 
Secretary to provide or disclose information under any other 
provision of law.''.
  (c) Conforming Amendment.--Section 301(j) (21 U.S.C. 331(j)) 
is amended by striking ``or to the courts when relevant in any 
judicial proceeding under this Act,'' and inserting ``to the 
courts when relevant in any judicial proceeding under this Act, 
or as specified in section 708,''.

SEC. 113. SAFE AND SECURE FOOD IMPORTATION PROGRAM.

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

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

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

SEC. 114. INFANT FORMULA.

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

                        Subtitle B--Intervention

SEC. 121. SURVEILLANCE.

  (a) Definition of Food-Borne Illness Outbreak.--In this 
section, the term ``food-borne illness outbreak'' means the 
occurrence of 2 or more cases of a similar illness resulting 
from the ingestion of a food.
  (b) Food-Borne Illness Surveillance Systems.--The Secretary 
of Health and Human Services (in this subtitle referred to as 
the ``Secretary''), acting through the Director of the Centers 
for Disease Control and Prevention, shall enhance food-borne 
illness surveillance systems to improve the collection, 
analysis, reporting, and usefulness of data on food-borne 
illnesses by--
          (1) coordinating Federal, State, and local food-borne 
        illness surveillance systems, including complaint 
        systems, and increasing participation in national 
        networks of public health and food regulatory agencies 
        and laboratories;
          (2) facilitating sharing of findings on a more timely 
        basis among governmental agencies, including the Food 
        and Drug Administration, the Department of Agriculture, 
        and State and local agencies, and with the public;
          (3) developing improved epidemiological tools for 
        obtaining quality exposure data, and microbiological 
        methods for classifying cases;
          (4) augmenting such systems to improve attribution of 
        a food-borne illness outbreak to a specific food;
          (5) expanding capacity of such systems, including 
        fingerprinting and other detection strategies for food-
        borne infectious agents, in order to identify new or 
        rarely documented causes of food-borne illness;
          (6) allowing timely public access to aggregated, de-
        identified surveillance data;
          (7) at least annually, publishing current reports on 
        findings from such systems;
          (8) establishing a flexible mechanism for rapidly 
        initiating scientific research by academic 
        institutions;
          (9) integrating food-borne illness surveillance 
        systems and data with other biosurveillance and public 
        health situational awareness capabilities at the 
        Federal, State, and local levels; and
          (10) other activities as determined appropriate by 
        the Secretary.
  (c) Improving Food Safety and Defense Capacity at the State 
and Local Level.--
          (1) In general.--The Secretary shall develop and 
        implement strategies to leverage and enhance the food 
        safety and defense capacities of State and local 
        agencies in order to achieve the following goals:
                  (A) Improve food-borne illness outbreak 
                response and containment.
                  (B) Accelerate food-borne illness 
                surveillance and outbreak investigation, 
                including rapid shipment of clinical isolates 
                from clinical laboratories to appropriate State 
                laboratories, and conducting more standardized 
                illness outbreak interviews.
                  (C) Strengthen the capacity of State and 
                local agencies to carry out inspections and 
                enforce safety standards.
                  (D) Improve the effectiveness of Federal, 
                State, and local partnerships to coordinate 
                food safety and defense resources and reduce 
                the incidence of food-borne illness.
                  (E) Share information on a timely basis among 
                public health and food regulatory agencies, 
                with the food industry, with health care 
                providers, and with the public.
          (2) Review.--In developing the strategies required by 
        paragraph (1), the Secretary shall, not later than 1 
        year after the date of enactment of this Act, complete 
        a review of State and local capacities, and needs for 
        enhancement, which may include a survey with respect 
        to--
                  (A) staffing levels and expertise available 
                to perform food safety and defense functions;
                  (B) laboratory capacity to support 
                surveillance, outbreak response, inspection, 
                and enforcement activities;
                  (C) information systems to support data 
                management and sharing of food safety and 
                defense information among State and local 
                agencies and with counterparts at the Federal 
                level; and
                  (D) other State and local activities and 
                needs as determined appropriate by the 
                Secretary.

SEC. 122. PUBLIC EDUCATION AND ADVISORY SYSTEM.

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

SEC. 123. RESEARCH.

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

                          Subtitle C--Response

SEC. 131. PROCEDURES FOR SEIZURE.

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

SEC. 132. ADMINISTRATIVE DETENTION.

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

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

  (a) Prohibited Act.--Section 301 (21 U.S.C. 331), as amended 
by sections 110 and 111, is amended by adding at the end by 
adding the following:
  ``(ww) The violation of a prohibition or restriction under 
section 304(i).''.
  (b) In General.--Section 304 (21 U.S.C. 334) is amended by 
adding at the end the following:
  ``(i) Authority to Prohibit or Restrict the Movement of Food 
Within a State or Portion of a State.--
          ``(1) Authority to prohibit or restrict the movement 
        of food.--
                  ``(A) In general.--
                          ``(i) After consultation with the 
                        Governor or other appropriate official 
                        of an affected State, if the Secretary 
                        determines that there is credible 
                        evidence that an article of food 
                        presents an imminent threat of serious 
                        adverse health consequences or death to 
                        humans or animals, the Secretary may 
                        prohibit or restrict the movement of an 
                        article of food within a State or 
                        portion of a State for which the 
                        Secretary has credible evidence that 
                        such food is located within, or 
                        originated from, such State or portion 
                        thereof.
                          ``(ii) In carrying out clause (i), 
                        the Secretary may prohibit or restrict 
                        the movement within a State or portion 
                        of a State of any article of food or 
                        means of conveyance of such article of 
                        food, if the Secretary determines that 
                        the prohibition or restriction is a 
                        necessary protection from an imminent 
                        threat of serious adverse health 
                        consequences or death to humans or 
                        animals.
          ``(2) Notification procedures.--Subject to paragraph 
        (3), before any action is taken in a State under this 
        subsection, the Secretary shall--
                  ``(A) notify the Governor or other 
                appropriate official of the State affected by 
                the proposed action;
                  ``(B) issue a public announcement of the 
                proposed action; and
                  ``(C) publish in the Federal Register--
                          ``(i) the findings of the Secretary 
                        that support the proposed action;
                          ``(ii) a statement of the reasons for 
                        the proposed action; and
                          ``(iii) a description of the proposed 
                        action, including--
                                  ``(I) the area affected; and
                                  ``(II) an estimate of the 
                                anticipated duration of the 
                                action.
          ``(3) Notice after action.--If it is not practicable 
        to publish in the Federal Register the information 
        required under paragraph (2)(C) before taking action 
        under paragraph (1), the Secretary shall publish the 
        information as soon as practicable, but not later than 
        10 business days, after commencement of the action.
          ``(4) Application of least drastic action.--No action 
        shall be taken under paragraph (1) unless, in the 
        opinion of the Secretary, there is no less drastic 
        action that is feasible and that would be adequate to 
        prevent the imminent threat of serious adverse health 
        consequences or death to humans or animals.
          ``(5) Nondelegation.--An action under paragraph (1) 
        may only be ordered by the Secretary or an official 
        designated by the Secretary. An official may not be so 
        designated unless the official is the Commissioner of 
        Food and Drugs or the Principal Deputy Commissioner.
          ``(6) Duration.--Fourteen days after the initiation 
        of an action under paragraph (1), and each 14 days 
        thereafter, if the Secretary determines that it is 
        necessary to continue the action, the Secretary shall--
                  ``(A) notify the Governor or other 
                appropriate official of the State affected of 
                the continuation of the action;
                  ``(B) issue a public announcement of the 
                continuation of the action; and
                  ``(C) publish in the Federal Register the 
                findings of the Secretary that support the 
                continuation of the action, including an 
                estimate of the anticipated duration of the 
                action.
          ``(7) Rulemaking.--The Secretary shall, consistent 
        with national security interests and as appropriate for 
        known hazards, establish by regulation standards for 
        conducting actions under paragraph (1), including, as 
        appropriate, sanitation standards and procedures to 
        restore any affected equipment or means of conveyance 
        to its status prior to an action under paragraph 
        (1).''.

SEC. 134. CRIMINAL PENALTIES.

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

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

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

SEC. 136. IMPROPER IMPORT ENTRY FILINGS.

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

                        TITLE II--MISCELLANEOUS

SEC. 201. FOOD SUBSTANCES GENERALLY RECOGNIZED AS SAFE.

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

               ``Substances Generally Recognized as Safe

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

SEC. 202. COUNTRY OF ORIGIN LABELING.

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

SEC. 203. EXPORTATION CERTIFICATE PROGRAM.

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

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

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

                                  
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