[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1332 Introduced in House (IH)]

111th CONGRESS
  1st Session
                                H. R. 1332

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
                       safety of the food supply.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 5, 2009

Mr. Costa (for himself, Mr. Putnam, Mr. Peterson, Mr. Deal of Georgia, 
Mr. Cardoza, Mr. Barton of Texas, Mr. Farr, Mr. Shimkus, Mr. Engel, Mr. 
  Radanovich, Mr. Thompson of California, Mr. Terry, Mr. Salazar, Mr. 
 Boswell, Ms. Herseth Sandlin, Mr. Walden, Mr. Cuellar, Mr. Kagen, Mr. 
    Scott of Georgia, Ms. Ros-Lehtinen, Mr. Burgess, and Mr. Baca) 
 introduced the following bill; which was referred to the Committee on 
 Energy and Commerce, and in addition to the Committee on Agriculture, 
for a period to be subsequently determined by the Speaker, in each case 
for consideration of such provisions as fall within the jurisdiction of 
                        the committee concerned

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
                       safety of the food supply.

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

SECTION 1. SHORT TITLE; REFERENCES; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Safe Food 
Enforcement, Assessment, Standards, and Targeting Act of 2009'' or as 
the ``Safe FEAST Act of 2009''.
    (b) 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 construed to be made to a 
section or other provision of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 301 et seq.).
    (c) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; references; table of contents.
                    TITLE I--GENERAL FOOD PROVISIONS

Sec. 101. Inspection of records during food-related emergencies.
Sec. 102. Registration of food facilities.
Sec. 103. Mandatory recall authority.
Sec. 104. Hazard analysis and risk-based preventive controls.
Sec. 105. Performance standards.
Sec. 106. Standards for the safety of fruits and vegetables.
Sec. 107. Targeting of inspection resources for domestic facilities, 
                            foreign facilities, and ports of entry; 
                            annual report.
Sec. 108. Administrative detention of food.
Sec. 109. National agriculture and food defense strategy.
Sec. 110. Food and Agriculture Coordinating Councils.
Sec. 111. Authority to collect fees.
                  TITLE II--DETECTION AND SURVEILLANCE

Sec. 201. Recognition of laboratory accreditation for analyses of 
                            foods.
Sec. 202. Integrated consortium of laboratory networks.
Sec. 203. Building domestic capacity.
Sec. 204. Enhancing traceback and recordkeeping.
Sec. 205. Surveillance.
            TITLE III--SPECIFIC PROVISIONS FOR IMPORTED FOOD

Sec. 301. Foreign supplier verification program.
Sec. 302. Voluntary qualified importer program.
Sec. 303. Authority to require import certifications for food.
Sec. 304. Prior notice of imported food shipments.
Sec. 305. Review of a regulatory authority of a foreign country.
Sec. 306. Building capacity of foreign governments with respect to 
                            food.
Sec. 307. Inspection of foreign food facilities.
Sec. 308. Third-party accreditation of qualified auditors and audit 
                            agents.
Sec. 309. Jurisdiction; authorities.

                    TITLE I--GENERAL FOOD PROVISIONS

SEC. 101. INSPECTION OF RECORDS DURING FOOD-RELATED EMERGENCIES.

    (a) In General.--Section 414 (21 U.S.C. 350c) is amended--
            (1) by redesignating subsections (b), (c), and (d) as 
        subsections (c), (d), and (e), respectively; and
            (2) by inserting after subsection (a) the following:
    ``(b) Records Inspections During Food-Related 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, during a food-related emergency, the Secretary--
            ``(1) may have access to and copy all records relating to 
        such article of food in the same manner and for the same 
        purpose as described in subsection (a); and
            ``(2) shall, from each person (excluding farms and 
        restaurants) who manufactures, processes, packs, distributes, 
        receives, holds, or imports an article of food related to the 
        article of food referred to under paragraph (1) (such as an 
        article of food produced on the same manufacturing line or any 
        other article of food that the Secretary reasonably believes is 
        likely to be affected in a similar manner) at the request of an 
        officer or employee duly designated by the Secretary, have 
        permission for such officer or employee, upon presentation of 
        appropriate credentials and a written notice to such person, at 
        reasonable times and within reasonable limits and in a 
        reasonable manner, to have access to and copy all records 
        relating to such article that are needed to assist the 
        Secretary in determining whether the food presents a threat of 
        serious adverse health consequences or death to humans or 
        animals.''.
    (b) Conforming Amendments.--
            (1) Section 301(e) (21 U.S.C. 331(e)) is amended by 
        striking ``414(b)'' and inserting ``414(c)''.
            (2) Section 704(a)(1) (21 U.S.C. 374(a)(1)) is amended by 
        striking ``414(d)'' and inserting ``414(e)''.

SEC. 102. REGISTRATION OF FOOD FACILITIES.

    (a) Updating of Food Category Regulations; Biennial Registration 
Renewal.--Section 415(a) (21 U.S.C. 350d(a)) is amended--
            (1) in paragraph (2), by--
                    (A) striking ``conducts business and'' and 
                inserting ``conducts business, the e-mail address for 
                the contact person of the facility, and''; and
                    (B) inserting ``, or any other food categories as 
                determined appropriate by the Secretary, including by 
                guidance)'' after ``Code of Federal Regulations'';
            (2) by redesignating paragraphs (3) and (4) as paragraphs 
        (4) and (5), respectively; and
            (3) by inserting after paragraph (2) the following:
            ``(3) Biennial registration renewal.--During the period 
        beginning on October 1 and ending on December 31 of each even-
        numbered year, a registrant that has submitted a registration 
        under paragraph (1) shall submit to the Secretary a renewal 
        registration containing the information described in paragraph 
        (2). The Secretary shall provide for an abbreviated 
        registration renewal process for any registrant that has not 
        had any changes to such information since the registrant 
        submitted the preceding registration or registration renewal 
        for the facility involved.''.
    (b) Suspension of Registration.--
            (1) In general.--Section 415 (21 U.S.C. 350d) is amended--
                    (A) in subsection (a)(2), by inserting after the 
                first sentence the following: ``The registration shall 
                contain a consent to permit the Secretary to inspect 
                such facility.'';
                    (B) by redesignating subsections (b) and (c) as 
                subsections (c) and (d), respectively; and
                    (C) by inserting after subsection (a) the 
                following:
    ``(b) Suspension of Registration.--
            ``(1) In general.--If the Secretary determines that food 
        manufactured, processed, packed, or held by a facility 
        registered under this section has a reasonable probability of 
        causing serious adverse health consequences or death to humans 
        or animals, the Secretary may by order suspend the registration 
        of the facility under this section in accordance with this 
        subsection.
            ``(2) Hearing on suspension.--The Secretary shall provide 
        the registrant subject to an order under paragraph (1) with an 
        opportunity for an informal hearing, to be held as soon as 
        possible but not later than 2 days after the issuance of the 
        order, on the actions required for reinstatement of 
        registration and why the registration that is subject to 
        suspension should be reinstated. The Secretary shall reinstate 
        a registration if the Secretary determines, based on evidence 
        presented, that adequate grounds do not exist to continue the 
        suspension of the registration.
            ``(3) Post-hearing corrective action plan; vacating of 
        order.--
                    ``(A) Corrective action plan.--If, after providing 
                opportunity for an informal hearing under paragraph 
                (2), the Secretary determines that the suspension of 
                registration remains necessary, the Secretary shall 
                require the registrant to submit a corrective action 
                plan to demonstrate how the registrant plans to correct 
                the conditions found by the Secretary. The Secretary 
                shall review such plan in a timely manner.
                    ``(B) Vacating of order.--Upon a determination by 
                the Secretary that adequate grounds do not exist to 
                continue the suspension actions required by the order, 
                or that such actions should be modified, the Secretary 
                shall vacate the order or modify the order.
            ``(4) Effect of suspension.--If the registration of a 
        facility is suspended under this subsection, such facility 
        shall not import food or offer to import food into the United 
        States, or otherwise introduce food into interstate commerce in 
        the United States.
            ``(5) Regulations.--The Secretary shall promulgate 
        regulations that describe the standards officials will use in 
        making a determination to suspend a registration, and the 
        format such officials will use to explain to the registrant the 
        conditions found at the facility.
            ``(6) No delegation.--The authority conferred by this 
        subsection to issue an order to suspend a registration or 
        vacate an order of suspension shall not be delegated to any 
        officer or employee other than the Commissioner.''.
            (2) Imported food.--Section 801(l) (21 U.S.C. 381(l)) is 
        amended by inserting ``(or for which a registration has been 
        suspended under such section)'' after ``section 415''.
    (c) Conforming Amendments.--
            (1) Section 301(d) (21 U.S.C. 331(d)) is amended by 
        inserting ``415,'' after ``404,''.
            (2) Section 415(d), as redesignated by subsection (b), is 
        amended by adding at the end before the period ``for a facility 
        to be registered, except with respect to the reinstatement of a 
        registration that is suspended under subsection (b)''.

SEC. 103. MANDATORY RECALL AUTHORITY.

    (a) In General.--Chapter IV (21 U.S.C. 341 et seq.) is amended by 
adding at the end the following:

``SEC. 418. MANDATORY RECALL AUTHORITY.

    ``(a) Voluntary Procedures.--If the Secretary determines, based on 
information gathered through the reportable food registry under section 
417 or through any other means, that there is a reasonable probability 
that an article of food (other than infant formula) is adulterated 
under section 402 or misbranded under section 403(w) and the use of or 
exposure to such article will cause serious adverse health consequences 
or death to humans or animals, the Secretary shall provide the 
responsible party (as defined in section 417) with an opportunity to 
cease distribution and recall such article.
    ``(b) Prehearing Order To Cease Distribution and Give Notice.--If 
the responsible party refuses to or does not voluntarily cease 
distribution or recall such article within the time and in the manner 
prescribed by the Secretary (if so prescribed), the Secretary may, by 
order require, as the Secretary deems necessary, such person to--
            ``(1) immediately cease distribution of such article; or
            ``(2) immediately notify all persons--
                    ``(A) manufacturing, processing, packing, 
                transporting, distributing, receiving, holding, or 
                importing and selling such article; and
                    ``(B) to which such article has been distributed, 
                transported, or sold, to immediately cease distribution 
                of such article.
    ``(c) Hearing on Order.--The Secretary shall provide the 
responsible party subject to an order under subsection (b) with an 
opportunity for an informal hearing, to be held as soon as possible but 
not later than 2 days after the issuance of the order, on the actions 
required by the order and on why the article that is the subject of the 
order should not be recalled.
    ``(d) Post-Hearing Recall Order and Modification of Order.--
            ``(1) Amendment of order.--If, after providing opportunity 
        for an informal hearing under subsection (c), the Secretary 
        determines that removal of the article from commerce is 
        necessary, the Secretary shall, as appropriate--
                    ``(A) amend the order to require recall of such 
                article or other appropriate action;
                    ``(B) specify a timetable in which the recall shall 
                occur;
                    ``(C) require periodic reports to the Secretary 
                describing the progress of the recall; and
                    ``(D) provide notice to consumers to whom such 
                article was, or may have been, distributed.
            ``(2) Vacating of order.--If, after such hearing, the 
        Secretary determines that adequate grounds do not exist to 
        continue the actions required by the order, or that such 
        actions should be modified, the Secretary shall vacate the 
        order or modify the order.
    ``(e) Cooperation and Consultation.--The Secretary shall work with 
State and local public health officials in carrying out this section, 
as appropriate.
    ``(f) Public Notification.--In conducting a recall under this 
section, the Secretary shall ensure that a press release is published 
regarding the recall, as well as alerts and public notices, as 
appropriate, in order to provide notification of the recall to 
consumers and retailers to whom such article was, or may have been, 
distributed. The notification shall include, at a minimum--
            ``(1) the name of the article of food subject to the 
        recall; and
            ``(2) a description of the risk associated with such 
        article.
    ``(g) No Delegation.--The authority conferred by this section to 
order a recall or vacate a recall order shall not be delegated to any 
officer or employee other than the Commissioner.
    ``(h) Effect.--Nothing in this section shall affect the authority 
of the Secretary to request or participate in a voluntary recall.''.
    (b) Prohibited Acts.--Section 301 (21 U.S.C. 331 et seq.) is 
amended by adding at the end the following:
    ``(oo) The refusal or failure to follow an order under section 
418.''.

SEC. 104. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS.

    (a) In General.--Chapter IV (21 U.S.C. 341 et seq.), as amended by 
section 103, is amended by adding at the end the following:

``SEC. 419. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS.

    ``(a) In General.--Each owner, operator, or agent in charge of a 
facility shall, in accordance with this section, evaluate the hazards 
that could affect food manufactured, processed, packed, or held by such 
facility, identify and implement preventive controls to significantly 
minimize or prevent their occurrence and provide assurances that such 
food is not adulterated under section 402 or misbranded under section 
403(w), monitor the performance of those controls, and maintain records 
of this monitoring as a matter of routine practice.
    ``(b) Hazard Analysis.--The owner, operator, or agent in charge of 
a facility shall--
            ``(1) identify and evaluate known or reasonably foreseeable 
        hazards that may be associated with the facility, including--
                    ``(A) biological, chemical, physical, and 
                radiological hazards, natural toxins, pesticides, drug 
                residues, decomposition, parasites, allergens, and 
                unapproved food and color additives; and
                    ``(B) hazards that occur naturally, may be 
                unintentionally introduced, or may be intentionally 
                introduced, including by acts of terrorism; and
            ``(2) develop a written analysis of the hazards.
    ``(c) Preventive Controls.--The owner, operator, or agent in charge 
of a facility shall identify and implement preventive controls, 
including at critical control points, if any, to provide assurances 
that--
            ``(1) hazards identified in the hazard analysis conducted 
        under subsection (b) will be significantly minimized or 
        prevented; and
            ``(2) the food manufactured, processed, packed, or held by 
        such facility will not be adulterated under section 402 or 
        misbranded under section 403(w).
    ``(d) Monitoring of Effectiveness.--The owner, operator, or agent 
in charge of a facility shall monitor the effectiveness of the 
preventive controls implemented under subsection (c) to provide 
assurances that the outcomes described in subsection (c) shall be 
achieved.
    ``(e) Corrective Actions.--The owner, operator, or agent in charge 
of a facility shall establish procedures that a facility will implement 
if the preventive controls implemented under subsection (c) are found 
to be ineffective through monitoring under subsection (d).
    ``(f) Verification.--The owner, operator, or agent in charge of a 
facility shall verify that--
            ``(1) the preventive controls implemented under subsection 
        (c) are adequate to control the hazards identified under 
        subsection (b);
            ``(2) the owner, operator, or agent is conducting 
        monitoring in accordance with subsection (d);
            ``(3) the owner, operator, or agent is making appropriate 
        decisions about corrective actions taken under subsection (e); 
        and
            ``(4) there is documented, periodic reanalysis of the plan 
        under subsection (i) to ensure that the plan is still relevant 
        to the raw materials, as well as to conditions and processes in 
        the facility, and to new and emerging threats.
    ``(g) Recordkeeping.--The owner, operator, or agent in charge of a 
facility shall maintain, for not less than 2 years, records documenting 
the monitoring of the preventive controls implemented under subsection 
(c), instances of nonconformance material to food safety, instances 
when corrective actions were implemented, and the efficacy of 
preventive controls and corrective actions.
    ``(h) Written Plan and Documentation.--Each owner, operator, or 
agent in charge of a facility shall prepare a written plan that 
documents and describes the procedures used by the facility to comply 
with the requirements of this section, including analyzing the hazards 
under subsection (b) and identifying the preventive controls adopted to 
address those hazards under subsection (c). High-risk facilities, as 
determined by the Secretary, shall submit such written plan to the Food 
and Drug Administration's Center for Food Safety and Applied Nutrition. 
The Secretary or a duly authorized representative of the Secretary may 
review the plan and may make recommendations regarding the 
effectiveness of the plan in preventing or minimizing the threat of 
serious adverse health consequences or death to humans or animals. All 
facilities shall promptly make available such written plan, together 
with documentation that the plan is being implemented, to a duly 
authorized representative of the Secretary upon oral or written 
request.
    ``(i) Requirement To Reanalyze.--Each owner, operator, or agent in 
charge of a facility shall conduct a reanalysis under subsection (b) 
whenever a significant change is made in the activities conducted at a 
facility operated by such owner, operator, or agent if the change 
creates a reasonable potential for a new hazard or a significant 
increase in a previously identified hazard or not less frequently than 
once every 3 years, whichever is earlier. Such reanalysis shall be 
completed and additional preventive controls needed to address the 
hazard identified, if any, shall be implemented before the change in 
activities at the facility is commenced. Such owner, operator, or agent 
shall revise the written plan required under subsection (h) if such a 
significant change is made or document the basis for the conclusion 
that no additional or revised preventive controls are needed. The 
Secretary may require a reanalysis under this section to respond to new 
hazards and developments in scientific understanding.
    ``(j) Deemed Compliance of Seafood, Juice, and Low-Acid Canned Food 
Facilities in Compliance With HACCP.--An owner, operator, or agent in 
charge of a facility required to comply with 1 of the following 
standards and regulations with respect to such facility shall be deemed 
to be in compliance with this section, with respect to such facility:
            ``(1) The Seafood Hazard Analysis Critical Control Points 
        Program of the Food and Drug Administration.
            ``(2) The Juice Hazard Analysis Critical Control Points 
        Program of the Food and Drug Administration.
            ``(3) The Thermally Processed Low-Acid Foods Packaged in 
        Hermetically Sealed Containers standards of the Food and Drug 
        Administration (or any successor standards).
    ``(k) Exception for Facilities in Compliance With Section 420.--
This section shall not apply to a facility that is subject to section 
420.
    ``(l) Authority With Respect to Certain Facilities.--The Secretary 
may, by regulation, exempt or modify the requirements for compliance 
under this section with respect to facilities that are solely engaged 
in the storage of packaged foods that are not exposed to the 
environment.
    ``(m) Definitions.--For purposes of this section:
            ``(1) Critical control point.--The term `critical control 
        point' means a point, step, or procedure in a food process at 
        which control can be applied and is essential to prevent or 
        eliminate a food safety hazard or reduce it to an acceptable 
        level.
            ``(2) Facility.--The term `facility' means a domestic 
        facility or a foreign facility that is required to register 
        under section 415.
            ``(3) Preventive controls.--The term `preventive controls' 
        means those risk-based, reasonably appropriate procedures, 
        practices, and processes that a person knowledgeable about the 
        safe manufacturing, processing, packing, or holding of food 
        would have employed to significantly minimize or prevent the 
        hazards identified under the hazard analysis conducted under 
        subsection (a) and that are consistent with the current 
        scientific understanding of safe food manufacturing, 
        processing, packing, or holding at the time of the analysis. 
        Those procedures, practices, and processes shall include the 
        following:
                    ``(A) Sanitation procedures for food contact 
                surfaces and utensils and food-contact surfaces of 
                equipment.
                    ``(B) Supervisor, manager, and employee hygiene 
                training.
                    ``(C) An environmental monitoring program to verify 
                the effectiveness of pathogen controls.
                    ``(D) An allergen control program.
                    ``(E) A recall contingency plan.
                    ``(F) Good Manufacturing Practices (GMPs).
                    ``(G) Supplier verification activities.''.
    (b) Regulations.--
            (1) In general.--The Secretary of Health and Human Services 
        (referred to in this Act as the ``Secretary'') shall promulgate 
        regulations to establish science-based minimum standards for 
        conducting a hazard analysis, documenting hazards, implementing 
        preventive controls, and documenting the implementation of the 
        preventive controls under section 419 of the Federal Food, 
        Drug, and Cosmetic Act (as added by subsection (a)).
            (2) Content.--The regulations promulgated under paragraph 
        (1) shall provide sufficient flexibility to be applicable in 
        all situations, including in the operations of small 
        businesses.
            (3) Rule of construction.--Nothing in this subsection shall 
        be construed to provide the Secretary with the authority to 
        apply specific technologies, practices, or critical controls to 
        an individual facility.
            (4) Review.--In promulgating the regulations under 
        paragraph (1), the Secretary shall review regulatory hazard 
        analysis and preventive control programs in existence on the 
        date of enactment of this Act to ensure that the program under 
        such section 419 is consistent, to the extent practicable, with 
        applicable internationally recognized standards in existence on 
        such date.
    (c) Guidance Document.--The Secretary shall issue a guidance 
document related to hazard analysis and preventive controls required 
under section 419 of the Federal Food, Drug, and Cosmetic Act (as added 
by subsection (a)).
    (d) Prohibited Acts.--Section 301 (21 U.S.C. 331), as amended by 
section 103, is amended by adding at the end the following:
    ``(pp) The operation of a facility that manufacturers, processes, 
packs, or holds food for sale in the United States if the owner, 
operator, or agent in charge of such facility is not in compliance with 
section 419.''.
    (e) No Effect on HACCP Authorities.--Nothing in 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.) 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.
    (f) Effective Date.--
            (1) General rule.--The amendments made by this section 
        shall take effect 18 months after the date of enactment of this 
        Act.
            (2) Exceptions.--Notwithstanding paragraph (1)--
                    (A) the amendments made by this section shall apply 
                to a small business (as defined by the Secretary) after 
                the date that is 2 years after the date of enactment of 
                this Act; and
                    (B) the amendments made by this section shall apply 
                to a very small business (as defined by the Secretary) 
                after the date that is 3 years after the date of 
                enactment of this Act.

SEC. 105. PERFORMANCE STANDARDS.

    The Secretary shall, not less frequently than every 2 years, review 
and evaluate relevant health data and other relevant information, 
including from toxicological and epidemiological studies and analyses, 
to determine the most significant food-borne contaminants and, when 
appropriate to reduce the risk of serious illness or death to humans or 
animals, to prevent the adulteration of the food under section 402 of 
the Federal Food, Drug, or Cosmetic Act (21 U.S.C. 342), or to prevent 
the spread of communicable disease under the Public Health Service Act 
(42 U.S.C. 201 et seq.), shall issue contaminant-specific, science-
based guidance documents, actions levels, or regulations. Such guidance 
documents, action levels, or regulations shall apply to products or 
product classes, take into account naturally occurring substances in 
the case of raw agricultural products, and shall not be written to be 
facility-specific.

SEC. 106. STANDARDS FOR THE SAFETY OF FRUITS AND VEGETABLES.

    (a) In General.--Chapter IV (21 U.S.C. 341 et seq.), as amended by 
section 104, is amended by adding at the end the following:

``SEC. 420. STANDARDS FOR THE SAFETY OF FRUITS AND VEGETABLES.

    ``(a) Definition.--For purposes of this section, the term `fruits 
and vegetables' means raw agricultural products as defined in section 
201(r).
    ``(b) In General.--Not later than 1 year after enactment of this 
section, the Secretary, in consultation with the Secretary of 
Agriculture and representatives of State departments of agriculture, 
shall publish a notice of proposed rulemaking to establish regulations 
for the safe production, harvesting, handling, and packing of those 
types of fruits and vegetables for which the Secretary has determined 
that such regulations are necessary to minimize the risk of serious 
adverse health consequences.
    ``(c) Final Regulation.--Not later than 1 year after the close of 
the comment period on the notice of proposed rulemaking under 
subsection (a), the Secretary shall adopt a final regulation covering 
those types of fruits and vegetables for which the Secretary has 
determined that such regulations are necessary to minimize the risk of 
serious adverse health consequences. The final regulation shall provide 
a reasonable period of time for implementation, taking into account the 
needs of small businesses for additional time to comply. The final 
regulation shall provide for coordination of education and enforcement 
activities by the Secretary of Agriculture, appropriate State and local 
agencies, and appropriate agencies of foreign governments.
    ``(d) Cooperation.--The Secretary shall work with State and local 
public health officials in carrying out this section. The Secretary 
shall coordinate activities with the Secretary of Agriculture related 
to on-farm requirements for growers including the development of food 
safety standards and enforcement mechanisms that will address 
regulations adopted under subsection (c).
    ``(e) Criteria.--The regulations adopted under subsection (b) 
shall--
            ``(1) set forth such procedures, processes, and practices 
        as the Secretary determines to be reasonably necessary to 
        minimize the introduction of known or reasonably foreseeable 
        biological, chemical, and physical hazards into fruits and 
        vegetables and to provide reasonable assurance that the fruits 
        and vegetables are not adulterated under section 402;
            ``(2) permit States and foreign governments to seek 
        variances from the requirements of the regulations, where the 
        State or foreign government determines that the variance is 
        necessary in light of local growing conditions and that the 
        procedures, processes, and practices to be followed under the 
        variance are reasonably likely to ensure that the fruits or 
        vegetables are not adulterated within the meaning of section 
        402 to the same extent as the requirements of the regulation 
        adopted under subsection (b);
            ``(3) require that any State or foreign government seeking 
        a variance under paragraph (2) shall first notify the Secretary 
        of the intended variance and the basis for it, and the 
        Secretary may grant the variance after 90 days of such 
        notification if Secretary does not communicate objections or 
        modifications to the intended variance to the respective State 
        or foreign government prior to the conclusion of the 90-day 
        period; and
            ``(4) provide for publication of notices of requests for 
        variances under paragraph (2) at the time they are received.
    ``(f) Enforcement.--The Secretary shall coordinate enforcement 
under this section with appropriate State and local agencies and with 
appropriate agencies of foreign governments. In enforcing any standards 
for the safety of fruits and vegetables, the Secretary shall, to the 
maximum extent practicable, use the Department of Agriculture and state 
agricultural agencies. Such enforcement may be in the form of audit-
based verification systems or other methods of inspection.
    ``(g) Guidance for Good Agricultural Practices.--Not later than 1 
year after the date of the enactment of this section, the Secretary 
shall publish updated guidance, in coordination with the Secretary of 
Agriculture and representatives of State departments of agriculture, 
based on the most currently available scientific evidence, for the safe 
production, harvesting, handling, packing, and traceability of fruits 
and vegetables. The Secretary shall publish subsequently updated 
guidance, as necessary.
    ``(h) Scope.--This section shall apply to the production, 
harvesting, packaging, and traceability of fruits and vegetables 
intended for human consumption, but not to--
            ``(1) activities involving the further processing of fruits 
        and vegetables which shall be subject to section 419; or
            ``(2) those activities that occur in a retail food 
        establishment (as such term is defined in regulations to carry 
        out section 415(b)(1)).''.
    (b) Prohibited.--Section 301 (21 U.S.C. 331), as amended by section 
104, is further amended by adding at the end the following:
    ``(qq) Production, harvesting, handling, and packing of fruits or 
vegetables not in accordance with the regulations under section 419 or 
a variance issued under section 419(e)(2).''.

SEC. 107. TARGETING OF INSPECTION RESOURCES FOR DOMESTIC FACILITIES, 
              FOREIGN FACILITIES, AND PORTS OF ENTRY; ANNUAL REPORT.

    (a) Targeting of Inspection Resources for Domestic Facilities, 
Foreign Facilities, and Ports of Entry.--Chapter IV (21 U.S.C. 341 et 
seq.), as amended by section 106, is amended by adding at the end the 
following:

``SEC. 421. TARGETING OF INSPECTION RESOURCES FOR DOMESTIC FACILITIES, 
              FOREIGN FACILITIES, AND PORTS OF ENTRY; ANNUAL REPORT.

    ``(a) Identification and Inspection of Facilities.--
            ``(1) Identification.--The Secretary shall allocate 
        resources to inspect facilities according to the risk profile 
        of the facilities, which shall be based on the following 
        factors:
                    ``(A) The risk profile of the food manufactured, 
                processed, packed, or held at the facility.
                    ``(B) The facility's history of food recalls, 
                outbreaks, and violations of food safety standards.
                    ``(C) The rigor of the facility's hazard analysis 
                and risk-based preventive controls.
                    ``(D) Whether the food manufactured, processed, 
                packed, handled, prepared, treated, distributed, or 
                stored at the facility meets the criteria for priority 
                under section 801(h)(1).
                    ``(E) Whether the facility has received a 
                certificate as described in section 809(b).
                    ``(F) Any other criteria deemed necessary and 
                appropriate by the Secretary for purposes of allocating 
                inspection resources.
            ``(2) Inspections.--The Secretary shall increase the 
        frequency of inspections of all facilities such that--
                    ``(A) all facilities registered under section 415 
                are inspected not less than once every 4 years; and
                    ``(B) all facilities identified under paragraph (1) 
                as a high-risk facility are inspected--
                            ``(i) not less than once within a 2-year 
                        period after the date of enactment of this 
                        section; and
                            ``(ii) for each succeeding year, each high-
                        risk facility is inspected not less than once 
                        each year.
    ``(b) Identification and Inspection at Ports of Entry.--The 
Secretary, in consultation with the Secretary of Homeland Security, 
shall allocate resources to inspect articles of food imported into the 
United States according to the risk profile of the article of food, 
which shall be based on the following factors:
            ``(1) The risk profile of the food imported.
            ``(2) The risk profile of the countries of origin and 
        countries of transport of the food imported.
            ``(3) The history of food recalls, outbreaks, and 
        violations of food safety standards of the food importer.
            ``(4) The rigor of the foreign supplier verification 
        program under section 805.
            ``(5) Whether the food importer participates in the 
        Voluntary Qualified Importer Program under section 806.
            ``(6) Whether the food meets the criteria for priority 
        under section 801(h)(1).
            ``(7) Whether the food is from a facility that has received 
        a certificate as described in section 809(b).
            ``(8) Any other criteria deemed appropriate by the 
        Secretary for purposes of allocating inspection resources.
    ``(c) Coordination.--The Secretary shall improve coordination and 
cooperation with the Secretary of Agriculture to target food inspection 
resources.
    ``(d) Facility.--For purposes of this section, the term `facility' 
means a domestic facility or a foreign facility that is required to 
register under section 415.''.
    (b) Annual Report.--Section 903 (21 U.S.C. 393) is amended by 
adding at the end the following:
    ``(h) Annual Report Regarding Food.--Not later than February 1 of 
each year, the Secretary shall submit to Congress a report regarding--
            ``(1) information about food facilities including--
                    ``(A) the appropriations used to inspect facilities 
                registered pursuant to section 415 in the previous 
                fiscal year;
                    ``(B) the average cost of both a non-high-risk food 
                facility inspection and a high-risk food facility 
                inspection, if such a difference exists, in the 
                previous fiscal year;
                    ``(C) the number of domestic facilities and the 
                number of foreign facilities registered pursuant to 
                section 415 that the Secretary inspected in the 
                previous fiscal year;
                    ``(D) the number of domestic facilities and the 
                number of foreign facilities registered pursuant to 
                section 415 that the Secretary did not inspect in the 
                previous fiscal year;
                    ``(E) the number of high-risk facilities identified 
                pursuant to section 421 that the Secretary inspected in 
                the previous fiscal year; and
                    ``(F) the number of high-risk facilities identified 
                pursuant to section 421 that the Secretary did not 
                inspect in the previous fiscal year; and
            ``(2) information about food imports including--
                    ``(A) the number of lines of food imported into the 
                United States that the Secretary physically inspected 
                or sampled in the previous fiscal year;
                    ``(B) the number of lines of food imported into the 
                United States that the Secretary did not physically 
                inspect or sample in the previous fiscal year; and
                    ``(C) the average cost of physically inspecting or 
                sampling a food line subject to this Act that is 
                imported or offered for import into the United States.
    ``(i) Public Availability of Annual Food Reports.--The Secretary 
shall make the reports required under subsection (h) available to the 
public on the Internet Web site of the Food and Drug Administration.''.

SEC. 108. ADMINISTRATIVE DETENTION OF FOOD.

    (a) In General.--Section 304(h)(1)(A) (21 U.S.C. 334(h)(1)(A)) is 
amended by--
            (1) striking ``credible evidence or information 
        indicating'' and inserting ``reason to believe''; and
            (2) striking ``presents a threat of serious adverse health 
        consequences or death to humans or animals'' and inserting ``is 
        adulterated or misbranded under section 403(w)''.
    (b) Regulations.--Not later than 120 days after the date of 
enactment of this Act, the Secretary shall issue an interim final rule 
amending subpart K of part 1 of title 21, Code of Federal Regulations, 
to implement the amendment made by this section.
    (c) Effective Date.--The amendment made by this section shall take 
effect 180 days after the date of enactment of this Act.

SEC. 109. NATIONAL AGRICULTURE AND FOOD DEFENSE STRATEGY.

    (a) Development and Submission of Strategy.--
            (1) In general.--Not later than 1 year after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services and the Secretary of Agriculture, in coordination with 
        the Secretary of Homeland Security, shall prepare and submit to 
        the relevant committees of Congress, and make publicly 
        available on the Internet Web site of the Department of Health 
        and Human Services and the Department of Agriculture, the 
        National Agriculture and Food Defense Strategy.
            (2) Implementation plan.--The strategy shall include an 
        implementation plan for use by the Secretaries described under 
        paragraph (1) in carrying out the strategy.
            (3) Research.--The strategy shall include a coordinated 
        research agenda for use by the Secretaries described under 
        paragraph (1) in conducting research to support the goals and 
        activities described in paragraphs (1) and (2) of subsection 
        (b).
            (4) Revisions.--Not later than 4 years after the date on 
        which the strategy is submitted to the relevant committees of 
        Congress under paragraph (1), and not less frequently than 
        every 4 years thereafter, the Secretary of Health and Human 
        Services and the Secretary of Agriculture, in coordination with 
        the Secretary of Homeland Security, shall revise and submit to 
        the relevant committees of Congress the strategy.
            (5) Consistency with existing plans.--The strategy 
        described in paragraph (1) shall be consistent with--
                    (A) the National Incident Management System;
                    (B) the National Response Framework;
                    (C) the National Infrastructure Protection Plan;
                    (D) the National Preparedness Goals; and
                    (E) other relevant national strategies.
    (b) Components.--
            (1) In general.--The strategy shall include a description 
        of the process to be used by the Department of Health and Human 
        Services, the Department of Agriculture, and the Department of 
        Homeland Security--
                    (A) to achieve each goal described in paragraph 
                (2); and
                    (B) to evaluate the progress made by Federal, 
                State, local, and tribal governments towards the 
                achievement of each goal described in paragraph (2).
            (2) Goals.--The strategy shall include a description of the 
        process to be used by the Department of Health and Human 
        Services, the Department of Agriculture, and the Department of 
        Homeland Security to achieve the following goals:
                    (A) Preparedness goal.--Enhance the preparedness of 
                the agriculture and food system by--
                            (i) conducting vulnerability assessments of 
                        the agriculture and food system;
                            (ii) mitigating vulnerabilities of the 
                        system;
                            (iii) improving communication and training 
                        relating to the system;
                            (iv) developing and conducting exercises to 
                        test decontamination and disposal plans;
                            (v) developing modeling tools to improve 
                        event consequence assessment and decision 
                        support; and
                            (vi) preparing risk communication tools and 
                        enhancing public awareness through outreach.
                    (B) Detection goal.--Improve agriculture and food 
                system detection capabilities by--
                            (i) identifying contamination in food 
                        products at the earliest possible time; and
                            (ii) conducting surveillance to prevent the 
                        spread of diseases.
                    (C) Emergency response goal.--Ensure an efficient 
                response to agriculture and food emergencies by--
                            (i) immediately investigating animal 
                        disease outbreaks and suspected food 
                        contamination;
                            (ii) preventing additional human illnesses;
                            (iii) organizing, training, and equipping 
                        animal, plant, and food emergency response 
                        teams of--
                                    (I) the Federal Government; and
                                    (II) State, local, and tribal 
                                governments;
                            (iv) designing, developing, and evaluating 
                        training and exercises carried out under 
                        agriculture and food defense plans; and
                            (v) ensuring consistent and organized risk 
                        communication to the public by--
                                    (I) the Federal Government;
                                    (II) State, local, and tribal 
                                governments; and
                                    (III) the private sector.
                    (D) Recovery goal.--Secure agriculture and food 
                production after an agriculture or food emergency by--
                            (i) working with the private sector to 
                        develop business recovery plans to rapidly 
                        resume agriculture and food production;
                            (ii) conducting exercises of the plans 
                        described in subparagraph (C) with the goal of 
                        long-term recovery results;
                            (iii) rapidly removing, and effectively 
                        disposing of--
                                    (I) contaminated agriculture and 
                                food products; and
                                    (II) infected plants and animals; 
                                and
                            (iv) decontaminating and restoring areas 
                        affected by an agriculture or food emergency.

SEC. 110. FOOD AND AGRICULTURE COORDINATING COUNCILS.

    The Secretary of Homeland Security, in consultation with the 
Secretary of Health and Human Services and the Secretary of 
Agriculture, shall within 180 days of enactment of this Act, and 
annually thereafter, submit to the relevant committees of Congress, and 
make publicly available on the Internet Web site of the Department of 
Homeland Security, a report on the activities of the Food and 
Agriculture Government Coordinating Council and the Food and 
Agriculture Sector Coordinating Council, including the progress of such 
Councils on--
            (1) facilitating partnerships between public and private 
        entities to help unify and enhance the protection of the 
        agriculture and food system of the United States;
            (2) providing for the regular and timely interchange of 
        information between each council relating to the security of 
        the agriculture and food system (including intelligence 
        information);
            (3) identifying best practices and methods for improving 
        the coordination among Federal, State, local, and private 
        sector preparedness and response plans for agriculture and food 
        defense; and
            (4) recommending methods by which to protect the economy 
        and the public health of the United States from the effects 
        of--
                    (A) animal or plant disease outbreaks;
                    (B) food contamination; and
                    (C) natural disasters affecting agriculture and 
                food.

SEC. 111. AUTHORITY TO COLLECT FEES.

    (a) Fees for Reinspection, Recall, and Importation Activities.--
Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is amended by 
inserting after section 742 the following:

                     ``PART 6--FEES RELATED TO FOOD

``SEC. 743. AUTHORITY TO COLLECT AND USE FEES.

    ``(a) In General.--
            ``(1) Purpose and authority.--For fiscal year 2010 and each 
        subsequent fiscal year, the Secretary shall, in accordance with 
        this section, assess and collect fees from--
                    ``(A) each domestic facility (as defined in section 
                415(b)) subject to a reinspection in such fiscal year, 
                to cover reinspection-related costs for such year;
                    ``(B) each domestic facility (as defined in section 
                415(b)) and importer subject to a food recall in such 
                fiscal year, to cover food recall activities performed 
                by the Secretary, including technical assistance, 
                follow-up effectiveness checks, and public 
                notifications, for such year;
                    ``(C) each importer participating in the voluntary 
                qualified importer program under section 806 in such 
                year, to cover the administrative costs such program 
                for such year; and
                    ``(D) each importer subject to a reinspection in 
                such fiscal year at a port of entry, to cover 
                reinspection-related costs at ports of entry for such 
                year.
            ``(2) Definitions.--For purposes of this section--
                    ``(A) the term `reinspection' means--
                            ``(i) with respect to domestic facilities 
                        (as defined in section 415(b)), 1 or more 
                        inspections conducted under section 704 
                        subsequent to an inspection conducted under 
                        such provision which identified noncompliance 
                        materially related to a food safety requirement 
                        of this Act, specifically to determine whether 
                        compliance has been achieved to the Secretary's 
                        satisfaction; and
                            ``(ii) with respect to importers, 1 or more 
                        examinations conducted under section 801 
                        subsequent to an examination conducted under 
                        such provision which identified noncompliance 
                        materially related to a food safety requirement 
                        of this Act, specifically to determine whether 
                        compliance has been achieved to the Secretary's 
                        satisfaction; and
                    ``(B) the term `reinspection-related costs' means 
                all expenses, including administrative expenses, 
                incurred in connection with--
                            ``(i) arranging, conducting, and evaluating 
                        the results of reinspections; and
                            ``(ii) assessing and collecting 
                        reinspection fees under this section.
    ``(b) Establishment of Fees.--
            ``(1) In general.--Subject to subsections (c) and (d), the 
        Secretary shall establish the fees to be collected under this 
        section for each fiscal year specified in subsection (a)(1), 
        based on the methodology described under paragraph (2), and 
        shall publish such fees in a Federal Register notice not later 
        than 60 days before the start of each such year.
            ``(2) Fee methodology.--
                    ``(A) Fees.--Fees amounts established for 
                collection--
                            ``(i) under subparagraph (A) of subsection 
                        (a)(1) for a fiscal year shall be based on the 
                        Secretary's estimate of 100 percent of the 
                        costs of the reinspection-related activities 
                        (including by type or level of reinspection 
                        activity, as the Secretary determines 
                        applicable) described in such subparagraph (A) 
                        for such year;
                            ``(ii) under subparagraph (B) of subsection 
                        (a)(1) for a fiscal year shall be based on the 
                        Secretary's estimate of 100 percent of the 
                        costs of the activities described in such 
                        subparagraph (B) for such year;
                            ``(iii) under subparagraph (C) of 
                        subsection (a)(1) for a fiscal year shall be 
                        based on the Secretary's estimate of 100 
                        percent of the costs of the activities 
                        described in such subparagraph (C) for such 
                        year; and
                            ``(iv) under subparagraph (D) of subsection 
                        (a)(1) for a fiscal year shall be based on the 
                        Secretary's estimate of 100 percent of the 
                        costs of the activities described in such 
                        subparagraph (D) for such year.
                    ``(B) Other considerations.--
                            ``(i) Voluntary qualified importer 
                        program.--
                                    ``(I) Participation.--In 
                                establishing the fee amounts under 
                                subparagraph (A)(iii) for a fiscal 
                                year, the Secretary shall provide for 
                                the number of importers who have 
                                submitted to the Secretary a notice 
                                under section 806 informing the 
                                Secretary of the intent of such 
                                importer to participate in the program 
                                under section 806 in such fiscal year.
                                    ``(II) Recoupment.--In establishing 
                                the fee amounts under subparagraph 
                                (A)(iii) for the first 5 fiscal years 
                                after the date of enactment of this 
                                section, the Secretary shall include in 
                                such fee a reasonable surcharge that 
                                provides a recoupment of the costs 
                                expended by the Secretary to establish 
                                and implement the first year of the 
                                program under section 806.
                            ``(ii) Crediting of fees.--In establishing 
                        the fee amounts under subparagraph (A) for a 
                        fiscal year, the Secretary shall provide for 
                        the crediting of fees from the previous year to 
                        the next year if the Secretary overestimated 
                        the amount of fees needed to carry out such 
                        activities, and consider the need to account 
                        for any adjustment of fees and such other 
                        factors as the Secretary determines 
                        appropriate.
            ``(3) Use of fees.--The Secretary shall make all of the 
        fees collected pursuant to clause (i), (ii), (iii), and (iv) of 
        paragraph (2)(A) available solely to pay for the costs referred 
        to in such clause (i), (ii), (iii), and (iv) of paragraph 
        (2)(A), respectively.
            ``(4) Compliance with international agreements.--Nothing in 
        this section shall be construed to authorize the assessment of 
        any fee inconsistent with the agreement establishing the World 
        Trade Organization or any other treaty or international 
        agreement to which the United States is a party.
    ``(c) Limitations.--
            ``(1) In general.--Fees under subsection (a) shall be 
        refunded for a fiscal year beginning after fiscal year 2010 
        unless appropriations for the Center for Food Safety and 
        Applied Nutrition and the Center for Veterinary Medicine and 
        related activities of the Office of Regulatory Affairs at 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 Center 
        for Food Safety and Applied Nutrition and the Center for 
        Veterinary Medicine and related activities of the Office of 
        Regulatory Affairs at the Food and Drug Administration for the 
        preceding fiscal year (excluding the amount of fees 
        appropriated for such fiscal year) multiplied by 1 plus 4.5 
        percent.
            ``(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, under subsection (a), notwithstanding the provisions of 
        subsection (a) relating to the date fees are to be paid.
            ``(3) Limitation on amount of certain fees.--
                    ``(A) In general.--Notwithstanding any other 
                provision of this section and subject to subparagraph 
                (B), the Secretary may not collect fees in a fiscal 
                year such that the amount collected--
                            ``(i) under subparagraph (B) of subsection 
                        (a)(1) exceeds $20,000,000; and
                            ``(ii) under subparagraphs (A) and (D) of 
                        subsection (a)(1) exceeds $25,000,000 combined.
                    ``(B) Exception.--If a domestic facility (as 
                defined in section 415(b)) or an importer becomes 
                subject to a fee described in subparagraph (A), (B), or 
                (D) of subsection (a)(1) after the maximum amount of 
                fees has been collected by the Secretary under 
                subparagraph (A), the Secretary may collect a fee from 
                such facility or importer.
    ``(d) Crediting and Availability of Fees.--Fees authorized under 
subsection (a) shall be collected and available for obligation only to 
the extent and in the amount provided 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 account without fiscal year limitation to such 
appropriation account for salaries and expenses with such fiscal year 
limitation. The sums transferred shall be available solely for the 
purpose of paying the operating expenses of the Food and Drug 
Administration employees and contractors performing activities 
associated with these food safety fees.
    ``(e) Collection of Fees.--
            ``(1) In general.--The Secretary shall specify in the 
        Federal Register notice described in subsection (b)(1) the time 
        and manner in which fees assessed under this section shall be 
        collected.
            ``(2) Collection of unpaid fees.--In any case where the 
        Secretary does not receive payment of a fee assessed under this 
        section within 30 days after it is due, such fee shall be 
        treated as a claim of the United States Government subject to 
        provisions of subchapter II of chapter 37 of title 31, United 
        States Code.
    ``(f) Annual Report to Congress.--Not later than 120 days after 
each fiscal year for which fees are assessed under this section, the 
Secretary shall submit a report to the Committee on Health, Education, 
Labor, and Pensions of the United States Senate and the Committee on 
Energy and Commerce of the United States House of Representatives, to 
include a description of fees assessed and collected for each such year 
and a summary description of the entities paying such fees and the 
types of business in which such entities engage.
    ``(g) Authorization of Appropriations.--For fiscal year 2010 and 
each fiscal year thereafter, there is authorized to be appropriated for 
fees under this section an amount equal to the total revenue amount 
determined under subsection (b) for the fiscal year, as adjusted or 
otherwise affected under the other provisions of this section.''.
    (b) Export Certification Fees for Foods and Animal Feed.--
            (1) Authority for export certifications for food, including 
        animal feed.--Section 801(e)(4)(A) (21 U.S.C. 381(e)(4)(A)) is 
        amended--
                    (A) in the matter preceding clause (i), by striking 
                ``a drug'' and inserting ``a food, drug'';
                    (B) in clause (i), by striking ``exported drug'' 
                and inserting ``exported food, drug''; and
                    (C) in clause (ii), by striking ``the drug'' each 
                place it appears and inserting ``the food, drug''.
            (2) Clarification of certification.--Section 801(e)(4) (21 
        U.S.C. 381(e)(4)) is amended by inserting after subparagraph 
        (B) the following new subparagraph:
                    ``(C) For purposes of this paragraph, a 
                certification by the Secretary shall be made on such 
                basis, and in such form (including a publicly available 
                listing) as the Secretary determines appropriate.''.

                  TITLE II--DETECTION AND SURVEILLANCE

SEC. 201. RECOGNITION OF LABORATORY ACCREDITATION FOR ANALYSES OF 
              FOODS.

    (a) In General.--Chapter IV (21 U.S.C. 341 et seq.), as amended by 
section 107, is amended by adding at the end the following:

``SEC. 422. RECOGNITION OF LABORATORY ACCREDITATION FOR ANALYSES OF 
              FOODS.

    ``(a) Recognition of Laboratory Accreditation.--
            ``(1) In general.--Not later than 2 years after the date of 
        enactment of this section, the Secretary shall--
                    ``(A) provide for the recognition of accreditation 
                bodies that accredit laboratories, including 
                laboratories run and operated by a State or locality, 
                with a demonstrated capability to conduct analytical 
                testing of food products; and
                    ``(B) establish a publicly available registry of 
                accreditation bodies, including the name of, contact 
                information for, and other information deemed necessary 
                by the Secretary about such bodies.
            ``(2) Model accreditation standards.--The Secretary shall 
        develop model standards that an accreditation body shall 
        require laboratories to meet in order to be included in the 
        registry provided for under paragraph (1). In developing the 
        model standards, the Secretary shall look to existing standards 
        for guidance. The model standards shall include methods to 
        ensure that--
                    ``(A) appropriate sampling and analytical 
                procedures are followed and reports of analyses are 
                certified as true and accurate;
                    ``(B) internal quality systems are established and 
                maintained;
                    ``(C) procedures exist to evaluate and respond 
                promptly to complaints regarding analyses and other 
                activities for which the laboratory is recognized;
                    ``(D) individuals who conduct the analyses are 
                qualified by training and experience to do so; and
                    ``(E) any other criteria determined appropriate by 
                the Secretary.
            ``(3) Review of accreditation.--To assure compliance with 
        the requirements of this section, the Secretary shall--
                    ``(A) periodically, or at least every 5 years, 
                reevaluate accreditation bodies recognized under 
                paragraph (1); and
                    ``(B) promptly revoke the recognition of any 
                accreditation body found not to be in compliance with 
                the requirements of this section.
    ``(b) Testing Procedures.--Food testing shall be conducted by 
either Federal laboratories or non-Federal laboratories that have been 
accredited by an accreditation body on the registry established by the 
Secretary under subsection (a) whenever such testing--
            ``(1) is either conducted by or on behalf of an owner or 
        consignee--
                    ``(A) in support of admission of an article of food 
                under section 801(a); or
                    ``(B) under an Import Alert that requires 
                successful consecutive tests; or
            ``(2) is required by the Secretary as the Secretary deems 
        appropriate to identify or address a threat of serious adverse 
        health consequences or death to humans or animals.
The results of any such testing shall be sent directly to the Food and 
Drug Administration.
    ``(c) Review by Secretary.--If food testing performed by a 
laboratory run and operated by a State or locality that is accredited 
by an accreditation body on the registry established by the Secretary 
under subsection (a) result in a State recalling a food, the Secretary 
shall review the testing results for the purpose of determining the 
need for a national recall or other compliance and enforcement 
activities.''.
    (b) Food Emergency Response Network.--The Secretary, in 
coordination with the Secretary of Agriculture, the Secretary of 
Homeland Security, and State, local, and tribal governments shall, not 
later than 180 days after the date of enactment of this Act, and 
biennially thereafter, submit to the relevant committees of Congress, 
and make publicly available on the Internet Web site of the Department 
of Health and Human Services, a report on the progress in implementing 
a national food emergency response laboratory network that--
            (1) provides ongoing surveillance, rapid detection, and 
        surge capacity for large-scale food-related emergencies, 
        including intentional adulteration of the food supply;
            (2) coordinates the food laboratory capacities of State 
        food laboratories, including the sharing of data between State 
        laboratories to develop national situational awareness;
            (3) provides accessible, timely, accurate, and consistent 
        food laboratory services throughout the United States;
            (4) develops and implements a methods repository for use by 
        Federal, State, and local officials;
            (5) responds to food-related emergencies; and
            (6) is integrated with relevant laboratory networks 
        administered by other Federal agencies.

SEC. 202. INTEGRATED CONSORTIUM OF LABORATORY NETWORKS.

    (a) In General.--The Secretary of Homeland Security, in 
consultation with the Secretary of Health and Human Services, the 
Secretary of Agriculture, and the Administrator of the Environmental 
Protection Agency, shall maintain an agreement through which relevant 
laboratory network members, as determined by the Secretary of Homeland 
Security, shall--
            (1) agree on common laboratory methods in order to 
        facilitate the sharing of knowledge and information relating to 
        animal health, agriculture, and human health;
            (2) identify the means by which each laboratory network 
        member could work cooperatively--
                    (A) to optimize national laboratory preparedness; 
                and
                    (B) to provide surge capacity during emergencies; 
                and
            (3) engage in ongoing dialogue and build relationships that 
        will support a more effective and integrated response during 
        emergencies.
    (b) Reporting Requirement.--The Secretary of Homeland Security 
shall, on a biennial basis, submit to the relevant committees of 
Congress, and make publicly available on the Internet Web site of the 
Department of Homeland Security, a report on the progress of the 
integrated consortium of laboratory networks, as established under 
subsection (a), in carrying out this section.

SEC. 203. BUILDING DOMESTIC CAPACITY.

    (a) In General.--
            (1) Initial report.--The Secretary shall, not later than 2 
        years after the date of enactment of this Act, submit to 
        Congress a comprehensive report that identifies programs and 
        practices that are intended to promote the safety and security 
        of food and to prevent outbreaks of food-borne illness and 
        other food-related hazards that can be addressed through 
        preventive activities. Such report shall include a description 
        of the following:
                    (A) Analysis of the need for regulations or 
                guidance to industry.
                    (B) Outreach to food industry sectors, including 
                through the Food and Agriculture Coordinating Councils 
                referred to in section 111, to identify potential 
                sources of emerging threats to the safety and security 
                of the food supply and preventive strategies to address 
                those threats.
                    (C) Systems to ensure the prompt distribution to 
                the food industry of information and technical 
                assistance concerning preventive strategies.
                    (D) Communication systems to ensure that 
                information about specific threats to the safety and 
                security of the food supply are rapidly and effectively 
                disseminated.
                    (E) Surveillance systems and laboratory networks to 
                rapidly detect and respond to food-borne illness 
                outbreaks and other food-related hazards, including how 
                such systems and networks are integrated.
                    (F) Outreach, education, and training provided to 
                States to build State food safety and food defense 
                capabilities, including progress implementing 
                strategies developed under sections 109 and 205.
                    (G) The estimated resources needed to effectively 
                implement the programs and practices identified in the 
                report developed in this section over a 5-year period.
            (2) Biennial reports.--On a biennial basis following the 
        submission of the report under paragraph (1), the Secretary 
        shall submit to Congress a report that--
                    (A) reviews previous food safety programs and 
                practices;
                    (B) outlines the success of those programs and 
                practices;
                    (C) identifies future programs and practices; and
                    (D) includes information related to any matter 
                described in subparagraphs (A) through (G) of paragraph 
                (1), as necessary.
    (b) Risk-Based Activities.--The report developed under subsection 
(a)(1) shall describe methods that seek to ensure that resources 
available to the Secretary for food safety-related activities are 
directed at those actions most likely to reduce risks from food, 
including the use of preventive strategies and allocation of inspection 
resources. The Secretary shall promptly undertake those risk-based 
actions that are identified during the development of the report as 
likely to contribute to the safety and security of the food supply.
    (c) Capability for Laboratory Analyses; Research.--The report 
developed under subsection (a)(1) shall provide a description of 
methods to increase capacity to undertake analyses of food samples 
promptly after collection, to identify new and rapid analytical 
techniques, including techniques that can be employed at ports of entry 
and through Food Emergency Response Network laboratories, and to 
provide for well-equipped and staffed laboratory facilities.
    (d) Information Technology.--The report developed under subsection 
(a)(1) shall include a description of such information technology 
systems as may be needed to identify risks and receive data from 
multiple sources, including foreign governments, State, local, and 
tribal governments, other Federal agencies, the food industry, 
laboratories, laboratory networks, and consumers. The information 
technology systems that the Secretary describes shall also provide for 
the integration of the facility registration system under section 415 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), and the 
prior notice system under section 801(m) of such Act (21 U.S.C. 381(m)) 
with other information technology systems that are used by the Federal 
Government for the processing of food offered for import into the 
United States.
    (e) Automated Risk Assessment.--The report developed under 
subsection (a)(1) shall include a description of progress toward 
developing and improving an automated risk assessment system for food 
safety surveillance and allocation of resources.
    (f) Traceback and Surveillance Report.--The Secretary shall include 
in the report developed under subsection (a)(1) an analysis of the Food 
and Drug Administration's performance in food-borne illness outbreaks 
during the 5-year period preceding the date of enactment of this Act 
involving fruits and vegetables that are raw agricultural commodities 
(as defined in section 201(r) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321(r))) and recommendations for enhanced surveillance, 
outbreak response, and traceability. Such findings and recommendations 
shall address communication and coordination with the public and 
industry, outbreak identification, and traceback.
    (g) Biennial Food Safety and Food Defense Research Plan.--The 
Secretary and the Secretary of Agriculture shall, on a biennial basis, 
submit to Congress a joint food safety and food defense research plan 
which may include studying the long-term health effects of food-borne 
illness. Such biennial plan shall include a list and description of 
projects conducted during the previous 2-year period and the plan for 
projects to be conducted during the following 2-year period.

SEC. 204. ENHANCING TRACEBACK AND RECORDKEEPING.

    (a) In General.--The Secretary, in consultation with the Secretary 
of Agriculture and representatives of State departments of health and 
agriculture, shall improve the capacity of the Secretary to effectively 
and rapidly track and trace, in the event of an outbreak, fruits and 
vegetables that are raw agricultural commodities.
    (b) Pilot Project.--
            (1) In general.--Not later than 12 months after the date of 
        enactment of this Act, the Secretary shall establish a pilot 
        project in coordination with the produce industry to explore 
        and evaluate new methods for rapidly and effectively tracking 
        and tracing fruits and vegetables that are raw agricultural 
        commodities so that, if an outbreak occurs involving such a 
        fruit or vegetable, the Secretary may quickly identify the 
        source of the outbreak and the recipients of the contaminated 
        food.
            (2) Content.--The Secretary shall select participants from 
        the produce industry to run projects which overall shall 
        include at least 3 different types of fruits or vegetables that 
        have been the subject of outbreaks during the 10-year period 
        preceding the date of enactment of this Act, and shall be 
        selected in order to develop and demonstrate--
                    (A) methods that are applicable and appropriate for 
                small businesses; and
                    (B) technologies, including existing technologies, 
                that enhance traceback and trace forward.
    (c) Report.--Not later than 18 months after the date of enactment 
of this Act, the Secretary shall report to Congress on the findings of 
the pilot project under subsection (b) together with recommendations 
for establishing more effective traceback and trace forward procedures 
for fruits and vegetables that are raw agricultural commodities.
    (d) Traceback Performance Requirements.--Not later than 24 months 
after the date of enactment of this Act, the Secretary shall publish a 
notice of proposed rulemaking to establish standards for the type of 
information, format, and timeframe for persons to submit records to aid 
the Secretary in effectively and rapidly tracking and tracing, in the 
event of an outbreak, fruits and vegetables that are raw agricultural 
commodities. Nothing in this section shall be construed as giving the 
Secretary the authority to prescribe specific technologies for the 
maintenance of records.
    (e) Public Input.--During the comment period in the notice of 
proposed rulemaking under subsection (d), the Secretary shall conduct 
not less than 3 public meetings in diverse geographical areas of the 
United States to provide persons in different regions an opportunity to 
comment.
    (f) Raw Agricultural Commodity.--In this section, the term ``raw 
agricultural commodity'' has the meaning given that term in section 
201(r) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(r)).

SEC. 205. 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.--
            (1) In general.--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--
                    (A) 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;
                    (B) 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;
                    (C) ensuring early notification to the affected 
                food industry when a particular food may be suspected 
                in the outbreak and sharing of all relevant data with 
                the affected food industry during the course of the 
                investigation;
                    (D) developing improved epidemiological tools for 
                obtaining quality exposure data, and microbiological 
                methods for classifying cases;
                    (E) augmenting such systems to improve attribution 
                of a food-borne illness outbreak to a specific food;
                    (F) expanding capacity of such systems, including 
                working toward automatic electronic searches, for 
                implementation of fingerprinting strategies for food-
                borne infectious agents, in order to identify new or 
                rarely documented causes of food-borne illness and 
                submit standardized information to a centralized 
                database;
                    (G) allowing timely public access to aggregated, 
                de-identified surveillance data;
                    (H) at least annually, publishing current reports 
                on findings from such systems;
                    (I) establishing a flexible mechanism for rapidly 
                initiating scientific research by academic 
                institutions;
                    (J) integrating food-borne illness surveillance 
                systems and data with other biosurveillance and public 
                health situational awareness capabilities at the state 
                and federal levels; and
                    (K) other activities as determined appropriate by 
                the Secretary.
            (2) Advisory group on improving foodborne illness 
        surveillance and outbreak investigations.--
                    (A) In general.--The Secretary shall support and 
                maintain a diverse working group of experts and 
                stakeholders from Federal, State, and local food safety 
                and health agencies, the food industry, consumer 
                organizations, and academia. Such working group shall 
                provide the Secretary, through at least annual meetings 
                of the working group and an annual public report, 
                advice and recommendations on an ongoing and regular 
                basis regarding the improvement of food-borne illness 
                surveillance, outbreak investigation, and 
                implementation of this section, including advice and 
                recommendations on--
                            (i) the priority needs of regulatory 
                        agencies, the food industry, and consumers for 
                        information and analysis on food-borne illness 
                        and its causes;
                            (ii) the priority needs of regulatory 
                        agencies, the food industry, and consumers for 
                        information and analysis on outbreak 
                        investigations that can be used to improve the 
                        line of authority and accountability;
                            (iii) opportunities to improve the 
                        effectiveness of initiatives at the Federal, 
                        State, and local levels, including coordination 
                        and integration of activities among Federal 
                        agencies, and between the Federal, State, and 
                        local levels of government;
                            (iv) improvement in the timeliness and 
                        depth of access by regulatory and health 
                        agencies, the food industry, academic 
                        researchers, and consumers to food-borne 
                        illness surveillance data and food recall 
                        survey data collected by government agencies at 
                        all levels, including data compiled by the 
                        Centers for Disease Control and Prevention;
                            (v) key barriers to improvement in food-
                        borne illness surveillance and its utility for 
                        preventing food-borne illness at Federal, 
                        State, and local levels;
                            (vi) the capabilities needed for 
                        establishing automatic electronic searches of 
                        surveillance data; and
                            (vii) specific actions to reduce barriers 
                        to improvement, implement the working group's 
                        recommendations, and achieve the purposes of 
                        this section, with measurable objectives and 
                        timelines, and identification of resource and 
                        staffing needs.
            (3) Additional duties.--The Secretary shall also utilize 
        the working group under paragraph (1) to assist in outbreak 
        investigations as deemed appropriate.
    (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 
                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.
                    (F) Strengthen the capacity of State and local 
                agencies to achieve the goals described in section 109.
            (2) Review.--In developing of 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.
    (d) Food Safety Capacity Building Grants.--Section 317R(b) of the 
Public Health Service Act (42 U.S.C. 247b-20(b)) is amended--
            (1) by striking ``2002'' and inserting ``2010''; and
            (2) by striking ``2003 through 2006'' and inserting ``2011 
        through 2014''.

            TITLE III--SPECIFIC PROVISIONS FOR IMPORTED FOOD

SEC. 301. FOREIGN SUPPLIER VERIFICATION PROGRAM.

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

``SEC. 805. FOREIGN SUPPLIER VERIFICATION PROGRAM.

    ``(a) In General.--
            ``(1) Verification requirement.--Each United States 
        importer of record shall perform risk-based foreign supplier 
        verification activities in accordance with regulations 
        promulgated under subsection (c) for the purpose of verifying 
        that the food imported by the importer of record or its agent 
        is--
                    ``(A) produced in compliance with the requirements 
                of section 419 or 420, as appropriate; and
                    ``(B) is not adulterated under section 402 or 
                misbranded under section 403(w).
            ``(2) Importer exclusion.--For purposes of this section, an 
        `importer of record' shall not include a person holding a valid 
        license under section 641 of the Tariff Act of 1930 (19 U.S.C. 
        1641) (referred to as a `customs broker') if the customs broker 
        has executed a written agreement with another person who has 
        agreed to comply with the requirements of this section with 
        regard to food imported or offered for import by the customs 
        broker.
    ``(b) Guidance.--Not later than 270 days after the date of the 
enactment of this section, the Secretary shall issue guidance to assist 
United States importers of record in developing foreign supplier 
verification programs.
    ``(c) Regulations.--
            ``(1) In general.--Not later than 1 year after issuing 
        guidance under subsection (b), the Secretary shall promulgate 
        regulations to provide for the content of the foreign supplier 
        verification program established under subsection (a). Such 
        regulations shall, as appropriate, include a process for 
        verification by a United States importer of record, with 
        respect to each foreign supplier from which it obtains food, 
        that the imported food is produced in compliance with the 
        requirements of section 419 or 420, as appropriate, and is not 
        adulterated under section 402 or misbranded under section 
        403(w).
            ``(2) Verification.--The regulations under paragraph (1) 
        shall require that the foreign supplier verification program of 
        each importer of record be adequate to provide assurances that 
        each foreign supplier to the importer of record produces the 
        imported food employing processes and procedures, including 
        risk-based reasonably appropriate preventive controls, that are 
        documented in a written plan under subsection (d) and 
        equivalent in preventing adulteration and reducing hazards as 
        those required by section 419 or section 420, as appropriate.
            ``(3) Activities.--Verification activities under a foreign 
        supplier verification program under this section may include 
        monitoring records for shipments, lot-by-lot certification of 
        compliance, annual on-site inspections, checking the hazard 
        analysis and risk-based preventive control plan of the foreign 
        supplier, and periodically testing and sampling shipments.
    ``(d) Record Maintenance and Access.--Each facility required to be 
registered under section 415 that is, as determined by the Secretary, a 
high-risk facility shall submit to the Secretary a written plan that 
documents and describes its hazard analysis and preventative control 
procedures. The Secretary or a duly authorized representative of the 
Secretary may review the plan and may make recommendations to improve 
the effectiveness of the plan in preventing or minimizing the threat of 
serious adverse health consequences or death to humans or animals. 
Records of all United States importers related to a foreign supplier 
verification program shall be maintained for a period of not less than 
2 years and shall be made available promptly to a duly authorized 
representative of the Secretary upon request.
    ``(e) Deemed Compliance of Seafood, Juice, and Low-Acid Canned Food 
Facilities in Compliance With HACCP.--An owner, operator, or agent in 
charge of a facility required to comply with 1 of the following 
standards and regulations with respect to such facility shall be deemed 
to be in compliance with this section with respect to such facility:
            ``(1) The Seafood Hazard Analysis Critical Control Points 
        Program of the Food and Drug Administration.
            ``(2) The Juice Hazard Analysis Critical Control Points 
        Program of the Food and Drug Administration.
            ``(3) The Thermally Processed Low-Acid Foods Packaged in 
        Hermetically Sealed Containers standards of the Food and Drug 
        Administration (or any successor standards).
    ``(f) Publication of List of Participants.--The Secretary shall 
publish and maintain on the Internet Web site of the Food and Drug 
Administration a current list that includes the name of, location of, 
and other information deemed necessary by the Secretary about, 
importers participating under this section.''.
    (b) Prohibited Act.--Section 301 (21 U.S.C. 331), as amended by 
section 106, is amended by adding at the end the following:
    ``(rr) The importation or offering for importation of a food if the 
importer of record does not have in place a foreign supplier 
verification program in compliance with section 805.''.
    (c) Imports.--Section 801(a) (21 U.S.C. 381(a)) is amended by 
adding ``or the importer of record is in violation of section 805'' 
after ``or in violation of section 505''.
    (d) Effective Date.--The amendments made by this section shall take 
effect 2 years after the date of enactment of this Act.

SEC. 302. VOLUNTARY QUALIFIED IMPORTER PROGRAM.

    Chapter VIII (21 U.S.C. 381 et seq.), as amended by section 301, is 
amended by adding at the end the following:

``SEC. 806. VOLUNTARY QUALIFIED IMPORTER PROGRAM.

    ``(a) In General.--Beginning not later than 1 year after the date 
of enactment of this section, the Secretary shall--
            ``(1) establish a program, in consultation with the 
        Department of Homeland Security, to provide for the expedited 
        review and importation of food offered for importation by 
        United States importers who have voluntarily agreed to 
        participate in such program; and
            ``(2) issue a guidance document related to participation 
        and compliance with such program.
    ``(b) Voluntary Participation.--An importer may request the 
Secretary to provide for the expedited review and importation of 
designated foods in accordance with the program procedures established 
by the Secretary.
    ``(c) Eligibility.--In order to be eligible, an importer shall be 
offering food for importation from a facility that has a certification 
described in section 809(b). In reviewing the applications and making 
determinations on such requests, the Secretary shall consider the risk 
of the food to be imported based on factors, such as the following:
            ``(1) The nature of the food to be imported.
            ``(2) The compliance history of the foreign supplier.
            ``(3) The capability of the regulatory system of the 
        country of export to ensure compliance with United States food 
        safety standards.
            ``(4) The compliance of the importer with the requirements 
        of section 805.
            ``(5) The recordkeeping, testing, inspections and audits of 
        facilities, traceability of articles of food, temperature 
        controls, and sourcing practices of the importer.
            ``(6) The potential risk for intentional adulteration of 
        the food.
            ``(7) Any other factor that the Secretary determines 
        appropriate.
    ``(d) Review and Revocation.--Any importer qualified by the 
Secretary in accordance with the eligibility criteria set forth in this 
section shall be reevaluated not less often than once every 3 years and 
the Secretary shall promptly revoke the qualified importer status of 
any importer found not to be in compliance with such criteria.
    ``(e) Definition.--For purposes of this section, the term 
`importer' means the person that brings food, or causes food to be 
brought, from a foreign country into the customs territory of the 
United States.''.

SEC. 303. AUTHORITY TO REQUIRE IMPORT CERTIFICATIONS FOR FOOD.

    (a) In General.--Section 801(a) (21 U.S.C. 381(a)) is amended by 
inserting after the third sentence the following: ``With respect to an 
article of food, if importation of such food is subject to, but not 
compliant with, the requirement under subsection (p) that such food be 
accompanied by a certification or other assurance that the food meets 
some or all applicable requirements of this Act, then such article 
shall be refused admission.''.
    (b) Addition of Certification Requirement.--Section 801 (21 U.S.C. 
381) is amended by adding at the end the following new subsection:
    ``(p) Certifications Concerning Imported Foods.--
            ``(1) In general.--The Secretary, based on public health 
        considerations, including risks associated with the food or its 
        place of origin, may require as a condition of granting 
        admission to an article of food imported or offered for import 
        into the United States, that an entity specified in paragraph 
        (2) provide a certification or such other assurances as the 
        Secretary determines appropriate that the article of food 
        complies with some or all applicable requirements of this Act, 
        as specified by the Secretary. Such certification or assurances 
        may be provided in the form of shipment-specific certificates, 
        a listing of certified entities, or in such other form as the 
        Secretary may specify. Such certification shall be used for 
        designated food imported from countries with which the Food and 
        Drug Administration has an agreement to establish a 
        certification program.
            ``(2) Certifying entities.--For purposes of paragraph (1), 
        entities that shall provide the certification or assurances 
        described in such paragraph are--
                    ``(A) an agency or a representative of the 
                government of the country from which the article of 
                food at issue originated, as designated by such 
                government or the Secretary; or
                    ``(B) such other persons or entities accredited 
                pursuant to section 809 to provide such certification 
                or assurance.
            ``(3) Renewal and refusal of certifications.--The Secretary 
        may--
                    ``(A) require that any certification or other 
                assurance provided by an entity specified in paragraph 
                (2) be renewed by such entity at such times as the 
                Secretary determines appropriate; and
                    ``(B) refuse to accept any certification or 
                assurance if the Secretary determines that such 
                certification or assurance is no longer valid or 
                reliable.
            ``(4) Electronic submission.--The Secretary shall provide 
        for the electronic submission of certifications under this 
        subsection.''.
    (c) Conforming Technical Amendment.--Section 801(b) (21 U.S.C. 
381(b)) is amended in the second sentence by striking ``with respect to 
an article included within the provision of the fourth sentence of 
subsection (a)'' and inserting ``with respect to an article described 
in subsection (a) relating to the requirements of sections 760 or 
761,''.
    (d) No Limit on Authority.--Nothing in the amendments made by this 
section shall limit the authority of the Secretary to conduct random 
inspections of imported food or to take such other steps as the 
Secretary deems appropriate to determine the admissibility of imported 
food.

SEC. 304. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.

    (a) In General.--Section 801(m)(1) (21 U.S.C. 381(m)(1)) is amended 
by inserting ``any country to which the article has been refused 
entry;'' after ``the country from which the article is shipped;''.
    (b) Regulations.--Not later than 120 days after the date of 
enactment of this Act, the Secretary shall issue an interim final rule 
amending subpart I of part 1 of title 21, Code of Federal Regulations, 
to implement the amendment made by this section.
    (c) Effective Date.--The amendment made by this section shall take 
effect 180 days after the date of enactment of this Act.

SEC. 305. REVIEW OF A REGULATORY AUTHORITY OF A FOREIGN COUNTRY.

    Chapter VIII (21 U.S.C. 381 et seq.), as amended by section 302, is 
amended by adding at the end the following:

``SEC. 807. REVIEW OF A REGULATORY AUTHORITY OF A FOREIGN COUNTRY.

    ``The Secretary may review information from a country outlining the 
statutes, regulations, standards, and controls of such country, and 
conduct on-site audits in such country to verify the implementation of 
those statutes, regulations, standards, and controls. Based on such 
review, the Secretary shall determine whether such country can provide 
reasonable assurances that the food supply of the country is equivalent 
in safety to food manufactured, processed, packed, or held in the 
United States.''.

SEC. 306. BUILDING CAPACITY OF FOREIGN GOVERNMENTS WITH RESPECT TO 
              FOOD.

    (a) In General.--The Secretary shall, not later than 2 years of the 
date of enactment of this Act, develop a comprehensive plan to expand 
the technical, scientific, and regulatory capacity of foreign 
governments, and their respective food industries, from which foods are 
exported to the United States.
    (b) Consultation.--In developing the plan under subsection (a), the 
Secretary shall consult with the Secretary of Agriculture, Secretary of 
State, Secretary of the Treasury, and the Secretary of Commerce, 
representatives of the food industry, appropriate foreign government 
officials, and nongovernmental organizations that represent the 
interests of consumers, and other stakeholders.
    (c) Plan.--The plan developed under subsection (a) shall include, 
as appropriate, the following:
            (1) Recommendations for bilateral and multilateral 
        arrangements and agreements, including provisions to provide 
        for responsibility of exporting countries to ensure the safety 
        of food.
            (2) Provisions for electronic data sharing.
            (3) Provisions for mutual recognition of inspection 
        reports.
            (4) Training of foreign governments and food producers on 
        United States requirements for safe food.
            (5) Recommendations to harmonize requirements under the 
        Codex Alimentarius.
            (6) Provisions for the multilateral acceptance of 
        laboratory methods and detection techniques.

SEC. 307. INSPECTION OF FOREIGN FOOD FACILITIES.

    Chapter VIII (21 U.S.C. 381 et seq.), as amended by section 305, is 
amended by inserting at the end the following:

``SEC. 808. INSPECTION OF FOREIGN FOOD FACILITIES.

    ``(a) Inspection.--The Secretary--
            ``(1) may enter into arrangements and agreements with 
        foreign governments to facilitate the inspection of foreign 
        facilities registered under section 415; and
            ``(2) shall direct resources to inspections of foreign 
        facilities, suppliers, and food types, especially such 
        facilities, suppliers, and food types that present a high risk 
        (as identified by the Secretary), to help ensure the safety and 
        security of the food supply of the United States.
    ``(b) Effect of Inability To Inspect.--Notwithstanding any other 
provision of law, food shall be refused admission into the United 
States if it is from a foreign facility registered under section 415 of 
which the owner, operator, or agent in charge of the facility, or the 
government of the foreign country, refuses to permit entry of United 
States inspectors, upon request, to inspect such facility. For purposes 
of this subsection, such an owner, operator, or agent in charge shall 
be considered to have refused an inspection if such owner, operator, or 
agent in charge refuses such a request to inspect a facility more than 
48 hours after such request is submitted.''.

SEC. 308. THIRD-PARTY ACCREDITATION OF QUALIFIED AUDITORS AND AUDIT 
              AGENTS.

    Chapter VIII (21 U.S.C. 381 et seq.), as amended by section 307, is 
further amended by adding at the end the following:

``SEC. 809. THIRD-PARTY AUDITORS AND AUDIT AGENTS ACCREDITATION.

    ``(a) Definitions.--In this section:
            ``(1) Accreditation body.--The term `accreditation body' 
        means a recognized authority that performs accreditation of 
        third-party auditors and audit agents.
            ``(2) Audit agent.--The term `audit agent' means an 
        individual who is qualified to conduct food safety audits, and 
        who may be an employee or an agent of a third-party auditor.
            ``(3) Accredited audit agent.--The term `accredited audit 
        agent' means an audit agent accredited by an accreditation body 
        under this section.
            ``(4) Accredited third-party auditor.--The term `accredited 
        third-party auditor' means a third-party auditor accredited by 
        an accreditation body under this section.
            ``(5) Consultative audit.--The term `consultative audit' 
        means an audit of an eligible entity--
                    ``(A) to determine whether such entity is in 
                compliance with the provisions of this Act and with 
                applicable industry standards and practices; and
                    ``(B) the results of which are for internal 
                facility purposes only.
            ``(6) Eligible entity.--The term `eligible entity' means a 
        foreign entity, including foreign facilities registered under 
        section 415, in the food import supply chain that chooses to be 
        audited by an accredited third-party auditor or audit agent.
            ``(7) Regulatory audit.--The term `regulatory audit' means 
        an audit of an eligible entity--
                    ``(A) to determine whether such entity is in 
                compliance with the provisions of this Act; and
                    ``(B) the results of which determine--
                            ``(i) whether an entity is eligible to 
                        receive a certification under section 801(p); 
                        and
                            ``(ii) whether the entity is eligible to 
                        participate in the voluntary qualified importer 
                        program under section 806.
            ``(8) Third-party auditor.--The term `third-party auditor' 
        means a foreign government, foreign cooperative, or any other 
        qualified third party, as the Secretary determines appropriate, 
        that conducts audits of eligible entities to certify that such 
        eligible entities meet the applicable requirements of this 
        section.
    ``(b) System of Accreditation.--
            ``(1) Accreditation bodies.--
                    ``(A) Accreditation bodies recognition.--No later 
                than 2 years after the date of enactment of the Safe 
                Food Enforcement, Assessment, Standards and Targeting 
                Act of 2009, the Secretary shall establish a system for 
                the recognition of accreditation bodies that accredit 
                third-party auditors and audit agents to certify that 
                eligible entities meet the applicable requirements of 
                this Act.
                    ``(B) Notification.--Each accreditation body 
                recognized by the Secretary under this section shall 
                submit to the Secretary a list of all accredited third-
                party auditors and audit agents accredited by such 
                body.
                    ``(C) Revocation of accreditation body 
                recognition.--The Secretary shall promptly revoke the 
                recognition of any accreditation body found not to be 
                in compliance with the requirements of this section.
            ``(2) Model accreditation standards.--The Secretary shall 
        develop model standards, including audit report requirements, 
        and each recognized accreditation body shall ensure that third-
        party auditors and audit agents meet such standards in order to 
        qualify as an accredited third-party auditor or audit agent 
        under this section. In developing the model standards, the 
        Secretary shall look to standards in place on the date of the 
        enactment of this section for guidance, to avoid unnecessary 
        duplication of efforts and costs.
    ``(c) Third-Party Auditors and Audit Agencies.--
            ``(1) Third-party auditor or audit agent accreditation 
        requirements.--
                    ``(A) Foreign governments.--Prior to accrediting a 
                foreign government as an accredited third-party 
                auditor, the accreditation body shall perform such 
                reviews and audits of food safety programs, systems, 
                and standards of the government as the Secretary deems 
                necessary to determine that the foreign government is 
                capable of adequately ensuring that eligible entities 
                certified by such government meet the requirements of 
                this Act with respect to food manufactured, processed, 
                packed, or held for import to the United States.
                    ``(B) Foreign cooperatives and other third 
                parties.--Prior to accrediting a foreign cooperative 
                that aggregates the products of growers or processors, 
                or any other third party that the Secretary determines 
                appropriate to be an accredited third-party auditor or 
                audit agent, the accreditation body shall perform such 
                reviews and audits of the training and qualifications 
                of auditors used by that cooperative or party and 
                conduct such reviews of internal systems and such other 
                investigation of the cooperative or party as the 
                Secretary deems necessary to determine that each 
                eligible entity certified by the cooperative or party 
                has systems and standards in use to ensure that such 
                entity meets the requirements of this Act.
            ``(2) Requirement to issue certification of eligible 
        entities.--
                    ``(A) In general.--An accreditation body may not 
                accredit a third-party auditor or audit agent unless 
                such third-party auditor or audit agent agrees to issue 
                a written and electronic certification to accompany 
                each food shipment for import into the United States 
                from an eligible entity certified by the third-party 
                auditor or audit agent, subject to requirements set 
                forth by the Secretary. The Secretary shall consider 
                such certificates when targeting inspection resources 
                under section 421.
                    ``(B) Purpose of certification.--The Secretary 
                shall use evidence of certification provided by 
                accredited third-party auditors and audit agents--
                            ``(i) to determine the eligibility of an 
                        importer to receive a certification under 
                        section 801(p); and
                            ``(ii) to determine the eligibility of an 
                        importer to participate in the voluntary 
                        qualified importer program under section 806.
            ``(3) Audit report requirements.--
                    ``(A) Requirements in general.--As a condition of 
                accreditation, an accredited third-party auditor or 
                audit agent shall prepare the audit report for an 
                audit, in a form and manner designated by the 
                Secretary, which shall include--
                            ``(i) the identity of the persons at the 
                        audited eligible entity responsible for 
                        compliance with food safety requirements;
                            ``(ii) the dates of the audit;
                            ``(iii) the scope of the audit; and
                            ``(iv) any other information required by 
                        the Secretary that relates to or may influence 
                        an assessment of compliance with this Act.
                    ``(B) Submission of reports to the secretary.--
                            ``(i) In general.--Following any 
                        accreditation of a third-party auditor or audit 
                        agent, the Secretary may, at any time, require 
                        the accredited third-party auditor or audit 
                        agent to submit to the Secretary an onsite 
                        audit report and such other reports or 
                        documents required as part of the audit 
                        process, for any eligible entity certified by 
                        the third-party auditor or audit agent. Such 
                        report may include documentation that the 
                        eligible entity is in compliance with any 
                        applicable registration requirements.
                            ``(ii) Limitation.--The requirement under 
                        clause (i) shall not include any report or 
                        other documents resulting from a consultative 
                        audit by the accredited third-party auditor or 
                        audit agent, except that the Secretary may 
                        access the results of a consultative audit in 
                        accordance with section 414.
            ``(4) Audit agent requirements.--
                    ``(A) Public health risks.--If, at any time during 
                an audit, an accredited audit agent discovers a 
                condition that could cause or contribute to a serious 
                risk to the public health, the audit agent shall 
                immediately notify the Secretary of--
                            ``(i) the identification of the eligible 
                        entity subject to the audit; and
                            ``(ii) such condition.
                    ``(B) Audit types.--An accredited audit agent may 
                perform consultative and regulatory audits of eligible 
                entities.
                    ``(C) Limitations.--An accredited audit agent may 
                not perform a regulatory audit of an eligible entity if 
                such agent has performed a consultative audit or a 
                regulatory audit of such eligible entity during the 
                previous 24-month period.
            ``(5) Conflicts of interest.--
                    ``(A) Third-party auditors.--An accredited third-
                party auditor shall--
                            ``(i) not be owned, managed, or controlled 
                        by any person that owns or operates an eligible 
                        entity to be certified by such auditor;
                            ``(ii) in carrying out audits of eligible 
                        entities under this section, have procedures to 
                        ensure against the use of any officer or 
                        employee of such auditor that has a financial 
                        conflict of interest regarding an eligible 
                        entity to be certified by such auditor; and
                            ``(iii) annually make available to the 
                        Secretary disclosures of the extent to which 
                        such auditor and the officers and employees of 
                        such auditor have maintained compliance with 
                        clauses (i) and (ii) relating to financial 
                        conflicts of interest.
                    ``(B) Audit agents.--An accredited audit agent 
                shall--
                            ``(i) not own or operate an eligible entity 
                        to be certified by such agent;
                            ``(ii) in carrying out audits of eligible 
                        entities under this section, have procedures to 
                        ensure that such agent does not have a 
                        financial conflict of interest regarding an 
                        eligible entity to be certified by such agent; 
                        and
                            ``(iii) annually make available to the 
                        Secretary disclosures of the extent to which 
                        such agent has maintained compliance with 
                        clauses (i) and (ii) relating to financial 
                        conflicts of interest.
                    ``(C) Regulations.--The Secretary shall promulgate 
                regulations not later than 18 months after the date of 
                enactment of the Safe Food Enforcement, Assessment, 
                Standards, and Targeting Act of 2009 to ensure that 
                there are protections against conflicts of interest 
                between an accredited third-party auditor or audit 
                agent and the eligible entity to be certified by such 
                auditor or audit agent. Such regulations shall 
                include--
                            ``(i) requiring that audits performed under 
                        this section be unannounced;
                            ``(ii) a structure, including timing and 
                        public disclosure, for fees paid by eligible 
                        entities to accredited third-party auditors or 
                        audit agents to decrease the potential for 
                        conflicts of interest; and
                            ``(iii) appropriate limits on financial 
                        affiliations between an accredited third-party 
                        auditor or audit agent and any person that owns 
                        or operates an eligible entity to be certified 
                        by such auditor or audit agent.
            ``(6) Withdrawal of accreditation.--The Secretary shall 
        withdraw accreditation from an accredited third-party auditor 
        or audit agent--
                    ``(A) if food from an eligible entity certified by 
                such third-party auditor or audit agent is linked to an 
                outbreak of human or animal illness;
                    ``(B) following a performance audit and finding by 
                the Secretary that the third-party auditor or audit 
                agent no longer meets the requirements for 
                accreditation; or
                    ``(C) following a refusal to allow United States 
                officials to conduct such audits and investigations as 
                may be necessary to ensure continued compliance with 
                the requirements set forth in this section.
            ``(7) Neutralizing costs.--The Secretary shall establish a 
        method, similar to the method used by the Department of 
        Agriculture, by which accredited third-party auditors and audit 
        agents reimburse the Food and Drug Administration for the work 
        performed to establish and administer the accreditation system 
        under this section. The Secretary shall make operating this 
        program revenue-neutral and shall not generate surplus revenue 
        from such a reimbursement mechanism.
    ``(d) Eligible Entities Recertification.--An eligible entity shall 
apply for annual recertification by an accredited third-party auditor 
or audit agent if such entity--
            ``(1) intends to participate in voluntary qualified 
        importer program under section 806; or
            ``(2) must provide to the Secretary a certification under 
        section 801(p) for any food from such entity.
    ``(e) False Statements.--Any statement or representation made--
            ``(1) by an employee or agent of an eligible entity to an 
        accredited third-party auditor or audit agent; or
            ``(2) by an accredited third-party auditor or an audit 
        agent to the Secretary,
shall be subject to section 1001 of title 18, United States Code.''.

SEC. 309. JURISDICTION; AUTHORITIES.

    Nothing in this Act, or an 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 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 
                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, the 
        Poultry Products Inspection Act, or the Egg Products Inspection 
        Act.
                                 <all>