[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5904 Introduced in House (IH)]







110th CONGRESS
  2d Session
                                H. R. 5904

  To amend the Federal Food, Drug, and Cosmetic Act to establish new 
  procedures and requirements to improve the safety of food, whether 
   produced and distributed domestically or imported into the United 
 States, by providing for improved information technology to identify 
high-risk imports and for enhanced capacity in the United States and in 
  foreign governments to identify and address food safety issues on a 
               scientific basis, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 24, 2008

  Mr. Costa (for himself, Mr. Putnam, Mr. Cardoza, Mr. Nunes, and Mr. 
    Farr) introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
  To amend the Federal Food, Drug, and Cosmetic Act to establish new 
  procedures and requirements to improve the safety of food, whether 
   produced and distributed domestically or imported into the United 
 States, by providing for improved information technology to identify 
high-risk imports and for enhanced capacity in the United States and in 
  foreign governments to identify and address food safety issues on a 
               scientific basis, and for other purposes.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Safe Food 
Enforcement, Assessment, Standards and Targeting Act of 2008'' or as 
the ``Safe FEAST Act of 2008''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings and purposes.
Sec. 3. Inspection of records during food-related emergencies.
Sec. 4. Hazard analysis and risk-based preventive controls.
Sec. 5. Mandatory foreign supplier safety assurance program.
Sec. 6. Certification of certain imports by competent authority of 
                            exporting country.
Sec. 7. Voluntary qualified importer program.
Sec. 8. Recognition of qualified laboratories for analyses of imported 
                            foods.
Sec. 9. Standards for the safety of fruits and vegetables.
Sec. 10. Targeting of inspection resources for domestic facilities and 
                            points of entry.
Sec. 11. Recognition of third party certification programs.
Sec. 12. Fees relating to food.
Sec. 13. Biennial registration renewal.
Sec. 14. Mandatory recall authority.
Sec. 15. Building capacity of foreign governments.
Sec. 16. Domestic capacity building and annual report on food safety 
                            programs.
Sec. 17. Authorization of appropriations.

SEC. 2. FINDINGS AND PURPOSES.

    (a) Findings.--Congress finds that--
            (1) American consumers have a vital interest in a safe, 
        affordable, and wholesome food supply;
            (2) maintenance of a safe food supply requires 
        scientifically based food safety standards;
            (3) food production and distribution is increasingly 
        global;
            (4) ensuring the safety of the food supply, regardless of 
        the source of the food, is a responsibility shared by food 
        producers, processors, and retailers and by Federal, State, and 
        local agencies;
            (5) assurance of the safety of food is best achieved by the 
        adoption of appropriate food production and processing 
        practices and procedures;
            (6) enhanced cooperation among regulatory agencies 
        worldwide is critical to maintenance of a safe food supply;
            (7) food producers, processors, and retailers have a vital 
        role in ensuring the safety of the food supply;
            (8) food producers, processors, and retailers are best 
        situated to ensure the implementation of science-based food 
        safety standards worldwide;
            (9) in order to provide appropriate oversight, regulatory 
        agencies with responsibility for food safety must have access 
        to adequate scientific resources, modern information technology 
        systems, modern and efficient laboratories, and adequate 
        inspectional capacity;
            (10) ensuring the adequacy of resources for regulatory 
        agencies is a public responsibility; and
            (11) efficient and effective enforcement of food safety 
        requirements for imported foods necessitates a risk-based 
        systems approach.

SEC. 3. INSPECTION OF RECORDS DURING FOOD-RELATED EMERGENCIES.

    (a) In General.--Section 414 of the Federal Food, Drug, and 
Cosmetic Act (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 as such 
        article of food under paragraph (1)) 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 related 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) of such Act (21 U.S.C. 331(e)) is 
        amended by striking ``414(b)'' and inserting ``414(c)''.
            (2) Section 704(a)(1) of such Act (21 U.S.C. 374(a)(1)) is 
        amended by striking ``414(d)'' and inserting ``414(e)''.

SEC. 4. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS.

    (a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.) is amended by adding at the end the 
following:

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

    ``(a) In General.--Each owner, operator, or agent in charge of a 
facility, as defined in subsection (k)(1), shall, in accordance with 
this section--
            ``(1) evaluate the hazards that could affect products from 
        such facility;
            ``(2) identify and implement risk-based preventive controls 
        to keep such hazards from occurring or to significantly 
        minimize their occurrence and provide reasonable assurances 
        that a product is not adulterated;
            ``(3) monitor the performance of those controls;
            ``(4) maintain records of this monitoring as a matter of 
        routine practice; and
            ``(5) provide for inspection of the facility at such 
        frequency, but not less often than biennially, as the Secretary 
        may specify, with an increase in the periodicity of such 
        inspections based on facilities identified as having an 
        increased risk.
    ``(b) Hazard Analysis.--The owner, operator, or agent in charge of 
a facility shall identify and evaluate known or reasonably foreseeable 
biological, chemical, and physical hazards that may be associated with 
the facility.
    ``(c) Preventive Controls.--
            ``(1) Implementation.--The owner, operator, or agent in 
        charge of a facility shall identify and implement reasonably 
        appropriate preventive controls so that--
                    ``(A) risks identified in the hazard analysis 
                conducted under subsection (b) will not affect the food 
                manufactured, processed or packed by such facility;
                    ``(B) the food will not be adulterated under 
                section 402; and
                    ``(C) the food will not present a threat of serious 
                adverse health consequences or death to humans or 
                animals.
            ``(2) Controls.--Preventive controls include, at a minimum, 
        the following practices that improve the safety of the food:
                    ``(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 to ensure that 
                products do not contain allergens that are not declared 
                on the label.
                    ``(E) A recall contingency plan.
                    ``(F) Good manufacturing practices.
    ``(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 
reasonable assurances that none of the outcomes set forth in subsection 
(c)(1) shall occur.
    ``(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 effectiveness monitoring under subsection (d) 
or if an adulteration or recall situation warrants such action.
    ``(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 found 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 revalidation of the 
        plan under subsection (h) to ensure that the plan is still 
        relevant to the raw materials as well as to conditions and 
        processes in the facility.
    ``(g) Risk Assessment and Preventive Control Implementation Plan.--
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). Such written plan, together with documentation that the plan is 
being implemented, shall be made promptly available to a duly 
authorized representative of the Secretary upon oral or written request 
for the purpose of verifying compliance with this requirement.
    ``(h) Requirement To Reanalyze.--Each owner, operator, or agent in 
charge of a facility shall conduct a reanalysis under subsection (b), 
at a minimum, biennially, or 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. 
Such reanalysis shall take into account any new scientific or 
technological advances and any additional preventive controls needed to 
address the hazard identified, if any, and shall be implemented before 
any change in activities at the facility is commenced. Such owner, 
operator, or agent shall revise the written plan required under 
subsection (g) if such a significant change is made or document the 
basis for the conclusion that no additional or revised preventive 
controls are needed.
    ``(i) Exception for Food Facilities in Compliance With Applicable 
HACCP or Other Regulatory Standards.--This section shall not apply to 
an owner, operator, or agent in charge of a facility that processes a 
food if such facility is subject to the standards for a Hazard Analysis 
Critical Control Points Program or other regulatory program of the Food 
and Drug Administration relating to that food.
    ``(j) Exception for Facilities in Compliance With Section 419.--
This section shall not apply to an owner, operator, or agent in charge 
of a facility that is subject to section 419.
    ``(k) Definitions.--For purposes of this section:
            ``(1) Facility.--The term `facility' means a domestic or a 
        foreign facility that is required to register under section 
        415, but does include a warehouse that--
                    ``(A) holds food packaged for sale to consumers or 
                packed in cases for commercial distribution; and
                    ``(B) does not process food or otherwise expose 
                food to the environment in a way as to dramatically 
                increase the likelihood for contamination, not 
                including processing incidental to the handling of 
                fruits and vegetables that may be held in the warehouse 
                and regulated under section 419.
            ``(2) Reasonably appropriate science-based preventive 
        controls.--The term `reasonably appropriate science-based 
        preventive controls' means those procedures, practices, and 
        processes that a person knowledgeable about the processing and 
        packing of food and science-based food safety practices would 
        have employed to address the hazards identified during the 
        hazard analysis under subsection (b) at the time of such 
        analysis. Such term does not include those controls that result 
        in a food that is not commercially viable.''.
    (b) Guidance Document.--Not later than 1 year after the date of 
enactment of this Act, the Secretary shall issue a guidance document 
related to the preparation of a hazard analysis and preventive control 
plan required under section 418 of the Federal Food, Drug, and Cosmetic 
Act, as added by subsection (a).
    (c) Regulations.--
            (1) In general.--The Secretary of Health and Human Services 
        shall promulgate regulations to establish minimum standards for 
        the effective implementation of section 418 of the Federal 
        Food, Drug, and Cosmetic Act, as added by subsection (a).
            (2) Content.--The regulations promulgated under paragraph 
        (1) shall--
                    (A) be consistent with the principles contained in 
                internationally recognized hazard analysis and 
                preventive control standards; and
                    (B) provide sufficient flexibility to be applicable 
                in all situations, including in the operations of small 
                businesses.
            (3) 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 418 is consistent with applicable internationally 
        recognized standards in existence on such date.
    (d) Prohibited Acts.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the 
following:
    ``(oo) The operation of a facility that processes or packs food for 
sale in the United States if the person who operates such facility has 
not conducted the hazard analysis required under section 418(b), 
implemented reasonably appropriate science-based preventive controls 
under section 418(c) in accordance with 418(g), failed to conduct a 
reanalysis as required under section 418(h), or failed to have a plan 
documenting compliance with section 418.''.
    (e) Effective Date.--
            (1) General rule.--The amendments made by this section 
        shall take effect 1 year 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 in the small business 
                size regulations of the Small Business Administration, 
                as specified in part 121 of title 13, Code of Federal 
                Regulations) 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 in such 
                regulations) after the date that is 3 years after the 
                date of enactment of this Act.

SEC. 5. MANDATORY FOREIGN SUPPLIER SAFETY ASSURANCE PROGRAM.

    (a) In General.--Chapter VIII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381 et seq.) is amended by adding at the end 
the following:

``SEC. 805. MANDATORY FOREIGN SUPPLIER SAFETY ASSURANCE PROGRAM.

    ``(a) Foreign Supplier Safety Assurance Program.--
            ``(1) In general.--Each U.S. importer of record shall adopt 
        and document a foreign supplier safety assurance program to 
        assure that food imported into the United States--
                    ``(A) is in compliance with the requirements of 
                section 418;
                    ``(B) is not adulterated under section 402; and
                    ``(C) does not pose a threat of serious adverse 
                health consequences or death.
            ``(2) Treatment of certain customs brokers.--For purposes 
        of this section, an `importer of record' shall not include a 
        person holding a valid license under section 1641 of title 19, 
        United States Code (commonly 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) Requirements.--
            ``(1) In general.--A foreign supplier safety assurance 
        program shall include such risk-based processes and procedures 
        as the U.S. importer of record determines to be necessary and 
        appropriate to reasonably ensure that food imported into the 
        United States by the importer of record complies with U.S. food 
        safety requirements in accordance with section 418 and is not 
        adulterated within the meaning of section 402.
            ``(2) Components of a foreign supplier safety assurance 
        program.--In establishing a foreign supplier safety assurance 
        program, a U.S. importer of record shall verify, with respect 
        to each foreign supplier from which it obtains food, that the 
        foreign supplier has an effective safety assurance program. 
        Such verification may include certification by a recognized 
        third party certification program (under section 421), but such 
        certification from the approved third party certification 
        program shall not serve as the sole means that may be accepted 
        by the Secretary of verification of adherence to a foreign 
        supplier safety assurance program. An effective safety 
        assurance program shall include, at a minimum, an evaluation of 
        hazards in accordance with section 418 and the implementation 
        of reasonable and appropriate preventive controls.
    ``(c) Guidance.--Within 270 days of the date of the enactment of 
this section, the Secretary shall issue guidance to assist U.S. 
importers of record in developing foreign supplier safety assurance 
programs.
    ``(d) Record Access.--Records of a U.S. importer of record related 
to a foreign supplier safety assurance program shall, for a period of 
not less than 2 years, be made available promptly to the Secretary upon 
written or oral request.''.
    (b) Prohibited Acts.--Section 301 of such Act (21 U.S.C. 331), as 
amended by section 4(d), is further amended by adding at the end the 
following:
    ``(pp) The importation or offering for importation of a food if the 
importer of record does not have in place a foreign supplier safety 
assurance program in compliance with section 805.''.
    (c) Imports.--Section 801(a) of such Act (21 U.S.C. 381(a)) is 
amended by inserting ``or section 805'' after ``or in violation of 
section 505''.

SEC. 6. CERTIFICATION OF CERTAIN IMPORTS BY COMPETENT AUTHORITY OF 
              EXPORTING COUNTRY.

    (a) In General.--Whenever the Secretary of Health and Human 
Services (in this section referred to as the ``Secretary'') determines 
to enter into a memorandum of understanding or equivalent agreement 
with the regulatory authorities of another country with responsibility 
for food safety, the Secretary shall include in such memorandum of 
understanding or equivalent agreement a provision to provide for the 
certification of certain foods offered for import into the United 
States by a competent regulatory authority in the country of export.
    (b) Certification.--Such certification provision shall provide 
that, upon reasonable notice given by the Secretary, and as a condition 
of permitting the importation of food from a specific foreign country 
or from a specific facility within a foreign country, a competent 
regulatory authority in the exporting country agrees to certify that 
each specific shipment of food or food from a specific facility offered 
for importation into the United States has been produced, packaged, and 
held under conditions that meet United States food safety standards. 
Nothing in this section shall limit the Secretary's ability to conduct 
random checks of imported food or to take such other steps as the 
Secretary deems necessary to assure the safety of imported food.
    (c) Notification and Detention.--Whenever the Secretary has entered 
into a memorandum of agreement that includes a certification 
requirement, the Secretary shall notify the Secretary of Homeland 
Security. The Secretary of Homeland Security shall deny entry to any 
food offered for import for which a certification under this section 
has been required if such certification has not been provided in a 
manner deemed timely and appropriate by the Secretary.
    (d) Registry of Certified Facilities.--The Secretary shall maintain 
a registry of facilities with respect to which certification has been 
made under this section.

SEC. 7. VOLUNTARY QUALIFIED IMPORTER PROGRAM.

    Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
381 et seq.), as amended by section 5(a), is further 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 establish a program, 
in consultation with the Secretary of Agriculture and Secretary of 
Homeland Security, to provide for the expedited review and importation 
of food products offered for importation by U.S. importers of record 
who have voluntarily agreed to participate in such program. In 
establishing such a program, the Secretary shall ensure that the 
program does not impose redundant requirements on persons who 
participate in existing border security programs. In determining 
eligibility to participate in such a program, the Secretary shall 
consider, among other relevant information, the following:
            ``(1) Nature and risk-profile of the food or ingredient to 
        be imported.
            ``(2) Compliance history of the foreign supplier.
            ``(3) Capability of the regulatory system of the country of 
        export to ensure compliance with United States food safety 
        standards, including hazard analysis and preventive control 
        measures in accordance with section 418.
            ``(4) Compliance of the importer of record with the 
        requirements of section 805.
            ``(5) Whether the importer of record has been certified by 
        a recognized third party certification program under section 
        421.
            ``(6) Any other factors the Secretary deems necessary.
    ``(b) Voluntary Participation.--An importer of record may request 
the Secretary to provide for the expedited review and importation of 
designated foods in accordance with the procedures established by the 
Secretary and the Secretary may establish a list of foods for which 
expedited review and importation under this section is authorized.
    ``(c) Fee.--A fee is established under section 741 for 
participation of facilities in the program under this section.''.

SEC. 8. RECOGNITION OF QUALIFIED LABORATORIES FOR ANALYSES OF IMPORTED 
              FOODS.

    (a) In General.--The Secretary of Health and Human Services shall 
provide for the recognition of laboratories with a demonstrated 
capability to conduct analytical testing of food products through 
programs administered by other government agencies, or by qualified 
nongovernmental organizations and shall establish a registry of 
laboratories that have been so recognized.
    (b) Criteria.--The Secretary of Health and Human Services shall 
require, as a condition of inclusion in the registry provided for under 
subsection (a), that entities providing laboratory analyses establish 
to the satisfaction of the agency or organization that is providing the 
recognition that--
            (1) appropriate sampling and analytical procedures are 
        followed and reports of analyses are certified as true and 
        accurate;
            (2) internal quality systems are established and 
        maintained;
            (3) procedures exist to evaluate and respond promptly to 
        complaints regarding analyses and other activities for which 
        the laboratory is recognized; and
            (4) individuals who conduct the analyses are qualified by 
        training and experience to do so.
    (c) Review of Recognition.--Any agency or organization that 
maintains a program under which laboratories are recognized as 
qualified to conduct analyses in accordance with the criteria set forth 
in this section shall conduct periodic assessments of the 
qualifications of the laboratories that have been recognized by it and 
shall promptly revoke the recognition of any laboratory found not to be 
in compliance with the agency's or organization's standards. The agency 
or organization shall also promptly notify the Secretary of Health and 
Human Services of any change in the status of a previously recognized 
laboratory and the Secretary shall promptly revise the registry 
maintained under subsection (a).
    (d) Alternative Laboratories.--Nothing in this section shall 
prevent a person from using an alternative laboratory, such as a 
university or food company laboratory, so long as such person submits--
            (1) to the Secretary evidence to establish the 
        qualifications of the laboratory and a reference to the 
        validated test method (or methods) used; and
            (2) to the Food and Drug Administration all testing results 
        and data.

SEC. 9. STANDARDS FOR THE SAFETY OF FRUITS AND VEGETABLES.

    (a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.), as amended by section 4(a), is amended by 
adding at the end the following:

``SEC. 419. STANDARDS FOR THE SAFETY OF FRUITS AND VEGETABLES.

    ``(a) Definition.--For purposes of this section, the term `fruits 
and vegetables' shall mean 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, and packaging 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 those 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, and packaging of fruits and vegetables. The 
Secretary shall publish subsequently updated guidance, as necessary.
    ``(h) Scope.--This section shall apply to the production, 
harvesting, and packaging 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 418; 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 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331), as amended by sections 4(d) and 5(b), is 
further amended by adding at the end the following:
    ``(qq) Production, harvesting, or packaging of fruits or vegetables 
not in accordance with the regulations or a variance issued under 
section 419(d)(2).''.

SEC. 10. TARGETING OF INSPECTION RESOURCES FOR DOMESTIC FACILITIES AND 
              POINTS OF ENTRY.

    Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
341 et seq.), as amended by sections 4(a) and 9(a), is amended by 
adding at the end the following:

``SEC. 420. TARGETING OF INSPECTION RESOURCES FOR DOMESTIC FACILITIES 
              AND POINTS OF ENTRY.

    ``(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, handled, prepared, treated, 
                distributed, or stored 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 facility has been certified to 
                conform with United States food safety standards by a 
                recognized third party certification program under 
                section 421.
                    ``(E) Any other criteria deemed necessary and 
                appropriate by the Secretary for purposes of allocating 
                inspection resources.
            ``(2) Inspections.--The Secretary shall conduct inspections 
        of domestic facilities identified under paragraph (1) as high-
        risk facilities not less often than once a year.
    ``(b) Identification and Inspection of Points of Entry.--The 
Secretary shall inspect shipments of food imported into the United 
States according to the risk profile of the food shipment, which shall 
be based on the following factors:
            ``(1) The risk profile of the food imported.
            ``(2) The risk profile of the origin 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 of the 
        food importer under section 805.
            ``(5) Whether the food importer participates in the 
        Voluntary Qualified Importer Program under section 806.
            ``(6) Whether the facility has been certified to conform 
        with United States food safety standards by a recognized third 
        party certification program under section 421.
            ``(7) Any other criteria deemed necessary and appropriate 
        by the Secretary for purposes of allocating inspection 
        resources.
    ``(c) Facility.--For purposes of this section, the term `facility' 
has the meaning given that term in section 415.''.

SEC. 11. RECOGNITION OF THIRD PARTY CERTIFICATION PROGRAMS.

    Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
341 et seq.), as amended by sections 4(a), 9(a), and 10, is amended by 
adding at the end the following:

``SEC. 421. RECOGNITION OF THIRD PARTY CERTIFICATION PROGRAMS.

    ``(a) In General.--Beginning not later than 2 years after the date 
of the enactment of this section, the Secretary shall establish a 
process under which a third party may apply to the Secretary for 
recognition of a third party certification program it operates.
    ``(b) Recognition of Programs.--
            ``(1) In general.--The Secretary may not recognize a third 
        party with respect to its operation of a third party 
        certification program unless the following requirements are 
        met:
                    ``(A) The third party has demonstrated the capacity 
                and competence to operate a third party certification 
                program.
                    ``(B) The processes and standards used by the third 
                party in the auditing and certification of food 
                processors and producers are sufficient to verify 
                compliance of such producers and processors with 
                federal food safety standards.
                    ``(C) The third party must conform to requirements 
                established by the Secretary, including periodic 
                reevaluation by the Secretary. In establishing such 
                requirements, the Secretary shall consider existing 
                standards and procedures established by national and 
                international accreditation organizations.
            ``(2) Application of accreditation.--In approving third 
        parties with respect to third party accreditation programs 
        under this section, the Secretary may take into account the 
        accreditation of such entities and programs by national and 
        international accreditation organizations.
            ``(3) Registry.--The Secretary shall maintain a registry of 
        recognized third party certification programs.
    ``(c) Third Party Certification Program Defined.--In this section:
            ``(1) The term `third party certification program' means an 
        independent auditing and certification program--
                    ``(A) that evaluates the food safety management 
                systems and practices of food producers and processors 
                using recognized auditing standards; and
                    ``(B) that only certifies such producers or 
                processors that it determines are in compliance with 
                such standards.
            ``(2) The term `recognized third party certification 
        program' means a third party certification program, and the 
        entity operating which, is recognized under this section.
    ``(d) Construction.--Nothing in the section should be construed to 
limit the ability of the Secretary or a designated agent of the 
Secretary to conduct random checks of imported food or audit facilities 
as the Secretary deems necessary to ensure compliance with federal food 
safety standards.
    ``(e) Termination of Recognition.--The Secretary may terminate the 
recognition of a third party with respect to its operation of a third 
party accreditation program under this section--
            ``(1) following an investigation and finding by the 
        Secretary that the third party or program is no longer in 
        compliance with requirements for recognition under this 
        section; or
            ``(2) following the party's refusal to allow United States 
        officials to conduct such audits as may be necessary to ensure 
        continued compliance of the entity and program with the 
        applicable requirements of this section.''.

SEC. 12. FEES RELATING TO FOOD.

    (a) In General.--Chapter VII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 371 et seq.) is amended--
            (1) by redesignating sections 741 and 742 as sections 744 
        and 745, respectively; and
            (2) by adding at the end of subchapter C the following:

                    ``PART 3--FEES RELATING TO FOOD

``SEC. 741. AUTHORITY TO COLLECT AND USE REIMBURSABLE FEES FOR 
              VOLUNTARY QUALIFIED IMPORTER PROGRAM.

    ``(a) Fees for Voluntary Qualified Importer Program.--For fiscal 
year 2009 and each subsequent fiscal year, the Secretary shall, in 
accordance with this section, assess and collect fees from each 
importer required to register under section 415 which participates in 
the voluntary qualified importer program under section 806 in such 
year, to reimburse the Food and Drug Administration for the 
administrative costs of that importer's participation in such program 
for such year.
    ``(b) Establishment of Fees.--
            ``(1) In general.--Subject to subsection (c), the Secretary 
        shall establish a fee schedule for reimbursable expenses to be 
        collected under this section for each fiscal year specified in 
        section (a), based on the methodology described in paragraph 
        (2). The Secretary shall publish such fee schedule for a fiscal 
        year in a Federal Register notice not later than 60 days before 
        the beginning of each fiscal year.
            ``(2) Fee methodology and fee schedule.--
                    ``(A) Fee methodology.--Fees amounts established 
                for collection shall be based on 100 percent of the 
                Secretary's actual costs of the activities for each 
                importer participating in the voluntary qualified 
                importer program, as described in subsection (a), for 
                such fiscal year.
                    ``(B) Fee schedule.--The Secretary shall establish 
                in each such fiscal year a fee schedule to include all 
                reimbursable expenses, including an hourly rate for 
                salaries and expenses for government personnel carrying 
                out of such activities, as well as a rate to cover 
                indirect costs necessary for the efficient conduct of 
                such activities. The Secretary's publication of the fee 
                schedule under paragraph (1) shall be accompanied by a 
                written explanation of the methodology for determining 
                each fee on the fee schedule.
                    ``(C) Other considerations.--In establishing the 
                fee schedule for a fiscal year, the Secretary shall 
                also consider the need to account for any adjustment of 
                fees under paragraph (3) and such other factors as the 
                Secretary determines appropriate.
            ``(3) Adjustment of fees.--The Secretary may provide for 
        the waiver or reduction of fees under this subsection based on 
        financial hardship or other circumstances as determined 
        appropriate by the Secretary.
            ``(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) Crediting and Availability of Fees.--Fees collected for each 
fiscal year under this section shall be credited to a fund, hereby 
established in the Treasury of the United States and to be known as the 
`Food and Drug Administration Food User Fee Account', and shall be 
available in accordance with appropriations Acts until expended, 
without fiscal year limitation. Such fees shall be made available 
solely to carry out the activities by the Center for Food Safety and 
Applied Nutrition and related activities of the Office of Regulatory 
Affairs related to the voluntary qualified importer program.
    ``(d) 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, but in no case shall a facility be required to pay a 
        reimbursable fee less than 60 days after the date of receipt of 
        a notice from the Secretary assessing such fee.
            ``(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.
    ``(e) Annual Report to Congress.--Not later than 90 days after the 
end of 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, that includes a description of fees assessed and 
collected for each such fiscal year and a summary description of the 
entities paying such fees and the types of business in which such 
entities engage.''.
    (b) Export Certification Fees for Foods and Animal Feed.--
            (1) Authority for export certifications for food, including 
        animal feed.--Section 801(e)(4)(A) of the Federal Food, Drug, 
        and Cosmetic Act (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'' and 
                ``the drug,'' and inserting ``the food, drug'' and 
                ``the food, drug,'', respectively.
            (2) Treatment of fees.--Section 801(c)(4) of such Act (21 
        U.S.C. 381(3)(4)) is amended--
                    (A) in subparagraph (B), by striking all that 
                follows the first sentence; and
                    (B) by adding at the end the following:
    ``(C)(i) In the case of fees collected for a fiscal year pursuant 
to this paragraph for certification of exported drugs, animal drugs, or 
devices, the fees shall be credited to the appropriation account for 
salaries and expenses of the Food and Drug Administration and be 
available in accordance with appropriations Acts until expended, 
without fiscal year limitation. To cover the cost of issuing such 
certifications, such sums as necessary may be transferred from such 
appropriation account for salaries and expenses of the Food and Drug 
Administration without fiscal year limitation to such appropriation 
account for salaries and expenses with fiscal year limitation.
    ``(ii) In the case of fees collected for a fiscal year pursuant to 
this paragraph for the certification of exported foods, the fees shall 
be credited to the Food and Drug Administration Food User Fee Account 
and be available in accordance with appropriations Acts until expended, 
without fiscal year limitation.''.
            (3) Clarification of certification.--Section 801(e)(4) of 
        such Act (21 U.S.C. 381(e)(4)), as amended by paragraph (2), is 
        further amended by adding at the end the following:
    ``(D) 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.''.

SEC. 13. BIENNIAL REGISTRATION RENEWAL.

    Section 415(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 350d(a)) is amended--
            (1) by redesignating paragraphs (3) and (4) as paragraphs 
        (4) and (5), respectively; and
            (2) by inserting after paragraph (2) the following:
            ``(3) Biennial registration renewal.--On a biennial basis, 
        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 may 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.''.

SEC. 14. MANDATORY RECALL AUTHORITY.

    (a) In General.--Section 417 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 350f) is amended by adding at the end the 
following:
    ``(l) Recall of Reportable Food.--
            ``(1) Voluntary procedures.--If the Secretary determines 
        that there is a reasonable probability that the use of or 
        exposure to an article of food (other than infant formula) will 
        cause serious adverse health consequences, the Secretary shall 
        provide the responsible party that produced or processed packed 
        or held the reportable food with an opportunity to--
                    ``(A) cease distribution of such article;
                    ``(B) notify all persons--
                            ``(i) producing, manufacturing, packing, 
                        processing, preparing, treating, packaging, 
                        distributing, or holding such articles; or
                            ``(ii) to which such article has been 
                        distributed, transported, or sold, to 
                        immediately cease distribution of such article;
                    ``(C) recall such article;
                    ``(D) provide, in consultation with the Secretary 
                and where deemed necessary, notice to consumers to whom 
                such article was, or may have been, distributed; and
                    ``(E) take any combination of the above measures, 
                as appropriate in the circumstances.
        The Secretary may not delegate recall authority under this 
        subsection to any person other than the Commissioner.
            ``(2) Pre-hearing order to cease distribution and give 
        notice.--If the responsible party refuses to or does not 
        voluntarily cease distribution, make notification, recall such 
        article, or provide notice to consumers as applicable, the 
        Secretary may, by order, require, as the Secretary deems 
        necessary, such person to--
                    ``(A) immediately cease distribution of such 
                article;
                    ``(B) immediately notify all persons--
                            ``(i) producing, manufacturing, packing, 
                        processing, preparing, treating, packaging, 
                        distributing, or holding such articles; or
                            ``(ii) to which such article has been 
                        distributed, transported, or sold, to 
                        immediately cease distribution of such article; 
                        or
                    ``(C) immediately take the actions specified in 
                both subparagraphs (A) and (B).
            ``(3) Notification of consumers by secretary.--The 
        Secretary may, as the Secretary deems necessary, provide notice 
        to consumers to whom such article was, or may have been, 
        distributed.
            ``(4) Hearing on order.--The Secretary shall provide the 
        responsible party subject to an order under paragraph (2) with 
        an opportunity for a hearing, to be held as soon as possible 
        but not later than 2 days after the date of 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.
            ``(5) Post-hearing recall order.--
                    ``(A) Amendment of order.--If, after providing 
                opportunity for a hearing under paragraph (4), the 
                Secretary determines that removal of the product is 
                necessary, the Secretary, as the Secretary deems 
                necessary, may--
                            ``(i) amend the order to require recall of 
                        such article or other appropriate action;
                            ``(ii) specify a timetable in which the 
                        recall shall occur;
                            ``(iii) require periodic reports to the 
                        Secretary describing the progress of the 
                        recall; and
                            ``(iv) provide notice to consumers to whom 
                        such article was, or may have been, 
                        distributed.
                    ``(B) Vacating of order.--If, after such a hearing, 
                the Secretary determines that adequate grounds do not 
                exist to continue the actions required by the order, 
                the Secretary shall vacate or modify the order.
            ``(6) Failure to comply with recall order.--Any person who 
        does not comply with a recall order under this subsection shall 
        be liable to a fine not to exceed $10,000 for each day of such 
        noncompliance or to a term of imprisonment not exceeding 6 
        months, or both.
            ``(7) Remedies not exclusive.--The remedies provided in 
        this subsection shall be in addition to and not exclusive of 
        other remedies that may be available.
            ``(8) Cooperation.--The Secretary shall work with the 
        Secretary of Agriculture and State and local public health 
        officials in carrying out this subsection.''.
    (b) Prohibited Acts.--Section 301 of such Act (21 U.S.C. 331 et 
seq.), as amended by sections 4(d), 5(b), and 9(b), is further amended 
by adding at the end the following:
    ``(rr) The refusal or failure to follow an order under section 
417(l).''.

SEC. 15. BUILDING CAPACITY OF FOREIGN GOVERNMENTS.

    (a) In General.--The Secretary of Health and Human Services (in 
this section referred to as the ``Secretary'') shall, within 2 years 
after the date of the 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, the 
Secretary of State, the Secretary of Treasury, and the Secretary of 
Commerce, and representatives of the food industry 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 
        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 reciprocal inspectional authority.
            (4) Training of foreign governments and ingredient 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. 16. DOMESTIC CAPACITY BUILDING AND ANNUAL REPORT ON FOOD SAFETY 
              PROGRAMS.

    (a) In General.--The Secretary of Health and Human Services (in 
this section referred to as the ``Secretary'') shall, not later than 
December 31 of each year following the first full year after the date 
of the enactment of this Act, and annually thereafter, submit to the 
Congress a report on the following:
            (1) Progress in implementing the food protection plan and 
        the import safety action plan issued in November 2007.
            (2) Progress in modernizing good manufacturing practice 
        regulations for food.
            (3) Progress in implementing the requirements and programs 
        required under this Act.
            (4) Adequacy of resources available to the Secretary to 
        ensure the safety of the food supply.
            (5) Adequacy of laboratory facilities available to the 
        Secretary to conduct analyses on food and progress in the 
        development of rapid detection technologies.
            (6) Progress in modernizing the information technology used 
        by the Secretary for food safety related activities and 
        progress in developing and implementing modern information 
        technology systems for the review and processing of foods 
        offered for importation into the United States.
            (7) Food safety research projects conducted during the 
        previous year, including the extent to which these projects 
        have helped identify potential food safety hazards and have 
        provided appropriate preventive control steps to address such 
        hazards.
            (8) Federal-State coordination on food safety activities 
        and proposals to improve the effectiveness of such Federal-
        State partnerships, including with respect to information 
        sharing, conducting inspections, performing analysis and 
        sampling, and conducting education and outreach.
            (9) Progress in increasing coordination between relevant 
        Federal, State, and local agencies responsible for food safety.
    (b) Annual Food Safety Improvement Plan.--In addition to the annual 
report to Congress under subsection (a), the Secretary shall submit a 
plan for improving food safety infrastructure. Such plan shall include 
steps to address inadequacies as described in the annual report.

SEC. 17. AUTHORIZATION OF APPROPRIATIONS.

    There is authorized to be appropriated $50,000,000 as necessary to 
carry out this Act.
                                 <all>