110 HR 5904 IH: Safe FEAST Act of 2008 U.S. House of Representatives 2008-04-24 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I 110th CONGRESS 2d Session H. R. 5904 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.

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.

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.

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).

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:

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.

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:

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.

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.

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:

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.

.

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.

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:

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). .

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:

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.

.

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:

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.

.

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: 3

Fees Relating to Food

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. .

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. .

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). .

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.

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.

17.

Authorization of appropriations

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