Short title

This Act may be cited as the

Keeping America’s Food Safe Act of 2008

Certification of private laboratories and sampling services

(a)

Amendment

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.

Food safety laboratories and sampling services

(a)

Definitions

In this section: (1)

Food safety laboratory

The term food safety laboratory means an establishment that analyzes or tests samples of imported food to ensure the safety of such food. (2)

Sampling service

The term sampling service means an establishment that collects samples of an imported food. (b)

Certification requirement

(1)

In general

Any entity that is a food safety laboratory or a sampling service shall submit to the Secretary an application for certification. Upon review, the Secretary may grant or deny certification to the food safety laboratory or sampling service. (2)

Certification standards

The Secretary shall establish criteria and methodologies for the evaluation of an application for certification submitted under paragraph (1). Such criteria shall include the requirements that a food safety laboratory or sampling service— (A)be accredited as being in compliance with standards set by the International Organization for Standardization; (B)agree to permit the Secretary to conduct an inspection of the facilities of the food safety laboratory or sampling service and the procedures of such facilities before making a certification determination; (C)agree to permit the Secretary to conduct routine audits of the facilities to ensure ongoing compliance with accreditation and certification requirements; (D)submit with such application a fee established by the Secretary in an amount sufficient to cover the cost of application review, including inspection; and (E)agree to submit to the Secretary, in accordance with the process established, the results of tests conducted by such food safety laboratory or sampling service on behalf of an importer. (c)

Submission of test results

The Secretary shall establish a process by which a food safety laboratory or sampling service certified under this section shall submit to the Secretary the results of all tests conducted by such food safety laboratory or sampling service on behalf of an importer. (d)

Certification of importers for testing and sampling own products

An importer shall not be federally certified for the purposes of analyzing, testing, or sampling its own food products for import unless the Secretary establishes a process under this section by which an importer can become certified for such purposes.

(b)

Enforcement

Section 303(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)) is amended— (1)by redesignating paragraphs (5), (6), and (7) as paragraphs (7), (8), and (9), respectively; (2)by inserting after paragraph (4) the following:

(5)An importer (as such term is used in section 418) shall be subject to a civil penalty in an amount not to exceed $1,000,000 if such importer knowingly engages in the falsification of test results submitted to the Secretary by a food safety laboratory or sampling service certified under section 418. (6)A food safety laboratory or sampling service certified under section 418 shall be subject to a civil penalty in an amount not to exceed $1,000,000 for knowingly submitting to the Secretary false test results under section 418.

(3)in paragraph (2)(C), by striking paragraph (5)(A) and inserting paragraph (7)(A); (4)in paragraph (7), as so redesignated, by striking paragraph (1), (2), (3), or (4) each place it appears and inserting paragraph (1), (2), (3), (4), (5), or (6); (5)in paragraph (8), as so redesignated, by striking paragraph (5)(A) and inserting paragraph (7)(A); and (6)in paragraph (9), by striking paragraph (6) each place it appears and inserting paragraph (8).

Foreign certification and equivalency

(a)

Amendment

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.

Certification of food importers

(a)

In general

Not later than 2 years after the date of enactment of this section, the Secretary shall establish a certification program in accordance with this section to ensure that food imported into the United States meets the food safety standards applied to food produced in the United States. (b)

Certification Standard

A foreign facility or foreign country requesting a certification to import food to the United States shall demonstrate, in a manner determined appropriate by the Secretary, that food produced under the supervision of the foreign facility or foreign country has met standards for food safety, inspection, labeling, and consumer protection that are at least equivalent to standards applicable to food produced in the United States. In determining whether standards are so equivalent, the Secretary shall consider— (1)the potential for health, sanitary, environmental, or other conditions within the foreign country involved to adversely affect the safety of food products exported from such nation; and (2)how well the food safety programs of the foreign country function to minimize any adverse effects on such safety. (c)

Requirement of Certification for Importing

(1)

In general

Except as provided in paragraph (2), no food shall be permitted entry into the United States from a foreign facility in a foreign country unless there is— (A)a certification for such facility in effect under subsection (d)(1); or (B)a certification for such country in effect under subsection (d)(2). (2)

Equivalency determination by Secretary

Notwithstanding paragraph (1), the Secretary shall have authority, to determine that the certification process under subsection (d) is not needed for the Secretary’s understanding of the facility’s or country’s standards for food safety, inspection, labeling, and consumer protection for food imported to the United States to be at least equivalent to standards applicable to food produced in the United States. (d)

Certification

(1)

Foreign facility

Each foreign facility seeking to import food into the United States may obtain a certification by the Secretary stating that the facility maintains a program using reliable analytical methods to ensure compliance with all the food safety standards described in subsection (a) to import such food. (2)

Foreign country

A foreign country may obtain a certification by the Secretary stating that— (A)the country has in effect and is enforcing food safety standards at least as protective of food safety as the standards applicable to food in the United States; and (B)the country has a program in effect to monitor and enforce its food safety standards with respect to food being exported from such country to the United States, ensuring that the food products intended for export to the United States are safe for human consumption, and not adulterated or misbranded. (e)

Agreements With Foreign Nations

Any certification of a foreign country under subsection (d)(2) shall— (1)require the foreign country to promptly notify the Secretary of any violations affecting the safety of food products exported or intended for export to the United States; (2)provide for such activities (whether in the foreign country or at the port of entry during importation) by the Secretary, including analysis, testing, and sampling, at such stages in the growth or harvest of food, or in the processing or handling of food products, as the Secretary considers appropriate to ensure that the foreign country has in effect and is enforcing food safety standards at least as protective of food safety as the standards applicable to food in the United States; and (3)provide for reciprocity with respect to the treatment of food imports and exports between the United States and the foreign country. (f)

Documentation

The Secretary shall provide to the Congress annual documentation demonstrating the Secretary’s confidence in the standards of any foreign facility or country for which the Secretary has made a determination under paragraph (2) of subsection (c). (g)

Revocation of Certification

The Secretary may, with respect to a foreign facility or foreign country, revoke a certification under subsection (d) if— (1)food from the foreign facility or foreign country is linked to an outbreak of human illness; (2)the Secretary determines that the foreign facility or foreign country is no longer meeting the requirements described in subsection (d); or (3)United States officials are not allowed to conduct such audits and investigations as may be necessary to carry out this section. (h)

Duration of Certification

Each certification under subsection (d) shall be for a period of not more than 5 years. (i)

Inspection; Independent Audits

(1)

Authorization

In determining whether to issue a certification under subsection (d) or revoke a certification under subsection (g), the Secretary is authorized to— (A)inspect foreign facilities to ensure compliance with the food safety standards described in subsection (a); and (B)consider independent audits, product test data, and other relevant information generated by the facility, importer, or foreign country involved. (2)

Renewal of certification

The Secretary shall audit foreign countries and foreign facilities at least every 5 years to ensure the continued compliance with the standards set forth in this section. (j)

Enforcement

The Secretary is authorized to— (1)deny importation of food from any foreign country that does not permit United States officials to enter the foreign country to conduct such audits and inspections as may be necessary to fulfill the requirements of this section; (2)deny importation of food from any foreign country or foreign facility that does not consent to an investigation by the Secretary when food from that foreign country or foreign facility is linked to a food-borne illness outbreak or is otherwise found to be adulterated or mislabeled; and (3)promulgate rules and regulations to carry out the purposes of this section, including setting terms and conditions for the destruction of products that fail to meet the standards of this Act. (k)

Foreign Facility

In this section, the term foreign facility means a foreign facility (as defined in section 415(b)(3)) that is required to be registered under section 415.

(b)

Transitional program

Not later than 180 days after the date of enactment of this Act, the Secretary shall promulgate regulations to establish a transitional food safety import review program, with minimal disruption to commerce, that shall be in effect until the date of implementation of the food import certification program under section 805 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a) of this section.

Information clearinghouses

Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 et seq.), as amended by section 2 of this Act, is amended by adding at the end the following:

419.

Information clearinghouses

(a)

Website on food safety issues

(1)

In general

The Secretary, in consultation with the Secretary of Agriculture, shall develop and maintain a Website with public information that— (A)provides information on Federal food standards and best practice requirements for food preparation; (B)assists health professionals to improve their ability— (i)to diagnose and treat food-related illness; and (ii)to advise individuals whose health conditions place them at particular risk; and (C)promotes the public awareness of food safety issues. (2)

Resources

The Secretary shall utilize the resources of the Food and Drug Administration and the Centers for Disease Control and Prevention to carry out this subsection. (b)

Website on school curricula regarding food safety

The Secretary, in consultation with the Secretary of Education, shall develop and maintain a Website to provide the public with appropriate information on developing school curriculum regarding food safety issues.

Whistleblower protection

Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 et seq.), as amended by sections 2 and 4 of this Act, is amended by adding at the end the following:

420.

Whistleblower protection

(a)

Prohibition

No employee or other person may be harassed, prosecuted, held liable, or discriminated against in any way because that person— (1)has commenced, caused to be commenced, or is about to commence a proceeding, testified or is about to testify at a proceeding, or assisted or participated or is about to assist or participate in any manner in such a proceeding or in any other action to carry out the purposes, functions, or responsibilities of this Act; or (2)is refusing to violate or assist in violation of this Act. (b)

Procedures

The process and procedures with respect to prohibited discrimination under subsection (a) shall be governed by the applicable provisions of section 31105 of title 49, United States Code, unless the party bringing an action under this subsection chooses alternative dispute resolution procedures such as mediation or arbitration. (c)

Burdens of Proof

The legal burdens of proof with respect to prohibited discrimination under subsection (a) shall be governed by the applicable provisions of sections 1214 and 1221 of title 5, United States Code.

Authorization of appropriations

There are authorized to be appropriated to carry out this Act and the amendments made by this Act such sums as may be necessary for each of fiscal years 2009 through 2013.