HR 5827 IHCommentsClose CommentsPermalink

To amend the Federal Food, Drug, and Cosmetic Act to improve food safety.CommentsClose CommentsPermalink

April 16, 2008

Mr. ROSKAM (for himself and Mr. KIRK) introduced the following bill; which was referred to the Committee on Energy and CommerceCommentsClose CommentsPermalink

To amend the Federal Food, Drug, and Cosmetic Act to improve food safety.CommentsClose CommentsPermalink

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

SECTION 1. SHORT TITLE.

This Act may be cited as the `Keeping America's Food Safe Act of 2008'.CommentsClose CommentsPermalink

SEC. 2. 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:CommentsClose CommentsPermalink

`SEC. 418. FOOD SAFETY LABORATORIES AND SAMPLING SERVICES.

`(a) Definitions- In this section:CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(2) SAMPLING SERVICE- The term `sampling service' means an establishment that collects samples of an imported food.CommentsClose CommentsPermalink





`(b) Certification Requirement-CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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--CommentsClose CommentsPermalink





`(A) be accredited as being in compliance with standards set by the International Organization for Standardization;CommentsClose CommentsPermalink





`(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;CommentsClose CommentsPermalink





`(C) agree to permit the Secretary to conduct routine audits of the facilities to ensure ongoing compliance with accreditation and certification requirements;CommentsClose CommentsPermalink





`(D) submit with such application a fee established by the Secretary in an amount sufficient to cover the cost of application review, including inspection; andCommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.'.CommentsClose CommentsPermalink





(b) Enforcement- Section 303(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)) is amended--CommentsClose CommentsPermalink





(1) by redesignating paragraphs (5), (6), and (7) as paragraphs (7), (8), and (9), respectively;CommentsClose CommentsPermalink





(2) by inserting after paragraph (4) the following:CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.'.CommentsClose CommentsPermalink





(3) in paragraph (2)(C), by striking `paragraph (5)(A)' and inserting `paragraph (7)(A)';CommentsClose CommentsPermalink





(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)';CommentsClose CommentsPermalink





(5) in paragraph (8), as so redesignated, by striking `paragraph (5)(A)' and inserting `paragraph (7)(A)'; andCommentsClose CommentsPermalink





(6) in paragraph (9), by striking `paragraph (6)' each place it appears and inserting `paragraph (8)'.CommentsClose CommentsPermalink

SEC. 3. 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:CommentsClose CommentsPermalink

`SEC. 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.CommentsClose CommentsPermalink





`(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--CommentsClose CommentsPermalink





`(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; andCommentsClose CommentsPermalink





`(2) how well the food safety programs of the foreign country function to minimize any adverse effects on such safety.CommentsClose CommentsPermalink





`(c) Requirement of Certification for Importing-CommentsClose CommentsPermalink





`(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--CommentsClose CommentsPermalink





`(A) a certification for such facility in effect under subsection (d)(1); orCommentsClose CommentsPermalink





`(B) a certification for such country in effect under subsection (d)(2).CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(d) Certification-CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(2) FOREIGN COUNTRY- A foreign country may obtain a certification by the Secretary stating that--CommentsClose CommentsPermalink





`(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; andCommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(e) Agreements With Foreign Nations- Any certification of a foreign country under subsection (d)(2) shall--CommentsClose CommentsPermalink





`(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;CommentsClose CommentsPermalink





`(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; andCommentsClose CommentsPermalink





`(3) provide for reciprocity with respect to the treatment of food imports and exports between the United States and the foreign country.CommentsClose CommentsPermalink





`(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).CommentsClose CommentsPermalink





`(g) Revocation of Certification- The Secretary may, with respect to a foreign facility or foreign country, revoke a certification under subsection (d) if--CommentsClose CommentsPermalink





`(1) food from the foreign facility or foreign country is linked to an outbreak of human illness;CommentsClose CommentsPermalink





`(2) the Secretary determines that the foreign facility or foreign country is no longer meeting the requirements described in subsection (d); orCommentsClose CommentsPermalink





`(3) United States officials are not allowed to conduct such audits and investigations as may be necessary to carry out this section.CommentsClose CommentsPermalink





`(h) Duration of Certification- Each certification under subsection (d) shall be for a period of not more than 5 years.CommentsClose CommentsPermalink





`(i) Inspection; Independent Audits-CommentsClose CommentsPermalink





`(1) AUTHORIZATION- In determining whether to issue a certification under subsection (d) or revoke a certification under subsection (g), the Secretary is authorized to--CommentsClose CommentsPermalink





`(A) inspect foreign facilities to ensure compliance with the food safety standards described in subsection (a); andCommentsClose CommentsPermalink





`(B) consider independent audits, product test data, and other relevant information generated by the facility, importer, or foreign country involved.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(j) Enforcement- The Secretary is authorized to--CommentsClose CommentsPermalink





`(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;CommentsClose CommentsPermalink





`(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; andCommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.'.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink

SEC. 4. 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:CommentsClose CommentsPermalink

`SEC. 419. INFORMATION CLEARINGHOUSES.

`(a) Website on Food Safety Issues-CommentsClose CommentsPermalink





`(1) IN GENERAL- The Secretary, in consultation with the Secretary of Agriculture, shall develop and maintain a Website with public information that--CommentsClose CommentsPermalink





`(A) provides information on Federal food standards and best practice requirements for food preparation;CommentsClose CommentsPermalink





`(B) assists health professionals to improve their ability--CommentsClose CommentsPermalink





`(i) to diagnose and treat food-related illness; andCommentsClose CommentsPermalink





`(ii) to advise individuals whose health conditions place them at particular risk; andCommentsClose CommentsPermalink





`(C) promotes the public awareness of food safety issues.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.'.CommentsClose CommentsPermalink

SEC. 5. 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:CommentsClose CommentsPermalink

`SEC. 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--CommentsClose CommentsPermalink





`(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; orCommentsClose CommentsPermalink





`(2) is refusing to violate or assist in violation of this Act.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.'.CommentsClose CommentsPermalink

SEC. 6. 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.CommentsClose CommentsPermalink