Text: H.R.999 — 111th Congress (2009-2010)All Information (Except Text)

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Introduced in House (02/11/2009)


111th CONGRESS
1st Session
H. R. 999


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


IN THE HOUSE OF REPRESENTATIVES

February 11, 2009

Mr. Roskam (for himself and Mr. Kirk) 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 improve food safety.

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

SECTION 1. Short title.

This Act may be cited as the “Keeping America’s Food Safe Act of 2009”.

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:

“SEC. 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)”.

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:

“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.

“(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.—Paragraph (1) does not apply if the Secretary determines that the certification process described in subsection (d) is not needed for the Secretary’s evaluation of whether the facility’s or country’s standards for food safety, inspection, labeling, and consumer protection are 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.

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:

“SEC. 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.”.

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:

“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—

“(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.”.

SEC. 6. Reportable Food Registry.

(a) Responsible parties.—Paragraph (1) of section 417(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350f(a)) is amended to read as follows:

“(1) RESPONSIBLE PARTY.—The term ‘responsible party’, with respect to an article of food, means a person that—

“(A) submits the registration under section 415(a) for a food facility that is required to register under section 415(a), at which such article of food is manufactured, processed, packed, or held; or

“(B) is an establishment that analyzes or tests samples of food for consumption in the United States to ensure the safety of such food.”.

(b) Individual analysis or test.—Subsection (d) of section 417 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350f(d)) is amended by adding at the end the following:

“(9) INDIVIDUAL ANALYSIS OR TEST.—If any individual analysis or test of an article of food by a responsible party produces a result suggesting that the article is reportable food, the responsible party shall send a notice within 24 hours to the Food and Drug Administration containing the results of such analysis or test for review consistent with subsection (b)(2), irrespective of whether the party subsequently determines, based on additional analysis or testing or other factors, that such article is not reportable food.”.

(c) Conforming amendments.—Section 417 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350f) is amended—

(1) in subsection (e)(1), by striking “The registration” and inserting “In the case of a responsible party described in subsection (a)(1)(A), the registration”; and

(2) in subsection (f)(2)(A), by striking “not required to register under section 415” and inserting “not responsible parties”.

SEC. 7. Recall authority.

(a) Prohibition.—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 violation of an order to recall food under section 417A.”.

(b) Recall authority.—Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amended by inserting after section 417 the following:

“SEC. 417A. Recall authority.

“(a) Request To initiate a recall.—The Secretary may request an establishment to initiate a recall of food when the Secretary makes each of the following determinations:

“(1) The food has been distributed and presents a risk of illness or injury or gross consumer deception.

“(2) The establishment has not initiated a recall of the food.

“(3) Action by the Secretary is necessary to protect the public health.

“(b) Order.—If an establishment subject to a request under subsection (a) does not initiate a voluntary recall of the food involved within 24 hours of receiving such request, the Secretary may issue an order requiring such establishment to conduct a recall of the food.

“(c) Definition.—In this section, term ‘establishment’ means an establishment required to be registered under section 415.”.

SEC. 8. 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 2010 through 2014.


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