[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 999 Introduced in House (IH)]

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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