2000
<PRE>[DOCID: f:s1551is.txt]






107th CONGRESS
  1st Session
                                S. 1551

  To amend the Federal Food, Drug, and Cosmetic Act to add provisions 
          regarding protecting the United States food supply.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            October 15, 2001

 Mrs. Clinton introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
  To amend the Federal Food, Drug, and Cosmetic Act to add provisions 
          regarding protecting the United States food supply.

    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 ``Protecting the Food Supply from 
Bioterrorism Act''.

SEC. 2. REGISTRATION OF PROCESSORS AND IMPORTERS.

    (a) Registration.--
            (1) In general.--Any facility engaged in processing or 
        handling food products for consumption in the United States, 
        including any facility of an importer, shall be registered with 
        the Secretary. To obtain the registration--
                    (A) for a domestic facility not described in 
                subparagraph (B), the owner, operator, or agent in 
                charge of the facility shall submit an application to 
                the Secretary; and
                    (B) for a facility of an importer, or for a foreign 
                facility, the importer seeking to import the food 
                product processed or handled in the facility shall 
                submit the application.
            (2) Application.--
                    (A) In general.--The applicant shall submit the 
                application to the Secretary in such manner and 
                containing such information as the Secretary shall 
                prescribe.
                    (B) Submission.--The applicant shall submit the 
                application as provided for by the Secretary.
                    (C) Contents.--In the case of an application 
                submitted for a foreign facility, the application shall 
                contain, at a minimum, such information as the 
                Secretary may require demonstrating that the facility, 
                and the foreign nation involved, will permit 
                inspections described in this title.
            (3) Procedure.--Upon receipt and review of a completed 
        application described in paragraph (1), the Secretary shall 
        issue to the applicant a certificate of registration unless the 
        Secretary finds that there is good cause for denial of the 
        application. The Secretary shall promptly notify the applicant 
        of the denial, include in the notification a written 
        explanation of the reasons for such denial, and provide an 
        opportunity for a hearing or reapplication upon request.
            (4) List.--The Secretary shall compile and maintain an up-
        to-date list of facilities that are registered under this 
        section.
    (b) Suspension of Registration.--
            (1) Basis.--The registration of a facility, including the 
        facility of an importer, may be suspended immediately by the 
        Secretary for--
                    (A) failure to permit access to the facility for 
                inspection under this Act;
                    (B) violation of a food safety law, including a 
                regulation issued under a food safety law, concerning 
                the facility, in a case in which the Secretary 
                determines that such suspension is likely to prevent a 
                significant risk of adverse health consequences; or
                    (C) conviction of the applicant or registrant in 
                any Federal or State court of--
                            (i) any felony relating to food, whether or 
                        not the felony is based upon the acquisition, 
                        handling, or distribution of adulterated or 
                        misbranded food; or
                            (ii) more than 1 violation of any law 
                        relating to food, whether or not the violation 
                        involves any fraud in connection with 
                        transactions in food.
            (2) Impact.--No person may introduce a food product into 
        interstate commerce, or offer a food product for import into 
        the United States, from a facility with a suspended 
        registration.
            (3) Reinstatement.--Any registration suspended under 
        paragraph (1) may be reinstated whenever the Secretary 
        determines that the suspension is no longer necessary.
    (c) Exemption Authority.--The Secretary may by regulation exempt 
classes of facilities from the requirements of subsection (a) if the 
Secretary determines that the registration of such facilities is not 
needed for effective enforcement of a food safety law.
    (d) Definitions.--In this section:
            (1) Facility.--The term ``facility'' includes any factory, 
        warehouse, or establishment (including a factory, warehouse, or 
        establishment of an importer), that handles or processes food.
            (2) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.

SEC. 3. ENFORCEMENT AUTHORITIES.

    (a) Detention.--Chapter III of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 331 et seq.) is amended by inserting after section 303 
the following:

``SEC. 304A. ADMINISTRATIVE DETENTION.

    ``Any food that the Secretary reasonably believes may be 
adulterated or misbranded when introduced into or while in interstate 
commerce, or while held for sale (whether or not the first sale) after 
shipment in interstate commerce, may be detained and held by the 
Secretary for not more than 20 days, pending action regarding such food 
under sections 302 or 304. During such 20-day period, such food shall 
not be moved by any person (other than the Secretary) from the place at 
which such food was seized until the Secretary authorizes a release.''.
    (b) Records.--Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.) is amended by inserting after section 404 
the following:

``SEC. 404A. RECORDS.

    ``(a) In General.--The Secretary shall promulgate regulations 
requiring each factory, warehouse, or establishment in which food is 
manufactured, processed, packed, or held for introduction into 
interstate commerce to retain records to effect and monitor any recall 
authorized under this Act and to retain any other records reasonably 
bearing on food that is manufactured or held in the facility that may 
be in violation of a Federal or State food safety law. Such regulations 
shall require that the Secretary have access to and be allowed to copy 
such records at all times. It shall be unlawful for any person to fail 
to retain such records or to fail to permit the Secretary to inspect or 
copy such records.
    ``(b) Content.--The records retained under subsection (a) shall be 
maintained for a reasonable period of time as determined by the 
Secretary. The records shall include information concerning--
            ``(1)(A) the origin, receipt, delivery, sale, movement, 
        holding, and disposition of food products, or ingredients for 
        food products, processed or handled at the facility;
            ``(B) the identity and amount of ingredients used in the 
        food involved;
            ``(C) the processing or handling of food;
            ``(D) the results of laboratory, sanitation, or other 
        quality control tests performed on the food or in the facility; 
        and
            ``(E) consumer complaints concerning food or the packaging 
        of the food; and
            ``(2) other
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 matters reasonably related to whether food 
        products processed or handled at the facility may be in 
        violation of a food safety law under this Act.
    ``(c) Rule of Construction.--Nothing in this section shall be 
construed to alter or amend in any way section 301(j) of this Act or 
section 552 of title 5 or section 1995 of title 18, United States 
Code.''.
    (c) Penalties.--Section 303(g)(2)(A) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 333(g)(2)(A)) is amended by striking 
``402(a)(2)(B)'' and inserting ``402''.
    (d) Cross-Utilization of Inspectors.--Section 702 of the Federal 
Food, Drug, and Cosmetic Act is amended by inserting after the first 
sentence: ``In the case of food, the Secretary is additionally 
authorized to conduct examinations and investigations for the purposes 
of this Act through the officers and employees of the Department of 
Agriculture, duly commissioned by the Secretary as an officer of the 
Department of Health and Human Services.''.
    (e) Clarification of Authorities Based on Epidemiological 
Evidence.--Section 402 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 342) is amended--
            (1) in subsection (a)--
                    (A) by striking ``; or (7)'' and inserting ``; 
                (7)''; and
                    (B) by striking ``to section 409.'' and inserting 
                ``to section 409; or (8) if the Secretary declares such 
                food to pose an immediate risk of significant harm to 
                public health or safety based on epidemiological 
                evidence, except that the authority to make such 
                declaration shall not be delegated and the Secretary 
                shall promptly after such a declaration initiate a 
                proceeding in accordance with sections 554 and 556 of 
                title 5, United States Code, to affirm or withdraw the 
                declaration.''.

SEC. 4. NOTIFICATION AND RECALL.

    Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
341 et seq.) is amended by adding after section 409 the following:

``SEC. 409A. NOTIFICATION AND RECALL OF UNSAFE FOOD.

    ``(a) Notice to Secretary of Violation.--Any person (other than a 
household consumer or other individual who is the intended consumer of 
an article of food) that has a reasonable basis for believing that any 
article of food introduced into or in interstate commerce, or held for 
sale (whether or not the first sale) after shipment in interstate 
commerce, may be in violation of a food safety law shall immediately 
notify the Secretary, in such manner and by such means as the Secretary 
may by regulation prescribe, of the identity and location of such 
article.
    ``(b) Recall and Consumer Notification.--
            ``(1) Voluntary procedures.--If the Secretary finds, on 
        notification under subsection (a) or otherwise, that any 
        article of food is in violation of a food safety law when 
        introduced into or while in interstate commerce or while held 
        for sale (whether or not the first sale) after shipment in 
        interstate commerce and there is a reasonable probability that 
        such article, if consumed, would present a threat to public 
        health, as determined by the Secretary, the Secretary shall 
        provide the appropriate persons (including the manufacturers, 
        importers, distributors, or retailers of the article) 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 article to 
                        immediately cease such activities with respect 
                        to such article; 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, 
                notice of the finding of the Secretary to consumers to 
                whom such article was, or may have been, distributed; 
                or
                    ``(E) take any combination of the above measures, 
                as determined by the Secretary to be appropriate in the 
                circumstances.
            ``(2) Prehearing order to cease distribution and give 
        notice.--If such appropriate person refuses to or does not 
        voluntarily cease distribution, make notification, recall such 
        article, or provide notice to consumers, as applicable, within 
        the time and in the manner prescribed by the Secretary, the 
        Secretary shall, by order, require, as the Secretary determines 
        to be 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 article to 
                        immediately cease such activities with respect 
                        to such article; 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 shall, as the Secretary determines to be necessary, 
        provide notice of the finding of the Secretary under paragraph 
        (1) to consumers to whom such article was, or may have been, 
        distributed.
    ``(c) Hearing on Order.--The Secretary shall provide any person 
subject to an order under subsection (b) with an opportunity for a 
hearing, to be held as soon as practicable but not later than 2 days 
after the issuance of the order, on the actions required by the order 
and on whether the article that is the subject of the order should be 
recalled.
    ``(d) Post-Hearing Recall Order.--
            ``(1) Amendment of order.--If, after providing an 
        opportunity for a hearing under subsection (c), the Secretary 
        determines that there is a reasonable probability that the 
        article that is the subject of an order under subsection (b), 
        if consumed, presents a threat to public health, the Secretary, 
        as the Secretary determines to be necessary, may--
                    ``(A) amend the order to require recall of such 
                article or other appropriate action;
                    ``(B) specify a timetable in which the recall shall 
                occur;
                    ``(C) require periodic reports to the Secretary 
                describing the progress of the recall; and
                    ``(D) provide notice of the recall to consumers to 
                whom such article was, or may have been, distributed.
            ``(2) Vacation 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 the order.
    ``(e) Remedies Not Exclusive.--The remedies provided in this 
section shall be in addition to and not exclusive of other remedies 
that may be available.''.

SEC. 5. DEFINITIONS AND STANDARDS FOR FOOD.

    Section 401 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
341 et seq.) is amended--
            (1) by striking ``Whenever in the judgment'' and inserting 
        ``(a) Whenever in the judgment''; and
            (2) by adding at the end the follow
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ing:
    ``(b) The Secretary shall issue regulations that establish 
standards for process controls and tolerances for contaminants in food 
products as appropriate to assure that food from both domestic and 
imported facilities are in compliance with the requirements of food 
safety laws under this Act.''.

SEC. 6. STRENGTHENING IMPORT INSPECTIONS.

    (a) Assuring Equivalent Standards for Imports.--Section 402 of the 
Federal Food, Drug, and Cosmetic Act is amended by adding at the end 
the following:
    ``(h) If it is food that is offered for import into the United 
States and has not been manufactured, processed, packed or held under a 
system or conditions, or subject to measures that meet the requirements 
of this Act, or that otherwise achieve the level of protection 
required, as determined by the Secretary, for such food manufactured, 
processed, packed or held in the United States. In determining whether 
a system, conditions, or measures meet the requirements of this Act or 
otherwise achieve the level of protection required, the Secretary may 
consider whether an officer or employee, duly designated by the 
Secretary has requested, and has been refused, access to the 
establishment or location where such food was manufactured, processed, 
packed or held for the purpose of inspection (including sample 
collection), testing, or other relevant procedures, at a reasonable 
time and in a reasonable manner, and may deny the importation of such 
food from such establishment or location on the basis of such refusal 
and other relevant factors.''.
    (b) Advance Notice Regarding Imported Food.--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. NOTICE REGARDING IMPORTED FOOD.

    ``The Secretary of Health and Human Services, in consultation with 
the Secretary of the Treasury, may require a manufacturer or importer 
of food imported or offered for import into the United States to 
provide the Secretary of Health and Human Services with advance notice 
of such importation before such importation.''.

SEC. 7. RESEARCH AND TRAINING AMENDMENTS TO THE PUBLIC HEALTH SERVICE 
              ACT.

    Subpart 6 of title IV of the Public Health Service Act (42 U.S.C. 
285f et seq.) is amended by adding at the end the following:

``SEC. 447C. FOOD SECURITY RESEARCH INITIATIVE THROUGH DIRECTOR OF 
              NATIONAL INSTITUTES OF HEALTH.

    ``(a) Expansion, Intensification, and Coordination of Activities.--
            ``(1) In general.--The Director of NIH, in consultation 
        with the Joint Institute for Food Safety Research, and other 
        agencies as appropriate, shall coordinate, expand, and 
        intensify their programs concerning food-borne illness, 
        including food-borne illnesses potentially associated with 
        terrorism.
    ``(b) Centers of Excellence.--
            ``(1) In general.--The Director of NIH shall award grants 
        and contracts to public or nonprofit private entities to pay 
        all or part of the costs of planning, establishing, improving, 
        and providing basic operating support for centers of excellence 
        for research into and training in food-borne illness, including 
        food-borne illnesses potentially associated with terrorism.
            ``(2) Policies.--A grant or contract awarded under 
        paragraph (1) shall be entered into an accordance with policies 
        established by the Director of NIH.
            ``(3) Use of funds.--Funds awarded under this subsection 
        may be used for--
                    ``(A) the development of diagnostic techniques that 
                are capable of rapidly detecting and identifying agents 
                of food-borne illness, including food-borne illnesses 
                that are potentially associated with terrorism; and
                    ``(B) clinical training, including training for 
                allied health professionals, continuing education for 
                health professionals and allied health professions 
                personnel, and information programs for the public with 
                respect to food-borne illness, including food-borne 
                illness potentially associated with terrorism.
    ``(c) Coordination With Other Institutes.--The Director of NIH 
shall coordinate the activities under this section with similar 
activities conducted by other national research institutes, centers, 
and agencies of the National Institutes of Health, the Food and Drug 
Administration, and other agencies to the extent that such institutes, 
centers, and agencies have responsibilities that are related to food-
borne illness, including food-borne illness potentially associated with 
terrorism.
    ``(d) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $50,000,000 for fiscal year 
2002, and such sums as may be necessary for subsequent fiscal years.''.

SEC. 8. SURVEILLANCE AND INFORMATION GRANTS AND AUTHORITIES.

    Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) 
is amended by inserting after section 317P the following:

``SEC. 317Q. FOOD SAFETY GRANTS.

    ``(a) In General.--The Secretary may award food safety grants to 
States to expand the number of States participating in Pulsenet, the 
Foodborne Diseases Active Surveillance Network, and other networks to 
enhance Federal, State, and local food safety efforts.
    ``(b) Use of Funds.--Funds awarded under this section shall be used 
by States to assist such States in meeting the costs of establishing 
and maintaining the food safety surveillance, technical and laboratory 
capacity needed to participate in Pulsenet, Foodborne Diseases Active 
Surveillance Network, and other networks to enhance Federal, State, and 
local food safety efforts.
    ``(c) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $40,000,000 for fiscal year 
2002, and such sums as may be necessary for subsequent fiscal years.

``SEC. 317R. SURVEILLANCE OF ANIMAL AND HUMAN HEALTH.

    ``(a) In General.--The Secretary, through the Commissioner of the 
Food and Drug Administration, the Director of the Centers for Disease 
Control and Prevention, and the Secretary of Agriculture, shall develop 
and implement a plan for coordinating the surveillance for zoonotic 
disease and human disease.
    ``(b) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, such sums as may be necessary.

``SEC. 317S. INFORMATION RESOURCES FOR HEALTH PROFESSIONALS.

    ``(a) In General.--The Secretary, through the Director of the 
Centers for Disease Control may establish, or, may enter into contracts 
to establish hotlines, information technology systems, or other 
information resources to assist and educate health professionals in the 
diagnosis and detection of illnesses caused by bioterrorism, including 
food-borne bioterrorism.
    ``(b) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $10,000,000 for fiscal year 
2002, and such sums as may be necessary for subsequent fiscal years.''.

SEC. 9. DEFINITIONS.

    Chapter II of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321 et seq.) is amended by adding at the end the following:
    ``(kk) The term `contaminant' includes a bacterium, a chemical 
contaminant, a natural toxin, a virus, a parasite, and a physical 
hazard, that when found on or in food can cause human illness or 
injury.
    ``(ll) The term `process' means the commercial harvesting, 
preparation, manufacture, or transportation of a food product.''.
                                 &lt;all&gt;

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