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U.S. Department of Health and Human Services

Regulatory Information

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Title III -- Protecting Safety and Security of Food and Drug Supply

Subtitle A--Protection of Food Supply

SEC. 301. <<NOTE: 21 USC 341 note.>>  FOOD SAFETY AND SECURITY STRATEGY.

    (a) In General.--The President's Council on Food Safety (as 
established by Executive Order No. 13100) shall, in consultation with 
the Secretary of Transportation, the Secretary of the Treasury, other 
relevant Federal agencies, the food industry, consumer and producer 
groups, scientific organizations, and the States, develop a crisis 
communications and education strategy with respect to bioterrorist 
threats to the food supply. Such strategy shall address threat 
assessments; technologies and procedures for securing food processing 
and manufacturing facilities and modes of transportation; response and 
notification procedures; and risk communications to the public.
    (b) Authorization of Appropriations.--For the purpose of 
implementing the strategy developed under subsection (a), there are 
authorized to be appropriated $750,000 for fiscal year 2002, and such 
sums as may be necessary for each subsequent fiscal year.

SEC. 302. PROTECTION AGAINST ADULTERATION OF FOOD.

    (a) Increasing Inspections for Detection of Adulteration of Food.--
Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) 
is amended by adding at the end the following subsection:
    ``(h)(1) The Secretary shall give high priority to increasing the 
number of inspections under this section for the purpose of enabling the 
Secretary to inspect food offered for import at ports of entry into the 
United States, with the greatest priority given to inspections to detect 
the intentional adulteration of food.''.
    (b) Improvements to Information Management Systems.--Section 801(h) 
of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a) 
of this section, is amended by adding at the end the following 
paragraph:
    ``(2) The Secretary shall give high priority to making necessary 
improvements to the information management systems of the Food and Drug 
Administration that contain information related to foods imported or 
offered for import into the United States for purposes of improving the 
ability of the Secretary to allocate resources, detect the intentional 
adulteration of food, and facilitate the importation of food that is in 
compliance with this Act.''.
    (c) Linkages With Appropriate Public Entities.--Section 801(h) of 
the Federal Food, Drug, and Cosmetic Act, as amended by subsection (b) 
of this section, is amended by adding at the end the following 
paragraph:
    ``(3) The Secretary shall improve linkages with other regulatory 
agencies of the Federal Government that share responsibility for food 
safety, and shall with respect to such safety improve linkages
with the States and Indian tribes (as defined in section 4(e) of the 
Indian Self-Determination and Education Assistance Act (25 U.S.C. 
450b(e))).''.
    (d) Testing for Rapid Detection of Adulteration of Food.--Section 
801 of the Federal Food, Drug, and Cosmetic Act, as amended by 
subsection (a) of this section, is amended by adding at the end the 
following:
    ``(i)(1) For use in inspections of food under this section, the 
Secretary shall provide for research on the development of tests and 
sampling methodologies--
            ``(A) whose purpose is to test food in order to rapidly 
        detect the adulteration of the food, with the greatest priority 
        given to detect the intentional adulteration of food; and
            ``(B) whose results offer significant improvements over the 
        available technology in terms of accuracy, timing, or costs.

    ``(2) In providing for research under paragraph (1), the Secretary 
shall give priority to conducting research on the development of tests 
that are suitable for inspections of food at ports of entry into the 
United States.
    ``(3) In providing for research under paragraph (1), the Secretary 
shall as appropriate coordinate with the Director of the Centers for 
Disease Control and Prevention, the Director of the National Institutes 
of Health, the Administrator of the Environmental Protection Agency, and 
the Secretary of Agriculture.
    ``(4) <<NOTE: Reports.>>  The Secretary shall annually submit to the 
Committee on Energy and Commerce of the House of Representatives, and 
the Committee on Health, Education, Labor, and Pensions of the Senate, a 
report describing the progress made in research under paragraph (1), 
including progress regarding paragraph (2).''.

    (e) <<NOTE: Deadline.>>  Assessment of Threat of Intentional 
Adulteration of Food.--The Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, shall ensure that, 
not later than six months after the date of the enactment of this Act--
            (1) the assessment that (as of such date of enactment) is 
        being conducted on the threat of the intentional adulteration of 
        food is completed; and
            (2) <<NOTE: Reports.>>  a report describing the findings of 
        the assessment is submitted to the Committee on Energy and 
        Commerce of the House of Representatives and to the Committee on 
        Health, Education, Labor, and Pensions of the Senate.

    (f) Authorization of Appropriations.--For the purpose of carrying 
out this section and the amendments made by this section, there are 
authorized to be appropriated $100,000,000 for fiscal year 2002, and 
such sums as may be necessary for each of the fiscal years 2003 through 
2006, in addition to other authorizations of appropriations that are 
available for such purpose.

SEC. 303. ADMINISTRATIVE DETENTION.

    (a) Expanded Authority.--Section 304 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 334) is amended by adding at the end the 
following subsection:
    ``(h) Administrative Detention of Foods.--
            ``(1) Detention authority.--
                    ``(A) In general.--An officer or qualified employee 
                of the Food and Drug Administration may order the 
                detention, in accordance with this subsection, of any 
                article of food
                that is found during an inspection, examination, or 
                investigation under this Act conducted by such officer 
                or qualified employee, if the officer or qualified 
                employee has credible evidence or information indicating 
                that such article presents a threat of serious adverse 
                health consequences or death to humans or animals.
                    ``(B) Secretary's approval.--An article of food may 
                be ordered detained under subparagraph (A) only if the 
                Secretary or an official designated by the Secretary 
                approves the order. An official may not be so designated 
                unless the official is the director of the district 
                under this Act in which the article involved is located, 
                or is an official senior to such director.
            ``(2) Period of detention.--An article of food may be 
        detained under paragraph (1) for a reasonable period, not to 
        exceed 20 days, unless a greater period, not to exceed 30 days, 
        is necessary, to enable the Secretary to institute an action 
        under subsection (a) or section 302. <<NOTE: Regulation.>>  The 
        Secretary shall by regulation provide for procedures for 
        instituting such action on an expedited basis with respect to 
        perishable foods.
            ``(3) Security of detained article.--An order under 
        paragraph (1) with respect to an article of food may require 
        that such article be labeled or marked as detained, and shall 
        require that the article be removed to a secure facility, as 
        appropriate. An article subject to such an order shall not be 
        transferred by any person from the place at which the article is 
        ordered detained, or from the place to which the article is so 
        removed, as the case may be, until released by the Secretary or 
        until the expiration of the detention period applicable under 
        such order, whichever occurs first. This subsection may not be 
        construed as authorizing the delivery of the article pursuant to 
        the execution of a bond while the article is subject to the 
        order, and section 801(b) does not authorize the delivery of the 
        article pursuant to the execution of a bond while the article is 
        subject to the order.
            ``(4) Appeal of detention order.--
                    ``(A) In general.--With respect to an article of 
                food ordered detained under paragraph (1), any person 
                who would be entitled to be a claimant for such article 
                if the article were seized under subsection (a) may 
                appeal the order to the Secretary. Within five days 
                after such an appeal is filed, the Secretary, after 
                providing opportunity for an informal hearing, shall 
                confirm or terminate the order involved, and such 
                confirmation by the Secretary shall be considered a 
                final agency action for purposes of section 702 of title 
                5, United States Code. If during such five-day period 
                the Secretary fails to provide such an opportunity, or 
                to confirm or terminate such order, the order is deemed 
                to be terminated.
                    ``(B) Effect of instituting court action.--The 
                process under subparagraph (A) for the appeal of an 
                order under paragraph (1) terminates if the Secretary 
                institutes an action under subsection (a) or section 302 
                regarding the article of food involved.''.

    (b) Prohibited Act.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the 
following:

    ``(bb) The transfer of an article of food in violation of an order 
under section 304(h), or the removal or alteration of any mark or label 
required by the order to identify the article as detained.''.
    (c) Temporary Holds at Ports of Entry.--Section 801 of the Federal 
Food, Drug, and Cosmetic Act, as amended by section 302(d)of this 
Act, <<NOTE: 21 USC 381.>>  is amended by adding at the end the 
following:

    ``(j)(1) If an officer or qualified employee of the Food and Drug 
Administration has credible evidence or information indicating that an 
article of food presents a threat of serious adverse health consequences 
or death to humans or animals, and such officer or qualified employee is 
unable to inspect, examine, or investigate such article upon the article 
being offered for import at a port of entry into the United States, the 
officer or qualified employee shall request the Secretary of Treasury to 
hold the food at the port of entry for a reasonable period of time, not 
to exceed 24 hours, for the purpose of enabling the Secretary to 
inspect, examine, or investigate the article as appropriate.
    ``(2) The Secretary shall request the Secretary of Treasury to 
remove an article held pursuant to paragraph (1) to a secure facility, 
as appropriate. During the period of time that such article is so held, 
the article shall not be transferred by any person from the port of 
entry into the United States for the article, or from the secure 
facility to which the article has been removed, as the case may be. 
Subsection (b) does not authorize the delivery of the article pursuant 
to the execution of a bond while the article is so held.
    ``(3) An officer or qualified employee of the Food and Drug 
Administration may make a request under paragraph (1) only if the 
Secretary or an official designated by the Secretary approves the 
request. An official may not be so designated unless the official is the 
director of the district under this Act in which the article involved is 
located, or is an official senior to such director.
    ``(4) With respect to an article of food for which a request under 
paragraph (1) is made, the Secretary, promptly after the request is 
made, shall notify the State in which the port of entry involved is 
located that the request has been made, and as applicable, that such 
article is being held under this subsection.''.

SEC. 304. DEBARMENT FOR REPEATED OR SERIOUS FOOD IMPORT VIOLATIONS.

    (a) Debarment Authority.--
            (1) Permissive debarment.--Section 306(b)(1) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)(1)) is amended--
                    (A) in subparagraph (A), by striking ``or'' after 
                the comma at the end;
                    (B) in subparagraph (B), by striking the period at 
                the end and inserting ``, or''; and
                    (C) by adding at the end the following subparagraph:
                    ``(C) a person from importing an article of food or 
                offering such an article for import into the United 
                States.''.
            (2) Amendment regarding debarment grounds.--Section 306(b)) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)) 
        is amended--
                    (A) in paragraph (2), in the matter preceding 
                subparagraph (A), by inserting ``subparagraph (A) or (B) 
                of'' before ``paragraph (1)'';
                    (B) by redesignating paragraph (3) as paragraph (4); 
                and
                    (C) by inserting after paragraph (2) the following 
                paragraph:
            ``(3) Persons subject to permissive debarment; food 
        importation.--A person is subject to debarment under paragraph 
        (1)(C) if--
                    ``(A) the person has been convicted of a felony for 
                conduct relating to the importation into the United 
                States of any food; or
                    ``(B) the person has engaged in a pattern of 
                importing or offering for import adulterated food that 
                presents a threat of serious adverse health consequences 
                or death to humans or animals.''.

    (b) Conforming Amendments.--Section 306 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 335a) is amended--
            (1) in subsection (a), in the heading for the subsection, by 
        striking ``Mandatory Debarment.--'' and inserting ``Mandatory 
        Debarment; Certain Drug Applications.--'';
            (2) in subsection (b)--
                    (A) in the heading for the subsection, by striking 
                ``Permissive Debarment.--'' and inserting ``Permissive 
                Debarment; Certain Drug Applications; Food Imports.--''; 
                and
                    (B) in paragraph (2), in the heading for the 
                paragraph, by striking ``permissive debarment.--'' and 
                inserting ``permissive debarment; certain drug 
                applications.--'';
            (3) in subsection (c)(2)(A)(iii), by striking ``subsection 
        (b)(2)'' and inserting ``paragraph (2) or (3) of subsection 
        (b)'';
            (4) in subsection (d)(3)--
                    (A) in subparagraph (A)(i), by striking ``or 
                (b)(2)(A)'' and inserting `` or paragraph (2)(A) or (3) 
                of subsection (b)'';
                    (B) in subparagraph (A)(ii)(II), by inserting ``in 
                applicable cases,'' before ``sufficient audits'';
                    (C) in subparagraph (B), in each of clauses (i) and 
                (ii), by inserting ``or subsection (b)(3)'' after 
                ``subsection (b)(2)(B)''; and
                    (D) in subparagraph (B)(ii), by inserting before the 
                period the following: ``or the food importation process, 
                as the case may be''.

    (c) Effective Dates.--Section 306(l)(2) of the Federal Food, Drug, 
and Cosmetic Act <<NOTE: 21 USC 335a.>>  (21 U.S.C. 335a(l)(2)) is 
amended--
            (1) in the first sentence--
                    (A) by striking ``and'' after ``subsection 
                (b)(2),''; and
                    (B) by inserting ``, and subsection (b)(3)(A)'' 
                after ``subsection (b)(2)(B)''; and
            (2) in the second sentence, by inserting ``, subsection 
        (b)(3)(B),'' after ``subsection (b)(2)(B)''.

    (d) Prohibited Act.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act, as amended by section 303(b) of this Act, is amended by 
adding at the end the following:
    ``(cc) The importing or offering for import into the United States 
of an article of food by, with the assistance of, or at the direction 
of, a person debarred under section 306(b)(3).''.
    (e) Importation by Debarred Persons.--Section 801 of the Federal 
Food, Drug, and Cosmetic Act, as amended by section 303(c) of this 
Act, <<NOTE: 21 USC 381.>>  is amended by adding at the end the 
following subsection:

    ``(k)(1) If an article of food is being imported or offered for 
import into the United States, and the importer, owner, or consignee of 
the article is a person who has been debarred under section 306(b)(3), 
such article shall be held at the port of entry for the article, and may 
not be delivered to such person. Subsection (b) does not authorize the 
delivery of the article pursuant to the execution of a bond while the 
article is so held. The article shall be removed to a secure facility, 
as appropriate. During the period of time that such article is so held, 
the article shall not be transferred by any person from the port of 
entry into the United States for the article, or from the secure 
facility to which the article has been removed, as the case may be.
    ``(2) An article of food held under paragraph (1) may be delivered 
to a person who is not a debarred person under section 306(b)(3) if such 
person affirmatively establishes, at the expense of the person, that the 
article complies with the requirements of this Act, as determined by the 
Secretary.''.

SEC. 305. REGISTRATION OF FOOD FACILITIES.

    (a) In General.--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. 415. <<NOTE: 21 USC 350d.>>  REGISTRATION OF FOOD FACILITIES.

    ``(a) Registration.--
            ``(1) <<NOTE: Regulations.>>  In general.--The Secretary 
        shall by regulation require that any facility engaged in 
        manufacturing, processing, packing, or holding food for 
        consumption in the United States be registered with the 
        Secretary. To be registered--
                    ``(A) for a domestic facility, the owner, operator, 
                or agent in charge of the facility shall submit a 
                registration to the Secretary; and
                    ``(B) for a foreign facility, the owner, operator, 
                or agent in charge of the facility shall submit a 
                registration to the Secretary and shall include with the 
                registration the name of the United States agent for the 
                facility.
            ``(2) Registration.--An entity (referred to in this section 
        as the `registrant') shall submit a registration under paragraph 
        (1) to the Secretary containing information necessary to notify 
        the Secretary of the name and address of each facility at which, 
        and all trade names under which, the registrant conducts 
        business and, when determined necessary by the Secretary through 
        guidance, the general food category (as identified under section 
        170.3 of title 21, Code of Federal Regulations) of any food 
        manufactured, processed, packed, or held at such 
        facility. <<NOTE: Notification.>>  The registrant shall notify 
        the Secretary in a timely manner of changes to such information.
            ``(3) <<NOTE: Notification.>>  Procedure.--Upon receipt of a 
        completed registration described in paragraph (1), the Secretary 
        shall notify the registrant of the receipt of such registration 
        and assign a registration number to each registered facility.
            ``(4) <<NOTE: Records.>>  List.--The Secretary shall compile 
        and maintain an up-to-date list of facilities that are 
        registered under this section. Such list and any registration 
        documents submitted pursuant
        to this subsection shall not be subject to disclosure under 
        section 552 of title 5, United States Code. Information derived 
        from such list or registration documents shall not be subject to 
        disclosure under section 552 of title 5, United States Code, to 
        the extent that it discloses the identity or location of a 
        specific registered person.

    ``(b) Facility.--For purposes of this section:
            ``(1) The term `facility' includes any factory, warehouse, 
        or establishment (including a factory, warehouse, or 
        establishment of an importer) that manufactures, processes, 
        packs, or holds food. Such term does not include farms; 
        restaurants; other retail food establishments; nonprofit food 
        establishments in which food is prepared for or served directly 
        to the consumer; or fishing vessels (except such vessels engaged 
        in processing as defined in section 123.3(k) of title 21, Code 
        of Federal Regulations).
            ``(2) The term `domestic facility' means a facility located 
        in any of the States or Territories.
            ``(3)(A) The term `foreign facility' means a facility that 
        manufacturers, processes, packs, or holds food, but only if food 
        from such facility is exported to the United States without 
        further processing or packaging outside the United States.
            ``(B) A food may not be considered to have undergone further 
        processing or packaging for purposes of subparagraph (A) solely 
        on the basis that labeling was added or that any similar 
        activity of a de minimis nature was carried out with respect to 
        the food.

    ``(c) Rule of Construction.--Nothing in this section shall be 
construed to authorize the Secretary to require an application, review, 
or licensing process.''.
    (b) Prohibited Acts.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331), as amended by section 304(d) of this Act, 
is amended by adding at the end the following:
    ``(dd) The failure to register in accordance with section 415.''.
    (c) Importation; Failure to Register.--Section 801 of the Federal 
Food, Drug, and Cosmetic Act, as amended by section 304(e) of this 
Act, <<NOTE: 21 USC 381.>>  is amended by adding at the end the 
following subsection:

    ``(l)(1) If an article of food is being imported or offered for 
import into the United States, and such article is from a foreign 
facility for which a registration has not been submitted to the 
Secretary under section 415, such article shall be held at the port of 
entry for the article, and may not be delivered to the importer, owner, 
or consignee of the article, until the foreign facility is so 
registered. Subsection (b) does not authorize the delivery of the 
article pursuant to the execution of a bond while the article is so 
held. The article shall be removed to a secure facility, as appropriate. 
During the period of time that such article is so held, the article 
shall not be transferred by any person from the port of entry into the 
United States for the article, or from the secure facility to which the 
article has been removed, as the case may be.''.
    (d) <<NOTE: 21 USC 350d note.>>  Electronic Filing.--For the purpose 
of reducing paperwork and reporting burdens, the Secretary of Health and 
Human Services may provide for, and encourage the use of, electronic 
methods of submitting to the Secretary registrations required pursuant 
to this section. In providing for the electronic submission of
such registrations, the Secretary shall ensure adequate authentication 
protocols are used to enable identification of the registrant and 
validation of the data as appropriate.

    (e) <<NOTE: Deadline.>>  Rulemaking; Effective Date.--Not later than 
18 months after the date of the enactment of this Act, the Secretary of 
Health and Human Services shall promulgate proposed and final 
regulations for the requirement of registration under section 415 of the 
Federal Food, Drug, and Cosmetic Act (as added by subsection (a) of this 
section). Such requirement of registration takes effect--
            (1) upon the effective date of such final regulations; or
            (2) upon the expiration of such 18-month period if the final 
        regulations have not been made effective as of the expiration of 
        such period, subject to compliance with the final regulations 
        when the final regulations are made effective.

SEC. 306. MAINTENANCE AND INSPECTION OF RECORDS FOR FOODS.

    (a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic 
Act, as amended by section 305 of this Act, is amended by inserting 
before section 415 the following section:

``SEC. 414. <<NOTE: 21 USC 350c.>>  MAINTENANCE AND INSPECTION OF 
            RECORDS.

    ``(a) Records Inspection.--If the Secretary has a reasonable belief 
that an article of food is adulterated and presents a threat of serious 
adverse health consequences or death to humans or animals, each person 
(excluding farms and restaurants) who manufactures, processes, packs, 
distributes, receives, holds, or imports such article shall, at the 
request of an officer or employee duly designated by the Secretary, 
permit such officer or employee, upon presentation of appropriate 
credentials and a written notice to such person, at reasonable times and 
within reasonable limits and in a reasonable manner, to have access to 
and copy all records relating to such article that are needed to assist 
the Secretary in determining whether the food is adulterated and 
presents a threat of serious adverse health consequences or death to 
humans or animals. <<NOTE: Applicability.>>  The requirement under the 
preceding sentence applies to all records relating to the manufacture, 
processing, packing, distribution, receipt, holding, or importation of 
such article maintained by or on behalf of such person in any format 
(including paper and electronic formats) and at any location.

    ``(b) Regulations Concerning Recordkeeping.--The Secretary, in 
consultation and coordination, as appropriate, with other Federal 
departments and agencies with responsibilities for regulating food 
safety, may by regulation establish requirements regarding the 
establishment and maintenance, for not longer than two years, of records 
by persons (excluding farms and restaurants) who manufacture, process, 
pack, transport, distribute, receive, hold, or import food, which 
records are needed by the Secretary for inspection to allow the 
Secretary to identify the immediate previous sources and the immediate 
subsequent recipients of food, including its packaging, in order to 
address credible threats of serious adverse health consequences or death 
to humans or animals. The Secretary shall take into account the size of 
a business in promulgating regulations under this section.
    ``(c) Protection of Sensitive Information.--The Secretary shall take 
appropriate measures to ensure that there are in effect effective 
procedures to prevent the unauthorized disclosure of any trade secret or 
confidential information that is obtained by the Secretary pursuant to 
this section.

    ``(d) Limitations.--This section shall not be construed--
            ``(1) to limit the authority of the Secretary to inspect 
        records or to require establishment and maintenance of records 
        under any other provision of this Act;
            ``(2) to authorize the Secretary to impose any requirements 
        with respect to a food to the extent that it is within the 
        exclusive jurisdiction of the Secretary of Agriculture pursuant 
        to the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the 
        Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the 
        Egg Products Inspection Act (21 U.S.C. 1031 et seq.);
            ``(3) to have any legal effect on section 552 of title 5, 
        United States Code, or section 1905 of title 18, United States 
        Code; or
            ``(4) to extend to recipes for food, financial data, pricing 
        data, personnel data, research data, or sales data (other than 
        shipment data regarding sales).''.

    (b) Factory Inspection.--Section 704(a) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 374(a)) is amended--
            (1) in paragraph (1), by inserting after the first sentence 
        the following new sentence: ``In the case of any person 
        (excluding farms and restaurants) who manufactures, processes, 
        packs, transports, distributes, holds, or imports foods, the 
        inspection shall extend to all records and other information 
        described in section 414 when the Secretary has a reasonable 
        belief that an article of food is adulterated and presents a 
        threat of serious adverse health consequences or death to humans 
        or animals, subject to the limitations established in section 
        414(d).''; and
            (2) in paragraph (2), in the matter preceding subparagraph 
        (A), by striking ``second sentence'' and inserting ``third 
        sentence''.

    (c) Prohibited Act.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended--
            (1) in paragraph (e)--
                    (A) by striking ``by section 412, 504, or 703'' and 
                inserting ``by section 412, 414, 504, 703, or 704(a)''; 
                and
                    (B) by striking ``under section 412'' and inserting 
                ``under section 412, 414(b)''; and
            (2) in paragraph (j), by inserting ``414,'' after ``412,''.

    (d) <<NOTE: Deadline. 21 USC 350c note.>>  Expedited Rulemaking.--
Not later than 18 months after the date of the enactment of this Act, 
the Secretary shall promulgate proposed and final regulations 
establishing recordkeeping requirements under subsection 414(b) of the 
Federal Food, Drug, and Cosmetic Act (as added by subsection (a)).

SEC. 307. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.

    (a) In General.--Section 801 of the Federal Food, Drug, and Cosmetic 
Act, as amended by section 305(c) of this Act, is amended by adding at 
the end the following subsection:
    ``(m)(1) <<NOTE: Regulations.>>  In the case of an article of food 
that is being imported or offered for import into the United States, the 
Secretary, after consultation with the Secretary of the Treasury, shall 
by regulation require, for the purpose of enabling such article to be 
inspected at ports of entry into the United States, the submission to 
the Secretary of a notice providing the identity of each of the 
following: The article; the manufacturer and shipper of the article; if 
known within the specified period of time that notice is required to be
provided, the grower of the article; the country from which the article 
originates; the country from which the article is shipped; and the 
anticipated port of entry for the article. An article of food imported 
or offered for import without submission of such notice in accordance 
with the requirements under this paragraph shall be refused admission 
into the United States. Nothing in this section may be construed as a 
limitation on the port of entry for an article of food.

    ``(2)(A) Regulations under paragraph (1) shall require that a notice 
under such paragraph be provided by a specified period of time in 
advance of the time of the importation of the article of food involved 
or the offering of the food for import, which period shall be no less 
than the minimum amount of time necessary for the Secretary to receive, 
review, and appropriately respond to such notification, but may not 
exceed five days. In determining the specified period of time required 
under this subparagraph, the Secretary may consider, but is not limited 
to consideration of, the effect on commerce of such period of time, the 
locations of the various ports of entry into the United States, the 
various modes of transportation, the types of food imported into the 
United States, and any other such consideration. Nothing in the 
preceding sentence may be construed as a limitation on the obligation of 
the Secretary to receive, review, and appropriately respond to any 
notice under paragraph (1).
    ``(B)(i) If an article of food is being imported or offered for 
import into the United States and a notice under paragraph (1) is not 
provided in advance in accordance with the requirements under paragraph 
(1), such article shall be held at the port of entry for the article, 
and may not be delivered to the importer, owner, or consignee of the 
article, until such notice is submitted to the Secretary, and the 
Secretary examines the notice and determines that the notice is in 
accordance with the requirements under paragraph (1). Subsection (b) 
does not authorize the delivery of the article pursuant to the execution 
of a bond while the article is so held. The article shall be removed to 
a secure facility, as appropriate. During the period of time that such 
article is so held, the article shall not be transferred by any person 
from the port of entry into the United States for the article, or from 
the secure facility to which the article has been removed, as the case 
may be.
    ``(ii) In carrying out clause (i) with respect to an article of 
food, the Secretary shall determine whether there is in the possession 
of the Secretary any credible evidence or information indicating that 
such article presents a threat of serious adverse health consequences or 
death to humans or animals.
    ``(3)(A) This subsection may not be construed as limiting the 
authority of the Secretary to obtain information under any other 
provision of this Act.
    ``(B) This subsection may not be construed as authorizing the 
Secretary to impose any requirements with respect to a food to the 
extent that it is within the exclusive jurisdiction of the Secretary of 
Agriculture pursuant to the Federal Meat Inspection Act (21 U.S.C. 601 
et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), 
or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).''.
    (b) Prohibited Act.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act, as amended by section 305(b) of this Act, <<NOTE: 21 USC 
331.>>  is amended by adding at the end the following:

    ``(ee) The importing or offering for import into the United States 
of an article of food in violation of the requirements under section 
801(m).''.
    (c) <<NOTE: 21 USC 351 note.>>  Rulemaking; Effective Date.--
            (1) <<NOTE: Deadline.>>  In general.--Not later than 18 
        months after the date of the enactment of this Act, the 
        Secretary of Health and Human Services shall promulgate proposed 
        and final regulations for the requirement of providing notice in 
        accordance with section 801(m) of the Federal Food, Drug, and 
        Cosmetic Act (as added by subsection (a) of this section). Such 
        requirement of notification takes effect--
                    (A) upon the effective date of such final 
                regulations; or
                    (B) upon the expiration of such 18-month period if 
                the final regulations have not been made effective as of 
                the expiration of such period, subject to compliance 
                with the final regulations when the final regulations 
                are made effective.
            (2) Default; minimum period of advance notice.--If under 
        paragraph (1) the requirement for providing notice in accordance 
        with section 801(m) of the Federal Food, Drug, and Cosmetic Act 
        takes effect without final regulations having been made 
        effective, then for purposes of such requirement, the specified 
        period of time that the notice is required to be made in advance 
        of the time of the importation of the article of food involved 
        or the offering of the food for import shall be not fewer than 
        eight hours and not more than five days, which shall remain in 
        effect until the final regulations are made effective.

SEC. 308. AUTHORITY TO MARK ARTICLES REFUSED ADMISSION INTO UNITED 
            STATES.

    (a) In General.--Section 801 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 381(a)), as amended by section 307(a) of this Act, is 
amended by adding at the end the following:
    ``(n)(1) If a food has been refused admission under subsection (a), 
other than such a food that is required to be destroyed, the Secretary 
may require the owner or consignee of the food to affix to the container 
of the food a label that clearly and conspicuously bears the statement: 
`UNITED STATES: REFUSED ENTRY'.
    ``(2) All expenses in connection with affixing a label under 
paragraph (1) shall be paid by the owner or consignee of the food 
involved, and in default of such payment, shall constitute a lien 
against future importations made by such owner or consignee.
    ``(3) A requirement under paragraph (1) remains in effect until the 
Secretary determines that the food involved has been brought into 
compliance with this Act.''.
    (b) Misbranded Foods.--Section 403 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the 
following:
    ``(v) If--
            ``(1) it fails to bear a label required by the Secretary 
        under section 801(n)(1) (relating to food refused admission into 
        the United States);
            ``(2) the Secretary finds that the food presents a threat of 
        serious adverse health consequences or death to humans or 
        animals; and
            ``(3) upon or after notifying the owner or consignee 
        involved that the label is required under section 801, the 
        Secretary informs the owner or consignee that the food presents 
        such a threat.''.

    (c) <<NOTE: 21 USC 381 note.>>  Rule of Construction.--With respect 
to articles of food that are imported or offered for import into the 
United States, nothing in this section shall be construed to limit the 
authority of the Secretary of Health and Human Services or the Secretary 
of the Treasury to require the marking of refused articles of food under 
any other provision of law.

SEC. 309. PROHIBITION AGAINST PORT SHOPPING.

    Section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
342) is amended by adding at the end the following:
    ``(h) If it is an article of food imported or offered for import 
into the United States and the article of food has previously been 
refused admission under section 801(a), unless the person reoffering the 
article affirmatively establishes, at the expense of the owner or 
consignee of the article, that the article complies with the applicable 
requirements of this Act, as determined by the Secretary.''.

SEC. 310. NOTICES TO STATES REGARDING IMPORTED FOOD.

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

``SEC. 908. <<NOTE: 21 USC 398.>>  NOTICES TO STATES REGARDING IMPORTED 
            FOOD.

    ``(a) In General.--If the Secretary has credible evidence or 
information indicating that a shipment of imported food or portion 
thereof presents a threat of serious adverse health consequences or 
death to humans or animals, the Secretary shall provide notice regarding 
such threat to the States in which the food is held or will be held, and 
to the States in which the manufacturer, packer, or distributor of the 
food is located, to the extent that the Secretary has knowledge of which 
States are so involved. In providing notice to a State, the Secretary 
shall request the State to take such action as the State considers 
appropriate, if any, to protect the public health regarding the food 
involved.
    ``(b) Rule of Construction.--Subsection (a) may not be construed as 
limiting the authority of the Secretary with respect to food under any 
other provision of this Act.''.

SEC. 311. GRANTS TO STATES FOR INSPECTIONS.

    Chapter IX of the Federal Food, Drug, and Cosmetic Act, as amended 
by section 310 of this Act, is amended by adding at the end the 
following section:

``SEC. 909. <<NOTE: 21 USC 399.>>  GRANTS TO STATES FOR INSPECTIONS.

    ``(a) In General.--The Secretary is authorized to make grants to 
States, territories, and Indian tribes (as defined in section 4(e) of 
the Indian Self-Determination and Education Assistance Act (25 U.S.C. 
450b(e))) that undertake examinations, inspections, and investigations, 
and related activities under section 702. The funds provided under such 
grants shall only be available for the costs
of conducting such examinations, inspections, investigations, and 
related activities.
    ``(b) Notices Regarding Adulterated Imported Food.--The Secretary 
may make grants to the States for the purpose of assisting the States 
with the costs of taking appropriate action to protect the public health 
in response to notification under section 908, including planning and 
otherwise preparing to take such action.
    ``(c) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated $10,000,000 
for fiscal year 2002, and such sums as may be necessary for each of the 
fiscal years 2003 through 2006.''.

SEC. 312. SURVEILLANCE AND INFORMATION GRANTS AND AUTHORITIES.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.) is amended by inserting after section 317P the following:

``SEC. 317R. <<NOTE: 42 USC 247b-20.>>  FOOD SAFETY GRANTS.

    ``(a) In General.--The Secretary may award grants to States and 
Indian tribes (as defined in section 4(e) of the Indian Self-
Determination and Education Assistance Act (25 U.S.C. 450b(e))) to 
expand participation in networks to enhance Federal, State, and local 
food safety efforts, including meeting the costs of establishing and 
maintaining the food safety surveillance, technical, and laboratory 
capacity needed for such participation.
    ``(b) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated $19,500,000 
for fiscal year 2002, and such sums as may be necessary for each of the 
fiscal years 2003 through 2006.''.

SEC. 313. <<NOTE: 7 USC 8319.>>  SURVEILLANCE OF ZOONOTIC DISEASES.

    The Secretary of Health and Human Services, through the Commissioner 
of Food and Drugs and the Director of the Centers for Disease Control 
and Prevention, and the Secretary of Agriculture shall coordinate the 
surveillance of zoonotic diseases.

SEC. 314. AUTHORITY TO COMMISSION OTHER FEDERAL OFFICIALS TO CONDUCT 
            INSPECTIONS.

    Section 702(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 372(a)) is amended--
            (1) by striking ``(a)'' and inserting ``(a)(1)'';
            (2) by striking ``In the case of food packed'' and inserting 
        the following:

    ``(3) In the case of food packed'';
            (3) by striking ``For the purposes of this subsection'' and 
        inserting the following:

    ``(4) For the purposes of this subsection,''; and
            (4) by inserting after paragraph (1) (as designated by 
        paragraph (1) of this section) the following paragraph:

    ``(2)(A) In addition to the authority established in paragraph (1), 
the Secretary, pursuant to a memorandum of understanding between the 
Secretary and the head of another Federal department or agency, is 
authorized to conduct examinations and investigations for the purposes 
of this Act through the officers and employees of such other department 
or agency, subject to subparagraph (B). Such a memorandum shall include 
provisions to ensure adequate training of such officers and employees to 
conduct the examinations
and investigations. The memorandum of understanding shall contain 
provisions regarding reimbursement. Such provisions may, at the sole 
discretion of the head of the other department or agency, require 
reimbursement, in whole or in part, from the Secretary for the 
examinations or investigations performed under this section by the 
officers or employees of the other department or agency.
    ``(B) A memorandum of understanding under subparagraph (A) between 
the Secretary and another Federal department or agency is effective only 
in the case of examinations or inspections at facilities or other 
locations that are jointly regulated by the Secretary and such 
department or agency.
    ``(C) <<NOTE: Reports.>>  For any fiscal year in which the Secretary 
and the head of another Federal department or agency carries out one or 
more examinations or inspections under a memorandum of understanding 
under subparagraph (A), the Secretary and the head of such department or 
agency shall with respect to their respective departments or agencies 
submit to the committees of jurisdiction (authorizing and appropriating) 
in the House of Representatives and the Senate a report that provides, 
for such year--
            ``(i) the number of officers or employees that carried out 
        one or more programs, projects, or activities under such 
        memorandum;
            ``(ii) the number of additional articles that were inspected 
        or examined as a result of such memorandum; and
            ``(iii) the number of additional examinations or 
        investigations that were carried out pursuant to such 
        memorandum.''.

SEC. 315. <<NOTE: 21 USC 331 note.>>  RULE OF CONSTRUCTION.

    Nothing in this title, or an amendment made by this title, shall be 
construed to alter the jurisdiction between the Secretaries of 
Agriculture and of Health and Human Services, under applicable statutes 
and regulations.

                  Subtitle B--Protection of Drug Supply

SEC. 321. ANNUAL REGISTRATION OF FOREIGN MANUFACTURERS; SHIPPING 
            INFORMATION; DRUG AND DEVICE LISTING.

    (a) Annual Registration; Listing.--Section 510 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360) is amended--
            (1) in subsection (i)(1)--
                    (A) by striking ``Any establishment'' and inserting 
                ``On or before December 31 of each year, any 
                establishment''; and
                    (B) by striking ``shall register'' and all that 
                follows and inserting the following: ``shall, through 
                electronic means in accordance with the criteria of the 
                Secretary, register with the Secretary the name and 
                place of business of the establishment, the name of the 
                United States agent for the establishment, the name of 
                each importer of such drug or device in the United 
                States that is known to the establishment, and the name 
                of each person who imports or offers for import such 
                drug or device to the United States for purposes of 
                importation.''; and
            (2) in subsection (j)(1), in the first sentence, by striking 
        ``or (d)'' and inserting ``(d), or (i)''.
    (b) Importation; Statement Regarding Registration of Manufacturer.--
            (1) In general.--Section 801 of the Federal Food, Drug, and 
        Cosmetic Act, as amended by section 308(a) of this Act, is 
        amended by adding at the end the following subsection:

    ``(o) If an article that is a drug or device is being imported or 
offered for import into the United States, and the importer, owner, or 
consignee of such article does not, at the time of offering the article 
for import, submit to the Secretary a statement that identifies the 
registration under section 510(i) of each establishment that with 
respect to such article is required under such section to register with 
the Secretary, the article may be refused admission. If the article is 
refused admission for failure to submit such a statement, the article 
shall be held at the port of entry for the article, and may not be 
delivered to the importer, owner, or consignee of the article, until 
such a statement is submitted to the Secretary. Subsection (b) does not 
authorize the delivery of the article pursuant to the execution of a 
bond while the article is so held. The article shall be removed to a 
secure facility, as appropriate. During the period of time that such 
article is so held, the article shall not be transferred by any person 
from the port of entry into the United States for the article, or from 
the secure facility to which the article has been removed, as the case 
may be.''.
            (2) Prohibited act.--Section 301 of the Federal Food, Drug, 
        and Cosmetic Act, as amended by section 307(b) of this Act, is 
        amended by adding at the end the following:

    ``(ff) The importing or offering for import into the United States 
of a drug or device with respect to which there is a failure to comply 
with a request of the Secretary to submit to the Secretary a statement 
under section 801(o).''.
    (c) <<NOTE: 21 USC 331 note.>>  Effective Date.--The amendments made 
by this section take effect upon the expiration of the 180-day period 
beginning on the date of the enactment of this Act.

SEC. 322. REQUIREMENT OF ADDITIONAL INFORMATION REGARDING IMPORT 
            COMPONENTS INTENDED FOR USE IN EXPORT PRODUCTS.

    (a) In General.--Section 801(d)(3) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381(d)(3)) is amended to read as follows:
    ``(3)(A) Subject to subparagraph (B), no component of a drug, no 
component part or accessory of a device, or other article of device 
requiring further processing, which is ready or suitable for use for 
health-related purposes, and no article of a food additive, color 
additive, or dietary supplement, including a product in bulk form, shall 
be excluded from importation into the United States under subsection (a) 
if each of the following conditions is met:
            ``(i) The importer of such article of a drug or device or 
        importer of such article of a food additive, color additive, or 
        dietary supplement submits to the Secretary, at the time of 
        initial importation, a statement in accordance with the 
        following:
                    ``(I) Such statement provides that such article is 
                intended to be further processed by the initial owner or 
                consignee, or incorporated by the initial owner or 
                consignee, into a drug, biological product, device, 
                food, food additive,
                color additive, or dietary supplement that will be 
                exported by the initial owner or consignee from the 
                United States in accordance with subsection (e) or 
                section 802, or with section 351(h) of the Public Health 
                Service Act.
                    ``(II) The statement identifies the manufacturer of 
                such article and each processor, packer, distributor, or 
                other entity that had possession of the article in the 
                chain of possession of the article from the manufacturer 
                to such importer of the article.
                    ``(III) The statement is accompanied by such 
                certificates of analysis as are necessary to identify 
                such article, unless the article is a device or is an 
                article described in paragraph (4).
            ``(ii) At the time of initial importation and before the 
        delivery of such article to the importer or the initial owner or 
        consignee, such owner or consignee executes a good and 
        sufficient bond providing for the payment of such liquidated 
        damages in the event of default as may be required pursuant to 
        regulations of the Secretary of the Treasury.
            ``(iii) Such article is used and exported by the initial 
        owner or consignee in accordance with the intent described under 
        clause (i)(I), except for any portions of the article that are 
        destroyed.
            ``(iv) <<NOTE: Records.>>  The initial owner or consignee 
        maintains records on the use or destruction of such article or 
        portions thereof, as the case may be, and submits to the 
        Secretary any such records requested by the Secretary.
            ``(v) <<NOTE: Reports.>>  Upon request of the Secretary, the 
        initial owner or consignee submits a report that provides an 
        accounting of the exportation or destruction of such article or 
        portions thereof, and the manner in which such owner or 
        consignee complied with the requirements of this subparagraph.

    ``(B) Notwithstanding subparagraph (A), the Secretary may refuse 
admission to an article that otherwise would be imported into the United 
States under such subparagraph if the Secretary determines that there is 
credible evidence or information indicating that such article is not 
intended to be further processed by the initial owner or consignee, or 
incorporated by the initial owner or consignee, into a drug, biological 
product, device, food, food additive, color additive, or dietary 
supplement that will be exported by the initial owner or consignee from 
the United States in accordance with subsection (e) or section 802, or 
with section 351(h) of the Public Health Service Act.
    ``(C) This section may not be construed as affecting the 
responsibility of the Secretary to ensure that articles imported into 
the United States under authority of subparagraph (A) meet each of the 
conditions established in such subparagraph for importation.''.
    (b) Prohibited Act.--Section 301(w) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331(w)) is amended to read as follows:
    ``(w) The making of a knowingly false statement in any statement, 
certificate of analysis, record, or report required or requested under 
section 801(d)(3); the failure to submit a certificate of analysis as 
required under such section; the failure to maintain records or to 
submit records or reports as required by such section; the release into 
interstate commerce of any article or portion thereof imported into the 
United States under such section or any finished product made from such 
article or portion, except for export in
accordance with section 801(e) or 802, or with section 351(h) of the 
Public Health Service Act; or the failure to so export or to destroy 
such an article or portions thereof, or such a finished product.''.
    (c) <<NOTE: 21 USC 331 note.>>  Effective Date.--The amendments made 
by this section take effect upon the expiration of the 90-day period 
beginning on the date of the enactment of this Act.

   Subtitle C--General Provisions Relating to Upgrade of Agricultural 
                                Security

SEC. 331. <<NOTE: 7 USC 8320.>>  EXPANSION OF ANIMAL AND PLANT HEALTH 
            INSPECTION SERVICE ACTIVITIES.

    (a) In General.--The Secretary of Agriculture (referred to in this 
section as the ``Secretary'') may utilize existing authorities to give 
high priority to enhancing and expanding the capacity of the Animal and 
Plant Health Inspection Service to conduct activities to--
            (1) increase the inspection capacity of the Service at 
        international points of origin;
            (2) improve surveillance at ports of entry and customs;
            (3) enhance methods of protecting against the introduction 
        of plant and animal disease organisms by terrorists;
            (4) develop new and improve existing strategies and 
        technologies for dealing with intentional outbreaks of plant and 
        animal disease arising from acts of terrorism or from 
        unintentional introduction, including--
                    (A) establishing cooperative agreements among 
                Veterinary Services of the Animal and Plant Health 
                Inspection Service, State animal health commissions and 
                regulatory agencies for livestock and poultry health, 
                and private veterinary practitioners to enhance the 
                preparedness and ability of Veterinary Services and the 
                commissions and agencies to respond to outbreaks of such 
                animal diseases; and
                    (B) strengthening planning and coordination with 
                State and local agencies, including--
                          (i) State animal health commissions and 
                      regulatory agencies for livestock and poultry 
                      health; and
                          (ii) State agriculture departments; and
            (5) otherwise improve the capacity of the Service to protect 
        against the threat of bioterrorism.

    (b) Automated Recordkeeping System.--The Administrator of the Animal 
and Plant Health Inspection Service may implement a central automated 
recordkeeping system to provide for the reliable tracking of the status 
of animal and plant shipments, including those shipments on hold at 
ports of entry and customs. The Secretary shall ensure that such a 
system shall be fully accessible to or fully integrated with the Food 
Safety Inspection Service.
    (c) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $30,000,000 for fiscal year 
2002, and such sums as may be necessary for each subsequent fiscal year.

SEC. 332. <<NOTE: 21 USC 679c.>>  EXPANSION OF FOOD SAFETY INSPECTION 
            SERVICE ACTIVITIES.

    (a) In General.--The Secretary of Agriculture may utilize existing 
authorities to give high priority to enhancing and expanding the 
capacity of the Food Safety Inspection Service to conduct activities 
to--
            (1) enhance the ability of the Service to inspect and ensure 
        the safety and wholesomeness of meat and poultry products;
            (2) improve the capacity of the Service to inspect 
        international meat and meat products, poultry and poultry 
        products, and egg products at points of origin and at ports of 
        entry;
            (3) strengthen the ability of the Service to collaborate 
        with relevant agencies within the Department of Agriculture and 
        with other entities in the Federal Government, the States, and 
        Indian tribes (as defined in section 4(e) of the Indian Self-
        Determination and Education Assistance Act (25 U.S.C. 450b(e))) 
        through the sharing of information and technology; and
            (4) otherwise expand the capacity of the Service to protect 
        against the threat of bioterrorism.

    (b) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $15,000,000 for fiscal year 
2002, and such sums as may be necessary for each subsequent fiscal year.

SEC. 333. <<NOTE: Appropriation authorization. State listing.>>  
            BIOSECURITY UPGRADES AT THE DEPARTMENT OF AGRICULTURE.

    There is authorized to be appropriated for fiscal year 2002, 
$180,000,000 for the purpose of enabling the Agricultural Research 
Service to conduct building upgrades to modernize existing facilities, 
of which (1) $100,000,000 shall be allocated for renovation, updating, 
and expansion of the Biosafety Level 3 laboratory and animal research 
facilities at the Plum Island Animal Disease Center (Greenport, New 
York), and of which (2) $80,000,000 shall be allocated for the 
Agricultural Research Service/Animal and Plant Health Inspection Service 
facility in Ames, Iowa. There are authorized to be appropriated such 
sums as may be necessary for fiscal years 2003 through 2006 for the 
purpose described in the preceding sentence, for the planning and design 
of an Agricultural Research Service biocontainment laboratory for 
poultry research in Athens, Georgia, and for the planning, updating, and 
renovation of the Arthropod-Borne Animal Disease Laboratory in Laramie, 
Wyoming.

SEC. 334. <<NOTE: 7 USC 3353.>>  AGRICULTURAL BIOSECURITY.

    (a) Security at Colleges and Universities.--
            (1) Grants.--The Secretary of Agriculture (referred to in 
        this section as the ``Secretary'') may award grants to covered 
        entities to review security standards and practices at their 
        facilities in order to protect against bioterrorist attacks.
            (2) Covered entities.--Covered entities under this 
        subsection are colleges or universities that--
                    (A) are colleges or universities as defined in 
                section 1404 of the National Agricultural Research, 
                Extension, and Teaching Policy Act of 1977 (7 U.S.C. 
                3103); and
                    (B) have programs in food and agricultural sciences, 
                as defined in such section.
            (3) Limitation.--Each individual covered entity may be 
        awarded one grant under paragraph (1), the amount of which shall 
        not exceed $50,000.
            (4) Contract authority.--Colleges and universities receiving 
        grants under paragraph (1) may use such grants to enter into 
        contracts with independent private organizations with 
        established and demonstrated security expertise to conduct the 
        security reviews specified in such paragraph.

    (b) Guidelines for Agricultural Biosecurity.--
            (1) In general.--The Secretary may award grants to 
        associations of food producers or consortia of such associations 
        for the development and implementation of educational programs 
        to improve biosecurity on farms in order to ensure the security 
        of farm facilities against potential bioterrorist attacks.
            (2) Limitation.--Each individual association eligible under 
        paragraph (1) may be awarded one grant under such paragraph, the 
        amount of which shall not exceed $100,000. Each consortium 
        eligible under paragraph (1) may be awarded one grant under such 
        paragraph, the amount of which shall not exceed $100,000 per 
        association participating in the consortium.
            (3) Contract authority.--Associations of food producers 
        receiving grants under paragraph (1) may use such grants to 
        enter into contracts with independent private organizations with 
        established and demonstrated expertise in biosecurity to assist 
        in the development and implementation of educational programs to 
        improve biosecurity specified in such paragraph.

    (c) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section such sums as may be necessary for 
each fiscal year.

SEC. 335. <<NOTE: 7 USC 3354.>>  AGRICULTURAL BIOTERRORISM RESEARCH AND 
            DEVELOPMENT.

    (a) In General.--The Secretary of Agriculture (referred to in this 
section as the ``Secretary'') may utilize existing research authorities 
and research programs to protect the food supply of the United States by 
conducting and supporting research activities to--
            (1) enhance the capability of the Secretary to respond in a 
        timely manner to emerging or existing bioterrorist threats to 
        the food and agricultural system of the United States;
            (2) develop new and continue partnerships with institutions 
        of higher education and other institutions to help form stable, 
        long-term programs to enhance the biosecurity and food safety of 
        the United States, including the coordination of the 
        development, implementation, and enhancement of diverse 
        capabilities for addressing threats to the nation's agricultural 
        economy and food supply, with special emphasis on planning, 
        training, outreach, and research activities related to 
        vulnerability analyses, incident response, detection, and 
        prevention technologies;
            (3) strengthen coordination with the intelligence community 
        to better identify research needs and evaluate materials or 
        information acquired by the intelligence community relating to 
        potential threats to United States agriculture;
            (4) expand the involvement of the Secretary with 
        international organizations dealing with plant and animal 
        disease control;
            (5) continue research to develop rapid detection field test 
        kits to detect biological threats to plants and animals and to 
        provide such test kits to State and local agencies preparing for 
        or responding to bioterrorism;
            (6) develop an agricultural bioterrorism early warning 
        surveillance system through enhancing the capacity of and 
        coordination between State veterinary diagnostic laboratories, 
        Federal and State agricultural research facilities, and public 
        health agencies; and
            (7) otherwise improve the capacity of the Secretary to 
        protect against the threat of bioterrorism.

    (b) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $190,000,000 for fiscal year 
2002, and such sums as may be necessary for each subsequent fiscal year.

SEC. 336. ANIMAL ENTERPRISE TERRORISM PENALTIES.

    (a) In General.--Section 43(a) of title 18, United States Code, is 
amended to read as follows:
    ``(a) Offense.--Whoever--
            ``(1) travels in interstate or foreign commerce, or uses or 
        causes to be used the mail or any facility in interstate or 
        foreign commerce for the purpose of causing physical disruption 
        to the functioning of an animal enterprise; and
            ``(2) intentionally damages or causes the loss of any 
        property (including animals or records) used by the animal 
        enterprise, or conspires to do so,

shall be punished as provided for in subsection (b).''.
    (b) Penalties.--Section 43(b) of title 18, United States Code, is 
amended to read as follows:
    ``(b) Penalties.--
            ``(1) Economic damage.--Any person who, in the course of a 
        violation of subsection (a), causes economic damage not 
        exceeding $10,000 to an animal enterprise shall be fined under 
        this title or imprisoned not more than 6 months, or both.
            ``(2) Major economic damage.--Any person who, in the course 
        of a violation of subsection (a), causes economic damage 
        exceeding $10,000 to an animal enterprise shall be fined under 
        this title or imprisoned not more than 3 years, or both.
            ``(3) Serious bodily injury.--Any person who, in the course 
        of a violation of subsection (a), causes serious bodily injury 
        to another individual shall be fined under this title or 
        imprisoned not more than 20 years, or both.
            ``(4) Death.--Any person who, in the course of a violation 
        of subsection (a), causes the death of an individual shall be 
        fined under this title and imprisoned for life or for any term 
        of years.''.

    (c) Restitution.--Section 43(c) of title 18, United States Code, is 
amended--
            (1) in paragraph (1), by striking ``and'' at the end;
            (2) in paragraph (2), by striking the period at the end and 
        inserting ``; and''; and
            (3) by adding at the end the following:
            ``(3) for any other economic damage resulting from the 
        offense.''.