Mental Modeling attachment TITLE III of the PHS and Bioterrorism Preparedness and Response Act

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.

Title III of the Public Health Security and Bioterrorism

Preparedness and Response Act of 2002 (Public Law 107-188)

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.''.