H. R. 3448—58
individual, the Secretary shall submit the name of such
person to the Attorney General, who shall use criminal,
immigration, national security, and other electronic data-
bases available to the Federal Government, as appropriate
for the purpose of promptly notifying the Secretary whether
the person, or, where relevant, the individual who owns
or controls such person, is within any of the categories
described in section 175b(d)(1) of title 18, United States
Code (relating to restricted persons), or is reasonably sus-
pected by any Federal law enforcement or intelligence
agency of being within any category specified in paragraph
(3)(B)(ii) (as applied to persons, including individuals). Such
regulations shall provide that a person who seeks to reg-
ister under either of such subsections is subject to the
same processes described in paragraphs (2) and (4) as
apply to names and other identifying information submitted
to the Attorney General under paragraph (2)(B). Paragraph
(5) does not apply for purposes of this subparagraph. The
Secretary may exempt Federal, State, or local governmental
agencies from the requirements of this subparagraph.
(7) REVIEW.—
(A) ADMINISTRATIVE REVIEW.—
(i) IN GENERAL.—Regulations under subsections (b)
and (c) shall provide for an opportunity for a review
by the Secretary—
(I) when requested by the individual involved,
of a determination under paragraph (2) to deny
the individual access to listed agents and toxins;
and
(II) when requested by the person involved,
of a determination under under paragraph (6) to
deny or revoke registration for such person.
(ii) EX
PARTE
REVIEW.—During a review under
clause (i), the Secretary may consider information rel-
evant to the review ex parte to the extent that disclo-
sure of the information could compromise national
security or an investigation by any law enforcement
agency.
(iii) FINAL AGENCY ACTION.—The decision of the
Secretary in a review under clause (i) constitutes final
agency action for purposes of section 702 of title 5,
United States Code.
(B) CERTAIN PROCEDURES.—
(i) SUBMISSION OF EX PARTE MATERIALS IN JUDICIAL
PROCEEDINGS.—When reviewing a decision of the Sec-
retary under subparagraph (A), and upon request made
ex parte and in writing by the United States, a court,
upon a sufficient showing, may review and consider
ex parte documents containing information the disclo-
sure of which could compromise national security or
an investigation by any law enforcement agency. If
the court determines that portions of the documents
considered ex parte should be disclosed to the person
involved to allow a response, the court shall authorize
the United States to delete from such documents speci-
fied items of information the disclosure of which could
compromise national security or an investigation by
H. R. 3448—59
any law enforcement agency, or to substitute a sum-
mary of the information to which the person may
respond. Any order by the court authorizing the disclo-
sure of information that the United States believes
could compromise national security or an investigation
by any law enforcement agency shall be subject to
the processes set forth in subparagraphs (A) and (B)(i)
of section 2339B(f)(5) of title 18, United States Code
(relating to interlocutory appeal and expedited consid-
eration).
(ii) DISCLOSURE
OF
INFORMATION.—In a review
under subparagraph (A), and in any judical proceeding
conducted pursuant to such review, neither the Sec-
retary nor the Attorney General may be required to
disclose to the public any information that under sub-
section (h) shall not be disclosed under section 552
of title 5, United States Code.
(8) NOTIFICATIONS REGARDING THEFT OR LOSS OF AGENTS.—
Requirements under paragraph (1) shall include the prompt
notification of the Secretary, and appropriate Federal, State,
and local law enforcement agencies, of the theft or loss of
listed agents and toxins.
(9) TECHNICAL ASSISTANCE FOR REGISTERED PERSONS.—The
Secretary, in consultation with the Attorney General, may pro-
vide technical assistance to registered persons to improve secu-
rity of the facilities of such persons.
(f) INSPECTIONS.—The Secretary shall have the authority to
inspect persons subject to regulations under subsection (b) or (c)
to ensure their compliance with such regulations, including prohibi-
tions on restricted persons and other provisions of subsection (e).
(g) EXEMPTIONS.—
(1) OVERLAP AGENTS AND TOXINS.—
(A) IN GENERAL.—
(i) LIMITATION.—In the case of overlap agents and
toxins, exemptions from the applicability of provisions
of regulations under subsection (b) or (c) may be
granted only to the extent provided in this paragraph.
(ii) DEFINITIONS.—For purposes of this section:
(I) The term ‘‘overlap agents and toxins’’
means biological agents and toxins that—
(aa) are listed pursuant to subsection
(a)(1); and
(bb) 
are 
listed 
pursuant 
to 
section
315A(a)(1) of the Public Health Service Act.
(II) The term ‘‘overlap agent or toxin’’ means
a biological agent or toxin that—
(aa) is listed pursuant to subsection (a)(1);
and
(bb) 
is 
listed 
pursuant 
to 
section
315A(a)(1) of the Public Health Service Act.
(B) CLINICAL OR DIAGNOSTIC LABORATORIES.—Regula-
tions under subsections (b) and (c) shall exempt clinical
or diagnostic laboratories and other persons who possess,
use, or transfer overlap agents or toxins that are contained
in specimens presented for diagnosis, verification, or pro-
ficiency testing, provided that—
H. R. 3448—60
(i) the identification of such agents or toxins is
reported to the Secretary, and when required under
Federal, State, or local law, to other appropriate
authorities; and
(ii) such agents or toxins are transferred or
destroyed in a manner set forth by the Secretary by
regulation.
(C) PRODUCTS.—
(i) IN GENERAL.—Regulations under subsections (b)
and (c) shall exempt products that are, bear, or contain
overlap agents or toxins and are cleared, approved,
licensed, or registered under any of the Acts specified
in clause (ii), unless the Secretary by order determines
that applying additional regulation under subsection
(b) or (c) to a specific product is necessary to protect
animal or plant health, or animal or plant products.
(ii) RELEVANT LAWS.—For purposes of clause (i),
the Acts specified in this clause are the following:
(I) The Federal Food, Drug, and Cosmetic Act.
(II) Section 351 of the Public Health Service
Act.
(III) The Act commonly known as the Virus-
Serum-Toxin Act (the eighth paragraph under the
heading ‘‘Bureau of Animal Industry’’ in the Act
of March 4, 1913; 21 U.S.C. 151–159).
(IV) The Federal Insecticide, Fungicide, and
Rodenticide Act.
(iii) INVESTIGATIONAL USE.—
(I) IN GENERAL.—The Secretary may exempt
an investigational product that is, bears, or con-
tains an overlap agent or toxin from the applica-
bility of provisions of regulations under subsection
(b) or (c) when such product is being used in an
investigation authorized under any Federal Act
and the Secretary determines that applying addi-
tional regulation under subsection (b) or (c) to
such product is not necessary to protect animal
and plant health, and animal and plant products.
(II) CERTAIN PROCESSES.—Regulations under
subsections (b) and (c) shall set forth the proce-
dures for applying for an exemption under sub-
clause (I). In the case of investigational products
authorized under any of the Acts specified in clause
(ii), the Secretary shall make a determination
regarding a request for an exemption not later
than 14 days after the first date on which both
of the following conditions have been met by the
person requesting the exemption:
(aa) The person has submitted to the Sec-
retary an application for the exemption
meeting the requirements established by the
Secretary.
(bb) The person has notified the Secretary
that the investigation has been authorized
under such an Act.
(D) AGRICULTURAL EMERGENCIES.—The Secretary may
temporarily exempt a person from the applicability of the
H. R. 3448—61
requirements of this section with respect to an overlap
agent or toxin, in whole or in part, if the Secretary deter-
mines that such exemption is necessary to provide for
the timely participation of the person in a response to
a domestic or foreign agricultural emergency that involves
such an agent or toxin. With respect to the emergency
involved, the exemption under this subparagraph for a
person may not exceed 30 days, except that the Secretary,
after review of whether such exemption remains necessary,
may provide one extension of an additional 30 days.
(E) PUBLIC HEALTH EMERGENCIES.—Upon request of
the Secretary of Health and Human Services, after the
granting by such Secretary of an exemption under
351A(g)(3) of the Public Health Service Act pursuant to
a finding that there is a public health emergency, the
Secretary of Agriculture may temporarily exempt a person
from the applicability of the requirements of this section
with respect to an overlap agent or toxin, in whole or
in part, to provide for the timely participation of the person
in a response to the public health emergency. With respect
to the emergency involved, such exemption for a person
may not exceed 30 days, except that upon request of the
Secretary of Health and Human Services, the Secretary
of Agriculture may, after review of whether such exemption
remains necessary, provide one extension of an additional
30 days.
(2) GENERAL AUTHORITY FOR EXEMPTIONS NOT INVOLVING
OVERLAP AGENTS OR TOXINS.—In the case of listed agents or
toxins that are not overlap agents or toxins, the Secretary
may grant exemptions from the applicability of provisions of
regulations under subsection (b) or (c) if the Secretary deter-
mines that such exemptions are consistent with protecting
animal and plant health, and animal and plant products.
(h) DISCLOSURE OF INFORMATION.—
(1) NONDISCLOSURE OF CERTAIN INFORMATION.—No Federal
agency specified in paragraph (2) shall disclose under section
552 of title 5, United States Code, any of the following:
(A) Any registration or transfer documentation sub-
mitted under subsections (b) and (c), or permits issued
prior to the date of the enactment of this Act, for the
possession, use or transfer of a listed agent or toxin; or
information derived therefrom to the extent that it identi-
fies the listed agent or toxin possessed, used or transferred
by a specific person or discloses the identity or location
of a specific person.
(B) The national database developed pursuant to sub-
section (d), or any other compilation of the registration
or transfer information submitted under subsections (b)
and (c) to the extent that such compilation discloses site-
specific registration or transfer information.
(C) Any portion of a record that discloses the site-
specific or transfer-specific safeguard and security meas-
ures used by a registered person to prevent unauthorized
access to listed agents and toxins.
(D) Any notification of a release of a listed agent or
toxin submitted under subsections (b) and (c), or any
H. R. 3448—62
notification of theft or loss submitted under such sub-
sections.
(E) Any portion of an evaluation or report of an inspec-
tion of a specific registered person conducted under sub-
section (f) that identifies the listed agent or toxin possessed
by a specific registered person or that discloses the identity
or location of a specific registered person if the agency
determines that public disclosure of the information would
endanger animal or plant health, or animal or plant prod-
ucts.
(2) COVERED
AGENCIES.—For purposes of paragraph (1)
only, the Federal agencies specified in this paragraph are the
following:
(A) The Department of Health and Human Services,
the Department of Justice, the Department of Agriculture,
and the Department of Transportation.
(B) Any Federal agency to which information specified
in paragraph (1) is transferred by any agency specified
in subparagraph (A) of this paragraph.
(C) Any Federal agency that is a registered person,
or has a sub-agency component that is a registered person.
(D) Any Federal agency that awards grants or enters
into contracts or cooperative agreements involving listed
agents and toxins to or with a registered person, and
to which information specified in paragraph (1) is trans-
ferred by any such registered person.
(3) OTHER EXEMPTIONS.—This subsection may not be con-
strued as altering the application of any exemptions to public
disclosure under section 552 of title 5, United States Code,
except as to subsection 552(b)(3) of such title, to any of the
information specified in paragraph (1).
(4) RULE OF CONSTRUCTION.—Except as specifically pro-
vided in paragraph (1), this subsection may not be construed
as altering the authority of any Federal agency to withhold
under section 552 of title 5, United States Code, or the obliga-
tion of any Federal agency to disclose under section 552 of
title 5, United States Code, any information, including informa-
tion relating to—
(A) listed agents and toxins, or individuals seeking
access to such agents and toxins;
(B) registered persons, or persons seeking to register
their possession, use, or transfer of such agents and toxins;
(C) general safeguard and security policies and require-
ments under regulations under subsections (b) and (c);
or
(D) summary or statistical information concerning reg-
istrations, registrants, denials or revocations of registra-
tions, listed agents and toxins, inspection evaluations and
reports, or individuals seeking access to such agents and
toxins.
(5) DISCLOSURES TO CONGRESS; OTHER DISCLOSURES.—This
subsection may not be construed as providing any authority—
(A) to withhold information from the Congress or any
committee or subcommittee thereof; or
(B) to withhold information from any person under
any other Federal law or treaty.
(i) CIVIL MONEY PENALTY.—
H. R. 3448—63
(1) IN GENERAL.—In addition to any other penalties that
may apply under law, any person who violates any provision
of regulations under subsection (b) or (c) shall be subject to
the United States for a civil money penalty in an amount
not exceeding $250,000 in the case of an individual and
$500,000 in the case of any other person.
(2) APPLICABILITY OF CERTAIN PROVISIONS.—The provisions
of sections 423 and 425(2) of the Plant Protection Act (7 U.S.C.
7733 and 7735(2)) shall apply to a civil money penalty or
activity under paragraph (1) in the same manner as such
provisions apply to a penalty or activity under the Plant Protec-
tion Act.
(j) NOTIFICATION IN EVENT OF RELEASE.—Regulations under
subsections (b) and (c) shall require the prompt notification of
the Secretary by a registered person whenever a release, meeting
criteria established by the Secretary, of a listed agent or toxin
has occurred outside of the biocontainment area of a facility of
the registered person. Upon receipt of such notification and a finding
by the Secretary that the release poses a threat to animal or
plant health, or animal or plant products, the Secretary shall take
appropriate action to notify relevant Federal, State, and local
authorities, and, if necessary, other appropriate persons (including
the public). If the released listed agent or toxin is an overlap
agent or toxin, the Secretary shall promptly notify the Secretary
of Health and Human Services upon notification by the registered
person.
(k) REPORTS.—The Secretary shall report to the Congress
annually on the number and nature of notifications received under
subsection (e)(8) (relating to theft or loss) and subsection (j) (relating
to releases).
(l) DEFINITIONS.—For purposes of this section:
(1) The terms ‘‘biological agent’’ and ‘‘toxin’’ have the
meanings given such terms in section 178 of title 18, United
States Code.
(2) The term ‘‘listed agents and toxins’’ means biological
agents and toxins listed pursuant to subsection (a)(1).
(3) The term ‘‘listed agents or toxins’’ means biological
agents or toxins listed pursuant to subsection (a)(1).
(4) The terms ‘‘overlap agents and toxins’’ and ‘‘overlap
agent or toxin’’ have the meaning given such terms in sub-
section (g)(1)(A)(ii).
(5) The term ‘‘person’’ includes Federal, State, and local
governmental entities.
(6) The term ‘‘registered person’’ means a person registered
under regulations under subsection (b) or (c).
(7) The term ‘‘Secretary’’ means the Secretary of Agri-
culture.
(m) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
such sums as may be necessary for each of the fiscal years 2002
through 2007, in addition to other funds that may be available.
SEC. 213. IMPLEMENTATION BY DEPARTMENT OF AGRICULTURE.
(a) DATE CERTAIN FOR PROMULGATION OF LIST.—Not later than
60 days after the date of the enactment of this Act, the Secretary
of Agriculture (referred to in this section as the ‘‘Secretary’’) shall
promulgate an interim final rule that establishes the initial list
H. R. 3448—64
under section 212(a)(1). In promulgating such rule, the Secretary
shall provide written guidance on the manner in which the notice
required in subsection (b) is to be provided to the Secretary.
(b) DATE CERTAIN FOR NOTICE OF POSSESSION.—Not later than
60 days after the date on which the Secretary promulgates the
interim final rule under subsection (a), all persons (unless exempt
under section 212(g)) in possession of biological agents or toxins
included on the list referred to in subsection (a) shall notify the
Secretary of such possession.
(c) DATE
CERTAIN
FOR
PROMULGATION; EFFECTIVE
DATE
REGARDING CRIMINAL AND CIVIL PENALTIES.—Not later than 180
days after the date of the enactment of this Act, the Secretary
shall promulgate an interim final rule for carrying out section
212, other than for the list referred to in subsection (a) of this
section (but such rule may incorporate by reference provisions
promulgated pursuant to subsection (a)). Such interim final rule
shall take effect 60 days after the date on which such rule is
promulgated, including for purposes of—
(1) section 175b(c) of title 18, United States Code (relating
to criminal penalties), as added by section 231(a)(5) of this
Act; and
(2) section 212(i) of this Act (relating to civil penalties).
(d) TRANSITIONAL PROVISION REGARDING CURRENT RESEARCH
AND EDUCATION.—The interim final rule under subsection (c) shall
include time frames for the applicability of the rule that minimize
disruption of research or educational projects that involve biological
agents and toxins listed pursuant to section 212(a)(1) and that
were underway as of the effective date of such rule.
Subtitle C—Interagency Coordination
Regarding Overlap Agents and Toxins
SEC. 221. INTERAGENCY COORDINATION.
(a) IN GENERAL.—
(1) COORDINATION.—The Secretary of Agriculture and the
Secretary of Health and Human Services shall in accordance
with this section coordinate activities regarding overlap agents
and toxins.
(2) OVERLAP AGENTS AND TOXINS; OTHER TERMS.—For pur-
poses of this section:
(A) The term ‘‘overlap agent or toxin’’ means a
biological agent or toxin that—
(i) is listed pursuant to section 315A(a)(1) of the
Public Health Service Act, as added by section 201
of this Act; and
(ii) is listed pursuant to section 212(a)(1) of this
Act.
(B) The term ‘‘section 351A program’’ means the pro-
gram under section 351A of the Public Health Service
Act.
(C) The term ‘‘section 212 program’’ means the program
under section 212 of this Act.
(b) CERTAIN MATTERS.—In carrying out the section 351A pro-
gram and the section 212 program, the Secretary of Health and
Human Services and the Secretary of Agriculture shall, to the
H. R. 3448—65
greatest extent practicable, coordinate activities to achieve the fol-
lowing purposes:
(1) To minimize any conflicts between the regulations
issued under, and activities carried out under, such programs.
(2) To minimize the administrative burden on persons sub-
ject to regulation under both of such programs.
(3) To ensure the appropriate availability of biological
agents and toxins for legitimate biomedical, agricultural or
veterinary research, education, or other such purposes.
(4) To ensure that registration information for overlap
agents and toxins under the section 351A and section 212
programs is contained in both the national database under
the section 351A program and the national database under
the section 212 program.
(c) MEMORANDUM OF UNDERSTANDING.—
(1) IN GENERAL.—Promptly after the date of the enactment
of this Act, the Secretary of Agriculture and the Secretary
of Health and Human Services shall enter into a memorandum
of understanding regarding overlap agents and toxins that is
in accordance with paragraphs (2) through (4) and contains
such additional provisions as the Secretary of Agriculture and
the Secretary of Health and Human Services determine to
be appropriate.
(2) SINGLE REGISTRATION SYSTEM REGARDING REGISTERED
PERSONS.—The memorandum of understanding under para-
graph (1) shall provide for the development and implementation
of a single system of registration for persons who possess,
use, or transfer overlap agents or toxins and are required
to register under both the section 351A program and the section
212 program. For purposes of such system, the memorandum
shall provide for the development and implementation of the
following:
(A) A single registration form through which the person
submitting the form provides all information that is
required for registration under the section 351A program
and all information that is required for registration under
the section 212 program.
(B) A procedure through which a person may choose
to submit the single registration form to the agency admin-
istering the section 351A program (in the manner provided
under such program), or to the agency administering the
section 212 program (in the manner provided under such
program).
(C) A procedure through which a copy of a single
registration form received pursuant to subparagraph (B)
by the agency administering one of such programs is
promptly provided to the agency administering the other
program.
(D) A procedure through which the agency receiving
the single registration form under one of such programs
obtains the concurrence of the agency administering the
other program that the requirements for registration under
the other program have been met.
(E) A procedure through which—
H. R. 3448—66
(i) the agency receiving the single registration form
under one of such programs informs the agency admin-
istering the other program whether the receiving
agency has denied the registration; and
(ii) each of such agencies ensures that registrations
are entered into the national database of registered
persons that is maintained by each such agency.
(3) PROCESS
OF
IDENTIFICATION.—With respect to the
process of identification under the section 351A program and
the section 212 program for names and other identifying
information submitted to the Attorney General (relating to
certain categories of individuals and entities), the memorandum
of understanding under paragraph (1) shall provide for the
development and implementation of the following:
(A) A procedure through which a person who is
required to submit information pursuant to such process
makes (in addition to the submission to the Attorney Gen-
eral) a submission, at the option of the person, to either
the agency administering the section 351A program or
the agency administering the section 212 program, but
not both, which submission satisfies the requirement of
submission for both of such programs.
(B) A procedure for the sharing by both of such agencies
of information received from the Attorney General by one
of such agencies pursuant to the submission under subpara-
graph (A).
(C) A procedure through which the agencies admin-
istering such programs concur in determinations that
access to overlap agents and toxins will be granted.
(4) COORDINATION OF INSPECTIONS AND ENFORCEMENT.—
The memorandum of understanding under paragraph (1) shall
provide for the development and implementation of procedures
under which Federal personnel under the section 351A program
and the section 212 program may share responsibilities for
inspections and enforcement activities under such programs
regarding overlap agents and toxins. Activities carried out
under such procedures by one of such programs on behalf
of the other may be carried out with or without reimbursement
by the agency that administers the other program.
(5) DATE
CERTAIN
FOR
IMPLEMENTATION.—The memo-
randum of understanding under paragraph (1) shall be imple-
mented not later than 180 days after the date of the enactment
of this Act. Until the single system of registration under para-
graph (2) is implemented, persons who possess, use, or transfer
overlap agents or toxins shall register under both the section
351A program and the section 212 program.
(d) JOINT REGULATIONS.—Not later than 18 months after the
date on which the single system of registration under subsection
(c)(2) is implemented, the Secretary of Health and Human Services
and the Secretary of Agriculture shall jointly issue regulations
for the possession, use, and transfer of overlap agents and toxins
that meet the requirements of both the section 351A program
and the section 212 program.
H. R. 3448—67
Subtitle D—Criminal Penalties Regarding
Certain Biological Agents and Toxins
SEC. 231. CRIMINAL PENALTIES.
(a) IN GENERAL.—Section 175b of title 18, United States Code,
as added by section 817 of Public Law 107–56, is amended—
(1) by striking ‘‘(a)’’ and inserting ‘‘(a)(1)’’;
(2) by transferring subsection (c) from the current place-
ment of the subsection and inserting the subsection before
subsection (b);
(3) by striking ‘‘(c)’’ and inserting ‘‘(2);
(4) by redesignating subsection (b) as subsection (d); and
(5) by inserting before subsection (d) (as so redesignated)
the following subsections:
‘‘(b) TRANSFER TO UNREGISTERED PERSON.—
‘‘(1) SELECT
AGENTS.—Whoever transfers a select agent
to a person who the transferor knows or has reasonable cause
to believe is not registered as required by regulations under
subsection (b) or (c) of section 351A of the Public Health Service
Act shall be fined under this title, or imprisoned for not more
than 5 years, or both.
‘‘(2) CERTAIN OTHER BIOLOGICAL AGENTS AND TOXINS.—Who-
ever transfers a biological agent or toxin listed pursuant to
section 212(a)(1) of the Agricultural Bioterrorism Protection
Act of 2002 to a person who the transferor knows or has
reasonable cause to believe is not registered as required by
regulations under subsection (b) or (c) of section 212 of such
Act shall be fined under this title, or imprisoned for not more
than 5 years, or both.
‘‘(c) UNREGISTERED FOR POSSESSION.—
‘‘(1) SELECT
AGENTS.—Whoever knowingly possesses a
biological agent or toxin where such agent or toxin is a select
agent for which such person has not obtained a registration
required by regulations under section 351A(c) of the Public
Health Service Act shall be fined under this title, or imprisoned
for not more than 5 years, or both.
‘‘(2) CERTAIN OTHER BIOLOGICAL AGENTS AND TOXINS.—Who-
ever knowingly possesses a biological agent or toxin where
such agent or toxin is a biological agent or toxin listed pursuant
to section 212(a)(1) of the Agricultural Bioterrorism Protection
Act of 2002 for which such person has not obtained a registra-
tion required by regulations under section 212(c) of such Act
shall be fined under this title, or imprisoned for not more
than 5 years, or both.’’.
(b) CONFORMING AMENDMENTS.—Chapter 10 of title 18, United
States Code, is amended—
(1) in section 175b (as added by section 817 of Public
Law 107–56 and amended by subsection (a) of this section)—
(A) in subsection (d)(1), by striking ‘‘The term’’ and
all that follows through ‘‘does not include’’ and inserting
the following: ‘‘The term ‘select agent’ means a biological
agent or toxin to which subsection (a) applies. Such term
(including for purposes of subsection (a)) does not include’’;
and
H. R. 3448—69
(2) in subsection (c)(2)(C), by striking ‘‘a disease organism’’
and inserting ‘‘a biological agent, toxin, or vector (as those
terms are defined in section 178 of this title)’’.
TITLE III—PROTECTING SAFETY AND
SECURITY OF FOOD AND DRUG SUPPLY
Subtitle A—Protection of Food Supply
SEC. 301. 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 transpor-
tation; response and notification procedures; and risk communica-
tions 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
H. R. 3448—70
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 Protec-
tion Agency, and the Secretary of Agriculture.
‘‘(4) 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) 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) 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
H. R. 3448—71
that is found during an inspection, examination, or inves-
tigation under this Act conducted by such officer or quali-
fied employee, if the officer or qualified employee has cred-
ible 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. 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 para-
graph (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 con-
strued 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 oppor-
tunity, 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:
H. R. 3448—72
‘‘(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, 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 con-
sequences 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 Fed-
eral 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 subpara-
graph (A), by inserting ‘‘subparagraph (A) or (B) of’’ before
‘‘paragraph (1)’’;
H. R. 3448—73
(B) by redesignating paragraph (3) as paragraph (4);
and
(C) by inserting after paragraph (2) the following para-
graph:
‘‘(3) PERSONS SUBJECT TO PERMISSIVE DEBARMENT; FOOD
IMPORTATION.—A person is subject to debarment under para-
graph (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 (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 ‘‘sub-
section (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).’’.
H. R. 3448—74
(e) IMPORTATION BY DEBARRED PERSONS.—Section 801 of the
Federal Food, Drug, and Cosmetic Act, as amended by section
303(c) of this Act, 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 execu-
tion 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 trans-
ferred 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 per-
son, 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. REGISTRATION OF FOOD FACILITIES.
‘‘(a) REGISTRATION.—
‘‘(1) 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 reg-
istered 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 con-
ducts business and, when determined necessary by the Sec-
retary 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. The registrant shall notify the Secretary in a timely
manner of changes to such information.
‘‘(3) PROCEDURE.—Upon receipt of a completed registration
described in paragraph (1), the Secretary shall notify the reg-
istrant of the receipt of such registration and assign a registra-
tion number to each registered facility.
‘‘(4) 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
H. R. 3448—75
to this subsection shall not be subject to disclosure under sec-
tion 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 establish-
ment 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 Regula-
tions).
‘‘(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, 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) ELECTRONIC FILING.—For the purpose of reducing paper-
work 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 pursu-
ant to this section. In providing for the electronic submission of
H. R. 3448—76
such registrations, the Secretary shall ensure adequate authentica-
tion protocols are used to enable identification of the registrant
and validation of the data as appropriate.
(e) 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 regula-
tions 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 expira-
tion of such period, subject to compliance with the final regula-
tions 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. 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 manu-
factures, 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. The requirement under the preceding sentence applies
to all records relating to the manufacture, processing, packing,
distribution, receipt, holding, or importation of such article main-
tained by or on behalf of such person in any format (including
paper and electronic formats) and at any location.
‘‘(b) REGULATIONS
CONCERNING
RECORDKEEPING.—The Sec-
retary, in consultation and coordination, as appropriate, with other
Federal departments and agencies with responsibilities for regu-
lating 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.
H. R. 3448—77
‘‘(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, proc-
esses, 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 sen-
tence’’.
(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) 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 require-
ments 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) 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