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Center > Industry Focus > Article
List > The
Implications of Bioterrorism Preparedness Act of 2001 on Food
Exports and Imports |
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| The Implications of Bioterrorism
Preparedness Act of 2001 on Food Exports and Imports |
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| Published on April 25, 2002 |
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The terrorist attack on September 11,
2001 has caused the U.S. government to step up preventive measures
in all aspects, including drafting a new law called "Bioterrorism
Preparedness Act of 2001". The new law aims to prevent
terrorist attacks that could come in forms of food poisoning
or contamination in locally produced and imported food. The
law has been proposed since November 2001, and is currently
under consideration by the upper house of the U.S. Congress.
Since the Bioterrorism Preparedness
Act has not been passed as a law, or implemented, its potential
effects on food exporting from and importing to the U.S. cannot
be clearly determined yet. Also, the details of the Act would
still be subject to the final approval in the U.S. Congress.
The potential implications of the new law are as follows:
1. There would be more import restrictions
to the U.S. market, making the process for foreign exporters
more complicated and costly.
2. New import rules and regulations would be added. Some
of the rules may also apply to overseas exporters on certain
areas, such as requirement of factory registration.
3. Food products would have to go through stricter inspection
process, citing the need to prevent terrorism attacks.
4. More U.S. government officials, if with justified reasons,
would have the authority to inspect goods, even though
their positions might not be directly related to the regular
inspection process.
5. The probability that the imported goods would be detained
or prohibited for entry would increase.
6. The law would allow related authorities to detain the
imported goods for as long as 45 days; and in the meantime,
there is, nevertheless, no exception for perishable food.
7. A company could be banned permanently if it repeatedly
violates the law or if it could be proved that the company
intentionally violates the law.
8. Importers would have to ask for permission in advance
before each shipment, or else the shipment would not be
allowed to enter the country.
9. Any shipment that is denied entry of the U.S. ports
would be stamped accordingly with the phrase "United
States: Refused Entry"
10. The new law would not allow the goods, which have
been refused by one U.S. port, to enter another U.S. port
(called "port shopping") anymore, even though
this practice is currently allowed.
11. US FDA would have to report full details of any occurrence
of food contamination to every state. |
The following is the sections
of the Bioterrorism Preparedness Act of 2001, which are
related to food imports to the U.S for reference. The
sections involving food imports are included into two
major subtitles of the Act, covering the rights and duties
of the related government officials and control of the
food distribution.
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TITLE V--PROTECTING
THE SAFETY AND SECURITY OF THE FOOD SUPPLY
Subtitle A--General Provisions
to Expand and Upgrade Security |
SEC. 512.
EXPANSION OF ANIMAL AND PLANT HEALTH INSPECTION SERVICE ACTIVITIES.
(a) IN GENERAL- The Secretary of Agriculture (referred
to in this section as the `Secretary') shall enhance and expand
the capacity of the Animal and Plant Health Inspection Service
through the conduct of 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) adopt new 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 |
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| (5) otherwise expand the capacity
of the Service to protect against the threat of
bioterrorism. |
(b) HIGH-TECH AGRICULTURE EARLY WARNING AND EMERGENCY
RESPONSE SYSTEM-
(1) IN GENERAL- To provide
the agricultural system of the United States with
a new, enhanced level of protection and biosecurity
that does not exist on the date of enactment of
this Act, the Secretary of Agriculture, in coordination
with the Secretary of Health and Human Services,
shall implement a fully secure surveillance and
response system that utilizes, or is capable of
utilizing, field test devices capable of detecting
biological threats to animals and plants and that
electronically integrates the devices and the tests
on a real-time basis into a comprehensive surveillance,
incident management, and emergency response system.
(2) EXPANSION OF SYSTEM- The Secretary shall
expand the system implemented under paragraph (1)
as soon as practicable to include other Federal
agencies and the States where appropriate and necessary
to enhance the protection of the food and agriculture
system of the United States. To facilitate the expansion
of the system, the Secretary shall award grants
to States. |
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(c) AUTOMATED RECORDKEEPING SYSTEM- The Administrator
of the Animal and Plant Health Inspection Service shall
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.
(d) 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. 513. EXPANSION OF
FOOD SAFETY INSPECTION SERVICE ACTIVITIES.
(a) IN GENERAL- The
Secretary of Agriculture shall enhance and expand the
capacity of the Food Safety Inspection Service through
the conduct of 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 through
the sharing of information and technology; and
(4) otherwise expand the capacity of the Service
to protect against the threat of bioterrorism. |
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(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. 514. EXPANSION OF FOOD AND DRUG ADMINISTRATION
ACTIVITIES.
(a) IN GENERAL- The Secretary of Health and Human
Services shall expand the capacity of the Food and Drug
Administration to--
(1) increase inspections to
ensure the safety of the food supply consistent
with the amendments made by subtitle B; and
(2) improve linkages between the Agency and other
regulatory agencies of the Federal Government, the
States, and Indian tribes with shared responsibilities. |
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(b) AUTHORIZATION OF APPROPRIATIONS- There is authorized
to be appropriated to carry out this section, $60,000,000
for fiscal year 2002, and such sums as may be necessary
for each subsequent fiscal year.
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| Subtitle
B--Protection of the Food Supply |
SEC. 531. 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:
`(h) ADMINISTRATIVE DETENTION OF FOODS-
`(1) AUTHORITY-
Any 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 the article is in violation of this
Act and presents a threat of serious adverse health
consequences or death to humans or animals.
`(2) PERIOD OF DETENTION; APPROVAL BY SECRETARY
OR SECRETARY'S DESIGNEE-
`(A) DURATION-
An article of food may be detained under this
subsection for a reasonable period, not to
exceed 20 days, unless a greater period of
time, not to exceed 30 days, is necessary
to enable the Secretary to institute an action
under subsection (a) or section 302.
`(B) SECRETARY'S APPROVAL- Before an
article of food may be ordered detained under
this subsection, the Secretary or an officer
or qualified employee designated by the Secretary
must approve such order, after determining |
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that the article presents a threat of serious adverse
health consequences or death to humans or animals.
`(3) SECURITY OF DETAINED
ARTICLE- A detention order under this subsection
with respect to an article of food may require that
the article be labeled or marked as detained, and
may require that the article be removed to a secure
facility. An article subject to a detention order
under this subsection shall not be moved by any
person from the place at which it is ordered detained
until release by the Secretary, or the expiration
of the detention period applicable to such order,
whichever occurs first.
`(4) APPEAL OF DETENTION ORDER- Any person
who would be entitled to claim a detained article
if it were seized under subsection (a) may appeal
to the Secretary the detention order under this
subsection. Within 15 days after such an appeal
is filed, the Secretary, after affording opportunity
for an informal hearing, shall by order confirm
the detention order or revoke it.
`(5) PERISHABLE FOODS- The Secretary shall
provide in regulation or in guidance for procedures
for instituting and appealing on an expedited basis
administrative detention of perishable foods.'. |
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(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
new subsection:
| `(bb) The movement 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 in order to identify the article
as detained.'. |
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SEC. 532. 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) by striking the period
at the end of subparagraph (B) and inserting
`; or'; and
(B) by adding at the end the following:
`(C) a person from importing a food or offering
a food for import into the United States if--
`(i) the person
has been convicted of a felony for conduct
relating to the importation into the
United States of any food; or
`(ii) 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.'. |
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(2) CONFORMING AMENDMENT-
Section 306(b)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 335a(b)(2)) is amended--
(A) in the paragraph
heading, by inserting `RELATING TO DRUG APPLICATIONS'
after `DEBARMENT'; and
(B) in the matter preceding subparagraph (A),
by striking `paragraph (1)' and inserting
`subparagraphs (A) and (B) of paragraph (1)'. |
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(3) DEBARMENT PERIOD-
Section 306(c)(2)(A)(iii) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 335a(c)(2)(A)(iii))
is amended by striking `subsection (b)(2)' and inserting
`subsection (b)(1)(C) or (b)(2)'.
(4) TERMINATION OF DEBARMENT- Section 306(d)(3)
of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 335a(d)(3)) is amended--
(A) in subparagraph (A)(i),
by striking `or (b)(2)(A)' and inserting `,
or (b)(2)(A), or (b)(1)(C)';
(B) in subparagraph (A)(ii)(II), by inserting
`in applicable cases,' before `sufficient
audits'; and
(C) in subparagraph (B), in each of clauses
(i) and (ii), by inserting `or (b)(1)(C)'
after `(b)(2)(B)'. |
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(5) EFFECTIVE DATES-
Section 306(l)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 335a(l)(2)) is amended--
(A) in the first sentence,
by inserting `and subsection (b)(1)(C)' after
`subsection (b)(2)(B)'; and
(B) in the second sentence, by striking `and
subsections (f) and (g) of this section' and
inserting `subsections (f) and (g), and subsection
(b)(1)(C)'. |
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(b) CONFORMING AMENDMENT-
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 by, with the assistance
of, or at the direction of, a person debarred under section
306(b)(1)(C).'.
SEC. 533. MAINTENANCE AND INSPECTION OF RECORDS FOR
FOODS.
(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. 414. MAINTENANCE AND INSPECTION OF RECORDS.
`(a) IN GENERAL- If the Secretary has reason
to believe that an article of food is adulterated
or misbranded under this Act and presents a threat
of serious adverse health consequences or death
to humans or animals, each person (excluding restaurants
and farms) that manufactures, processes, packs,
distributes, receives, holds, or imports such food
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 to copy all records
relating to such food that may assist the Secretary
to determine the cause and scope of the violation.
This requirement applies to all records relating
to such manufacture, processing, packing, distribution,
receipt, holding, or importation of such food 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 shall promulgate regulations regarding
the maintenance and retention of records for inspection
for not longer than 2 years by persons (excluding
restaurants and farms) that manufacture, process,
pack, transport, distribute, receive, hold, or import
food, as may be needed to allow the Secretary--
`(1) to promptly trace
the source and chain of distribution of food
and its packaging to address threats of serious
adverse health consequences or death to humans
or animals; or
`(2) to determine whether food manufactured,
processed, packed, or held by the person may
be adulterated or misbranded to the extent
that it presents a threat of serious adverse
health consequences or death to humans or
animals under this Act. |
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The Secretary may impose
reduced requirements under such regulations for small
businesses with 50 or fewer employees.
`(c) LIMITATIONS- Nothing in this section shall
be construed--
`(1) to limit the authority
of the Secretary to inspect records or to require
maintenance of records under any other provision
of or regulations issued under 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 extend to recipes for food, financial data,
sales data other than shipment data, pricing data,
personnel data, or research data; or
`(4) to alter, amend, or affect in any way the disclosure
or nondisclosure under section 552 of title 5, United
States Code, of information copied or collected
under this section, or its treatment under section
1905 of title 18, United States Code.'. |
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(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 adding
after the first sentence the following: `In the
case of any person (excluding restaurants and farms)
that manufactures, processes, packs, transports,
distributes, receives, holds, or imports foods,
the inspection shall extend to all records and other
information described in section 414(a), or required
to be maintained pursuant to section 414(b).'; and
(2) in paragraph (2), in the matter preceding subparagraph
(A), by striking `second sentence' and inserting
`third sentence'. |
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(c) PROHIBITED ACT-
Section 301 of the Federal Food, Drug and Cosmetic Act
(21 U.S.C. 331) is amended--
(1) in subsection (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 |
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| (2) in section (j), by inserting
`414,' after `412,'. |
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| (d) EXPEDITED RULEMAKING-
Not later than 18 months after the date of enactment of
this Act, the Secretary shall promulgate proposed and
final regulations establishing recordkeeping requirements
under subsection 414(b)(1) of the Federal Food, Drug,
and Cosmetic Act. |
SEC. 534. REGISTRATION OF FOOD MANUFACTURING, PROCESSING,
AND HANDLING FACILITIES.
(a) IN GENERAL- Chapter IV of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 341 et seq.), as amended by
section 533, is further amended by adding at the end the
following:
`SEC. 415. REGISTRATION OF FOOD MANUFACTURING, PROCESSING,
AND HANDLING FACILITIES.
`(a) REGISTRATION-
`(1) IN GENERAL- Any
facility engaged in manufacturing, processing, or
handling food for consumption in the United States
shall 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. |
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`(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, or handled
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 registrant of the receipt of such
registration and assign a registration 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 other
information required to be submitted under this
subsection shall not be subject to the disclosure
requirements of section 552 of title 5, United States
Code. |
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`(b) EXEMPTION AUTHORITY-
The Secretary may by regulation exempt types of retail
establishments or farms from the requirements of subsection
(a) if the Secretary determines that the registration
of such facilities is not needed for effective enforcement
of chapter IV and any regulations issued under such chapter.
`(c) FACILITY- In this section, the term `facility'
includes any factory, warehouse, or establishment (including
a factory, warehouse, or establishment of an importer),
that manufactures, handles, or processes food. Such term
does not include restaurants.
`(d) RULE OF CONSTRUCTION- Nothing in this section
shall be construed to authorize the Secretary to require
an application, review, or licensing process.'.
(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:
`(t) If it is a food from a facility for which registration
has not been submitted to the Secretary under section
415(a).'.
(c) EFFECTIVE DATE- The amendment made by subsection (b)
shall take effect 180 days after the date of enactment
of this Act.
SEC. 535. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.
(a) PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS- Section
801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381) is amended by adding at the end the following:
`(j) PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS-
`(1) IN GENERAL- At
least 4 hours before a food is imported or offered
for importation into the United States, the producer,
manufacturer, or shipper of the food shall provide
documentation to the Secretary of the Treasury and
the Secretary of Health and Human Services that--
`(A) identifies--
`(i) the food;
`(ii) the countries of origin of the
food; and
`(iii) the quantity to be imported;
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| `(B) includes such other information
as the Secretary may require by regulation. |
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`(2) REFUSAL OF ADMISSION-
If documentation is not provided as required by
paragraph (1) at least 4 hours before the food is
imported or offered for importation, the food may
be refused admission.
`(3) LIMITATION- Nothing in this subsection shall
be construed 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.).'. |
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(b) PROHIBITION OF
KNOWINGLY MAKING FALSE STATEMENTS- Section 301 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331),
as amended by section 531(b), is further amended by inserting
after subsection (bb) the following:
`(cc) Knowingly making a false statement in documentation
required under section 801(j).'. |
SEC. 536. AUTHORITY TO MARK REFUSED ARTICLES.
(a) MISBRANDED FOODS- Section 403 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 343), as amended by
section 534(b), is further amended by adding at the end
the following:
`(u) If--
`(1) it has been refused admission
under section 801(a);
`(2) it has not been required to be destroyed under
section 801(a);
`(3) the packaging of it does not bear a label or
labeling described in section 801(a); and
`(4) it presents a threat of serious adverse health
consequences or death to humans or animals.'. |
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(b) REQUIREMENT-
Section 801(a) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 381(a)) is amended by adding at the end
the following: `The Secretary of Health and Human Services
may require the owner or consignee of a food that has
been refused admission under this section, and has not
been required to be destroyed, to affix to the packaging
of the food a label or labeling that--
`(1) clearly and conspicuously
bears the statement: `United States: Refused Entry';
`(2) is affixed to the packaging until the food
is brought into compliance with this Act; and
`(3) has been provided at the expense of the owner
or consignee of the food.'. |
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(c) RULE OF CONSTRUCTION-
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 marketing
of refused articles under any other provision of law.
SEC. 537. 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 in the first sentence--
(1) by inserting `qualified'
before `employees'; and
(2) by inserting `or of other Federal Departments
or agencies, notwithstanding any other provision
of law restricting the use of a Department's or
agency's officers, employees, or funds,' after `officers
and employees of the Department'. |
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SEC. 538. PROHIBITION AGAINST PORT SHOPPING.
Section 402 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 342), as amended by section 532(b), is further
amended by adding at the end the following:
`(i) 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.'.
Note: For full details
of Bioterrorism Preparedness Act of 2001, please click
the link below. http://www.asmusa.org/pasrc/s1715.htm
Source: Thai Frozen Foods Association
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