M E M O R A N D U M
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| TO: | Clients and Friends of the Firm
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| FROM: | John M. Peterson
Neville Peterson LLP
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| RE: |
H.R. 3448-The Public Health Security and Bioterrorism Preparedness
and Response Act of 2002 |
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I. Introduction
The Senate and House of Representatives recently
passed a single version of H.R 3448, the Public Health Security and Bioterrorism
Preparedness Response Act of 2002. President Bush has indicated that he will
sign the bill into law.
H.R. 3448 will make numerous amendments to the Federal
Food, Drug and Cosmetic Act (FDCA) to require the submission of information to
the government in advance of the importation of food products. It also establishes
new enforcement procedures to be applied to food products which are refused admission
into the United States. This Memorandum describes the basic provisions of the
new legislation, which will be implemented by regulation within the next eighteen
(18) months.
II. Major Provisions of the Bill
Advance Notification of Imported Food Shipments
The legislation adds a new subsection 801(m) to
the FDCA, to require the submission of information to the government in advance
of the entry of imported food shipments.
For each food article imported or offered for import
into the United States, Section 801(m) would require the Secretary of Health and
Human Services (HHS), after consultation with the Secretary of the Treasury, to
require the advance submission of the following information for the purpose of
enabling the inspection of food imports at U.S. Ports of Entry:
- Identification of the article
of food;
- The manufacturer and shipper
of the article;
- The grower of the article
(if known within the 5-day advance period during which this information is
required to be provided);.
- The country in which the article
originates;
- The country from which the
article is shipped; and
- The anticipated port of entry
for the article.
Regulations
implementing the advance notification requirement would be implemented within
eighteen (18) months after the date of enactment of the bill.
The Secretary of HHS would have authority to determine
the period of time in advance of the date of importation in which this information
would be required. By law, this period would be no less than the minimum amount
of time for HHS to receive, review and respond to such notification, but not more
than 5 days.
Food products imported, or offered for import, without
the required information would be refused admission into the United States. Such
products would be held at the port of entry in a secure facility, and could not
be delivered to the importer, owner or consignee until the required information
is submitted to and examined by HHS.
Under Section 801(m), food products refused admission
could not delivered to the importer or consignee pursuant to the execution of
a bond. Where food products are refused admission for lack of information, they
must remain in a secure facility at the Port of Entry, and cannot be transferred
to other persons.
Registration of U.S. Importers and U.S. Foreign
Manufacturers
H.R. 3448 also adds a new Section 415 to the FDCA.
This new section would authorize HHS to establish regulations requiring U.S. and
foreign facilities (including factories, warehouses or importer establishments)
which are engaged in manufacturing, processing, packing or holding food for consumption
into the United States, to submit a registration to the HHS Secretary. For each
foreign facility, a U.S. agent would have to be identified. The HHS Secretary
would compile and maintain an up-to-date list of these registered facilities,
which would be exempt from certain disclosure requirements.
A new Section 801(l) will be added to the FDCA to
specify that if a food article is imported from a foreign facility for which registration
has not been submitted, such article would be held in a secure facility at the
Port of Entry, and could not be delivered to the importer, owner or consignee,
until the foreign facility is registered.
In similar fashion, goods which are refused admission
due to the lack of registration of the foreign facility could not be released
under bond.
Temporary Detention of Suspect Imported Foods
The new legislation adds a new subsection 304(h) to the FDCA, which authorizes an officer or qualified employee of the Food and Drug Administration (FDA) to order the detention of any article of food that is found during an inspection, examination or investigation to present a "serious threat of adverse health consequences or death to human or animals". The standard for such a temporary detention would be the existence of credible evidence or information concerning the hazard.
The detention would be for a reasonable period not to exceed 20 days, (although a longer period of up to 30 days could be authorized in some cases, to enable HHS to take specified actions regarding the detained foodstuffs). Detained foodstuffs would need to be labeled or marked as "detained" and kept in a secure facility. They could not be transferred, under bond or otherwise, until the expiration of the detention period.
Persons who would be entitled to act as a claimant for the food if it were seized would have standing to appeal a detention order to the FDA.
Marking Requirements
H.R. 3448 adds a new subsection 801(n) to the FDCA,
which provides that if a food product has been refused admission (other than food
which is required to be destroyed) the HHS Secretary could require the owner or
consignee of the food to affix to the container a label which clearly and conspicuously
bears the statement:
UNITED STATES REFUSED ENTRY
The marking would be required to remain on the food
product or its container until HHS determines that the food involved has been
brought into compliance with the FDCA.
Any article of food which fails to bear a label as specified in this section
and which is found by HHS to present a ìthreat of serious adverse health consequences
or death to human or animalsî would be deemed to be ìmisbrandedî and refused
admission into the United States.
All expenses
in connection with affixing these labels would be paid by the owner or consignee
of the food and, in default of such payment, would constitute a lien on the merchandise.
Recordkeeping Requirements
The new legislation establishes Section 414 to the FDCA, which requires (with exceptions) that each person who imports, manufactures, processes or distributes an article of food that HHS believes is adulterated or presents a threat of serious adverse health consequences or death to humans or animals, to maintain records pertaining to that food. These persons would be required to permit authorized HHS personnel to have access to, and obtain copies of, all records related to that food which are necessary to allow HHS to identify the immediate previous sources and immediate subsequent recipients of food, including its packaging.
The law authorizes HHS to issue regulations requiring importers and others to maintain records of imported food products for not more than two (2) years.
Increased Port Examinations: Prohibition Against "Port Shopping"
The new legislation
amends Section 801(h) of the FDCA and requires HHS to give high priority to increasing
the number of inspections of imported foods at U.S. Ports of Entry, with priority
given to inspections to detect ìthe intentional adulteration of foodî. The law
also authorizes improvements to FDA information management systems to better allocate
HHS resources to detect the intentional adulteration of imported food.
A new subsection
402(h) is added to the FDCA, which provides that an article of food is deemed
to be adulterated (and thus refused admission into the U.S.), it may not be imported
or offered for import into the U.S. at any other port, unless the person re-offering
the food for import affirmatively establishes, at the expense of the foodís owner
or consignee, that the article complies with all legal requirements. This prohibition
is intended to prevent ìport shoppingî, a practice in which goods refused admission
at one port of entry are subsequently attempted to be entered at a different port.
Penalties: Debarments
The new legislation amends the FDCA to make violations of
the new requirements subject to penalties under the Act. Among the new requirements
for which penalties could be imposed would include the provisions in Section 801(m)
of the FDCA requiring the advance submission of information regarding food imports,
the provisions of FDCA Section 415 requiring the registration of importersí and
manufacturersí facilities, and the new subsection 304(h) provisions regarding
temporary detention of suspect imported food.
In addition, the new law amends
Subsection 306(b) of the FDCA in order to allow the HHS Secretary, either on his
own initiative or in response to a petition, to debar a person from importing
an article of food, or offering such food for import into the United States, if
that person has either (a) been convicted of a felony of conduct relating to the
importation into the U.S. of any food, or (b) engaged in a pattern of importing
or offering for importing adulterated food.
Research, Training and Inspections
H.R. 3448 also contains provisions expanding research and training of government
officials to enhance food safety and security. These include grants relating to
food safety studies, surveillance of animal and human health, and agricultural
bioterrorism. The bill also provide to grants to state governments for agricultural
inspections designed to ensure the continued security of the food supply.
The
bill contains general provisions directing federal agencies to enhance protection
of the safety and security of the food supply. In addition to the expansion of
food safety inspection and FDA activities, the bill provides for biosecurity upgrades
at the Departments of Agriculture and HHS, and for the funding of new countermeasures
against bioterrorism.
The bill also provides for the designation of ìbioterrorism
response medical centersî, the establishment of state public emergency announcement
plans, and enhanced training of physicians to deal with pediatric issues regarding
biological agents used in warfare and terrorism.
III. Conclusion
A copy
of H.R. 3448, as enacted by Congress is enclosed herewith.
Most of the billís
requirements pertaining to imported merchandise will be implemented through regulations
to be adopted by HHS. It is expected that the agency will, in the relatively near
future, publish proposed regulations for public comment. However, it is possible
that some regulations may be deemed sufficiently urgent that they may be implemented
on an interim basis before public comments are evaluated.
The new law radically
change the way food products are imported into the United States. Our firm stands
ready to provide any additional information or assistance which may be required
concerning this important new legislation. Please do not hesitate to call if you
have any questions.
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