[Congressional Record Volume 147, Number 178 (Thursday, December 20, 2001)]
[Extensions of Remarks]
[Pages E2387-E2389]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




          PUBLIC HEALTH SECURITY AND BIOTERRORISM RESPONSE ACT

                                 ______
                                 

                           HON. JOHN SHIMKUS

                              of illinois

                    in the house of representatives

                      Thursday, December 20, 2001

  Mr. SHIMKUS. Mr. Speaker, as a sponsor of H.R. 3448, which was 
introduced in the House on December 11, 2001, I would like to include 
for the record the following description of the bill:
  Section 302 would provide the Secretary authority to administratively 
detain any article of food where FDA has credible evidence or 
information indicating that such article ``presents a threat of serious 
adverse health consequences or death to humans or animals.'' The 
``serious adverse health consequences'' standard, which is used 
consistently in Title III of this Act, relates to the situation in 
which there is a reasonable probability that the use of, or exposure 
to, a violative product will cause serious adverse health consequences 
or death. This corresponds to FDA guidance pursuant to Title 21, 
Section 7.3 of the Code of Federal Regulations.
  The authority provided under Section 302 may not be delegated by the 
Secretary to any official less senior than the FDA district director in 
which the article is located. Under this authority, the article may be 
detained for a

[[Page E2388]]

reasonable period, not to exceed 20 days, unless the Secretary requires 
up to an additional 10 days. Because there is potential for food of 
limited shelf life to be detained, the ``reasonable period'' may, 
depending upon the perishability of the food, be significantly shorter 
than 20 days. The Secretary is required to institute rulemaking to 
establish expedited procedures for the detention of perishable foods, 
such as fresh produce, fresh fish and seafood products. The Secretary 
should promptly complete that rulemaking.
  Within 72 hours of filing an appeal the Secretary is required to 
provide opportunity for an informal hearing and render a final decision 
regarding the appeal. The Secretary's decision regarding the appeal is 
subject to judicial review consistent with the Administrative Procedure 
Act, Title 5, Section 706, of the United States Code. There is great 
need for timely review of an administrative detention order and the 
Secretary should assure that appeals are resolved in a timely manner. 
The value of perishable foods may be lost entirely, and even the value 
of foods that have considerable shelf life may be reduced substantially 
if administrative and judicial review are inappropriately delayed.
  While an article of food is subject to administrative detention, the 
Secretary may order that it be held in a secure facility. Detention of 
the food in a secure facility is not a requirement. The Secretary 
should ensure that the food would be held under commercially 
appropriate conditions of cleanliness, temperature, humidity and 
whatever other considerations are reflected in industry practice 
regarding holding the article of food under detention. Conditions of 
the secure storage facility should not erode the safety or quality of a 
detained article. The Secretary should also take reasonable precautions 
to protect against an inappropriate release of a detained food. Secured 
storage requirements should apply if there is a reasonable apprehension 
that the article of detained foods are likely to be inappropriately 
released. This section does not impose any obligation on the owner of a 
detained food to bear the cost of the secure storage facility.
  This section also permits the Secretary to order a temporary hold for 
a reasonable period of time, but not longer than 24 hours, of food 
offered for import if an FDA official is unable to inspect the article 
at the time it is offered for import and where the Secretary already 
has ``credible evidence or information indicating that such article of 
food presents a threat of serious adverse health consequences or death 
to humans or animals;'' the same standard employed for administrative 
detention under this section. The period of the hold is intended to 
allow the Secretary sufficient time to dispatch an inspector to the 
port of entry in order to conduct the needed inspection, examination or 
investigation. The authority to temporarily hold an article of food is 
not provided to facilitate mere administrative convenience. Instead, it 
is intended to reflect the physical absence of an inspector at the port 
of entry, or other situations, that render inspection impossible at the 
time of entry. The authority to temporarily hold an article of food 
under this section should not delay or unnecessarily disrupt the flow 
of commerce, and both the authority to detain foods and the authority 
to temporarily hold foods under this section are intended to be used to 
deter bioterrorism and therefore apply to specific instances where 
particular items of food meet the standard for detention.
  Section 303 provides authority to the Secretary to debar from 
importing articles of food, any person that is convicted of a felony 
relating to food importation, or any person that repeatedly imports 
food and who knew, or should have known, that the food was adulterated. 
This section would authorize debarment following a felony conviction 
regarding food importation. In the great majority of situations 
permissive debarment authority will be employed in situations involving 
a felony conviction. In addition, this section includes authority that 
would allow debarment of a person without a relevant criminal 
conviction. This authority is intended to bolster efforts to deter 
bioterrorism. The Secretary should primarily use this authority to 
debar bad actors that repeatedly and knowingly import food that 
seriously threatens public health.
  Most forms of adulteration do not pose a serious threat to public 
health and many forms of adulteration pose no public health threat at 
all. When food adulteration occurs, food importers are often innocent 
purchasers of the food. This debarment authority should not be used 
against innocent purchasers of food, nor is this authority to be used 
as an administrative shortcut to act against an importer where criminal 
prosecution is not sustainable.
  Section 304 provides the Secretary the authority to inspect and copy 
all records relating to an article of food if the Secretary has 
credible evidence or information indicating that an article of food 
presents a threat of serious health consequences or death to humans or 
animals. This provision excludes farms and restaurants and is subject 
to certain limitations including limitations to ensure the protection 
of trade secrets and confidential information.
  Section 304 authorizes the Secretary to issue a regulation requiring 
maintenance of additional records that are needed to trace the source 
and chain of distribution of food, in order to address credible threats 
of serious adverse health consequences to humans or animals. This 
provision excludes restaurants and farms, and the Secretary is provided 
the authority to take into account the size of the business when 
imposing any record keeping requirements and tailor the requirements to 
accommodate burden and costs considerations for small businesses.

  Section 304 authorizes the issuance of regulations to require the 
maintenance of so-called ``chain of distribution'' records that would 
enable the Secretary to trace the source and distribution of food in 
the event of a problem with food that presented a threat of serious 
adverse health consequences or death to humans or animals. This 
authority may not be used to require a business to maintain records 
regarding transactions or activities to which it was not a party. The 
Secretary has indicated that chain of distribution records that 
document the person from whom food was directly received, and to whom 
it was directly delivered, would sufficiently enable adequate tracing 
of the source and distribution of food.
  This records access would not extend to the most commercially 
sensitive or confidential records, including recipes, financial data, 
pricing data, personnel data, research data, or sales data (other than 
shipment data regarding sales). This authority would not permit access 
to any records regarding employees, research or customers (other than 
shipment data). Nor does it permit access to marketing plans.
  Under Section 304 the Secretary must take appropriate measures to 
prevent the unauthorized disclosure of trade secret or confidential 
information obtained by the Secretary pursuant to this section. The 
Secretary shall ensure that adequate procedures are in place to ensure 
agency personnel will not have access to records without a specific 
reason and need for such access, and that possession of all copies of 
records will be strictly controlled, and that detailed records 
regarding all handling and access to these records will be kept.
  Section 305 requires all facilities (excluding farms) that 
manufacture, process, pack or hold food for consumption in the United 
States to file with the Secretary, and keep up to date, a registration 
that contains the identity and address of the facility and the general 
category of food manufactured, processed, packed or held at the 
facility. This section authorizes the Secretary to exempt certain 
retail establishments only if the Secretary determines that the 
registration of such facilities is not needed for effective 
enforcement. The purpose of registration under this section is to 
authorize the Secretary to compile an up-to-date list of relevant 
facilities to enable the Secretary to rapidly identify and contact 
potentially affected facilities in the context of an investigation of 
bioterrorism involving the food supply.
  Enforcement of Section 305 would be delayed 180 days from the date of 
enactment, and this section requires the Secretary to take sufficient 
measures to notify and issue guidance within 60 days identifying 
facilities required to register. This section also requires the 
Secretary to promulgate adequate guidance, where needed, to enable 
facilities to determine whether and how to comply with these 
registration requirements. The Secretary is encouraged to utilize the 
notice and comment process as an appropriate method for notifying 
potential registrants of their obligation to register and to receive 
advice and assistance from registrants on how best to develop a 
registration system that is both workable and cost-effective. In many 
instances, additional steps may be needed since the notice and comment 
may not be adequate to inform small businesses and other importers who 
may not have the resources or capabilities to research and track 
federal regulatory notices in a timely manner prior to the expiration 
of the 180-day enforcement bar.

  This section does not impose a registration fee, and calls for a one-
time registration. In other words, once a facility is registered it 
will only have to amend its original registration in a timely manner to 
reflect any changes. This section also allows and encourages electronic 
registration to help reduce paperwork and reporting burden, but 
registration would also be permitted using a paper form. The Department 
should work in a cooperative manner with facilities in terms of their 
obligations to register, and should be reasonable in situations where 
facilities are making good faith efforts to comply.
  Registration should be made as simple as possible (such as permitting 
both electronic and paper registration, as well as permitting a 
headquarters to register on behalf of all establishments of a company) 
and the Secretary shall promptly complete a rulemaking regarding 
exemption from registration requirements for various types of retail 
establishments. As

[[Page E2389]]

part of this rulemaking the Secretary should look broadly at the 
various types of the food establishments in order to ascertain whether 
they should be exempted and shall exempt from registration those 
facilities that are not necessary to accomplish the purpose of this 
section. The Secretary should assure that implementation of this 
section does not unnecessarily disrupt the flow of commerce.
  Section 306 requires the Secretary to promulgate a rule to provide 
for prior notice to the Secretary of food being offered for import. The 
prior notice is to occur between 24 and 72 hours before the article is 
offered for import. In circumstances where timely prior notice is not 
given, the article is to be held at the port until such notice is given 
and the Secretary, in no more than 24 hours, examines the notice and 
determines whether it is in accordance with the notice regulations. At 
that time, the Secretary must also determine whether there is in his 
possession any credible evidence or information indicating that such 
article presents a threat of serious adverse health consequences or 
death to humans or animals. This determination by the Secretary should 
not delay or unnecessarily disrupt the flow of commerce.
  Section 306 is not intended as a limitation on the port of entry for 
an article of food. In some instances, such as inclement weather, 
routine shipping delays, or natural disasters, a shipment of food may 
arrive at a port of entry other than the anticipated port of entry 
provided on the notice. When such situations arise, arrival at a port 
other than the anticipated port should not be the sole basis for 
invalidating a notice that is otherwise in accordance with the 
regulations. Also, the importer of an article of food is required to 
provide information about the grower of the article of food, if that 
information is known to the importer at the time that prior notice is 
being provided in accordance with the regulations. This provision only 
requires the importer to provide any information he has in his 
possession at the time that prior notice is being provided. The 
Secretary shall closely coordinate this prior notice regulation with 
similar notifications that are required by the U.S. Customs Service 
with the goal of minimizing or eliminating unnecessary, multiple or 
redundant notifications.

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