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					 Public Health Security and
Bioterrorism Preparedness and
    Response Act of 2002
      (Bioterrorism Act)
     Public Law 107-188
Presentation Outline
  Overview
  Registration
  Prior Notice (PN)
  Submitting PN
  CBP Processing
  Where Are we now
  Compliance Policy Guide
  Resources



                         Public Health Security and
                         Bioterrorism Preparedness
                         and Response Act of 2002     2
Bioterrorism Act (BTA)

                 Purpose
To ensure the security of food for human or animal
consumption imported or offered for import into the
United States




                        Public Health Security and
                        Bioterrorism Preparedness
                        and Response Act of 2002      3
BTA Key dates
06/12/02   Signed by President
02/03/03   Notice of Proposed Rule Making (NPRM)
           issued (PN and Registration)
04/04/03   Comment period ends
05/09/03   NPRM (Detention and Recordkeeping)
07/08/03   Comment period ends
10/10/03   Final Interim PN and Registration Rule issued
10/16/03   FDA’s Prior Notice System Interface (PNSI),
           aka website, available for Registration
12/12/03   BTA Implemented - Informed Compliance begins
08/13/04   Full Implementation - Enforced Compliance
                             Public Health Security and
                             Bioterrorism Preparedness
                             and Response Act of 2002      4
FDA Process 801(a) & 801(m)
801 (a) existing FDA Process
Required by full range of FDA related laws and regulations
covering foods, drugs, medical devices, and cosmetics
Currently in place
No Change in practice
801 (m) BTA Requirement
Established by BTA of 2002
New requirement focuses on anti-terrorism
Focus for CBP is on ensuring PN submitted and accepted
PN not satisfied will result in refusal of admission
                              Public Health Security and
                              Bioterrorism Preparedness
                              and Response Act of 2002        5
Changes in Interim Final Rule
There have been significant changes from the NPRM
published in February 2003
Regulations on the disposition of shipments that fail to
meet the requirements of the BTA were modified
   Language has changed from ―shall be refused admission‖ to ―may
    be subject to refusal of admission‖

The regulations were published as an Interim Final Rule
A comment period of 75 days ended on December 24,
2003
The Scope of the Act was narrowed
   HTS numbers refined
                               Public Health Security and
                               Bioterrorism Preparedness
                               and Response Act of 2002              6
Changes in Interim Final Rule
(cont)
Time Frames were shortened
ACS/ABI can be used for submission of PN
Greater flexibility as to who can submit PN
Reduction in data elements required for PN
Homemade goods shipped as gifts excluded
Phase-In requirements
CBP Officers Commissioned to act on FDA’s behalf to
enforce BTA
                            Public Health Security and
                            Bioterrorism Preparedness
                            and Response Act of 2002     7
                       BTA Scope
How is food defined?
Covered under Title III, Subtitle A (Safety of Food)
Defined in the BTA Interim Final Rule as
   Articles used for food or drink for man or animals
   Chewing gum, and
   Articles used for components or any such article

Food imported or offered for import into the U.S. for
Human or Animal Consumption
Excludes food contact surfaces and pesticide chemicals


                                 Public Health Security and
                                 Bioterrorism Preparedness
                                 and Response Act of 2002     8
                    BTA Inclusions
What Food is Covered?
All food as defined by FDA, ―Being imported or offered for
import into the U.S.‖
Food stored or distributed in the U.S.
Gifts, Trade, and Quality Assurance/Control Samples
Transshipments through the U.S. to another country
(Transportation & Exportations (T&E’s))
Food imported for future export
Food admitted into a U.S. Foreign Trade Zone (FTZ)

                             Public Health Security and
                             Bioterrorism Preparedness
                             and Response Act of 2002        9
             BTA Registration
Who Must Register?
Domestic and Foreign facilities that manufacture, process,
pack, or hold food subject to the BTA

Registration Deadlines
Domestic and foreign firms that manufacture, process,
pack or hold articles subject to the BTA began registration
on October 16, 2003
As of December 12, 2003 all firms must be registered prior
to importation


                            Public Health Security and
                            Bioterrorism Preparedness
                            and Response Act of 2002          10
BTA Registration Exemptions
Which Facilities are Exempt from Registration?
Nonprofit facilities
Retailers
Farms
Restaurants
Fishing Vessels, except those that engage in processing
as defined in FDA’s seafood HACCP regulations (21 CFR
123.3(k))
Facilities subject to the exclusive jurisdiction of USDA
Homemade gifts
                             Public Health Security and
                             Bioterrorism Preparedness
                             and Response Act of 2002       11
Registration under BTA
How To Register
Registration may be via
   FDA Website: www.FDA.gov/FURLS
   Submitting paper copy of Form 3537 or CD/ROM to:
     Mailing   address: (See www.FDA.gov)
     Fax   Number: 1-877-FDA-3882

Form may be downloaded from the BTA page at
www.FDA.gov
Tutorial help available at www.FDA.gov/FURLS
Toll-free number in U.S. is 1-800-216-7331

                               Public Health Security and
                               Bioterrorism Preparedness
                               and Response Act of 2002     12
Registration under BTA (cont.)
Outside the U.S. the number is 301-575-0156
Questions may be Faxed to 301-210-0247 (not Toll-free)
These numbers are staffed from 7 AM to 11 PM U.S.
Eastern Time




                          Public Health Security and
                          Bioterrorism Preparedness
                          and Response Act of 2002        13
                    U.S. Agent

Any facility that registers with the FDA must appoint a U.S.
agent who resides and maintains a place of business in the
U.S. and must be physically present in the U.S
The agent will act as the emergency contact for the FDA




                            Public Health Security and
                            Bioterrorism Preparedness
                            and Response Act of 2002           14
             Prior Notice - Overview

Why is Prior Notice (PN) Required on Importation of
Food?
The intent is to provide FDA with advance information to
target potentially high risk shipments that could threaten
Public Health and the Security of the food chain by an act of
Bioterrorism




                            Public Health Security and
                            Bioterrorism Preparedness
                            and Response Act of 2002            15
Prior Notice - Overview (cont.)

Who Submits PN?
Any person with knowledge of the required information
may submit PN or have it transmitted on their behalf
   Submitter:   Person submitting the PN
   Transmitter: Individual filer submitting PN on behalf of
                 submitter




                                 Public Health Security and
                                 Bioterrorism Preparedness
                                 and Response Act of 2002      16
Prior Notice - Overview (cont.)

When is PN Required?
PN is required when:
Merchandise covered by the BTA is imported or offered
for import into the U.S. [801(m)]
Each item covered under the BTA that has a separate
FDA product code requires a separate PN




                           Public Health Security and
                           Bioterrorism Preparedness
                           and Response Act of 2002      17
Prior Notice - Overview (cont.)
Failure to Register/Provide PN
FDA can bring civil and/or criminal action against a party
that is not registered
FDA can bring about debarment (prohibits further trade
activity) of any person convicted of a felony violation of the
BTA
Merchandise can be:
   Held at Port
   Sent to a Secure Storage
   Exported
   CBP can issue penalties

                               Public Health Security and
                               Bioterrorism Preparedness
                               and Response Act of 2002          18
Prior Notice - Overview (cont.)
PN requirements not met
Failure to submit, Inadequate, Untimely or Inaccurate PN
   Article may be subject to refusal and unless immediately exported
    with CBP concurrence, may be held at the port or removed to a
    secure facility

Refused merchandise CAN NOT Go to the importer,
owner, or consignees premises




                                Public Health Security and
                                Bioterrorism Preparedness
                                and Response Act of 2002                19
Prior Notice - Overview (cont.)
What Food imports are Exempted from PN?
Food accompanying a traveler for his/her personal use
Food imported for Immediate Export (IE)
   Can not leave port of arrival except for export

Meat, Poultry, and Egg products
   Subject to USDA

Homemade gifts shipped as gifts




                                 Public Health Security and
                                 Bioterrorism Preparedness
                                 and Response Act of 2002     20
Prior Notice Time Frames
Land Border
   2 Hours prior to arrival at U.S. port
      Trucks,   Cars, Pedestrians, Carts, all types of vehicles
      Any of the above arriving by ferry must meet the Land Border
       time frames

Rail and Air
   4 hours prior to arrival at U.S. port

Vessel
   8 hours prior to arrival at U.S. port

International Mail
   At time of mailing

                                   Public Health Security and
                                   Bioterrorism Preparedness
                                   and Response Act of 2002           21
Commissioning CBP Officers

  Memorandum of Understanding (MOU) between
   FDA and CBP signed December 3, 2003
  In the absence of FDA, perform PN initiated exams
   and/or sampling under the BTA
  FDA has provided a 24x7 toll free to assist both the
   trade and CBP, 866-521-2297




                           Public Health Security and
                           Bioterrorism Preparedness
                           and Response Act of 2002       22
Submitting Prior Notices
How Prior Notices Are Submitted
   Via ABI/ACS
     Includes   the (WP) for automated in-bond
   Via FDA Prior Notice System Interface (PNSI)
    (www.access.FDA.gov)
    A   paper copy of the PN will be required for release
   Via E-Mail (when PNSI is unavailable)
     E-Mail   address to be announced
   Via FAX (when PNSI is unavailable)
     Fax   Number to be announced
        See www.FDA.gov


                               Public Health Security and
                               Bioterrorism Preparedness
                               and Response Act of 2002      23
Submitting Prior Notice
ACS/ABI/OASIS Changes
  PN submission can be done using several new or enhanced
   components of FDA’s and CBP’s existing electronic systems
    CBP’s ACS to FDA’s OASIS system has been enhanced to
     support PN
    ABI   software changes were required to support PN information
    New   ABI/ACS/OASIS interface (known as WP), modeled after
     existing process, is available to submit PN for entering the U.S.
     as automated in-bond




                                Public Health Security and
                                Bioterrorism Preparedness
                                and Response Act of 2002                 24
Submitting Prior Notice via ABI /
ACS (Entry)
How to Submit PN
   PN information supplied along with ABI entry data


   80% of entries that require prior notice processed via ABI/ACS


   FDA provides PN confirmation number electronically to CBP
    and CBP advises filer


   PN results matched to the ABI entry and electronically provided
    to CBP officers


                                Public Health Security and
                                Bioterrorism Preparedness
                                and Response Act of 2002              25
Submitting PN via ACS (No Entry)
Known as WP:
 Estimated to be roughly 10% of submissions
   Electronic transmission through ACS—no consumption
    entry information.
   Required information:
     In-bond  number
     Complete AWB/Master Airway Bill

     Bill of Lading number

   Working on Bar Coding on FDA PN Form



                           Public Health Security and
                           Bioterrorism Preparedness
                           and Response Act of 2002      26
Entries Not Processed Via ABI/ACS

   Any transaction involving a human or animal food
    subject to prior notice requirements can be input
    through FDA Prior Notice System Interface (PNSI)
   Non-automated and/or paper entries
     Mail

     FTZ    admissions
   In-bonds unable to be filed through ACS/ABI (WP)




                           Public Health Security and
                           Bioterrorism Preparedness
                           and Response Act of 2002     27
Submitting PN via FDA Prior
Notice System Interface
How to Submit PN
   Filer submits PN information via the FDA PN System
    Interface and receives PN confirmation number which
    filer then adds to paper entry submissions
   CBP Officers will need to query new database file for PN
    results
   A paper copy of the PN will be required for release, if
    requested by CBP

 FDA PN System Interface (www.access.FDA.gov)


                               Public Health Security and
                               Bioterrorism Preparedness
                               and Response Act of 2002        28
Merchandise with Inadequate or No
PN is Subject to Refusal
 At the CBP Port Director’s discretion in
 consultation with FDA, based on availability of
 storage and resources merchandise subject to
 refusal may be:
   Held at the port
     For  seaports, airports, and courier hubs, the terminal
      facility of the arriving carrier is considered to be within the
      port of arrival
   Directed to secure facility (must be done under bond)
   Exported


                               Public Health Security and
                               Bioterrorism Preparedness
                               and Response Act of 2002                 29
Status of Merchandise with No PN
or Inadequate PN
  Legal status is G.O. merchandise
  If carrier has a terminal facility, it will be held in
   ―constructive G.O.‖ at the terminal facility until final
   disposition (entry, export, sale for export only, or
   destruction)
  If no terminal facility available, Port Director may send it
   to nearest G.O. warehouse or suitable facility, which
   may be inside or outside the port limits
  The Port Director will make an operational decision if
   and when a G.O. number should be assigned to the
   shipment
                              Public Health Security and
                              Bioterrorism Preparedness
                              and Response Act of 2002            30
Procedures for Movement of Goods
to a Facility Not Within the Port of
Arrival
Documentation Required
   Requires the appropriate CBP control documentation
     CBP   6043 – Permit to Transfer – for movements within
      CBP limits
     CBP 7512 ―Restricted in-bond‖ for movements outside of
      port entities
     No documents needed for movement of merchandise to
      terminal facility of carrier within the port of arrival



                            Public Health Security and
                            Bioterrorism Preparedness
                            and Response Act of 2002            31
Procedures for Merchandise Held in
Secure Facility
   Merchandise held under G.O. procedures for each port
   Perishable shipments, or where no suitable G.O. facility
    exists, will be held under ―constructive G.O.‖ or directed
    by the Port Director to a suitable facility; will be
    destroyed or sold for export after 3-days’ public notice
   Carrier will assume cost of destruction. Storage costs
    are between carrier and importer




                             Public Health Security and
                             Bioterrorism Preparedness
                             and Response Act of 2002            32
Secure Facility Definition

What Is a Secure Facility?
   A bonded facility designated by the CBP Port Director (may
    include G.O. warehouses or other suitable facilities)
   Facilities must be registered with FDA
   Facilities may be outside the immediate vicinity of the port, if
    suitable for the storage of food
   May not be the importer’s,owner’s, or consignee’s facility
   Merchandise may be sent to a suitable facility in another port if no
    other options exist




                                   Public Health Security and
                                   Bioterrorism Preparedness
                                   and Response Act of 2002                33
Procedures for Merchandise Held in
Secure Facility (continued)
What Happens to Merchandise
   Merchandise under ―constructive G.O.‖ will stay at the
    carrier’s facility until final disposition of the merchandise
   If eventually sold, it will be for:
     Exportonly (PN not required) and shipped directly
      (Immediate Export) out of the port in which it is being
      held




                                Public Health Security and
                                Bioterrorism Preparedness
                                and Response Act of 2002            34
Registration of Facilities with FDA
Which Facilities Must Register?
   All facilities that hold food for consumption in the United
    States must be registered with the FDA
     This   includes:
        Terminal facilities (unless holding in the course of
         transportation)
        Container freight stations (CFS)
        Bonded warehouses (includes duty free warehouse)
        Centralized examination stations (CES)
        G.O. warehouses
        Customs approved storage rooms (CASR)



                                 Public Health Security and
                                 Bioterrorism Preparedness
                                 and Response Act of 2002         35
Procedures for Export of
Merchandise
  Shipper, importer, or carrier may decide to export with
   CBP concurrence
  Should be under physical control and custody of CBP
  May be documented using an Immediate Export (IE) in-
   bond




                            Public Health Security and
                            Bioterrorism Preparedness
                            and Response Act of 2002         36
Procedures for Abandoned Goods

  Foods that are, abandoned, refused for no or
   inadequate prior notice (treated same as if no prior
   notice), will be considered G.O. merchandise and will
   follow normal G.O. guidelines




                            Public Health Security and
                            Bioterrorism Preparedness
                            and Response Act of 2002       37
Procedures for Segregation of BTA
Refused Foods
 For foods refused under 801(m) that are commingled
 shipments either within same container or truck where you
 have foods that are ―PN satisfied‖ and ―PN not satisfied‖
   Goods may be segregated, in accordance with local
    procedures and in coordination with the secure facility and
    carrier, so that ―PN satisfied‖ foods may enter
   Food that is ―PN not satisfied‖ is treated as refused and
    subject to being held at port, moved to a secured facility, or
    exported
   The carrier must bear all costs

                                Public Health Security and
                                Bioterrorism Preparedness
                                and Response Act of 2002             38
Entry Types Impacted by BTA

   BRASS
   Permit Ports
   Customs Form 3461 Entry/Immediate Delivery
   In-bond Filing Trade Requirements
   FTZ admissions
   Express consignment
   Non-automated informal/walk-up
   International mail
   Carnets




                              Public Health Security and
                              Bioterrorism Preparedness
                              and Response Act of 2002     39
BRASS

As of 12/12/03 Releases under BRASS are no
longer be permitted for foods subject to prior
notice.




                        Public Health Security and
                        Bioterrorism Preparedness
                        and Response Act of 2002     40
Role of Permit Ports

As of 12/12/03 Permit Ports are able to run ACS/ABI
selectivity
This does not extend ―permit‖ rights to new shippers
through permit ports. New shippers wishing to cross
at permit ports must still obtain the Port Director’s
approval




                           Public Health Security and
                           Bioterrorism Preparedness
                           and Response Act of 2002     41
ABI/ACS Customs Form 3461
Entry/Immediate Delivery
  Prior notice requirements must be satisfied for
   merchandise to be released from CBP custody and
   entered into the commerce of the U.S.




                         Public Health Security and
                         Bioterrorism Preparedness
                         and Response Act of 2002     42
In-Bond Filing Trade Requirements
  PN submission (through ABI/ACS or FDA PN
   System Interface) must include in-bond number and
   bill number (if applicable)
  PN must be submitted for Immediate Transportation
   (IT) in-bond shipments, however, absent an
   identified threat, they will be allowed to travel to the
   port of entry for satisfaction of PN
  Prior notice requirements must be satisfied at the
   port of arrival for merchandise to be released from
   CBP custody and have a Transportation and Export
   (T&E) entry processed. This will allow merchandise
   to be transshipped through the U.S.
  In-bond (electronic or paper) includes indicator of PN
   compliance
                             Public Health Security and
                             Bioterrorism Preparedness
                             and Response Act of 2002         43
In-Bond Processing with PN
Indicator
PN Requirements/How to Process
   Automated in-bonds will query ACS PN database
    and return status messages to AMS/ABI
   Paper in-bonds will require manual input by CBP of
    PN indicator; ACS PN database will be queried
    automatically and return status messages to CBP
    officer




                           Public Health Security and
                           Bioterrorism Preparedness
                           and Response Act of 2002      44
Foreign Trade Zones

PN Requirements/How to Process
   No automated system for goods admitted to an FTZ
   PN requirements must be met prior to admission of
    goods into the FTZ
   Paper copy of PN confirmation number shall be
    submitted with admission document
   Direct delivery only permitted if PN requirements,
    including time frames are satisfied
     48-hour   post arrival reporting time disallowed


                               Public Health Security and
                               Bioterrorism Preparedness
                               and Response Act of 2002     45
Foreign Trade Zones (continued)

PN Requirements/How to Process
   All other movement to the FTZ done as follows:
     Under   dray or delivery ticket
     By   CF214
       FDA PN System Interface used to submit PN
       In-bond permitted if PN satisfied




                               Public Health Security and
                               Bioterrorism Preparedness
                               and Response Act of 2002     46
 Express Consignment
PN Requirements/How to Process
  PN is required for all Express Consignment Courier
   Facility (ECCF) food shipments subject to prior
   notice requirements
  Consolidated entries for foods subject to prior notice
   requirements will not be allowed unless PN is
   satisfied for all.
  If not, then separate entries will be required. This
   represents fundamental change in business
   practices
  No Section 321 release(on manifest) for foods
   subject to prior notice requirements unless PN
   requirements have been met
                             Public Health Security and
                             Bioterrorism Preparedness
                             and Response Act of 2002       47
Non-Automated Informal Entries/
Walk-ups
PN Requirements/How to Process
   All foods subject to the prior notice and food facility registration
    requirements must file PN unless specifically exempted
   There is no De Minimus under the prior notice rule
   Household goods containing items subject to prior notice
    requirements are not exempt and require PN
   PN must be filed on each item by FDA product code
   Paper copy of PN confirmation number must accompany the
    shipment
   Failure to have PN confirmation number may result in a refusal
    of admission



                                   Public Health Security and
                                   Bioterrorism Preparedness
                                   and Response Act of 2002                48
Non-Automated Informal Entries/
Walk-ups (continued)
PN Requirements/How to Process
   Inspector will query PN database to determine status
   Most of these will not have a bond and as a result
    will not be able to move their goods to a secure
    facility
   Many may not be able to meet PN requirements and
    shipment will most likely be exported or abandoned




                            Public Health Security and
                            Bioterrorism Preparedness
                            and Response Act of 2002       49
 International Mail
PN Requirements/How to Process
  PN requirements apply to food as defined in the interim final
   regulations imported through international mail
  A Food shipment must have PN confirmation number on Postal
   Declaration Form CN22 or CN23
  Home-made foods sent as gifts are not subject to prior notice
   requirements
  If there is no PN confirmation number CBP will hold shipment
   for 72 hours for FDA inspection and disposition
  If there is no return address, shipment will be destroyed
  If shipment contains food subject to PN and items not subject
   to PN, the shipment will be treated as commingled, where the
   items not subject to PN or if in compliance with PN, will be
   segregated and processed and the non-compliant food items
   will either be returned or destroyed

                                 Public Health Security and
                                 Bioterrorism Preparedness
                                 and Response Act of 2002          50
Carnets
PN Requirements/How to Process
  Definition
    An international customs document that facilitates
     temporary imports into foreign countries and is valid
     up to 1 year
  Foreign facilities exporting food products to the U.S.
   using carnets must register with the FDA; PN
   requirements also apply
  Process normally except CBP inspectors must query
   PN documents (PN confirmation) and database.
    Paper copy of PN confirmation number shall be
     submitted with carnet

                             Public Health Security and
                             Bioterrorism Preparedness
                             and Response Act of 2002        51
Compliance Policy Guide

Prior Notice (PN) Enforcement Guidelines: Although the
BTA was implemented on December 12, 2003,
enforcement of the PN reporting requirements of the BTA
will be phased in over eight months. Unless a threat is
identified and FDA working in conjunction with CBP at the
National Targeting Center (NTC) orders a hold,
enforcement actions will be taken based on the following
schedule:




                           Public Health Security and
                           Bioterrorism Preparedness
                           and Response Act of 2002         52
Compliance Policy Guide (continued)
Phase 1: December 12, 2003 – March 12, 2004: No
shipments will be stopped for administrative failure. Only
the National Targeting Center (NTC) will be able to place a
hold on any shipment subject to the BTA and that would
only be for a perceived threat. All other shipments will be
processed under informed compliance with educational
materials e.g., flyers and pamphlets, and outreach, letters
and meetings with the trade.
Phase 2: March 13, 2004-May 12, 2004: No shipments
will be stopped for administrative failure. Penalties against
egregious violators who have been counseled begin.


                             Public Health Security and
                             Bioterrorism Preparedness
                             and Response Act of 2002           53
 Compliance Policy Guide (continued)
Phase 3: May 13, 2004 – August 12, 2004: Failure to
provide Prior Notice will result in refusal of the shipment
and/or penalty. Refusal results in merchandise being held
at port of arrival, sent to a secure facility as determined by
the CBP port director or exported under CBP supervision.


Phase 4: August 13, 2004 and thereafter: Full
enforcement. Failure to provide Prior Notice will result in
refusal of shipment and/or penalty. FDA determination that
Prior Notice data is either incomplete or inadequate will
also result in refusal of merchandise.

                               Public Health Security and
                               Bioterrorism Preparedness
                               and Response Act of 2002          54
CBP Processing - Identified
problems

  Ability to disclaim PN for goods subject to FDA
  HTS 9801 ability to disclaim BTA
  System flags FD 1-3 being modified to allow FDA
   and/or PN submission or FDA disclaim




                           Public Health Security and
                           Bioterrorism Preparedness
                           and Response Act of 2002     55
Harmonization of Advance Notice
Time Frames
   CBP and FDA have agreed to harmonize advance
    notice (Prior Notice) time frames to the extent
    possible.
   FDA and CBP will publish a document in the Federal
    Register on or before March 12, 2004 laying out any
    changes to the time frames.




                           Public Health Security and
                           Bioterrorism Preparedness
                           and Response Act of 2002       56
Help Resources

   FDA registration help:
     U.S.   Toll-free: 1-800-216-7331
     Outside   U.S.: 301-575-0156
     Fax:   301-210-0247
     Registration   tutorial:www.fda.gov/furls
   Federal Register: www.gpoaccess.gov/fr
   Legislation: www.thomas.loc.gov
   CBP web site: www.CBP.gov


                                Public Health Security and
                                Bioterrorism Preparedness
                                and Response Act of 2002     57
Help Resources (continued)

  FDA web site: www.FDA.gov
  FDA regional points of contacts
  Each CBP field office will have 2 BTA trained experts
  FDA Compliance Policy Guide
  FDA Publication ―What Do I Need To Know About
   FDA’s New Bioterrorism Rules‖ will available through
   trade associations, state agencies,U.S. embassies,
   and at the FDA website



                          Public Health Security and
                          Bioterrorism Preparedness
                          and Response Act of 2002         58

				
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