20 th Annual Frozen Foods Fiesta

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20 th AnnualFrozen Foods Fiesta

• Texas-Mexico Frozen Food Council
• May 12-14, 2005
• Presented by
• Daniel B. Hastings, Jr.
• President
• Daniel B. Hastings, Inc.

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Table of Contents

• Bio- Terrorism Act of 2002
• Who must register?
• FDA Food Facility Registration
• Import Requirements -Prior Notice
• Submitters versus Transmitters
• Deadlines for Prior Notice
• How to Submit a Prior Notice
• Food Registration by Country
• Delays in Processing Shipments
• Manifest Advance Cargo/E-Manifest
• Penalties
• Express (Northbound Southbound)
• Links

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Public Health, Security, and Bioterrorism
Preparedness and Response Act of 2002, the
Bioterrorism Act, or BTA as it is referred to,
requires domestic and foreign facilities that

• Manufacture
• Process
• Pack or
• Hold food
• For human or animal consumption in the United
• States to register with the FDA.

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Who must register?

• Owners
• Operators
• Agents in charge of
• Domestic facilities or
• Foreign facilities that
• Manufacture/process
• Pack or
• Hold food for human or animal consumption

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DOMESTIC FACILITIES

• Whether or not food from the facility enters
  interstate commerce.

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FOREIGN FACILITIES

• That manufacture
• Process
• Pack or
• Hold food unless food from that facility
  undergoes further processing (including
  packaging) by another foreign facility before the
  food is exported to the U.S.
• If the subsequent foreign facility performs only
  a minimal activity, such as putting on a label,
  both facilities are required to register.

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Facilities exempted from registration

• Farms
• Retail food establishments
• Restaurants
• Non-Profit establishments that prepare food for,
  or serve food directly to consumers
• Fishing vessels not engaged in processing as
  defined in 21 CFR 123.3 (k) and
• Facilities regulated exclusively throughout the
  entire facility by the U.S. Dept. of Agriculture.

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Requirements for Imports

• PRIOR NOTICE (PN)
• Prior notice is a notification to the FDA that an
  article of food, including animal feed or pet
  food, is being imported or offered for import
  into the USA in advance of the arrival of the
  article of food at the U.S. border. (68 FR 58974
  October 10, 2003)

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Why is prior notice required?

• Prior notice is required by a new section,
  801(m), of the Federal Food, Drug, and Cosmetic
  Act (the FD C Act) 21 U.S.C. 801(m)
• Section 801 (m) requires advance notification to
  FDA prior to the arrival of food imported or
  offered for import into the United States.

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When did Prior Notice go into effect?

• Prior Notice took effect on Dec. 12, 2003.
• Transition Period
• To assure that the Prior Notice could have been
  implemented efficiently and with minimal
  disruption, FDA exercised broad enforcement of
  imports with discretion until August 12, 2004.
• FDA wanted to focus efforts on educating
  importers how to comply with the regulations and
• Wanted to work with trade associations and
  foreign governments to make sure Importers and
  Exporters were well informed of the new
  requirements.

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Submitters and Transmitters

• Who may submit prior notice to FDA?
• The Submitter
• Any person with knowledge of the required
  information.
• May also use another person to transmit the
  required information on his or her behalf.
• The Transmitter
• Any person with knowledge of the required
  information.
• The submitter and transmitter may be the same
  person (21
• CFR 1.278) If someone transmits the required
  information
• on behalf of a submitter, that person is the
  transmitter.

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Submitters and Transmitters , contd.

• There are no geographic restrictions on the
  location
• of the submitter or the transmitter. (21 CFR
  1.278)
• It is possible for the submitter to have his/her
  legal
• residence in the country of origin and for the
• transmitter to have legal residence in the U.S.

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Deadlines for Prior Notice to be submitted

• Prior Notice must be submitted and the submission
  must be confirmed by FDA no more than 5 calendar
  days BEFORE the anticipated date of arrival, and
  no less than
• 2 hours before arrival by land/road
• 4 hours before arrival by land/rail
• 4 hours before arrival by air and
• 8 hours before arrival by water
• 21 CFR 1.279 (a) and (b)

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How to submit Prior Notice to FDA for Consumption
or In-Bonds

• Prior Notice can be submitted to FDA thru the
  existing ABI/ACS interface (21 CFR 1.280 (a) (1)
  and
• FDAs Prior Notice System Interface (PNSI)
  available thru FDAs website at
  http//www.access.fda.gov (21 CFR 1.280 (a) (2)
• Both ABI/ACS and the FDA PNSI are available 24
  hours a day, 7 days a week for submitting
  required information.
• To use the CBPs ABI/ACS, one must be authorized,
  ie., U.S. Broker or Importer Entry Filer with a
  filer code (19 CFR 143.1)
• Anyone may use PNSI.

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Food Registration by Country

• www.cfsan.fda.gov/furls/ffregsum.htmlftn1
• FDA has received
• September 17, 2004
• 221,450 Registrations
• 118,963 Foreign
• 102,487 Domestic
• January 18, 2005
• 238,129 Registrations (7.5 increase)
• 118,086 Foreign
• 107,043 Domestic

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The following table is a sampling of the listed
countries and number food facility registrations
for each, as tallied by FDA

• Canada 9,363
• China 9,680
• India 2,513
• Japan 15,446

• Mexico 7,300
• Taiwan 1,604
• Thailand 1,709
• Vietnam 3,111

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Rejection Codes

• 20 Rejection Codes
• www.brokerpower.com/cgi-bin/adminsearch/
  admmsg.view.pl?article2004/2004-563.ADM

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ADVANCE ELECTRONIC MANIFEST / e MANIFEST
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Advanced Electronic Manifest

• 01/2005 CBP enforced Advanced Electronic
  Manifest to be transmitted electronically prior
  to the conveyance arriving at C BP
• In-Bonds
• CAFES
• ABI In-Bonds (QP/WQ)
• Pre-Arrival Processing System (PAPS)
• PAPS / FAST
• NOTE FAST IS NOT A PART OF THIS

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PAPS FAST FAST/PAPS

• CARRIER REQUIREMENTS
• PAPS Must Have
• SCAC Code
• Unique Number
• 600 dpi Laser Printer
• Prepared Inward Manifest-CBP Form 7533
• PAPS Bar Code On Inward Manifest-CBP Form 7533

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FAST

• FAST -Must Have
• SCAC Code
• Unique Number
• C-TPAT Certification
• Company Registration with CBP
• Drivers must be FAST registered w/FAST (RF) D.L.
• 600 dpi Laser Printer
• Prepared Inward Manifest-CBP Form 7533
• FAST Bar Code on Inward Manifest- CBP Form 7533

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FAST/PAPS

• FAST/PAPS Must Have
• SCAC Code
• Unique Number
• C-TPAT Certification
• Company Registered with CBP
• Drivers must be FAST registered w/FAST (RF) D.L.
• 600 dpi Laser Printer
• Prepared Inward Manifest CBP Form 7533
• FAST/PAPS Bar Code on Inward Manifest - CBP Form
  7533

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BRASS

• Effective May 2005, C BP has mandated that
  BRASS shipments will require FAST
  Dray/Cartage/Shuttle Companies with FAST Drivers

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BAR CODES PAPS FAST PAPS/FAST

• PAPS
• SCAC Code Unique Number Filer Code
• FAST
• SCAC Code Tractor Number Trailer Number
  Driver Name Seal Number Filer Code
• PAPS/FAST
• SCAC Code Unique Number Filer Code

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DELAYS IN PROCESSING SHIPMENTS

• Changes that will require Cancellation of
  Manifest and Re-issuing of a new Manifest
• PAPS
• FAST
• PAPS/FAST

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E MANIFEST

• Requires over 126 Data Elements to be
  transmitted to
• C BP Direct via EDI or some ABI transmission.
• Who will transmit this data?
• The Carrier that will bring the cargo into the C
  BP
• compound.
• Effective Date
• Originally scheduled for 1st Quarter of 2005
• Postponed to sometime in 2005

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PENALTIES

• Importer/Broker/Agent/Submitter/Transmitter
• NO PRIOR NOTICE
• 1ST Offense Subsequent
• Offenses 5,000.00 USD
• (19 CFR 113.62 (J) (2)

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PENALTIES

• CARRIER (as defined by C BP as the
  Drayage/Shuttle/
• Cartage Agent)
• Wrong SCAC Code
• Arriving Prior to the 2 Hours
• Arriving After the 5 Days
• Wrong Advanced Manifest Information transmitted
  by them

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PENALTIES contd.

• Wrong Advanced Manifest Information on the Hard
  Copy VS the Transmitted Information
• No Hard Copy in Manifest - CBP 7533
• 1ST Offense 5,000.00 USD
• 2nd and subsequent offenses 10,000.00 USD
• (19 CFR 1436)

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THERE ARE NO MITIGATING CIRCUMSTANCES THAT C
BP WILL ACCEPT AT THIS TIME!
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EXPRESS-MEXICOHigh Volume

• Imports into Mexico
• Importer Empresa Certificada
• Carrier C-TPAT Certified and FAST Certified
• Export out of Mexico
• Carrier C-TPAT Certified and FAST Certified

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LINKS

• The complete Bioterrorism Act of 2002
• www.fda.gov/oc/bioterrorism/PL107-188.pdf
• Food Facility Registration on line
• www.cfsan.fda.gov/furls/ovffreg.html
• Food Facility Update the facility on line
• www.cfsan.fda.gov/furls/ffupdate.html

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LINKS

• Frequently Asked Questions
• www.cfsan.fda.gov/pn/pnqagui2.html
• Prior Notice System Interphase PNSI
• www.cfsan.fda.gov/pn/pnoview.html
• Compliance Policy Guide Guidance for FDA and
• CBP Staff Prior Notice of Imported Food
  (Revised March 2005)
• www.cfsan.fda.gov/pn/cpgpn5.html

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LINKS

• Protecting the Food Supply from Intentional
• Adulteration An Introductory Training Session
  to
• Raise Awareness
• www.cfsan.fda.gov/dms/sectrain.html
• List to check for denied persons/company by
• C BP
• www.bis.doc.gov/complianceandenforcement/idex.htm
  ltc
• Reporting Violations
• www.bis.doc.gov/forms/eeleadsntips.html

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LINKS

• Food registrations by country
• www.cfsan.fda.gov/furls/ffregsum.htmlftn1
• What you need to know about Administrative
• detentions of Foods
• www.cfsan.fda.gov/acrobat/fsbtad.pdf
• Prior Notice of Imported Food Harmonized
• Tariff Schedule Codes Flagged with Prior
• Notice Indicators
• www.cfsan.fda.gov/pn/htscodes.html

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LINKS

• C-TPAT
• www.cbp.gov/xp/cgov/import/commercialenforcement/
  ctpat
• FAST
• www.cbp.gov/xp/cgov/import/commercialenforcement/
  ctpat/fast
• INFORMED COMPLIANCE
• http//www.cbp.gov/xp/cgov/import/informedcomplia
  nce

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LINKS

• Help Desk
• www.cfsan.fda.gov/furls/helpf.html
• e Manifest- Release 4
• www.cbp.gov/xp/cgov/toolbox/about/modernization/a
  ce_ edi_drafts/edi_messages/

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LINKS

• BORDER CROSSING WAIT TIMES
• http//apps.cbp.gov/bwt/
• BRIDGE CAMERAS
• McAllen
• http//www.mcallen.net/bridge/bridge-cam.html
• Laredo
• www.laredotexas.gov/bridgesys/bridge4cam.html

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THANK YOU!