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ST&R Presents. The Best and The Worst Of. The FDA’s BTA Rulemaking Presented by Lauren V. Perez. The Law: Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-1888) The Effect:

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ST&R Presents....

The Best and

The Worst

Of

The FDA’s BTA Rulemaking

Presented by Lauren V. Perez


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The Law:

Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-1888)

The Effect:

  • All food facilities located anywhere in the world that store, pack, process, hold, label or manufacture food or beverages must be registered with the FDA NOW

  • The FDA must be provided with Prior Notice of all arriving food articles

  • All domestic food manufacturers, processors, packers, labelers, warehouses, holders, distributors, importers and transporters as well as foreign food transporters must maintain and provide access to particular and complex records related to each separate article of food

  • The FDA has the ability to administratively detain any food or beverage upon credible evidence of threat of death or injury to human or animal no matter that article is in the distribution system


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What’s The “Best Thing” About The Current State of BTA Rulemaking?

The FDA Heard You!

The Agency Took Measures To Protect the Marketplace Without Sacrificing Competitive Trade


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  • The Highlights of Revisions re: Prior Notice: Rulemaking?

  • Importers Can Import Without Confidential Registration Numbers – Include Reason Code

  • Shippers Can Ship Via Express Courier Without Without Knowing Exactly When It Will Arrive – Use Tracking Number

  • Competitors Can Sample Without Permission – Use Non Commercial Shipper and ship in small quantities

  • Colleagues Can Send Xmas Gifts Through International Mail

  • Grandma Can Send You Your Favorite Holiday Candies No Matter Where They Come From!


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Combining the Old… Rulemaking?

Only food articles from registered facilities will be admitted into the United States for consumption

With the New…

Importers can provide reasons to the FDA indicating why the manufacturing facility’s registration number is not included on the Prior Notice and it is up to the FDA to then validate the registration status of the manufacturing facility


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Give the FDA A Reason: Rulemaking?

A. Facility is out of business

B. Facility is private residence

C. Facility is a restaurant

D. Facility is retail food establishment

E. Facility is non-processing fishing vessel

F. Facility is non-bottled drinking water collection and distribution establishment

G. Individual gift - label name/address in lieu of registration number

H. Grower - satisfies farm exemption

I. Samples - quality assurance, research or analysis purposes only

J. U.S. manufacturing facility that is not required to register

K. Unable to determine the registration number of the manufacturer.

L. Unable to determine identity of manufacturer - providing identity of manufacturer's headquarters

M. Unable to determine identity of manufacturer or headquarters - providing invoicing firm's identity

O. Gift pack for non-business purposes - providing single prior notice and identity of packer


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And Then They Might Give You One… Rulemaking?

F Foreign consignee

R Missing Registration

F Registration Not on File

M Mismatch in registration

I Invalidated registration

C Cancelled registration


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Just Because the Rulemaking?

FDA May Confirm PN Without the RN,

Doesn't Mean That

The Goods Won't Be Refused


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PNSI vs. ABI Rulemaking?

Need PN Confirmation Prior To Loading Food But Container will be on water for 7 days? PNSI

Don’t want to have to give PN Confirmation Number to Carrier? ABI

Need to resubmit PN after refusal? PNSI

Not an authorized ABI user? PNSI

Get frustrated by Internet delays? ABI

ABI not working? PNSI

PNSI not working? ABI, Email or Fax

ABI and PNSI not working? Email or Fax


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PN Can Be Disclaimed on FD3s - if the product is not a food for consumption by human or animal in the U.S.

Examples of FD3s for which disclaimer may be appropriate:

0505902040 Bird Skins w/Feathers; feathers & parts, other

0507900090 Tortoise –Shell, Whalebone, Horn, Other

0713401000 Lentils; Seeds Used for Sowing

1508100000 Peanut (Grnd Nut) Oil & Its Fractions; not chem

2804300000 Nitrogen

2918111000 Lactic Acid

3507907000 Enzymes; Prepared Enzymes, Other

4102101000 Raw Sheep or Lamb Skins; w/wool

9801001015 U.S. Goods Returned; Chap 2 or 16; N/advanced in Value

98050050 Effects of U.S. Gov Extended Duty Employee & Family or Evacuee

98060050 Personal Use Articles For Other Representatives of Foreign Governments


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  • Some Urban Legends….Already – for consumption by human or animal in the U.S.

  • Registration has to be annually renewed

  • Your U.S. Agent distributes directly to the retailer

  • You can purchase a list of registered food facilities

  • A product that enters the U.S. from an unregistered facility, will always be allowed to enter the U.S. from an unregistered facility

  • Final regulations for all BTA provisions have finally been published


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  • Some Thoughts To Ponder for consumption by human or animal in the U.S.…

  • When is a Commercial Shipment a Commercial Shipment?

  • When it is imported for non-commercial purposes from a non-commercial shipper

  • Why is a Carrier not the Shipper?

  • Because the shipper is the entity who owns or exports the goods to the U.S., not necessarily the entity who gets it there

  • Can Samples Be Imported Without A Prior Notice if Sampling will take place at a promotional tasting event?

  • No! Test marketing is not the same as sampling (quality assurance, research and analysis)

    Is International Mail Sent Through Federal Express?

  • No! International Mail is mail sent through foreign national mail services only – not express couriers


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Have You Heard About The Recordkeeping Regs??? for consumption by human or animal in the U.S.

Compliance Efforts Underway, but what a Mess!!!!


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Pressure from Tommy Thompson prompts publication of complicated, politically correct regulations:

For the life of me, I cannot understand why the terrorists have not attacked our food supply because it is so easy to do

Quote from speech announcing resignation: 12/3/04


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  • FDA publishes final recordkeeping regulations on December 9, 2004:

  • All domestic persons, corporations, partnerships, and associations that manufacture, process, pack, store, distribute, import, receive, or transport food or beverages, whether or not for consumption in the US, must establish and maintain required records accessible to the FDA within 24 hours notice.• Foreign and domestic food transporters, whether or not located in the US, are also governed by these regulations, without regard to whether or not they actually have possession, custody, or control of the food articles.• Domestic manufacturers, packers, and processors are required to maintain records detailing product lot numbers or other identifiers.

  • • All animal food, feed, and related products are covered by these regulations, without exception.• Records required to be established and maintained by non-transporters in connection with both sources and recipients, whether foreign or domestic, include the following: the name of the firm; address; telephone number; fax number and e-mail address, if available; type of food, including brand name and specific variety; date received/released; quantity and type of packaging; and identity of the immediate transporter previous source and subsequent recipient, including the name, address, telephone number and, if available, fax number and e-mail address.

  • • Food transporters can comply with the regulations either by establishing and maintaining the records required by the FDA, the Department of Transportation (DOT), or the Warsaw Convention, or by contracting with a non-transporter to keep the required records on their behalf.


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  • FDA publishes final recordkeeping regulations on December 9, 2004 (cont’d)

  • Retailers are not required to maintain records as to immediately subsequent consumer recipients of food products, but must establish and maintain records to identify immediately previous sources of food and business recipients of those products.

  • The regulations do not apply to customs brokers provided that they act only to facilitate distribution, sale, or transportation of food by processing information or paperwork.

  • • The regulations do not apply to truck terminals or similar facilities if they are merely part of the transportation process providing a location for trucks to transfer possession.

  • • Consumers, if they are not part of the actual shipping transaction, are not subject to the regulations.


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So, What's the Problem? 2004 (cont’d)

The Agency tried to make everyone happy

and, as a result, issued confusing, complex and complicated regulations


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The final regulations are binding upon 2004 (cont’d)only domestic persons (i.e. individuals, corporations, partnerships or other associations) that manufacture, process, pack, transport, distribute, receive, hold or import food; foreign persons that transport food in the U.S.; and persons who place food directly in contact with its finished container.

Accordingly, foreign manufacturers are not required to keep records, but must be registered; foreign carriers must keep records but do not need to be registered and some food packers may need to keep records but others may not depending upon how “directly in contact” the finished food packaging is to the food product.


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The final regulations provide food transporters with the ability to (i) maintain the records specifically described in the Rules; or (ii) to establish and maintain the records required by the Department of Transportation's Federal Motor Carrier Safety Administration; or (iii) to establish and maintain the records required by the Department of Transportation's Surface Transportation Board; or (iv) to establish and maintain the records required of international air transporters by the Warsaw Convention; or (v) to enter into an agreement with a non-transporter immediate previous source or immediate subsequent recipient (if located in the United States) to establish, maintain, or establish and maintain the required records.

Each of these options carries with it different definitions and different requirements and is more than likely going to only be good news ---

FOR LAWYERS!


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The final rules include 4 different possible retention requirements of between 6 months to 2 years, depending upon whether the records are kept by transporters or non-transporters and/or whether the food may spoil after, within or before 6 months. Again, the FDA has mitigated the possibility of resentment against these regulations because no one can be certain for how long they are bound by them.


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So, What's the Problem? requirements of between 6 months to 2 years, depending upon whether the records are kept by transporters or non-transporters and/or whether the food may spoil after, within or before 6 months. Again, the FDA has mitigated the possibility of resentment against these regulations because no one can be certain for how long they are bound by them.

The FDA tried to make everyone happy…

with regulations that do little to protect America’s food supply

The final regulations only require domestic food manufacturers, packers and processors to keep records that include lot number identification and hold food transporters to some vague, undefined standard of “describing” the food articles they carry from one nontransporter to another

The final regulations specifically list those “persons” who are entirely exempt from the rulemaking, some who are exempt from some but not all portions of the rules and others who may be exempt but only in particular circumstances        

Will it really be possible

to track contaminated

food products throughout

the entire supply chain?


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And…it’s not over yet ---- requirements of between 6 months to 2 years, depending upon whether the records are kept by transporters or non-transporters and/or whether the food may spoil after, within or before 6 months. Again, the FDA has mitigated the possibility of resentment against these regulations because no one can be certain for how long they are bound by them.

Final Facility Registration and Prior Notice Rules expected Spring 2005

Import Strategic Plan – promised by Fall 2004

Continued, Necessary Port Shopping

No method of verifying facility registration prior to export

Shipper Registration Number still required on Prior Notice

Each FDA-regulated Entry Still Treated Separately – OASIS has no memory


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Overall…the BTA regulations are definitely requirements of between 6 months to 2 years, depending upon whether the records are kept by transporters or non-transporters and/or whether the food may spoil after, within or before 6 months. Again, the FDA has mitigated the possibility of resentment against these regulations because no one can be certain for how long they are bound by them.

new and improved

Although, probably of little use in protecting American citizens against threats of bioterrorism


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  • But…There are always Opportunities… requirements of between 6 months to 2 years, depending upon whether the records are kept by transporters or non-transporters and/or whether the food may spoil after, within or before 6 months. Again, the FDA has mitigated the possibility of resentment against these regulations because no one can be certain for how long they are bound by them.

  • Especially in the Midst of Complicated, Confusing and Overwhelming Federal Agency Regulations

  • All supply chain participants need assistance

  • Product Labeling

  • SID/FCE/HAACP registration, certification

  • Food facility registration

  • Timely communication of prior notice information

  • Compliance with recordkeeping regulations

  • Negotiation of vendor agreements, purchase orders, bills of lading and invoices

  • A Knowledgeable, Accessible and SMART Customs Broker!


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And everyone needs some help… requirements of between 6 months to 2 years, depending upon whether the records are kept by transporters or non-transporters and/or whether the food may spoil after, within or before 6 months. Again, the FDA has mitigated the possibility of resentment against these regulations because no one can be certain for how long they are bound by them.

Give Me A Call!

Lauren V. Perez

[email protected]

Call Us For More Information About ST&R’s FDA Compliance Program, its ongoing seminar series and related services for all importers and exporters of FDA-regulated goods

Please log on to www.strtrade.com or call us directly at 305-267-9200.


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