Click here to
view the PDF version.
FDA’S
NEW ANTI-BIOTERRORISM POWERS TARGET IMPORTS
Importing
food into the U.S. becomes increasingly complex
With the creation of the Department
of Homeland Security (DHS), tougher Customs enforcement
at the country’s ports of entry, and a multitude
of new import and export regulations, shipping
into the United States is growing in complexity.
But conspicuously left out of
the massive DHS merger, the Food and Drug Administration
(FDA) still has the primary responsibility for
public safety concerning the nation’s food supply.
As a result, agri-food traders face additional
– even over-lapping – responsibilities when shipping
to the U.S.
Concurrent with ongoing security
measures driven by the Bureau of Customs & Border
Protection (formerly U.S. Customs), the FDA is
undertaking some far-reaching changes of its
own. Understanding the scope of the proposed
changes is critical to anyone involved in supply
chain management in the agri-food industry.
The FDA’s newfound authority
emanates from the Public Health Security and
Bioterrorism Response Act of 2002 (“Bioterrorism
Act”). In February 2003, the FDA set forth
a series of proposals to implement the Bioterrorism
Act. Final regulations are expected by October,
with implementation scheduled for December
12, 2003.
Registration
of food facilities – is your business affected?
The
FDA wants to maintain a complete listing of all
facilities involved in the nation’s food supply
to improve its efficiency in regulating the industry
and to help it respond more quickly to potential
emergencies.
The proposal is ambitious, requiring
registration by domestic and foreign companies
of all facilities that process, pack or store
food for consumption in the U.S. Estimates suggest
that over 400,000 facilities will be affected.
The registration process is intended to be fairly
simple through an on-line system, and must be
done by the facility itself or through a U.S.-based
agent before December 12, 2003. However, the
FDA will only accept registration after its rules
are finalized, expected in October.
The FDA also seeks to require
that all foreign food facilities have a U.S.
resident agent. The FDA will communicate with
that agent who, in effect, will proffer a U.S.
presence for the foreign food facility. Many
service providers, including PBB Global Logistics,
are in a position for a fee to serve as an agent,
a practical solution since they are already privy
to shipment and trade details.
Businesses will need to
familiarize themselves with the final regulation,
since there will be a number of exemptions.
Farms, retailers and restaurants are generally
exempt, but there are some exceptions. Meat
and poultry processors, which fall under the
regulatory boundary of the U.S. Department
of Agriculture (USDA), are likewise exempt.
Otherwise, affected companies may be involved
in manufacturing, processing, packaging and
holding food, reflecting the FDA’s broad definition
of “food”, which even includes anything that
comes in direct contact with food or drink.
The regulations list some examples, and manufacturers
of bottled water, plastic film, dietary supplements,
and paper plates might be surprised to find
that they are producing “food” as defined by
the FDA.
Prior
notice – adjusting your supply chain
Much more onerous to the agri-food
industry is the proposed requirement to provide
prior notice before importing food products.
Fewer exemptions exist beyond USDA-regulated
products. Even shipments from farms are subject
to prior notice.
The measure is deemed necessary
to give the FDA sufficient information and time
to determine whether a potential threat exists
and whether shipment inspection might be warranted.
Under the proposal, the FDA
must be notified by noon of the day before the
food is to arrive at the port of entry, a period
technically 12 to 36 hours long. Not surprisingly,
of all the changes in the Bioterrorism Act, the
prior notice rule is the one of greatest concern
to the industry.
The agri-food industry argues
that the notification period is unrealistic in
many situations, particularly when the shipper
is close to the border. Prior notice would slow
down many supply chains, particularly disconcerting
for fresh produce and other highly perishable
shipments. Submissions from various industry
groups recommend anywhere from a two hour notice
period to a graduated system that takes into
account mode of transportation, proximity to
the border and other circumstances.
As originally proposed, the
process was to be separate from Customs’ Automated
Commer-cial System (ACS). Fortunately, both agencies
have since announced streamlined measures enabling
ACS to serve as the single system including FDA
prior notice requirements.
But complicating the importing
process is the potential level of detail the
FDA would demand on all notices, substantially
more comprehensive than required by either Customs
or current FDA regulations. One amendment would
be permitted, up to two hours before arrival
at the border, as long as the nature of the food
does not change (in which case a brand new submission
must be made within the prescribed time period).
If a shipment were to arrive more than an hour
before, or three hours later than first indicated,
the FDA would need to be notified accordingly.
If adequate prior notice is
not provided, the FDA will refuse admission into
the United States and shipments will be held
at the port of entry or in a nearby secure facility,
with transportation and storage costs at the
expense of the purchaser, owner, importer or
consignee. There may also be the potential for
penalties.
Food will be held until
proper prior notice is submitted and accepted
by the FDA. Only then, barring FDA inspection
or outstanding Customs entry issues, would
the shipment
be released.
New
recordkeeping requirements
Finally, the Bioterrorism Act
also authorizes the FDA to mandate the type of
records that businesses will need to create and
maintain for up to two years. This will affect
manufacturers, processors, packers, carriers,
distributors, receivers, storage facilities and
importers alike, while exempting farms and restaurants.
The intention is to improve the FDA’s ability
to follow up on credible threats and investigate
any food-related disease outbreaks.
How
can you prepare for December 12, 2003?
In light of the proposed rules
and the breadth of the FDA’s new regulatory requirements,
any business operating directly or indirectly
in the agri-food industry is wise to familiarize
itself with the changes to come, particularly
after final regulations are published in October.
Registration of facilities and
recordkeeping requirements will place additional
administrative burdens upon food companies, but
the most significant impact will stem from prior
notice regulations. Depending on the nature of
your supply chain, adjustments may be necessary
to comply, especially if the FDA does not significantly
reduce the length of the prior notification period.
Inevitably, these new administrative
and logistics burdens will force agri-food businesses
to incur additional costs. Companies should analyze
the overall financial impact before or shortly
after implementation to determine whether increased
costs warrant any revisions in pricing.
It is also important to ensure
that trading partners – vendors, carriers, third
party logistics providers – are up-to-date. Foreign
companies should look into finding a U.S. resident
agent as soon as possible. Also, prior to the
new regulations, all parties should come to agreement
about financial and logistical responsibilities
in the event a shipment is refused entry.
As with the numerous security
initiatives underway with the Bureau of Customs & Border
Protection, the new FDA framework is the reality
of supply chain management today. As any shipper
with experience in new Customs regulations
can attest, advance preparation is the key
to avoiding unpleasant and costly surprises.
Ten years after NAFTA, many
forward thinking companies look at the continent
as a single market, as evidenced by the massive
volume of trade between Canada and the U.S. Currently,
Canada buys 19 percent of all U.S. exported goods
and services, and supplies 16.5 percent of all
U.S. imports of goods and services.
The elimination of the old tariff
walls opened the Canadian market and spelled
the end of the branch plant economy. Today, there
is no longer the need for a physical presence
to service Canadian customers, especially with
the advances in supply chain management in the
past decade.
Non-Resident
Importer: the ideal exporting model in a
free trade environment
Many American manufacturers
are implementing a Non-Resident Importer (NRI)
strategy, where the company can supply the entire
Canadian market from its U.S. facilities, relying
on sales, customer service representatives and
agents in the field.
NRI status provides efficient
and cost-effective access to Canadian markets,
allowing a company to become an importer of record.
Goods are sold in Canada on a delivered basis,
including all charges in Canadian dollars. To
the customer, there is no perceived difference
between goods produced locally or those imported
from the U.S.
It is a simple procedure
to register with Canada Customs Revenue Agency
as an NRI, although proper planning is required
to comply with marking and labelling requirements
as well as product regulations from various
governmental bodies. Companies must also consider
whether or not to register for the Goods and
Services Tax (GST), which is applied to almost
all goods imported and sold in Canada.
The
logistics of NRI
The
importance of a solid logistics strategy cannot
be overestimated. The biggest mistake is to fulfill
small orders individually from existing U.S.
distribution centers. This can result in substantial
transportation costs and delivery delays.
Instead, businesses should consolidate
shipments whenever possible in order to take
advantage of the lowest possible transportation
rates. Product should be line hauled directly
to a Canadian regional distribution centre to
clear Customs efficiently. By placing the goods
closer to consumers, companies can reduce the
time involved from order to delivery. By partnering
with a Canadian third-party logistics provider
(3PL), the NRI will have access to strong regional
distribution and delivery capabilities, minimizing
transportation costs and delivery times and maximizing
customer service. All without bricks and mortar
expenses.
The use of a 3PL provider enables
businesses to offer landed cost pricing and to
invoice in Canadian dollars, providing a definite
competitive advantage. Some providers, including
PBB Global Logistics, also provide hassle-free
inventory management and returns management,
helping to minimize carrying costs. Providers
should also be thoroughly versed in ever-changing
Customs regulations and new technologies needed
to expedite the clearance of goods on both sides
of the border. PBB’s Trade & Regulatory Services
experts and its e-globallogistics.comÔ on-line
supply chain management tools ensure these critical
functions for its NRI customers.
For American manufacturers using
an NRI strategy, exporting to Canada is as easy
as supplying their own domestic market. Canada’s
population of 31.5 million can be a lucrative
new market for companies, whether new or experienced
in the export business.
For more information about
growing your business as an NRI, contact PBB
at 1-866-820-0340, e-mail info@pbb.com or
visit the “Global Solutions - Canada” section
of our Web site at www.pbb.com.
PBB will serve as an official
Canadian coordinator for next year’s China International
Fair for Investment & Trade (CIFIT), in Xiamen,
China. The annual event, designed to help promote
foreign direct investment (FDI) around the world,
involves 10,000 participants and around 100 countries
and investment regions. Last year’s event led
to over 1,000 signed contracts.
Although dates have yet to be
finalized for 2004, the event is expected to
take place over four days in September. CIFIT
offers a comprehensive seminar series, with dozens
of topics relevant to foreign investment opportunities
in China and other developing countries.
Through PBB’s Access China program,
Corporate Travel specialists will facilitate
all aspects of the 2004 show for Canadian delegates
and participants. This includes making travel
and accommodation arrangements, as well as planning
“matchmaking” sessions for firms seeking one-on-one
meetings with potential Chinese partners.
PBB’s Access China program
helps North American businesses access key
resources and services specializing in the
Chinese market. For more information visit www.pbb.com/china/index.html or www.chinafair.org.cn.


Six months after its controversial
“Straw-man” proposals were shelved, Customs & Border
Protection (CBP) has issued new rules for advance
filing of shipping data. Up to now, only ocean
freight imports have been subject to such a requirement
(24 hours notice prior to loading).
The new rules cover all
modes of transport and include both import
and export freight. In developing the new regulations,
CBP has been responsive to the business community’s
concerns about how advance filing would impact
Just-in-Time supply chain systems and other
time-sensitive freight. The pre-scribed time
periods for notification, as follow, have been
modified considerably from the earlier proposals
in January 2003:
| MODE |
IMPORT |
EXPORT |
| Ocean |
24 hours prior to loading |
24 hours to departure (72
hours for licensed exports) |
Air
|
At “wheels up” if cargo originates
in the Americas north of the Equator; otherwise,
four hours prior to arrival |
Two hours before departure |
| Road |
30 minutes to one hour before
arrival |
One hour prior to arrival
at the border |
Rail
|
Two hours arrival at border |
Four hours before before locomotive
is connected |
Pending any final revision,
the rules will become effective in October 2003.
Within 90 days of the publication of this requirement
as a final rule in the Federal Register, all
carriers will be required to electronically transmit
advance manifest information to CBP through an
approved data interchange.
- Inbound Vessels - Automated
Manifest System (AMS);
- Inbound Aircraft - Air Automated
Manifest System (Air AMS);
- Inbound Rail - Rail Automated
Manifest System (Rail AMS);
- Inbound Road - Free and Secure
Trade (FAST), Pre-Arrival Processing System
(PAPS), Border Release Advanced Screening and
Selectivity (BRASS), Customs Automated Forms
Entry System (CAFES) or ABI in-bond reporting;
- Exports - Automated Export
System (AES).
Ports of entry that are unable
to receive or transmit electronic data through
the CBP-approved interchange system will eventually
be automated. Carriers will then be required
to transmit to CBP, the advance information on
or after 90 days from the date that CBP publishes
notice in the Federal Register that the approved
interchange system is operational in that port.
Meanwhile,
Canada Customs and Revenue Agency (CCRA) has
proposed similar rules on advance filing of
manifest data, to be effective in April 2004:
| Rail |
Two hours prior
to arrival |
| Air |
“Wheels-up” for flights departing
from foreign ports in North America including
Mexico, Canada, Central America (from north
of the Equator only), the Caribbean and
Bermuda
Four hours prior to arrival
for flights departing from other foreign
areas
|
Higway
|
No advance reporting requirement,
if using FAST
One hour prior to arrival,
if not using FAST
|
| Marine |
24 hours prior to lading. |
Importers and exporters
should take the time to review any operational
challenges resulting from the advance filing
requirements in both the U.S. and Canada. New
shipping procedures may be needed to accommodate
the earlier release of shipment information.
Finally, food-related businesses must also
consider the impact of separate prior notice
regulations pro-posed by the FDA.
The ten years of NAFTA have
seen Mexico surpass Japan to become America’s
second largest export market. Trade between Canada
and Mexico has also flourished, having increased
at an annual rate of 14 percent since NAFTA’s
inception.
The border crossing at Laredo,
Texas – the busiest along America’s southern
border – is evidence of this upsurge in trade.
In the 1990s, truck and rail traffic increased
300 and 323 percent, respectively. Air cargo
through Laredo International Airport increased
a phenomenal 897 percent (this dropped considerably
after September 11, 2001 but is recovering slowly).
Yet behind these astonishing
figures, trade complexities still linger. For
both U.S. and Canadian companies, reaching markets
south of the Rio Grande is not quite as easy
as managing northbound trade.
Symptomatic of the challenges of trading between
Mexico and the U.S. are the restrictions placed
on truckers from driving in each other’s jurisdictions.
As a result, carriers frequently hand off trailers
to other carriers right at the border, creating
traffic and delays. Furthermore, many trucks
are unable to backhaul, increasing overall
logistics costs. The right cross-border trucking
partnership, however, can help alleviate the
frequency of empty loads.
“Mexico’s transportation environment
is truly unique, but certainly manageable,” says
Gary Vince, Vice President, Logistics Operations,
PBB Global Logistics. “Expertise, attention to
details and good communication are qualities
to look for in a logistics provider when it comes
to handling your Mexican freight.”
PBB offers complete logistics
services for NAFTA freight, including truck,
air and ocean transportation. With the help of
a strong strategic Mexican partnership, PBB provides
an efficient streamlined and seamless service
specializing in southern border trade.
For freight quotes or
information on shipping to Mexico, please contact mexico@pbb.com.
PBB Global Logistics recently
won six prestigious Transportation Marketing
awards from the Transportation Marketing & Communications
Association (TMCA), beating out competition that
included several Fortune 500 companies. The “Tranny”
awards were presented during the TMCA’s Annual
Conference in South Carolina. PBB received the
largest number of awards handed out this year
and was a winner for the third consecutive year.
“An organization’s work must
go through intense critique through a rigorous
judging process,” said Brian Everett, Executive
Director, TMCA. “The fact that PBB received six
awards by judging teams throughout North America
speaks volumes to the quality of its marketing
and communications.”
PBB was recognized for its integrated
marketing communications program, Solutions newsletter,
Web site (www.pbb.com), Initial Public Offering
investor presentation, Executive Briefing seminar
series and China Trade Mission.
“PBB’s
innovative and successful marketing program combines
all aspects of print, digital and electronic
marketing tactics,” said Mike Scott, President & CEO,
PBB Global Logistics. “We are proud to receive
recognition for our efforts from such an esteemed
organization for the third year in a row.”
The TMCA awards program recognizes
the best communications practices in the transportation
and passenger transit industries. It is sponsored
by the U.S.-based TMCA, which is the only association
dedicated to serving marketing and communications
professionals in all modes in the North American
transportation industry.
The annual awards are considered among the
industry’s most prestigious honors.
“It is an honor to be recognized
for marketing excellence by our peers in the
industry,” said John Ferguson, Vice President,
Sales & Marketing, PBB Global Logistics.
“PBB’s marketing strategy is focused on positioning
our company as an expert in global integrated
logistics solutions and receiving
these awards is a testament to the efforts of
our very dedicated PBB employees.”
PBB was recently recognized
for its supply chain management innovations by
the Supply Chain & Logistics Canada (SCL),
a leading association dedicated to educational,
research and networking opportunities for logistics
professionals.
SCL’s annual Innovation Award
honors professionals and businesses that have
promoted strong industry partnerships and advanced
the logistics and supply chain profession.
PBB’s advances in Internet-based
supply chain management was a key factor in winning
the award. Its suite of integrated supply chain
management solutions, e-globallogistics.comÔ,
provides clients with Web access to shipments
and transactions, allowing increased visibility
and control over the entire logistics process.
In addition to tracking their shipments, clients
have access to a wide range of Customs and trade
documentation, can conduct on-line ordering and
inventory management functions, and create and
manage purchase orders via an efficient paperless
system.
“PBB has always been at
the forefront of emerging supply chain technologies,
and our integrated marketing communications
plan was strategically developed to position
these services as cutting edge within the industry,”
said Mike Scott, President & CEO, PBB Global
Logistics. “We are committed to facilitating
the movement of goods as quickly and efficiently
as possible on behalf of our clients. To receive
recognition from such an esteemed organization
is a testament to this philosophy and the best-practices
we have put into place through many of our
supply chain management tools.”
PBB recently welcomed dozens
of representatives from NAAMO (North American
Agricultural Marketing Officials), who were in
Niagara Falls for their annual conference and
had previously approached PBB to conduct an information
session as part of their agenda. PBB staff hosted
a tour of the company headquarters and Peace
Bridge border operations, including a presentation
on the latest Customs and trade issues of relevance
to the agricultural industry.
NAAMO’s primary goal is to promote
education, communication and cooperation among
members, and thereby enhance worldwide market
opportunities for North American agricultural
products. The organization consists of director-level
state, provincial and federal government agricultural
marketing officials.
Sarnia
Office Wins Prestigious Chamber Award
PBB’s Sarnia office was recognized
at the Sarnia-Lambton Chamber of Commerce awards
ceremony, winning the Business Advocacy Award
and the prestigious Business Excellence Award.
The Business Advocacy award
was given for PBB’s ongoing efforts to promote
international trade throughout the Great Lakes
area and beyond. By winning the Business Excellence
Award, the local Chamber’s top business award,
PBB automatically becomes eligible for the Ontario
Chamber of Commerce Awards in October 2003.
FSIS
Issues New Registration, Recordkeeping
Proposal
The U.S. Department of Agriculture’s
Food Safety and Inspection Service (FSIS) has
issued a policy proposal to enforce the registration
and record-keeping requirements contained in
meat and poultry inspection legislation.
Affected businesses will
have to register, or re-register, by March
24, 2004 using a new registration form. The
policy statement also contains information
on the types of records that must be retained,
as well as the length of time involved.
White
Papers Available On-line
All of PBB’s popular White
Papers are now available free of charge at
www.pbb.com/whitepapers.html. Each paper offers
timely insight and analysis into key logistics
issues and new regulations that affect the
trading community. Unclear about the impact
of new government proposals on your supply
chain? Make www.pbb.com/whitepapers.html your
first stop for answers!
PBB is pleased to announce the
recent promotion of four senior managers to the
level of Vice President, where they will bring
their logistics expertise, strategic vision and
leadership skills to the company’s executive
group. The quartet possesses a wealth of knowledge
thanks to over 80 years of combined experience
in the logistics industry.

The individuals involved in
the new appointments are:
John
Ferguson, Vice President, Sales & Marketing
Mr. Ferguson joined PBB in 1987. Formerly Director,
Sales & Marketing, he has been the recipient
of the 2000 Ontario Global Traders Award and
had a pivotal role in PBB receiving TMCA “Tranny”
awards for three consecutive years. Mr. Ferguson
holds a degree in business and economics and
is a Certified Canadian Customs Specialist.
Mark
Lidkea, Vice President, Customs Operations
Mr. Lidkea joined PBB in 1985. He is a Licensed
Professional Canadian Customs Broker and a Certified
Canadian Customs Specialist. Mr. Lidkea is also
an executive board member with the Air Courier
Conference of America’s “International Committee”.
He previously held the position of Director,
Western Operations with PBB.
Joe
Morinello, Vice President, Finance & Administration
Mr. Morinello’s career with PBB has spanned more
than 15 years in both the Canadian and U.S. accounting
departments. He earned his Certified Management
Accounting designation in 1992 and most recently
held the position of Director Accounting, Canadian
Operations. Mr. Morinello now assumes the position
of Vice President, Finance & Administration.
Gary
Vince, Vice President, Logistics Operations
With 20 years in the logistics industry, Mr.
Vince, P.Log, joined PBB in 1998 and most recently
held the position of Director, International
Freight. He has now been appointed Vice President,
Logistics Operations, where he will oversee PBB’s
inter-national freight and North American transportation
services, as well as its Third Party Logistics
(3PL) solutions.
|