U.S. FDA Food Safety Modernization Act (FSMA) for Customs Brokers

04/11/23

U.S. FDA Food Safety Modernization Act: Are you

Ready?

Presented by Cornelia Rooks, Senior Regulatory Specialist

Registrar CorpAugust 2012

FDA Food Safety Modernization Act

“FSMA” signed by President Obama 01/04/2011Phased in over time thru 2016Most significant update to food safety laws since 1938

Motivators for FSMA

About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from food borne diseases

Public health burden that is largely preventable.

High Profile Cases

Imports in the spotlightMelamine in pet foodIllegal antibiotics in aquacultureBetter detection of common pathogens, and strains of new

pathogens.

Imports of FDA-Regulated Food Have Almost Doubled Since 2002

Burden on Manufacturers and Importers

Port-of-Entry inspection cannot handle increase in imported foods

FSMA makes Importers more responsible for quality of products from foreign manufacturers

Vision of FSMA

Prevention

Inspections, Compliance,

and Response

Import Safety

Enhanced Partnerships

NEW FDA REQUIREMENTS CURRENTLY IN EFFECT

Latest Developments

New User Fees- Registration Suspension Administrative Detentions Updated Prior Notice Filings Anti-Smuggling New Dietary Supplements guidance Processed foods and produce pilots to

explore how to quickly trace foods back to source of contamination-

Registration Renewal

Each food facility must renew its U.S. FDA registration every two years (4th quarter of every even-numbered year). Starting October 2012

Low acid and acidified food manufacturers typically must have two separate FDA registrations for each location, • (1) a Food Facility Registration (“FFR”), which all food facilities must

file, regardless of whether they handle low acid and acidified foods, and

• (2) a Food Canning Establishment (“FCE”) registration.

Note: An Update to electronic system on 8/1/12, for new companies entering data into system

The data in these two registrations must match precisely.

United States Agent

Foreign Establishments must notify FDA of the name, business name, address, phone number, and email address of their United States agent.

The US Agent must reside or maintain a place of business in the US.

United States Agent

U.S. Agents have been designated since 2003, and foreign companies have not had to update that information since the initial designation

Since 2003, many customs brokers and importers have allowed foreign companies to designate them as the required “U.S. Agent”

New FDA User Fees

New FDA User Fees Effective October 1, 2011FDA Hourly Rate For Reinspections and

Reconditioning: $221 per hour, domestic $289 per hour for foreign travel

Revision Announced August 1, 2012, effective October 1, 2012

FSMA Reinspection Fees

Invoiced to the foreign facility’s designated “U.S. Agent”

That could be an importer who agreed to act as the U.S. Agent

That could be YOU ----- if you have been designated as the “U.S. Agent” by a foreign food facility’s FDA registration

Reinspection

“Reinspection” is one or more inspections subsequent to such an inspection which identified non-compliance materially related to a food safety requirement.

New FDA User Fees

Reinspection Fees Fee is based on the number of direct hours, including:time spent conducting the physical surveillance at the facility,whatever components of such an inspection are deemed

necessarymaking preparations and arrangements for the reinspection

New FDA User Fees

Reinspection Fees traveling to and from the facilitypreparing any reports,analyzing any samplesexamining any labels if requiredperforming other activities until the facility is in compliance.

New FDA User Fees

“Reconditioning Fees” on Imported Food Fees must be paid by owner of food or importer, depending on

circumstancesFees must be paid at the hourly rate for all expenses in

connection with arranging, conducting, and evaluating the results of examinations and additional examinations of product

New FDA User Fees

“Reconditioning Fees” on Imported Food. Will be charged where reconditioning is required to bring food

into complianceWill be charged if product is destroyed

Fees Related to Import Alerts (DWPE)

Will be charged where food is detained by an Import Alert

No charge if food is detained, not subject to an Import Alert, and Shipper or Importer submits satisfactory proof that food is not adulterated.

Fees Related to Import Alerts (DWPE)

Exporters applying for removal from DWPE must pay FDA's hourly charges for evaluating the application, including the cost of inspecting the foreign facility if necessary.

New FDA User Fees

Not Complying with a Recall Order(1) Not initiating a recall as ordered by FDA(2) Not conducting the recall in the manner specified by FDA(3) not providing FDA with information regarding the recall as

ordered by FDA.An importer who does not comply with a recall order is

responsible for paying the feeThe party paying the fee would be the party that received the

recall order.

Other Recent Changes By FSMA Affecting Customs

Brokers, Freight Forwarders and Importers

Prior Notice

Filers need to indicate whether a food product has been refused entry to another country

Registration Suspension

FDA’s power to suspend the registration of food facilities effectively closes any facility that created, caused, or is responsible for food having a reasonable probability of adverse health consequences to humans or animals. 

FDA may also suspend registration of facilities suspected to have prior knowledge or involvement in introducing such food into commerce in the United States. 

Registration Suspension

Registration may be held in suspension until U.S. FDA determines the cause to be rectified and that no further health consequences exist. 

FDA also announced its right to require “corrective action plans” from suspended facilities as proof that no further health consequences exist.

Administrative Detention

Allows FDA to proactively halt food suspected of adulteration or misbranding at the border instead of being required to wait for a proven health concern.  

If FDA suspects food to have been produced or processed in unsanitary conditions, the agency may administratively detain food products for up to 30 days.

Import Safety

Voluntary Qualified Importer Program(VQIP) Implementation was due June 2012FDA must establish a user-fee funded VQIP to expedite entry

into the United States of imported food from eligible, qualified importers.

To be eligible to participate, an importer must offer food for importation from a facility that has a certification by an accredited third party.

FDA will qualify eligible importers to participate in VQIP based on risk considerations.

The new law directs FDA to issue guidance on participation in and compliance with VQIP.

Import Safety

Foreign Supplier Verification Program (FSVP)Regulation was due January 2012FSVP requires all importers to conduct risk-based foreign

supplier verification activities to verify that imported food is not adulterated and that it was produced in compliance with FDA’s preventive controls requirements and produce safety standards, where applicable.

04/11/23

FSMA and Inspections

FDA Registered Facilities

Domestic registrations: 169,884Foreign registrations: 445,884Total: 615,768

**As of May 22, 2012

Inspections and Detentions

U.S. FDA’s review of a facility or product can have serious impact on business

Reasons for Inspection

Routine scheduleSurveyResponse to reported problemFulfillment of FSMA mandate

FDA’s Foreign Inspection History

FDA’s 2010 Foreign Inspection Totals

FSMA Foreign Facility Inspection Schedule

Double the previous year, minimum of:

Year Foreign Inspections

2011 600

2012 1,200

2013 2,400

2014 4,800

2015 9,600

2016 19,200

04/11/23

One Big Challenge…

Detentions

Shipment Detained?

Shipment arrives, FDA has options: 1. Release

2. Detain –Review – Release

3. Detain – Review – Test – Release

4. Detain – Review – Test – Refuse entry

Phone call in the nightIf importer advises you of detention,

ask for a copy of the “Notice of FDA Action.”

Compliance Issues

Misbranding: FDA has jurisdiction to ensure that food labeling is truthful, non-misleading, and adequate to ensure that foods are safe and effective for their intended uses.

Adulteration: FDA has jurisdiction to ensure that foods are properly processed, meet their specifications and are not contaminated.

Analysis of FDA Detentions

Common Reasons for Detention

Failure to label product correctly – Most of these detentions could have been avoided by pre-shipment label review.

Failure to make required electronic filings – Registrations, Process Filings, Prior Notices…

Food Labeling & Ingredients

A top reason product is detained: Incorrect labeling, unapproved ingredients, prohibited health claims

Easy problems to avoidCommon errors in trying to avoid problems:

Copy other wrong labelsOnly follow part of the regulations

“Notice of FDA Action” Example

http://www.accessdata.fda.gov/scripts/importrefusals

OASIS

FDA Automatic Detention

Products from certain countries, foreign manufacturer, a specific product, or shipper may be placed on “Automatic Detention,” also called DWPE.

Reasons may include: article has been manufactured, processed, or packed under

insanitary conditionsarticle is adulterated, misbranded

Removal from FDA Automatic Detention/DWPE

Not easy: FDA must believe the issue(s) causing the listing have been resolved (i.e. what have you changed?);

A minimum of five consecutive non-violative commercial shipments before the FDA will consider removal;

Shipments should represent routine commercial entries and include certain documentation;

A written petition with documentation must be submitted to FDA for their review/action

Proactive versus Reactive

Numerous regulations already existU.S. offers enormous market potential

and products will only need to comply with specific regulations, not all.

Best advice: stay informed. Many changes are coming over the next 4 years.

Investing in compliance is much cheaper than reacting to a failed inspection or detention in the U.S.

Detentions mean demurrage, laboratory testing fees, warehousing fees, cost to “recondition” product, return freight, possible FDA fees, and loss of a customer.

Compliance to U.S. FDA Regulations

BEFORE first shipment to the U.S is

much cheaper than a single detention.

Think about the various costs of a detention:1. Demurrage: $$$ per day

2. Laboratory testing fees: $$$ per sampling/test

3. Warehousing fees: $,$$$ ?

4. Freight cost to return the product: $,$$$ ?

5. Cost to “recondition” the product (re-label, for example): $,$$$ ?

6. Cost of loosing a client: $$$,$$$ ?

7. FDA Fees $$$?

About Registrar Corp

Expertise in Food & Beverages, Medical Devices, Cosmetics, Radiation Emitting Devices, and Drugs

Founded in 2003, based in Hampton, Virginia, USA with over 100 employees

All services are fixed fee, no hourly rates25,000 total clients served from more than 150 countries“Live Help” on web site19 overseas offices.

Food & Beverage Services

FDA Food Facility RegistrationsRegistration Renewals in 2012U.S. Agent ServiceFood Labeling ReviewsLow-Acid & Acidified Canned Food RegistrationsPrior Notice FilingsDetention AssistanceAudit Service starting October 2012

Pre-Inspection Audit Service

COMING SOON• As part of our U.S. Agent service, Registrar Corp will dispatch

a food safety expert trained in FDA inspections to facilities to help prepare if a notice of FDA inspection after October 1, 2012 is received.

• This assistance is included at no additional charge other than travel and lodging expenses.

Need Additional Assistance?

US Agent and Detention Services

Drug ProductsEstablishment RegistrationProduct ListingLabel & Ingredient ReviewsDrug Master Files (DMF)

Medical DevicesEstablishment RegistrationDevice Listings510(k) Administrative ReviewMedical Device Master Files (MAF)

About Registrar Corp

Registrar Corp Headquarters144 Research Drive Hampton, Virginia USA 23666 P: +757-224-0177 F: +757-224-0179 E: info@registrarcorp.com

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