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ADMINISTRATIVE DETENTION ADMINISTRATIVE DETENTION FINAL RULE FINAL RULE

ANDAND

REGISTRATION UPDATE REGISTRATION UPDATE

Ohio State UniversityOhio State UniversityFebruary 16, 2005February 16, 2005

Robert HahnRobert HahnOlsson, Frank and Weeda, P.COlsson, Frank and Weeda, P.C

1400 Sixteenth Street, N.W.1400 Sixteenth Street, N.W.

Suite 400Suite 400

Washington, D.C. 20036Washington, D.C. 20036

202/789-1212202/789-1212

202/234-3537 (FAX)202/234-3537 (FAX)

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Who We AreWho We Are

Olsson, Frank and Weeda, P.C. is a 25 Olsson, Frank and Weeda, P.C. is a 25 attorney Washington, D.C. law firm that attorney Washington, D.C. law firm that specializes in representing business entities, specializes in representing business entities, individuals, and associations in industries individuals, and associations in industries regulated by the U.S. Food and Drug regulated by the U.S. Food and Drug Administration or the U.S. Department of Administration or the U.S. Department of Agriculture. Agriculture.

OFW represents its clients before federal and OFW represents its clients before federal and state agencies, the courts, Congress, and the state agencies, the courts, Congress, and the White House. White House.

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PrefacePreface

This presentation is for general This presentation is for general informational purposes only and is not informational purposes only and is not intended to constitute legal advice. intended to constitute legal advice. Please contact your attorneys if you Please contact your attorneys if you need legal advice.need legal advice.

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I.I.

ADMINISTRATIVE ADMINISTRATIVE DETENTIONDETENTION

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Administrative DetentionAdministrative Detention

The Bioterrorism Act gave FDA the The Bioterrorism Act gave FDA the authority to administratively detain authority to administratively detain foodfood Section 303 of Bioterrorism Act is self-Section 303 of Bioterrorism Act is self-

implementing, so FDA has had implementing, so FDA has had detention authority since enactment in detention authority since enactment in 20022002

FDA final rule became effective July FDA final rule became effective July 4, 2004 4, 2004

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FDA’s New PowerFDA’s New Power

FDA may detain an article of food FDA may detain an article of food that is found during an inspection, that is found during an inspection, examination, or investigation if there examination, or investigation if there is “credible evidence or information” is “credible evidence or information” indicating it presents a threat of indicating it presents a threat of “serious adverse health “serious adverse health consequences or death to humans or consequences or death to humans or animals” (SAHCODHA)animals” (SAHCODHA)

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PurposePurpose

To enable FDA to prevent To enable FDA to prevent adulterated food from entering adulterated food from entering commerce before FDA is able to commerce before FDA is able to bring a court action to seize it or bring a court action to seize it or enjoin its distributionenjoin its distribution

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EffectEffect

Probably limited Probably limited Most states have detention/embargo Most states have detention/embargo

authority, and FDA traditionally has authority, and FDA traditionally has asked state agencies to detain food asked state agencies to detain food when this was deemed necessary -- when this was deemed necessary -- the only difference is now FDA can the only difference is now FDA can do itself do itself

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““Food”Food”

““Food” is defined broadly to include all Food” is defined broadly to include all FDA-regulated foods, including food FDA-regulated foods, including food contact substances (contact substances (i.ei.e., substances ., substances that migrate into food from food that migrate into food from food packaging)packaging) NB: Registration and prior notice interim NB: Registration and prior notice interim

final rules do final rules do notnot apply to food contact apply to food contact substancessubstances

Foods regulated exclusively by USDA Foods regulated exclusively by USDA not subject to this rulenot subject to this rule

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Who May Order Who May Order Detention?Detention?

Detention may be Detention may be orderedordered by an by an officer or qualified employee of FDA officer or qualified employee of FDA ((e.ge.g., an FDA field investigator, ., an FDA field investigator, other FDA employees, State or local other FDA employees, State or local employees commissioned by FDA)employees commissioned by FDA)

The detention order must be The detention order must be approvedapproved by FDA District Director or by FDA District Director or a more senior FDA officiala more senior FDA official

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Who Receives the Who Receives the Detention Order?Detention Order?

FDA must issue the detention order to the FDA must issue the detention order to the owner, operator, or agent in charge of the owner, operator, or agent in charge of the place where the article of food is locatedplace where the article of food is located

If owner of the food is different from the If owner of the food is different from the above parties and the owner’s identity is above parties and the owner’s identity is readily determinable, FDA must give readily determinable, FDA must give owner a copy of the detention orderowner a copy of the detention order

If detained food is on a vehicle or other If detained food is on a vehicle or other carrier, FDA must give a copy to shipper carrier, FDA must give a copy to shipper of record and owner/operator of vehicleof record and owner/operator of vehicle

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Period of DetentionPeriod of Detention

FDA may detain food for up to 30 FDA may detain food for up to 30 calendar days after the detention calendar days after the detention order is issuedorder is issued

The detention order terminates The detention order terminates when: (a) FDA terminates the order; when: (a) FDA terminates the order; (b) the detention period expires; or (b) the detention period expires; or (c) FDA initiates a seizure or (c) FDA initiates a seizure or injunction action injunction action

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Perishable FoodsPerishable Foods

If the detained food is perishable, If the detained food is perishable, FDA will expedite decision whether FDA will expedite decision whether to bring seizure actionto bring seizure action

FDA will send any seizure FDA will send any seizure recommendation to DOJ within 4 recommendation to DOJ within 4 calendar days after the detention calendar days after the detention order is issuedorder is issued

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Perishable FoodsPerishable Foods

““Perishable food” means food that is Perishable food” means food that is not heat-treated, not frozen, and not not heat-treated, not frozen, and not otherwise preserved to prevent otherwise preserved to prevent quality from being adversely quality from being adversely affected if held longer than 7 days affected if held longer than 7 days under normal conditionsunder normal conditions Fluid milk, fresh fish and shellfish, fresh Fluid milk, fresh fish and shellfish, fresh

fruits and vegetablesfruits and vegetables

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The Detention OrderThe Detention Order

The detention order must contain The detention order must contain specific information, including:specific information, including: Identification of detained article of foodIdentification of detained article of food Location and conditions of detentionLocation and conditions of detention Date and hour detention beginsDate and hour detention begins Detention period Detention period Statement of reasons for detentionStatement of reasons for detention Information regarding right to appeal Information regarding right to appeal

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Consequences of Consequences of DetentionDetention

Detained food may Detained food may notnot be delivered to be delivered to its importers, owners, or consigneesits importers, owners, or consignees

FDA may require that detained food FDA may require that detained food be moved to a secure facility (be moved to a secure facility (e.ge.g., if ., if FDA concerned it may enter FDA concerned it may enter commerce) – owner bears storage and commerce) – owner bears storage and transportation coststransportation costs

FDA may require marking or tagging FDA may require marking or tagging of detained foodof detained food

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Modification of Modification of Detention OrderDetention Order

Recipient of detention order may Recipient of detention order may request a modification of detention request a modification of detention order to permit movement of the order to permit movement of the detained food to another location detained food to another location ((e.ge.g., to refrigerated storage to ., to refrigerated storage to preserve quality)preserve quality)

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Appeal of Detention Appeal of Detention OrderOrder

Any person who would be entitled to Any person who would be entitled to claim a detained article of food in a claim a detained article of food in a seizure action may appeal a seizure action may appeal a detention orderdetention order

Appeal must be submitted in writing Appeal must be submitted in writing to FDA District Director in the to FDA District Director in the district where the detained food is district where the detained food is locatedlocated

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Timeframes for Timeframes for AppealingAppealing

If the detained food is perishable:If the detained food is perishable: Claimant must file appeal within 2 Claimant must file appeal within 2

calendar days after receiving detention calendar days after receiving detention orderorder

If claimant requests a hearing, and FDA If claimant requests a hearing, and FDA grants hearing, FDA must conduct grants hearing, FDA must conduct hearing within 2 calendar days after hearing within 2 calendar days after appeal is filedappeal is filed

FDA must issue decision within 5 FDA must issue decision within 5 calendar days after appeal is filedcalendar days after appeal is filed

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Timeframes for Timeframes for AppealingAppealing

If the detained food is non-perishable:If the detained food is non-perishable: Claimant must file appeal within 10 calendar Claimant must file appeal within 10 calendar

days after receiving detention orderdays after receiving detention order If claimant wants a hearing, must request one If claimant wants a hearing, must request one

within 4 calendar days after receiving within 4 calendar days after receiving detention orderdetention order

If FDA grants hearing, FDA must conduct If FDA grants hearing, FDA must conduct hearing within 2 calendar days after appeal is hearing within 2 calendar days after appeal is filedfiled

FDA must issue decision within 5 calendar FDA must issue decision within 5 calendar days after appeal is fileddays after appeal is filed

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Appeal DecisionAppeal Decision

If FDA confirms detention order on If FDA confirms detention order on appeal, that is final agency action appeal, that is final agency action subject to appeal in federal courtsubject to appeal in federal court

If FDA terminates detention order, If FDA terminates detention order, FDA will issue a detention FDA will issue a detention termination noticetermination notice

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Can FDA Detain Imports?Can FDA Detain Imports?

Yes, but FDA predicts this will happen Yes, but FDA predicts this will happen infrequentlyinfrequently

FDA and Customs more likely to use FDA and Customs more likely to use other enforcement tools:other enforcement tools: Refusal of admission under FD&C Act 801(a)Refusal of admission under FD&C Act 801(a) 24-hour hold: FDA may request that Customs 24-hour hold: FDA may request that Customs

hold imported food for 24 hours if credible hold imported food for 24 hours if credible evidence of SAHCODHA and unable to evidence of SAHCODHA and unable to inspect or examine food immediately inspect or examine food immediately

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II.II.

FACILITYFACILITY

REGISTRATIONREGISTRATION

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RegistrationRegistration

The Bioterrorism Act added a The Bioterrorism Act added a requirement to register food requirement to register food facilities with FDAfacilities with FDA

FDA interim final rule on FDA interim final rule on registration effective December 12, registration effective December 12, 20032003

FinalFinal rule expected by June 2005 rule expected by June 2005

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Basic RegistrationBasic RegistrationRequirementRequirement

The owner, operator, or agent in The owner, operator, or agent in charge of every domestic or foreign charge of every domestic or foreign facility that engages in facility that engages in manufacturing/processing, packing, manufacturing/processing, packing, or holding food intended for human or holding food intended for human or animal consumption in the United or animal consumption in the United States must register with FDA, States must register with FDA, unless exemptunless exempt

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Purposes Of RegistrationPurposes Of Registration To enable FDA to determine the source of, To enable FDA to determine the source of,

and communicate quickly with, affected and communicate quickly with, affected facilities during an actual or potential facilities during an actual or potential bioterrorist event or other food-related bioterrorist event or other food-related emergencyemergency

Other purposes:Other purposes: To identify and locate facilities for inspectionTo identify and locate facilities for inspection During inspection, to match registration During inspection, to match registration

information to inspector’s observationsinformation to inspector’s observations To assist screening of food imports by matching To assist screening of food imports by matching

registration information (registration information (e.ge.g., food product ., food product category) with information in prior notice of importcategory) with information in prior notice of import

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Who Is Responsible forWho Is Responsible forRegistration?Registration?

Owner, operator, or agent in charge Owner, operator, or agent in charge of the facility is responsible for of the facility is responsible for registering registering

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Who Can SubmitWho Can SubmitRegistration?Registration?

Owner, operator, or agent in charge of the Owner, operator, or agent in charge of the facility facility

Certain other persons may submit the Certain other persons may submit the registration, including:registration, including: Any individual authorized by the owner, Any individual authorized by the owner,

operator, or agent in charge of the facilityoperator, or agent in charge of the facility A parent company may register its subsidiaries’ A parent company may register its subsidiaries’

facilitiesfacilities For foreign facilities, an authorized individual of For foreign facilities, an authorized individual of

facility’s U.S. agent (if foreign facility authorizes facility’s U.S. agent (if foreign facility authorizes its U.S. agent to register on its behalf)its U.S. agent to register on its behalf)

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““Facility”Facility”

““Facility”: defined as “any Facility”: defined as “any establishment, structure, or establishment, structure, or structures under one ownership at structures under one ownership at one general physical location, or in one general physical location, or in the case of a mobile facility, the case of a mobile facility, traveling to multiple locations, that traveling to multiple locations, that manufacturers/processes, packs, or manufacturers/processes, packs, or holds food for consumption in the holds food for consumption in the United States”United States”

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““Facility” – Not IncludedFacility” – Not Included

Private residencesPrivate residences Transport vehicles that only hold Transport vehicles that only hold

food in usual course of business as food in usual course of business as carriers carriers If vehicle used for storage, packing, or If vehicle used for storage, packing, or

manufacturing/processing food, it is a manufacturing/processing food, it is a “facility”“facility”

Public or community water systems Public or community water systems that collect and distribute tap waterthat collect and distribute tap water

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““Food”Food”

““Food”: broadly defined to include Food”: broadly defined to include all FDA-regulated foods, all FDA-regulated foods, exceptexcept:: Food contact substances; andFood contact substances; and PesticidesPesticides

Articles not yet in consumable form Articles not yet in consumable form ((e.ge.g., gum base to be used in ., gum base to be used in chewing gum) are “food” if chewing gum) are “food” if reasonably expected to be directed reasonably expected to be directed to a food use to a food use

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Retail ExemptionRetail Exemption Retail facilities that Retail facilities that primarilyprimarily sell food sell food

directly to consumers directly to consumers Includes grocery stores, vending machinesIncludes grocery stores, vending machines

Facility sells “primarily” to consumer if Facility sells “primarily” to consumer if annual dollar sales to consumers exceed annual dollar sales to consumers exceed annual dollar sales to all other buyersannual dollar sales to all other buyers

A retail facility that A retail facility that manufactures/processes food is still manufactures/processes food is still exempt, as long as its primary business exempt, as long as its primary business is selling food directly to consumersis selling food directly to consumers

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Restaurant ExemptionRestaurant Exemption

Restaurants (Restaurants (i.e.,i.e., facilities that prepare facilities that prepare and sell food and sell food directlydirectly to consumers for to consumers for immediate consumption)immediate consumption) Includes cafes, cafeterias, bars, food stands, Includes cafes, cafeterias, bars, food stands,

fast food establishments, kennelsfast food establishments, kennels Does Does notnot include facilities that do not serve include facilities that do not serve

food directly to consumers:food directly to consumers: Central kitchens not exemptCentral kitchens not exempt Facilities that provide food to interstate Facilities that provide food to interstate

conveyances for service to passengers (conveyances for service to passengers (e.ge.g., ., airline caterers) not exempt airline caterers) not exempt

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Foreign Facility Foreign Facility ExemptionExemption

A foreign facility is exempt, if food from A foreign facility is exempt, if food from the facility undergoes further the facility undergoes further manufacturing/processing (including manufacturing/processing (including packaging) of more than a packaging) of more than a dede minimisminimis nature at another foreign facility before nature at another foreign facility before export to the U.S. export to the U.S. Thus, the Thus, the lastlast foreign facility that foreign facility that

manufactures/ processes the food, and any manufactures/ processes the food, and any subsequentsubsequent foreign facility that packs, foreign facility that packs, holds, or labels that food, must registerholds, or labels that food, must register

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Foreign Facilities –Foreign Facilities –“De Minimis” Operations“De Minimis” Operations

Adding labeling to packaged food is Adding labeling to packaged food is considered considered dede minimisminimis, because the , because the food is not directly contacted or food is not directly contacted or manipulatedmanipulated

Packaging is Packaging is notnot regarded as regarded as dede minimisminimis ““Packaging” defined as “placing food Packaging” defined as “placing food

into a container that directly contacts into a container that directly contacts the food and that the consumer receives”the food and that the consumer receives”

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Foreign Facility Foreign Facility Exemption –Exemption –

ExampleExample Facility A in Canada makes milk Facility A in Canada makes milk

chocolate in 25 pound bags for chocolate in 25 pound bags for manufacturing use and ships it to manufacturing use and ships it to Facility B in CanadaFacility B in Canada

Facility B in Canada uses chocolate to Facility B in Canada uses chocolate to make boxed chocolates and ships them make boxed chocolates and ships them to Facility C in Canadato Facility C in Canada

Facility C in Canada puts the boxed Facility C in Canada puts the boxed chocolates into gift baskets and ships chocolates into gift baskets and ships them to the U.S. them to the U.S.

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Farm ExemptionFarm Exemption Farms (Farms (i.ei.e.., a facility in one general physical location devoted to , a facility in one general physical location devoted to

the growing and harvesting of crops, the raising of animals the growing and harvesting of crops, the raising of animals (including seafood), or both)(including seafood), or both) Fruit orchards, dairy farms, feedlots, aquaculture facilitiesFruit orchards, dairy farms, feedlots, aquaculture facilities

Growing and harvesting includes:Growing and harvesting includes: Washing, trimming, cooling of produceWashing, trimming, cooling of produce Natural drying of harvested cropsNatural drying of harvested crops

Includes facilities that pack or hold food, provided all such food is grown, Includes facilities that pack or hold food, provided all such food is grown, raised, or consumed on that farm or another farm under same ownershipraised, or consumed on that farm or another farm under same ownership

Includes facilities that manufacture/process food, provided all such food Includes facilities that manufacture/process food, provided all such food is consumed on that farm or another farm under the same ownershipis consumed on that farm or another farm under the same ownership

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Farm ExemptionFarm Exemption An exempt farm may also An exempt farm may also pack or holdpack or hold food, food,

provided all such food is grown, raised, or provided all such food is grown, raised, or consumed on that farm or another farm under consumed on that farm or another farm under the same ownershipthe same ownership ““Packing” includes placing harvested crop into Packing” includes placing harvested crop into

consumer-ready containers (consumer-ready containers (e.ge.g., plastic bags, mesh ., plastic bags, mesh bags, clamshells)bags, clamshells)

An exempt farm may also An exempt farm may also manufacture/processmanufacture/process food, provided all such food is consumed on that food, provided all such food is consumed on that farm or another farm under the same ownershipfarm or another farm under the same ownership ““Manufacturing/processing” includes any activity that Manufacturing/processing” includes any activity that

changes or manipulates the food (changes or manipulates the food (e.ge.g., chopping ., chopping carrots before placing them in a plastic bag)carrots before placing them in a plastic bag)

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Other Exemptions from Other Exemptions from FDA RegistrationFDA Registration

Facilities regulated Facilities regulated exclusivelyexclusively by by USDA, throughout the USDA, throughout the entireentire facility facility ((e.ge.g., a slaughterhouse that ., a slaughterhouse that slaughters only poultry, cattle, slaughters only poultry, cattle, sheep, swine, equines, or goats)sheep, swine, equines, or goats)

Non-profit “soup kitchens” and the Non-profit “soup kitchens” and the likelike

Fishing vessels that do not engage in Fishing vessels that do not engage in processingprocessing

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Registration OptionsRegistration Options

Must use Form 3537Must use Form 3537 Filing optionsFiling options

Electronic (http://www.access.fda.gov)Electronic (http://www.access.fda.gov) Paper (by mail or fax)Paper (by mail or fax) CD-ROM in PDF format (by mail)CD-ROM in PDF format (by mail)

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Electronic FilingElectronic Filing

FDA strongly encourages electronic FDA strongly encourages electronic filing through a link on FDA website: filing through a link on FDA website: http://www.fda.gov/furls http://www.fda.gov/furls

Registrant will receive Registrant will receive “instantaneous” confirmation, “instantaneous” confirmation, facility registration number, and PIN facility registration number, and PIN numbernumber

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Registration UpdatesRegistration Updates

If any If any requiredrequired registration information registration information changes, the facility must submit an changes, the facility must submit an update to FDA within 60 calendar days update to FDA within 60 calendar days after the changeafter the change

Update not required for change in Update not required for change in optionaloptional information, but FDA information, but FDA encouragesencourages

Use Form 3537Use Form 3537 If electronic registration used, only need to If electronic registration used, only need to

enter any changes in information enter any changes in information

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Cancellation of Cancellation of RegistrationRegistration

Separate form (Form 3537a) for Separate form (Form 3537a) for canceling registration canceling registration

If facility is sold, goes out of business, If facility is sold, goes out of business, or ceases providing food for or ceases providing food for consumption in the U.S., within 60 consumption in the U.S., within 60 days:days: Old owner, operator, or agent in charge Old owner, operator, or agent in charge

must cancelmust cancel New owner, operator, or agent in charge New owner, operator, or agent in charge

must re-register, if appropriatemust re-register, if appropriate

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FDA CancellationFDA CancellationOf RegistrationOf Registration

FDA will cancel registration on own FDA will cancel registration on own initiative initiative onlyonly if it independently if it independently verifies:verifies: Change of ownershipChange of ownership Facility out of businessFacility out of business Facility does not existFacility does not exist

FDA will notify facility of FDA will notify facility of cancellation by mailcancellation by mail

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Relationship To Other Relationship To Other FDAFDA

Registration Registration RequirementsRequirements FDA’s facility registration FDA’s facility registration

requirement is requirement is in addition toin addition to, not in , not in lieu of, any lieu of, any otherother FDA registration FDA registration requirements that may apply to a requirements that may apply to a food facility (food facility (e.ge.g., low acid canned ., low acid canned food)food)

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Foreign FacilitiesForeign Facilities

A foreign facility is a facility not A foreign facility is a facility not located in a State or Territory, the located in a State or Territory, the District of Columbia, or Puerto Rico District of Columbia, or Puerto Rico (regardless of whether owned by (regardless of whether owned by U.S. or foreign company)U.S. or foreign company)

Unless exempt, a foreign facility Unless exempt, a foreign facility must:must: Register with FDA; Register with FDA; andand Designate a “U.S. agent”Designate a “U.S. agent”

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““U.S. Agent”U.S. Agent” ““U.S. agent”: defined as “a person residing or U.S. agent”: defined as “a person residing or

maintaining a place of business in the U.S. maintaining a place of business in the U.S. whom a foreign facility designates as its whom a foreign facility designates as its agent” to act as a communications link agent” to act as a communications link between FDA and the foreign facilitybetween FDA and the foreign facility May be a parent company, business partner, May be a parent company, business partner,

broker, U.S. lawyer, or specialized firm. May not broker, U.S. lawyer, or specialized firm. May not be a mailbox, answering machine, or answering be a mailbox, answering machine, or answering serviceservice

A responsible individual must be physically A responsible individual must be physically presentpresent

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““U.S. Agent”U.S. Agent”

FDA will use “U.S. agent” for routine FDA will use “U.S. agent” for routine communications with foreign facilitycommunications with foreign facility

FDA will contact “U.S. agent” in FDA will contact “U.S. agent” in emergency, emergency, unlessunless other person other person identified as emergency contact on identified as emergency contact on Form 3537Form 3537

““U.S. agent” does not preclude U.S. agent” does not preclude having other agents for business having other agents for business purposespurposes

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U.S. Agent ServicesU.S. Agent Services

Some private firms are offering Some private firms are offering registration and U.S. agent services registration and U.S. agent services for foreign facilities. These firms are for foreign facilities. These firms are notnot affiliated with FDA affiliated with FDA

OFW and The Food Institute have OFW and The Food Institute have teamed up to form USA Food teamed up to form USA Food Agents, LLC to offer this service. Agents, LLC to offer this service. For more information, go to For more information, go to www.usafoodagents.comwww.usafoodagents.com

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Sanctions – Sanctions – Failure To RegisterFailure To Register

Failure to register, update, or cancel is Failure to register, update, or cancel is also a “prohibited act.” FDA may bring also a “prohibited act.” FDA may bring a civil lawsuit to compel registration or a civil lawsuit to compel registration or a criminal prosecution against the a criminal prosecution against the offenderoffender

ButBut, registration violations do , registration violations do notnot render food adulterated or misbranded, render food adulterated or misbranded, and will not be a basis for recall or legal and will not be a basis for recall or legal action once food is in commerceaction once food is in commerce

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Sanctions – Sanctions – Failure To RegisterFailure To Register

Food from a foreign facility that is Food from a foreign facility that is required to register but fails to do so required to register but fails to do so may be refused admission and held may be refused admission and held at port of entry at port of entry It is especially important for foreign It is especially important for foreign

facilities to keep their registrations up-facilities to keep their registrations up-to-date. If import does not match to-date. If import does not match registration information, may have registration information, may have problems at the border problems at the border

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FDA Enforcement Policy FDA Enforcement Policy ––

Compliance Policy Guide Compliance Policy Guide 110.300110.300 During routine inspections, FDA and During routine inspections, FDA and

state inspectors will check to see if state inspectors will check to see if facility registered and if registration facility registered and if registration information is accurateinformation is accurate

For violations, FDA will enforce For violations, FDA will enforce registration “as appropriate in each registration “as appropriate in each situation” situation”

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FDA Enforcement Policy FDA Enforcement Policy ––

CPG 110.300CPG 110.300 FDA District Offices will first send an FDA District Offices will first send an Untitled LetterUntitled Letter

If no response after 30 working days, If no response after 30 working days, FDA will send a Warning LetterFDA will send a Warning Letter

Enforcement action is likely if (a) Enforcement action is likely if (a) continuing failure to register continuing failure to register following issuance of a Warning following issuance of a Warning Letter, or (b) inspection of Letter, or (b) inspection of unregistered facility finds serious unregistered facility finds serious violations of other requirementsviolations of other requirements

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Verification of Verification of RegistrationRegistration

FDA has sent verification notices to FDA has sent verification notices to registered facilities to confirm registered facilities to confirm accuracy of registration informationaccuracy of registration information

FDA also conducted a “surveillance FDA also conducted a “surveillance assignment” around the time of last assignment” around the time of last year’s elections involving inspections year’s elections involving inspections of facilities handling six food of facilities handling six food categories categories

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Compliance InformationCompliance Information

As of January 18, 2005, FDA had As of January 18, 2005, FDA had received registrations for 238,129 received registrations for 238,129 facilitiesfacilities

FDA estimates there are 420,000 FDA estimates there are 420,000 facilities required to register facilities required to register

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ResourcesResources

http://www.fda.gov/oc/bioterrorism/bhttp://www.fda.gov/oc/bioterrorism/bioact.htmlioact.html

Registration Q&A’s: Registration Q&A’s: http://www.cfsan.fda.gov/~dms/ffregui4http://www.cfsan.fda.gov/~dms/ffregui4

.html.html To register a facility, go to: To register a facility, go to:

http://www.access.fda.gov http://www.access.fda.gov

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Thank youThank you

Robert HahnRobert Hahn

rhahn@ofwlaw.comrhahn@ofwlaw.com