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U.S. Department of Health and Human Services

Food

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Compliance Information on Food Facility Registration

July 19, 2012

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), section 305, added section 415 to the Federal Food, Drug, and Cosmetic Act, which requires domestic and foreign facilities to register with FDA by December 12, 2003, if they manufacture, process, pack, or hold food for human or animal consumption in the U.S. The purpose of registration is to provide FDA with sufficient and reliable information about food and feed facilities. When used with the administrative detention, recordkeeping, and prior notice provisions in sections 303, 306, and 307, respectively, of the Bioterrorism Act, registration helps provide FDA with information on the origin and distribution of food and feed products and thereby aid in the detection and quick response to actual or potential threats to the U.S. food supply. Registration information also helps FDA to notify facilities that may be affected by the actual or potential threat.

In November, 2004, FDA issued an updated Compliance Policy Guide (CPG) to replace the previous version issued in December, 2003. The updated CPG provides guidance on the agency's strategy for enforcing and achieving compliance with the registration interim final rule. The CPG states that if FDA, or a state agency acting on its behalf, determines that a domestic facility required to register has not registered, or failed to update mandatory elements of the registration, the investigator should note this failure in the establishment inspection report and bring such failure to the attention of the District Compliance Branch. The CPG further states that the field investigator should advise the facility's management of the requirement and provide the facility with a copy of FDA's booklet (dated November 2003), "What You Need to Know About Registration of Food Facilities," which includes the website for electronic registration (www.access.fda.gov) and the address of the FDA office from which a paper copy of the registration form (Form 3537) may be obtained.

The updated CPG states that after November 8, 2004, FDA will enforce the registration provision as appropriate in each situation regarding domestic facilities. Circumstances which could merit regulatory action include a continuing failure to register, and a threat on the food supply that poses a threat of serious adverse health consequences or death to humans or animals. In addition, FDA may also consider the failure to register as an additional charge in an enforcement action that is based on other statutory violations.

For foreign facilities, FDA generally intends to enforce the registration requirement in accordance with the policies set out in CPG 110.310, "Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness Response Act of 2002" (revised November, 2005).

In the preamble to the Registration Final Rule (68 FR 58894 (Oct. 10, 2003), as affirmed by 70 FR 57505 (Oct. 3, 2005)), FDA estimates that the total number of food facilities that must register with FDA is approximately 420,000, approximately half of which are domestic. As of July 17, 2012, FDA had received 449,859 registrations, of which 278,307 are foreign facilities and 171,552 are domestic facilities. The following graph shows the rate of these registrations by date:

Food Registrations - Graph of foreign, domestic, and total food registrations versus date.

FDA has received an estimated 15, 266 more registrations since we issued the previous compliance summary information guide on January 14, 2009. FDA will continue to ensure that all facilities required to register have done so.

The table below shows a country-by-country breakdown of the number of registrations per country (listed in alphabetical order) as of July 19, 2012:

 

Registrations By Country
Country NameNumber of Registrations
AFGHANISTAN37
ALBANIA112
ALGERIA57
ANDORRA2
ANGOLA7
ANGUILLA5
ANTIGUA AND BARBUDA21
ARGENTINA4266
ARMENIA177
ARUBA23
AUSTRALIA4811
AUSTRIA1150
AZERBAIJAN95
BAHAMAS94
BAHRAIN18
BANGLADESH390
BARBADOS76
BELARUS133
BELGIUM1555
BELIZE94
BENIN16
BERMUDA19
BHUTAN10
BOLIVIA, PLURINATIONAL STATE OF552
BOSNIA AND HERZEGOVINA127
BOTSWANA6
BRAZIL5169
BRUNEI DARUSSALAM9
BULGARIA753
BURKINA FASO25
BURUNDI27
CAMBODIA76
CAMEROON113
CANADA16509
CAPE VERDE30
CAYMAN ISLANDS21
CENTRAL AFRICAN REPUBLIC2
CHAD11
CHILE4825
CHINA26743
COLOMBIA3731
COMOROS15
CONGO11
CONGO, THE DEMOCRATIC REPUBLIC OF THE19
COOK ISLANDS12
COSTA RICA1869
COTE D'IVOIRE372
CROATIA278
CURACAO1
CYPRUS142
CZECH REPUBLIC451
DENMARK680
DJIBOUTI11
DOMINICA39
DOMINICAN REPUBLIC1375
ECUADOR5284
EGYPT654
EL SALVADOR1068
EQUATORIAL GUINEA1
ERITREA5
ESTONIA113
ETHIOPIA711
FALKLAND ISLANDS (MALVINAS)9
FAROE ISLANDS31
FIJI257
FINLAND271
FRANCE16162
FRENCH GUIANA4
FRENCH POLYNESIA72
GABON5
GAMBIA26
GEORGIA221
GERMANY4789
GHANA566
GIBRALTAR1
GREECE1702
GREENLAND34
GRENADA53
GUADELOUPE19
GUATEMALA1585
GUINEA231
GUINEA-BISSAU4
GUYANA465
HAITI179
HOLY SEE (VATICAN CITY STATE)1
HONDURAS1191
HONG KONG SAR3307
HUNGARY736
ICELAND391
INDIA6785
INDONESIA2598
IRAN, ISLAMIC REPUBLIC OF414
IRAQ17
IRELAND559
ISRAEL1677
ITALY18383
JAMAICA669
JAPAN28223
JORDAN251
KAZAKHSTAN32
KENYA466
KIRIBATI3
KOREA, DEMOCRATIC PEOPLE'S REPUBLIC OF28
KOREA, REPUBLIC OF8339
KOSOVO6
KUWAIT71
KYRGYZSTAN11
LAO PEOPLE'S DEMOCRATIC REPUBLIC33
LATVIA203
LEBANON397
LESOTHO3
LIBERIA73
LIBYAN ARAB JAMAHIRIYA8
LIECHTENSTEIN4
LITHUANIA298
LUXEMBOURG61
MACAO SAR30
MACEDONIA, THE FORMER YUGOSLAV REPUBLIC OF184
MADAGASCAR169
MALAWI61
MALAYSIA2791
MALDIVES62
MALI30
MALTA29
MARSHALL ISLANDS14
MARTINIQUE22
MAURITANIA35
MAURITIUS79
MEXICO23829
MICRONESIA, FEDERATED STATES OF9
MOLDOVA, REPUBLIC OF162
MONACO25
MONGOLIA25
MONTENEGRO9
MONTSERRAT1
MOROCCO524
MOZAMBIQUE80
MYANMAR11
NAMIBIA74
NEPAL102
NETHERLANDS1930
NETHERLANDS ANTILLES40
NEUTRAL ZONE (IRAQ-SAUDI ARAB)1
NEW CALEDONIA15
NEW ZEALAND2915
NICARAGUA833
NIGER4
NIGERIA530
NIUE3
NORWAY893
OMAN41
PAKISTAN817
PALAU4
PALESTINIAN TERRITORY, OCCUPIED54
PANAMA749
PAPUA NEW GUINEA131
PARAGUAY216
PERU4179
PHILIPPINES1983
POLAND1940
PORTUGAL1638
QATAR7
REUNION29
ROMANIA296
RUSSIAN FEDERATION2839
RWANDA84
SAINT BARTHELEMY1
SAINT KITTS AND NEVIS20
SAINT LUCIA38
SAINT MARTIN2
SAINT VINCENT AND THE GRENADINES43
SAMOA33
SAN MARINO14
SAO TOME AND PRINCIPE2
SAUDI ARABIA239
SENEGAL156
SERBIA221
SEYCHELLES13
SIERRA LEONE60
SINGAPORE905
SINT MAARTEN2
SLOVAKIA118
SLOVENIA233
SOLOMON ISLANDS19
SOMALIA5
SOUTH AFRICA2088
SPAIN7898
SRI LANKA890
SUDAN18
SURINAME38
SWAZILAND13
SWEDEN525
SWITZERLAND1318
SYRIAN ARAB REPUBLIC277
TAIWAN4005
TAJIKISTAN9
TANZANIA, UNITED REPUBLIC OF151
THAILAND4038
TIMOR-LESTE6
TOGO53
TONGA70
TRINIDAD AND TOBAGO324
TUNISIA259
TURKEY2418
TURKMENISTAN5
TURKS AND CAICOS ISLANDS15
UGANDA147
UKRAINE1144
UNITED ARAB EMIRATES517
UNITED KINGDOM4402
UNITED STATES171552
URUGUAY526
UZBEKISTAN66
VANUATU25
VENEZUELA, BOLIVARIAN REPUBLIC OF504
VIET NAM6636
VIRGIN ISLANDS, BRITISH43
WALLIS AND FUTUNA1
WEST BANK8
YEMEN45
YUGOSLAVIA171
ZAMBIA23
ZIMBABWE47
Total Registrations449859[1]

The table below shows a state-by-state breakdown of the number of registrations (listed in alphabetical order) as of July 19, 2012:

 

Domestic Registrations by State
State NameState IdNumber of Registrations
ALABAMAAL1673
ALASKAAK677
AMERICAN SAMOAAS19
ARIZONAAZ2457
ARKANSASAR1518
CALIFORNIACA26654
COLORADOCO2648
CONNECTICUTCT1351
DELAWAREDE399
DISTRICT OF COLUMBIADC273
FLORIDAFL11042
GEORGIAGA4078
GUAMGU70
HAWAIIHI1221
IDAHOID1256
ILLINOISIL7416
INDIANAIN2766
IOWAIA4592
KANSASKS2419
KENTUCKYKY2185
LOUISIANALA1875
MAINEME1235
MARYLANDMD2344
MASSACHUSETTSMA3246
MICHIGANMI4216
MINNESOTAMN3532
MISSISSIPPIMS1177
MISSOURIMO3223
MONTANAMT1025
NEBRASKANE1821
NEVADANV950
NEW HAMPSHIRENH573
NEW JERSEYNJ5750
NEW MEXICONM973
NEW YORKNY10656
NORTH CAROLINANC3532
NORTH DAKOTAND1037
NORTHERN MARIANA ISLANDSMP24
OHIOOH4915
OKLAHOMAOK1762
OREGONOR3272
PENNSYLVANIAPA5888
PUERTO RICOPR1210
RHODE ISLANDRI514
SOUTH CAROLINASC1683
SOUTH DAKOTASD814
TENNESSEETN2194
TEXASTX11576
UNITED STATES MINOR OUTLYING ISLANDSUM1
UTAHUT1226
VERMONTVT657
VIRGINIAVA3078
VIRGIN ISLANDS, U.S.VI59
WASHINGTONWA5663
WEST VIRGINIAWV655
WISCONSINWI4028
WYOMINGWY452
Total Registrations171550[2]

  [1] Under the Bioterrorism Act, the following are not subject to disclosure under 5 U.S.C. 552 (the Freedom of Information Act): FDA's list of specific registered facilities, documents submitted under the registration requirement, and any information derived from such list or registration documents that would disclose the identity or location of a specific registered facility. Thus, to protect the identity of registered facilities, FDA has eliminated from the above list countries from which FDA has received less than ten registrations. However, the number of total registrations reflects all registrations FDA has received.

  [2] Under the Bioterrorism Act, the following are not subject to disclosure under 5 U.S.C. 552 (the Freedom of Information Act): FDA's list of specific registered facilities, documents submitted under the registration requirement, and any information derived from such list or registration documents that would disclose the identity or location of a specific registered facility. Thus, to protect the identity of registered facilities, FDA has eliminated from the above list states from which FDA has received less than ten registrations. However, the number of total registrations reflects all registrations FDA has received.

 


Compliance Policy Guide - Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

Booklet (SECG) - What You Need to Know About Registration of Food Facilities