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Food

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 Name Number of Registrations
AFGHANISTAN 37
ALBANIA 112
ALGERIA 57
ANDORRA 2
ANGOLA 7
ANGUILLA 5
ANTIGUA AND BARBUDA 21
ARGENTINA 4266
ARMENIA 177
ARUBA 23
AUSTRALIA 4811
AUSTRIA 1150
AZERBAIJAN 95
BAHAMAS 94
BAHRAIN 18
BANGLADESH 390
BARBADOS 76
BELARUS 133
BELGIUM 1555
BELIZE 94
BENIN 16
BERMUDA 19
BHUTAN 10
BOLIVIA, PLURINATIONAL STATE OF 552
BOSNIA AND HERZEGOVINA 127
BOTSWANA 6
BRAZIL 5169
BRUNEI DARUSSALAM 9
BULGARIA 753
BURKINA FASO 25
BURUNDI 27
CAMBODIA 76
CAMEROON 113
CANADA 16509
CAPE VERDE 30
CAYMAN ISLANDS 21
CENTRAL AFRICAN REPUBLIC 2
CHAD 11
CHILE 4825
CHINA 26743
COLOMBIA 3731
COMOROS 15
CONGO 11
CONGO, THE DEMOCRATIC REPUBLIC OF THE 19
COOK ISLANDS 12
COSTA RICA 1869
COTE D'IVOIRE 372
CROATIA 278
CURACAO 1
CYPRUS 142
CZECH REPUBLIC 451
DENMARK 680
DJIBOUTI 11
DOMINICA 39
DOMINICAN REPUBLIC 1375
ECUADOR 5284
EGYPT 654
EL SALVADOR 1068
EQUATORIAL GUINEA 1
ERITREA 5
ESTONIA 113
ETHIOPIA 711
FALKLAND ISLANDS (MALVINAS) 9
FAROE ISLANDS 31
FIJI 257
FINLAND 271
FRANCE 16162
FRENCH GUIANA 4
FRENCH POLYNESIA 72
GABON 5
GAMBIA 26
GEORGIA 221
GERMANY 4789
GHANA 566
GIBRALTAR 1
GREECE 1702
GREENLAND 34
GRENADA 53
GUADELOUPE 19
GUATEMALA 1585
GUINEA 231
GUINEA-BISSAU 4
GUYANA 465
HAITI 179
HOLY SEE (VATICAN CITY STATE) 1
HONDURAS 1191
HONG KONG SAR 3307
HUNGARY 736
ICELAND 391
INDIA 6785
INDONESIA 2598
IRAN, ISLAMIC REPUBLIC OF 414
IRAQ 17
IRELAND 559
ISRAEL 1677
ITALY 18383
JAMAICA 669
JAPAN 28223
JORDAN 251
KAZAKHSTAN 32
KENYA 466
KIRIBATI 3
KOREA, DEMOCRATIC PEOPLE'S REPUBLIC OF 28
KOREA, REPUBLIC OF 8339
KOSOVO 6
KUWAIT 71
KYRGYZSTAN 11
LAO PEOPLE'S DEMOCRATIC REPUBLIC 33
LATVIA 203
LEBANON 397
LESOTHO 3
LIBERIA 73
LIBYAN ARAB JAMAHIRIYA 8
LIECHTENSTEIN 4
LITHUANIA 298
LUXEMBOURG 61
MACAO SAR 30
MACEDONIA, THE FORMER YUGOSLAV REPUBLIC OF 184
MADAGASCAR 169
MALAWI 61
MALAYSIA 2791
MALDIVES 62
MALI 30
MALTA 29
MARSHALL ISLANDS 14
MARTINIQUE 22
MAURITANIA 35
MAURITIUS 79
MEXICO 23829
MICRONESIA, FEDERATED STATES OF 9
MOLDOVA, REPUBLIC OF 162
MONACO 25
MONGOLIA 25
MONTENEGRO 9
MONTSERRAT 1
MOROCCO 524
MOZAMBIQUE 80
MYANMAR 11
NAMIBIA 74
NEPAL 102
NETHERLANDS 1930
NETHERLANDS ANTILLES 40
NEUTRAL ZONE (IRAQ-SAUDI ARAB) 1
NEW CALEDONIA 15
NEW ZEALAND 2915
NICARAGUA 833
NIGER 4
NIGERIA 530
NIUE 3
NORWAY 893
OMAN 41
PAKISTAN 817
PALAU 4
PALESTINIAN TERRITORY, OCCUPIED 54
PANAMA 749
PAPUA NEW GUINEA 131
PARAGUAY 216
PERU 4179
PHILIPPINES 1983
POLAND 1940
PORTUGAL 1638
QATAR 7
REUNION 29
ROMANIA 296
RUSSIAN FEDERATION 2839
RWANDA 84
SAINT BARTHELEMY 1
SAINT KITTS AND NEVIS 20
SAINT LUCIA 38
SAINT MARTIN 2
SAINT VINCENT AND THE GRENADINES 43
SAMOA 33
SAN MARINO 14
SAO TOME AND PRINCIPE 2
SAUDI ARABIA 239
SENEGAL 156
SERBIA 221
SEYCHELLES 13
SIERRA LEONE 60
SINGAPORE 905
SINT MAARTEN 2
SLOVAKIA 118
SLOVENIA 233
SOLOMON ISLANDS 19
SOMALIA 5
SOUTH AFRICA 2088
SPAIN 7898
SRI LANKA 890
SUDAN 18
SURINAME 38
SWAZILAND 13
SWEDEN 525
SWITZERLAND 1318
SYRIAN ARAB REPUBLIC 277
TAIWAN 4005
TAJIKISTAN 9
TANZANIA, UNITED REPUBLIC OF 151
THAILAND 4038
TIMOR-LESTE 6
TOGO 53
TONGA 70
TRINIDAD AND TOBAGO 324
TUNISIA 259
TURKEY 2418
TURKMENISTAN 5
TURKS AND CAICOS ISLANDS 15
UGANDA 147
UKRAINE 1144
UNITED ARAB EMIRATES 517
UNITED KINGDOM 4402
UNITED STATES 171552
URUGUAY 526
UZBEKISTAN 66
VANUATU 25
VENEZUELA, BOLIVARIAN REPUBLIC OF 504
VIET NAM 6636
VIRGIN ISLANDS, BRITISH 43
WALLIS AND FUTUNA 1
WEST BANK 8
YEMEN 45
YUGOSLAVIA 171
ZAMBIA 23
ZIMBABWE 47
Total Registrations 449859[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 Name State Id Number of Registrations
ALABAMA AL 1673
ALASKA AK 677
AMERICAN SAMOA AS 19
ARIZONA AZ 2457
ARKANSAS AR 1518
CALIFORNIA CA 26654
COLORADO CO 2648
CONNECTICUT CT 1351
DELAWARE DE 399
DISTRICT OF COLUMBIA DC 273
FLORIDA FL 11042
GEORGIA GA 4078
GUAM GU 70
HAWAII HI 1221
IDAHO ID 1256
ILLINOIS IL 7416
INDIANA IN 2766
IOWA IA 4592
KANSAS KS 2419
KENTUCKY KY 2185
LOUISIANA LA 1875
MAINE ME 1235
MARYLAND MD 2344
MASSACHUSETTS MA 3246
MICHIGAN MI 4216
MINNESOTA MN 3532
MISSISSIPPI MS 1177
MISSOURI MO 3223
MONTANA MT 1025
NEBRASKA NE 1821
NEVADA NV 950
NEW HAMPSHIRE NH 573
NEW JERSEY NJ 5750
NEW MEXICO NM 973
NEW YORK NY 10656
NORTH CAROLINA NC 3532
NORTH DAKOTA ND 1037
NORTHERN MARIANA ISLANDS MP 24
OHIO OH 4915
OKLAHOMA OK 1762
OREGON OR 3272
PENNSYLVANIA PA 5888
PUERTO RICO PR 1210
RHODE ISLAND RI 514
SOUTH CAROLINA SC 1683
SOUTH DAKOTA SD 814
TENNESSEE TN 2194
TEXAS TX 11576
UNITED STATES MINOR OUTLYING ISLANDS UM 1
UTAH UT 1226
VERMONT VT 657
VIRGINIA VA 3078
VIRGIN ISLANDS, U.S. VI 59
WASHINGTON WA 5663
WEST VIRGINIA WV 655
WISCONSIN WI 4028
WYOMING WY 452
Total Registrations 171550[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

Page Last Updated: 09/18/2015
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