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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 will help 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 will help FDA to notify facilities that may be affected by the actual or potential threat.
FDA issued a Compliance Policy Guide (CPG) in December 2003 to provide guidance on the agency's strategy for enforcing and achieving compliance with the registration interim final rule. The CPG states that for domestic facilities, FDA intends to focus its initial efforts on educating industry on how to comply with the rule. The CPG provides that circumstances which could merit regulatory action with respect to domestic facilities 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 also may consider the failure to register as an additional charge in an enforcement action that is based on other statutory violations.
For foreign facilities, FDA intends to enforce the registration requirement through prior notice by requiring the registration number of the foreign manufacturer and shipper as part of the prior notice. The prior notice CPG explains the agency's strategy for enforcing and achieving compliance with foreign facility registrations through prior notice. FDA has issued several revisions to the prior notice CPG since its issuance, the most recent of which was on August 12, 2004. See http://www.cfsan.fda.gov/~pn/cpgpn3.html for more details.
FDA estimates that the total number of food facilities that must register is approximately 420,000, approximately half of which are domestic. As of September 17, 2004, FDA had received 221,450 registrations, of which 118,963 are foreign and 102,487 are domestic. The following graph shows the rate of these registrations by date:
As the above graph demonstrates, the rate of registrations leveled off during the middle of December, 2003, around the same time the December 12, 2003 statutory effective date approached and the CPG was issued. To date, FDA has only received a little over half of the approximately 420,000 registrations estimated in the interim final rule. FDA hopes that it has overestimated the number of facilities required to register and that its statement in the CPG regarding enforcement discretion has not resulted in the balance of facilities delaying registering. FDA reiterates that the intent of the enforcement discretion period is to educate facilities on the registration requirement, not to encourage them to delay registering.
The table below shows a country-by-country breakdown of the number of registrations per country (listed in alphabetical order) as of September 17, 2004:
| Country Name | Number of Registrations |
|---|---|
| ALBANIA | 19 |
| ANTIGUA AND BARBUDA | 15 |
| ARGENTINA | 1795 |
| ARMENIA | 57 |
| ARUBA | 13 |
| AUSTRALIA | 2250 |
| AUSTRIA | 497 |
| AZERBAIJAN | 15 |
| BAHAMAS | 50 |
| BANGLADESH | 141 |
| BARBADOS | 48 |
| BELARUS | 30 |
| BELGIUM | 695 |
| BELIZE | 39 |
| BERMUDA | 12 |
| BOLIVIA | 135 |
| BOSNIA AND HERZEGOVINA | 37 |
| BRAZIL | 2361 |
| BULGARIA | 273 |
| BURUNDI | 15 |
| CAMEROON | 33 |
| CANADA | 9363 |
| CAYMAN ISLANDS | 11 |
| CHILE | 2536 |
| CHINA | 9680 |
| COLOMBIA | 1948 |
| COMOROS | 10 |
| COOK ISLANDS | 10 |
| COSTA RICA | 925 |
| CROATIA | 78 |
| CYPRUS | 50 |
| CZECH REPUBLIC | 169 |
| DENMARK | 404 |
| DOMINICA | 28 |
| DOMINICAN REPUBLIC | 483 |
| ECUADOR | 3002 |
| EGYPT | 252 |
| EL SALVADOR | 361 |
| ESTONIA | 60 |
| ETHIOPIA | 122 |
| FAROE ISLANDS | 25 |
| FIJI | 112 |
| FINLAND | 154 |
| FRANCE | 8764 |
| FRENCH POLYNESIA | 40 |
| GEORGIA | 47 |
| GERMANY | 2448 |
| GHANA | 218 |
| GREECE | 577 |
| GREENLAND | 27 |
| GRENADA | 21 |
| GUADELOUPE | 17 |
| GUATEMALA | 676 |
| GUINEA | 42 |
| GUYANA | 157 |
| HAITI | 72 |
| HONDURAS | 487 |
| HONG KONG, CHINA | 1026 |
| HUNGARY | 265 |
| ICELAND | 252 |
| INDIA | 2513 |
| INDONESIA | 995 |
| IRAN (ISLAMIC REPUBLIC OF) | 91 |
| IRELAND | 324 |
| ISRAEL | 573 |
| ITALY | 7558 |
| IVORY COAST | 183 |
| JAMAICA | 364 |
| JAPAN | 15446 |
| JORDAN | 71 |
| KENYA | 177 |
| KOREA,DEMOCRATIC PEOPLES REPUBLIC | 14 |
| KOREA, REPUBLIC OF | 2601 |
| KUWAIT | 14 |
| LATVIA | 72 |
| LEBANON | 144 |
| LIBERIA | 13 |
| LITHUANIA | 109 |
| LUXEMBOURG | 21 |
| MACEDONIA | 53 |
| MADAGASCAR | 52 |
| MALAWI | 38 |
| MALAYSIA | 626 |
| MARTINIQUE | 10 |
| MAURITANIA | 13 |
| MAURITIUS | 33 |
| MEXICO | 7300 |
| MOLDOVA | 36 |
| MOROCCO | 209 |
| MOZAMBIQUE | 18 |
| NAMIBIA | 35 |
| NEPAL | 11 |
| NETHERLANDS | 1013 |
| NETHERLANDS ANTILLES | 22 |
| NEW ZEALAND | 1697 |
| NICARAGUA | 317 |
| NIGERIA | 123 |
| NORWAY | 495 |
| OMAN | 17 |
| PAKISTAN | 218 |
| PANAMA | 376 |
| PAPUA NEW GUINEA | 83 |
| PARAGUAY | 80 |
| PERU | 1091 |
| PHILIPPINES | 909 |
| POLAND | 947 |
| PORTUGAL | 611 |
| REUNION | 18 |
| ROMANIA | 95 |
| RUSSIAN FEDERATION | 798 |
| RWANDA | 13 |
| SAINT KITTS AND NEVIS | 14 |
| SAINT LUCIA | 16 |
| SAINT VINCENT AND THE GRENADINES | 21 |
| SAMOA | 14 |
| SAUDI ARABIA | 40 |
| SENEGAL | 26 |
| SIERRA LEONE | 14 |
| SINGAPORE | 364 |
| SLOVAKIA (Slovak Republic) | 57 |
| SLOVENIA | 62 |
| SOLOMON ISLANDS | 13 |
| SOUTH AFRICA | 877 |
| SPAIN | 3036 |
| SRI LANKA | 301 |
| SURINAME | 21 |
| SWAZILAND | 10 |
| SWEDEN | 224 |
| SWITZERLAND | 621 |
| SYRIAN ARAB REPUBLIC | 77 |
| TAIWAN (CHINA) | 1604 |
| TANZANIA | 60 |
| THAILAND | 1709 |
| TONGA | 27 |
| TRINIDAD AND TOBAGO | 176 |
| TUNISIA | 45 |
| TURKEY | 715 |
| TURKS AND CAICOS ISLANDS | 10 |
| UGANDA | 51 |
| UKRAINE | 319 |
| UNITED ARAB EMIRATES | 125 |
| UNITED KINGDOM | 2116 |
| UNITED STATES | 102,487 |
| URUGUAY | 286 |
| VENEZUELA | 286 |
| VIET NAM | 3111 |
| VIRGIN ISLANDS (BRITISH) | 25 |
| YEMEN | 16 |
| YUGOSLAVIA | 116 |
| ZIMBABWE | 21 |
| Total Registrations | 221,450[1] |
[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.
