2004D-0065 - Guidance for Industry: Questions and Answers Regarding the Interim Final Rule on Prior Notice of Imported Food (Edition 2); Availability
FDA Comment Number : EC10
Submitter : Ms. Yoo DongHee Date & Time: 06/10/2004 05:06:57
Organization : Korea Food and Drug Administration
State Government
Category :
Issue Areas/Comments
Comments on U.S. Bioterrorism Preparedness and Response Act of 2002

- It is very difficult for individuals, except for food expert with a good command in English, to create FDA product code in Prior Notice and almost impossible for traders or related people to know exactly what the HTS code means and choose the right one.

-Different experts could give one item different product codes in the following cases.
- in case where one item can be classified into multiple codes
ex) Potassium Phosphate, a food additive packed in plastic bag, can be classified into the following product code
45HG_99 (emulsifiers and emulsifier salts)
46CG_99 (sequestrants)
46EG_99 (stabilizer)
46IG_99 (texturizer)
45EG_99 (pH control agents)

- Codex classifies potassium phosphate into acidity regulator, sequestrants emulsifier texturizer, stabilizer, water retention agent( CODEX STAN 192-1995(Rev.2 -1999).

- One item, especially well-known food additives including phosphate, sulphite and modified starch can be given different product codes by different people.

-It is difficult to classify Korean traditional food such as soy sauce(kahnjang), soybean paste(doenjang), thick soypaste with red pepper(kochujang).

Even though 21CFR has a code matching a specific food in Option 3- Search Product Name, the matching code cannot be selected.
-When 21CFR133.113(cheddar cheese) is entered, the message pops up 'There were no products matching the search word you entered, cheddar cheese'.

- The FDA says that facility registration is intended for preventing terrorism. However, the FDA doesn't require food manufactured in the U.S to submit the PN. Is there any equivalent to PN registration requirements to domestically manufactured food? If not, it can be regarded as discrimination against food exports.

Risk Assessment for Food Terrorism and Other Food Safety Concerns, http://www.cfsan,fda,gov~dms/rabtact.htm) argues that food can pose risk to the public health. The argument is valid to some extent. However, the case in which imported food poses risk was only one case(Reference 15) among all cases (Reference 13-16) where food creates any risk. On top of that, the risk posed by imported food was not intentional contamination. And there was no case yet where food export/import in the U.S. intentionally causes any food-related risk either.

Because some Korean companies export food in small quantity on each item and, its kind is various, complicated procedure involving registration of all the Korean exports is unnecessary barrier to trade between the two countries.

We doubt that PN of a small quantity of food for the purpose of a present, analysis and exhibition will achieve the goal of protecting the American people from possible food terrorism. Therefore, we ask the requirement of the PN to be eliminated or to be set for de minimus.

The PN should be submitted 5 days prior to food exports' arrival at the arrival port of U.S. however, we recommend that PN submission should be done when shipment of food exports leaves for the U.S, because it takes a long time for the food shipment to arrive at the arrival port, especially by sea.