CSMS Message: 95-000090

SUBJECT: FDA LOW VALUE SHIPMENTS

THIS MESSAGE IS TO PROVIDE ADDITIONAL INFORMATION REGARDING
LOW VALUE SHIPMENTS OF SELECTED MERCHANDISE SUBJECT TO FDA
REGULATION. THE CHANGE IN REPORTING REQUIREMENTS FOR THESE
SHIPMENTS WAS FIRST OUTLINED IN ADMINISTRATIVE MESSAGE 94-1260,
ISSUED ON DEC 15, 1994.

THE REVISED REQUIREMENTS OUTLINED IN ADMIN MESSAGE 94-1260
PRIMARILY APPLY TO ENTRIES NOT FILED THROUGH THE FDA INTERFACE,
ALTHOUGH THE DISCUSSION ON CATEGORIES OF LOW-VALUE PRODUCTS
APPLIES TO BOTH INTERFACE AND NON-INTERFACE ENTRIES.

LOW VALUE ENTRIES MAY BE GROUPED INTO THE FOLLOWING CATEGORIES:

1) THE CATEGORY MENTIONED IN ADMIN 94-1260, WHICH
ADDRESSES ENTRIES THAT MEET CERTAIN FDA AND CUSTOMS
REQUIREMENTS WHERE "NO" ELECTRONIC (ABI) DATA OR PAPER
DOCUMENTATION IS NECESSARY FOR FDA OR CUSTOMS PURPOSES.
THIS MERCHANDISE IS USUALLY REFERRED TO AS "SECTION 321"
CARGO.

2) THE SECOND CATEGORY WOULD INCLUDE LOW-VALUE CARGO NOT
OTHERWISE ELIGIBLE FOR RELEASE UNDER SECTION 321 OF THE
CUSTOM REGULATIONS AND WOULD BE REPORTED VIA REGULAR
ENTRY PROCEDURES. IF THESE ARE TRANSMITTED TO ABI WITH
TWO ADDITIONAL FDA ELEMENTS AND ONE OF THE APPROPRIATE
AFFIRMATION OF COMPLIANCE CODES DESCRIBED BELOW, A HIGHER
RATE OF "MAY PROCEEDS" MAY BE ACCORDED SUCH ENTRIES THAN
IS CURRENTLY IN EFFECT.

THERE ARE FIVE NEW AFFIRMATION OF COMPLIANCE CODES WHICH DESCRIBE
THESE SHIPMENTS.

A) FOR CERTAIN FOODS/COSMETICS/DINNERWARE: (AS DESCRIBED IN
ADMIN # 94-1260)
A OF C FDA VALUE REQUIREMENTS
-------- --------------------------------------
LF1 FDA ENTRY VALUE LESS THAN OR EQUAL TO $200
LF2 FDA ENTRY VALUE GREATER THAN $200 AND LESS
THAN OR EQUAL TO $500
LF3 FDA ENTRY VALUE GREATER THAN $500 AND LESS
THAN OR EQUAL TO $1000

B) FOR CERTAIN NON-MEDICAL RADIATION EMITTING ARTICLES:(AS DESCRIBED
IN ADMIN #
A OF C FDA VALUE REQUIREMENTS 94-1260)
-------- --------------------------------------
LR1 FDA ENTRY VALUE LESS THAN OR EQUAL TO $200
LR2 FDA ENTRY VALUE GREATER THAN $200 AND LESS
THAN OR EQUAL TO $1000

NOTE: THE "FDA ENTRY VALUE" REFERS TO THE PORTION OF THE ENTRY
WHICH IS REGULATED BY FDA, (AS FLAGGED WITH AN FD1 OR FD2)
NOT THE TOTAL VALUE OF THE ENTRY. IN ADDITION, THE FDA
VALUE CAN BE BROKEN DOWN INTO THE 2 CATEGORIES LISTED
ABOVE (A: CERTAIN FOODS/COSMETICS/DINNERWARE AND B: CERTAIN
NON-MEDICAL RADIATION EMITTING ARTICLES). THESE FDA VALUES
SHOULD BE TOTALED SEPARATELY WHEN DETERMINING WHICH
AFFIRMATION OF COMPLIANCE CODE CAN BE USED. IN ONE ENTRY,
THE FDA VALUE OF CERTAIN FOODS MAY ADD UP TO $1200 DOLLARS,
ELIMINATING THOSE FDA FOOD LINE ITEMS FROM USING THE "LF3"
AFFRIMATION CODE, BUT THE FDA VALUE OF THE NON-EMITTING
RADIATION ARTICLES MAY TOTAL ONLY $400 DOLLARS AND THE "LR2"
CODE CAN STILL BE USED.

ABI FILERS WHO USE ONE OR MORE OF THE ABOVE AFFIRMATION OF
COMPLIANCE CODES, ALONG WITH AN APPROPRIATE FDA VALUE, QUANTITY
AND UNIT OF MEASURE, WILL BE ELIGIBLE FOR A SIGNIFICANTLY
HIGHER PERCENTAGE OF "FDA MAY PROCEED" SELECTIVITY RESULTS THAN
IS CURRENTLY AVAILABLE. THE USE OF THESE NEW CODES IS
ENTIRELY VOLUNTARY AT THE DISCRETION OF THE FDA PARTICIPANT
AND DOES NOT IMPACT OTHER FDA REPORTING CURRENTLY BEING DONE
THROUGH ABI.

FILERS MUST TRANSMIT APPROPRIATE LINE VALUE AND QUANTITY
DATA IN ORDER FOR THE INTERFACE TO PROCESS THE ABOVE
AFFIRMATION OF COMPLIANCE CODES.

FOR MULTI-LINE ENTRIES, THE CORRECT CODE FOR EACH QUALIFYING
LINE WILL BE THE ONE WHICH APPLIES TO THE FDA VALUE FOR THE
CATEGORY THAT APPLIES TO THE PRODUCT.
FOR EXAMPLE:

ENTRY LINE 1 - FDA VALUE $250 PRODUCT - FOOD
ENTRY LINE 2 - FDA VALUE $530 PRODUCT - DINNERWARE
ENTRY LINE 3 - FDA VALUE $280 PRODUCT - COSMETICS
ENTRY LINE 4 - FDA VALUE $300 PRODUCT - CD PLAYER
ENTRY LINE 5 - FDA VALUE $150 PRODUCT - MICROWAVE OVEN

FOR THIS HYPOTHETICAL ENTRY, LINES 1, 2, AND 3 HAVE AN FDA
VALUE OF $1060, WHICH IS OVER THE $1000 LIMIT FOR THE
FOOD/COSMETICS/DINNERWARE CATEGORY, THUS NONE OF THESE THREE
LINES MAY BE TRANSMITTED WITH ANY OF THE THREE LF1, LF2, OR
LF3 AFFIRMATION OF COMPLIANCE CODES, EVEN THOUGH LINES 1 AND
3 WOULD APPEAR TO QUALIFY AS LF2 AND LINE 2 APPEARS TO QUALIFY
FOR CODE LF3. IT IS THE TOTAL VALUE, BY CATEGORY, WHICH
DETERMINES THE AFFIRMATION OF COMPLIANCE CODE THAT WILL APPLY
TO EACH LINE IN THAT CATEGORY.

CONTINUING WITH THE EXAMPLE, LINES 4 AND 5 FALL INTO THE
CATEGORY OF NON-MEDICAL RADIATION EMITTING DEVICES.
THE FDA VALUE FOR THIS CATEGORY IS $450, WHICH WOULD QUALIFY
BOTH LINES TO USE AFFIRMATION OF COMPLIANCE CODE LR2, EVEN
THOUGH IT APPEARS THAT LINE 5 SHOULD TAKE CODE LR1, SINCE ITS
VALUE IS UNDER $200.

FDA RESERVES THE RIGHT TO PERIODICALLY SPOT CHECK ENTRIES
WHICH RECEIVE "MAY PROCEED" UNDER THIS NEW PROGRAM TO VERIFY
THE ACTUAL FDA VALUE OF THE IMPORTED ARTICLES.

IT IS IMPORTANT TO NOTE THAT ONLY LOW VALUE SHIPMENTS WHICH
MEET FDA'S LOW VALUE ELIGIBILITY REQUIREMENTS SHOULD BE
FILED THROUGH ABI WITH THESE NEW AFFIRMATION OF COMPLIANCE CODES.

IMPORTANT:
----------
AS OF JANUARY 1, 1995, FDA HAS DISABLED THE AFFIRMATION
OF COMPLIANCE CODES OF "PFS" AND "PRD". FILERS SHOULD
DISCONTINUE USING THOSE 2 CODES AND BEGIN USING THE NEW
CODES LISTED ABOVE, IF APPLICABLE.

IF YOU HAVE ANY QUESTIONS PLEASE CALL YOU LOCAL FDA CONTACT.

Referenced By

CSMS #17-000388