IA #12-12 REVISION - 4/17/01

SUBJ:          IMPORT ALERT #12-12, "Detention Without Physical Examination of
               Cheeses Containing Nitrates."

(Note:    This import alert represents the Agency's current guidance to FDA
          field personnel regarding the manufacturer(s) and/or product(s) at
          issue.  It does not create or confer any rights for or on any
          person, and does not operate to bind FDA or the public).

TYPE OF ALERT: Detention without Physical Examination

PRODUCT:       Cheese

PRODUCT CODE:  See Attachment

PROBLEM:       Nitrates

PAF:           FAD (Food Additive)

PAC FOR
COLLECTION:         09006A

COUNTRY:       See Attachment

MANUFACTURERS/
SHIPPER/FEI #: See Attachment

CHARGE:        "The article is subject to refusal of admission pursuant to
               Section 801(a)(3) in that it appears to contain a food
               additive which is unsafe within the meaning of Section 409."
               [Adulteration, Section 402(a)(2)(c)].

OASIS CHARGE
CODE:               UNSAFE ADD

RECOMMENDING
OFFICE:        NYK-DO (HFR-NE152)

REASON FOR
ALERT:         Label review of an entry of pasteurized, part skim, Spiced
               Cheese, found the label to declare "Conserveringsmiddel
               (E251)" (Preservative E251).  Label review of a second entry
               of Spanish Cured, Sheep Milk Cheese, found the label to
               declare "conservante (E252)." Currently the European system
               of naming food additives lists E251 as sodium nitrate and
               E252 as potassium nitrate.  There are no regulations that
               provide for the use of these or other salts of nitrates in
               dairy products including cheeses.  In addition, FDA believes
               that these ingredients are not "generally recognized as
               safe" for their intended uses in cheese.

GUIDANCE:      Districts may detain without physical examination the
               specified products from the firm's identified on the
               attachment for this alert.

               For questions or issues concerning science, science policy,
               sample collection, analysis, preparation, or analytical
               methodology, contact the Division of Field Science at (301)
               443-3320 or 3007.

PRIORITIZATION
GUIDANCE:      I

FOI:           No purging is necessary

KEYWORDS:      Cheese, nitrates, additives

PREPARED BY:   Stella Notzon, Division of Import Operations and Policy,
               HFC-170, 301-443-6553

DATE LOADED
INTO FIARS:         April 17, 2001

                                                Attachment to Import Alert # 12-12

           (Firms/products that may be subject to DWPE)

                           NORWAY (NO)

Firm Name and Address:             Product/PC               Date of DWPE:

Norwegian Dairies Association      Part-Skim Spiced         4/17/01
P.O. Box 9051 Vaterland            Cheese
Oslo 1, Norway                "Nokkel Skorpefri"
FEI # 1000181201                   Nokelost Brand
                              12A- -19


                            SPAIN (ES)


Hijos de Salvador Rodriguez, S.A.  Cured Sheep Milk Cheese  4/17/01
Ctra. de Mozar, Km. 1              El Pastor de Santa Cristina Brand
49620 Sta. Cristina de la Polvorosa     "Queso Zamorano"
Zamora, Spain                 12A- - 52
FEI # 3002973879