Import Alert 72-07

Import Alert # 72-07

Published Date: 11/09/2016

Type: DWPE

"DETENTION WITHOUT PHYSICAL EXAMINATION OF POULTRY JERKY-TYPE PET TREATS DUE TO THE PRESENCE OF ANTIBIOTIC AND/OR ANTIVIRAL RESIDUE(S)"

NOTE: Revision to this Import Alert dated October 27, 2016 is to update the removal from DWPE language. Changes are noted and bracketed by three asterisks (***).

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.

Poultry jerky-type pet treats, generally containing chicken or duck meat, have been associated with clinical illness in dogs and cats for over 10 years. Since 2007, FDA has been sampling and analyzing chicken jerky-type pet treats. These products have primarily originated from China. Over 250 poultry jerky-type pet treats have been analyzed with over 1200 tests to determine potential causes for the renal, gastrointestinal, and other illnesses in dogs.

Trace residues of antibiotics and antivirals were identified in poultry jerky-type treats from China based on investigational analysis by FDA with outside laboratories and FDA regulatory analysis. Antibiotics detected include: sulfaclozine, tilmicosin, trimethoprim, enrofloxacin, and sulfaquinoxaline. Amantadine, an antiviral, has also been detected.

The presence of antibiotics and antivirals in poultry jerky-type pet treats is a concern for the potential safety of the jerky-type treat products for animals. Sulfaclozine, tilmicosin, trimethoprim, and enrofloxacin are not approved for use in poultry. Sulfaquinoxaline, which is approved for use in chickens and turkeys, has a tolerance level of 0.1 ppm, and no finished product should have a residue level above the established tolerance. The antivirals listed below are prohibited for use in poultry including chickens, duck, and turkeys.

Districts may detain, without physical examination, the specified products from the firms listed in the Red List of this import alert.

Districts should submit a recommendation for addition to the Red List when poultry jerky-type pet treat are found through laboratory analysis to contain the antibiotics and/or antivirals listed below. Recommendations for detention without physical examination should be forwarded to the Division of Import Operations (DIO). DIO and FDA’s Center for Veterinary Medicine (CVM) will evaluate regulatory packages on a case-by-case basis.

In order to secure release of an entry that has been detained the importer should provide results of a third-party laboratory analysis, which verifies the product does not contain the following antibiotics and/or antivirals referenced in the Red List or is within an established tolerance level (i.e. sulfaquinaxaline).


Antibiotics

- Sulfaclozine

- Tilmicosin

- Trimethoprim

- Enrofloxacin

- Sulfaquinoxaline

Antivirals

- Amantadine

- Rimantadine

- Memantine

A sample consists of three subsamples (at least 100 g per subsample). From each subsample, prepare three individual portions using only whole pieces. The target weight for a portion is 30 g. If the individual piece is less than 30 g, whole pieces can be combined to obtain the lowest possible sample weight meeting a minimum of 30 g. If the individual piece is greater than 30 g, use that one piece in its entirety. Grind each portion to a powder and store frozen in a whirl-pak or other suitable container until analysis. All nine portions should be prepared and tested individually.

A firm wishing to be removed from detention without physical examination should provide information to FDA that adequately demonstrates that the firm has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance with applicable regulations. FDA recommends a firm requesting removal from detention without physical examination provide the following information:

A. Results of the firm’s investigation(s) into the product failure.

B. Documentation showing corrective action(s) taken in response to the findings of this investigation. This should include, at a minimum:

1) A description of current manufacturing processes which ensure the product is free of non-permitted drug residues; and

2) Verification of the process’s adequacy; and

C. ***For requests to remove products manufactured from one poultry source (i.e.,chicken only)from DWPE, a minimum of five (5) consecutive non-violative commercial shipments must have been offered for import to FDA and subsequently*** released by FDA, based on private laboratory analyses demonstrating the product is free of non-permitted drug residues. ***For requests to remove multiple products representing more than one poultry source (i.e., chicken and duck) from DWPE, a minimum of twelve (12) consecutive non-violative commercial shipments must have been offered for import to FDA and subsequently released by FDA, based on private laboratory analyses demonstrating the products are free of non-permitted drug residues***.

For additional guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual, Chapter 9, Section 9-6, "Detention Without Physical Examination (DWPE)."

A firm, shipper, or importer wishing to request removal from detention without physical examination should forward information supporting its request to FDA at the following address:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or

Via email: Importalerts2@fda.hhs.gov

Requests for removal from detention without physical examination will be reviewed by DIO and referred to CVM for additional evaluation.

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Office of Regulatory Science at (301) 796-6600.

For questions or issues involving import operations, contact DIO’s Import Operations and Maintenance Branch at (301) 796-0356.

For questions or issues involving OASIS or PREDICT screening, contact DCS’s Import Compliance Systems Branch at ORAOISMDSSIMPCOMPLSYSBR@fda.hhs.gov.

Other questions may be directed to CVM, Division of Compliance, Imports Complaint Emergency Recall Team (HFV-230) at (240) 276-9200.

PRODUCTS: Poultry Jerky-Type Pet Treats

PRODUCT CODES:
72B[][]02 Poultry Prod Pet Dog Food
72B[][]99 Pet Dog Food N.E.C.
72F[][]17 Bone, Poultry, Pet Chews (Non-Nutritive)
72F[][]99 Pet Chews (Non-Nutritive), N.E.C.
72G[][]02 Poultry Products, Pet Treats
72G[][]99 Pet Treats, N.E.C

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a new animal drug (or conversion product thereof) that is unsafe within the meaning of Section 512. Product contains.[ADULTERATION, 402(a)(2)(C)(ii)]

OASIS charge code - VETDRUGRES

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)

Desc: Duck Jerky Pet Treats

Notes: Problem; Amantadine

Desc: Duck Jerky Pet Treats

Notes: Problem; Amantadine

Desc: Duck Jerky Pet Treats

Notes: Problem; Amantadine

Desc: Duck Jerky Pet Treats

Notes: Problem; Amantadine

Desc: Chicken Jerky Pet Treats

Notes: Problem;Amantadine

Desc: Chicken Jerky Pet Treats

Notes: Problem; Amantadine

Desc: Duck Jerky Pet Treats

Problems: ENROFLOXACIN;

Desc: Duck Jerky Pet Treats

Problems: ENROFLOXACIN;

Desc: Duck Jerky Pet Treats

Notes: Problem; Amantadine

Desc: Duck Jerky Pet Treats

Notes: Problem; Amantadine

Desc: Duck Jerky Pet Treats

Notes: Problem; Amantadine

Desc: Chicken Breast Jerky

Notes: Problem: Amantadine

Desc: Chicken Breast Jerky

Notes: Problem: Amantadine

Desc: Chicken Jerky Pet Treats

Notes: Problem; Amantadine ;