IA #72-03 - REVISION - 6/9/00, IMPORT ALERT #72-03, "DETENTION WITHOUT
PHYSICAL EXAMINATION AND INTENSIFIED COVERAGE OF PIG EARS *** AND OTHER PET
TREATS *** DUE TO THE PRESENCE OF SALMONELLA," ATTACHMENT - 10/28/04
NOTE: The text of this import alert is being revised to include the
criteria for removal from detention without physical examination (DWPE).
This information should be used by districts for inquiries from industry
regarding removal from DWPE. New information is bracketed by asterisks
(***).
TYPE OF ALERT: Detention without Physical Examination and Intensified
Coverage
(Note: This import alert represents the Agency's current guidance
to FDA field personnel regarding the manufacturer(s) and/or products(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).
PRODUCTS: Pig ear dog chews or pet treats
PRODUCT
CODE: 72B[][]01, 70M[][]99, 70Y[][]99 (Dog Food)
72B[][]05 (Dog Chews, Dog Food)
72B[][]99 (Dog Treats)
PROBLEM: Salmonella
PAF: MIC (microbiological contamination)
PAC FOR
COLLECTION: 71V017
COUNTRY: See Attachment
MANUFACTURERS/
SHIPPER
FEI: See Attachment
CHARGE: "The article is subject to refusal of admission pursuant to
Section 801(a)(3) of the FD&C; Act in that it appears to contain a
poisonous and deleterious substance, namely Salmonella, which may
render it injurious to health [Adulteration, 402(a)(1)]."
OASIS CHARGE
CODE: BACTERIA
RECOMMENDING
OFFICE: CVM, Division of Compliance (HFV-230)
Division of Import Operations and Policy (HFC-170)
REASON FOR
ALERT: In September 1999, FDA learned that 30 cases of Salmonella
infantis in Canada were strongly associated with pig ear dog
treats. All affected individuals are dog owners. Many of the
cases have been children.
Rollover Brand pig ear dog treats, manufactured by Farm Meats
Canada, Ltd., High River, Alberta, Canada had been determined to
be the most likely source of contamination. An inspection was
conducted at Farm Meats Canada, Ltd. by Canadian health
authorities. Multiple positive samples were found in the plant.
Analysis also identified a PFGE (Pulsed Field Gel Electrophoresis)
match to an opened box in a home of a dog owner (1 band
difference) with samples taken at the plant. Additional product
from other homes, phage type matches.
Farm Meats Canada, Ltd., has recalled the product from the
Canadian marketplace. A safety alert issued by the Canadian Food
Inspection Agency (CFIA) on September 24, 1999, advised that the
elderly, children and persons with weakened immune systems should
avoid handling the pig ear dog treats.
Further, other Canadian companies have been under investigation by
the Canadian Food Inspection Agency (CFIA). Samples from Euro Can
Manufacturing Inc. (Pet Products), collected on September 13,
1999, and analyzed by Health Canada, have been found positive for
Salmonella. Euro Can Manufacturing and Farm Meats have recalled
their pig ear dog treats in Canada. On September 25, 1999 the
CFIA issued a safety alert on Euro Can pet chews.
Review of OASIS data indicates that both firms have routinely
shipped products to the U.S.
FDA and CDC are not aware of any cases of Salmonella in the U.S.
that have been linked to pig ear dog treats; however, CDC has
notified state health departments so they can ask about possible
exposure to pig ear dog treats.
GUIDANCE: Detain without physical examination the identified pet treat
products from the manufacturers named in the attachment to this
import alert.
Intensified coverage of pet treats from other Canadian
manufacturers or manufacturers in other countries appears
warranted. Entries identified as pet treats, chews, etc. should be
examined to determine if they are in fact pig ear dog treats or
other products subject to detention without physical examination.
Samples collected and found positive for Salmonella should be
reported to John Young, CVM, Division of Compliance (HFV-230) at
301-594-1791. Recommendations for detention without physical
examination for firms not listed on the attachment should be
forwarded to DIOP.
For questions or issues concerning science, science policy, sample
collection, analysis, preparation, or analytical methodology,
contact the Division of Field Science at (301) 827-7605.
***In order to fully evaluate whether the problem of Salmonella in
pet treats has been corrected, CVM is requiring the following
information from those firms requesting removal from detention
without physical examination:
1. The firm must provide evidence that the it has identified
the source of the problem and has taken appropriate steps to
prevent future occurrences. This should be documented by:
a. Results of the firm=s investigation(s) into the
problem of Salmonella contamination
b. Documentation showing corrective action(s) This
should include at a minimum:
1) a description of the current process(es)being used;
2) verification that the process is adequate;
and
3) measures that have been taken to prevent
recontamination.
c. Copies of three (3) production records showing at a
minimum, the process, quantities processed, lot numbers and
dates of processing,
AND
2. For requests for removal of a single product, using the
current process, documentation showing that a minimum of
five(5)consecutive, non-violative shipments have been released
based on private laboratory analyses. Requests to remove
multiple products from a manufacturer will require a minimum of
twelve (12) non-violative shipments representative of products
covered by detention without physical examination.
All requests for removal from DWPE should be forwarded to DIOP
(HFC-170) which in turn will forward the requests to CVM for
evaluation.***
PRIORITIZATION
GUIDANCE: I
FOI: No purging is necessary
KEYWORDS: Pig ears, Dog, Treats, Chews
PREPARED
BY: Linda Wisniowski and Stella Notzon, Division of Import Operations
and Policy, HFC-170
DATE LOADED
INTO FIARS: June 9, 2000
Attachment for Import Alert# 72-03
Firms recommended for Detention Without Physical Examination 10/28/04
ARGENTINA
Firm Name and Address DWPE Date Product
Transuniversal S.A.C.Y.F. 2/25/04 Pet Chew
Av Cordoba 1505 72B[][]01, 72B[][]99
5th Fl. Appt. 9 72B[][]05, 70M[][]99
Buenos Aires 70Y[][]99, 71A[][]05
Argentina 71B[][]99
FEI# 3003644846
BRAZIL (BR)
Firm Name and Address DWPE Date Product
Kelco Sul Alimentos E 12/20/99 Smoked Cow Ears
Racoes Ltda 72B[][]99
Rua Pinto Bandeira, 95
Esteio-Rs, Brazil
FEI# 3000183866
Raul Sander & Cia Ltda. 09/17/03 Beef Dog Chews
Rua Santo Agostinho 915 72E[][]99
Sao Leopoldo RS
Brazil, 93025-700
FEI# 3004005130
CANADA (CA)
Firm Name and Address DWPE Date Product
3 Kuz Foods Inc. 10/15/01 Pig Ears
Aliments 3 Kuz Inc. 72B[][]99/72B[][]01
165 Bouthillier Street 70M[][]9/70Y[][]99
St. Jean Sur Richelieu 72B[][]05/72A[][]99
Quebec, Canada J3B 5Y8
FEI # 3003292751
Aron Pet Food (Western) Ltd. 12/9/99 Dog Chews (Pizzles)
19323 94th Avenue #B5 72B--01
Surrey, B.C., Canada V4N 4S1
FEI# 3000126281
Distinctive Pet Products, Inc.* 01/5/00 Pig Ears-Strips
1870 Mclean 72B[][]01
Port Coquitlam, B.C.
Canada V3C 1N2 *Formerly - Great Canadian Pet Treat Co.
FEI#: 3002842682
Hub Meat Packers Ltd. 10/25/99 Pig Ears
144 Edinburgh Dr.
Moncton, New Brunswick, Canada
E1E 2K7
FEI # 3000175382
IVE Group Inc. 2/22/00 Pig Ears
5456 Tomken Road, Unit #12
Mississauga, Ontario, Canada L4W 2Z5
FEI# 3002876882
CHINA (CN)
Pingyang Kongying Pet Products 10/7/02 Dog chew (cattle bone with
Co. Ltd. leather strap)
80 Hubin Road Shuitou 72B[][]01
Pingyang, Zhejiang Province, 70M[][]99
China 70Y[][]99
FEI #3003519794 72B[][]05
72B[][]99
71A[][]99
Pingyang Pet Leather Manufacture 12/28/01 Chicken Jerky
Factory Dog Chew and
Dongmen Rd., Nanyan Town Chicken Jerky
Zhejiang Province, Bleached Pressed
Pingyang, China Bone Dog Chew
FEI # 3003095890 72B[][]01/70M[][]99/
70Y[][]99/72B[][]05/
72B- - 99
Sino Goal Tianjin Pet Products Co. 2/10/03 Pork Hide Dog Treats
125-127 Weidi Road Room 1608-1609 (Piggy Rope Bone)
Hexi District, Tianjin, 300074 72B[][]99
Peoples Republic of China
FEI #3003526304
GERMANY (DE)
Firm Name and Address DWPE Date Product
Poske GmBH & Co. Kg 5/29/02 Pig Ears
Lunort 5 72B- - 99/72B- - 01
49586 Neuenkirchen, Germany 72E- - 99/70M- - 99
FEI # 3001182360 70Y- - 99/72B- - 05
72A- - 99
Atico Int'l Ltd. 4/13/04 Rawhide Dog Chew
G/F-2/F Hunghom Bay Centre "Holiday Accessories"
22-24 Hunghom Wan Street 72B[][]99
Hunghom kowloon
Hong Kong
FEI# 1000569734
KOREA, REPUBLIC OF (KR)
Firm Name and Address DWPE Date Product
Dai Sung Company 4/21/00 Dried Pig Ears
153-1 Muji Dong
Sihung City, Korea
FEI# 3000193382
MEXICO (MX)
FIRM DWPE PRODUCT/CODE
Abastecedores Pecuarios 10/28/04 Raw Hide Scrap
Lozano S.A. De C.V. 70Y -99
Carretera San Luis 71A -99
Rioverde KM 72B -99
6.5 C.P.78394
San Luis Potosi, Mexico
FEI# 3000255353
NEW ZEALAND (NZ)
Firm Name and Address DWPE Date Product
Progressive Processors Limited 3/13/00 Dog chews
37 Howell Street
Taneatua, New Zealand
FEI# 1000586988
Dairy Meats NZ Limited 3/13/00 Dog chews
6 Leek Street
P.O. Box 2240
Aucklund, NZ
FEI# 1000262560
PARAGUAY (PY)
Firm Name and Address DWPE Date Product
Dennis J. Fraser 4/13/00 Dog Chews
Aca Caraya 595
Asuncion, Paraguay
FEI #3002529865
PORTUGAL(PT)
Luso Petisco Productos 03/14/03 Dried Pig Ear Pet Treats
Carneos, S.A. 72B[][]99
Zona Industrial, Lote 1 3520-095 72B[][]05
Nelas, Portugal 72B[][]01
FEI #3003431940 70M[][]99
70Y[][]99
71A[][]99
SPAIN (ES)
Firm Name and Address DWPE Date Product
Sedealca 10/4/00 Dried Pig Ears
Miramar 1-3 Roda de Para 4388
Tarragona, Spain
FEI #3002354233
TAIWAN (TW)
Firm Name and Address DWPE Date Product
Fong Yuan Leather Co., Ltd 11/29/00 Rawhide dog chews
No. 1-6 Ho Chuang Ho Mou 72B--05
Village Chung Pao, Taiwan
FEI #3000199927
THAILAND (TH)
Firm Name and Address DWPE Date Product
Birds Eye View Co. Ltd. 11/23/01 Raw Hide Dog Chews
486/62-63 Soi Charoennakorn 16 72B[][]05
Charoennakorn Rd., Klongsarn 72B[][]99
Bangkok 10600 Thailand 72B[][]01
FEI #3003452320
Bura Rak Tannery Co., Ltd 7/15/03 Rawhide Dog Chews
429 Moo 1 SOI K.M. 30 72B[][]01
Sukhumvit Road 72B[][]05
Tambol Taiban Amphur Muang 72B[][]99
Samutprakarn 10280 Thailand
FEI #3002583370
Khon Kaen Tanner Group Ltd 2/25/04 Rawhide Dog Chew
9 Moo 9 Mitraparb Hwy. 72B[][]01, 72B[][]99
Khon Kaen 72B[][]05, 70M[][]99
Thailand 70Y[][]99, 71A[][]05
FEI# 3002553272 71B[][]99
Santa's Hall Int'l Ltd. 4/13/04 Rawhide Dog Chew
62/1 M003 "Holiday Accessories"
SOT Sornthong 72B[][]99
Phetkasem 91 Rd.,
Omnoi, Kratumbaen
Samutsakorn 74130
Thailand
FEI# 3004504926
Thip Pioneer Products Co., Ltd. 2/5/02 Rawhide Moccasin Dog
657/162 Mooban Pricha, 3, Treats/Chews
Patanakarn 72B[][]01/72B[][]05
Bangkok, Thailand 72B[][]99
FEI #1000546961
VENEZUELA (VE)
Firm Name and Address DWPE Date Product
Gol-Can, S.A. 12/17/99 Pig Ears
Calle 66A, APTO 5A 72B- - 99
Edificio Dominican
Maracaibo, Venezuela 5/3/00 Dog Chews
FEI # 3002522785 (rawhide sticks)
Promoto Auropiel 6/8/00 Rawhide Dog Chews
Carretera Pan Americana Km 21
Sector Taria, Yaracuy
Venezuela
FEI #3003028164