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 - 6/17/08
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 Jack Geltman, CVM, Division of Compliance,
HFV-232, at (240)276-9203. 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. For questions regarding, or
clarification of the requirements for, removal from DWPE,
contact Jack Geltman, CVM, Division of Compliance, HFV-232,
at (240) 276-9203. ***
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 6/17/08
ARGENTINA
Firm Name and Address DWPE Date Product
San Isidro Pets S.A. 2/16/05 Dried Steer Penis
Lavalle 353, 5th Floor Pet Chews
Buenos Aires 72B[][]99, 72E[][]99
Argentina
FEI# 3004468421
(MANUFACTURER)
Segata y Cia. S.R.L. 10/3/06 Dog Chews
Murguiondo 2678 (Lamb Lungs, Bull Penises)
Buenos Aires 72B[][]99
Capital Federal 1470 72E[][]99
Argentina
FEI# 3004008724
(SHIPPER)
Proalde S.A.
Venezuela 1689
Buenos Aires
Capital Federal 1096
Argentina
FEI# 3004632243
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
Primo Schincariol Industria 7/25/05 Bacon Basted Small
de Cervejas e Refrigerantes SA Rawhide Bones
Av. Primo Schincariol, 2300 72B[][]01
Itu (City) 72B[][]99
Sao Paulo 70Y[][]99
Brazil
FEI# 3004252266
RCM Industria e Comercio Ltd. 2/13/08 Rawhide Dog Chews
Rua Sao Domingos 501, Quintas (Pizzles)
Natal 72B[][]99
Brazil 72B[][]01
FEI# 3004300694 72B[][]05
2000008649
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[][]99/70Y[][]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
Orviande Inc. 5/16/05 Pig ears
11151 Rue Mirabeau 72B[][]99
Anjou, Quebec, Canada H1J 2S2
FEI# 1000351252
CHILE (CL)
DWPE
FIRM NAME AND ADDRESS DATE PRODUCT/PRODUCT CODE
Sociedad Agroindustrial El 3/3/06 PIG EARS PET TREAT
Barrancon Ltda. 72B[][]99
El Barrancon 2526 San Bernardo
Santiago, Chile
FEI# 3004402068
SHIPPER
Comercial Movimento Ltda
Nueva Central 4473
Santiago, Chile
FEI# 3004136300
CHINA (CN)
DWPE
FIRM NAME AND ADDRESS DATE PRODUCT/PRODUCT CODE
Dalian Lovepet 6/17/08 Dried Chicken Jerky
Trading Co., Ltd Pet. Treat/pet chews
No. 10 Benxi Street 72B[][]02
E&T Development Zone 72B[][]99
Dalian, Liaoning China
FEI #3005765368
Fuzhou Eden Toys Co. Ltd. 2/25/05 Rawhide Dog Chews
A30A, 30th Floor 72B--99
Fujian Golden Bridge Plaza No.8 71A--99 72E--99
Dong Da Road, Fuzhou 72B--05
China
FEI# 3004660846
Jiujiang Huaheng Leather 7/25/05 Chicken Breast Dog Treats
& Plastic Co., Ltd. 72B[][]02
North Area Ruichang 72B[][]99
Golden Industry District 70Y[][]99
Jiujiang (City)
Jiangxi (Province)
China
FEI# 3004332793
Pingyang Huaxing Leather 2/6/08 Munchy Donuts on
& Plastic Co., Ltd. Knot Rope
No. 13 Nange Rd., 72B[][]99, 72E[][]99,
Leather Manufacturing Zone 72B[][]05
Tenjiao, Pingyang County
Zhejiang Province
Wenzhou, China
FEI# 3004264849
Pingyang Jinhua Pet Products 2/15/06 Rolled Pork Skin
Co. Ltd. 72B[][]01
No. 1 Jingshan Industrial Area 72B[][]99
Shuitou Town, Pingyang 72Y[][]99
Zhejiang, China
FEI# 3004347154
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
Pingyang Pet Product Co. (Factory) 5/6/05 Chicken Jerky Strips
Xiazhai Rd., Xiaojiang 70Y[][]99
Pingyang, Zhejaing ***71A[][]01
Zhejiang (Province), China ***71A[][]05
FEI# 3004331518 ***71E[][]02
***71E[][]99
AND ***71Y[][]99
72B[][]02
72B[][]99
2/9/06 Rawhide Chicken Basted
Twist Sticks
72B[][]02
72B[][]99
72Y[][]99
Headquarters for the above factory:
Shanghai Bestro Enterprises Inc. 8/29/07 Chicken Jerky Strips
258 Gaozianghuan Road 70Y[][]99
Gaodong Industrial Zone, Pudong ***71A[][]01
Shanghai, China ***71A[][]05
FEI# 3005299066 ***71E[][]02
FEI# 3006238093 ***71E[][]99
***71Y[][]99
72B[][]02
72B[][]99
Pingyang Pet Toys Industrial Co. 5/4/06 Pet Treats
Siqian Shuitou Town, Pingyang County 72B[][]05
Wenghou, Zhejiang, China 72B[][]99
FEI# 3004273178
FEI# 3005151080
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
Tianjin Guangyuan Electric 1/10/06 Chicken Breast Strips
Project Co., Ltd. Dog Chews
Rm 2801, Tianjin River 72B[][]02/72B[][]99
Front Square 72E[][]99
No 81-11 Jing Road 70Y[][]99
Tianjin, Tianjin, China
FEI# 3004598995
Weifang Meicheng Foodstuffs 7/25/05 Roasted Chicken Strips
No. 278 Baotong Street (Dog Chews)
Weifang City 72B[][]02
Shandong 72B[][]99
China 70Y[][]99
FEI# 3004634866
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
Wilhelm Naumann 2/25/05 Rawhide Rollups Pet Treat
Postfach 5161 72B[][]99 71A[][]99
Iserlohn 72E[][]99 72B[][]05
Germany
FEI# 3002977630
Hong Kong (HK)
Firm Name and Address DWPE Date Product
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
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
Sua International S.A. de C.V 9/23/05 Deer Antlers
Carretera International, Km 3.5 72B[][]99
C/La Victoria
Hermosillo
Sonora, Mexico
FEI# 3004590837
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
Pet Supply S.A. 2/25/05 Rawhide Dog Chews
Planta Industrial: Ruta 3 72B[][]05 71A[][]99
Rincon El Penon Km 6 72B[][]99 72E[][]99
Limpio Paraguay
FEI# 3004257668
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
Ho Ho Favorite Co., Ltd. 6/13/06 Dog Chew Bones,
No. 10-5 521 Street Hickory Beef Flavor
Wu Fong South Road 72B[][]05
Chia Yi City, TW 72B[][]99
FEI# 3004269447
Home Pet Co., Ltd. 1/10/06 Rawhide Dog Chews
No 5 Wu Fong South Road (Munchies)
521-10 Ave. 72B[][]02/72B[][]99
Chia 1, Taiwan 72E[][]99
FEI# 3004538509 70Y[][]99
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 #3004332863
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
Pet Smart International Co., Ltd. 1/25/06 Rawhide Canes
aka Thai Chew International Co. 72B[][]02
20/22, Moo 9, Chonburi-Banbung Rd. 72B[][]99
T. Nongri, A. Muang 72E[][]99
Chonburi 70Y[][]99
Chon Buri, Thailand
FEI# 3004305618
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
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