IN RE: PET FOOD PRODUCTS LIABILITY LITIGATION

Filing 196

DECLARATION of Stephen S. Miller re #194 Notice (Other) in Support of Chemnutra's Motion to Destroy Its Remaining Recalled Wheat Gluten by CHEMNUTRA, INC.. (BRAZIL, ANTHONY)

IN RE: PET FOOD PRODUCTS LIABILITY LITIGATION

Doc. 196

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY
IN RE PET FOODS PRODUCTS LIABILITY LITIGATION

MDLDOCKETNO.1850 Case No. 07-2867 (NH) Judge Noel L. Hilman
DECLAR TION OF STEPHEN S. MILLER OF CHEMNTRA, INC. IN SUPPORT OF CHEMNTRA'S MOTION TO DESTROY ITS

REMAING RECALLED WHAT
GLUTEN

STATE

OF

NEVADA )
) SS:

COUNTY OF CLAR )

I, Stephen S. Miler, being first sworn upon oath, says:
1. I am the Chief Executive Officer of Defendant ChemNutra Inc.

("ChemNutra"). The following facts are within my personal knowledge and if
called upon to do so, I could and would competently testify thereto.
2. ChemNutra sold raw wheat gluten purchased from XuZhou Anying

Biologic Technology Development Co. Ltd. ("XuZhou Anying") in China to

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Dockets.Justia.com

several manufacturers of

pet food including Menu Foods. Wheat gluten is used as

an ingredient in the manufacture of certain pet foods.

3. On April 2, 2007 ChemNutra recalled all of its wheat gluten that had
been supplied to it by XuZhou Anying. Since this recall, ChemNutra has retained
its remaining inventory of XuZhou Anying wheat gluten at 3 warehouses.
the XuZhou Anying wheat gluten in ChemNutra's

4. The majority of

possession is being stored at MoKan Container Service, Inc. in Kansas City,

Missouri. There are over 277 metric tons metric tons of XuZhou Anying wheat
gluten in that warehouse.
5. Commencing in March of2007, the Food and Drug Administration

("FDA") conducted a detailed inspection of that warehouse. The inspection
resulted in the FDA obtaining samples and testing various bags of XuZhou wheat
gluten stored at the warehouse.
6. Approximately an additional 80 metric tons of XuZhou Anying

wheat gluten are being stored by ChemNutra at the Standard Warehouse and

Distribution Co., Ltd. in Pennsauken, New Jersey. The wheat gluten at that
warehouse consists of gluten from XuZhou Anying Batch numbers 20070116 and

20070111. Bags ofXuZhou Anying wheat gluten from those same Batch numbers

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are also located at the Kansas City, Missouri warehouse which was the subject of
the FDA inspection and sampling referenced in paragraph 5 above.

7. There is also XuZhou Anying wheat gluten being stored in totes by

ChemNutra at the Steven Shannon Warehouse in Bloomsburg, Pennsylvania. All
of

the wheat gluten at that location is from XuZhou Anying Batch number
the wheat

20070106. ChemNutra did not sell, distribute or supply any portion of

gluten from Batch number 20070106 to anyone. Therefore, no pets would have
been exposed to food containing ChemNutra supplied wheat gluten from this Batch
number.
8. ChemNutra's raw wheat gluten is perishable. On June 29,2007, the

FDA sent a letter to ChemNutra expressing its concerns regarding the "public

health risks" associated with ChemNutra's storing their approximately 430 metric

tons of wheat gluten. The FDA expressly stated that "until the product is
destroyed, there is a risk of reintroduction into interstate commerce, whether

intention or not, and/or risk of export." The FDA urged ChemNutra to "seek
whatever relIefis appropriate from the Court." A true and correct copy of

the June

29,2007 letter from David Elder of

the FDA to ChemNutra is attached hereto as

Exhibit "A."

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9. Since receipt of

the letter from FDA, ChemNutra has received

numerous follow up requests seeking the status of destruction. At my request,
since receipt of

this letter, my attorneys have been working with codefendants,

plaintiffs counsel and the FDA to try to respond to the FDA's request.
10. ChemNutra is unnecessarily incurring great expense to store its raw

wheat gluten in the three storage facilities in Kansas City, Pennsauken and

Bloomsburg. In addition to the storage facility costs, if ChemNutra is required to
continue its retention of its Wheat Gluten, ChemNutra would be compelled to incur
additional costs and great expenses.
11. For over 6 months the New Jersey warehouse in which the wheat

gluten has been stored has demanded that ChemNutra immediately remove the
wheat gluten from the facilty. As of July 1, 2008 that warehouse has substantially

increased the storage costs. These increased storage costs as well as the ongoing
storage costs incurred at the other facIlIties has been a severe economic burden on

ChemNutra. The storage costs are imposing a substantial economic burden on
ChemNutra.

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l 2. CheniNulra is ready and wiling to dispose of the XuZhou Anying
\vheat gluten as requested by the FDA. If the Court allows the destruction
requested in tl1is motion, ChemNutra \vill dispose of

the wheat gluten in

accordance \Aiith the FDA 'g recommendations and under the FDA's supervision.

I declare under penalty of perjury that the foregoing is true and
('or"t~CL

¡

/

:~/. l.--.,,___

StephcnMìler

P\.I J. /Jod - H\~vi:-i;d f)Ç( of Sh:phçn '\1 iller in Suppiirl of mul (1.013-1075) (3) 5

EXHIBIT A

(l~ DEPARTME OF IlL TH AN HI SERVCE!
l''f~

'-

P~blic Health Service

Food and Drug Administon
Rockvme MD 20857

June 29,2007 .
Marc S. UUni Esq.
ULLma Shairo & Ullmn, LLP 299 BrowaY,.Suire )700
New York, New York 10007

Dea Mr. Ol:
J am writing in regard to the dispositon of cert quantities of whea gluten, owned by your client,

Cheil'utr Inc. (CIiNiitr) and held at multiple fàlliies thoughout the COUDlJ.l

F))A's iospecott.aualysIs, atd recrds show tht Chel1Nutra's whea glten, cont melame and/or melamine analogs, causing the product to be adulterate within the meag of th Federa Fóod, Drug,
and Cosmetic Act (the Act), 21 U.S.C. §§ 301 et seq.
Ai you may know, repreentatives from severa FDA Distrct Ofces, including Kaas Cit;

Plulaelphia, and New Jersey, have been involved in continued discussions with ChemNuba Tegg its
adultemted wheat gluten. FDA acknowledges tht ChemNutm has COeraed in the recl of

and that presently there is a large quantity on voluntary hold at multile facilties thughout the United the product, Sta. ChemNutr previously agreed to voluntary destoy thi recalC( product, however, you have
Stated that Chell1Nutra is now unabl~ to destroy the product.due to II May 22, 2007 Order

Stat Distrct Judge George H. Kiug in the Centtal Distct of California in Townsend v. Menu Foods. ct. from Uiútöd

aI.
FDA continues to be conccniöd about the potential public health risk, ~sptlcia1ly to anals, associated wit the retention of approximately 430 metric tons of adulterate wheat gluten in storae in varous par
oftIe COUlltr. Untl the product is destroyed the1'e is a risk of

wheter intentional or not, and/or a risk of export.

reinoduction into interstate commerc,

FDA understnds tht your client ha assur you that it will not move the produ.c, nor have anyone

move the product on its behalf. However, in light oftle large quantity ofprodiict in storae, the
poentially lengthy stprae time, aiid a lac of uniforni control over nccl".ss to the whea gluten and
relevant security issues, FDA continues to be concerned tht SODle of

the market and be \¡sed coouercially.

tile. product may find .i way back to

. J Infornuton provided to FDA by ChemNuta inicates th as of June 5. 2007, ChemNutra bad
approx.iiuitely 430 metric tons (MT of whea ghiten at three locaions in the ÙnIted Sta: appro).1TÜately 2781v at MoRan Conter Servce, me. in Kasas City, Missouri; 72 MT at Steven

Shannon Warhouse in Bloomsburg, PeMsylvania; and 80 MT at Stadard Warehouse an Distibution
Co.. Lt. in Pennsaukeii. New Jersey.

)

Page 2 - Mr. un~
FDA understa tlia a cert amoun of

ongoing or potetial Iitigiron. However. the vqlue ofproduèt curenly on had at.the n'luItpJe domestc faciHti~ would appear to be úi excess Oftllat tyically necssary for evidentiary purposes. FDA
requests that your client consder the option of

the adulerå product may need to be reed for use in
retaning a repreentave samle ofChemNutr's

adulterat wbeat gluten, and desying the reiIaider undor FDA .suprvon. Of course. the Agency
urges you to sek whatever. relief

ths.

is appropriat frm theConrt in your underlyig litition to acompli

at 240-632-6800. .
Sincerely,

If you have any questions or concerns relating to the contnts of this letter, pleae feel free to 'contat me

..': . . ~ ¿/'-:7. ;.7 ? .....l...___.__,
David K. Elder
Directr, Offce. Offce of of Eii for

cement

Regulatory Affairs

U.S. Food and Drug Admllison