From: julianheron Heron [julianheron@msn.com]
Sent: Tuesday, July 08, 2003 3:24 PM
To: fdadockets@oc.fda.gov
Subject: Public Health Security and Bioterrorism Preparedness and Response Act of 2002

TUTTLE TAYLOR & HERON

SUITE 502 EAST

1025 THOMAS JEFFERSON ST., NW

WASHINGTON, DC 20007-5201

TELEPHONE: (202) 342-1300

FACSIMILE: (202) 342-5880

 

July 8, 2003

 

VIA ELECTRONIC SUBMISSION

 

Dockets Management Branch (HFS-305)

Food and Drug Administration

5630 Fishers Lane, Rm. 1061

Rockville, Maryland 20852

 

Re:      Request for Comments concerning the Proposed Establishment and  Maintenance of Records Regulations under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

 

Dear Mr. Secretary:

 

Penny Newman Grain Company, Inc., submits the following written comments in response to the Food and Drug Administrations request announced in the Federal Register on May  9, 2003, 68 F.R. 25187.   As requested, this information is provided on the adverse effect of the proposed regulation that would require domestic persons that manufacture, process, pack, or hold food for human or animal consumption in the United States to establish and maintain records. 

 

Penny Newman Grain Company, Inc. was established in 1878 as a mercantile company in Fresno, California. It has grown to be one of the largest grain and feed by-product distributors in California. It operates the largest dairy feed manufacturing facility in California. It operates port facilities at the Port of Stockton, California. It exports wheat, rice and safflower. Penny Newman receives imported products at this facility including a wide variety of animal feed products including palm kernel meal, cottonseed, sunflower meal, canola meal, barley, citrus pulp pellets, broken rice and urea. These products come from various countries including Indonesia, Australia, Benin, Togo, Argentina, China, Canada, Finland and Brazil.

 

Penny Newman Grain Company strongly supports strengthening the security of this countrys food supply, as intended by the Bioterrorism Act of 2002.  We have internally adopted an aggressive food safety and security program and take this responsibility very seriously.  We realize that public confidence in our food supply is essential to the health and welfare of our Nation.

 

The Penny Newman Grain Company understands and accepts its responsibility under the proposed regulations to make available to the FDA appropriate records and information concerning previous sources  and subsequent recipients  of our  feed products.  The nature of our business operations is that we receive bulk feed products that may have been commingled prior to our purchase and receipt of such product.  An example is the feed ingredient that we will distribute as a feed product.  Thus, we will be able to identify all the farms or other sources that have contributed products, such as cotton seed, to specific batches of feed.  

 

It would not be possible to identify specifically on which farm a pound of feed was grown.  The feed is commingled.  It is not possible for us to provide trace back information that is more specific than the list of farms from which the product was collected. Once our feed is prepared, it is not possible to separate and identify the specific farm on which the particular ingredients were grown.  Depending on the product, the pool of farms may range up to 2,000 farms.

   

This problem expands when dealing with imported quantities of feed such as cotton seed.  We may be able to identify all the farms that contributed to a specific load, but we could not provide a lot number or other identifier corresponding to the specific amount of feed from a particular farm since the feed product is commingled at the place where it is gathered.  The record requirement is unworkable where commingling often takes place.   We are able to provide information identifying the farms that a load of feed product came from, the quantity supplied and the date received.  

 

Reference is also made to our comments filed on April 4th concerning prior notification of imports. The relevant comments of that submission are incorporated herein by reference. 

 

The four hour turnaround time for furnishing records pursuant to an FDA  request  made between 8 am-6 pm is burdensome.  Good faith efforts still may not comply  considering the volumes  of  information related  to  our  deliveries.  We would be able to furnish information, but not always in a four hour time period. There are not sufficient human resources on hand that would be required to meet this requirement.

 

The twelve month effective date cannot be met.  It requires the uneconomic expenditure of funds which are not available in any event. The proposed rule would require our company to revise and improve our system in order to furnish information  on such short notice. Thus, either provide the funds or extend the time to eighteen months or do not require a four hour time band.

 

 If you would like any additional information or have any questions, please advice and additional information will be furnished.

 

Respectfully submitted,

 

                                                                                      _________________________

Julian B. Heron

Counsel for

                                                                                      Penny Newman Grain Co.