Frequent hold ups by US FDAGroup:
One of the responder's to my e-mail to Sndhar below pointed out that USFDA will correspond with an outside person/organization if that outside person/organization has written authorization to represent the importer/broker or manufacturer. In some cases that is true. However, in other cases it is not. That is at the discretion of the local USFDA Import Office - i.e. whether to deal with, for example, a consultant on the basis of a written letter of authorization. Correspondence between outside organizations is easier with the Center for Food Safety & Applied Nutrition, than with many Field Import Offices. For example, TechniCAL has often represented foreign manufacturers relative to detentions of low-acid canned foods by getting authorization from the customer and dealing with the Center on issues such as this (where the Import District has informed the importer to deal directly with CFSAN); and also with items such as registration and process filing. However, too many District import officers are locked in to a local policy of responding only to the importer, broker or, if necessary, the manufacturer. Their electronic system - OASIS - is really programmed for automatic generation of documents; and responses from the importer and broker. Unfortunately the Regulatory Procedures Manual gives them this license and many are only too glad to adopt a strict interpretation. An example from the current RPM, Sept. 2002:
Issuance of Notice of Detention and Hearing
The Notice of Detention and Hearing which lists product as being detained is addressed to the filer, the importer of record who is legally responsible for assuring compliance with all laws and regulations affecting the importation of the merchandise in question, and consignee (if different from the importer of record). Copies should also be sent to whomever else was sent copies of the "Notice" for the sample collected. (See RPM Chapter "Notice of Sampling" for specific guidance on issuance of this notice).
I wish it were otherwise, but ....
Also, Chapter 9 of the RPM (Imports) is apparently under revision.
The best thing, I think, is to contact the particular import district with whom you deal ("you" as in manufacturers, brokers or importers), and see if they will, in fact deal directly with an outside person/organization with a written letter of authorization.
Just wanted to clarify that.
Regards to all,
Bill Cole
----- Original Message -----
From: Bill Cole
To: Sridhar Jaganathan ; seafood@ucdavis.edu
Sent: Wednesday, September 27, 2006 9:27 AM
Subject: Re: Frequent hold ups by US FDA
Dear Sridhar:
I spent 25 years with the US Food and Drug Administration as an Investigator in 3 different Districts; a National Food Processing Specialist in the (then) International & Technical Support Branch) and my last 3 years at the Center for Food Safety & Applied Nutrition, in the (then) Division of HACCP Programs.
Without more information relative to what the product involved is; what types of samples were collected, etc. I can only offer general comments. The USFDA - on an annual basis - comes up with specific goals in the form of sampling and/or inspection programs for specific imported products. Having checked your web site, I see that your company harvests/produces a wide variety of seafood products. Sometimes these USFDA sampling/inspection programs check a wide cross-section of products - such as seafood - on a revolving basis, looking to see if any large-scale (in terms of distribution or seriousness - or both) are occurring year-to-year. This is routine surveillance and is usually based on a risk assessment for the seafoods, and influenced by prior history. For example, the Agency knows there have been ongoing problems with Listeria monocytogenes in smoked seafood. In other cases, where there have not been any defined problems - ever or for quite a while - they will develop a sampling/inspection program just to see if anything "pops up."
In other cases, they may have acquired evidence a potentially serious problem has cropped up, where none previously existed. When this happens, USFDA will target that particular group of foods, from particular countries, for expanded monitoring. An example - several years ago, there was a problem with aquacultured shrimp and crabmeat being treated with chloramphenicol, a highly potent antibiotic whose use is any food for any reason is forbidden by USFDA. It is approved for use in human drug therapy in the US, but doctors only like to use it when there are no other alternatives. The reason: one of the side effects of chloramphenicol, for an undetermined number of people, at undetermined levels, is a virtually irreversible aplastic anemia. FDA targeted these products from two particular countries for extensive sampling of these products. The tolerance for residue in products when found: 0
In other cases, USFDA may start receiving reports - either Agency generated or through other sources - of persistent decomposition in a particular class of seafood, where none previously existed based on prior years available evidence. In some cases, such evidence may be in the form of actual inspectional evidence gathered in a foreign factory visit. The USFDA's Office of Seafood has had an ongoing foreign inspection program for at least 10 years where Office of Seafood and Field Inspectional personnel actually travel to the foreign country and do inspections of selected factories. If they find problems in a few factories, they might decide, after returning, that they need to more intensely focus on a particular product - or products - from all factories producing that product (those products) that are being shipped to the US.
And finally, the USFDA inspects importer offices in the US under the USFDA Seafood HACCP regulation. They may obtain information from those inspections that indicate - at least to the agency - that they need to sample more of a particular product - and more often.
This is really a brief capsule summary of some of the reasons why the USFDA may suddenly be targeting your customer's products. Since you do not mention any past history with detentions for your customer, and there is no more specific information, it sounds to me like perhaps it is an FDA surveillance program because something has "popped up" as a potential problem. When they sample 6 consecutive entries (have they all been released??) then it has the appearance of USFDA trying to assure itself that there is not a specific problem with these particular product(s).
What I would suggest is that the customer contact the local USFDA District Import Office that is collecting the samples and ask why the intensified sampling. When USFDA issues a "Notice of FDA Action - Notice of Sampling" they usually list the name, address and phone number of the Import Inspector who collects the sample or, at least, is responsible for managing the sample collection. I would simply call that person and say "Hey - what's going on with your continuing to sample this product?" This assumes that they have not yet found a problem within any of these 6 consecutive entries. And it needs to be the importer, or broker, or the manufacturer/shipper who asks this question. USFDA will not talk to consultants or other outsiders. But they definitely are obligated to give some sort of answer to you, or your importer or broker.
I hope this helps.
Bill Cole
======================================
William R. Cole
TechniCAL, Inc.
P.O. Box 65
Glenwood, MD 21738
PH: (410) 489-9927
FX : (410) 489-7373
E-mail : wmcole@erols.com
Internet: www.tcal.com
===================================
----- Original Message -----
From: Sridhar Jaganathan
To: seafood@ucdavis.edu
Sent: Wednesday, September 27, 2006 12:02 AM
Subject: Frequent hold ups by US FDA
Hello List members
One of our customer in USA is facing the inconvenience of hold up of his containers more frequently than normal. Here is the excerpt from his mail:
Quote:
Our import have been frequently getting placed on hold even though we have been importing them regularly for over a decade.
The first case for this year had been in February and then released.
We then had following six shipments placed on hold in less than six month despite the review, collection, and release of the previous first container:
It's our understanding that a shipment from the same shipper and containing the same product as a container that was collected/released within the last 6 months should be exempt from re-occurring holds.
Our company, as well as our customers and vendors, have been greatly hindered by these recent holds. We would really like to understand why this is happening.
Moreover, we would also like to know how we can work and cooperate better with the FDA in order to avoid these situations in the future.
- Unquote
We would really appreciate your feedback and comments if you had similar experience on dealing with such problems.
Thanks & regards
Sridhar Jaganathan
Food Safety Coordinator
Sanford Limited
VPN: 9330
DDI (09) 357 3330
Mob. 0210 575 134
This archive was generated by hypermail 2b29 : Wed Sep 27 2006 - 18:38:20 PDT