From: La Ferme Martinette [info@lafermemartinette.com] Sent: Friday, July 02, 2004 11:48 AM To: fdadockets@oc.fda.gov Subject: Docket No 2002N-0278 Dear Sir or Madame, There are several issues which concern us here at La Ferme Martinette in regards to the FDA, prior notice as well as Fast and C-Pat programs. A: Registration of Food Facilities: In regards to us, here at La Ferme Martinette being able to expand its sales of fine maple products in the USA, I am very concerned with the cost of hiring a US Agent. A recent document perceived the annual cost of a US agent would range from $ 400 to $ 1200. Depending on the cost of the agent, it is understood the cost of completing the prior notices also varies in price from $ 5.00 to $ 12.00 per prior notice. We are an exporter of fine maple products and currently we have no established sales in the USA. However, we currently have a shopping cart link on our internet site which permits individuals worldwide to purchase our products and are considering exposing our fine maple products at the Winter Fancy Food Show in San Francisco January 2005 in hopes of generating curiousity and interest leading to sales of our fine maple products. Sales of our products to the USA since January of this year total $ 179.85. With the above mentioned cost implications of hiring a US agent, we seem to be faced with few options. First, hire the agent and try to increase our USA sales to be able to cover the cost of the agent or give up on the American market altogether. Given our current sales volume to the USA, we are unable to even cover the cost of hiring a US agent. In addition to the cost of the agent, we have to cosider the cost of preparing prior notices. At $ 5.00, the cost does seem reasonable. However, in terms of our current sales to the USA and current selling costs, $ 5.00 per prior notice is quite steap. Consider the scenario, a 250 g jar of maple butter costs our US client $ 5.99. How do we transfer the cost of the prior notice into the cost of our product? Do we increase our price to $ 10.99 to cover the cost of the prior notice? This price makes our pure maple spread unmarketable. So, the prior notice has taken away any possible profit we could potentially have made. Our gift packages generally require more than 1 prior notice, as a prior notice is required per product. A recent gift package sent to MD required 4 prior notices only had a total product cost of $ 40.00. In order to clear customs however, this package required 4 prior notices $5.00 each, for instance, cost an additional $ 20.00. These additional costs will certainly have a cost impact on our feasibility in the US market. One of which is the number of small to medium size foreign facilities which may cease to export to the USA may be substantially higher than previously forecasted. The issue of prior notices is of overwhelming concern to me. Especially for packages which are only in transit in the USA. It is understandable goods being imported into the USA are required by rules, guidelines and laws of the USA to comply with US legislation. However, for goods which have transitions in the USA, there should be some modifications in these guidelines. Goods which are destined for various other countries in the world and have transits in the USA should not be subjected to the same rules and laws as those which are destined for the USA market, especially since these goods are not staying in the USA. For example, a package containing maple products destined for Japan has a stopover in Tennesse. This means we would be required to fournish prior notices for these items. Does this make sense? Logically, these goods are not staying in the USA. They are destined for another country. However, the plane of the transport company must make a stop in the USA, either to fuel, pick up more packages, etc. These goods have simply touched down in the USA. Basically requiring prior notices for such packages in transit is extra paperwork which are is costly, especially at $ 5.00 to $ 12.00 per prior notice. Even the transport companies are unsure as to the regulations. DHL advises us we are required to provide prior notices whereas Fedex does not advise one way or the other. Can there be clarifications to this issue? B: Prior Notice of Imported Food and Feed Products: In response to the Canadian Government’s question in regards to FAST and C-Pat, we here at La Ferme Martinette would register under these programs if there were benefits offered under Prior Notice. Since they are not mandatory, we have decided to wait on our participation in them. This may be the case with other firms as well. Concerning the FAST program, I understand the objective of the program. However, what happens to those small companies who have to rely on various small package carriers to deliver their products? How can I ensure that they will be FAST qualified? I am sure the larger companies such as UPS and Fedex will have the means to comply. One also has to mention they are also amongst the most expensive. What about the Canadian post office? Will they be required to comply? What about DHL? What will be the cost of implementing such a program? Are there any cost benefits for us? What will be the advantages of this for a small company such as La Ferme Martinette? In the last month, we have only shipped out 2 packages via Fedex. What will be the cost to us importers who have FAST compliance account managers? What will be the benefits of this? The timeframe reduction of 1 hour for submitting a prior notice is of great importance. This new reduction will permit us, as well as other companies who are in similar situations, the ability to expedite packages containing either goods or samples at the last minute. Sometimes customers take a long time in making decisions but when they have reached their decision they would have liked the goods to have left yesterday. I think the processes in food items and animal feed handling through US customs and FDA should be distinguished. The guidelines, rules and regulations are different for both of these items and should therefore be treated accordingly when shipped to the USA by the FDA. Other FDA Questions: I think there should be certain exceptions or regulations put into place whereby the US government can be assured of quality goods being imported into the USA. Companies which are inspected by the Federal government should be permitted some credit for the accreditation they hold. For instance, La Ferme Martinette is AAA certified by the Canadian Food and Inspection Agency. We are inspected up to 10 times in a given year for our manufacturing, handling, processing, storing and packaging processes. The US government should allocate some credit to the Canadian Food and Inspection Agency. Yes, FDA should offer prior notice submission training programs to ensure the accuracy of the data being submitted. This is critical, especially since they will be implementing penalties for errors and mistakes made. In addition to the education, I believe that FDA should find a means of upgrading their site which would enable copies to remain on file for products for longer periods of time as well as increase the time one is permitted to be logged in per session. When completing a prior notice which requires more than 1 for a shipment, often the system logs out. This causes a great deal of frustration for me. Maybe this stems from my lack of knowledge and education of the prior notice web site. Thank you for the opportunity of expressing my concerns. Kindest regards, Cynthia Matthews Adjointe administrative /Assistant La Ferme Martinette 1728 Ch. Martineau Coaticook, Québec, Canada J1A 2S5 Tél. / Fax (819) 849-7089 Sans frais/ Toll free Canada & USA 1 888 881-4561 info@lafermemartinette.com www.lafermemartinette.com www.finemapleproducts.com Procurez-vous nos produits de l'érable haut de gamme purs et naturels. Visitez notre Panier d'achats et nos Promotions Touristiques pour des idées-cadeaux originales et raffinées! Try our fine pure and natural maple products. Visit our Shopping Cart and our Country Inn Promotions for original and refine gift ideas!