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| **FDA Division of Dockets Management**           | Solaris Court   |   |
|                                                  |                 |   |
| **e-mail: fdadockets@oc.fda.gov**                | Davy Avenue     |   |
|                                                  |                 |   |
| **[RE: Docket No. 2002N-0278]{.underline}**      | Knowlhill       |   |
|                                                  |                 |   |
| **[(prior notice of imported food -- reopening   | MILTON KEYNES   |   |
| of comment period)]{.underline}**                |                 |   |
|                                                  | MK5 8PP         |   |
|                                                  |                 |   |
|                                                  | T: + 44 1908    |   |
|                                                  | 687047          |   |
|                                                  |                 |   |
|                                                  | E:              |   |
|                                                  | bob.dar         |   |
|                                                  | t@royalmail.com |   |
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| Dear Sir / Madam,                                |                 |   |
|                                                  |                 |   |
| We are responding to your invitation to comment  |                 |   |
| on all aspects of the prior notice Interim Final |                 |   |
| Rule, as published in the Federal Register of    |                 |   |
| 14^th^ April 2004.                               |                 |   |
|                                                  |                 |   |
| Royal Mail is the national public postal         |                 |   |
| operator of the United Kingdom. We provide our   |                 |   |
| International mail services in accordance with   |                 |   |
| international treaty law, more specifically the  |                 |   |
| Acts of the Universal Postal Union. One of the   |                 |   |
| basic principles of these Acts is the provision  |                 |   |
| of a universal postal service, which implies the |                 |   |
| free circulation of postal items throughout the  |                 |   |
| world, through an interconnected single postal   |                 |   |
| territory. By virtue of its UPU membership every |                 |   |
| UPU member country has to offer the universal    |                 |   |
| postal service to every citizen and all          |                 |   |
| businesses and other organisations residing in   |                 |   |
| its country. In order to ensure this system      |                 |   |
| works the UPU and its members try to limit the   |                 |   |
| conditions with regard to the sending of         |                 |   |
| international mail to an acceptable minimum, and |                 |   |
| to ensure these work in practice and are capable |                 |   |
| of being enforced.                               |                 |   |
|                                                  |                 |   |
| We understand and fully support the need for     |                 |   |
| greater security. Since the announcement of the  |                 |   |
| prior notice measures last December we have      |                 |   |
| advised our customers of the FDA prior           |                 |   |
| notification requirements and have been          |                 |   |
| enforcing these at the point of acceptance to    |                 |   |
| our networks. However, we have faced many        |                 |   |
| questions from customers who have encountered    |                 |   |
| difficulty in complying with the complex         |                 |   |
| measures for sending of food products to the US. |                 |   |
|                                                  |                 |   |
| These measures apply to all shipments containing |                 |   |
| food, regardless of whether the sender is a      |                 |   |
| private person or a business. Business customers |                 |   |
| have informed us it is becoming increasingly     |                 |   |
| difficult for them to export consumer food       |                 |   |
| products to the US if they have to comply with   |                 |   |
| the FDA prior notification system.               |                 |   |
|                                                  |                 |   |
| Based on this feedback and our own experience we |                 |   |
| would like to point out the following major      |                 |   |
| concerns we have regarding the FDA prior         |                 |   |
| notification procedure:                          |                 |   |
|                                                  |                 |   |
| -   Customers having no access to the Internet   |                 |   |
|     are disadvantaged.                           |                 |   |
|                                                  |                 |   |
| -   The pre notification system is not           |                 |   |
|     customer-friendly and entries take a long    |                 |   |
|     time.                                        |                 |   |
|                                                  |                 |   |
| -   The data requirements are too complex for    |                 |   |
|     customers and very difficult to determine.   |                 |   |
|                                                  |                 |   |
| -   The system is only in English, and           |                 |   |
|     non-English speaking customers are           |                 |   |
|     disadvantaged.                               |                 |   |
|                                                  |                 |   |
| -   Each item has to be registered separately    |                 |   |
|     and there is no facility for obtaining       |                 |   |
|     multiple pre-notification numbers, causing   |                 |   |
|     great difficulty for businesses.             |                 |   |
|                                                  |                 |   |
| We have a responsibility to provide our          |                 |   |
| customers with clear and unambiguous advice, and |                 |   |
| we therefore need to know whether the date of    |                 |   |
| 12^th^ August 2004 still is intended as the date |                 |   |
| from which the prior notice measure will now be  |                 |   |
| fully enforced by US authorities. The            |                 |   |
| implication being from that date onwards any     |                 |   |
| mail items not having prior notification and not |                 |   |
| carrying the reference number provided by FDA    |                 |   |
| will be refused entry to the US.                 |                 |   |
|                                                  |                 |   |
| This situation provides us with a potential      |                 |   |
| dilemma, as since 12^th^ December 2003 we have   |                 |   |
| been enforcing the FDA requirements with our     |                 |   |
| customers. It is unclear from the information    |                 |   |
| posted on the FDA website at which final date    |                 |   |
| the US authorities will be fully enforcing the   |                 |   |
| FDA rules. Our customers are understandably      |                 |   |
| confused whether they can in the interim send    |                 |   |
| foodstuffs to the US without prior notification  |                 |   |
| and without penalty.                             |                 |   |
|                                                  |                 |   |
| We request you to urgently reconsider the FDA    |                 |   |
| prior notification procedure and consider        |                 |   |
| modifying it in such a way, that at least        |                 |   |
| consumers and small businesses can continue to   |                 |   |
| send food items to the US in accordance with the |                 |   |
| international mail system that has been          |                 |   |
| developed over the years on the basis of the UPU |                 |   |
| Acts. Complying with the requirements of FDA     |                 |   |
| prior notification procedure is causing our      |                 |   |
| customers great inconvenience and costing them   |                 |   |
| money. Our customers also include many US        |                 |   |
| citizens, currently either residing in or        |                 |   |
| visiting the UK, who may wish to send food home  |                 |   |
| to friends or family.                            |                 |   |
|                                                  |                 |   |
| We would be happy to work with you, and other    |                 |   |
| UPU members, to develop alternative practical    |                 |   |
| solutions to resolve these issues.               |                 |   |
|                                                  |                 |   |
| We look forward to receiving your response.      |                 |   |
|                                                  |                 |   |
| Yours sincerely,                                 |                 |   |
|                                                  |                 |   |
| Bob Dart                                         |                 |   |
|                                                  |                 |   |
| Head of Customs Policy                           |                 |   |
|                                                  |                 |   |
| Royal Mail plc                                   |                 |   |
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