The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, commonly known as the “Bioterrorism Act”, went into effect in December of 2003. Part of the Act requires the Food & Drug Administration (FDA) to put systems into place to insure the safety of the US food chain. One of the goals is to prevent the importation of disease causing agents in either human food or animal feed. As a result, new regulations will monitor imports to insure no infectious agents are imported through food destined for either human or animal consumption.

Animal feed samples submitted for analytical purposes are also covered by the Act. It is unclear why, as the samples will never be consumed and are destroyed upon the completion of analysis. However, we will be forced to comply with the new import regulations.

Under the provisions of the new Act, the following are required:

1. The importer (Dairy One) is required to register it’s facility with the FDA. We are registered and will provide you with the registration number upon request.

2. The exporter (customer submitting samples) must also be registered with the FDA. You can apply for a registration number on the FDA web site www.fda.gov/furls. Registration is a simple, straight forward process. Once registered, all shipments of samples must include both your and our registration numbers.

3. You must declare a US Agent. This is explained on the FDA web site.

4. You must file “prior notification” with the FDA in advance of sending your samples. This will also be done through the FDA web site. Prior notification alerts the FDA of your intent to export samples. They will either approve or reject your request.
   

We are still trying to learn all of the details of the Bioterrorism Act. As we learn more, we’ll post the information on our web site to keep you informed. We strongly recommend that you contact your shipper (DHL, FedEx, UPS, etc.) for more information regarding the requirements of the new act.

In the meantime:

1. Continue to follow the shipping guidelines in the international section of our web site.

2. Obtain a FDA registration number for your business.

3. Contact us for our registration number and be sure to include both with your shipment.

4. Work with your shipper regarding the prior notification process.
   
   Like anything else, once all of the rules are clear, the process should become more streamlined. Currently, US Customs is putting systems in place to comply with the Act. It will take several months to accomplish. In the interim, it is important that Dairy One and it’s customers strive to learn as much as possible about the new requirements and begin to take the necessary steps to become in full compliance.
   
   It is Dairy One’s goal to continue to provide quality analytical services to our international customers. The rules have changed and we will work with you to provide the appropriate mechanisms for getting your samples into the US.