Guidelines for Importation of Lactose and Lactose Derivatives 1107

Guidelines for Importation of Lactose and Lactose Derivatives 1107

GUIDELINES FOR IMPORTATION #1107 (September 30, 2016)

This Guideline applies to:

Products for human and animal consumption including but not limited to pharmaceuticals, nutraceuticals, dietary/nutritional supplements, culture media, medical devices, placebos, and investigational pharmaceuticals that contain lactose (milk sugar) and the following lactose derivatives, galactose and lactulose, as the ONLY animal origin ingredient. This would include bulk amounts of lactose or galactose or lactulose.

This Guideline does not apply to:

Products that contain other animal origin ingredients besides lactose or galactose or lactulose

INTRODUCTION:

Material derived from any animal is potentially subject to U.S.Department of Agriculture (USDA) regulations and must be cleared by Department of Homeland Security, Customs and Border Protection (DHS, CBP) Agricultural Specialists/Officers at the U.S. port of arrival before entry into the United States is authorized. A USDA import permit is required for animal material that may pose a risk of introducing foreign livestock and poultry diseases into the United States. However, the USDA has assessed the risk of lactose (milk sugar) and the following lactose derivatives, galactose and lactulose, and determined that they are not a viable vectors for Foot and Mouth Disease (FMD), and the risk of entry of FMD via products containing lactose or galactose or lactulose is negligible. Therefore, products that contain lactose or galactose or lactulose as the ONLY animal origin ingredient may enter the United States without USDA, Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS) restrictions.

The U.S. Food and Drug Administration have primary jurisdiction over these materials.

They should be contacted for their importation requirements at the following locations:

U.S. Food and Drug Administration (FDA)
Division of Import Operations and Policy, HFC-170
5600 Fishers Lane, Rockville, MD 20857
Tel. (301) 796-0356

Website address http://www.fda.gov/ora/import/

PROCEDURES:

A USDA, APHIS, VS import permit will not be required for pharmaceuticals, nutraceuticals, dietary/nutritional supplements, culture media, and products for human and animal consumption that contain lactose or galactose or lactulose as the ONLY animal derived ingredient. In order to facilitate correct identification of the shipment and to ensure timely delivery, USDA, APHIS, VS recommends that the following documentation or information accompanies each shipment, and be presented for review by the DHS, CBP Agricultural Specialists/Inspectors at the U.S. port of arrival.

  • A document on company letterhead prepared by the producer/manufacturer, shipper, or seller identifying lactose or galactose or lactulose as the only animal origin ingredient; OR

  • An official government certificate identifying lactose or galactose or lactulose as the only animal derived ingredient

We do not recommend that the foreign producer/shipper place this documentation inside the shipping containers. A copy of this Guideline for Importation should be provided for your producer/shipper.

If the pharmaceuticals, nutraceuticals, dietary/nutritional supplements, culture media, and products for human and animal consumption, etc. to be imported cannot meet the criteria, then a USDA import permit may be required. Permit applications may be obtained several ways:

IMPORT PERMIT

The permit application and instructions, including information on the user fee and e-authentication, is available on our web site at http://www.aphis.usda.gov/animal_health/permits/

The current permit processing fee is $150 and permit duration is one year.

Applications can be submitted by either of the following ways:

• By e-mail: animalproducts.application@aphis.usda.gov

• By fax: 301-734-8226

• By writing to: USDA, APHIS, VS
  Import Export Services (NIES)
  4700 River Road, Unit 40
  Riverdale, MD 20737

(301) 851-3300,Option 1
(301) 734-8226 fax

Applicable Federal regulation:

9 CFR 94.16


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