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Regulatory Documents for Biological Reagents: SDS, USDA Permits, Health Certificates

Regulatory Documents for Biological Reagents: SDS, USDA Permits, Health Certificates

Three documents follow an animal-derived reagent from our freezer to your bench, and a shipment stalls if any one of them is missing. The Safety Data Sheet is for the people who handle the product. The USDA permit and the health certificate are for the border it crosses.

Safety Data Sheet (SDS)

The SDS is the sixteen-section document that describes a product's hazards, safe handling, storage, spill response and disposal. It replaced the older MSDS when the United States adopted the Globally Harmonized System. OSHA's Hazard Communication Standard requires one to be available for every hazardous chemical in the workplace, and OSHA's laboratory safety guidance treats SDSs as a central part of that program (OSHA). For biological reagents the SDS covers the preservatives and buffers as well as the biological hazard, and it states the universal precautions for handling animal- and human-derived material.

Your side of it is simple: keep the current SDS for each product where everyone who handles it can find it, and check it when a formulation changes. We post the SDS for every product on our Safety Datasheets page.

USDA import permits

Animal-derived materials entering the United States are regulated by the USDA's Animal and Plant Health Inspection Service (APHIS) to keep foreign animal diseases out. Serum, plasma, tissue, blood products and cell-culture materials of animal origin generally need an APHIS Veterinary Services import permit, applied for by the importer, before the shipment leaves its country of origin. The permit specifies the material, the species, the country of origin and the permitted uses, and it carries conditions on how the material is handled after it arrives. Materials from countries with certain disease statuses, or from certain species, face additional restrictions or are refused outright.

If you're importing, apply well ahead of the order, check that the permit's material and species descriptions match the product exactly, and keep an eye on its expiry. If you're ordering from us within the United States, no import permit applies. For customers abroad, the permit comes from your own country's veterinary authority, and we'll need its number and conditions before we ship.

Health certificates

A health certificate, sometimes called a veterinary or export certificate, is issued by the competent veterinary authority of the exporting country (in the United States, APHIS). It attests that the animal-derived material meets the importing country's health requirements: that the animals came from herds free of specified diseases, that the material was collected and processed the way the destination requires, and so on. The importing country sets the wording, so the certificate for the same product differs from one destination to the next, and some destinations need it negotiated in advance.

Tell us the destination country and the intended use when you order. That lets us find out what your authority requires and have the certificate prepared and endorsed before the product ships. A shipment that leaves without it is the one that sits in customs while the dry ice sublimates.

Getting ahead of it

For any international order, send us your import permit (or confirmation that none is required) and the destination's certificate requirements when we quote, not when we ship. We handle the APHIS endorsement and pack the certificate with the shipment. If you have questions about a particular destination, ask before you order. We ship to most of the world and have usually done that country before.