Empty Promises

Cayman

An Animal Products Export Certificate (APEC) is a bland, illegible form bearing an impressive signature in blue ink. Required on all international shipments of research proteins and antibodies, an APEC informs the overseas importer that “These products have been obtained in a manner that precludes any chance of contamination or infectious disease. Promise.” Unfortunately, the United States Department of Agriculture is the only issuer of APECs, so since the time of the partial government shutdown, they are no longer available. For a small research biotech business, that means an abrupt halt to product sales to Korea, Japan, and elsewhere.

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Click to view APEC

If one reads an APEC carefully it becomes clear that nowhere on this document are there results from any test. No test for BSE, no tests for viruses, infectious agents – nothing. In fact, what’s written there is basically nonsense. For example: “LDL Uptake Cell-Based Assay raised in rabbit, goat, bovine.” One gets a garbled visualization of something part goat and part rabbit being birthed by a cow. The actual product, pictured at the end of this post, is a tidy plastic wrapped box.

The Animal Products Export Certificate is best described as an empty promise. Promises that are in short supply, since it is only the government that makes and requires them. APECs are quite the money maker, actually, as it costs my company $51 for each one, for each overseas customer, for every shipment we send to them. Plus the cost of overnight mail coming to and from the USDA. All that has come to a halt now, as we and our customers wait for the USDA to come chugging back to life. Meanwhile, October sales are down 7%.

Getting a License to Export your Thoughts. The logical extension of requiring export permits and licenses for everything came to pass in 2011, when Ron Fouchier of Erasmus Medical College in Rotterdam was required by the Dutch government to obtain a license to export his “thoughts” in the form of a manuscript, to Science magazine in the United States. Done under protest and then appealed to the courts, this startling form of repression was upheld on September 20, 2013 by the Dutch court, citing an obscure EU regulation. Liberal thinkers who have felt a certain smugness watching businesses cope with this costly and pointless burden of paperwork should remember a version of the timeless Martin Niemöller quote: “When the Nazis came for the trade unionists, I did not speak out, because I was not a unionist…”

This pause gives us time to reflect on this program and its merits, or lack thereof. It was initiated in response to the outbreak of Mad Cow Disease, which started in the 1980’s and peaked in the UK in 1993. Initially applied to whole animals, it suffered scope creep, and now 20 years later it applies to even the smallest traces of bovine serum albumin adherent to the insides of 96-well plastic microplates. It also applies to essentially every species that survived Noah’s Ark.

Since it is practically impossible to test every living animal for everything, the USDA has settled for the next best thing – baseless assurances. Without those, international commerce in a wide range of antibodies, serums, immunoassay kits, and other important biochemical commodities abruptly stops. Which is a shame, because those products are used primarily in – you guessed it – the fight against disease.

It wasn’t always like this. Equine Infectious Anemia (EIA), as an example, is a disease that killed many thousands of horses each year prior to 1970, and for which there was no vaccine and no cure. So the USDA developed a test (based, ironically, on a rabbit antibody) and one is now required to carry a signed copy of this (negative) Coggins’ test when transporting any horse across a state line. EIA is now so reduced in incidence that it is possible to discuss eradication. A vaccine has been developed in China, and the USDA has one under development here. This is how the USDA operated before it became overwhelmed by politics. And before it ceased operating all together this October.

A short to-do list emerges from this reflective exercise. First, (ahem) re-open the government. Next, exempt all research biochemical substances from any requirement to submit or obtain Animal Product Export Certificates. Seriously – this program in its current form should be terminated, as it seems to provide assurances where they do not exist. And the next time some emergent zoonosis seems to threaten, DO NOT attempt to thwart it with empty promises. Rely on science to develop an accurate test, and then require exporters to perform that test. That’s an APEC worth paying for.

LDH Assay Kit

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