While digging through the FDA investigations of the chicken jerky treat plants they visited in China this year, I uncovered a few interesting tidbits. Morsels, I know you will find as tasty as I did.

Always eager to find more rope for the FDA to hang themselves with, I am rarely disappointed to find a cache of coiled hemp waiting to be used. Today was no different.

Doomed from the start?

Remarkably, before the inspections even began, the FDA was informed by Chinese officials that they had no intention of allowing the inspectors to take samples for testing to the U.S. Before each inspection lead investigator Dennis Doupnik met with Chinese officials to determine whether their position had changed. When he was informed their position had not changed, Doupnik did not ask firm management if he could collect samples. It would seem the inspections were doomed before the FDA step foot in the plants.

It is important to realize that inspections of foreign food facilities are required to be pre-arranged with the country in which they plan to visit. As per protocol, the FDA sent a letter to Chinese officials in March identifying five Chinese firms for inspection. Inspectors were to be sent for several days to each of four plants: Gambol Pet Products Co. Ltd.; Shandong Honva Food Co. Ltd.; and Shandong Petswell Food Co. Ltd., all in Liaocheng, China, and Jinan Uniwell Pet Food Co. Ltd. in Jinan, China and Yantai Aska Food Co., Ltd. (the Yantai report is pending because of the need for additional information and “will be posted later”, according to FDA spokeswoman).

China said no way to sampling

While the inspections were pre-arranged and supervised by officials with China’s General Administration of Quality Supervision, Inspection and Quarantine, known as AQSIQ, refused to allow FDA inspectors to collect samples unless they agreed to “certain sampling conditions,” including having the jerky analyzed only in a Chinese government-run laboratory, or a third-party lab in China, wrote FDA investigator Doupnik. FDA investigators would have been allowed to witness the analysis, but not to remove samples.

“I was informed that FDA would not be allowed to ship any samples outside of China for testing in a FDA laboratory due to the issue of national sovereignty among other reasons,” Doupnik added.

No Samples? Fine. You’re Done.

Before each inspection, the reports indicated that Doupnik asked AQSIQ officials if their position on the sampling had changed. When he was informed it had not, Doupnik wrote that he did not ask to collect samples during the inspections

Food safety advocate and staunch critic of the FDA handling of the problem Congressman Dennis Kucinich said that Chinese officials’ refusal to release samples to U.S. inspectors should be grounds for banning the products from import — or for a mandatory recall.

“That would do it for that product. I would pull them all off the market,” said Kucinich. “Fine. You’re done.”

Inspections in China: The progression from practically non-existent to utterly pointless

Between fiscal year 2009 and 2010, FDA had a thirteen-fold increase in food-facility inspections in China. But what that headline grabbing number doesn’t tell you is that the increase was because in 2009 the FDA only conducted three food-facility inspections in China. Let me say that one more time: three inspections. However in 2010, FDA conducted thirty-nine food-facility inspections.

Which brings us to 2012. The FDA finally decides there is enough of a problem and enough pressure on them to inspect the Chinese poultry plants that export treats to the US for pets. Which might have proved useful had they had the ability to actually complete a proper inspection. So, before the investigation began, it appeared to be doomed to fail.

What part of ‘not optional’ do you not understand?

Yet, a FDA food facility inspection is not optional if the facility wishes to export its products to the United States. According to FSMA, FDA must refuse entry into the United States of any food from a facility that refused a FDA inspection.

[lightbox title=”LightboxTitle” url=”PageURL” width=”900″ height=”500″]FSMA, Sec. 306, Part (b)
Effect of Inability To Inspect.–Notwithstanding any other provision of law, food shall be refused admission into the United States if it is from a foreign factory, warehouse, or other establishment of which the owner, operator, or agent in charge, or the government of the foreign country, refuses to permit entry of United States inspectors or other individuals duly designated by the Secretary, upon request, to inspect such factory, warehouse, or other establishment.[/lightbox]

Inspectors mistake the I.O.M. for T.P.

In the FDA official Investigation Operations Manual (IOM), the massive tome to guide inspectors while protecting Americans from dangerous food, drugs and cosmetics, it is spelled out very clearly what the FDA’s role is and how they are to carry that out.

The FDA is to make no special provisions or allowances for foreign firms. They are to submitted to the same laws and scrutiny as US firms. Fragile trade relationships and politics are not to influence the FDA’s role in foreign inspections. Accordingly, the IOM in Chapters 4, 5, and 8 spells out exactly how the inspections are to be performed (abbreviated):

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FDA Investigations Operation Manual
Chapter 4 – Sampling
Chapter 4.1.1.1 – Examinations and Investigations
Collecting samples is a critical part of FDA’s regulatory activities. FD&C Act, Section 702(a) [21 U.S.C. 372 (a)] gives FDA authority to conduct investigations and collect samples.

While inspections and investigations may precede sample collection, a sample must ultimately be obtained for a case to proceed, under the law. Proper sample collection is the keystone of effective enforcement action.

Collect every sample as if you will be required to testify in court about everything you did concerning each and every event surrounding the sample collection. Mistakes or deficiencies, however trivial they may seem, can fatally damage the government’s case. Be objective, accurate, and thorough.

A valid sample is the starting point and keystone for most administrative and legal actions. As evidence, the sample must support the government’s charge there is a violation of the law.

If violative, the Official Sample provides a basis for administrative or legal action

Chapter 4.2.3 – Refusal to Permit Sampling
A challenge of FDA authority to collect samples may be raised by a dealer who, for varied reasons, both personal and professional opposes the activities of the agency, or of governmental units in general.

If refusal persists, point out the criminal prohibitions of Section 301(f) of the FD&C Act [21 U.S.C. 331(f)]. [Sec. 301(f) The refusal to permit entry or inspection as authorized by section 374 of this title]

Chapter 5.1.3 – Inspection of Foreign Firms
Inspectional requirements apply to all inspections, including foreign inspections…If faced with a refusal, or partial refusal of inspection proceed as outlined in IOM 5.2.5.4.

Chapter 5.2.5 – Inspection Refusal
Refusal as used in your IOM means refusing to permit an inspection or prohibiting you from obtaining information to
which FDA is entitled under the law.

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What happens if a foreign food facility or foreign government refuses to to play nice?

In theory or in reality? According to US law there is only one answer: Section 306 of the FDA Food Safety Modernization Act (FSMA) amended the Federal Food, Drug and Cosmetic Act, under Section 807 (b), by, among other things, directing FDA to refuse admission of food into the U.S. when that food is from a foreign factory, warehouse or other establishment that refuses to allow inspection.

What does the future hold?

Since the inspections, such as they were, the FDA has not issued an import alert or an import refusal for the firms, I think we can expect very little. However, a FDA spokeswoman assures us that the FDA is conducting “increased surveillance of shipments of jerky treats from China to provide guidance on possible products to target for sampling and analysis”. With only 2% of imported goods ever inspected and with a skeleton crew of 8 FDA officials assigned to posts in China, it’s not bloody likely.

Source: FDA Investigations Operations Manual