The Subcommittee on Oversight and Investigations hearing: â€œDiminished Capacity: Can the FDA Assure the Safety and Security of the Nationâ€™s Food Supply? â€“ Part 2â€ was held today. Itchmo liveblogged the hearing (and boy, was it one long hearing — it took about 6 hours) and here are some major points that were brought up in the hearing including many that surprised and shocked us.
From Committee on Energy and Commerce visits to FDA labs and ports:
- The review of operations of the San Francisco office: They found that it was physically impossible for office to complete even cursory reviews. There are four employees to review 4,000 entries. On average, they do 1 entry every 30 seconds. This is the time in which they decide if the entry is OK or if it needs to be investigated.
- When a product is “detained”, this means that the delivery is allowed to the importer. The companies then test the shipment using a private lab.
- These private labs are not accredited or inspected by the FDA. The FDA has no authority to audit or check the reliability of these labs. Many of the FDA employees describe some of these labs as “not good” and “spooky”. These labs use improper methods and produce shoddy work. For many of these labs, money is the bottom line. One private lab owner said that some private labs can guarantee that companies will get negative results.
- After the company has negative findings in 5 consecutive shipments, then the exporter is removed from the alert. After that, the exporter will be able to ship without any investigation or alert. This system can be abused. For example, with sword fish and tunafish, when the fish are larger and older, they may have a higher toxin level. Companies will send the first five shipments with smaller fish (that usually have little or no toxins), so they will test negative for any toxins. After the import alert is taken off, the company will then start shipping the larger fish that have higher toxin levels.
- 20% of seafood exports that came into the San Francisco port were found to be disguised as they were importing decomposing fish. Carbon monoxide has been used to hide the decomposition.
- Many FDA employees that they spoke to believe that voluntary recalls have no real impact. They say that mandatory protocols are necessary. They also say that the industry would prefer mandatory guidelines also.
- There are FDA 326 ports in the US, and only 91 of those ports have inspectors at those ports. Companies can go to ports where there are no inspectors at (Customs and Border Protection is at the ports) or they can also go to ports that they know the inspectors are not as strict. For example, some companies will bring their shipments to Las Vegas instead of San Francisco because San Francisco is known for their expertise. (USDA only has 10 ports.)
- The inspectors also believe that the closing of 7 of the 13 FDA labs and the proposed reorganization plan will exacerbate the system.
- The computer system that FDA inspectors use shows only 20% of the food imports that are being sampled for tests. The other 80% of foods are not being reviewed or tested at all (this did include wheat gluten before).
Testimony from the FDA labs:
- The employees from FDA labs that are proposed to close spoke about the significance of their labs and how there would be a brain drain in the FDA. They have not been given a reason on why the FDA will be closing down their labs. District offices will also be decreased from 20 to 16. Compliance branches will decrease from 20 to 10.
- All of the employees testified ranked the FDA as an agency a 5 or lower on a scale from 1 to 10. (1 being the lowest)
Testimony from FDA Commissioner Eschenbach:
- Eschenbach says that the agency is recognized as the “gold standard” around the world. He says that the FDA recognizes that they need to modernize their facilities, use their current authorities more efficiently and with greater clarity, need to work with other agencies, and he ends in his statement that the FDA will radically change.
- Eschenbach was continuously asked about the lack of communication from the FDA. Many committee members said that they had asked for documents or responses to questions and had never received it. Eschenbach said that he would look into it and says that the FDA is committed to being responsive.
- Eschenbach states the reorganization proposal is to not eliminate labs or the workforce. It is to consolidate labs to be more effective and to enhance the maximum impact of the agency.
- Eschenbach believes that voluntary procedures are working well. He states that in some areas, science is not mature enough to define a regulation that is mandatory all the time.
- Stupak lays into Eschenbach and asks where the $10 million dollars that Congress gave to the FDA for the food safety program. Stupak says $9.5 million of it was used for bonuses. Eschenbach said that it was taken from the budget and from the specific districts. Stupak states that employees in Eschenbach’s office collected 30% of the top FDAâ€™s cash awards and the Office of Regulatory Affairs only collected 19% cash bonuses but yet they have 35% of FDAâ€™s employees. His office went up by 80% in cash awards, while the Office of Regulatory Affairs only went up by 30%. As imports have increased, the cash award for field employees have gone down while the employees in his office went up. Eschenbach said that he didn’t have the details of the bonuses and said that he would get them that information. Stupak answered by saying “Damned if you do, damned if you don’t”.
- State Representative Burgess (TX) did bring up the point that he had spoken to a vet about the pet food recalls. Burgess said that he didn’t fully see how severe the problem was before. The vet told him that it was significantly more widespread than it appeared and the recall probably involved brands that were not recalled. Burgess said that it seemed that the pet food problems were more widespread than were reported.
Other food safety note: Safeway sent a letter to Congress saying that the company would stop selling fresh meat treated with carbon monoxide.