Ammonium Hydroxide and Phosphoric Acid, both GRAS. Photo by Benny BNut
On his blog Cold Truth (and on AOL News), Andrew Schneider brought our attention to the GAO’s recent investigation into the well-known FDA loophole created by the “generally regarded as safe” or GRAS designation.
The GRAS designation is meant to spare manufacturers lengthy and expensive testing that might otherwise slow the flow of new products to market. It’s conferred, Schneider writes, as long as a “scientific panel selected by the manufacturer can rule that no harm will result from the intended use of an additive.”
Schneider’s version of the highlights of the GAO report:
- The FDA generally doesn’t know about most of these determinations of “generally regarded as safe,” or GRAS, because companies are not required to inform the agency.
- The FDA has not taken steps that could help ensure the safety of additives listed as GRAS.
- Food products may contain numerous ingredients, including GRAS substances, making it difficult, if not impossible, for public health authorities to attribute a food safety problem to a specific GRAS additive.
- The FDA does not systematically reconsider the safety of GRAS substances as new information or new methods for evaluating safety become available.
The GAO said nanomaterials and imported additives were of particular concern.
(Hat tip to OMB Watch in general and Matthew Madia in particular)
Writing for AOL News (and his blog, Cold Truth) Andrew Schneider writes that the hydrolyzed vegetable protein recall reminds us that, no matter what was said in the wake of last year’s peanut butter recall, the FDA still doesn’t have the ability to pay close attention to source foods that are destined to end up in hundreds of different products.
In this most recent case, it was a test by a supplier, not an FDA representative, that caught the contaminated additive.
The FDA conducted an investigation at the company’s Las Vegas facility after a food producer that bought the flavoring from Basic Food Flavors notified federal agents that it had found Salmonella Tennessee in the vegetable protein.
In answer to the criticism about its actions during the peanut episode, FDA officials said they have no way knowing to whom suppliers sell their food products, what those products are and where they’re sold. The FDA says it doesn’t have the personnel or the needed regulations to handle the millions of shipments made within the food industry every week.
But what was seen with the dangerous peanuts, and what we’re beginning to see with the flavoring agent, is that producers of end products — those items that actually reach store and warehouse shelves — are declaring their own voluntary recalls.
AHCJ member Andrew Schneider of the Seattle Post-Intelligencer is covering the W.R. Grace criminal trial in Missoula, Mont. The federal government alleges that Grace officials mined vermiculite in the small town of Libby, Mont., for decades, even though the company was aware of health risks.
Ten years ago, Schneider and David McCumber exposed that W.R. Grace was polluting the town and hiding the risks that its vermiculite mine posed to the town. “Toxic dust contaminated with lethal asbestos fibers poured out of the mine for decades, poisoning the men who worked there, the families they went home to and the town that grew around in.”
Schneider writes on his personal blog:
“It’s bizarre and a bit prickly to sit in a federal courtroom and watch a story that you broke a decade ago, then chased with about 240 follow-ups and a book, being played out in front of you.
It becomes surreal when the judge talks about the book from the bench and defense lawyers introduce excerpts into evidence and then do dramatic readings to the star witness for the prosecution.”
Schneider is writing about the trial for the Seattle P-I and on his personal blog as well. Although the P-I is expected to close or move to an online-only publication very soon, he says he will continue to cover the trial.
“I plan to keep covering the trial as money permits on schneiderinvestigates.com.”
University of Montana students from the law school and the journalism school also are covering the Grace trial and provide a great deal of background on the Grace Case Web site.