pet connection

USA Today, from the start of it all and still on top of it. Julie Schmit, reporting:

Menu Foods, other pet food makers and retailers involved in last year’s massive pet food recall will set up a $24 million cash fund to compensate pet owners, according to a proposed settlement filed Thursday in federal court.

The fund is expected to compensate thousands of pet owners in the U.S. and Canada who bought recalled pet foods made by Menu and 11 others. The products had a contaminated ingredient from China that sickened dogs and cats.

The $24 million is in addition to $8 million that pet food makers have already paid to pet owners. Legal fees and expenses, which haven’t been determined, will come out of the fund. The settlement, negotiated over the past seven months, would resolve more than 100 lawsuits by more than 250 plaintiffs brought in the U.S. and a dozen in Canada.

If the settlement is approved by the court, the fund is expected to be set up and disbursed over a period of months. Unlike many large settlements, consumers will get cash rather than coupons.

In addition to Menu, defendants include pet-food makers Del Monte, Hill’s Pet Nutrition and Iams; retailers such as Wal-Mart and importers ChemNutra and Wilbur-Ellis.

[...]

The FDA never identified how many pets were affected, but it received more than 17,000 pet-owner complaints.

The settlement document doesn’t say how much each defendant will pay. The recall covered 180 brands of pet food and treats.

Once it is approved, the settlement will be widely publicized. A toll-free number and website will be set up to disburse information.

Here’s the rest.

The comments, as usual, contain their share of pet-hating crap, it’s just a pet, so what, children are in need and all we care about is pets, etc.

Talk about clueless! Aside from the deaths of the innocent and the costs in the millions to the people who loved these pets, this was massive consumer fraud and just the tip of the iceberg as far as what we’ve learned since about a non-functioning federal bureaucracy unable to protect our country — so much for homeland security! — from deadly imports.

Thanks, Mike, for tipping us. From Newsday:

CAMDEN, N.J. - Details of a legal settlement over contaminated pet food blamed for the deaths of perhaps thousands of dogs and cats are to be made public on Wednesday.

Around 300 pet owners have sued Streetsville, Ontario-based Menu Foods Income Fund in U.S. District Court since the contamination was discovered more than a year ago.

The company announced on April 1 that it was settling lawsuits with pet owners in the U.S. and Canada, but terms were not disclosed.

Details of the deal were due in U.S. District Court in Camden on Tuesday, but lawyers in the case asked for a 24-hour extension. A hearing on the settlement agreement is scheduled for May 30.

“Perhaps thousands.” Thanks, Newsday, and ain’t that better than whatever crap the FDA is still handing out?

We’ll update as we can.

And also, this incredible piece Therese has on her PetsitUSA blog:

For her science fair project, a seventeen year old high school student from Mississippi developed a faster, less expensive way to detect chemicals such as melamine & cyanuric acid in pet (and other) food. Natalie Saranga Omattage won a $50,000 scholarship for her efforts.

More here.

In more wonky news, an interesting article in Chemical & Engineering News was just released last week. (Shut up. I like science journals.)

It contains a pretty good comprehensive timeline of last year’s pet food recall, with a focus on the scientific detective work that finally led to the identification of the contaminants responsible for so much animal sickness and death:

FDA, which regulates the manufacture and distribution of animal food and drugs, logged more than 18,000 phone calls after the recalls were announced. “This was the largest recall in FDA history,” says Tolleson, who works in the agency’s National Center for Toxicological Research (NCTR) in Jefferson, Ark. “There were more calls to FDA over this issue than anything we’ve ever handled before.”

They peg the number of dead animals at “as many as 1,000,” relying on the survey information released by the American Association of Veterinary Laboratory Diagnosticians. However, that survey is not complete, nor was it designed to elicit any kind of final or total number of dead pets. The actual number is undoubtedly much larger, based on numbers from the Veterinary Information Network, Banfield the Pet Hospital, and our own database. However, it’s still much more accurate than the 12-14 we used to see so much of.

The article goes on to recap the 2004 recall (which we covered here) that turns out to have been an earlier melamine-related incident, although blamed at the time on mycotoxins.

Sadly, the 2007 incidents might not have been the first. A 2004 outbreak of kidney failure that reportedly struck thousands of dogs and cats in Asia originally was attributed to contamination of pet food ingredients by fungal toxins. But University of Georgia veterinary pathologist Cathy A. Brown and colleagues reported in September 2007 that they had found “compelling evidence” in tissue samples from autopsies of affected pets that both outbreaks were caused by the same toxic chemical combination (J. Vet. Diagn. Invest. 2007, 19, 525).

In the “Pet Food CSI” department, the article discusses some of the science used to identify melamine and cyanuric acid in the foods, and the distinguishing crystals they form in dogs’ and cats’ kidneys:

On March 30, FDA and Cornell University—whose animal health experts had been enlisted in the investigation by Menu Foods—announced that they had independently identified melamine as a contaminant.

[....]

The finding was a bit mysterious because the small amount of information available in the scientific literature indicated that melamine wasn’t particularly toxic.

FCC staff next examined samples of the suspect wheat protein concentrate under a light microscope and separated out what appeared to be foreign particles. Fourier transform infrared and Raman spectra of the particles, as well as DART and GC-MS, confirmed the presence of melamine. FCC’s analysis also unearthed further triazine contaminants, particularly cyanuric acid. [The FDA's R. Duane] Satzger says that total adulterant levels in the protein concentrate ran as high as 25% by weight.

Why was tracking down the contaminants so difficult?

The DART technique is much quicker than GC-MS because it requires no sample preparation, Satzger notes, but it depends on expensive equipment that’s not widely available. Throughout April 2007, FCC scientists labored to develop a GC-MS method to rapidly screen pet food samples—one that could be replicated in other labs across the country with commonly available instrumentation. One challenge involved finding a way to test for multiple triazines, which have widely varying solubilities, in a single run. FCC researchers working in collaboration with FDA’s Pacific Regional Laboratory Northwest, in Bothell, Wash., found that a solvent system of acetonitrile, water, and diethylamine did the trick.

During this same period, other FCC scientists were examining crystals from kidney tissue provided by FDA’s Rockville, Md.-based Center for Veterinary Medicine, Satzger says. Raman mapping studies indicated the crystals could be melamine cyanurate. Lab tests also showed that mixing melamine and cyanuric acid in water forms melamine cyanurate crystals.

Meanwhile, Tolleson was gathering data about the toxicity of the pet food contaminants using cultured cells from the immune system known as macrophages. He found that cyanuric acid by itself was only slightly toxic; by contrast, melamine and the combination of both compounds were toxic to the macrophages.

I tried to elicit a comment from Procter & Gamble for an earlier story of my own, and somewhat surprisingly got a very polite ” no comment.” The article gives a hint as to a possible reason:

In April 2007, Procter & Gamble toxicologist George P. Daston showed that the triazine compounds are deadly to rats when consumed in combination, Tolleson says. Rats that ate the mixture developed the same kidney disorder seen in pet cats and dogs. Neither Daston nor other P&G representatives would comment for this story because the company is involved in ongoing litigation associated with the contaminated pet food.

Regardless, the forensic scientific work continued, broadening our understanding of just what happened when these compounds were consumed in large amounts by pets:

In November 2007, University of California, Davis, veterinary toxicologist Birgit Puschner and colleagues reported on the results of feeding melamine and cyanuric acid individually and in combination to a few cats (J. Vet. Diagn. Invest. 2007, 19, 616). The researchers found that a single 32 mg/kg dose of the combination can cause acute renal failure in cats. Puschner suggested that the compounds cause renal damage at least in part through precipitation of melamine cyanurate crystals out of acidic urine in the kidneys.

“That pretty much brought the story full circle,” Tolleson says. “Melamine cyanurate was present in the contaminated raw material, it was detected in the crystals that were responsible for kidney failure, and feeding animals with melamine cyanurate reproduced the kidney toxicity.”

That’s where the science is today; now it’s time to follow the money.

While the technical studies continue, the legal and financial mess spawned by the pet food adulteration is also gradually unfolding. This February, a federal grand jury in the U.S. indicted ChemNutra and its owners; Xuzhou Anying Biologic Technology Development Co. and its Chinese owner; and the export broker Suzhou Textiles, Silk, Light Industrial Products, Arts & Crafts (SSC) and its Chinese president for their roles in the contamination scheme. SSC had obtained the contaminated wheat from Xuzhou Anying on behalf of ChemNutra. According to the indictment, the shipments were falsely labeled to avoid inspection in China. ChemNutra’s owners reportedly deny the allegations involving their company.

Menu Foods’ Henderson says it’s unlikely that customers of the Chinese companies will be able to obtain restitution because they have been shut down (C&EN, July 30, 2007, page 31). However, his firm has sued ChemNutra. Menu Foods itself faces considerable liability. The recall cost the company $54 million. Furthermore, on April 1, 2008, Menu Foods announced it had reached a tentative mediated settlement with pet owners who had filed claims against the company. A court hearing is scheduled for May 14.

The full article is here.

Tomorrow, Tuesday, May 13, 2008, in Gaithersburg, Maryland, the FDA will hold a public meeting intended to improve — excuse me, “discuss” — pet food safety standards.

As we wrote earlier this year, FDA is looking for pet food owner input on this matter prior to the meeting, and will also accept comments until June 13.

Here’s where it gets a bit tricky, however.

There has been a docket number change (new docket number is FDA-2007-N-0442), and I was not able to get a definite confirmation as to whether or not comments submitted under the old docket number (2007N-0487) are being included. Also, FDA had some problems with its online comment system.

If you submitted a comment, you can check to see if it was received here. There are currently only 23 comments listed.

I contacted FDA, and was told that if someone submitted a comment and doesn’t see it, they need to call the “reading room” and ask to have it scanned. The number is 301-827-6860.

If you want to submit a comment, it’s not easy. I know my way around the Interwebs pretty well, and it took me, oh, an hour to figure it out. But now that I’ve done that, I have a little map for you to follow.

First, go here.

There is a line that says “Meeting Being Planned to Obtain Public Input for Ensuring the Safety of Pet Food,” dated January 7, 2008. At the far right on that same line, there is a little yellow button in the “Add Comments” column. Click on it.

What is the meeting intended to cover? You can read the whole announcement here, but it’s pretty hard to slog through. Notice that the first part is aimed not at the general public but more at industry and regulatory agencies, and there’s also discussion of a second meeting about animal feed regulation on May 14. All of that is coverered before you get to the part on pet food and the kind of input they’re looking for.

Section A basically sets forth the proposal to make the labeling and other requirements of pet food match not human food, but animal feed:

(B)ecause pet food is well-integrated into the overall animal foods and feeds industry, FDA is concerned that certain new requirements, if limited to pet food only, would be impractical to implement, difficult to enforce, and would not effectively provide the safety enhancements intended by FDAAA. Furthermore, because the standards mandated by FDAAA do not currently exist for any animal food or feed, limiting new requirements to pet food only would fail to address the broader food safety concerns associated with food intended for other animal species, particularly food-producing animals.

FDA is interested in obtaining input from interested stakeholders and the public as to whether the ingredient standards and definitions and processing standards should be developed for all animal feeds. There appears to be little or no difference between ingredients intended for use in pet foods and those intended for use in other animal foods and feeds. Therefore, the agency believes the most appropriate course of action is to develop ingredient standards and definitions and processing standards for all animal feeds, including pet food. FDA believes that such an approach would more effectively carry out the safety objectives of FDAAA, and the broader human food safety provisions of the Federal Food, Drug, and Cosmetic Act.

I can now see every rancher and agribusiness interest in the country going excuse me, what? We’re supposed to label livestock feed the same way some latte-sippin’ liberal out in California needs to have their organic teacup poodle chow from Whole Foods Market labeled? Say what? Talk about de-fanging this whole proposal before it’s even in its final form.

When you get to Section B, where the considerations are actually spelled out, including things like nutritional labeling similar to what’s on human food packaging, it’s easy to see how rolling this into an animal feed regulation is going to seriously dilute what can be done to improve pet food labeling. You tell me what you think the chances are that we’re going to see livestock feed labeling issues like these be taken seriously?

1. How could the nutritional information (e.g., guaranteed analysis, nutritional adequacy statements/life-stage claims) already present on pet food labels be improved?

2. How could the ingredient information already present on pet food labels (i.e., the ingredient list) be improved?

3. How could the current feeding instructions/recommendations section already present on pet food labels be improved?

4. Should feeding recommendations be required on the labels for all types of pet food?

5. Should a Nutrition Facts box, similar to the format that appears on human food labels, replace the current Guaranteed Analysis that currently appears on pet food labels? If so, how could this Nutrition Facts box be made to clearly distinguish it from human food labeling?

6. What other information should be required on pet food labels that is not generally present on pet food products sold in the United States?

7. Are there existing state laws, regulations, guidelines, or other models that FDA should consider when drafting the proposed pet food labeling?

In case anyone’s keeping track, I am adamantly in favor of a “yes” answer to number 5. There’s no consumer-benefiting reason to use the “guaranteed analysis,” which you need a calculator to get any useful information from, instead of the simple calories per serving, serving size, calcium/fat/protein/carbohydrate per gram, and other useful, easy-to-understand facts that human food is required to include. It serves only an industry that wants leeway in what it includes in the food from batch to batch to do it the other way. It’s not acceptable to me as a consumer.

And I can’t even begin to understand why the box needs to “clearly distinguish it from human food labeling.” Huh? I don’t know, put “PET FOOD NUTRITIONAL LABEL” on it?

Section C discusses issues related to standardized ingredient definitions.

Section D returns to a discussion of combining regulation of pet food with regulation of animal feed. The basic description of animal feed systems is here, and while it’s extremely vague, it’s easy to see that simply writing one standard for both is going to make any kind of meaningful consumer reform of pet food labeling and processing far more difficult both to write and to “sell.”

Please let us know if you submitted a comment, if it’s showing up on the comments page, and your thoughts on these proposed changes.

I was shocked to get a press release from the FDA that started out with these words (emphasis mine, but the missing period is theirs):

The U.S. Food and Drug Administration today issued a final regulation barring certain cattle materials from all animal feed, including pet food. The final rule further protects animals and consumers against bovine spongiform encephalopathy (BSE, also known as “mad cow disease”)

Can you imagine them even thinking about, let alone mentioning, pet food before the pet food recall? In the very first sentence, even.

The rest of the release was the usual kind of thing… blah blah, risk of BSE in the United States incredibly low, in fact, so low it’s amazing we’re wasting your time doing this, and please don’t look at the man behind the curtain fact that we actually prohibit farmers from testing their livestock for BSE in the first place, but honestly we care about you and your pets just not as much as agribusiness.

The entire release is under the jump. (more…)