Third party certification: FDA final guidance

Valerie of the Fresh Produce Industry Discussion Group linked first to this press release from the FDA today. Looks like all third party inspectors, including state and federal government, are cut in to the deal. I've lopped off parts of the news release that don't apply to food....Look for more reaction/analysis tomorrow.

The U.S. Food and Drug Administration today issued three guidances designed to help ensure the safety of FDA-regulated products in the supply chain. The documents issued today include the following:

• Final Guidance for Industry on Voluntary Third-Party Certification Programs for Foods and Feeds;
• Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories; and
• Draft Guidance for Industry on Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages.

"The guidance documents reflect the FDA's continued vigorous efforts to minimize the chances of unsafe products reaching American consumers," said Jeffrey Shuren, M.D., J.D., associate commissioner for policy and planning.

The Final Guidance for Industry on Voluntary Third-Party Certification Programs for Foods and Feeds discusses the attributes of a third-party certification program that would merit the FDA's confidence in the quality of the program's audit. The guidance, finalizing a draft published on July 10, 2008, is intended as one of the steps in the FDA's future recognition of voluntary third-party certification programs for foods and animal feeds. The document makes clear that it applies to any third-party certification body, including a private entity or a non-FDA federal, state, local or foreign regulatory body. Third-party certification programs can augment the ability of the FDA and the importing community to verify product safety.

Final Guidance for Industry on Voluntary Third-Party Certification Programs for Foods and Feeds: http://www.fda.gov/oc/guidance/thirdpartycert.html

Slow pay and trust rights and other top headlines for Jan. 15

Talking to a couple of industry lobbyists today, there appears to be some talk of a regulatory fix to what may be a court weakening of PACA trust rights. Basic issue, as I understand it at this point: does the extending of credit terms by a supplier weaken or remove that supplier's PACA trust rights? The USDA AMS may be able to clean up the issue with rulemaking that won't require a change in the statutory language.. Will follow up with WG, United, PMA, USDA and the "usual suspects" on this issue. The fruit and vegetable industry advisory committee may play a role in pursuing this with AMS.....

Meanwhile, here are some other headlines snatched from the Web:

Another stretching your dollars food story Here are the tips, such as they are:
1. Buy in season produce
2. Buy local produce
3. Shop for deals
4. Choose frozen over canned
5. Use staples as a base

Healthy snacks improve kids' diet Pivonka quoted

10 food choices to keep you slim, strong and solvent You are curious, I know. Here are all produce related choices:

1. Potatoes
4. Frozen veggies
5. Cabbage
8. Bananas
9. Sweet potatoes


Immigration slows as downturn bites Here is the 35 page report from The Migration Policy Institute

Fresh and Easy expansion to create 200 jobs

Foreclosures up 81% nationwide in 2008 Ugg...
Foreclosure filings were reported on more than 303,000 U.S. properties in December 2008, up 17 percent from the previous month and nearly 41 percent from December 2007.

World cocoa foundation sets sustainability standard The three p's of plant, profit and people - not necessarily in that order?

Leading nutrition expert comes to N.C. research campus Dr. Sangita Sharma comes to the campus David Murdock built

Citrus pest threatens California crops preparing for the dread pest

Keystone Alliance defines sustainability A competitor to the Stewardship Index?
Find the link here. NPC, American Farm Bureau among participants.

Cash for clunkers Congress considering vouchers of $4,500 to prime the car selling pump

House Democrats propose stimulus bill $825 billion bill expected to be ready for passage by mid-February\

Ten tax hike threats in the new Congress Human Events feature; hold on to your wallets

Redlands strives to keep citrus heritage But with declining capacity, is citrus still profitable?

Minnesota settles lawsuit with Wal-Mart state receives $14 million out of $54 million settlement

Women accused of running prostitution ring from USDA office Definitely over the line, I'd say

Lee Scott of Wal-Mart says consumers, small businesses are pinched Scott says:
“If you’re out walking stores, it’s clearly a deep recession. I have no idea how long it’s going to last.”

Wal-Mart promotes energy efficiency in Central America

Grocer to flag healthful foods Supervalu's good for you initiative. From the story:
Set for roll out at 1,300 stores in the next six months, the program will place tags of various colors next to the bar code and product price, communicating that a product meets U.S. Food and Drug Administration criteria with nutrient content. For example, foods that are excellent or good sources of fiber are given orange tags, while products with low saturated fat will carry a red tag. It is possible for one product to meet multiple criteria and have more than one colored stripe.

It is always darkest before the dawn

The sun will come out tomorrow, right? Like the senator from Illinois appointed by the corrupt (allegedly) Chicago mayor, we can say: "It is always darkest just before the dawn." I can't actually believe that Illinois Senator designate Roland Burris used that tired cliche, but we may be in store for many more cliches, or newly minted cliches-to-be, with President Obama's inaugural speech.

Check out this Web site on cliches. From that Web site, a reflection on Kennedy's legacy:

Now don’t get me wrong, I’m just as patriotic as the next intoxicated monster truck driver, but I also have a deep and abiding hatred of cliches, and Mr. Kennedy created a species of cliche that has since grown popular enough to strangle a whole truckload of bay pigs. I’m talking about the form of truism that says: x followed by y equals a commonly accepted truth, but y followed by x yields a deeper truth made more profound by its juxtaposition with x followed by y.

People say things like “No one cares how much you know until they know how much you care” and everyone is supposed to furrow their brows and nod their heads furiously as if this were the deepest, most interesting thing they’ve ever heard. “It’s nice to be important, but it’s more important to me nice.” OMG! You’re so right! Here this whole time I’ve been thinking it’s kind of enjoyable being thought of as important, but YOU’RE SO RIGHT! I need to focus more on treating others with kindness and compassion and less on others perceiving me as superior.

To shed further light on the pithy banality of these proverbs, I thought we might create some of our own. You can use this form to say just about anything, while somehow managing to say nothing at all.

TK: How about these:

Local is the new organics, but the old organic is the new local.

While all we have to fear is fear itself, fear itself is pretty scary.

Those who fail to plan, plan to fail except sometimes when they fail to plan and they somehow succeed.

Times they are a changing, and change is all about timing.

It is always darkest before the dawn, but it is always brightest way before sunset.

You can take the consumer out of the produce department, but you can't take the produce department out of the consumer.

Any others out there, readers....

Marler: This should be done

Bill Marler passed on these thoughts concerning the salmonella outbreak linked to peanut butter.


People should not die from eating peanut butter. According to the Brainerd Dispatch and AP, health officials in Idaho and Minnesota are reporting two more deaths associated with a nationwide salmonella outbreak that has sickened more than 425 people in 43 states. That brings the total number of people who had salmonella when they died to five.

So, when is FDA, CDC, King Nut and Peanut Corporation of America going to respond?

1. Make sure ALL product is promptly recalled;
2. Do not destroy any documents;
3. The companies should pay the medical bills and all related expenses of the innocent victims and their families;
4. The companies should pay the cost of all related Health Department, CDC and FDA investigations;
5. Provide all bacterial and viral testing of all recalled product and any other tested product (before and after recall);
6. Release all inspection reports on the plants by any Governmental Entity or Third-party Auditor;
7. Release all Salmonella safety precautions taken by either King Nut or Peanut Corporation of America - especially after the 2007 Salmonella Peanut Butter Outbreak;
8. Provide the public with the Epidemiological investigation (with names redacted), so it is clear who knew what and when about the likely source of the outbreak; and,
9. Show the public what is being done to prevent the next outbreak.

The families of five dead people are waiting.


William D. Marler, Esq.
Marler Clark LLP PS
6600 Columbia Center
701 Fifth Avenue
Seattle, Washington 9810

COOL Final rule

The USDA has issued its final rule on country of origin labeling, and here is some coverage in the consumer press:

Canada shelves WTO complaint over U.S. meat rules Canada pleased with relaxation of COOL rules for meat


Final country of origin labeling law draws criticism: From Bloomberg, the lede:

Longtime supporters of U.S. regulations requiring meat and fresh produce to be labeled by country of origin say the government’s final rule on the matter doesn’t do enough to distinguish U.S. meat from competitors.

TK: No mention of produce provisions; focus on meat

Secret ingredients From Seattle PI, a blog quoting Food and Water Watch

The USDA definition exempts from labeling over 60 percent of pork, the majority of frozen vegetables, an estimated 95 percent of peanuts, pecans and macadamia nuts, and multi-ingredient fresh produce items, such as fruit salads and salad mixes.

"It is inexcusable to exempt so much food from this basic labeling requirement just because one ingredient has been added or because something has been roasted or cooked," Hauter says.

TK: United Fresh Produce Association earlier issued a member communication that identified revisions included in the final COOL rule: From United:

• USDA is barred from requiring any new record-keeping other than normal records kept during the regular course of doing business.
• A new specific provision will allow labeling of a U.S. State, region or locality in which a product is produced to meet label standards as a product of the U.S. Therefore, a descriptor such as "Minnesota Grown" or "Pride of New York" would be sufficient labeling to comply with the law.
• The potential liability for retail mistakes or absence of labeling at point of purchase has been significantly reduced.
• Retailers will not be liable for misinformation provided by suppliers.
• All proposed fines on either retailers or suppliers who are found to be "willfully violating" the Act are subject to a hearing before USDA, and are limited to $1,000 for each violation.

TK: Big Apple published the final rule on COOL in the Fresh Produce Discussion Group. Find it here.