by Marion Nestle

Search results: fda new food safety rules

Aug 12 2009

What the FDA is doing while waiting for Congress to get busy

The FDA must be in a bit of a quandary as it waits to see what Congress orders it to do about food safety (see previous post).  But it is not sitting around doing nothing.  Instead, it seems to be unblocking regulations that have been in the works for a long time.

On July 9, the FDA announced a final rule for prevention of Salmonella Enteriditis contamination of shell eggs during production, storage, and transportation.  This might seem unremarkable except for two points: (1) it requires science-based food safety procedures – with pathogen testing – from farm to table (an all-time first), and (2) it was first proposed in 2004 and has been stuck ever since (that’s politics for you).

On July 31, the FDA proposed safety guidance for melons, tomatoes, and leafy greens that would apply to everyone involved in the supply chains for these foods – growers, packers, processors, transporters, retailers, and others.  Guidance, alas, is just that: voluntary.  But this puts the producers of such foods on alert that the guidance could swiftly turn into rules  if Congress gets busy and does what it ought to be doing about food safety.  The guidance is open for comment but it is designed to be implemented within two years.  This is quick in FDA regulatory time.

And now the FDA announces that it is speeding up its system for issuing warning notices to companies in violation of safety regulations.  This is a good step, although it falls far short of recall authority.  For that, Congress must act.

Applaud the FDA and keep fingers crossed that no new outbreaks occur while Congress takes its own sweet time to act.

Jul 7 2009

Michael Taylor appointed to FDA: A good choice!

On Monday this week, Michael Taylor began his new job as special assistant to the FDA Commissioner for food safety.  He will be in charge of implementing whatever food safety laws Congress finally decides to pass.

I know that what I am about to say will surprise, if not shock, many of you, but I think he’s an excellent choice for this job. Yes, I know he worked for Monsanto, not only once (indirectly) but twice (directly). And yes, he’s the first person whose name is mentioned when anyone talks about the “revolving door” between the food industry and government. And yes, he signed off on the FDA’s consumer-unfriendly policies on labeling genetically modified foods.

But before you decide that I must have drunk the Kool Aid on this one, hear me out.  He really is a good choice for this job.  Why?  Because he managed to get USDA to institute HACCP (science-based food safety regulations) for meat and poultry against the full opposition of the meat industry — a truly heroic accomplishment.  His position on food safety has been strong and consistent for years.  He favors a single food agency, HACCP for all foods, and accountability and enforcement.  We need this for FDA-regulated foods (we also need enforcement for USDA-regulated foods, but he won’t be able to touch that unless Congress says so).  So he’s the person most likely to be able to get decent regulations in place and get them enforced.

I say this in full knowledge of his history.  In the 1990s, Mr. Taylor held positions in both FDA and USDA and his career in these agencies is complicated.  As I explained in my 2003 book, Safe Food  (see the endnotes for full documentation), Mr. Taylor began his career as a lawyer with the FDA. When he left the FDA, he went to work for King & Spalding, a law firm that represented Monsanto, the company that developed genetically engineered bovine growth hormone (BGH), corn, and soybeans.

He revolved back to the FDA in 1991 as deputy commissioner for policy, and he held that position during the time the agency approved Monsanto’s BGH. At the time of the review, he had been with FDA for more than two years. This made him exempt from newly passed conflict-of-interest guidelines that applied only to the first year of federal employment.  He also was a coauthor of the FDA’s 1992 policy statement on genetically engineered plant foods, and he signed the Federal Register notice stating that milk from cows treated with BGH did not have to be labeled as such.

For whatever it is worth, a 1999 lawsuit and GAO report revealed considerable disagreement about these decisions within FDA. These also revealed that Mr. Taylor had recused himself from matters related to Monsanto’s BGH and had “never sought to influence the thrust or content” of the agency’s policies on Monsanto’s products.  I can’t tell whether there were ethical breaches here or not, but there is little question that his work at FDA gave the appearance of conflict of interest, if nothing more.

But wait! Watch what happened when he moved to USDA in 1994 as head of its Food Safety and Inspection Service (FSIS). Just six weeks after taking the job, Mr. Taylor gave his first public speech to an annual convention of the American Meat Institute. There, he announced that USDA would now be driven by public health goals as much or more than by productivity concerns. The USDA would soon require science-based HACCP systems in every meat and poultry plant, would be testing raw ground beef, and would require contaminated meat to be destroyed or reprocessed. And because E. coli O157.H7 is infectious at very low doses, the USDA would consider any level of contamination of ground beef with these bacteria to be unsafe, adulterated, and subject to enforcement action.  Whew.  This took real courage.

The amazing thing is that he actually made this work.  Now, HACCP rules apply more to USDA-regulated products than to FDA-regulated products. This new appointment gives Mr. Taylor the chance to bring FDA’s policies in line with USDA’s and even more, to make sure they are monitored and enforced.

In Safe Food, I summarize Mr. Taylor’s position on food safety regulation from 2002. Then, he argued for, among other things:

  • A single agency accountable for providing consistent and coordinated oversight of food safety, from farm to table.
  • Institution of Pathogen Reduction: HACCP, with performance standards verified by pathogen testing, at every step of food production.
  • Recall authority, access to records, and penalties for lapses in safety procedures.
  • Standards for imported foods equivalent to those for domestic foods.
  • Food safety to take precedence over commercial considerations in trade disputes.

Yes, he revolved back to Monsanto after leaving FDA but he didn’t stay long. He left Monsanto for Resources for the Future, a think tank on policy issues.   In 2007, he went to academia and joined the food policy think tank (see his bio) at George Washington University.  There, he produced the excellent food safety report I mentioned in a previous post, which repeats these points. This is about as good a position on food safety as can be expected of any federal official.

I wish him all the luck in the world in getting the safety of FDA-regulated foods under control. For those of you who are still dubious, how about giving him a chance to show what he can do?  But do keep the pressure on – hold his feet to the fire – so he knows he has plenty of support for doing the right thing.

[Posted from Skagway, Alaska, en route to Fairbanks]

Mar 28 2009

Fixing the food safety system: new ideas

The Trust for America’s Health and the Robert Wood Johnson Foundation announce the release of a new report on how to fix the food safety system.  The report, Keeping America’s Food Safe: A Blueprint for Fixing the Food Safety System at the U.S. Department of Health and Human Services (HHS), makes a bunch of suggestions for strengthening the FDA.  The FDA, it says, needs to concentrate resources on the highest risks, enforce existing rules (what a concept), establish a position with authority over all food safety programs in the agency, and work with Congress to establish a Food Safety Administration within HHS.

Wait a minute: I thought two agencies were involved in food safety regulation.  Yes, HHS regulates most foods through the FDA, but the USDA regulates meat and poultry.  These are not two separate food systems. Wastes from food animals (USDA-regulated) contaminate fruits and vegetables (FDA-regulated).

Don’t we need one system?  I think we do.

And buried in the mess of bills submitted to Congress and currently under consideration (handily summarized by Bill Marler), are several aimed at doing just that.  This is a great time to weigh in on them, especially since polls show that nearly 75% of Americans are more afraid of food than they are of terrorists.

Mar 5 2009

Food Safety Legislation: Fix FDA vs. Fix the System?

Senator Dick Durbin (Dem-IL) has introduced The FDA Food Safety Modernization Act to give this beleaguered agency the tools and resources to do its job properly.  The proposed Act got immediate endorsements from food industry trade groups: grocery manufacturers, producers of fresh vegetables, and producers of frozen foods, for example.

How come food lobbying groups suddenly want a stronger FDA?  No doubt because the alternative is a single food safety agency that would impose real rules with real teeth, and would oversee the safety of food from farm to table.  Rosa DeLauro introduced just such a bill in the House.

And how’s this for today’s rumors (most definitely unconfirmed): Michael Osterholm is up for USDA undersecretary for food safety and Michael Taylor for head of the White House Office of Food Safety.  Caroline Smith DeWaal, a strong consumer advocate for foods safety is out of the running; she works for Center for Science in the Public Interest (CSPI).  These are just rumors.  If they turn out too be true, I will have more to say about the potential nominees.

Feb 2 2009

Food industry wants stronger FDA?

Food safety must be becoming a huge problem for the food industry.  A group of ten food trade associations, one of them the Grocery Manufacturers of America, is calling on Congress to give the FDA the resources and power to impose stronger food safety regulations.  Really?  Have food companies finally figured out that a strong FDA would be good for business (consumer confidence, level playing field)?  Or are they thinking that this will give them the chance to write the regulations?

Apr 1 2008

Your thoughts on FDA’s food protection plan?

The FDA is seeking public comment – that means you – on its food protection plan announced late last year. The request for comment points out that we now get our food from 150 countries through 300 ports-of-entry, and that imported foods account for 15% of all foods by volume, 60% of fresh fruits and vegetables, and 75% of seafood. Gulp. Here’s your chance to say what you think the FDA should be doing to ensure the safety of the food supply, domestic and imported. How about standard food safety rules (of the HACCP and pathogen reduction type) from farm to table, for starters? Just dreaming….

Jul 27 2007

Bored With Food Recalls? You Are Not Alone

On July 18 and again on July 21, the FDA announced a recall of canned chili and other foods, including pet foods, produced by Castleberry’s Food Company in Georgia because they made four people sick from botulism. Now the FDA and USDA have issued guidance to companies for proper handling of foods to prevent botulism, which can be fatal.

I don’t understand why people aren’t demonstrating in the streets for better oversight of food safety. Botulism used to be a big problem in low-acid canned foods until the FDA issued rules for dealing with them properly. If it’s still a problem, it’s either because companies are not following standard food safety procedures or because their systems failed and nobody noticed. We do not have a food safety system in this country that requires every food product made or imported into this country to be produced under standard food safety rules, monitored and enforced, from farm to table. I think we need them. Now. The endless “recalls” (in quotation marks because they are voluntary, unenforceable, and never able to get back more than a fraction of the products out there–they are still on shelves according to USA Today) may be endlessly boring but they ought to be inducing outrage–and lots of expressions of outrage to congressional representatives (easy to contact).

Feb 1 2024

Cultured meat: of great interest, still not on market

Cell-Based or Cultured Meat continues to generate predictions, positive (new products, new approvals, growth) and negative (doom, bans).

Current status: The FDA and USDA have approved sales of cell-cultured chicken but the only place selling it is Bar Crenn in San Francisco (where I have not been).

While waiting for it to get scaled up (if this ever will be possible), here are a few items I’ve collected recently.

THE POSITIVES

THE NEGATIVES

THE QUESTIONS