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I don’t track legislation very carefully because bills change so much between the time they are proposed and actually pass.  But I keep getting asked about the bills that seem to have the best chance this year,  H.R. 2749 (which has just been passed by the House) and its equivalent in the Senate, S. 510 (still in the works).  The bills are quite similar.  Both aim to fix the FDA.   Neither aims to fix the system, so forget about combining the food safety functions of USDA and FDA into one agency.  The bills bring the FDA’s rules closer to those of USDA, as they propose science-based food safety standards (much like HACCP) from farm to table.  Best, they give the FDA recall authority as well as a few other goodies.

The bills themselves are miserable to read and it is hard to believe that anyone in government does.  That is why the Congressional Research Service (CRS) does summaries that even legislators can understand.  CRS researchers have now produced blessedly short and hopefully accurate summaries of the House bill as well as the Senate bill.

As my contribution to the cause of clarity, I have done a quick edit of the CRS summaries, with comments in Italics.  The links above are to the original bills so you can plow your way through them to see if this does them justice.   Enjoy!

THE HOUSE BILL, H.R. 2749, requires each food facility to:

(1) Conduct a hazard analysis, (2) Implement preventive controls, and (3) Implement a food safety plan. [This sounds like HACCP, although they aren’t calling it that. I vote yes]

Requires FDA to:

(1) Issue science-based performance standards to minimize the hazards from foodborne contaminants [this means HACCP or its equivalent, and about time too],

(2) Establish science-based standards for raw agricultural commodities [this means some version of farm-t0-table HACCP, long awaited],

(3) Inspect facilities at a frequency determined pursuant to a risk-based schedule [this is an admission that the FDA can’t handle the work load; it will focus on products most likely to be contaminated]

(4) Establish a food tracing system [this will help identify where foods come from]

(5) Assess fees relating to food facility reinspection and food recall [make companies pay for all this, I hope in a way that avoids conflicts of interest],

(6) Establish a program for accreditation of laboratories that perform analytical testing of food for import or export [can’t believe we don’t already have this, but that’s why we need this legislation].

Authorizes FDA to:

(1) Order an immediate cessation of distribution, or a recall, of food [recall authority at last!]

(2) Establish an importer verification program [accountability for importers, at last!]

(3) Quarantine food in any geographic area within the United States [they can’t do this now?].

Defines the term “color additive” to include carbon monoxide that may affect the color of fresh meat, poultry products, or seafood [this will have to meet food additive regulations].

Requires country of origin labeling on food, and annual registration of importers [Yes!].

Provides for unique identifiers for food facilities and food importers [so FDA actually knows who they are].

Deems a food to be adulterated if an inspection is delayed or refused [Yes!].

Requires FDA to establish a corps of inspectors dedicated to inspections of foreign food facilities [Amazing that we don’t already have this].

Reorganizes the FDA field laboratories and district offices [Could this possibly be a euphemism for closing some?].

Gives the FDA Commissioner subpoena authority [Yes!].

Establishes whistleblower protections [OK].

THE SENATE BILL, S. 510, is pretty much the same except that it addresses food bioterrorism [fortunately, a rare event so far]. In addition to most of what is in the House bill, it requires HHS and USDA to prepare the National Agriculture and Food Defense Strategy [If this is done right, it ought to promote the safety of domestic foods and imports].

It also requires FDA to:

(1) Identify preventive programs and practices to promote the safety and security of food [worries about food bioterrorism again];

(2) Promulgate regulations on sanitary food transportation practices [good idea];

(3) Develop a policy to manage the risk of food allergy and anaphylaxis in schools and early childhood education programs [I’m not sure how this got in here]

Requires FDA and CDC to enhance foodborne illness surveillance systems [Good idea].

Requires EPA to assist state, local, and tribal governments in preparing for, assessing, decontaminating, and recovering from an agriculture or food emergency [in the military sense of food security].

There is much, much more in these bills.  Bill Marler, who has actually read the bills, has produced his own summary, which includes definitions and more.  If you are wondering what implementation of these bills might cost, the Congressional Budget Office has done an analysis: a mere $2 billion.

It’s hard to know how seriously to take all this until we see what Congress actually does when it gets back to work.  Stay tuned.

There is so much wrong with bottled water that it’s hard to know where to begin (read Elizabeth Royte’s Bottlemania, for starters).  But let’s start with the fact that bottled water is the most brilliantly marketed product ever invented.  The companies get it practically free out of a tap and charge you a dollar or more – sometimes a lot more – for a quart or less).  The plastic bottles pollute the environment.  Worst of all, drinking bottled water makes people less apt to be vigilant about protecting public water supplies.

And it isn’t even regulated very well, or so says a report from the Government Accountability Office.  The title says it all: “Bottled water: FDA safety and consumer protections are often less stringent than comparable EPA protections for tap water.”  The report was released in time for congressional hearings on the topic.   Reporters had a lot of fun with the self-interested statements of industry people who testified.

None of this gets into the additional question of bisphenol A and other endocrine disrupters in plastic bottles that are sometimes used for water.  The Canadians are now saying that bisphenol A is safe at amounts commonly used, and so is a California expert committee.  The American Chemistry Council is pleased with these decisions.

Where does that leave us?  Defend tap water!  As for endocrine disrupters, stay tuned but why use bisphenol A when other alternatives are so readily available.

July 24 update: The International Bottled Water Association is suing a maker of steel water bottles for false advertising.  The bottle maker’s ads apparently suggested that plastic water bottles leak synthetic estrogens.   Bisphenol A must be causing serious problems for the bottled water industry, along with all those pesky enviromental concerns.

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.

Legislators in the new administration are working on food laws.  Here is a quick sample:

Calorie labeling: it looks like we have bipartisan support for national menu labeling.  If passed, calories will have to be disclosed on menu boards of fast food and vending machine chains throughout the country – and not just in New York City and the few states that have passed their own laws.   Lots of health organizations are backing this proposal.

Food safety: the House just passed its version of a bill that will overhaul some aspects of the present food safety system.  This bill still has a long way to go but is a hopeful sign that Congress might actually do something to fix the FDA.  What the bill does not do is deal with fixing the system.  It exempts meat, poultry, and eggs under USDA jurisdiction.

Produce safety: The new head of the FDA, Margaret Hamburg, says her agency is going to put special efforts into ensuring the safety of high-risk produce. To do that, she will need Congress to pass laws that, among other things, give the FDA the authority to order recalls and a lot more money to carry out its work.

Organics: The U.S. and Canada have agreed to coordinate their organic standards, so foods certified organic in Canada can be sold here and vice versa.  Let’s hope the most stringent standards prevail.

These are (somewhat) hopeful signs.  Let’s hope Congress manages to keep at this and tries to get it right.

Keeping up with BPA is a headache.  BPA, you may recall from previous posts, is an endocrine disrupter increasingly associated with developmental disorders in experimental animals and with heart disease and diabetes in humans.  Is it OK to feed infants out of plastic bottles or not?

A new study out of Harvard says that BPA leaches out of plastic bottles even when what is in them is cold.  This, according to the investigators, means that even more BPA will get out when bottles are heated, as is typical of infant formulas.

But European and British Food Standards Agencies say they see no reason to review their previous decision that BPA is safe at current usage levels.

In contrast, the FDA has just announced that it intends to take another look at its previous judgment that BPA is safe.  This action is viewed as evidence that the new FDA Commissioner, Margaret Hamburg, means it when she says the agency’s decisions will henceforth be based on science, not politics.

As for the politics: the chemical industry says Chicago’s ban on plastic baby bottles and sippy cups is scientifically absurd.  And another industry group firmly denies that it was involved in a disinformation campaign using pregnant women to promote the safety of BPA.

Expect more of the same while waiting for the results of the FDA’s ongoing research review.  And in the meantime, why not switch to glass bottles for infant feeding (or breast feed for that matter)?

If the FDA is now going after health claims (see yesterday’s post), will it also start going after dietary supplements?  These, as I explained in my most recent column in the San Francisco Chronicle, get to make all kinds of unsubstantiated claims without the FDA being able to do much about them.  More and more evidence is coming in suggesting that supplements can be harmful as well as ineffective.   The latest example: antioxidant supplements are said to interfere with the beneficial effects of physical activity.    Will such studies encourage the FDA to insist that manufacturers demonstrate safety and efficacy before they put supplements on the market?  That would be a refreshing change, no?

It looks like the FDA is finally getting around to looking at the absurd health claims on boxes of breakfast cereals.  And about time too, I’d say.  For starters, the FDA picked on General Mills’ Cheerios.  Cheerios boxes display banners claiming that if you eat this cereal, you will reduce your cholesterol by 4% is 6 weeks (see previous post on this).  This, General Mills says, is “clinically proven.”  Yes, but the trial on which General Mills bases this claim substitutes one serving of Cheerios for each of two meals a day.  Hey – that ought to work!

In its warning letter, the FDA says that if Cheerios lowers cholesterol, it is claiming to work like a statin drug.  If Cheerios acts like a drug, it has to be treated like a drug.  Cheerios, says the FDA, “is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease. Therefore…it may not be legally marketed with the above claims in the United States without an approved new drug application.”

So what’s going on here?  I collect cereal boxes and I’m guessing that I bought the one shown here at least two years ago.  The boxes have changed since then but similar claims appear on the Cheerios website.  Maybe in this new administration the FDA can get a grip on silly and misleading health claims.  Let’s hope.

Update May 18: Advertising Age advises marketers about how to avoid FDA interference: know the rules, don’t assume that breaking them is OK even if you have done so for a long time, follow the rules.  Seems like good advice.

Update May 25: Europeans applaud this FDA action. They think we have gone much too far with health claims.

Update January 18, 2010: At a visit to the FDA last week, I saw a more recent Cheerios box that I somehow missed – lower your cholesterol by 10% in one month.  This one disappeared quickly, but I found a good description of what happened on the Consumer World Mouse Print site.  General Mills sponsored a study and rushed the box into print.

According to the Associated Press, Margaret Hamburg “breezed through” her Senate confirmation hearing yesterday.  Great news, and I was pleased to hear that she thinks food safety is a top priority. So what’s the hold up?  Everybody – even Senator Ted Kennedy – knows food safety is in crisis and needs strong leadership to get the system under control.  Why can’t Congress approve her appointment right away and send her off to work?  Don’t you think something is seriously wrong with a political system that holds food safety hostage to partisan politics? Let Congress know you want action in this area!  Tell them to approve this appointment now!