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Sunday’s New York Times has not one but two articles about “functional foods,” those with something added over and above what’s in the food in the first place.

A front-page story, “Dessert, laid-back and legal,” describes brownies.  No, not brownies laced with marijuana.  This time they contain the sleep-inducing drug melatonin.

The brownies, according to the Times, contain just as much melatonin as are found in drug pills but are cheaper and can be purchased with food stamps (another reason for taking a look at the whole question of SNAP benefits?).

Since melatonin is a drug and not an approved food additive, the makers of these products are trying to get around the annoying FDA restrictions by marketing the brownies as “dietary supplements.”  Supplements, by order of Congress when it passed the Dietary Supplement Health and Education Act (DSHEA) of 1994, do not have to meet FDA’s rigorous scientific criteria for safety or efficacy.

DSHEA applied to supplements, not foods, but the FDA has chosen to regulate foods containing such additives by the weaker rules applying to supplements and to deal with them as a regulatory gray area.   Is melatonin a drug, a supplement, or in brownie from a food?  The FDA is going to have to decide this, and fast.

A much longer story in the business section, “Foods with benefits, or so they say” (in which I am quoted) focuses on the entire point of functional foods: the ability to put something in a product that allows you to market it using health and wellness claims.  Health claims sell food products.  People like buying products with a “health aura,” no matter how poorly the health claim is supported by science.  Science is irrelevant here.  Marketing is what’s relevant.

As I discuss in my book, Food Politics, until the early 1990s, the FDA did not allow health claims on food products.  Claiming a specific health benefit for a food, said the FDA, meant that the food was being marketed as a drug.  If a food was being marketed as a drug, it needed to prove safety and efficacy, something no food maker wanted to do.

When Congress passed the Nutrition Labeling and Education Act in 1990, it struck a deal with the food industry.  The industry was objecting that because Nutrition Facts labels required them to say what was bad about their products, they ought to be allowed to say what was good about them.  Congress agreed, and forced the FDA to review the science linking certain food ingredients to health benefits as a basis for permitting health claims.

The FDA approved some claims but rejected others.  The rejected companies took the FDA to court, and the courts mostly ruled in favor of the companies on the grounds of the First Amendment.  The FDA stopped trying to control unsupported health claims and only recently has taken then on again.

But as sales soar, federal regulators worry that some packaged foods that scream healthy on their labels are in fact no healthier than many ordinary brands. Federal Trade Commission officials have been cracking down on products that, in their view, make dubious or exaggerated claims. Overwhelmed regulators concede that they are struggling to police this booming market, despite recent settlements with makers of brands like Kellogg’s Rice Krispies and Dannon’s Activia, which the authorities say oversold their health benefits.

To the distress of international food marketers, the U.S. currently has much looser regulations about health claims than are available in Europe.  The European Food Safety Authority has been reviewing thousands of petitions for health claims on food products and turning most of them down as scientifically unsubstantiated.  That doesn’t stop American food makers from loading on the claims.

From the ivory tower in which I sit, the remedy is easy: don’t allow health claims on processed foods at all.  The claims are all inherently misleading, as would be obvious if you gave it a minute’s thought.

But if they aren’t worth much to you, they are worth plenty to the marketers of processed foods.  And that’s what this is really about.

Thanks to FoodSafetyNews for the heads up on the latest Government Accountability Office(GAO) attempt to get Congress to consolidate federal food safety functions on one agency.

The GAO’s latest 345-page report on how the federal government can save money lists its proposals in alphabetical order by area.  Agriculture comes first and, therefore, so does food safety.  You have to love the way GAO titles its sections: “Fragmented food safety system has caused inconsistent oversight, ineffective coordination, and inefficient use of resources.”

GAO has been saying this for 20 years.  In 1990, for example, it published reports on who does what in the federal government about food safety and the inconsistencies in oversight.

As I wrote in Safe Food: The Politics of Food Safety (2010),

Today, an inventory of federal food safety activities reveals a system breathtaking in its irrationality: 35 separate laws administered by 12 agencies housed in six cabinet-level departments….

At best, a structure as fragmented as this one would require extraordinary efforts to achieve communication let alone coordination, and more than 50 interagency agreements govern such efforts.

Among the six agencies with the broadest mandates, all conduct inspections and collect and analyze samples, and at least three–though not necessarily the same ones–have something to do with regulating dairy products, eggs and egg products, fruits and vegetables, grains, and meat and poultry.

Until recently, the system had no mission statement (for whatever such statements are worth) and it still does not have consistent rules, clear lines of authority, a rational allocation of resources, or standards against which to measure success.

With such a system, some issues–such as use of animal manure to fertilize food crops—inevitably fall between the cracks and are governed by no rules whatsoever.

Not much has changed in the subsequent 20 years, as this new report attests.  As is inevitably the case, some of the areas of overlap are simply absurd:

The 2008 Farm Bill assigned USDA responsibility for catfish, thus splitting seafood oversight between USDA and FDA. In September 2009, GAO also identified gaps in food safety agencies’ enforcement and collaboration on imported food.

Specifically, the import screening system used by the Department of Homeland Security’s Customs and Border Protection (CBP) does not notify FDA’s or FSIS’s systems when imported food shipments arrive at U.S. ports.

But the worst is the situation with shell eggs, seemingly unfixable, given the 2010 recall of 500 million eggs:

FDA is generally responsible for ensuring that shell eggs, including eggs at farms such as those where the outbreak occurred, are safe, wholesome, and properly labeled and FSIS [USDA] is responsible for the safety of eggs processed into egg products.

In addition, while USDA’s Agricultural Marketing Service sets quality and grade standards for the eggs, such as Grade A, it does not test the eggs for microbes such as Salmonella.

Further, USDA’s Animal and Plant Health Inspection Service helps ensure the health of the young chicks that are supplied to egg farms, but FDA oversees the safety of the feed they eat.

I repeat.  This is not a new issue.  The hope was that the food safety act passed in January would pave the way to establish a single food safety agency.  The GAO report, while urging its creation, doubts that it will cut costs.

But it might save lives.

I listened in on yesterday’s White House conference call announcing that President Obama would sign the Food Safety Modernization Act today.

Speakers said the new bill will give the FDA the tools and authority it needs to help prevent the CDC’s new estimates of the annual burden of foodborne illness: 48 million cases,  180,000 hospitalizations, and 3,000 deaths.

But they barely mentioned the elephant in the room: funding.  The estimated cost of the new provisions is $1.4 billion, which will certainly require new appropriations at a time when Republican lawmakers balk at the mere thought.

Fortunately, reporters pressed hard on this issue.  Where, asked Sheryl Gay Stolberg of the New York Times, is the money coming from?

The FDA’s not-quite-satisfactory answer: the agency already has resources available from increased funding over the last several years and it “will work closely with industry in partnership.”

As reporters for the Washington Post explain today:

Rep. Jack Kingston, who hopes to become chairman of the agriculture subcommittee of the House Appropriations Committee, said that “our food supply is 99.999 percent safe”….He questioned giving the agency more money.

“I think we’ll look very carefully at the funding before we support $1.4 billion,” he told The Associated Press in an interview Monday, speaking of Republicans who will control the House when Congress comes back into session Wednesday.

Lyndsey Layton of the Washington Post noted that Republicans say we already have the safest food supply in the world and don’t need more money.  What, she asked, can FDA do without additional funds?  And when?

But nobody talked about the timing.  New laws require the FDA to engage in interminable rulemaking procedures: writing rules, opening them for public comment, commenting on the comments, re-writing rules, opening them for public comment, and, eventually, arriving at final rules.

What is FDA supposed to do in the meantime?  It can move more quickly by issuing “guidance” or “interim final rules.”

I’m hoping that the FDA is ready for this and will issue such things soon.

Yesterday, the FDA announced yet another voluntary recall of eggs produced by Wright County Egg in Galt, Iowa.  The first announcement on August 13 covered 228 million eggs.  This one adds 152 million for a grand total of 380 million—so far.

In that first announcement, the Wright company said: “Our farm strives to provide our customers with safe, high-quality eggs – that is our responsibility and our commitment.”

That, however, is not how the New York Times sees it.  According to today’s account, Wright has a long history of “run-ins with regulators over poor or unsafe working conditions, environmental violations, the harassment of workers, and the hiring of illegal immigrants.”

OK, so where are we on safety regulation?  The FDA, after many, many years of trying, finally introduced safety regulations for shell eggs.  These supposedly went into effect on July 9.

I recount the history of FDA’s persistence in the chapter entitled “Eggs and the Salmonella problem” in What to Eat. Check out the table  listing the key events in this history from 1980 to 2005.  It’s not pretty.

Preventing Salmonella should not be difficult.  The rules require producers to take precautions to prevent transmission, control pests and rodents, test for Salmonella, clean and disinfect poultry houses that test positive, divert eggs from positive-testing flocks, refrigerate the eggs right away, and keep records.  These sound reasonable to me, but I care about not making people sick.

Problems with Wright County Eggs started in May before the FDA’s mandatory rules went into effect meaning that the procedures were still voluntary.  The recalls this month are after the fact.  Chances are that most of the recalled eggs have already been eaten.

The CDC is tracking this recall and has logged about 200 reports of illness associated with it so far.  It has plenty to say about Salmonella and its hazards.

According to FoodSafetyNews, the first lawsuits have been filed.

As for food safety legislation that would give the FDA the authority to handle these incidents more efficiently—and, let us hope, maybe even prevent them—it is still sitting in the Senate.  For S.510 watchers, Bill Marler has a helpful new analysis.

The recall, by the way, affects eggs sold under many different brands: Lucerne, Albertson, Mountain Dairy, Ralph’s, Boomsma’s, Sunshine, Hillandale, Trafficanda, Farm Fresh, Shoreland, Lund, Dutch Farms, and Kemps in the first round, and now also James Farms, Glenview, and Pacific Coast.

The good news is that cooking kills Salmonella.  I’m buying eggs at farmers’ markets these days.

Addition: Tom Philpott of Grist on Wright County’s unsavory history.

USDA is the agency supposedly responsible for the safety of meat and poultry.  Unlike FDA, which is responsible for the safety of just about all other foods, USDA gets to impose HACCP (science-based food safety regulations) on meat and poultry.  It just doesn’t bother to enforce its own rules.  Hence recent events:

Consumer Reports, which for decades has been testing supermarket chickens for microbial contaminants, has just  tested chickens again. Sigh. Two-thirds were contaminated with Salmonella or Campylobacter. You will be relieved to know that this is an improvement. It was 80% the last time Consumer Reports did the testing.

In an effort to get USDA and the poultry industry moving on this problem, Senator Dianne Feinstein (Dem-CA) has introduced a bill to prohibit the sale of meat that has not been certified free of pathogens. Based on what’s been happening with meat safety, I’m betting it won’t get far.

So let’s talk about meat safety.  For this, we should all be reading USA Today, which seems to be one of the last newspapers in America still funding investigative reporting.  Its latest blockbuster is an account of the 826,000-pound recall by Beef Packers, Inc. (a subsidiary of Cargill) a few months ago. The meat made at least 28 people ill as a result of infections with a strain of Salmonella Newport highly resistant to antibiotics.

That’s bad enough, but it gets worse.  Beef Packers is a major supplier of meat to the USDA’s school lunch program. But oops.  The recall covered meat sent to retailers.  It did not cover meat sent to schools. According to the intrepid reporters at USA Today, USDA bought 450,000 pounds of ground beef produced by Beef Packers during the dates covered by the recall.

USDA should have known better.  Beef Packers had a history of positive Salmonella tests but the USDA did not disclose that information. An official told USA Today that doing so

would discourage companies from contracting to supply product for the National School Lunch Program and hamper our ability to provide the safe and nutritious foods to American school children.

You can’t make these things up.  USA Today provides the documents on its site to prove it.

I missed the earlier article in the USA Today series about school lunches in general and Del Rey Tortillas in particular, a company implicated in 20 cases of school food poisonings since 2003. Check out the article’s quick facts-and-figures about school lunches, the nifty interactive timeline for the Del Rey episodes, and the raft of documents in this case.

Good work, reporters. If you want to know why we need newspapers, here’s a good reason.

As for USDA: the new administration at the agency shows many signs of wanting to do the right thing about food safety but they have to deal with entrenched staff and inspectors who have been cozy with industry far too long.  USDA: deal with it!

Coming soon: updates on FDA and FTC.

Alas, Congress did not pass food safety legislation by Thanksgiving, and I’m getting lots of requests to comment on it.  For example, Johannes G writes: “Marion, I’m usually spot on with you about a lot of things you talk about, but your final comment truly irritates me. We don’t need more regulatory policy, we need a food policy that makes sense.”

Actually, I think we need both.  No question, a better food safety regulatory policy is high on my priority list.  Why?  Because the food industry will never produce safe food voluntarily.  It’s time to give regulation a try, and now is the time.  While the window of opportunity is open, we need to convince Congress to act.

Current legislative proposals

To recap where we are on this: the House passed H.R. 2749, the Food Safety Enhancement Act last July. The Senate is currently considering S. 510, the FDA Food Safety Act.  Some version of these bills seems likely to pass, although it is not at all clear by when.

Although food safety advocates generally agree that we need a single food safety agency that integrates the activities of USDA and FDA, these bills are designed to fix the FDA alone, not the overall food safety system. For a quick take on the provisions of some of the bills under consideration, see the summary chart produced by the Center for Science in the Public Interest.

The bills require science-based (HACCP-type) processes for producing food, starting on the farm. And at long last they authorize the FDA to order recalls or detain foods deemed unsafe. No, the FDA does not already have these basic tools.  It needs them.

One more time on HACCP: It means Hazard Analysis Critical Control Point with Pathogen Reduction.  Translation: identify where in the production process contamination might occur, take steps to prevent contamination from occurring at those points, document that the steps were taken, monitor and inspect periodically to make sure the documentation is accurate, and test to make sure no contamination has occurred.

Without much chance of getting a single food safety agency, fixing the FDA is a good thing to do.  We can hope that once the FDA bill is passed, Congress will work on legislation to reconcile the inconsistencies in FDA’s and USDA’s food safety rules.  But that cannot happen unless the FDA first has the ability to require science-based food production and can authorize recalls and detentions.

The “scale” problem

This brings us to the problem of small farmers, or what regulatory agencies refer to as the “scale” (translation: size) problem. Steve Gilman, the policy coordinator for the Interstate Council of the Northeast Organic Farming Association (NOFA) sent me a copy of a letter to Senators signed by 70 or so members of the National Sustainable Agriculture Coalition.

This group is deeply worried about the bill’s “unintended negative impact on family farms, value-added agricultural development, conservation and the environment, organic farming, and emerging local and regional food systems.”

The Coalition wants the Senate to consider, among other things:

• A two-track regulatory system based on the size, type, and diversity of a farm’s production.
• Rules based on level of risk (“fresh cut, ready-to-eat packaged fruits and vegetables pose a far greater risk than whole produce”).
• Exemptions for traceability requirements.
• Scale-appropriate food safety training as outlined in additional legislation (introduced as S. 2758, The Growing Safe Food Act).

I greatly favor support of small farmers.  But I think all farmers – no exceptions – should be producing safe food. Thinking through a food safety plan is not that hard to do and farmers of any size operations should be carefully designing and diligently following HACCP-type plans appropriate to their specific situations.

Farmers who produce foods unlikely to be cooked before eating — raw vegetables, raw milk, raw oysters, for example – should be testing for contaminants on some kind of regular basis at time intervals that depend on the level of risk.

I think testing is so badly needed that I would add support of testing facilities to the Coalition’s legislative wish list.

The scale issues are important and I hope the Senate will consider them seriously, incorporate them into the final legislation, and look for ways to support the food values outlined by the Coalition.   But the fix-the-FDA legislation should not be held hostage to the scale problem.  The FDA needs better methods for protecting the public from the hazards of industrial production methods.  While making sure the FDA gets food safety authority, we need to work hard to get scale-appropriate rules or enforcement for smaller farmers who want to opt out of industrial food production, grow diverse crops, and produce them sustainably.

On November 13, the FDA announced indefinite postponement of rules requiring raw oysters from the Gulf of Mexico to undergo postharvest processing to destroy their content of Vibrio vulnificus, a particularly nasty “flesh-eating” bacterium.  According to accounts in the New York Times and in industry newsletters,  the FDA caved under pressure from the oyster industry and members of Congress representing oyster-harvesting regions in the Gulf.

The FDA has been trying for years to get the oyster industry to clean up its act and use post-harvest technologies to sterilize oysters in order to prevent the 15 or so deaths they cause every year.  The technologies include quick freezing, frozen storage, high hydrostatic pressure, mild heat, and low dose gamma irradiation.  When used, the methods reduce bacteria to undectable levels and deaths from Vibrio vulnificus infections to zero.  As the FDA puts it, “seldom is the evidence on a food safety problem and solution so unambiguous.”

The FDA took action on October 16.  It wrote a letter to the industry announcing the new rules.  It would expect oyster producers to use the techniques, especially on oysters harvested in summer months when bacteria levels are higher.  It also issued a background paper on why the techniques are needed, a fact sheet on oyster hazards, and a Q and A on the new policy.

On October 17, FDA official Michael Taylor gave a speech to the oyster industry outlining the policy.

Oops.  The oyster industry did not take well to the idea and went into organized action.

Now, the proposed rules are history.  As the FDA explains:

Since making its initial announcement, the FDA has heard from Gulf Coast oyster harvesters, state officials, and elected representatives from across the region about the feasibility of implementing post-harvest processing or other equivalent controls by the summer of 2011.  These are legitimate concerns.

It is clear to the FDA from our discussions to date that there is a need to further examine both the process and timing for large and small oyster harvesters to gain access to processing facilities or equivalent controls in order to address this important public health goal.  Therefore, before proceeding, we will conduct an independent study to assess how post-harvest processing or other equivalent controls can be feasibly implemented in the Gulf Coast in the fastest, safest and most economical way.

My interpretation: 15 or more preventable deaths a year, every year, from oyster Vibrio must not be enough to elicit industry responsibility or FDA action.  That the FDA was forced to back down so quickly is not reassuring about this administration’s commitment to food safety.  Make no mistake.  This is a major setback to developing a strong food safety system.

One of the ironies here is that the FDA’s approach to oyster safety mirrored the approach taken by the very same Michael Taylor when he worked for the USDA in the mid-1990s.  Then, the administration backed him up on requiring science-based food safety procedures for meat and poulty producers.  This time, it looks like the administration pulled the rug out from under him and forced the FDA to back down.

Note: Thanks to Mike Taylor, safety rules are in place for meat and poultry.  Unfortunately, the current USDA isn’t enforcing them.  I will have more to say on that point in tomorrow’s post.

Another note: Center for Science in the Public Interest, which has been pushing for oyster safety for years, has organized a protest campaign.  Sign up here.

I can think of many reasons why school food is such a hot topic these days: kids eat a significant portion of their daily calories in schools, schools set an example for what is appropriate for kids to eat, and schools are a learning environment.  Here’s the latest on what’s happening on the school food scene:

1.  The New York City Education Department announces new rules for school vending machines, as part of its new school wellness policies.  According to the account in the New York Times, the vending machines have been empty since the Snapple contract ended in August (Really?  That’s not what I observed a couple of weeks ago).  The new standards will exclude the worst of the products but the lesser evils will still be competing for students’ food dollars, thereby continuing to undermine the solvency and integrity of the school meal programs.

2. The CDC reports (MMWR, October 5)  that junk food is rampant in schools, but the percentage of schools in which children are not permitted to buy junk food or sodas is increasing in at least 37 states.

3.  The Government Accountability Office (GAO) takes the USDA to task for not alerting schools when foods in the school meals programs – meat or peanut butter, for example – have been recalled because they are contaminated with dangerous bacteria.  Usually, the GAO talks straight to government.  I don’t know what happened in this case but here is its first, rather incoherent, recommendation to USDA regarding the USDA’s Food and Nutrition Service (FNS):

To better ensure the safety of foods provided to children through the school meal programs, and to make improvements in three areas related to recalls affecting schools: interagency coordination; notification and instructions to states and schools; and monitoring effectiveness, the Secretary of Agriculture should direct FNS and that the Secretary of HHS should direct FDA to jointly establish a time frame for completing a memorandum of understanding on how FNS and FDA will communicate during FDA investigations and recalls that may involve USDA commodities for the school meal programs, which should specifically address how FDA will include FNS in its prerecall deliberations.

The other recommendations make somewhat more sense.  They begin by repeating the first part up through “the Secretary of USDA should direct FNS to”:

• develop guidelines, in consultations with the Agricultural Marketing Service (AMS) and the Farm Service Agency (FSA), to be used for determining whether or not to institute an administrative hold on suspect commodities for school meal programs.
• work with states to explore ways for states to speed notification to schools.
• improve the timeliness and completeness of direct communication between FNS and schools about holds and recalls, such as through the commodity alert system.
• take the lead among USDA agencies to establish a time frame in which it will improve the USDA commodity hold and recall procedures to address the role of processors and determine distributors’ involvement with processed products, which may contain recalled ingredients, to facilitate providing more timely and complete information to schools.

This needs an editor, but you get the idea.

4.  The GAO has produced yet another report, this one devoted to getting states to comply with federal rules about meal counting and claims.  These are measures designed to make sure that ineligible kids don’t get fed.  I wish I knew how much money such measures cost.  They are a tragic waste.  We need universal school meals.  Period.

5.  And then there is Jamie Oliver, who has transformed the British school meals system and is now attempting to bring his school food revolution to the United States (see the food issue of the New York Times magazine).  One can only wish him luck.