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Thanks to Politico for alerting us to Monsanto’s sudden discovery:  it has just recognized—can you believe this?—that it has a public image problem.

In recent months the company has shaken up its senior public relations staff, upped its relationship with one of the nation’s largest public relations firms and helped launch a website designed to combat the fallacies surrounding genetically modified organisms.

Monsanto revealed its public image worries in its annual filing to the Securities and Exchange Commission.  The SEC requires companies to list societal factors that create risk to its profitability. Monsanto’s first three:

1.  Threats to patent rights

Efforts to protect our intellectual property rights and to defend claims against us can increase our costs and will not always succeed; any failures could adversely affect sales and profitability or restrict our ability to do business.

Intellectual property rights are crucial to our business, particularly our Seeds and Genomics segment. We endeavor to obtain and protect our intellectual property rights in jurisdictions in which our products are produced or used and in jurisdictions into which our products are imported.

2. Too much regulation

We are subject to extensive regulation affecting our seed biotechnology and agricultural products and our research and manufacturing processes, which affects our sales and profitability.

Regulatory and legislative requirements affect the development, manufacture and distribution of our products, including the testing and planting of seeds containing our biotechnology traits and the import of crops grown from those seeds, and non-compliance can harm our sales and profitability.

3. Bad public relations

The degree of public acceptance or perceived public acceptance of our biotechnology products can affect our sales and results of operations by affecting planting approvals, regulatory requirements and customer purchase decisions.

Some opponents of our technology actively raise public concern about the potential for adverse effects of our products on human or animal health, other plants and the environment. .. Public concern can affect the timing of, and whether we are able to obtain, government approvals.

Even after approvals are granted, public concern may lead to increased regulation or legislation or litigation…which could affect our sales and results of operations by affecting planting approvals, and may adversely affect sales of our products to farmers, due to their concerns about available markets for the sale of crops or other products derived from biotechnology.

Maybe if the company was less aggressive about defending itself against risks #1 and #2, public relations would be less of an issue.

Do the close calls on labeling initiatives in California and  Washington worry Monsanto?  Of course they do.  They should.

I was on the FDA food advisory committee in 1994 and witnessed Monsanto’s aggressive opposition to labeling.

If public image is a problem for the company, it has nobody to blame but itself. 

The only surprise:  Why did public demands for labeling take so long?

I’m in Washington, DC this week on a bit of book tour for Eat, Drink, Vote (see Appearances for schedule).

At my Politics & Prose bookstore event last night, I got asked why I think the food environment matters so much in dietary choice.  Isn’t food choice a matter of personal responsibility?

It is, of course, but the food environment greatly influences personal choice.

Two examples:

Large portions: just about anyone presented with a large portion of food with eat more from it, take in more calories (larger portions have more calories!), and underestimate the calories consumed by a much greater proportion than from a smaller amount.

Salt intake: Because 80% or so of salt in the American diet comes from processed and restaurant foods, people eating in restaurants have no control over the amount of salt they take in.

To make it easier for people to take in fewer calories and less salt requires changes in the food environment: serve smaller portions and reduce the salt in restaurant foods.

FDA: Get to work!

As I am endlessly complaining, the farm bill is so detailed, complicated, and opaque that no rational person can possibly understand it, let alone a member of Congress.

To wit: catfish inspection.

As Gail Collins noted in her New York Times column a week or so ago, some members of the House want the USDA to inspect catfish, not the FDA (which ordinarily is responsible for fish inspection).  The current FDA inspection office costs $700,000 per year.  The USDA office, established by the 2008 farm bill, costs about $14 million a year, even though the USDA has not gotten around to issuing rules or actually inspecting catfish.

What is this about?  Not fish safety, really.  It’s about protecting catfish farmers in the South and setting up “more rigorous” safety criteria that will exclude competitive foreign catfish imports, especially from Vietnam.

The House version of the farm bill calls for repeal of USDA catfish inspection as a cost-cutting measure (the Senate farm bill does not mention catfish inspection, which means it leaves the USDA office in place).

Thad Cochran, Republican Senator from Mississippi, wants the House to delete the repeal provision, keep USDA in charge, and, thereby, protect the Mississippi catfish industry from foreign catfish imports.

Politico Pro quotes a member of Cochran’s staff:

Sen. Cochran has made it clear that his priority is to complete the new farm bill and get it signed into law. It sounds like there are some who have a deep under-appreciation of the diversity of Mississippi’s agriculture industry and the importance of this bill to the state’s farmers, foresters, hunters, and those in need of nutrition assistance.

The New York Times also points out that although some watchdog consumer groups support tougher safety standards for catfish (because of lower foreign standards for antibiotics and other chemicals), a Government Accountability Office report in May 2012 called imported catfish a low-risk food and said an inspection program at the Agriculture Department would “not enhance the safety of catfish.”

Now, says the Times in another article, a coalition of budget watchdog groups and a seafood trade group are lobbying to repeal the USDA’s inspection program.

All of this is in the House version of the farm bill, but unless you are a lobbyist for the catfish industry, you would never know it from the bill itself.  Here’s the relevant section from the  House bill.

As Gail Collins puts it,

See, this is what I like about the farm bill. The agriculture parts harken back to the golden era when Republicans and Democrats could work together to promote stupid ideas that benefited the special interests in their districts. And then go out and get inebriated in bipartisan drinking sessions. Now everybody is in the gym and then shutting down the government.

The FDA has just announced a proposal to withdraw GRAS (Generally Recognized As Safe) status for trans-fat.

My first reaction: Isn’t trans-fat already out of the food supply?  Hasn’t this been one of the food industry’s greatest public health achievements?

Once the FDA started to require trans-fat to be listed on food labels, food companies quickly stopped using partially hydrogenated oils (the source of trans-fat) and found healthier substitutes.  That’s why most food labels list zero grams trans-fat.

But the FDA allows food labels to say zero trans-fat if its amount is below 0.5 gram per serving.

Some manufacturers are still using a little.  This new initiative will encourage them to get rid of those last little bits.

Contrary to the New York Times headline, this is not exactly a ban on trans-fat.  If trans-fat is no longer GRAS, manufacturers can still file a food additive petition to continue using partially hydrogenated oils.

The Federal Register notice asks for input for the next 60 days.

I say congratulations to all:

• To food companies who worked hard to find ways to substitute healthier fats for trans-fats.
• To the FDA for finally taking care of the trans-fat 0.5-gram loophole.
• To Center for Science in the Public Interest for bringing health problems with trans-fat to public attention.
• To all of the researchers who did the science linking trans-fat to higher LDL-cholesterol levels and to heart disease risk.
• To the New York City health department for banning trans-fats from use in city restaurants.

Americans will be healthier as a result of all of your efforts.

Resources

At the moment, the FDA has not yet posted its Federal Register notice on the GRAS status of trans-fat. When it does, the notice should be available here.

CSPI’s home page on trans fat

The FDA trans-fat home page

FDA consumer materials

• Talking About Trans Fat: What You Need to Know
• What are the different types of fat that a food can contain? How are they different?
• Trans Fat Now Listed With Saturated Fat and Cholesterol (Including Examples of Nutrition Labels)

FDA guidance for industry

• Guidance for Industry: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, Health Claims; Small Entity Compliance Guide
• Federal Register – 2003 Food Labeling rule on trans-fat (68 FR 41434)
• Health Claim Notification for Saturated Fat, Cholesterol, and Trans Fat, and Reduced Risk of Heart Disease

Research

• FDA Health and Diet Survey – 2004 Supplement – Fats and Carbs – A Snapshot of Consumer Knowledge from a Recent FDA Survey
• Trans Fat Basics (CDC)
• Updated Estimate of Trans Fat intake by the U.S. population, 2012

In 2012, ConAgra petitioned the FDA to approve use of a health claim on labels and advertising for its whole grain products.  Here’s what ConAgra asked for:

Scientific evidence suggests, but does not prove, that diets low in saturated fat and cholesterol that include three servings (48 grams) of whole grains per day may reduce the risk of diabetes mellitus type 2.

or

Scientific evidence suggests, but does not prove, that whole grains (three servings or 48 grams per day), as part of a low saturated fat, low cholesterol diet, may reduce the risk of diabetes mellitus type 2.

To say that the FDA was less than impressed with evidence supporting this claim is to understate the matter.  After a comprehensive review of the evidence, here’s what the FDA says ConAgra can use:

Whole grains may reduce the risk of type 2 diabetes, although the FDA has concluded that there is very limited scientific evidence for this claim.

or

Whole grains may reduce the risk of type 2 diabetes. FDA has concluded that there is very limited scientific evidence for this claim.

No, this is not a joke.

Congress insists that the FDA must approve health claims, whether supported by science or not.

According to FoodNavigator, ConAgra is happy about this decision.  The first thing anyone will read is “whole grains may reduce the risk of type 2 diabetes.”

As I keep saying, health claims are about marketing, not health.  And qualified health claims are the worst examples.  A plague on all of them!

I was invited to write the editorial to accompany a study published today in JAMA Internal Medicine looking at the highly conflicted process used to decide whether food additives are Generally Recognized as Safe (GRAS).

Here’s the study.

Here’s my editorial.

I know this sounds completely crazy, but here’s what the study found:

• Manufacturers get to decide whether food additives are safe or not.
• Manufacturers get to decide whether to bother to tell the FDA the additives are in the food supply.

And if they do volunteer to inform the FDA (and many do),

• Manufacturers get to decide who sits on the panels that review the evidence for safety.

In reading the study, it seemed to me that:

• As long as not too many people roll over dead after eating foods with new additives, nobody will ever have a clue whether the additive is safe.
• The regulatory gap has spawned an entire enterprise of GRAS consultants and GRAS consulting firms who are in the business—presumably lucrative—of providing the scientific documentation the FDA needs to determine additive safety.

Some of the consultants need to do a better job.  The FDA raises enough questions that about 15% (my estimate) of the requests would be denied.

The good news: If the FDA sees the safety documentation, it does its job.

But what happens to the rejected additives?  Or the ones that don’t get voluntarily sent to FDA?

Nobody really knows (think: caffeine in alcohol drinks–the FDA had no idea).

We need a better food safety system in this country and conflicts of interests in GRAS additive approvals are a good place to start.

Here’s what USA Today has to say about this (I’m quoted).

In what will surely be good news to people with celiac disease and other problems related to gluten intolerance, the FDA has just issued a final rule for defining foods as “gluten-free.”

This, after nine years of work on this issue (see timeline below).

The rule states that companies can label their products gluten-free if they contain less than 20 ppm (parts per million) gluten.  This, says FDA,

is the lowest level that can be consistently detected in foods using valid scientific analytical tools. Also, most people with celiac disease can tolerate foods with very small amounts of gluten. This level is consistent with those set by other countries and international bodies that set food safety standards.

As for gluten intolerance: Roughly 1% of the U.S. population has diagnosable gluten intolerance.  For those who do, eating grains containing gluten (wheat and some others) triggers an abnormal immune response that damages the intestinal tract.  To prevent symptoms—of which there can be many, none of them pleasant—people with this condition must scrupulously avoid eating gluten-containing foods.

The new rule will help establish some uniformity in labeling.  Note: gluten-free does not mean sugar-free.

In reading through the FDA’s notice in the Federal Register, I am struck by the complexity of the agency’s processes for doing something like this.

Policy wonk that I am, I immediately made a timeline.  This indicates that the FDA spent nine years getting to this point. Impressive, no?

Timeline: FDA’s Gluten-Free Rule

FDA’s documents on the gluten-free rule:

• FDA: Gluten-Free Labeling
• FDA: Gluten-Free Labeling Final Rule Q&A
• Consumer Update

The FDA has finally released safety rules for imported foods, two years after Congress passed the food safety law.  OK.   We now have them.  At last.

Here’s what the FDA is up against:

• 150 different countries ship foods to the U.S.
• These account for about 15% of the food supply, but 50% of fresh fruits and 20% of fresh vegetables.
• The agency has the capacity to inspect about 2% of imported foods.

To deal with this disconnect, the FDA proposes to hold importers accountable for the safety of what they ship to us.

The proposed rules allow two ways to do this: Importers can do their own onsite safety audit, or they can verify that their suppliers did so.

Both methods involve verification by certified verifiers that suppliers used “prevention-oriented food safety practices” (HACCP in other words), and achieved the same level of food safety as domestic growers and processors.

Neither requires inspection by FDA, although importers may use inspection.

The proposed rule and the third-party accreditation proposed rule are available for public comment for the next 120 days.

The previous proposed rules, for produce safety and food production facilities (see below), have been given another 60 days for public comment.  Comments on all proposals will now be due at the same time.  The FDA expect to issue the rules 12 to 18 months after the comments come in and then it will take another 18 months for rules to go into effect.

What does all this mean?

The FDA hardly has the resources to manage U.S. inspections so expecting it to do foreign inspections is unrealistic.  This plan shifts the regulatory burden to producers and shippers (why does this sound like foxes guarding henhouses?).

The FDA also intends to certify third-party auditors.  These invariably involve conflicts of interest, although that system  seems to have worked fairly reasonably well for organic foods.  But we are talking about the safety of imported foods here, and lives are at stake.

This is undoubtedly the best the FDA can do given its limited resources and its problems with Congress.  This Congress is hardly likely to view food safety as a national priority and give the FDA what it needs.

Recall: FDA appropriations go through agricultural appropriations committees, not health appropriations.  And this Congress cannot even pass a decent farm bill.

Congratulations to the FDA for making the best of a bad situation.  And fingers crossed that the proposals survive, get implemented by 2015, and nothing bad happens in the interim.

The document collection:

• FDA Food Safety Modernization Act (FSMA)
• Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
• Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
• Fact Sheet: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
• Fact Sheet: Proposed Rule on Accreditation of Third-Party Auditors 
• Consumer Update

For a detailed discussion of the pros, cons, and questions, see the account in Food Safety News